UK’s NICE To Lift Ban On Kidney Cancer Meds
1 CommentBy Ed Silverman // December 1st, 2008 // 6:58 am
A ban on drugs that can give kidney cancer patients many months of extra life is going to be lifted, The Guardian reports. At least two, and possibly all four, of the medicines that had previously been deemed too expensive to prescribe will be approved by the National Institute for Health and Clinical Excellence (Nice) early next year.
The move is a major victory for campaigners, patients and cancer specialists, who described Nice’s refusal to approve the drugs - which cost up to $100,000 a year per patient - as unfair, inhumane and condemning patients to an unnecessarily early death, the paper writes.
Oncologists believe Pfizer’s Sutent, Bayer’s Nexavar, Wyeth’s Torisel and Avastin, sold by Roche and Genentech, could benefit about half of the 7,000 people a year who are diagnosed with kidney cancer. In August, NICE refused to approve the drugs, calling them too pricey (back story). But sources at NICE tells the paper that Sutent will be given the green light when its appraisal committee holds its final meeting to discuss the drugs next month. And at least one more drug - likely to be Avastin or Nexavar - will also be approved.
The move follows Health Secretary Alan Johnson’s decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue, the Guardian writes, adding that NICE immediately promised to be more flexible when examining the merits of such drugs, even if they were so costly they failed to meet its appraisal criteria.
The paper also reports that the drugmakers have held talks with the Department of Health about introducing a pricing arrangement that might persuade NICE to approve their meds. One scheme being discussed is cost sharing, in which the National Health Service would pay for a drug if it extended a patient’s life by an agreed time, while the drugmaker would refund the cost if the patient experienced no benefit and died (back story).
Pfizer confirmed offering to cut the price of Sutent by five percent and provide a first course for free, but had not held talks about risk-sharing, the paper writes. NICE has also been studying new clinical trial data from Pfizer about the benefits Sutent can bring to kidney cancer sufferers. Roche has also offered additional evidence, prompting the review.
A NICE spokeswoman tells the paper that drugs are being reviewed because “there was more evidence submitted during a couple of periods of the appraisal process by manufacturers, which needs to be discussed by the committee. We will publish a next draft within four weeks of the committee’s meeting in January and issue final guidance in March 2009.”
At present, NICE rarely approves a drug which costs more than $45,000 a year, even if proven to extend patient lives. The spokeswoman confirmed that upper limit could rise as a result of ongoing public consultation.
Pat Hanlon, of the charity Kidney Cancer UK, tells the Guardian: “All four are marvelous, brilliant drugs, which provide a way of treating people with a horrible disease. If we can provide them on the NHS, thousands of people’s lives would be extended. We feel strongly that all four should be recommended for funding.”
Hanlon says the four drugs complied with new requirements, which Professor Mike Richards, the government’s cancer caar, says NICE should consider when examining end-of-life meds. All four would benefit patients not expected to live more than two years; offer “a substantial average extension to life compared to current treatment” and apply to a patient group whose number does not increase by more than 7,000 a year.
Source: The Guardian
harry harrinordiquy
I wonder which companies fund the Kidney Cancer patient group. I would question the ‘brilliance’ of all four products in that setting.
Neither Avastin or Sutent have demonstrated increased overall survival in this indication and the best either Nexavar or Torisel can do is extend survival by four months compared with placebo.
Should payers pay through the nose for drugs that only prove efficacy against a surrograte endpoint? If they should, they certainly won’t for much longer.
And four months extra versus placebo is hardly revolutionary.