This is the text extract for Proposal to list insulin pumps and consumables; Closing Date: Closed; Contact: diabetesfeedback, browse documents here.

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27 February 2012

Proposal to list insulin pumps and consumables

As a result of a Request for Proposals (RFP) for the supply of diabetes management products dated 26 August 2011, PHARMAC has entered into a provisional agreement with New Zealand Medical and Scientific (NZMS) to supply insulin pumps and consumables from 1 June 2012. PHARMAC is seeking feedback on the following proposal to fully fund insulin pumps and consumables for eligible patients. In summary, this proposal would result in:  Listing Animas 2020 insulin pumps and its relevant consumables in Section B of the Pharmaceutical Schedule from 1 June 2012; Listing Paradigm Luer Lock conversion cartridges to enable eligible patients to continue using their Paradigm insulin pump and use funded Animas consumables; A Panel of clinicians which would assess applications for funding using the Special Authority criteria proposed below as its terms of reference;

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Special Authority for Subsidy for insulin pump Initial application only from a relevant specialist. Approvals valid for three months for applications meeting the following criteria: Both 1. Patient has type 1 diabetes; and 2. Either 2.1. has adhered to an intensive MDI regimen using analogue insulin’s for at least three months but still has either: 2.1.1. four severe unexplained recurrent hypoglycaemic episodes over a six month period either due to hypoglycaemic unawareness or to nocturnal hypoglycaemia; or 2.1.2. unpredictable and significant variability in blood glucose including significant hypoglycaemia affecting the ability to reduce HbA1c and in the opinion of the treating clinician, HbA1c could be reduced by at least 11 mmol/mol (1.0%) using insulin pump treatment; and 2.1.3. has been evaluated by the multidisciplinary team for their suitability for insulin pump therapy, or 2.2. is already on pump treatment prior to xx date (date Special Authority is initiated) and met criteria 2.1 at the time of initiating that pump treatment and continues to benefit from pump treatment; and 3. has undertaken a carbohydrate counting course, and 4. Applicant is part of a multidisciplinary team experienced in the management of type 1 diabetes care; Renewal only from a relevant specialist. Approvals valid for three months for applications meeting the following criteria: Both 1. Patient is continuing to derive benefit according to the treatment plan agreed at induction which includes one or both of the following: 1.1. at least a 50% reduction from baseline in hypoglycaemic events; or 1.2. is achieving and maintaining a reduction in HbA1c from baseline of 11 mmol/ml (1.0%); and

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2. It has been at least 4 years since the last insulin pump received by the patient or, in the case of patients qualifying under part 1.2 for the initial application; the pump is due for replacement. Special Authority for Subsidy for insulin pump consumables Initial application only from a relevant specialist. Approvals valid for nine months for applications meeting the following criteria: 1. Patient has had a valid Special Authority approval for an insulin pump approved under SA xxx Renewal only from a relevant specialist. Approvals valid for two years for applications meeting the following criteria: Patient is continuing to derive benefit from insulin pump therapy as defined by: 1. Either 1.1. a reduction of hypoglycaemic events compared with pre-pump frequency by at least 50%; or 1.2. is maintaining a reduction of 11 mmol/mol (1%) HbA1c from baseline; and 2. the patient continues to be part of a multidisciplinary team experienced in type 1 diabetes care; and 3. the patient continues to be compliant.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 16 March 2012 to: Natalie Davis Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: diabetesfeedback@pharmac.govt.nz Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

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Details of the proposal

The proposal is to list Animas 2020 insulin pumps and relevant consumables in Section B of the Pharmaceutical Schedule from 1 June 2012 at the following prices (ex-man, ex-GST):

Price and subsidy (exman, ex-GST) $NZ $4,500.00

Device

Brand

Description

Pack size

Insulin Pump Insulin pump infusion set Insulin pump infusion set

Animas 2020

Black, silver, blue, green or pink colour

1 10 x needles; 5 x lines 10 x needles; 5 x lines 10 x needles; 5 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines

Comfort Short

13 mm Teflon cannula angle insertion; 60 cm grey line 17 mm Teflon cannula angle insertion; 60 cm grey line

$120.00

Comfort

$120.00

Insulin pump infusion set

Comfort

17 mm Teflon cannula angle insertion; 110 cm grey line

$120.00

Insulin pump infusion set

Inset II

6 mm Teflon cannula; straight insertion with auto injector; 60 cm grey line

$140.00

Insulin pump infusion set

Inset II

6 mm Teflon cannula; straight insertion with auto injector; 60 cm pink line

$140.00

Insulin pump infusion set

Inset II

6 mm Teflon cannula; straight insertion with auto injector; 60 cm blue line

$140.00

Insulin pump infusion set

Inset II

9 mm Teflon cannula; straight insertion with auto injector; 60 cm grey line

$140.00

Insulin pump infusion set

Inset II

9 mm Teflon cannula; straight insertion with auto injector; 60 cm pink line

$140.00

Insulin pump infusion set

Inset II

9 mm Teflon cannula; straight insertion with auto injector; 60 cm blue line

$140.00

Insulin pump infusion set

Inset II

6 mm Teflon cannula; straight insertion with auto injector; 110 cm grey line

$140.00

Insulin pump infusion set

Inset II

9 mm Teflon cannula; straight insertion with auto injector; 110 cm grey line

$140.00

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Device

Brand

Description

Pack size

Price and subsidy (exman, ex-GST) $NZ $140.00

Insulin pump infusion set

Inset 30

13 mm Teflon cannula; angle insertion with auto injector; 60 cm grey line

10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x needles; 10 x lines 10 x cartridges

