This is the text extract for Notification of approval of Diabetes Management Products and Mesalazine proposals, browse documents here.

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8 June 2009

Approval of Multiple Mesalazine proposals

Diabetes

Management

Products

and

PHARMAC is pleased to announce the approval of five agreements in relation to funding of blood glucose test strips, blood glucose diagnostic test meters, blood ketone test strips, urine ketone test strips, insulin pen needles, disposable insulin syringes, and mesalazine. Some of the proposals as originally consulted on in our letter dated 18 March 2009 are still under consideration and a notification will be issued when a decision is made.

Summary of the decisions

In relation to blood glucose test strips and blood glucose diagnostic test meters · Three new brands of blood glucose test strips and blood glucose diagnostic test meters (in addition to those already listed) will be funded: o o o · · FreeStyle Lite (as supplied by Medica Pacifica); CareSens II (as supplied by Pharmaco); and CareSens POP (as supplied by Pharmaco).

SensoCard blood glucose test strips (as supplied by Point of Care Diagnostics) will be funded for patients who are severely visually impaired; and Funded access to blood glucose diagnostic test meters will be widened to include people with gestational diabetes.

A decision on the proposed funding of the On Call Plus brand of blood glucose test strips and blood glucose diagnostic test meters (as supplied by Diabetes Supplies) is still under consideration. As a consequence, the related proposal to reduce the subsidy, through reference pricing, for the Accu-Chek Performa blood glucose test strips brand (as supplied by Roche Diagnostics) is still under consideration. In relation to ketone testing · · · Optium blood ketone test strips (as supplied by Medica Pacifica) will be funded via an endorsement restriction for people with type 1 diabetes; Ketostix (foiled strips) urine ketone test strips (as supplied by Bayer) will be funded; and The current, partially subsidised, glucose and/or ketones/urine testing brands will be delisted from the Pharmaceutical Schedule.

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In relation to insulin pen needles and disposable insulin syringes · · · The subsidy and price for ABM insulin pen needles and disposable insulin syringes (as supplied by ABM Pharma) will reduce; SC Profi-Fine insulin pen needles (as supplied by Pharmaco) and DM Ject disposable insulin syringes (as supplied by Pharmaco) will be funded; The SC Profi-Fine brand of insulin pen needles and the DM Ject brand of disposable insulin syringes will be subject to a volume related price adjustment, that will result in a price reduction to match that of the ABM brand of insulin pen needles, should SC Profi-Fine and DM Ject (in any total combination) obtain approximately 30% market share; and The subsidies for the B-D (as supplied by Becton Dickinson) and NovoFine (as supplied by Novo Nordisk) brands of insulin pen needles and disposable insulin syringes will reduce, through reference pricing, to match that of ABM or SC ProfiFine (where applicable). This will mean that a manufacturer’s surcharge could apply if the prices of B-D and NovoFine are not reduced.

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In relation to mesalazine · · The subsidy and price for Pentasa (as supplied by Pharmaco) will reduce; The current Retail pharmacy – Specialist restrictions applying to mesalazine preparations will be removed.

If you have any queries about this funding decision you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

Details of the decision

In relation to blood glucose diagnostic test strips · The following blood glucose test strips will be listed (where applicable) in Section B of the Pharmaceutical Schedule from the following dates and at the following prices and subsidies (ex-manufacturer, excluding GST):

Form and Strength Blood/glucose test strips Blood/glucose test strips Blood/glucose test strips Blood/glucose test strips Blood/glucose test strips Pack size 25 test OP 50 test OP 50 test OP 50 test OP 50 test OP Subsidy and price $10.82 $21.65 $21.65 $19.25 $26.20

Chemical Blood glucose diagnostic test strip Blood glucose diagnostic test strip Blood glucose diagnostic test strip Blood glucose diagnostic test strip Blood glucose diagnostic test strip

Brand Optium 5 second test Optium 5 second test FreeStyle Lite CareSens II SensoCard

Listing Date 1 July 2009 1 July 2009 1 July 2009 1 September 2009 1 July 2009

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Note: The chemical description will be renamed from glucose dehydrogenase to blood glucose diagnostic test strip from 1 July 2009.

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The above brands, excluding SensoCard, will be listed in Part II of Section H of the Pharmaceutical Schedule at the applicable dates and prices. The funding for SensoCard blood glucose test strips will be restricted by the following note:

“SensoCard blood/glucose test strips are subsidised only if prescribed for a patient who is severely visually impaired and is using a SensoCard Plus Talking Blood Glucose Monitor.”

