* Melanoma treatment Yervoy costs around 80,000 pounds a patient
* NICE says costs too high, longer-term benefits not clear enough
* Cost watchdog says draft guidance subject to appeal, revision
By Kate Kelland
LONDON, Oct 14 (Reuters) - Bristol-Myers Squibb’s Yervoy -- the first drug to help patients with advanced melanoma live longer -- is not cost effective for use in the taxpayer-funded National Health Service (NHS), Britain’s health costs watchdog said on Friday.
In a move which angered patient groups, the National Institute for Health and Clinical Excellence (NICE) said Yervoy, or ipilimumab -- which costs around 20,000 pounds ($31,550) a dose and is given in four doses -- could not be recommended because its longer-term benefits were not clear.
“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,” NICE’s chief executive Andrew Dillon said in a statement.
He said BMS may want to “consider whether it wishes to reduce the acquisition cost to the NHS of the drug”, since Yervoy costs around 80,000 pounds ($126,000) per patient whether the treatment is effective for them or not.
Advanced melanoma, a type of skin cancer, can quickly spread from the skin to internal organs, such as the brain and often kills its victims in months.
Yervoy is the first approved therapy to clearly demonstrate that patients with metastatic melanoma live longer, and patient groups said NICE’s decision against it was like handing down a “death sentence” to patients who could benefit from the drug.
The treatment was approved by drugs regulators in the United States in March and was in May recommended for approval in Europe by the European Medicines Agency.
According to Thomson Reuters Pharma data, market analysts see worldwide sales of Yervoy reaching $1.46 billion in 2016. ($1 = 0.634 British Pounds)
But Dillon said NICE was not convinced by the data BMS submitted.
He said the key numbers came from a trial which did not compare Yervoy with the drugs currently used to treat people with advanced or metastatic melanoma, although he added that “the results did show the drug could potentially be very effective for a small percentage of patients”.
“However, the follow up from the trial was too short to determine how long this effect would last,” he said.
“Clinical specialists also told the independent appraisal committee that only around 30 percent of people treated with ipilimumab would have improved survival, with only 10 percent potentially experiencing long-term benefits,” he added.
The drug is also linked with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain, Dillon said.
“The committee considered all these factors and concluded that ... ipilimumab could not be considered a cost effective use of NHS resources,” he said.
NICE said this decision was initial draft guidance and would be open for consultation -- including input from the manufacturer, healthcare professionals and members of the public -- before being issued to the NHS.
Patient support group Factor 50 and a leading UK skin cancer charity SKCIN said Yervoy was the “breakthrough that patients and clinicians... have been waiting for”.
They accused NICE of handing a “death sentence” to patients and urged it to reconsider its preliminary decision.
“Patients waiting for this decision were all hoping and praying that it would be favourable,” they said in a joint statement. “They are completely shattered, but have vowed, in the time they have left, to try and counter the decision.”