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Analysis of issued raised in consultation Blood glucose meters and test strips June 2012 Executive Summary
This summary of submissions outlines the key themes from the 2645 submissions received on the consultation document ‘Proposals relating to multiple diabetes products’ dated 23 February 2012. A representative sample of submitters’ responses are summarised under appropriate headings. This summary tries to reflect the content and tone of the submissions accurately. A code (C = clinician P = patients PG = patient groups S = supplier) is used to indicate the type of submitter who made the comments identified in the summary.. A PHARMAC staff response is also provided to detail how the proposal does (or does not) address the issue raised. The consultation document was sent to all suppliers, patient groups, clinicians and other parties that, in the view of PHARMAC, may be affected by the recommendations contained in this paper. This included all parties who have previously expressed an interest in funding decisions relating to Diabetes products, including the New Zealand Society for the Study of Diabetes and Diabetes New Zealand. The consultation letter was also sent to all DHB hospitals and published on PHARMAC’s website. Most of the submissions received came from patients, caregivers and consumer groups, some of which expressed very strong opinions (see Table 1 below for more detail on the submissions and submitters). Capturing and recording all of the differing submitter opinions has made this report long. The views included in submissions are set out in this summary, but these cannot be seen to reflect the views of all people who may be affected by the proposal. Table 1: List of Submissions (includes responses to both consultations for Diabetes Products and Insulin pump proposals) Group Individual consumers Clinicians/DHBs Patient Groups Suppliers/Industry Total Number of Submissions 2418 167 48 12 2,645 submissions
Contents: 1. Technical Issues a) Blood glucose meters b) Blood glucose test strips Software Lancets Clinical Service and support Sole Supply Process Financial/Resource Implementation Supplier/Industry Responses
2. 3. 4. 5. 6. 7. 8. 9. 10.
1. Technical Issues
a. Blood Glucose Meters
Issue Submission From PHARMAC staff response Currently, there are two funded meters which offer backlighting or a port light (Optium and Freestyle Lite). These meters have 21% of the funded market share; therefore 79% of patients currently use a funded meter with no backlight. Other meters with a backlight are available on the private (non-funded) market. Phamaco is currently having CareSens N POP evaluated in accordance with PHARMAC’s Guidelines for Funding Applications, which is a back lit meter. Pharmaco has proposed that CareSens N POP would replace CareSens POP (as is allowed under the provisional agreement between PHARMAC & Pharmaco). CareSens N POP would be available from 1 September, subject to an acceptable evaluation result. The port, or the site where the test strip is inserted into the meter is black on both the CareSens N and the CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP). There is also a groove in the casing at the port therefore we consider that the port could be identified by sight or by touch. Stickers called ‘Skins’ can be personalised and placed on the meter and these can help to clearly differentiate the port site. PHARMAC staff consider that either a backlight or port light would provide adequate illumination for testing in the dark and the Caresens n POP would provide this. Meters store a number of readings in the memory and these can be averaged over a defined period depending on the meter capability. Most funded meters with the exception of the currently funded CareSens meters (POP and II) offer averaging over 7, 14 and 30 days. CareSens N and CareSens II offer averaging over 14 days. CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) has 7, 14, 30 and 90 day averaging for pre and post prandial measures. C,P,P G,S The clinical utility of averaging individual blood glucose measurements is uncertain. We consider that the most clinically meaningful measure is HbA1c. The software that operates along with the CareSens meters provides greater ability to interpret blood glucose control over a week, month or over 90 days, and this would be available free to download, with a cost of $15 for a USB cable.
Backlighting or Port lighting
Back lighting is important for patients who have poor sight or who wish to test in a dark environment (eg to avoid waking up partner or child at night to test). Should meters become available at a later date which do have backlighting, these should be redistributed to patients if they have already received a free meter. The port for inserting strips is difficult to see on the CareSens N meter as it is black. This may be an issue when testing in the dark or for people with poor eye-sight.
CareSens N provides fewer averages. A 14 day average rather than the option of 30 day average - the latter can give health professionals and indeed the patients a more comprehensive picture of control and subsequent change to treatment.
Submission CareSens N allows fewer readings in its memory compared with other meters. Sufficient memory is needed to adequately track patterns in blood glucose control. Memory can be deleted if the batteries fall out. People who test 10 times per day will only have 25 days stored in the memory.
PHARMAC staff response CareSens N and CareSens II have a memory capacity of 250 readings. CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) has 500 – comparable with the currently funded Accuchek Performa. Should the batteries fall out, the memory and settings information will be retained by the CareSens N and CareSens N POP meters. The CareSens II would need to be reset. The accessibility of the software may facilitate patients to download and view their blood glucose readings. PHARMAC considers that the CareSens range of meters offer acceptable functionality. The meters within the proposal offer different levels of functionality, with CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) offering comparable and in some ways, better functionality than existing funded meters. CareSens N meters offer no-coding technology, which reduces the number of steps needed to set the meter up for use, and can reduce the risk of operator error. CareSens II does require coding. CareSens POP only stores 10 readings in its memory and is a simple meter.
Memory - stored readings
We want to receive devices which offer up to date technology. This proposal seems like a step back in diabetes care in NZ. Up to date functions technology CareSens N has much better functionality than CareSens II or POP - if the latter two are discontinued, there will only be one meter listed. C,P,P G,S
Patients and clinicians would need to discuss which meter meets the needs of the patient, however we consider that all meters in the proposal are clinically acceptable. The provisional agreement specifies that withdrawal of CareSens meters and test strips may only occur after 1 July 2015 and provided that at least 12 months written notice is provided. The agreement also allows for meters with improved technology to be supplied, so a listed meter can be replaced with an upgraded version as Pharmaco proposes with the Caresens N POP. Some CareSens meters operate with two batteries whilst others use one battery. Pharmaco is contracted to provide a free replacement battery service and therefore an increased consumption of batteries would not result in increased expenditure for patients who wish to utilise this service.
The battery life is half that of other meters and requires two batteries to operate
PHARMAC staff response The ability for the device to give an error message was noted by the Diabetes Subcommittee to be an essential feature at its 8 December 2011 meeting. It was noted that there were issues with the previously funded Accu-chek Advantage meter, which did not recognise expired strips. Use of expired strips can give inaccurate results and can lead to patients dosing insulin incorrectly. No-coding meters (Optium, Freestyle, CareSens N and N POP) do not require a code to be placed into the meter and therefore information about the strip expiry is not logged into the system. This means that the expiry date of the strip would need to be monitored by the patient. Older batches of CareSens test strips have a 3 month expiry date following the date of opening, which requires patients to write the date of opening on the vial.
Issue with meter reading expired strips
Expired strips don’t receive an error message on the CareSens N. If strips expire after 3 months, there is a high risk of people using expired strips without knowing and there may be wastage.
The manufacturer has completed studies on the stability of the test strips and has recently revised the expiry dates on the products. The expiry date for new CareSens strips is until the date listed on the vial – which is between 18 months and 2 years from manufacture. Incorrect coding of meters has led to significant clinical issues as a result of inaccurate readings. We consider that these two functions (no coding v error messages) are a trade-off. The Diabetes Subcommittee reviewed this data at its 20 April 2012 meeting and was satisfied that the CareSens meters were acceptable with regard to this function. CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) has the ability to recognise expired strips, however the strip expiry must be manually added into the device (as with existing funded meters). The other CareSens meters (II and POP) do not give an error reading when expired strips are used. The meters do give an error reading if the test strips are damaged – due to humidity or inadequate storage. CareSens meters have been designed to use the US date format. It is unlikely that this can be changed for the New Zealand market.
Date and time setting
The date and time on the CareSens meter is US - so month and day reversed, this could be confusing. C, P Lack of date and time in CareSens POP. The meter needs a calibration code to be entered. Manual coding of the proposed meters will be difficult to manage for some, especially with the 3 second time slot. There are up to 5 steps for correct coding of strips. Pharmaco has informed us that the calibration system on the meter, if used incorrectly and in a particular way can result in a 70-80% error in the reading. This is completely unacceptable in terms of patient safety and could result in loss of life.
The CareSens POP is not designed for data storage and therefore does not store date and time. Many blood glucose meters need to be calibrated. Calibration is a necessary step to ensure the meter reads blood glucose levels accurately and must be done with each new box of test strips. Either a code on the box of test strips is entered into the meters, or a key is placed in the side of the meter with each new box of test strip, providing the meter with information about the batch of test strips. For any meter that requires calibration, doing this incorrectly (whether by manual insertion or key insertion) can lead to inaccuracy. The no-coding
PHARMAC staff response technology now used by CareSens N and Optium and Freestyle reduces this risk (however is a trade off as mentioned above of expired strip recognition). CareSens N and CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) do not need to be calibrated – an improvement on many currently funded meters. CareSens II and CareSens POP devices do need to be calibrated using several steps. These steps are detailed in patient support leaflets, which would be available in 13 languages. Part of the implementation strategy would be to ensure that patients receive the information they need, including a YouTube clip to demonstrate clearly the calibration process. However, we estimate that most patients would choose to use either the CareSens N or N POP meters, therefore would not need to calibrate the meter.
