Evolution of evidence underpins PHARMAC’s pembrolizumab funding decision
PHARMAC is pleased to announce the funding of pembrolizumab, following successful commercial negotiations and evolution in evidence, says PHARMAC Director of Operations, Sarah Fitt.
From 1 September, pembrolizumab (Keytruda) will provide an additional treatment option for melanoma patients.
PHARMAC has remained open-minded to funding Keytruda since an application for funding was made by the supplier, Merck Sharp & Dohme (MSD), and has worked constructively with MSD to reach a favourable commercial arrangement.
“Clinical evidence constantly evolves, especially in new areas of medicine, and PHARMAC’s job is to assess new information as it becomes available” says Ms Fitt.
“Since we first received the funding application for pembrolizumab, new information has emerged that has given PHARMAC the confidence we needed to progress the funding decision.
“PHARMAC has been able to adapt to an evolving evidence base and changes in affordability that have come with our negotiations with MSD and an increase in the medicines budget.
“This reflects the flexibility of the PHARMAC model, while allowing us to make the high-quality decisions New Zealanders expect.”
As a part of the deal, PHARMAC will also fund a modified-release tablet form of the antifungal agent posaconazole (Noxafil) from 1 September 2016.
In addition to background information below, more information on today’s announcement can be found in the notification letter [link no longer available].
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Background
Further background
The proposal to fund pembrolizumab is a result of evolving information and better commercial proposals over time. This has been summarised below, as a sequence of specific phases:
- September 2015 – funding application to fund pembrolizumab was received.
- PHARMAC’s clinical advisers gave this application a low funding priority – influenced by the early evidence base, uncertainty about the longer term benefits and risks, and the very high cost.
- The application remained under review as PHARMAC continued discussions with the supplier over supply terms and pricing.
- April 2016 – funding application to fund a competitor product, nivolumab, was received.
- Clinical advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Cancer Treatments Subcommittee of PTAC (CaTSoP) was that the evidence for this treatment was, at the time, stronger than for pembrolizumab due to the clinical trial design.
- May 2016 – consulted on the funding of nivolumab
- It was during this consultation that our view of the evidence base for the class of medicines pembrolizumab and nivolumab are a part of, known as PD-1 inhibitors, evolved. This occurred as a result of two key inputs:
- a consensus statement from a number of medical oncologists who told PHARMAC that, in their view, nivolumab and pembrolizumab are considered clinically similar to the extent that they were comfortable switching patients from one treatment to the other; and
- further advice from PTAC and CaTSoP was received. They noted that the currently available evidence is consistent with different PD-1 inhibitors (i.e. pembrolizumab and nivolumab) providing the same or similar therapeutic effect in the treatment of advanced melanoma.
- It was during this consultation that our view of the evidence base for the class of medicines pembrolizumab and nivolumab are a part of, known as PD-1 inhibitors, evolved. This occurred as a result of two key inputs:
- June 2016 – decision made on the funding of nivolumab from 1 July 2016 and consulted on the funding of pembrolizumab
- As a result of the evolution of evidence, PHARMAC was more confident in the clinical efficacy and long term benefits of pembrolizumab.
- The commercial terms that PHARMAC was able to secure through negotiations with MSD were significantly better than in the original funding application.
- July 2016 – decision made on the funding of pembrolizumab from 1 September 2016.
Throughout this whole process, PHARMAC has remained open-minded to funding pembrolizumab and has continued to work with the supplier MSD throughout the process.