Well-known oncologist and Senator, Prof John Crown has called for a drug which treats advanced malignant melanomas to be made available to Irish patients, though it will be of limited effectiveness for most of them and will cost €85,000 per treatment.
The drug, Ipilimumab (Yervoy), which is made by Bristol Myers Squibb, has been turned down by the National Centre for Pharmoceconomics (NCPE) on the basis of cost and is now being considered by the National Cancer Control Programme’s (NCCP) technology review group.
Bristol Myers Squibb has disputed the valuation it is putting on the drug saying the €85,000 figure, provided by the NCPE, is not the current cost under discussion with the HSE.
Prof Crown, who practises as an oncologist at St Vincent’s Hospital in Dublin, said Yervoy had such a dramatic impact on those patients who responded to it, it should be given to every eligible patient.
He estimated about half of the 200 people annually diagnosed with advanced malignant melanoma could qualify for the drug at an annual cost of €10 million.
He maintained that evidence from the United States showed about 20 per cent of patients, who would otherwise have very poor outcomes, had gone into long-term remission and possible cure as a result of taking the drug.
“I want to see this drug being used. As a set of oncologists we should get our heads together and make reasonable guidelines for its reasonable use,” he said.
Prof Crown said the cost of the drug was worth it despite cuts in the health budget and the state of the economy in general.
Yervoy is regarded as offering hope for those with malignant melanoma along with a class of drugs called B-Raf inhibitors (most notably Vemurafenib) which target a mutation in the B-Raf gene which is present in about 60 per cent of people with the cancer.
The first Irish patient treated with it showed considerable tumour shrinkage.
The drug was given free as part of a trial.
The NCCP will now have to decide if it is going to fund Yervoy following a report from the NPCE which is tasked with evaluating the economic effectiveness of new drugs.
NCPE clinical director Dr Michael Barry said they based their decision on a study in the New England Journal of Medicine which found a median survival rate of 3.7 months extra for patients who took the drugs.
Based on those figures, the cost effectiveness was €147,899 per quality of life year (QALY) gained and €92,433 per life year gained (LYG). The drug “greatly exceeds” the threshold of €45,000 for QALY and €20,000 for LYG respectively, he said.
Dr Barry said they might reconsider if the drug company halved the cost of the treatment and found an effective way of targeting the patients who will respond to it.
“The problem for this drug, unlike other drugs, is that we have no marker to identify those patients who will do very well on this drug.”
In a statement the NCPP said its review committee is constituted from across the spectrum of clinicians with representatives with expertise in epidemiology, statistics, pharmacy and pharaeconomics.
Recommendations from the committee are received by the national director of the NCCP and are brought before the HSE senior management team.
"This process is not yet complete and no final decision regarding the introduction of this particular drug has been made," the statement concluded.
