PHARMAC has given the breakthrough melanoma drug Pembrolizumab a “low” priority – effectively meaning it won’t get funded. This is the fourth time funding has been declined for a melanoma treatment by PHARMAC.
The drug is already being funded in the US, UK and Australia, and works by allowing the immune system to fight advanced melanoma more effectively, shrinking tumours with fewer side effects than existing treatments, although it comes with a hefty price tag.
This means that the current PHARMAC-funded option for advanced melanoma in New Zealand is chemotherapy with Dacarbazine – a drug that has never been shown to extend life in melanoma.
Cancer Society Medical Director Dr Chris Jackson, says that “currently available treatments in New Zealand are well behind what are available in similar countries. PHARMAC seem to be saying that chemotherapy is the best treatment for patients with advanced melanoma – and that is very hard to understand.”
The previously declined treatments are ipilimumab, dabrafenib, and vemurafenib. Several of these scored 4/5 on the ESMO Magnitude of Clinical Benefit Scale (5 being the highest possible rating, and restricted to very few drugs in cancer).
PHARMAC have said they think the evidence for pembrolizumab is too immature and that longer term results are needed, but Jackson says this highlights a weakness of their evaluation system.
“PHARMAC’s system doesn’t cope with these breakthrough cancer drugs that have early but compelling data. The US Food and Drug Administration (FDA) has an ‘accelerated approval’ system, which recognises areas of unmet need, and grants approval for drugs pending longer term data. The UK also has an ‘Early Access to Medicines’ Scheme’, which could be another model for New Zealand to consider.
“Not every new cancer drug is an improvement on the last, and cost has to be considered. But melanoma is a disease with huge unmet need, and so patients, families, and oncologists around the country are going to be bitterly disappointed with this decision”.
TABLE: Excerpt from the ESMO Magnitude of Clinical Benefit summary of treatments for melanoma (completed prior to pembrolizumab studies)
UK Early Access to Medicines’ Scheme: http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/early-access-to-medicines-scheme
ESMO Magnitude of Clinical Benefit Scale: http://www.esmo.org/Policy/Magnitude-of-Clinical-Benefit-Scale/Manuscript
UK National Institute of Clinical Excellence recommendation on pembrolizumab: https://www.nice.org.uk/guidance/ta357
US FDA Accelerated Approval system: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm