Managed Care - February 2008 - (Page 60) TOMORROW’S MEDICINE More questions than answers S cientific discoveries often lead to some answers, but new questions arise as well. Limited resources Organizations such as ASCO must be applauded for their efforts to develop recommendations based upon the best science available. Health plans have looked to professional societies in determining policy, but the last time ASCO updated its guidelines was seven years ago. In this digital age, how can a finite organization possibly maintain up-to-date policies to assist in the making of complex medical treatment and payment decisions? In addition, biomarkers require validation. The FDA is attempting to provide guidance in this arena, but it does not have sufficient resources. The use of biomarkers has other limitations. Recently, the BlueCross BlueShield Technology Evaluation Center released an assessment titled “Gene Expression Profiling of Breast Cancer to Select Women for Adjuvant Chemotherapy.” The authors cited several limitations: “Among those willing to be guided by the test result, it is unknown what proportion of conventionally estimated intermediate- to-high risk patients will have sufficiently low risk score values to change their decision regarding chemotherapy.” Further, “the recurrence risk level below which women are comfortable without chemotherapy is unknown.” And “because the risk score is a continuous function with respect to recurrence rates, risk category cutoff values selected by the test developers are arbitrary and may not be optimal.” Managed care companies will increasingly need highly trained professionals to sort through all of these issues as Tomorrow’s Medicine continues to discover the wonder of life at the cellular and molecular level. MC The author is a director in the value-based health department at Genentech Inc. During the last three years, before taking the Genentech position, he received honoraria or other financial benefits from: Amgen, Amylin Pharmaceuticals, AstraZeneca, Biogen Idec, Centocor, Galderma, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Procter & Gamble, Q-Med, Sanofi-Aventis, Teva Pharmaceuticals Industries, UCB, and Wyeth. The views expressed in Tomorrow’s Medicine are the author’s alone. • Should the desired positive and negative predictive value differ when safety and effectiveness are considered separately? • Will every test be standardized? • Should only high-volume labs be allowed to perform tests? • Should labs be certified? If so, by whom? • Should only certified tests or labs be paid? • What will government payers do? • What incentives were involved in the development or use of the tests and can the incentives be quantified and will they be transparent? • Should drug manufacturers be required to provide a validated biomarker for their drugs? • What happens when a test predicts an efficacy for a given medication that is 1 percentage point less than what a health plan has set in policy? • What about subjectivity in the outcome of some tests where a cytologist or pathologist must make a visual judgment? • Will patients abide by the arbitrary nature of cutoff points? • What appeal processes will be in place to ensure due process of decisions by health plans? • If a payer pays for these expensive tests, should the patient be held to the result? • If a patient personally pays for a test that determines that a specific denied drug is indicated, how should the health plan respond? • If a new drug is developed that addresses the same specific receptor or biomarker as an older, more studied drug, will the new drug be seen as equal to the older one? • Can payers, providers, laboratories, and pharmaceutical manufacturers agree on how to use these new biomarkers? • Finally, how will politics treat these complex issues? more complex when a patient is faced with a life-threatening or life-limiting disease. In addition, our governmental regulatory agencies, medical training programs, and payment processes are poorly equipped to deal with this complexity. 60 MANAGED CARE / FEBRUARY 2008
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