With each new box of test strips, the glucose testing solution must be used. This process would be onerous. In the CareSens N, there is nothing to indicate a control solution that measures hypoglycaemia at less than 6.5 mmol/L. A hypoglycaemic episode is less than 4.0 mmol/L can CareSens N reliably measure hypoglycaemic episodes. We have concerns over the control solutions not being in the accurate range.
It is not necessary to ‘check’ meters with every new box of test strips. Control solutions are used, usually by pharmacies as part of a ‘clean and check’ service. Many patients are advised to have their meter checked on an annual basis. The control solutions check that the meter is reading accurately within a range. CareSens has two test solutions which read at medium ranges (6.5– 9.7 mmol/L) and at high ranges (11.2 – 16.8 mmol/L) Pharmaco has sourced a ‘low solution’ that would be available for clean and check services. The construction and robustness of all meters is assessed by the manufacturer and must meet international standards. In addition to analytical performance, physical and electrical tests are also completed to ensure that all devices are robust for home use. All CareSens meters within the proposal have been approved for use in the US and in Europe which require these assessments to have been performed. The meters have also been tested in New Zealand in accordance with PHARMACs Guidelines for Funding Applications. Should any CareSens meter fail to work after 5 years, funding would be provided for a replacement meter and modification to the funding rules would be required to enable patients to receive an additional funded meter. PHARMAC staff consider that suppliers are producing upgraded meters frequently, often more frequently than every 5 years. Most meters do not allow results to be deleted, rather when the memory is full, a new reading will replace the oldest reading. CareSens meters allow full memory deletion (not individual result deletion). This feature of CareSens meters will be clearly communicated in the supporting material to avoid accidental deletion by patients. We consider that HbA1c measures are the most clinically relevant measure and, where patients do not retain meter readings, this would give clinicians the best clinical picture.
Checking accuracy glucose solutions
Quality of meters poor
What is the quality of the Korean technology? Is it better than the German meters? The quality seems poor.
Warranty of meters
Only 5 years compared with Roche meters which have lifetime warranty
C, PG, P
History can be deleted from device
Being able to delete stored results could be problematic. Particularly for patients who want to conceal ‘poor’ results
PHARMAC staff response Each meter has slightly different temperature ranges within which it will operate. A comparison chart of all available meters was produced by PHARMAC in 2009 and is publically available to view on the PHARMAC website. The data provided by the suppliers for this table indicate that for Accu-chek Performa the operating temperature is 8 to 44 degrees, FreeStyle Optium is recorded as 10 to 50 degrees and CareSens is 10 to 40 degrees. Concern has been raised about operating the CareSens meters successfully at low temperatures – for example when skiing or in a very cold environment. Also, the CareSens operator guide stated that the meter could take 30 minutes to warm up. The manufacturer has informed us that this time frame would apply if the meter was -11 degrees. It is likely that meter temperature is similar to its environment’s temperature, therefore the time for it to warm up would be relative to the starting temperature. We do not anticipate that CareSens meters act thermodynamically differently than other meters of a similar size. Anecdotally, we know that meters can be quickly warmed up by placing close to the body or in the palm of the hand. Patients note that meters would usually take a few minutes to warm up using these methods. PHARMAC staff reviewed the usage of blood glucose test strips within DHBs in order to assess whether there was preference for using Accuchek (lower minimum temperature range of operation) compared with Optium in colder parts of the country. The proportion of patients using Optium is highest in Canterbury (33%) followed by Otago (30%), with the lowest use in the Wairarapa (5%). We interpret from this data that a significant number of patients using the Optium meter can operate it successfully in colder parts of the country. Given that the lower temp range of CareSens is also 10 degrees, we anticipate that it can also be successfully operated. Education could be provided to ensure the meter was stored appropriately, particularly in cold environments to ensure that it can be quickly operated.
We have read that in cold conditions, the meter takes 30 minutes to warm up – this would be unacceptable for patients requiring to test urgently. Temperature of operation In high temperatures, the meters can go outside the test range - could be an issue on hot days
C, PG, P, S
Submission The demonstration video on YouTube is confusing, even to a health professional. If performed incorrectly, results will be inaccurate. In addition, the video shows testing from the midpoint in the lower arm as well as the finger which has never been taught, and is incongruous, inconsistent and confusing for the patient. This does not instil confidence in the company which produces CareSens.
PHARMAC staff response Pharmaco would develop video/YouTube demonstrations for CareSens meters available in NZ. This would be developed taking into account advice from NZ clinicians, including whether alternative site testing should be shown in the video.
The YouTube demonstration clip is confusing
C Instructions for alternative site testing are also explained in the written material provided for CareSens, and it is advised that patients who use this form of testing, consult with their doctor to ensure the testing is being done correctly. The buttons for all meters vary however they all have either two or three buttons, with arrows and some with a ‘start’ or ‘select’ button. The CareSens II meter has two buttons with the letters M and C, and the CareSens POP meter has only one button. The functions of the buttons are described in the operation manuals. The instruction manuals provide information on how to use the meters and the function of the buttons. Implementation activities would support patients and health professionals in appropriate training on meter use (online, print materials, face-to-face), which will help to minimise confusion. The CareSens II device uses a static ‘LO’ to indicate a blood glucose level of less than 1.1, and a flashing ‘LO’ to indicate low battery. There are variations on this for the CareSens N and POP N, with flashing battery symbols for low battery and ‘LO C’ for low temperature. The supporting meter instructions provide information on interpreting the messages on the meter and this would be reinforced through patient training. Currently, there are no funded meters which offer this technology. PHARMAC has not, to date, assessed the clinical benefits and cost effectiveness of the ‘smart meters’ and would welcome a funding application.
Labelling of the buttons on the meter
The labelling is unclear which may lead to confusion in operating the meter
The error reading in the event of a hypo for the CareSens is the same as if the battery is low
The same word 'LO' is used for both hypo (blood glucose <1.1 mmol) and for low battery (flashing LO on the screen). This could be confusing and could cause serious harm. Two devices also read LO for low environmental temperature
There is no carbohydrate counting feature in these devices
The ability to input carbohydrate count into a meter to calculate the insulin dose is very useful - calculating insulin doses manually can lead to inaccurate doses and worse control.
Submission In a comparison with other meters at one DHB, CareSens performed the worst when compared with samples on the CI8200 and ABL800 laboratory machines. The DHB found that according to these test results, patients will be treating hypos that don't exist and either gain weight or increase medications to bring down their blood glucose test results. Do the CareSens meters have a standard of accuracy suitable for the hospital environment? One patient noted that he was 'surprised about the emotive and negative reactions surrounding the proposal'. He provided research from an Australian survey which identified CareSens to be the most accurate out of 5 competing products. Too small - These are too small (CareSens II and POP) for patients with large hands/fingers to easily operate.
PHARMAC staff response CareSens meters have obtained CE and FDA market approval and the analytical performance of the meters has been assessed by the Christchurch Diabetes Service according to protocols endorsed by the Diabetes Subcommittee. All manufacturers must evaluate the system accuracy and repeatability test according to protocols published in the ISO standards (ISO 15197) in order to receive a CE mark and FDA approval requires further evidence of precision testing. The current proposal is to fund CareSens meters in the community and the proposal would allow DHB hospitals to use any meter. Blood glucose meters for hospital use are often developed with technologies which enable greater precision and readings are less likely to be affected by interference (with oxygen, haematocrit, chemicals). Many such systems are more expensive and therefore are less viable for portable home testing. There are three different meters offering different features – CareSens N POP and CareSens POP being smaller and more discrete while CareSens II and CareSens N are slightly larger devices. Patients will have the choice to select the most usable funded device for them. Alternative site testing is when a blood sample is taken from a site other than the finger tip. Alternative site testing can be performed and instructions to do this are contained within the CareSens operator’s manual. It is advised that patients who use this form of testing, consult with their usual doctor to ensure the testing is being done correctly.
Size of device Too big - A discrete, portable device is preferred for young patients
Alternative site testing
There is no provision for alternative testing sites with CareSens meters
b. Test Strips
Issue Comments Patients who work outdoors in overalls and need to test regularly need the choice of a foil wrapped strip which can fit into their pockets with the smaller meter, rather than a large vial for their strips. One medical team elects to use Optium Xceed meters which are accompanied by foil wrapped test strips. The decision came after they found children having odd readings while at school using a meter requiring vial strips. Some families were taking the day’s allocated strips out of the vial and sending them to school in an envelope or plastic bag after their child had difficulties opening or contaminating vial containers. Individually wrapped strips are preferred as they don’t degrade when the pot is left open providing better accuracy and less wastage. Unlike those for the currently subsidised meters, the CareSens strips do not allow a top-up of blood if the initial prick does not provide sufficient blood. This results in a wasted strip. There is no fill trigger on the CareSens strip indicating the window has the required amount of blood to provide an accurate result. New meters only require 0.3 ml whereas CareSens requires 0.5 uL. This may seem like a small difference but extracting blood gets difficult as scarring affects fingers over time. Volume of blood required for sample Our clinic was given CareSens meters to try. I was very disappointed with the reliability of the strips - 20 to 25% of strips did not suck up the blood properly and thus gave a sampling error. This was compared with 1 or 2 sampling errors with Accu-chek and Optium meters - not only is this a cost/waste issue, patients may need to prick their fingers again for another test From PHARMAC staff response
Patients need to carry the meter and lancet device in addition to strips, therefore it is necessary for most patients to carry a kit for blood glucose testing. The size of the CareSens vial is small in comparison to other vials. C, P As there are many patients currently using funded test strips that are contained in a vial (approximately 90% of patients) we do not anticipate that this proposal would affect patients removing strips from vials for transporting. However, there is clearly a need to educate patients on appropriate strip storage. Full storage and handling information is provided within each box of strips.
