August 26, 2008 – Cancer experts in the United Kingdom have banded together to voice their dismay over the recent draft guidance from the National Institute for Health and Clinical Excellence (NICE) stating that 4 new cancer drugs should not be used in the treatment of advanced and/or metastatic renal cell cancer. This draft recommendation, issued on August 7, is now open for consultation; a further review is planned for September 10.
The 4 products involved are bevacizumab (Avastin, Roche/Genentech), sorafenib (Nexavar, Bayer), sunitinib (Sutent, Pfizer), and temsirolimus (Torisel, Wyeth). Although the drugs have been shown to extend patients' lives by some months, NICE ruled that they were not cost effective and hence should not be available on the National Health Service (NHS).
Such a ruling means that patients can only obtain the drugs with a private prescription and must pay full price for them, instead of the nominal fee charged for an NHS prescription. "We have seen distraught patients remortgaging their houses, giving up pensions, and selling cars to buy drugs that are freely available to those using health services in countries of comparable wealth," the experts wrote in a letter to the Sunday Times.
"It just can't be that everyone else around the world is wrong about access to innovative cancer care and the NHS right in rationing it so severely," they comment. The signatories include some of the most prominent cancer specialists in the United Kingdom, and the group of 26 is headed by Karol Sikora, MBBCh, PhD, medical director of CancerPartnersUK, professor of cancer medicine at Hammersmith Hospital, in London, and former chief of the World Health Organization Cancer Programme.
Economic Formulas Not Appropriate for Cancer
NICE has come under criticism for restricting the use of new and expensive drugs, and specialists in other fields of medicine have also protested against its rulings. But the oncologists suggest that the cost-effectiveness approach that NICE takes is particularly inappropriate when assessing new cancer drugs. "Its economic formulas are simply not suitable for addressing cost-effectiveness in this area of medicine," they write. "Mean survivals obscure the fact that some patients will obtain prolonged benefit from these drugs."
"Once again, NICE has shown how poorly it assesses new cancer treatments," the experts say.
But NICE says the experts are wrong. In the 9 years it has existed, NICE has appraised 56 anticancer drugs and has recommended the use of all of them, except the 4 for renal cancer currently under discussion.
"We have made it possible for thousands of cancer patients to receive treatment when, without our guidance, they would almost certainly have not," Andrew Dillon, chief executive of NICE, commented in a statement.
This controversy highlights the dilemma NICE is constantly faced with — deciding which drugs should be recommended for which patients, and which should not. "There is a finite pot of money for the NHS which is determined, annually, by parliament. If 1 group of patients is provided with cost-ineffective care, other groups — lacking powerful lobbyists — will be denied cost-effective care for miserable conditions like schizophrenia, Crohn's disease, or cystic fibrosis. NICE seeks to look after all patients who seek their care from the NHS."
In addition, NICE emphasizes the particularly high cost of the kidney cancer drugs, and suggests that the cancer experts reflect on why the price is so high. It mentions bevacizumab in particular, which NICE found to be the least cost effective of the 4 for the treatment of renal cancer. In its media statement, NICE quotes from a 2006 editorial in the New York Times, when bevacizumab was being considered for the treatment of breast and lung cancer, as follows:"This is not a miracle drug, bringing huge benefits to society. The high price seems to have been imposed mostly because the companies figured the market would bear it."
Clinically Effective, But Not Cost Effective
The NICE draft recommendation on the 4 kidney cancer drugs is available for viewing on the NICE website until August 29, after which the Appraisals Committee will take into consideration all comments that have been received. Among them are proposals from 2 manufacturers for reducing the cost of the drugs.
In the draft recommendation, NICE explained that the 4 kidney cancer drugs have the potential to extend progression-free survival by 5 to 6 months, but at the cost of around £20,000 to £35,000 (US$36,726 to $64,286) per patient per year.
This translates to a cost per quality-adjusted life-year (QALY) for these drugs of between £28,500 and £90,600 (US$52,348 and $166,411) per patient (estimated by the manufacturers) and between £71,500 and £171,300 (US$131,338 and $314,660) per patient (estimated by independent academics).
In the past, the upper limit for recommending use on the NHS has been around £30,000 ($55,106) per QALY per patient.
The 4 drugs for kidney cancer are clinically effective, but they are not a cost-effective use of NHS resources, the Institute decreed.
"If these treatments were provided on the NHS, other patients would lose out on treatments that are both clinically and cost effective," explained Peter Littlejohns, MBBS, MD, professor of public health at the University of London, United Kingdom, and clinical and public health director at NICE.
He cited the case of trastuzumab (Herceptin, Roche, Genentech) as an example of a cancer drug that is both clinically and cost effective. This drug is also expensive, costing around £20,000 (US$36,726) per patient. But its use in early breast cancer can extend progression-free survival for a number of years, which translates to a cost per QALY gained of around £18,000 (US$33,061) per patient.
Medscape Medical News © 2008 Medscape
Cite this: Zosia Chustecka. UK Cancer Experts Deplore NICE Decision on Kidney Cancer Drugs - Medscape - Aug 26, 2008.
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