Reimbursement and Managed Care News: May 25, 2010

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.

London Times

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 , “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.

August 7, 2008

The London Times. .

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.

Journal of the National Cancer Institute

The study, which appeared in the , 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.

P

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% ( = .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.

2008; 100:1144-1154.

J Natl Cancer Inst.

Bone Mineral Density Predictive of Breast Cancer Risk

Cancer

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 , 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.

This study did not determine whether a woman with high bone mineral density was at increased risk of breast cancer because that individual was more likely to be overweight, which is also an independent risk factor. It did show that the use of both the Gail score and bone mineral density as a marker can be important contributors to more accurate breast cancer risk calculations.

Zoledronic acid, a drug to treat osteoporosis, lowered the risk of the recurrence of breast cancer in premenopausal women. The results of that study were presented at the American Society of Clinical Oncology annual meeting.

Chen Z, Arendell L, Aickin M, et al. Hip bone density predicts breast cancer risk independently of Gail score: Results from the Women’s Health Initiative.

2008;113:907- 915.

Cancer.

Do PET Scans Add Value in Cancer?

A Medicare advisory panel evaluating the use of positron-emission tomography (PET) scanning has questioned whether PET scanning should be used over other imaging techniques for nine types of cancer.

Do PET scans guide physician decision making or improve outcomes? Not according to the panel, which met in late August in Baltimore. They pointed to “equivocal” or weak evidence in reviewing several studies on the subject. A registry of patient data, begun in 2006, further failed to support the value of the scanning technique.

The advisory panel included stakeholders from industry, medical groups, patient advocacy, and from the Academy of Molecular Imaging. Based on a cost per scan of at least $2,500 and the lack of strong data supporting the use of PET scanning in these nine tumor types, it is expected that Medicare’s coverage decision (a draft will be issued in January 2009, with the final decision registered in April 2009) will likely restrict reimbursement for PET scanning in Medicare beneficiaries.

Heavey S. US panel questions wider use of PET scans in cancer.

August 20, 2008.

Reuters.

Cervical Cancer Vaccine: Cost Effective for which Age Groups?

The Food and Drug Administration approved Merck’s cervical cancer vaccine for females up to age 26, and the Centers for Disease Control’s guidelines specifies that girls aged 11 and 12 should receive it routinely. The older girls and women could be vaccinated in a “catch-up” regimen, which would provide some protection. However, a study from the Harvard School of Public Health, Boston, demonstrates that vaccination has less value for older women.

The health economists asserted that as the target population is more likely to have been exposed to human papillomavirus (HPV), the cost effectiveness of vaccination declines. Therefore, in their health economic model, when administered to girls who are 12 years of age, the vaccine’s cost to society is approximately $43,600 per quality-adjusted life-year (QALY). The threshold for cost effectiveness is generally considered to be $50,000 per QALY. In comparison, the cost per QALY rises substantially through age 18, to over $150,000 per QALY at 26 years of age (Figure).

If one considers the vaccine’s benefit in preventing genital warts, the cost-effectiveness figures improve by one-fifth ($34,900 per QALY at age 12, $133,600 at age 26). One important limitation to these calculations is that the analysts assumed that the vaccine would provide cervical cancer protection throughout the lifespan, which is not proven; it is not yet known whether booster shots may be required, which would increase these cost-effectiveness estimates.

Based on these figures, the economists believe that vaccination against cervical cancer is cost effective for the intended primary group of patients—girls aged 11 and 12. However, using a catch-up vaccination program does not appear to provide value for the health system.

Kim JJ, Goldie SJ. Health and economic implications of HPV vaccination in the United States.

2008; 359:821-832.

N Engl J Med.