CareSens Strips are contained within a drum
Strip 'top up' capability
C, P, S
CareSens meters do not have a fill trigger, which prevents the glucose test from starting until an adequate sample has been applied to the strip. The CareSens strips do not allow a top-up of blood so a sufficient blood sample would need to be applied to the strip at once or a new strip would be required. However, test strips for all funded meters require very small samples of blood in comparison to older meters. Sample sizes required for currently funded meters range from 0.3 uL (FreeStyle Lite) to 0.8 uL (On-Call Advanced).CareSens strips require 0.5 uL to ‘fill the strip’, a relatively small volume of blood. One currently funded meter, FreeStyle Lite requires a 0.3 uL sample size, compared with 0.5 uL for all CareSens meters and 0.6 uL for Accu-chek Performa strips (used by 78% of patients).
The capillary action of test strips draws blood into the device. The Accuchek sample area and indeed the test strip itself is larger when compared with the CareSens sample area, which may affect the rate which blood is taken up into the test strip. Instructions are provided with the meter to support the correct application of blood to the test strip. Test strip sizes are variable, and the CareSens strips are slightly smaller than other strips, however all test strips are relatively small and handling of these by any patient with arthritis, neuropathy and visual problems would likely be difficult.
The size of the CareSens strip is very small
This would be an issue for elderly, people with arthritis, neuropathy and visual problems and if someone was hypoglycaemic.
C, PG, P
Issue Comments The lack of sophisticated software to accompany the new meters will have a major impact on the provision of specialist diabetes care. The current software available for CareSens has 3 major limitations: the inability to network data downloaded from the meters (so it can be viewed from multiple locations), it is not able to link data with NHI, and analysing data is limited by the lack of a 'modal day' display. We are increasingly working toward integrated care models with shared electronic records accessible to primary and secondary care and to pharmacies. The CareSens proposal would be a step backwards in this respect. Connectivity The software package provided with the Caresens meter is inadequate, it is designed for individual patient use and can only store a single patients data. It is of no use to a healthcare provider managing a group of patients. One patient in support of the proposal noted that 'we need to co-operate with proposals which can lower the cost of helping us to the community as a whole', and requested that consideration be given to working with the vendor to improve access to software to provide a record of the tests. If possible, data storage in the cloud would enable this. Ensure compatibility with MedTech (GP software programme) some practices have had issues with software incompatibility. CareSens meters are not compatible with CareLink the software used to operate the paradigm pumps. Compatibility Diabetes clinics around the country have systems in place to download the Optium meter when used in companion with the IPRO continuous glucose monitor. This feature will be made redundant. Does the software interact with the Diasend software at Starship hospital which enables me to send readings to the site and receive advice from clinicians on treatment? Functionality For patients/providers who have used alternative software to record data, can these be imported into the new software. Historic information from other meters would not be able to be transferred onto the CareSens software. This would mean that there would be a period of time that several software systems would be required to see historic patterns. We consider that this is a short term issue. C C, P From PHARMAC staff response
The PC Care software which supports the CareSens meters has been developed for patient use. However following consultation, we are aware that Pharmaco has made some modifications to the software to enable NHI input, multiple meter downloads and introduced a ‘modal day’ function. The supplier is also developing the software to enable simple practice integration and to allow meter blood glucose data to be saved within the health professional’s patient information file. A ‘cloud’ based system suitable for multi-users has been discussed and is being considered. The use of the software programs which support blood glucose meters varies, with some Diabetes Clinics having a fully integrated system which allows results to be viewed from other parts of the clinic, hospital or from another location. Some practices do not utilise the software at all.
The software, PC Care is being developed to be compatible with Practice Management Systems as discussed above. Information from blood glucose meters is often required when assessing insulin pump data and therefore compatibility with the software which operates with insulin pumps would be preferable. Diasend is a system which operates with Animas insulin pumps and is supported by NZMS, and CareSens meters are compatible with Diasend.
Issue Comments From PHARMAC staff response Lancets would continue to be provided under this proposal, however 50 lancets would be distributed with the meter kit, rather than being supplied with the boxes of test strips. This would provide a one off bulk supply of lancets. Patients change their lancet with different frequencies, therefore 50 lancets may last some patients several years, while for others 50 may last for several months. It is possible that some patients would need to self-fund additional lancets.
The free finger prickers are appreciated
Some patients currently using CareSens and are happy with them, the main reason is that the lancets are free.
‘At a very minimum, PHARMAC should insist that the new meter include a modern finger pricking device that will not create additional barriers to testing'. The lancets don't have half clicks to make finger pricking more precise. The device is flimsy and likely to break easily. It puts people at risk of needle stick injury. Unacceptable lancet device Lancet device has a clear tip which is no good for patients with needle phobias and children. The Roche lancet system hurts less due to its mechanism. Many respondents note that the Roche Multiclix system causes less pain and the lancets retract after use, leaving no needle exposed. The concern has been expressed by patients that Roche, should the proposal go ahead, would not continue to supply its lancets to the private market. The CareSens lancet devices operate with a mechanism which hurts more and can tear the skin. Need to use sharps bin for the lancets. spring C, PG, P, S
Currently the only lancets that are funded are those included with the CareSens and On Call Advanced test strips (receive 5 lancets in combination with each box of test strips). Patients receive a small number of lancets with their Roche or Optium meter kits, and privately purchase replacements. PHARMAC staff note that the current proposal is not specifically for lancets, however 50 lancets would be available free to patients who receive a new meter and that these could be used if desired. However, it is likely that many patients would wish to continue to use their current lancet system. It is possible that PHARMAC could consider funding lancets in the future, particularly if there are changes to the costs of distribution of such items.
Disposal of lancets
Many schools have a sharps policy that does not allow unenclosed lancet devices to be easily accessed by students. For this reason, many patients choose to use the Multiclix device in which the needle retracts post use.
C, P, PG
DHBs are responsible for appropriate disposal of sharps and the systems for disposal vary between DHBs. However, we note that many patients are likely to utilise a sharps container for insulin needles. Patients may continue to use the Multiclix device if they wish to do so however this would be at a cost to the patient.
Issue Comments From PHARMAC staff response For some patient with type 1 diabetes, it is advised to test ketones. Blood ketone testing is considered to be more clinically appropriate than urine ketone testing (although usage for both has been increasing). The Freestyle Optium meter (previously named Optium Xceed) has dual functionality, and therefore tests blood ketones and blood glucose (two different strips are needed). Our analysis indicates that there are currently about 2,000 patients testing blood ketones, 1,500 or whom use the device for its dual functionality. C, P, S, PG We propose to continue funded access for patients who have been using Optium for its dual functionality prior to the decision date. All other patients currently using two meters, or new patients would be required to use two meters to access this technology. The alternative option (dual supply with Medica) would mean foregoing significant savings and would still require a major patient change of meter. PHARMAC staff consider that on balance of risks and benefits, that continued funding for existing patients is an acceptable solution to the issues raised. Blood glucose test strips contain enzymes and other chemicals which react with a blood sample in order to produce a blood glucose reading on the meter. Test strip chemistry and design varies between the brands, however the most common enzymes used are glucose oxidase or glucose dehydrogenase. The enzymes system within the test strip can be affected by a range of exogenous and endogenous factors. For example factors such as temperature, humidity, and altitude can affect the stability and operation of test strips. Endogenous factors which may affect blood glucose results include haematocrit, oxygen saturation and pH level of the blood, and the presence of chemicals such as ascorbic acid, paracetamol, and sugars such as icodextrin, maltose and xylose. CareSens blood glucose test strips (both CareSens and CareSens N) use glucose oxidase technology. Glucose oxidase is not known to interfere with icodextrin (used in dialysis fluids) or maltose, therefore both can be used reliably in patients receiving dialysis. The literature reports that some types of glucose dehydrogenase based systems can be affected by the presence of sugars such as icodextrin and maltose, and by intravenous immunoglobulins such as Intragram P. The information leaflet of CareSens test strips notes that paracetamol, ascorbic acid, uric acid and other reducing substances at normal therapeutic concentrations do not significantly affect results, however if
Patients who need to test blood ketones would need to carry two meters, once for glucose and once for ketones. This is unacceptable. A Special Authority for Optium blood glucose strips would be an option for this group. Pump patients in particular need to test ketones - blood ketones are especially useful for children (urinalysis is not). Will parents need to purchase an Optium meter? I work with a group of youth and Maori patients in Northland the type 1 patients between 16 and 25 years are the highest risk group for DKA. We have enough trouble getting them to carry one meter, if they need to carry two meters it could reduce concordance.
