Revlimid talks confirm shift in approach to pricing
pharmafile | January 20, 2009 | News story | Sales and Marketing | NICE, par
Celgene is in negotiations to agree a deal to make its cancer drug Revlimid more affordable to the NHS and reverse a negative NICE decision.
The company is one of the first to take up the opportunity to negotiate under new 'patient access scheme' rules, which came into force as part of the new PPRS pricing agreement.
Over the last 18 months, pharma companies have shown themselves more willing to negotiate individual pricing deals in order to gain NICE approval, and this trend looks set to become much more common.
Celgene's multiple myeloma drug was initially rejected as too expensive last November, but Celgene could sway the final decision, expected in April 2009, by offering to refund the NHS if a patient showed no improvement.
Revlimid is a pill used in combination with standard therapy to treat multiple myeloma in patients who have received at least one prior therapy. Celgene says the drug is the first new pill for the cancer in 40 years and claims it doubles the survival rate of patients over the standard therapy (dexamethasone) alone.
The company says it has addressed both the 'clinical and financial' issues raised in the drug's initial rejection last year, and hopes to work with NICE to reverse the decision.
Dr Tim Paget, the UK medical director, said: "Celgene is committed to working with NICE and the multiple myeloma community to overturn the preliminary position."
The company has proposed a price-capping scheme by which, for patients who remain on treatment with Revlimid beyond two years, the cost of all future treatment with Revlimid will be met by Celgene.
Paget added: "Celgene believes that this scheme will not only improve the cost effectiveness of Revlimid but it will also benefit patients who can continue treatment and thus enable the appraisal committee to recommend Revlimid."
This type of arrangement between a company and the NHS has for years been referred to as 'risk-sharing deals', though are more known as 'patient-access schemes'.
With particular reference to cancer drugs, the government promised last year to increase to number of such schemes in order to see more medicines approved for the NHS. The most notable is Janssen-Cilag's arrangement with the NHS over its drug Velcade for multiple myeloma, and GSK is currently negotiating a similar deal for its breast cancer drug Tyverb.
End-of-life QALY
A patient-access arrangement would increase Revlimid's chance of meeting NICE's cost-effectiveness threshold, but its approval may also be eased by the new rules from NICE that came into force from January 2009.
The Institute has changed its approach for high cost drugs that extend the lives of terminally ill patients, and meet a certain criteria.
To be assessed under the new terms, a drug must be indicated for patients with a life expectancy of under two years and show an extension to life for at least three months compared to NHS treatment.
Furthermore, its benefits must not be comparable to any alternative treatment on the NHS, and only be licensed for populations of less than 7,000.
Celgene said the new rules for NICE appraisals of "end of life" medicines could be important for its drug.
"Revlimid closely matches the four criteria outlined in the guidance providing further confidence for a positive FAD for Revlimid," the company said.
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