Inpharmation - August 2015
In this issue:
- From the Chief Executive
- Public help us refresh our decision making: Factors for Consideration
- Talking with suppliers and diabetes groups about blood glucose meters and test strips
- Haemophilia treatment changes
- Late stage prostate cancer drug - abiraterone funded
- Seeking your views – funding of TNF Inhibitors
- Agreement with Rotorua whānau ora collective
- New CAC membership and leadership
- Prof Mark Weatherall appointed chair of clinical committee PTAC
- Named Patient Pharmaceutical Assessment (NPPA) policy review
From the Chief Executive
The Minister of Health has approved an increase to the Combined Pharmaceutical Budget of $5 million, taking it to $800 million this year. As usual, we will be working hard to secure the best health outcomes for New Zealanders from within the range of options available to us.
Central to managing within Athis budget is maintaining funding for products that are currently available, meeting the continued growth in demand for them and, where we can, adding new products to the Schedule that provide additional health gains for New Zealanders.
In order to meet this goal we do need to make savings. Every year New Zealanders’ use of medicine grows by around 3-4 percent, which equates to about $40 to $60 million. So PHARMAC needs to have active programmes to reduce the costs of existing medicines, through a range of commercial activities such as our annual multi-product tender or the use of reference pricing, or negotiation.
Our impact on health outcomes isn’t just limited to pharmaceuticals. If not for PHARMAC’s work, DHBs would have to fund the growth in spending from within their existing budgets. That $40-$60 million per year would quickly compound and place severe strain on DHBs’ ability to provide comprehensive health services.
We’re confident in our ability to fund the medicines needed in our communities and to improve people’s health outcomes. We achieve this by working closely with clinicians who provide regular feedback to our consultations and participate in a range of advisory committees and panels. This includes having pharmacy representation on our Tender medical committee, so that the range of issues we need to consider are understood
In November last year, PHARMAC announced a new framework for decision-making including the Factors for Consideration which replace our nine decision criteria. These were developed after a number of significant consultation rounds with the public. To help explain these we have developed an interactive tool that you can use on our website.
We will begin implementing the new decision-making framework from late this year. At that time, there will be some changes to the information we request for Schedule funding applications. You will be able to find this information in our Guidelines for Funding Applications to PHARMAC when they are updated later this year. We will let you know when these become available.
There is a significant amount of work involved in implementing the framework. A lengthy lead-in time will help ensure it is implemented as smoothly as possible. We will be engaging with people throughout the year to help familiarise them with the new framework and to help them and us understand what the changes will mean in practice before they come into effect.
In the meantime, the current Decision Criteria will continue to be used to make funding decisions.
PHARMAC has started the first stage in the procurement process for the supply of blood glucose meters and test strips used by people living with diabetes. We are talking with diabetes groups and experts around the country throughout this process about how we do this and what issues are important for them.
PHARMAC has issued an Expression of Interest (EOI) document for suppliers to respond to. The EOI is open until 10 August. This will lead to the second stage later in the year, a commercial Request for Proposals (RFP) from suppliers. It’s likely to be a further year before we make any changes to funding.
In this first stage, after the close of the EOI, the meters and test strips will be laboratory tested using an independently developed laboratory protocol, and also by health professionals who work with people with diabetes.
There will be further end-user testing by people living with diabetes during the RFP stage.
The sole supply contract for CareSens meters ended on 1 July, however until any future decisions are made funding of CareSens meters and test strips will continue.
About 110,000 people now use the CareSens meters to manage the monitoring of their blood glucose levels.
PHARMAC is moving to have a preferred brand of recombinant Factor VIII, while also maintaining full funding for the other three currently-funded haemophilia products. These changes will take effect from 1 September.
Recombinant blood factors are essential treatments for patients with haemophilia.
There are about 600 people in New Zealand with haemophilia. About 230 of them use Factor VIII each year and around half of these people may be required to participate in a clinician-managed brand change.
Under the changes, Xyntha will become the preferred brand of Factor VIII. For patients who can’t receive Xyntha for clinical reasons, two other brands will be available through application to a Haemophilia Treatments Panel that PHARMAC will establish and co-ordinate.
PHARMAC is following the lead of countries like the United Kingdom and Australia, where similar changes have been safely made.
Before making its decision, PHARMAC sought advice from specialist haemophilia treaters and the Haemophilia Foundation. This has helped PHARMAC understand the concerns of both health professionals and patients with haemophilia.
PHARMAC will support health professionals and patients, and work closely with haemophilia treaters and the Foundation throughout the implementation process.
The changes are driven by the need to manage the affordability and sustainability of haemophilia treatments into the future.
New Zealand spends approximately $25 million each year on these treatments, including $18 million for Factor VIII. Similar approaches overseas have resulted in savings of as much as 50 percent.
PHARMAC began funding for the oral prostate cancer treatment abiraterone (Zytiga) from 1 May 2015. As the most commonly-diagnosed form of cancer among New Zealand men, we estimate the funding of abiraterone will potentially benefit up to 1000 men annually.
Funding for abiraterone is for men with an advanced form of prostate cancer: metastatic castration-resistant prostate cancer. Savings and rebates in the multi-product agreement with the supplier Janssen have helped reduce the overall cost of abiraterone.