Requirement to carry two meters if ketone testing
CareSens N may not be suitable for patients on Total Parenteral Nutrition (TPN). Patients using oxygen can’t use a meter which uses glucose oxidase enzyme activity. Does the meter detect maltose and therefore would it be suitable for renal dialysis patients? CareSens not clinically suitable for all patient groups CareSens N is suitable for dialysis patients, however CareSens II and CareSens POP are not - will these meters be replaced? Lack of validation for neonatal testing and accuracy to manage haematocrit interference is a concern. Interferences – please confirm that patients receiving intravenous immunoglobulin IVIG treatment (IntragramP) can use CareSens meters. C, P, PG, S
PHARMAC staff response present in abnormally high concentrations, may cause inaccurate high results. Blood samples that contain a high concentration of dissolved oxygen (on oxygen therapy) may lower the test results. We are not aware of any interference of TPN with CareSens test strips. The validated haematocrit range for CareSens meters is between 20 and 60% and that for Accu-chek Performa is 10 to 65%. The normal range for most patients is between 30 and 50%, however lower levels are common in pregnancy (especially during the last trimester) as plasma volume increases. We note that a haematocrit of less than 15% is can result in cardiac failure, and over 60% may result in spontaneous blood clotting. Neonates and newborns may have high haematocrit levels up to 60%. Some of the original CareSens patient material stated that the meters can’t be used during pregnancy. However, this is not correct and has subsequently been amended. The Diabetes Subcommittee considered at its 20 April 2012 meeting that the haematocrit range for the CareSens meters is acceptable.
Available of CareSens suppliers internationally
CareSens does not enjoy a strong market share in any major developed country. So health is at greater risk if these people can't replace a stolen or damaged meter or trips when away from home.
C, P, PG
CareSens has a presence in approximately 30 countries. Patients should travel with sufficient supplies, as do patients who routinely use medicines for various conditions.
Meter funding (replacements) focuses on what medication the patient is on rather than the patient’s level of control. Patients whose good control to date rely’s on multiple testing and in the future will not be able to access enough strips to maintain good control. No funding of meters for patients on diet and metformin alone; Whilst the evidence for benefit is less clear, there is no doubt that on an individual basis many patients benefit from brief episodes of testing to aid education about diabetes to inform clinicians about patterns and aiding therapeutic decisions. Current funding criteria HbA1c does not show peaks and troughs. Periodic measurements of blood glucose is an important education tool for patients. One meter per patient per lifetime is unreasonable - people can lose their meters for a number of reasons. Differentiate type 1 patients and type 2 patients. People with type 1 diabetes have different needs than most people with type 2 diabetes. People with type 2 diabetes have less intense needs as hypoglycaemia is less common, blood glucose levels fluctuate less and treatment is less variable. Patients with type 1 diabetes use their meter in a different way - lifesaving device C, P, PG
PHARMAC staff response A number of responses oppose the current funding criteria. These criteria were put in place in 2005 and are in line with clinical advice on blood glucose testing. There was some confusion that the proposal was to withdraw or reduce funding for meters and test strips. Funding has never been provided for meters for patients who do not use insulin or sulphonylureas. There are no restrictions on the number of test strips funded for patients using insulin or sulphonylureas, however a restriction on the number of test strips funded for patients not using these treatments applies. Respondents to the consultation were supportive of amending the criteria to allow patients on metformin and diet alone to receive a funded meter. Current practice is that there is sufficient competition in the market so that suppliers offer meters free to these patients. Should the proposal be approved, there may be fewer free meters available to these patients and increased out of pocket expenses to self-fund a meter. At its March 2011 meeting, the Diabetes Subcommittee noted that ‘clinicians often initiated newly diagnosed type II diabetics on test strips to allow them to see what effect diet and exercise have on their blood glucose. Members considered that long term testing may be more damaging as increased testing may lead to increased anxiety and worry. Members considered that patients should only be testing if they are likely to change something, for example the insulin dose they are about to use.’ We consider that the CareSens meters are suitable and acceptable for general use in all patients – type 1 or type 2. The funding criteria for blood glucose meters and test strips are reviewed regularly by the Diabetes Subcommittee to ensure that they are clinically appropriate, and were most recently reviewed at its 20 April 2012 meeting and the Subcommittee did not recommend the funding criteria be amended.
Proposed amendments funding criteria
‘We agree and support the widening of access to patients using Total Parenteral Nutrition and patients with a genetic or acquired disorder of glucose homeostasis’. Mismanagement, including self monitoring leads to premature secondary complications and untimely death. Self-monitoring is an important component of management which demands time, effective education and competent literacy. The short term savings in test strips will be far out-weighed by long term secondary service costs. Given the type 2 diabetes epidemic facing this country, the greatest potential cost results from undiagnosed or poorly managed diabetes which results in secondary complications. From a physician and parent of a child with type 1 diabetes: 'Diabetes patients - particularly those who are insulin
PHARMAC staff note that no issues were raised with widening of access to the two patient groups. The proposal would require most patients to learn to operate a new meter. Should a decision to change the funded brand of meter be made, PHARMAC staff propose to support the change with a comprehensive implementation programme including training for health professionals and patients. The aim of implementation would be to ensure that those patients with a clinical requirement to use a blood glucose meter are adequately trained to operate a new meter. In addition to appropriate advice from healthcare professionals, training and use of mixed media (i.e. YouTube) and consumer networks would support any implementation providing consistent messages on how to use the meter/s.
Long term effects of losing-buy in to testing/lack of testing
C, P, PG, S
Comments dependent live with a condition that encompasses vigilance, mindfulness and monitoring on a 24 hour basis. It becomes an integral part of the 'person' whereby safety and survival is dependent on the use, readings and interpretations of a diabetic meter. As such, it is not surprising that this population group is emotionally responsive to change. Whilst I am open to using another brand of meter for my daughter and my patients, it is imperative that the meter is suitable for individual needs. Consideration is not just given to accuracy and ease of use, but also factors that ensure compliance and buy in'. Maintaining consumer confidence and the ability to manage diabetes is critical to reducing demand for more complex care The elderly, children, non-English speakers, patients with disabilities, dexterity issues or learning difficulties will struggle with this change. New procedures introduce the potential for error in interpretation when patient has been familiar with a particular system for some time. In Northland, many Maori patients with type 2 diabetes use Accu-chek due to it being very user friendly and the support is excellent. Generations of whanau members have used Accuchek. Evidence supports the observations that changes to everyday tools used to manage diabetes are destabilising, reduce monitoring of blood glucose levels and consequently have a negative impact on health (Lunt et al. 2010). Depression is now acknowledged as a significant problem in patients with type 2 diabetes. For these people forcing a change of meter impacts on their comfort zone and established sense of routine in life'.
PHARMAC staff response
We consider that appropriate advice and encouragement from healthcare professionals, training and use of mixed media (i.e. YouTube videos) and consumer networks will support any implementation. C, P, PG PHARMAC note that any proposed implementation plan would have to be modified and adapted to particular stakeholder groups and this is planned as part of implementation. Implementation would be focused on providing patients and caregivers with appropriate training in how to use a new meter in an environment and a way that suits their needs. We note that any change can require the repetition of messages over time in order to support change.
Issues for patients learning to use a new device
Lack of confidence CareSens meters
We have a history of using Accu-chek and Optium products we have not used CareSens products and therefore have no confidence in them'.
Confidence needs to be established, but we do not consider this to be insurmountable. Pharmaco is a smaller supplier in the diabetes market, however we are confident in its capability and commitment to supporting healthcare professionals and patients/patient groups. Pharmaco has supplied pharmaceuticals in New Zealand for many years and has a good supply record. Proposed implementation plan activities intend to support health professionals and patients in providing the information they need and also aim to reduce the administrative burden on sectors of the health-care community. We acknowledge the work that health professionals have done in order to provide patients with skills and knowledge in blood glucose testing. Should a funding decision be made, PHARMAC and the supplier intend to provide support activities, such as a national road-show, in order to reduce demand for health professionals to provide training.
Staff morale would be reduced by this proposal
One DHB noted that 'Blood glucose testing is a basic but very important skill that health professionals have already set their patients up to do and have spent considerable time and energy in doing so. For health professionals, to have to repeat this task would have a direct and negative impact on staff morale'.
Issue CareSens II are easy and useful to use
Comments One Primary Healthcare group involved in educating patients in South Auckland has been using CareSens - patients have been positive in their feedback to the clinical support team and particularly enjoy the free lancets with the current devices
PHARMAC staff response Comments noted. We propose to provide continued funding for patients who were using the Accu-Chek Combo Pump at the date of the decision, so they can access the Accu-Chek strips.
Delisting Accu-chek test strips would affect the usability of Combo pump
C, P, PG, S
We estimate that there are 100 patients who are using either a self-funded or DHB funded Combo pump. Whilst the pump would operate without the test strips, the Bluetooth remote device (usually the reason this pump was selected) would lose functionality.
5. Service and Support
Issue Comments From PHARMAC staff response Should a decision be made, the implementation activities would include: Roche receive 700 calls per week – could Pharmaco offer the same level of service/staffing and technical expertise. Technical support to clinicians and patients Technical backup is necessary for all clinically essential tools, the level of backup for CareSens is currently unknown because the products are not in use in NZ. C, S, PG, P 24 hour 0800 technical support (Pharmaco will outsource its call centre through – a NZ based operation - up scaled to expect 10,000 calls per month in first months; staff all trained in CareSens). Pharmaco to visit all healthcare providers to ensure software implemented successfully, and distribute free meters to GP practices/pharmacy/schools etc. Website, YouTube demo support, yearly clean and check services.