In relation to blood glucose diagnostic test meters · The following blood glucose diagnostic test meters will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from the following dates and at the following prices and subsidies (ex-manufacturer, excluding GST):

Form and Strength Meter Meter Meter Meter Pack size 1 1 1 1 Subsidy and price $9.00 $9.00 $9.00 $6.00

Chemical Blood glucose diagnostic test meter Blood glucose diagnostic test meter Blood glucose diagnostic test meter Blood glucose diagnostic test meter

Brand Optium Xceed FreeStyle Lite CareSens II CareSens POP

Listing Date 1 July 2009 1 July 2009 1 September 2009 1 September 2009

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As previously noted, SensoCard Plus Talking Blood Glucose Monitor will not be listed on the Pharmaceutical Schedule. We understand this will continue to be distributed and managed by the Royal New Zealand Foundation for the Blind. The current endorsement restriction applying to blood glucose diagnostic test meters will be amended from 1 July 2009 to allow funding for people with gestational diabetes (changes are indicated by bold text):

Subsidy by endorsement. a) Maximum of 1 meter per prescription. b) A diagnostic blood glucose test meter is subsidised for patients who begin insulin or sulphonylurea therapy after 1 March 2005 or is prescribed for a pregnant women with diabetes. c) Only one meter per patient. No further prescriptions will be subsidised. The prescription must be endorsed accordingly.

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Subsidy and delisting protection will apply to FreeStyle Lite, Optium, Optium Xceed, CareSens II and Care Sens POP until 30 June 2011 in relation to blood glucose test strips and blood glucose diagnostic test meters.

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In relation to ketone testing · Blood ketone test strips will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following subsidy and price (ex-manufacturer, excluding GST) from 1 July 2009:

Form and Strength Test strip

Chemical Ketone blood beta-ketone electrodes

Brand Optium Blood Ketone Test Strips

Pack size 10 strip OP

Subsidy and price $8.50

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Optium Blood Ketone Test Strips will be subject to the following restriction:

“Patient has type 1 diabetes and has had one or more episodes of ketoacidosis (excluding first presentation). Maximum quantity of 2 packs per annum. No further prescriptions will be subsidised.”

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Note that the Optium Blood Ketone Test Strips are only compatible with Optium Xceed blood glucose meters. The Optium Xceed meter is capable of performing both blood glucose and blood ketone testing without the need for repeated calibrations however funding is restricted to one meter per patient; therefore, in cases where patients had initially received a funded Accu-Chek meter, a second Optium Xceed meter will not be funded. Urine ketone individually foil wrapped test strips will be listed in Section B of the Pharmaceutical Schedule at the following subsidy and price (ex-manufacturer, excluding GST) from 1 August 2009:

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Chemical Sodium nitroprusside

Form and Strength Test strip

Brand Ketostix

Pack size 20 strip OP

Subsidy and price $14.14

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Subsidy and delisting protection will apply to Optium Blood Ketone Test Strips until 30 June 2011. The following partially subsidised urine ketone test strips will be delisted from Section B of the Pharmaceutical Schedule from 1 December 2009:

Subsidy (Price) $4.53 ($8.00) $4.53 ($7.50)

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Chemical

Form and Strength Urine diagnostic test with peroxidase, sodium nitroprusside and aminoacetic acid Urine diagnostic test with peroxidase, potassium iodide, sodium nitroprusside and aminoacetic acid

Brand KetoDiabur 5000 KetoDiastix

Pack size

Glucose oxidase

50 stick OP

Glucose oxidase

50 strip OP

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Chemical

Form and Strength

Brand KeturTest

Pack size

Subsidy (Price) $3.39 ($6.00) $3.40 ($7.15)

50 strip OP 50 strip OP

Sodium nitroprusside

Urine diagnostic strips, buffered Ketostix

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The current Glucose and/or Ketone/Urine Testing therapeutic subgroup will be renamed from 1 July 2009 to Ketone Testing. Both Optium Blood Ketone Test Strips and Ketostix will be listed in this therapeutic subgroup.

