NICE has failed to recommend Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab) for advanced melanoma, deeming its £80,000 price tag too costly.
NICE’s Appraisal Committee based its decision on clinical data that suggested the drug could be very effective for a small percentage of patients with advanced skin cancer who have received prior chemotherapy – but it was unknown how long this effect would last.
Sir Andrew Dillon, Chief Executive of NICE said: “We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.”
Clinical specialists said that approximately 30% of people treated with the medicine would have improved survival, with 10% potentially experiencing long-term benefits.
Sir Andrew added: “Unfortunately, no patient characteristics or biomarkers have yet been identified to help identify this small group of people most likely to gain long-term benefit from receiving ipilimumab.”
The Committee also cited that Yervoy is associated with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.
BMS expressed its disappointment at NICE’s rejection, and have stated it will submit further evidence “in the hope that NICE will reconsider this decision so that all patients with metastatic melanoma can access this potentially life‐extending treatment”.
“In a deadly disease with no standard of care, where inclusion in a clinical trial has been considered one of the few treatment options available to patients, Yervoy represents a significant innovation in treatment,” said Amadou Diarra, European Vice President and General Manager at BMS UK.
Dr Pippa Corrie, Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust, commented: “Treatment for metastatic melanoma is a huge unmet need, with many patients facing a life expectancy of 6‐9 months. It is essential that we all work to avoid any negative impact on facilitating patient access to this drug. Our patients have waited too long already.”
Consultees are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer will be able to reduce the acquisition cost of £80,000 to the NHS for ipilimumab by proposing a Patient Access Scheme.
BMS gained approval to market Yervoy in the US in March 2011, with an approval from the European Commission in July. The drug was launched in the UK in August 2011, becoming the first licensed treatment for advanced skin cancer since the 1970s.
There are approximately 40,000 deaths worldwide from skin cancer, with the number of cases predicted to double from 138,000 a year to 227,000 by 2019.