PHARMAC staff response Log books and free battery replacement service would be provided by Pharmaco. Children packs, resources are being considered. Pharmaco has advised PHARMAC that it is committed to attending and sponsoring key medical and consumer conferences. PHARMAC’s role is to make sure patients who require a blood glucose meter and test strips to manage their diabetes have access to these and know how to use them. PHARMAC will work with health professionals and consumers in the development of materials to help support any transition to different meters should this be required, This would include the provision of patient and health professional support material as appropriate in hardcopy and online format, as well as through consistent promotion and communication of key messages through many channels. It is clear from consultation responses that the incumbent suppliers of diabetes management products have provided considerable sponsorship of events for people with diabetes and there is concern that this sponsorship might stop with the current proposal. PHARMAC is not in a position to be able to say whether sponsorship will still be provided by non-funded suppliers. Training of health professionals and consumers in the use of the new meters would be delivered as part of implementation activities, should a decision be made.
Sponsorship of events, education, patient activities
One response notes 'Whilst PHARMAC may not acknowledge this and the ethics may be debated, the reality is that the Pharmaceutical companies producing the currently available meters and strips provide a great deal of support and added value in the diabetes sector. This is particularly important to patient education and direct support. This will be completely lost if the current proposal goes ahead. This gap is unlikely to be able to be filled by existing services which are already at capacity' Currently, Roche and Medica provide a lifetime of free batteries and replacement meters, no questions asked. They supply starter packs tor type 1 children including flip charts and parent manual. The log books and direct to patient email newsletters are supplied by Roche. Roche provide co-sponsorship for the annual diabetes nurse symposium and paediatric study day and would be a huge loss for our national support group of diabetes nurses.
C, S, PG, P
Roche have a proven track record and we trust them. Roche and Medica have, over time developed strong relationships with Roche and Medica which they would be reluctant to lose. Though the CareSens meters have been on the market for some time, it is indicative of the lack of support by both consumers and health practitioners that they have not gained significant market share. Trust in a new supplier We feel that this proposal ignores the good will and professional relationships that existing suppliers have worked hard to establish and maintain over many years' Almost all patients expressed their concern about switching from their current supplier as they were extremely happy with the service and support they have received, e.g. : I have come to depend on my Accu-chek meter and know that I can trust this system. My meter is my best friend .. It tells me if I'm safe to drive, safe to play sport, safe to go surfing ..' C, P, PG, S Existing suppliers were given an equal opportunity to submit bids for the on-going supply of funded meters. Careful consideration has been given to all proposals submitted to the RFP and the estimated effects of each one were evaluated. We are confident that Pharmaco would be a capable supplier and would build trust over time. Further details of Pharmaco’s obligations to the market have been discussed in other sections of this document.
Issue Instructions for CareSens are available in multiple languages
Comments One thing in favour of the CareSens products is that the user guides are available in many different languages (including Pacific languages) which is a distinct plus.
PHARMAC staff response User guides are available in 13 languages relevant to NZ population – these have been well received to date. This may help to overcome some of the issues raised above with training different populations.
6. Sole Supply
Comments One funded brand is sufficient, unfunded meters are cheap anyway and there is no case to argue for carte blanche funding of all brands. One clinician responded 'I wish to express that it is appropriate for PHARMAC to fund only one meter ... I have seen meters being used inappropriately and meter being uncared for. Many patients keep asking for new meters despite having received one which they have either wrecked or passed on to someone else. The tax payer cannot and should not keep supplying meters for free to patients who cannot look after them'.
PHARMAC staff response
In support of sole supply
One meter doesn't everyone, patient choice
Lack of patient choice - this doesn't take account of the principles of managing a long term condition (e.g. self management, risk reduction, partnership), feasibility of such a changeover, best practice recommendations, the principles of the Treaty of Waitangi and their application to health provision. The lack of choice takes away peoples independence. We want individuals to take ownership. Each meter has different features – the ability to select which meter fits best with patient is important Risk of mass failure (batch/logistics/force majeure) either with the test strips or meters– dangerous to patients. The sole supply arrangement for flu vaccines a few years back. 'There is a significant risk associated with having a sole supply arrangement for such a serious condition'. 'The Christchurch earthquake example was given by a respondent from Christchurch - many supplier of diabetes products pooled resources and ensured that Cantabrians with diabetes had access to replacement suppliers. This would not be easy in the case of sole supply. Any emergency that required the borders to be closed for any length of time (i.e. a pandemic) or in the event of an incident at the factory (not unlikely given the volatility of that region).
Three different meters will be offered under the proposal. CareSens N POP (which Pharmaco has proposed for replacement of CareSens POP) provides additional technology. Patients would be able to choose from one of these meters with their different functionality to ensure it fits their requirements
Risk of mass management
C, P, PG, S
PHARMAC considers that the proposal offers greater surety of supply than the current situation. Pharmaco is contractually bound to hold a minimum of four months stock of meters and test strips in New Zealand, This would be made up of several different batches of test strips (Maximum batch supply is only 5,000 boxes) ensuring that if one batch failed testing there would be alternatives batches. There are 3 production plants in Korea with sufficient capacity to upscale supply. The strips are manufactured daily. Urgent air shipment of stock could be sourced as required It is proposed that two strip types – CareSens II and CareSens N be funded. This provides additional security should a meter fail and is
Comments Individual patients with type 1 diabetes prefer to manage their own risk – i.e. patients will keep different meters and strips in case of an emergency. Sole supply poses untenable risks to PWD due to: Potential supply chain disruption.. NZ's isolation from the rest of the world .. The smallness of our market rendering us of lower priority in a global supply network (should scant resource ever have to be allocated). There have been many occasions involving recall of strips or meters, for example the NZ Roche Performa recall in 2007 and most recently in the US with LifeScan meters. If the CareSens strip or meter was recalled for any reason during the period of sole supply, there is no Plan B. The proposed 4 month stock pile strategy is not a valid defence as a recall from some identified production fault could eradicate the entire stock in an instant. Multiple suppliers with distribution/manufacturing sites in different countries provides options in the event of an adverse event. Can Pharmaco upscale supply sufficiently over 6 months? How will a short fall be addressed should it occur?
PHARMAC staff response consistent with the current funding situation. – Emergency stock can be obtained from a facility in which would take 2 to 3 weeks. Urgent stock could also be procured from In out of stock situations PHARMAC could close control test strips if needed, or restrict supply to insulin users if there was an emergency. This is consistent with the actions PHARMAC would take should the major incumbent supplier fail to supply. In the current situation should the major supplier to the market have a systemic supply failure the other suppliers to the market would be unlikely to be able to supply sufficient stock to provide cover. PHARMAC would then be required to source a solution at PHARMAC’s cost. Under the terms of the agreement Pharmaco would be responsible for the cost of any alternative supply sourced. In other situations where there have been potential out of stock situations PHARMAC has contracted with alternative suppliers to source stock. It is possible to contract with Roche and Medica to supply in the event of failure. If willing, this would provide greater certainty that other suppliers could supply if something happened to i-Sens or Pharmaco.
Supply from Korea
One respondent has attached an Associated press article relating to the history of political tensions between North and South Korea.
C, P, PG
We do not consider this to be a risk relevant to on-going supply. There is a perception that the funding multiple meters from different suppliers allows sufficient risk management to ensure that if one supplier goes out of stock, that another supplier would upscale to meet demand. PHARMAC considers this to be a false perception as there currently a 'pseudo' sole supply market, as should Roche, which has a 78% market share, have any major failure then the other suppliers could not upscale quickly enough. In current circumstances finding alternative supply could be at significant a cost to the pharmaceutical budget, whereas a sole supply arrangement allows PHARMAC to have stricter requirements on that supplier with respect to addressing any failure. This has not been our experience. The agreement allows for the supplier to upgrades within current proposal as Pharmaco is proposing to do. PHARMAC must weigh the costs of new technology with the health benefits. Given our budgetary constraints we must consider the health benefits from any investment.
Multiple suppliers provides risk mitigation for supply failure
‘If one supplier failed today, the other suppliers would step in’
Sole supply would prevent new technology being available in NZ
Having multiple suppliers, it is in the company’s best interests to provide the latest research and technology as well as evaluate current practice. This subsequently gets shared with clinical teams to keep us up to date
C, P, PG, S
What will happen beyond 2015 should suppliers leave NZ? Will there be less market choice? Loss of competition in market If suppliers leave NZ, there may be risk of them not coming back or supporting patients who wish to privately purchase its products. Sole supply is anti-competitive C, P, PG, S
PHARMAC staff response PHARMAC carried out a competitive process for the Sole Supply of Blood Glucose Meters and test strips and all suppliers were invited to bid. The terms of the request for proposals were sent to all providers and published on the PHARMAC website. We consider that a 3 year term is relatively short. It likely that we would seek agreements to supply to niche groups therefore would still be in market. We are aware of several DHB contracts to supply Accu-chek products which would indicate that Roche Diagnostics would remain in the market due to its supply obligations. It is possible that Roche would reduce its presence in New Zealand with respect to diabetes.