In relation to insulin pen needles and disposable insulin syringes · The following insulin pen needles will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from the following dates and at the following prices and subsidies (ex-manufacturer, excluding GST):

Form and Strength Subsidy and price $10.50 $11.75 $11.75 $10.50 $11.75 $10.50 $11.75 Date of Listing 1 July 2009 1 September 2009 1 September 2009 1 July 2009 1 September 2009 1 July 2009 1 September 2009

Chemical

Brand ABM

Pack size 100 100 100 100 100 100 100

Insulin pen needles Insulin pen needles Insulin pen needles

29 g x 12.7 mm

SC Profi-Fine SC Profi-Fine ABM

31 g x 5 mm

31 g x 6 mm

SC Profi-Fine ABM

Insulin pen needles

31 g x 8 mm

SC Profi-Fine

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The following disposable insulin syringes will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from the following dates and at the following prices and subsidies (ex-manufacturer, excluding GST):

Form and Strength Syringe 0.3 ml with 29 g x 12.7 mm needle Syringe 0.3 ml with 31 g x 8 mm needle Subsidy and price $13.00 $13.00 $13.00 $13.00 Date of Listing 1 July 2009 1 September 2009 1 July 2009 1 September 2009

Chemical Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle

Brand ABM DM Ject ABM DM Ject

Pack size 100 100 100 100

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Chemical Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle

Form and Strength Syringe 0.5 ml with 29 g x 12.7 mm needle Syringe 0.5 ml with 31 g x 8 mm needle Syringe 1 ml with 29 g x 12.7 mm needle Syringe 1 ml with 31 g x 8 mm needle

Brand ABM DM Ject ABM DM Ject ABM DM Ject ABM DM Ject

Pack size 100 100 100 100 100 100 100 100

Subsidy and price $13.00 $13.00 $13.00 $13.00 $13.00 $13.00 $13.00 $13.00

Date of Listing 1 July 2009 1 September 2009 1 July 2009 1 September 2009 1 July 2009 1 September 2009 1 July 2009 1 September 2009

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The subsidies for B-D Micro-Fine and NovoFine will be reduced to the same level as ABM or SC Profi-Fine (where applicable) through the application of reference pricing, from the following dates as follows:

Form and Strength 29 g x 12.7 mm 31 g x 5 mm 31 g x 6 mm 31 g x 8 mm Brand B-D MicroFine B-D MicroFine NovoFine B-D MicroFine Pack size 30 100 100 100 30 100 Current subsidy and price $3.93 $13.09 $13.09 $26.00 $3.93 $13.09 New subsidy $3.15 $10.50 $11.75 $10.50 $3.15 $10.50 Change date

Chemical Insulin pen needles Insulin pen needles Insulin pen needles Insulin pen needles

1 July 2009 1 September 2009 1 July 2009 1 July 2009

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The subsidies for B-D Ultra Fine and B-D Ultra Fine II will be reduced to the same level as ABM and DM Ject through the application of reference pricing, from 1 July 2009 as follows:

Chemical Form and Strength Syringe 0.3 ml with 29 g x 12.7 mm needle Brand Pack size 10 100 B-D Ultra Fine II 100 100 Syringe 0.5 ml with 29 g x 12.7 mm needle B-D Ultra Fine 10 100 Current subsidy and price $1.59 ($1.99) $15.92 $1.59 ($1.99) $15.92 $1.59 ($1.99) $15.92 New subsidy $1.30 $13.00 $1.30 $13.00 $1.30 $13.00

Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle

B-D Ultra Fine

Syringe 0.3 ml with 31 g x 8 mm needle

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Chemical Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle

Form and Strength

Brand

Pack size 10 100

Current subsidy and price $1.59 ($1.99) $15.92 $1.59 ($1.99) $15.92 $1.59 ($1.99) $15.92

New subsidy $1.30 $13.00 $1.30 $13.00 $1.30 $13.00

Syringe 0.5 ml with 31 g x 8 mm needle

B-D Ultra Fine II

Syringe 1 ml with 29 g x 12.7 mm needle

B-D Ultra Fine

10 100

Syringe 1 ml with 31 g x 8 mm needle

B-D Ultra Fine II

10 100

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Any supplier affected by the application of reference pricing above needs to notify PHARMAC by 12 June 2009 if it intends on reducing the price of its brand using the relevant product notification form on our website. The following price volume adjustment (ex-manufacturer, excluding GST) will apply to SC Profi-Fine and DM Ject based on the products (in any total combination) obtaining 30% market share (at Pharmaco’s prices, estimated to equal $200,000):

Chemical Form and Strength 29 g x 12.7 mm 31 g x 5 mm 31 g x 6 mm 31 g x 8 mm Syringe 0.3 ml with 29 g x 12.7 mm needle Syringe 0.3 ml with 31 g x 8 mm needle Syringe 0.5 ml with 29 g x 12.7 mm needle Syringe 0.5 ml with 31 g x 8 mm needle Syringe 1 ml with 29 g x 12.7 mm needle Syringe 1 ml with 31 g x 8 mm needle Brand SC Profi-Fine SC Profi-Fine SC Profi-Fine SC Profi-Fine DM Ject DM Ject DM Ject DM Ject DM Ject DM Ject Pack size 100 100 100 100 100 100 100 100 100 100 Subsidy and price $10.50 $10.50 $10.50 $10.50 $10.50 $10.50 $10.50 $10.50 $10.50 $10.50

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Insulin pen needles Insulin pen needles Insulin pen needles Insulin pen needles Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle Insulin syringes, disposable with attached needle

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The subsidy for B-D Ultra Fine and B-D Ultra Fine II will be further reduced to match the lower DM Ject prices in the event that its prices are reduced on obtaining 30% market share. An announcement will be made on any such price changes via the Pharmaceutical Schedule. Subsidy and delisting protection will apply to ABM, SC Profi-Fine and DM Ject until 30 June 2011.

