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A new paper to be published today highlights the lack of patient access to new therapies to treat melanoma in New Zealand.

The paper, authored by Michael Wonder of Wonder Drug Consulting and MAESTrO and medical oncologist Dr Rosalie Fisher, will be published in the New Zealand Medical Journal.

The paper compares reimbursed access to recent innovations in the treatment of melanoma, including BRAF and MEK inhibitors, and immune checkpoint inhibitors, across the UK, Australia and New Zealand.

"Melanoma is a particular health concern in Australia and New Zealand - countries with the highest global incidence of melanoma - and in the United Kingdom, where the incidence of melanoma has risen more rapidly over the last 30 years than those of the 10 most common cancers," say the authors.

"Significant advances have occurred in the drug treatment of patients with metastatic melanoma since 2010. The development of the BRAF and MEK inhibitors, and immune checkpoint inhibitors, offer unprecedented clinical benefits to patients with advanced disease.

"Important advantages of these novel drugs are their ability to treat sites of disease previously viewed as refractory to systemic therapy, and manageable toxicity profiles. As a result, there has been accelerated regulatory approval of some of these agents.

"However, all of these treatments are high-cost, and the reimbursement process fundamentally drives access to them. Timely access to at least one agent in each class of drug is critical in New Zealand, Australia and England, where metastatic melanoma is a major public health concern.

"When confronted by the evidence surrounding the funding process in the three countries, the differences are stark," they say.

Wonder and Fisher say agencies in Australia and England, recognising the unmet need of melanoma patients and acknowledging the importance of equitable geographical access, have taken innovative and extraordinary measures to make at least one drug from each novel class available in a timely manner.

"The recommendation by a technical advisory committee (PTAC) that PHARMAC run a competitive tender to fund one of ipilimumab, vemurafenib and dabrafenib mesylate, is unusual; we are not aware of the PBAC or any of the NICE Appraisal Committees having provided similar tactical advice to their corresponding bureaucracies.

"Furthermore, the PTAC recommendation that PHARMAC run a competitive tender to fund medicines that have different modes of action undermines the basic science and makes one start to question whether the primary focus of the Committee is science (pharmacology) or finance (money)."

PHARMAC has faced significant criticism over its failure to reimburse melanoma therapies. It recently funded Bristol-Myers Squibb's checkpoint inhibitor OPDIVO for advanced melanoma and will shortly fund MSD's KEYTRUDA (pembrolizumab). However, it has not funded Novartis' TAFINLAR (dabrafenib) or Roche's ZELBORAF (vemurafenib).

"These new medicines are expensive but they are also effective," say the authors. "We are not calling for their immediate reimbursement without a thorough and fair assessment of their value (eg, cost effectiveness). The PBAC rejected most of the initial submissions for these medicines. Nonetheless, we urge the Government and/or PHARMAC to find solutions to the current unacceptable access stalemate.

"New Zealanders with melanoma deserve better than this; we suspect that patients are suffering to the point of dying due as a result.

"It is nigh on impossible to obtain empirical data to prove this; whilst it is (somewhat) easy for PHARMAC to calculate how much money it has saved, it is much harder to determine how many lives have been lost as a consequence.

"New Zealand should not be in the unenviable position whereby it has the highest incidence of a fatal disease yet it is the last country in the Western world to fund effective treatments for it."

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