Insulin pump and consumables access changes
PHARMAC is pleased to announce a change to the mechanism of application for funding to insulin pumps and consumables.
In summary, from 1 July 2016 the effect of the decision is that:
- applications for insulin pumps and consumables will be processed through the standard Special Authority system as an electronic or hard copy form;
- there will be amended Special Authority criteria for access to insulin pumps and consumables; and
- the Insulin Pump Panel will be disestablished from 1 July 2016.
The proposal was approved as consulted on, except for an amendment to the implementation date. This was proposed to be 1 March 2016, but will be 1 July 2016.
Details of the decision
The Insulin Pump Panel will be disestablished effective 1 July 2016. We take this opportunity to thank and acknowledge members of the Insulin Pump Panel for their contribution.
Treating health professionals will still be able to access funded insulin pumps and consumables for their patients, noting the following changes to the mechanism from 1 July 2016:
- Applications for funded insulin pumps and consumables from a relevant Specialist or Nurse Practitioner working within their vocational scope and as part of a multidisciplinary team will now be made either electronically or in written form as per the usual Special Authority process.
- Amendments have been made to the Special Authority criteria for access to funded insulin pumps and consumables. The Special Authority criteria will be detailed in Section B of the Pharmaceutical Schedule and are set out in full in the consultation letter referred to above. The key amendments to the criteria are:
- Detailing HbA1c ranges in both the hypoglycaemic and HbA1c categories, specifically;
- In an initial application for the ‘haemoglobin A1c (HbA1c)’ category, the patient must have an HbA1c range between the following: equal to or greater than 65 mmol/mol and equal to or less than 90 mmol/mol.
- In an initial application for the ‘severe hypoglycaemia’ category the patient must have an HbA1c range between the following: equal to or greater than 53 mmol/mol and equal to or less than 90 mmol/mol.
- Creating a separate category for people who have accessed pump therapy prior to 1 September 2012 (these patients are known colloquially as grandparented patients), specifically;
- Detailing HbA1c ranges that the patient has achieved and is maintaining an HbA1c of equal to or less than 80 mmol/mol and that the patients HbA1c has not deteriorated more than 5 mmol/mol from baseline.
- The Special Authority criteria outline clinical parameters for patients to access funded insulin pumps and consumables. All patients that do not meet the criteria will not be eligible for funded products, unless a separate approval is granted through PHARMAC’s regular exceptional circumstances processes.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 29 September 2015 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:
|Concerns were raised regarding changes to the HbA1c clinical parameters in both the hypoglycaemic and HbA1c categories of the criteria.||The purpose of the criteria is to target funded access to insulin pumps and consumables to patients who will achieve the best health outcomes from pump therapy. With that in mind, the criteria were developed with the input of experts advice in relation to both adult and paediatric patients.|
|One respondent disagreed with the renewal criteria for severe hypos being that the HbA1c has not increased by more than 5 mmol/mol from baseline, proposing instead 15 mmol/mol as a deterioration criterion.||Our clinical advice is that any increase in HbA1c over 5 mmol/mol (ie the proposed 15 mmol/mol) in conjunction with a decrease in hypoglycaemic events could likely have been achieved on multiple daily injections (MDI).|
|One respondent questioned the difference in initial approval periods between pump hardware and consumables ie 3 months and 9 months respectively.||The difference in initial approval periods is to enable patients to collect their pump within 3 months of approval. A pump only requires dispensing once every 4 years. The 9 month initial approval period for consumables allows patients to start treatment and have multiple dispensings of consumables to get used to using the pump, following pump initiation training. After 9 months a reassessment of benefit is conducted for the purposes of a renewal application for ongoing funding of consumables.|
|One respondent proposed that PHARMAC should credential individual physicians to dispense pumps – one per DHB||PHARMAC is responsible for determining which pharmaceuticals will be funded and their criteria for funding. How services are implemented and delivered is the responsibility of each DHB.|
|Concerns were raised with the term ‘relevant specialist’ being an appropriate applicant type on the Special Authority, citing that patients need to be managed under a Multi- Disciplinary Team (MDT) scenario that GPs (who may be relevant specialists) are not included in.||‘Relevant specialist’ is defined in the Pharmaceutical Schedule as including Vocationally Registered General Practitioners (VRGP). The definition also includes the fact that the specialist must be working within a vocational scope related to the product being prescribed, which in this case would mean diabetes treatment. For the purposes of applying for funded access to insulin pumps or consumables, the Special Authority criteria also require that the relevant specialist is working within a MDT.|
|One respondent noted that there was no appeal process when a pump application is rejected.||The funding criteria provide clinical parameters for patients to access funded insulin pumps and consumables. Patients who do not meet the criteria will not be eligible for funding via this process. If an applicant thinks a patient meets the spirit and intent of the criteria (but not the technical requirements) they can apply for a special authority waiver. See here for information on how to apply for a waiver [link no longer available]. For other patients with exceptional circumstances, a NPPA application may be an appropriate route to seek funding.|
If you have any questions about this decision, you can email us at firstname.lastname@example.org