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The restriction applying to NovoFine pen needles 31 g x 6 mm (subsidised for children under 12 years of age) will be removed from 1 July 2009.

In relation to mesalazine · The subsidy and price of mesalazine (Pentasa) as listed in Section B of the Pharmaceutical Schedule will be reduced as follows from 1 November 2009 (ex manufacturer and ex GST):

Form and Strength Tab long-acting 500 mg Pack size 100 Current subsidy and price $69.06 Proposed subsidy $59.05

Chemical Mesalazine

Brand Pentasa

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Pentasa will be listed in Part II of Section H of the Pharmaceutical Schedule at the applicable price from 1 November 2009. A rebate will apply to Pentasa for the period from 1 March 2009 until 30 October 2009. The rebate has the effect of obtaining the lower price for Pentasa for the duration of this period. All mesalazine presentations (tablets and enemas) will no longer be subject to a “Retail pharmacy-Specialist” restriction, meaning that prescriptions written by other types of practitioners will no longer require a specialist endorsement for subsidy. Subsidy and delisting protection will apply to Pentasa until 30 June 2012.

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What feedback was received?

We appreciate the feedback we received and acknowledge the time people took to respond. A variety of consultation responses were received in relation to the proposals and all responses were considered in the decisions on the proposed changes. Some concerns were raised with specific aspects of the proposal and we have outlined those we are able to publicise below, along with our response:

Theme Response

Support was provided for listing of gestational Support noted. meters, listing the Sensocard test strip brand, and removing the mesalazine restrictions. Requests were made that PHARMAC review the funding of lancets. As mentioned in consultation PHARMAC intends to continue to search for an acceptable method for funding.

Requests were made for funding 0.5 unit PHARMAC was not aware of this issue and insulin syringes for paediatric patients. intends to investigate.

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Theme

Response

Queries were made regarding the suitability We note that ABM has already been listed and testing of the new brands of insulin pen for 12 months and that this brand and the needles and insulin syringes. Pharmaco brands are standardised to fit the existing insulin pens. Limited field testing has occurred without any significant concerns raised. Requests that the restriction on the number of blood ketone strips be increased especially for those patients who are using insulin pumps and that ketone test strips are available from diagnosis and not as proposed on presentation of DKA after diagnosis. Clinical advice from the Diabetes Subcommittee of PTAC was that 2 boxes annually was clinically appropriate (including those patients using insulin pumps) and that they should be restricted to patients that have had one or more episodes of ketoacidosis. We intend to ask the Diabetes Subcommittee to review the restriction at its meeting in August, to ensure that this is still appropriate.

Additional meters would dilute the training We are not proposing to delist the current and resources for people with diabetes. brands and healthcare professionals can continue to decide to use the current brands only. We note that some responders were positive towards a greater choice of meters. Requests that more test strips are available The Diabetes Subcommittee considered the for patients with type 2 diabetes. restriction last year and considered that it is clinically appropriate. Requests were made for the funding of Funding of pumps and consumables is a insulin pump consumables. related issue. Insulin pumps are not currently funded on the Pharmaceutical Schedule. We note that the Ministry of Health already provides some funding for insulin pumps to DHBs and is currently reviewing the funding availability. One pharmacist suggested that all There is a wider issue about entitlements to pharmacists should be able to endorse the authorise subsidy payments that this blood ketone test strip restriction proposal was not seeking to address. prescriptions. We did not consider this change appropriate or necessary at this time. The Christchurch Diabetes Centre has undertaken a meter evaluation for the new brands of blood glucose test strips and blood glucose diagnostic test meters. The independent study evaluated the accuracy and precision of the meters and showed good performance for all meters under controlled conditions. The performance of these brands appears similar to that of the two meters currently on the New Zealand market (namely the AccuChek Performa and Optium Xceed). Finally, we note that the field testing for the SensoCard Plus blood glucose test strips and blood glucose diagnostic test meter provided positive results.

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