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NICE gives Roche's Zelboraf a draft no

Cites the skin cancer drug's high cost and uncertain long-term benefit

Roche Zelboraf vemurafenib skin cancer

Roche has failed to win the backing of the UK's National Institute for Health and Clinical Excellence (NICE) for its skin cancer drug Zelboraf.

NICE's draft guidance does not recommend the use of Zelboraf (vemurafenib) for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

The cost-effectiveness body took issue with the personalised cancer drug's long-term survival data, and decided that the patient access scheme Roche agreed with the Department of Health did not do enough to mitigate Zelboraf's high cost.

NICE's chief executive Sir Andrew Dillon 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. Vemurafenib is an expensive drug and its long-term benefits are difficult to quantify.

“Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations, which are available for public consultation. Roche can also provide further comment on the evidence it provided and have the opportunity to submit a further patient access scheme if they wish.”

NICE also said Roche had significantly underestimated the cost of using Zelboraf, which comes with an average price tag of £52,000 for a course of treatment.

Roche said its drug had a cost per QALY of £56,400, compared to dacarbazine, but NICE disagreed saying it had received estimates that put the cost of the drug's benefits at more than £133,000 per QALY. 

“The Committee agreed that the most plausible ICER for vemurafenib was highly uncertain and likely to be considerably higher than £50,000 per QALY gained,” NICE said.

The survival data Roche submitted came from a trial known as BRIM3, which showed the drug was effective for patients with melanoma with the BRAF V600 mutation.

This compared the twice-daily pill Zelboraf with the chemotherapy dacarbazine, administered intravenously every three weeks, and found it reduced the risk of death by 63 per cent for patients compared dacarbazine .

Roche's drug was also found to significantly improved survival by more than three months, at 13.2 months versus 9.6 months for chemotherapy

But NICE said the longer-term effect on survival was uncertain because many of the patients involved in the BRIM3 trial were moved from dacarbazine to either Zelboraf or Bristol-Myers Squibb's (BMS) Yervoy.

Roche said it was highly disappointed with the decision, saying it had been penalised for acting “on compassionate grounds and at the request of regulatory authorities” after it allowed patients on the trial not receiving Zelboraf “to access the drug once its benefits became clear”.

In a statement the company said: “Roche feels it has been penalised for the decision to ethically ensure patients benefit from true advances in medicine. Additionally, Roche believes it is unsatisfactory that a treatment with acknowledged short term benefits to a group of patients with great need for an effective therapy should be rejected because of a lack of information on the impact of the drug five to 10 years after starting treatment.

“Although this information will emerge with time, it will be too late for most of those patients needing treatment today and who will, typically, live for less than a year with existing therapies.”

Zelboraf, which was launched in the UK in March, is a potential blockbuster for Roche, with analysts predicting it could reach peak-year sales of $1-1.5bn. 

Bristol-Myers Squibb's Yervoy

BMS' rival skin cancer treatment to Zelboraf received a similar knock-back from NICE in October last year.

The company has since persuaded NICE to take the unusual step of allowing Yervoy (ipilimumab) to be reappraised for previously treated unresectable stage III or IV malignant melanoma.

Earlier this year BMS submitted new clinical data for Yervoy that NICE said may address uncertainties in the evidence base considered by the Appraisal Committee. The pharma company also gave NICE details of a patient access scheme it has agreed with the Department of Health.

15th June 2012

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