作者: Dan W. Brock
关键词: Economic growth 、 Actuarial science 、 Excellence 、 Value (economics) 、 Argument 、 Intervention (law) 、 Marginal cost 、 Developed country 、 Medicaid 、 New product development 、 Medicine
摘要: Avastin, Genentech's monoclonal antibody that it proposes to offer at twice the dose (and price tag) treat breast and lung cancer, has already made billions of dollars for company through its original use--treating colon cancer. Now, with a potential pool hundreds thousands more patients, financial analysts predict United States sales alone could grow nearly sevenfold $7 billion by 2009. (1) Extremely expensive drugs are hardly new. The pharmaceutical companies have long argued these prices justified extraordinarily high costs getting new market. They typically estimate those $800 million, which is said reflect both large clinical trials required FDA establish safety efficacy, as well fact only small minority ultimately makes patent system pharmaceuticals designed encourage research development protecting returns from successful drugs. Since marginal producing like Avastin tiny in comparison their patent-protected prices, not justify very unless patents prevented other selling them costs. Drug raise many controversial issues. Is million figure cited industry accurate, or real substantially less? Does primarily biologically compounds, does instead promote so-called "me-too" drugs? Why do--and should--Americans pay higher than citizens developed countries? Such economic, legal, political issues great importance, but they apply across broadly. What apparently justification Genentech offered extremely price. Instead relying on traditional cost recovery argument, would be hard sustain if estimates market 2009 anything near appealing rationale--namely, inherent value life-sustaining therapies. It priced based "the innovation, therapies," according Susan Desmond-Hellman, president product Genentech. (2) should we make this argument? How economic life-extending intervention determined? basis setting intervention? We less experience addressing first question country because most insurance plans do explicitly openly give weight making coverage decisions. Centers Medicare Medicaid Services (CMS) foreclosed law taking account cost-effectiveness decisions about interventions. (3) While rule been criticized (correctly my view), so remains place CMS's look whether drug "is reasonable necessary diagnosis treatment illness injury," (4) without regard private tend follow CMS decisions, too fail consider values assigned life extension. can get some help abroad. In Kingdom, National Center Clinical Excellence (NICE) charged evaluating technologies (broadly construed include drugs) Health Service. Cost-effectiveness principal criterion evaluations using quality-adjusted years (QALYs) benefit measure. Although NICE denies any strict per QALY threshold, an analysis suggests threshold approximately $50,000 QALY. …