GSK hopeful of NICE approval for Tyverb
pharmafile | January 26, 2009 | News story | Sales and Marketing |Â Â Cancer, GSK, breast cancerÂ
NICE could be poised to reverse its rejection of GSK's breast cancer treatment Tyverb, the pharma company has said.
NICE rejected the drug last year on cost effectiveness grounds, but GSK's head of UK operations says he is now hopeful that a second review would yield a positive result.
Simon Jose, general manager and senior vice-president of UK Pharmaceuticals at GSK, said though it was impossible to presume the approval, GSK had reason to be optimistic.
Jose said Tyverb was eligible for consideration under NICE's new end of life QALY system, which allows more expensive life-extending drugs to gain approval.
He commented: "The outcome of that we are yet to see, but we are hopeful, because I think the criteria are designed for us to start looking at these types of medicines."
To further boost its chances, GSK has first put forward a patient access scheme to make the drug more affordable for the health service, offering to bear the cost for all eligible patients up to the first 12 weeks of treatment, after which the NHS would only pay for patients who continued to benefit.
He added: "Because frankly, there is little point spending billions of pounds and dollars researching these things if you don't get them out into the market place because of price – that's crazy."
Jose says GSK expect a decision from NICE – positive or not – within the first quarter.
End-of-life QALY
NICE's new appraisal method will only apply for medicines whose cost effectiveness ratio exceeds the usual £30,000 per quality adjusted life years (QALY) and are licensed for small patient populations of less than 7,000.
They must also be indicated for patients with life expectancy of less than two years and show an extension to life of at least three months compared to current NHS treatment.
Technologies already in the appraisal process when the new rule was introduced in January 2009 will be affected by it, should they meet the criteria.
The four kidney cancer drugs that were initially refused last year, creating a public backlash against NICE, are first to be measured against the new QALY, with Tyverb to follow.
Jose says observers will expect NICE's new approach to have a clear impact.
He said: "There will be products that start being measured up against these new criteria, and if we start seeing those recommendations come through then I think it will have been a good move and served its purpose.
"If we see more negatives coming through despite it, then I'm not sure what it was for."
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