A multiple supply model is more likely to meet the needs of patients (children with type 1 diabetes) and reduces adherence issues The current funding structure improves the viability of all companies through shared knowledge, staff migration, competitive innovation and the distribution of risk over multiple companies and multiple underwriters. A single company with a single underwriter, providing the same supply requirements carries a significant increased risk and therefore significant additional costs to manage that risk; One response noted that sole supply of meters and test strips was setting a 'dangerous precedent and goes against the assurances from Pharmac staff at the Forums in 2011 that Pharmac would not be contemplating sole supply situations'. ‘I suspect that the second level of proposals with other companies will still save you many and especially combined with an education package once again for GP's on appropriate testing for type 2s. Then almost everyone wins.' One organisation responded '.. A minimum of three separate suppliers of glucose meters and strips should be contracted for New Zealand. This could be in the form of an 80/20 market split (or even a 60/40 split). This model would also ensure a long-term competitive market for supply in New Zealand and address safety issues'. The current proposal is to list three different meters with different shapes and functionality which would allow a patient choice of their meter to meet their needs. Sole Supply has been used by PHARMAC consistently as a means of ensuring competitive pricing for pharmaceuticals which has allowed us to release significant amounts of funding to invest in new products. Hundreds of products have been awarded sole supply over many years, and if anything we have seen an increase in the number of competitors rather than a decrease. C, P, PG, S PHARMAC modelled the proposal as a result of the competitive process, the request for proposals, and considered that the savings offered by the proposed Sole Supply arrangement provided the greatest savings with a clinically acceptable range of meters. PHARMAC considers this to be a false perception of safety with having multiple suppliers with an 80/20 split. Should the 80% market share supplier have any major failure then the other suppliers could not upscale quickly enough to provide adequate supply.
Support multiple supply model
Issue Comments One group of respondents noted that it would expect that thorough testing and evaluation to be completed before CareSens N meter is introduced, and had not seen any other information other than the Christchurch Diabetes Service evaluation. Another responding group noted that a pilot study should be conducted on the new meters, before the meters are rolled out nationally. The CareSens N meters should be field tested or given to a consumer panel to provide further confidence in the device. Another tertiary centre noted that a long period of trialling the proposed meters (3 months) with feedback from patients and nurses would be prudent before contemplating any change. The evaluation relates only to accuracy and precision as assessed in a research environment. Testing of 50 patients is a minimum sample for detecting systematic bias. The evaluation process for any meter/strip family intended for sole supply should carry a higher burden of rigour than the evaluation of a meter/strip system which might be one of several subsidised choices. When consumers have a choice of meters from different manufacturers, if they are unhappy with their current meter's performance 'in the field', they can move to a meter they consider to have better performance characteristics for their particular clinical situation. This study is designed to ensure that meters meet the minimum standards in terms of accuracy and precision in a lab environment, not a field environment. Proposals to modify the international standards (ISO and American Diabetes Association) to meet tighter performance standards are underway. The test did not assess performance at low temperatures, assess ergonomic features, ease of operation and maintenance, readability of measured results, unambiguous messages to the user. These have not been adequately considered. One clinician suggested that a fault reporting system should CareSens be sole supply – this would ensure early detection of faults or issue with the devices. FDA have one of these From PHARMAC staff response
The meters within the proposal have received European Conformity (CE mark) and Federal Drug Authority (FDA) approval. A number of standards must be met to obtain this approval, including testing for performance which include tests for precision and accuracy. The protocol for the evaluation performed by the Christchurch Diabetes Service was recommended by the Diabetes Subcommittee and remains to be the benchmark for funding blood glucose meters in New Zealand. CareSens II and CareSens N are marketed in many countries including in Australia and the United Kingdom. We consider that whilst there have been calls for local usability testing with New Zealand based patients (which is being considered as part of the implementation plan), that both meters above are in use in other countries. With respect to fault reporting, Medsafe do operate a device recall process (the same process as for pharmaceuticals) however the function with respect to medical devices may not be well known.
C, P, PG
Devices are pharmaceuticals
Supply of medical devices differs radically from pharmaceuticals. PHARMAC must develop a process that reflects the differences and recognise the supplier support for devices that remain in the market; unlike a pill that is swallowed along with the supplier's responsibility'. 'PHARMAC needs to rethink their policy and process for assessing and funding of any medical device and understand the real differences and complexity compared to pharmaceuticals. The proposal for sole supply of blood glucose meters and test strips has not been thought through adequately, nor been made by the very people who have the most experience and knowledge of the impact to the consumer. It is disappointing that PHARMAC did not engage with both the consumers and industry associations as an advisory and test group during the process. This would have ensured that the current negative feedback from the diabetes community would have been better handled and avoided the real scare that PHARMAC's proposal is now generating amongst a very vulnerable group in the community.
C, S, P, PG
There is no single process for evaluating any product for funding – this is adapted according to the product under consideration. Consultation has been valuable in this case
Lack of consultation with wider parties
We would appreciate if PHARMAC would listen to the views of the Health workers on the frontline before they make their decisions. Healthcare staff have had to spend valuable time dealing with anxious patients enquiring about the changes. We are concerned that PHARMAC have made this decision without any engagement with our communities, Pacific Health Workforce and organisations. PHARMAC should have consulted with patients before the RFP was conducted. This would have informed the RFP and perhaps PHARMAC would have requested different proposals. This relates to the minutes of the December 2011 meeting where the Subcommittee noted the importance of faulty/damaged strip detection, software interface, the date and time being lost on battery removal, that a range of meters is important, that manufacturing occur on more than one site PHARMAC have already entered into a provisional contract with Pharmaco before the results of feedback are known which indicates to me whatever the results for feedback, the decision has been made. Public perception that PHARMAC have already made up its mind
C, P, PG
PHARMAC’s proposal included input from the expert diabetes sub-committee. The objective of consultation is to ensure PHARMAC has all relevant information from all interested stakeholders before it makes a decision. PHARMAC actively sought the views of the community and worked to ensure a wide range of voices was heard during consultation. PHARMAC received nearly 3000 submissions on the proposal, many from consumers and community groups. This indicates that the voice of the diabetes community has been clearly expressed during the decision-making process. PHARMAC has well defined criteria for blood glucose meters to be considered for listing and this can be found on the PHARMAC website (http://www.pharmac.govt.nz/2010/02/11) Some submitters did not seem to understand that their feedback was an essential part of the wide consultation that was underway. In addition to written feedback, PHARMAC has established a working group to ensure that any implementation activities are developed in collaboration with key stakeholders. The Subcommittee and PTAC provide advice to PHARMAC. PHARMAC must balance this advice with its legislative function ‘to secure the best health outcome for all New Zealander within the funding available’. However the concerns raised here have been discussed previously in this summary of consultation responses. PHARMAC consults on provisional agreements as it provides a clear proposal for people to respond to. This is standard practice for PHARMAC. The agreements are conditional on consultation and PHARMAC Board approval. The Board considers consultation responses in making its decision. The revised proposal being submitted to the Board includes a number of changes to that consulted on, reflecting the concerns of people submitting to consultation.
PHARMAC have not heeded the advice of the Diabetes Subcommittee
C, P, PG
C, P, PG
One DHB notes that NZ hospitals are trying to maintain ISO standards 15189 and 22870 for Point of care testing (which includes glucose testing). At present there are only 2 systems on the market that allow us to maintain those standards - StatStrip by ZMS and the AccuChek Inform II by Roche. We are 1 year into a 3+2 year contract - can you assure us that the changes to the glucose meters will only pertain to the outpatient market.
The current proposal is only for Section B of the Pharmaceutical Schedule (Community funding only) and has no effect on Hospital supply. That means that DHB hospitals are free to choose the type of blood glucose diagnostic systems appropriate for in-hospital use.
Breach of Patient Rights: ‘We believe that the current Pharmac Proposal breaches Item 4 – Proper standards – which states ‘you have the right .. to receive services that reflect your needs’.
Breach of other health related laws/declarations
Breach of UN General Assembly Resolution on the Prevention and Control of Non-communicable Diseases – Sept 2011
A monopoly funding arrangement contravenes the principals of the Treaty of Waitangi/Te Tiriti O Waitangi: Protection; Participation; and Partnership. Monopolies have been shown to be less efficient, less innovative and less responsive. These attributes are not conducive to the on-going wellbeing of our communities.
We do not consider that the proposal breaches the Code of Patient Rights, UN Resolutions or principles of the Treaty of Waitangi.
Issue Confidence in financial stability Pharmaco's Comments Have PHARMAC received any financial information on Pharmaco to satisfy its ability to supply the market and sustain its financial obligations in relation to a sole supply contract. From C, P PHARMAC staff response We requested a copy of Pharmaco’s financial statements and sought advice from an independent consulting accountant. Subsequently, PHARMAC are satisfied with Pharmaco’s financial position.
Test strip costs have reduced per head of diabetes population
One clinical body noted that 'we recognise that expenditure on glucose testing strips has increased in recent years - but the main reason for this has been the increase in diabetes prevalence of -5% per annum and the welcome increase in patients appropriately started on insulin treatment. When expressed per head of diabetes population, testing strip costs have actually fallen over the past 10 years.'