Insulin pump infusion set

Inset 30

13 mm Teflon cannula; angle insertion with auto injector; 60 cm pink line

$140.00

Insulin pump infusion set

Inset 30

13 mm Teflon cannula; angle insertion with auto injector; 60 cm blue line

$140.00

Insulin pump infusion set

Inset 30

13 mm Teflon cannula; angle insertion with auto injector; 110 cm grey line

$140.00

Insulin pump infusion set

Contact-D

6 mm Metal cannula; straight insertion; 60 cm grey line

$130.00

Insulin pump infusion set

Contact-D

8 mm Metal cannula; straight insertion; 60 cm grey line

$130.00

Insulin pump infusion set

Contact-D

8 mm Metal cannula; straight insertion; 110 cm grey line

$130.00

Insulin pump reservoirs

IR2020

200 U cartridge; luer lock

$50.00

Insulin pump reservoirs

Paradigm cartridge 1.8 and 3.0

Luer lock Paradigm conversion cartridge 1.8 ml and 3.0 ml

10 x cartridges

$50.00

Insulin pump battery cap

Animas Battery Cap

Replacement battery cap for insulin pump

1 x battery cap

$32.00

One insulin pump would be funded not more frequently than once every 4 years (warranty period). Patients are advised to note the terms of warranty at the time of being fitted with a pump. Patients would be responsible for theft or damage not covered by the warranty and therefore would be advised to consider personal insurance for the device. Funding for infusion sets and cartridges would be restricted to one pack per month and one Animas battery cap would be funded every six months. Background The Diabetes Subcommittee, at its March 2011 meeting, and PTAC, at its May 2011 meeting, each made positive recommendations to fund insulin pumps.

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In August 2011, PHARMAC began an RFP process inviting proposals for the sole, dual or standard supply of diabetes management products which included blood glucose diagnostic test strips and meters, blood ketone test strips and meters, urine ketone test strips, insulin pumps and consumables and rapid acting insulin. Details of the RFP can be found at the following link: http://pharmac.govt.nz/2011/08/26. Following the evaluation of all proposals, we have entered into a provisional agreement with NZMS for the supply of Animas 2020 insulin pumps and consumables. In addition, NZMS would supply Paradigm insulin pump cartridges with a luer lock connection to enable patients eligible for funding to continue to use their Paradigm insulin pump and receive funded consumables. The provisional agreement includes service specifications which include an urgent replacement policy, 24 hour technical support and would require NZMS to provide training and support to clinicians and patients. The provisional agreement is for dual supply and therefore would enable PHARMAC to list one other brand of insulin pump and consumables. We are not proposing to list another supplier at this time; however it would remain a possibility for the future. Developing criteria that would target patients most likely to benefit from insulin pumps has been challenging. The aim of our proposal is to target funding for patients with significant instability of glycaemic control despite optimum treatment with a multiple daily injection regimen with analogue insulin’s. The aims of insulin pump therapy would be to either reduce severe hypoglycaemic events or to enable closer blood glucose control and reduction of HbA1c. Introducing measureable outcomes into the renewal criteria provides greater certainty that patients would continue to receive benefit from treatment and would improve the cost effectiveness of insulin pump therapy. As part of the application, a determination of the patient’s suitability for an insulin pump would need to be made. We are proposing that insulin pump funding is initially administered via a panel of clinicians. The panel would use the Special Authority criteria to determine funding for pumps. An application form would be developed which would be available for download from the PHARMAC website. In addition to new patient applications, a panel would assess applications for patients currently using insulin pumps who may be eligible under the proposed criteria. The approval period for insulin pumps would be three months, a sufficient period of time to present a prescription prior to the patient’s initiation day. The distribution of insulin pumps and consumables would be via community or hospital pharmacy. In the event that this proposal is approved, further information would be distributed prior to listing to educate pharmacists and patients to ensure that the patient’s trial of their insulin pump is co-ordinated with their induction training. One pack of insulin pump infusion sets and cartridges would be funded per month. The Animas 2020 pump requires the battery cap to be replaced every 6 months in order to maintain its water-resistance and these would be funded. The Animas 2020 pump operates with AA 1.5V lithium batteries which would not be funded.

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