NICE Ruling on Kidney Cancer Drugs Stirs Outrage
In early August, the British National Institute for Health and Clinical Excellence (NICE), the agency that assesses the cost-effectiveness of products and recommends coverage decisions to the National Health Services, embroiled itself in controversy. It issued its guidance on four biologic drugs used to treat advanced or metastasized kidney cancer, stating that their cost did not equal good value and that they should not be covered by public British funds.
The agents—sunitinib, bevacizumab, sorafenib, and temsirolimus—were said to cost more than the £30,000 (approximately $55,500) per quality-adjusted life-year threshold set by NICE. However, by excluding these agents, NICE left patients with kidney cancer with only one alternative—interferon. Interferon has a low response rate (~25%), and oncologists in the United Kingdom complained that if they are not able to prescribe the other four drugs, there is “no point” in accepting referrals for kidney cancer patients. One oncologist commented in the London Times
, “These drugs have shown a small but definite improvement in an illness where there are few alternative treatments.” Dr. Peter Johnson of Cancer Research UK said, “This decision once again raises questions about whether NICE’s system of appraisal is appropriate for all types of drugs.”
The problem, NICE analysts point out, is that the four drugs extend progression-free survival by five or six months but cost up to £35,000 ($64,800) annually for one patient.
Clearly, NICE decisions need to be tempered with the realities of poor clinical alternatives, argue the critics. Dr. John Wagstaff, of the South Wales Cancer Institute, Swansea, stated, “[Sunitinib] produces a remarkable effect on survival for patients. It is now longer ethical or reasonable for patients to have access to treatment only with interferon."
Hawkes N. £35,000-a-year kidney cancer drugs too costly for NHS.
The London Times. August 7, 2008
.Watchful Waiting Versus Surgery for Prostate Cancer? Question Has Yet to be Settled
The newest research from the Scandinavian Prostate Cancer Group found that for patients who underwent radical prostatectomy, the early survival advantage over watchful waiting did not continue forever and the long-term survival of patients choosing surgery versus watchful waiting did not vary significantly.
The study, which appeared in the Journal of the National Cancer Institute
, updated a trial reported in 2005, which found that of approximately 350 men who were randomly assigned from 1989 to 1999 to either radical prostatectomy or watchful waiting, a survival benefit for surgery remained after 8.2 years. However, after another three years of follow-up, the oncologist and epidemiologist authors of the study found that 137 men in the surgery group and 156 in the watchful waiting group died (a nonsignificant difference). Additionally, of the patients who died, only 13% of those in the surgery group and 19% of those in the watchful waiting group died of prostate cancer. After 12 years, the differences between the two groups remained the same (did not increase), indicating that radical prostatectomy did not offer additional survival benefits beyond 10 years.
The investigators did find, however, that men with extracapsular tumor growth who had undergone prostatectomy had a risk of death from prostate cancer 14-fold greater than men without this growth. Furthermore, patients undergoing radical prostatectomy had a risk of distant metastases that was 35% (P
= .006) lower than that for patients who were assigned to the watchful waiting group.
They concluded that radical prostatectomy was associated with survival advantages up to eight years postoperatively, but the survival advantage over watchful waiting did not continue to increase after 10 years.
Bill-Axelson A, Holmberg L, Filén F, et al. Radical prostatectomy versus watchful waiting in localized prostate cancer: The Scandinavian Prostate Cancer Group-4 randomized trial.
J Natl Cancer Inst. 2008; 100:1144-1154.Bone Mineral Density Predictive of Breast Cancer Risk
Managed care organizations and insurance companies are looking toward the use of predictive modeling to help anticipate member risks. The more information available to inform the modeling algorithm, the greater the predictive accuracy of the model. In breast cancer, clinicians had used the Gail model to try to predict breast cancer risk. In a recent issue of Cancer
, researchers from the University of Arizona, Tucson, found that a woman’s bone mineral density may yield a more accurate prediction of breast cancer risk when used with the Gail model.
Utilizing data collected from 9,941 postmenopausal women participating in the Women’s Health Initiative, the researchers found that after 8.4 years of follow-up, a high Gail score was associated with a 35% excess risk of breast cancer, based on the 327 cases of breast cancer reported. However, it was determined that each incremental rise in a woman’s total hip bone mineral density was associated with an additional 25% risk.