PHARMAC staff response A number of variables affect both the prescribing and usage of test strips. Overall, the prevalence of diabetes in New Zealand is increasing therefore we expect expenditure on all diabetes treatments will increase. In line with clinical recommendations, many patients with type 2 diabetes are beginning insulin treatment earlier and along with that there is a greater requirement to test blood glucose levels. Prescribing and patient adherence factors also affect expenditure on test strips, and based on clinical advice, PHARMAC have conducted a number of activities to promote rational use and prescribing. Whilst patient and prescriber education will continue, we consider that separate from this reducing costs of medicines and devices are an important part of managing pharmaceutical expenditure. PHARMAC’s legislative role is to obtain the greatest health outcomes possible from pharmaceutical spending from within the amount of funding provided. One of the ways PHARMAC does this is by reducing spending on products while maintaining access for patients. This releases funding that PHARMAC can reinvest in other medicines or increasing access, leading to greater health outcomes overall. This is consistent with PHARMAC’s legislative objective. We consider that different patients would have different training needs and this will be carefully considered to ensure their needs are met. We consider that healthcare professionals each have key messages to offer patients during the transition, and that for some patients, learning would be incremental, (not a one off training session). Multi-media education and support activities run by PHARMAC and Pharmaco would be developed with the intention of minimising this impact. We acknowledge that while implementation activities would be larger than standard medication brand changes, PHARMAC intends to limit the anticipated extra burden for healthcare professionals as much as possible by providing other avenues for patients to receive training in the meters. Whilst we can only project the savings over the contracted period, it is likely that any reduction in price would be maintained or further reduced at the end of the supply period. This is countered by maintaining the status quo, which would see the long term costs of diabetes care escalating if no intervention is made. The software to operate CareSens meters is free to download, and Pharmaco will provide free USB cables to clinics and surgeries.
The proposal doesn't represent savings, rather a shift in costs to other areas of the health sector. One DHB estimates that it would take on average an hour of nursing time to transition a patient from their existing meter. This extrapolated across the district for 4370 in the area, it would take 109 weeks at 40 hours a week of health professional hours. The cost of the software change will be significant and some DHBs don't have the capability to implement this quickly. Cost shift, not cost savings The size and scale of the transition will require considerably more time and resourcing than anticipated, will reduce time available for other work, and will be disruptive, stressful and possibly not manageable given current funding and workforce constraints. 'Our service would almost certainly have to cease existing activities in order to be able to meet our part of the demand. Primary care practices have invested (money and time) into Accuchek/Optium software programmes and the ability for us to efficiently download meters is essential in managing our patients. C, P, PG, S
Issue Savings not worth implementing this proposal
Comments There are many more places funding could be gained from and in this case, scrimping a few cents worth is going to cause a lot of headaches for the government and public healthcare system in the future'. What is the risk mitigation for confusion, disengagement, interruption of supply, all of which may distract from current management, risk of acute destabilisation (DKA) and how are these accounted for in the proposal/forecasted savings. It is clear that noncompliance as a direct result of equipment not tailored to individual needs will carry clinical risk and most likely additional cost. One patient has performed an analysis on the costs involved to the health system if there is an increased 'incident' rate as a result of the changeover. Several estimates of the cost of unforeseen treatment expenses have been estimated as between 6 and 30 million for a 1 to 5 % 'incident rate'. It (The proposal) must be sustainable in the long run and cost effective to patients and the Department of Health'. What will happen in 3 years’ time? Will the whole process be run again? All meters currently in use have been brought which accounts for substantial costs which have already been paid - either by patients, PHARMAC/NZ rate payer or pharmaceutical companies. We need more than one meter per person – to keep in different places. While there would be one free, we need to keep two or more and there would be a great expense in replacing these. Free meters for healthcare providers, surgeries, after hours clinics, rest homes and ambulance services
PHARMAC staff response We consider that $10 million per annum is a significant sum which would be reinvested in other pharmaceuticals providing greater health benefits overall.
Negative Impact of proposals on health outcomes
C, P, PG, S
We acknowledge that there may be a group of patients who are not currently engaged in appropriate testing – providing increased focus and resource into testing may actually improve outcomes in this group by providing supplementary activities to support diabetes management. Implementation activities would be augmented to provide appropriate information and support to key vulnerable population groups as appropriate, through discussions with health professional and consumer groups.
Sustainability of proposal
C, P, PG
It is uncertain whether the process would be run again at the end of the proposed sole supply period. Many patients have a number of meters, some of which they have purchased privately. They would only receive one free meter with the swap out and therefore would incur a cost should they wish to replace second and third meters.
Cost of replacement meters
C, P, PG
Pharmaco will provide free meters for demonstration and insurgery use, to general practitioners, pharmacists, clinics and schools where required for training purposes. However, the current scenario of free meters being supplied to patients to take home is likely change given the proposal would result in less market competition.
Comments Several pharmacists estimate their time at between $40 and $100 per hour to administer the training for patients. Patients have raised significant concerns over the costs which would be incurred by them as a result of needing to switch, particularly elderly patients, those on a pension or benefit.
PHARMAC staff response
There will be a cost to see the GP for patients - Primary care can't be expected to provide this free. 'This change will involve the generation of a new prescription, for many patients this will be an added inconvenience and potential cost as they will have to visit their doctor for an extra visit as in many instances the need for a new prescription will go unnoticed in the usual consultation process. Improving diabetes and cardiovascular service is one of the Ministry of Health targets and recent gains risk being lost if resources are expended elsewhere.
C, P, PG
We are advocating that patients combine their visit to the GP along with a regular check-up which is why we are proposing a 6 month transition. To reduce the costs and time associated with visiting the GP, we are proposing to allow pharmacists to dispense a new meter to patients with a history of using insulin or sulphonylureas without a prescription. Should no other costs be incurred, there would be a $3 ($5 from 1 January 2013) cost of the co-payment on dispensing. We consider that the six month transition period is a sufficient period of time for patients to make contact with their health professional to receive a new meter.
Roche supply free batteries to patients – there will be more out of pocket expenses for patients if CareSens is adopted. Some patients use the software program at home and have already paid for the software. Accu-chek meters operate with infra-red so that meter data can be downloaded without the need to connect manually to the PC. CareSens requires a USB cable to connect the meter with the PC, and is charged at a cost of $15 per cable. The disruption to the lives of people with diabetes having to take more time off work to learn new skills with the new products. For rural people, this is magnified by travel costs, child care costs and reduced production while away from work. We believe that PHARMAC severely under-estimates the level of disruption to both patients and staff concerned. Patients on metformin or diet along would need to self-fund a replacement meter. One clinician noted the escalating number of patients admitted to hospital who say they cannot afford a meter, let alone find the money to replace an existing meter
For patients who wish to use the software, this is downloadable for free. However, a USB cable is needed to connect the device with a computer which would usually cost $15. Pharmaco has advised that it would supply a cable to patients and clinicians who had already invested in an alternative software system – therefore there would be no increased costs for these patients. Pharmaco has been contracted to supply free batteries for patients using the CareSens meter. It is proposed that there are many contact points where a patient can access a meter and receive training. As the proposed transition period is 6 months all patients using insulin or sulphonyureas would require 2 prescriptions from their doctor and would visit their pharmacy twice to receive their medication. We consider that these would present opportunities to change to a new meter. There was a significant number of responses about funding of meters for patients on metformin and diet alone, who debate that testing periodically is meaningful. Patients are likely to have purchased a meter, or have been given one (due to current market dynamics there are many free meters made available by suppliers). This situation is likely to be affected by sole supply, therefore patients would need to purchase one at retail rates – could be up to $40. Patients are only eligible for one funded meter. Currently there are six funded meters from four different suppliers so this proposal would represent a reduction in the amount of knowledge each trainer would need to have.
Other patient costs of proposal
C, P, PG
Training for three CareSens meters
Three CareSens meters will be available, tripling the amount of counselling and education we anticipate having to provide.
Comments Savings can be made within the existing system - there is wastage in primary care that can be avoided, both through dispensing systems and pointless testing. Healthcare professionals could take a more responsible approach to prescribing test strips. Rather than forcing existing users to switch, the new meter should be available for all new patients. Reference price all existing test strips to the CareSens test strips. One clinician suggested that PHARMAC use the basic NHS price 'which is often lower than the PHARMAC price' which would result in savings on negotiating, and patients can pay more if they wish to. This would reintroduce competition into the market. A Special Authority could be available for patients with type 1 diabetes for other meter devices. Patients not using insulin should be prescribed a CareSens meter - patients using insulin require a more technologically advanced meter One box of test strips per year could be funded for patients on diet and metformin alone
PHARMAC staff response Significant savings were made in 2005 when restrictions were placed on the funding of test strips for patients on metformin or diet. We consider that this proposal would be accompanied by other rational prescribing advice.
There are other ways to achieve savings in this market
C, P, PG, S
Reference pricing is not an option here – Pharmaco’s price offer was on the basis of sole supply. PHARMAC ran a competitive process for sole supply and this has resulted in the Sole supply arrangement proposed. If suppliers were sharing in the market it is highly likely that PHARMAC would have to pay a higher price for test strips as suppliers would have to pay for advertising to gain market share. PHARMAC considers that the CareSens meter range is appropriate for all people living with diabetes regardless of the medication they are using. PHARMAC has reviewed the claims data for patients and those on metformin and diet alone are responsible for approximately 12% of test strip consumption. We do not consider that further restricting supply would provide significant savings. PHARMAC and Pharmaco are considering disposal options and there will be no cost to patients. As part any swap out activity, there will be an option for patients to return their meters, however it is possible that many patients may wish to hold on their meter. Should a decision be made, PHARMAC intends to provide necessary resource and support to ensure that the change is managed as smoothly as possible without extra burden on health professionals. Proposed implementation activities have been estimated to cost approximately $1 million for the duration of the transition period. Comment noted It is likely that there would be ‘stock piling’ by patients in order to delay their need to switch. Eventually, supply will be exhausted as suppliers downscale. Pharmacy can order overnight additional stock during the transition period.
