Today, Bristol-Myers Squibb is pleased to welcome the decision by The National Institute for Health and Clinical Excellence (NICE) to recommend Yervoy (ipilimumab) for the treatment of previously-treated advanced (unresectable or metastatic) melanoma within the Final Appraisal Determination (FAD). This landmark announcement will enable patients in England and Wales suffering from this terminal illness to routinely access treatment with ipilimumab – the first treatment to demonstrate improved survival for patients with advanced melanoma and the first medicine to be licensed in the UK for the treatment of this disease since dacarbazine in the 1970s.2 Bristol-Myers Squibb have collaborated closely with NICE over the past year and the Company is pleased to have met all the clinical and economic requirements needed to reach today's positive recommendation.
“Today's decision is very welcome news and marks a major milestone in the treatment of advanced melanoma,” said Dr. Paul Lorigan, Senior Lecturer in Medical Oncology, the Christie NHS Foundation Trust. “Ipilimumab's potential to provide a long-term survival benefit in some patients makes it an important treatment option and represents a genuine step change in the management of this disease.”
Within its appraisal NICE acknowledged that ipilimumab represented a step-change in the treatment of advanced melanoma, a generally fatal disease with a median overall survival of just 6 to 9 months.3 In ipilimumab's pivotal Phase III clinical trial, published in The New England Journal of Medicine, 46% (63 people out of 137) of patients were still alive at one year in the ipilimumab arm and 25% (34 people out of 136) in the comparator arm, a vaccine called gp100. The median overall survival was 10.1 months among patients receiving ipilimumab alone, compared to 6.4 months among patients receiving gp100 alone.4 In some patients treated with ipilimumab long-term survival has been observed, with over 4.5 years of follow-up.5 The safety profile of ipilimumab is considered to be related to its mechanism of action as an immunotherapy. Immune-related adverse reactions, which can be severe or life threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Early diagnosis and appropriate management of adverse events using established product-specific guidelines are essential to minimise complications.
Commenting on NICE's decision, Gill Nuttall, Factor 50, said “Today's decision by NICE is very welcome news for patients with advanced melanoma, who have waited such a long time for any new treatment options that have the potential to extend life. The important thing now will be for positive guidance to be implemented as soon as possible so that suitable patients can be given a chance to benefit from this treatment.”
Ipilimumab is a fully human monoclonal antibody that works in a new way: by stimulating the body's own immune system to fight melanoma. Around 12,800 people in the UK are diagnosed with melanoma each year and, although the majority of skin cancers are treatable, this disease still kills over 2,200 people in the UK each year.6 Each day more than two young adults aged 15-34 in the UK are diagnosed with malignant melanoma.6 Over the last 30 years, the rate of melanoma in the UK has risen faster than any of the top 10 cancers in males and females and more average years of life are lost from melanoma than in many other cancers (approximately 22).7
Amadou Diarra, European Vice-President and General Manager, Bristol-Myers Squibb UK & Ireland, said, “Bristol-Myers Squibb is committed to leading advances in immuno-oncology. Recent developments in this area have provided further scientific evidence that these novel agents play a role in mediating cancer regression. This, coupled with the growing use of immunotherapies, has resulted in an increasing recognition of these medicines as a fourth pillar of the cancer-treatment platform. Ipilimumab's mechanism of action and its potential for long term survival in some patients, represents a fine example of medical innovation tackling a significant unmet clinical need. The Government has stated that access to innovative medicines is a key driver for better patient outcomes and today's decision from NICE supports this.”
Source: Bristol-Myers Squibb
What BMS doesn't sat in their press releases is always the real story:
1) that the action by NICE is limited to second-line use;
2) that they were forced to file a Patient Access Scheme reducing the price because they set the original price at an exorbitantly high level to take advantage of legislatively mandated patient access in the US;
3) that Roche also gained NICE approval for its BRAF inhibitor: and that they have been moving very slowly to gain FDA approval for their widely acclaimed version of anti-PD-1.
That being said, I am very happy to learn that metastatic melanoma patients in England and Wales will finally have access to these new drugs from BMS and Roche. Perhaps Scotland will be next? Perhaps Bristol Meyers-Squibb will speed up its efforts to bring anti-PD-1 to market and respond to the world-wide demand by melanoma patients, melanoma advocates and the entire oncology community.