‘Yes’ for B-MS’ skin cancer drug Yervoy leads SMC decisions

by | 9th Apr 2013 | News

Patients with advanced skin cancer living in Scotland will be given National Health Service access to the first new medicine for the disease to be licensed in the UK in more than 30 years.

Patients with advanced skin cancer living in Scotland will be given National Health Service access to the first new medicine for the disease to be licensed in the UK in more than 30 years.

Cost watchdog the Scottish Medicines Consortium has published final guidance recommending the use of Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with previously-treated advanced (unresectable or metastatic) melanoma on NHS Scotland.

According to B-MS, the decision means that patients in the country will be able to receive treatment with the first drug for the condition to show improved survival in a Phase III trial.

Indeed, the economic analysis included data from a study showing that, in previously treated patients with advanced melanoma, those given Yervoy survived 3.6 months longer than patients given the investigational cancer vaccine gp100.

In addition, B-MS has also offered a discount on the price of the medicine under a Patient Access Scheme to help improve its cost-effectiveness and persuade the SMC that the drug is indeed value for money.

Welcoming the decision, Tim Crook, Consultant Medical Oncologist at the University of Dundee, said Yervoy represents “a genuine step change in the treatment of advanced melanoma”, stressing that for many patients in Scotland the decision “could mean more months of life and, for some, there may also be potential for longer-term disease control”.

More decisions

Elsewhere, Bayer’s Eylea (aflibercept) was approved for use in patients with neovascular (wet) age-related macular degeneration, after the SMC certified its cost-effectiveness (also with the help of a PAS).

Rival drugmaker Novartis welcomed the decision, which, it states, will provide an additional treatment option for patients with the condition.

Nevertheless, the availability of Eylea could take a bite out of sales of its Lucentis (ranibizumab), which has become the gold-standard therapy for this leading cause of sight loss.

And Novartis was also quick to point out that Bayer’s drug showed “no additional benefits” over Lucentis “in relation to efficacy or duration of action”.

SMC approvals were also handed out to: Sanofi’s Lantus (insulin glargine) for the treatment of diabetes mellitus in adults, adolescents and children from age two; Janssen-Cilag’s Prezista (darunavir) for HIV-1 infection in adults as well as antiretroviral therapy-experienced paediatric patients from the age of three years (and 15kg); AbbVie’s Humira (adalimumab) for certain adults with severe axial spondyloarthritis; and B-MS’ Orencia (abatacept) for restricted for use in patients with active rheumatoid arthritis, as measured by disease activity score greater than 5.1 confirmed on at least two occasions.

On the downside, rejections – on the basis of weak economic cases – came for: Pfizer’s renal cell carcinoma drug Inlyta (axitinib); Allergan’s Botox (botulinum toxin type A) for the prophylaxis of headaches in adults with chronic migraine; and Novo Nordisk’s Tresiba (insulin degludec) for the treatment of diabetes mellitus in adults.

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