The environmental impact of disposing meters will be large
Meters are both e-waste and medical waste - cost of disposal will be large. Should the meters be sent somewhere else, who will decontaminate and validate
C, P, PG
In support of the change however some of the savings should be directed towards implementing the swap out smoothly MoH do not anticipate any technical or resource impacts as a result of the proposal
Healthcare professionals should be trained to use the new meters and could then directly counsel those patients who require assistance. One DHB noted that it would prefer to manage this process at a local level using nationally consistent support materials.
Concern over stock management in pharmacy
Pharmacists have expressed concern over the potential cost implications of managing stock of existing devices and strips for patients either slow or reluctant to change over, or are struggling with the changeover process.
C PHARMAC proposes to allow pharmacy to provide a CareSens meter to a patient without the need for a prescription from another health provider. This would allow pharmacy to encourage patients to change and help with stock control.
Issue Pharmaceutical company sponsorship will be lost
Comments Patient groups such as ADNZ are supported by industry for initiatives such as the ‘meter check and clean’ and camps for kids with diabetes. Without this support, organisations may not be viable.
From C, PG, P
PHARMAC staff response Sponsorship is not guaranteed under current arrangements. Pharmaco has indicated it would provide a clean and check service. Pharmaco has noted that it may provide other forms of support and this is discussed in other sections of this summary. Should a decision be made, part of our implementation proposal is that pharmacy would be able to access the brand switch payment for all meters during the transition period. PHARMAC propose to hold training days for patients in DHBs and patients requiring greater help could be directed to these. Many patients would be seeing their health professional throughout the transition period and training could be provided as part of this appointment.
Should the changes be approved, funding should be provided for all parties managing the change Funding implementation Current Brand Switch Fee for pharmacists would not be enough to cover the time involved in this swap out. This should cover the entire brand switch period C
Issue Comments Meter training is not a one off, most patients require continuing support and training to remind them how the meters work. Training 100,000 people with diabetes will be 'predominately a problem for primary care, where there is not only a lack of capacity but a lack of expertise'. Similarly we do not believe that pharmacists (who cannot deal with specific diabetes problems that arise during training consultations) will have the capacity or expertise to undertake this work satisfactorily.' Teaching patients to use a new meter is usually undertaken by specialist nurses in diabetes clinics or experienced nurses in general practice. This proposal suggests that PHARMAC would be contributing to the cost of training health care staff but not 100,000 patients with diabetes. The six month transition timeframe is unrealistic Should any changes occur, Patient support groups should be involved - 'we can and do now provide vital support, diabetes education resources and vital links to other diabetes services ..' Offering eligible patients a meter at the time of diagnosis improves their journey in managing their chronic condition. If a patient has to get a prescription, this may mean a delay in receiving a meter and the training to operate it. PG, C P, S, PG, C PHARMAC considers that a six month transition is manageable. This could be amended if necessary depending on roll out. PHARMAC intends to monitor the progress of the implementation and could extend the transition period if this was deemed appropriate. PHARMAC has initiated dialogue with patient groups which has been ongoing during the consideration phase. We have not been able to finalise implementation plans with these groups, as no decision has been made. However, we intend to invite diabetes support groups to play an active role in implementation activities. We also see diabetes support groups having an ongoing role in providing support, training and guidance to people living with diabetes and we will explore ways in which this can be facilitated. From PHARMAC staff response
Healthcare staff time and resource will be consumed by a swap out
Details of the implementation strategy has been provided in a separate paper.
Utilise wider implementation
Wider groups to consider for training
Comments Our school teachers would also need to learn how to use the devices. 'Young patients with diabetes are not able to manage their condition alone. A heavy workload is placed on parents and siblings to care for the patients with diabetes. Included in this are grandparents, extended family members, sports coaches, school nurses, teachers, parents of children’s friends, after school activity carers. All these people have been trained in caring for the young people. The implementation (Jun- December) co-insides with an extremely busy time of the year i.e. Winter/flu vaccinations/staff sickness. In rural areas, there are literally just not the extra staff to cope with the extra work. In addition, this activity will co-inside with the implementation of the Diabetes Improvement plan
PHARMAC staff response
These groups would be covered in the implementation strategies, which are discussed in a separate paper.
Timing of implementation
Implementation of the new diabetics should be phased. Newly diagnosed diabetics could be prescribed the testing products from the CareSens and the other testing products could remain in place with an end date for final phase out. This would also address members concerns about wastage Many patients expressed their desire to ensure that the call centre is based in New Zealand and operated by ‘New Zealanders’.
Call centre support
PHARMAC appreciates that clinician time is already time pressured. The delay in the decision has meant that implementation would now begin in September and run until March 2013 which may be a less busy time of the year. We consider that a change of meter could be included with any patient visit with respect to diabetes such as the diabetes improvement plan as it would be an opportune time to discuss how to get the best health outcomes from testing. PHARMAC propose to transition patients over a six month period. The end date for the phase out would be March 2013. The sole supply agreement was made on the basis of the entire market and the current pricing would not be viable in a very extended phase in model. As suppliers provide free meters to patients there would never be a reason for a patient to change to a new supplier and therefore no benefit for the incoming supplier. The call centre will be NZ based and operated by in New Zealand.
10. Comments from Suppliers & Industry Representatives
Comments PHARMAC staff response PHARMAC staff evaluated all RFP proposals submitted based on the information provided and selected the preferred proposal as a result of this evaluation. We are unable to consider counter offers made after the time period for bids have closed – this is particularly unfair in a commercial process once a preferred supplier’s pricing has been publicly disclosed.
Additional cost savings from that offered in original proposal
Roche estimates that the initial cost to the healthcare system is close to $9 million. This could be avoided by not switching. Accu-chek Performa strips reduce the number of repeat tests needed by individuals to get a successful result - this reduces cost compared to other systems.
We estimate the cost of a swap out to be significantly less than $9 million and note that savings offered by this proposal are estimated to be $10 million per annum resulting in significant long term savings above any cost of implementation. The ability to top up blood if the sample isn’t a sufficient volume and the reduced wastage of test strips has been discussed above.
Promotion of appropriate testing
Comments Promotion of appropriate testing - Roche refer to the 'Step' study published in Diabetes Care 2011 which used a paper based tool supporting testing over a three day period over a quarter. Outcomes were improved HbA1c (type 2 study). Roche notes that it supports structured testing as outlined above and only provides access to meters for patients who are willing, where self-monitoring is clinically indicated, give guidelines with testing and have systems in place for review. Roche note that 'merely testing your blood glucose level will not improve diabetes control however, the clinical decision making resulting from this analysis and decisions will.' Abbott and most other manufacturers had stopped using glucose oxidase enzyme system in 90's due to imprecision caused by oxygen interference, humidity, altitude, temperature and expiry issues. Surprised by CareSens N choice given it is not currently listed; suggest dual supply; issue around warranty at less than cost price must set price of meter. Medica will close - 6 - 7 staff members will lose jobs; Raises concern around Pharmaco's capability to support the diabetes market - specialised ‘I sometimes suspect that PHARMAC is happy to see the exit of multinationals'.
PHARMAC staff response
Appropriate blood glucose testing regimens has been reviewed most recently by the Diabetes Subcommittee at its 3 March 2011 meeting (relevant minutes are attached). Approaches to rational testing have been issued by the Best Practice Advocacy Centre (BPAC) to prescribers.
Glucose oxidase technology
Enzyme technologies are discussed earlier in this summary.
This proposal is a package containing both meters and test strips therefore would not be considered to be less than cost price.
We note business.
response with respect to the proposals impact on its
Industry Representatives More rigorous testing of blood glucose systems is required - the entire ISO standard should be a baseline for data requirement from a supplier in a sole supply situation. The protocol followed by the Christchurch Diabetes Service is a much less rigorous protocol than described by clause 7.3 of ISO standard 15197 and therefore the report is misleading when it states ‘the meter performed satisfactorily and complied with the criteria set by the National Committee on Clinical Laboratory and ISO 15197 standards’. The FDA and ISO are due to upgrade the analytical performance standards required for blood glucose testing devices with 15/15 the new benchmark and 10/10 the goal within the next 4 years. i-Sens only has a 'special 510k FDA approval’. The FDA recognised in 2010 that this standard of approval was inadequate and no longer allows a company to use a ‘predicate device’ as the basis for 510K submission as was the case for CareSens N.
As discussed above, the CareSens meters meet all requirements for funding in New Zealand and the international regulatory approvals are discussed above.
Analysis of issued raised in consultation Blood glucose meters and test strips June 2012 Executive Summary This summary of submissions outlines the key themes from the 2645 submissions received on the consultation document ‘Proposals relating to multiple diabetes products’ dated…
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