Clinical trials show abiraterone significantly improves the quality of life for men with advanced prostate cancer and extends life by around five months.
PHARMAC is currently consulting on a proposal to reduce spending on two of New Zealand most costly yet much-needed medicines. Adalimumab (Humira) and etanercept (Enbrel) are from a class of ‘biologic’ medicines called TNF-alpha inhibitors, which are used to treat autoimmune and immune-mediated conditions including rheumatoid arthritis.
The proposal would change the funding conditions for adalimumab, while the funding of etanercept would remain unchanged except for price and contractual terms.
Any proposed changes wouldn’t affect people who are already taking these medicines. They would continue to take and receive funding for the medicine they are currently using. Changes would only apply to new patients from 1 January 2016 at the earliest.
Both etanercept and adalimumab are funded to treat rheumatology (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, adult-onset Still’s disease) and dermatology conditions (plaque psoriasis and pyoderma gangrenosum).
Our proposal is to change the funding rules so any rheumatology or dermatology patients new to TNF-alpha inhibitor therapy and who meet the funding criteria would need to first access funded etanercept. If their condition doesn’t respond or they cannot tolerate etanercept, they could then have funded access to adalimumab.
Consultation is open until 11 August.
The proposal is expected to release more than $20 million savings over five years that would enable us to reinvest in other medicines. This could then be used to fund things like further vaccines, or other medicines.
Adalimumab is also funded for treatment of Crohn’s disease and fistulising Crohn’s disease. There is no proposal to change funding for these indications.
PHARMAC has signed a further Memorandum of Agreement, this time with the Te Arawa Whānau Ora Collective in Rotorua.
The agreement is the latest struck by PHARMAC with community groups, through which PHARMAC can support delivery of programmes. Memoranda have been signed with two
Bay of Plenty whānau ora collectives, and with the Māori Pharmacists Association.
Having reached an agreement, PHARMAC will work closely with the Collective on schedules of service to initially part-fund two health-focussed workshops/hui per annum.
The agreements signal PHARMAC’s intention to be long-term partners with whānau for delivering health programmes to Māori.
The agreements are consistent with PHARMAC’s Te Whaioranga strategy – to promote tino rangatiratanga with whānau in health interventions.
Wellington smoking cessation advocate Shane Bradbrook has been appointed chair of PHARMAC’s Consumer Advisory Committee.
Shane Bradbrook, a member of the Committee since 2010, will succeed Kate Russell when her term on the Committee ends on 31 July.
The Consumer Advisory Committee is a statutory advisory committee to PHARMAC, with members appointed by the PHARMAC Board.
As well as Shane Bradbrook’s appointment, Auckland mental health consultant David Lui has been appointed as Deputy Chair.
And four new members have been appointed to fill vacancies that become available this year and next. The incoming members are:
- Stephanie Clare – acting Chief Executive of Parkinsons NZ, Wellington (appointed from 1 August 2015)
- Francesca Holloway – Northern Regional manager of Arthritis NZ, Auckland (appointed from 1 August 2016)
- Adrienne von Tunzelmann – Board member of Age Concern NZ and Osteoporosis NZ, Tauranga (appointed from 1 August 2015)
- Neil Woodhams – vice-president of Multiple Sclerosis NZ (appointed from 1 August 2015).
The Director-General of the Ministry of Health has appointed a new Chair and two new members to the Pharmacology and Therapeutics Advisory Committee (PTAC).
PTAC is a statutory committee that provides clinical input to PHARMAC. It reviews clinical evidence around Pharmaceutical Schedule funding applications and provides recommendations to PHARMAC.
Professor Mark Weatherall has been appointed as the incoming Chair of the Committee effective 1 November 2015. He will succeed Wellington general physician Sisira Jayathissa whose term on the Committee is coming to an end.
Prof Weatherall, a specialist geriatrician, has been a member of PTAC since October 2008.
Also joining PTAC from 1 November 2015 will be Dr Giles Newton-Howes, a Wellington-based psychiatrist, and Associate Professor Alan Fraser, a general physician and gastroenterologist from Auckland.
Dr Newton-Howes is currently a Senior Lecturer in the Department of Psychological Medicine at the University of Otago in Wellington. He has served as a medical member of an ethics committee and acts as a systematic reviews editor for the British Journal of Psychiatry.
Assoc Prof Fraser is an established academic teacher, researcher and editor of international journals. He has broad experience working with both PHARMAC and Ministry of Health, and has been a member of PTAC’s Gastrointestinal Subcommittee since 2008.
PHARMAC has completed the review of its NPPA policy, part of its ongoing Operating Policies and Procedures review. As a result of the review, a revised NPPA policy is included as part of a new Exceptional Circumstances Framework.
The feedback received during consultation was that the NPPA Policy was difficult to interpret and apply, and the application process could be cumbersome. We have made changes to ensure the policy is clearer and easier to use. Additionally, we are streamlining and simplifying the application process, and developing an online form to make it easier to apply.
The intent of the NPPA policy has not changed. This means that previous NPPA decisions would not change under the new Framework unless new information is available to support the application.
The new Exceptional Circumstances Framework is expected to come into effect in the later in 2015.
Last updated: 3 December 2018