Skip to main content

Currently Skimming:

4. Public Policy and Access to New Drugs: The Case of Cancer Chemotherapy
Pages 53-68

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 53...
... The case of cancer research and clinical care is illustrative of the broad impact of reimbursement policies on the availability of new therapies. A broad array of incentives and disincentives influence the actions and rules of the many players involved in health care.
From page 54...
... Within a few years a profound change in cancer care occurred, advanced by significant federal and industry funding for cancer research and by the creation of a new profession—medical oncology. The locus and nature of clinical care for cancer patients changed significantly in this period.
From page 55...
... The development of the Association of Community Cancer Centers (ACCC) was based on the concept that community oncologists and hospitals should emulate university cancer centers and provide programs that included clinical research, use of the latest therapies, interdisciplinary cancer treatment planning, prevention, early detection projects, and public and professional education activities.
From page 56...
... In less than a decade we have moved from an era in which new technologies were heavily promoted to an era in which they are sometimes offered reluctantly and in which patients may have to sue their insurance companies to receive the new types of care. This has been the case for several patients desiring coverage for autologous bone marrow transplantation in the treatment of breast cancer (2~.
From page 57...
... Cancer patients clearly benefit from coordinated, multimodality therapy involving surgeons, medical and radiation oncologists, and nursing personnel in a progressive management activity. However, instead of a coordinated single site for cancer care, we see patients moving from the hospital to freestanding radiation therapy centers to medical oncologists' offices and back again.
From page 58...
... While the FDA has a mandate to approve combinations of drugs, approval of all the current chemotherapy combinations and their addition to the FDA label would require a herculean effort well beyond the resources of the agency. If insurers deny payment for combination therapy because a drug is not approved for use in combination, we would see 90 percent of all effective chemotherapy disappear (5~!
From page 59...
... Table 4.1 illustrates the eight top cancer drugs and the percentage of their off-label use in an audit of 165 oncologists' offices. Another way to understand the implications of these findings is to consider the potential number of treatments that could be denied if only the drugs Unlabeled Usage $128.S million Approved $151.2 million FIGURE 4.1 Percentage and total annual sales of approved versus unlabeled usage of eight common chemotherapy drugs, 1986.
From page 60...
... 60 TABLE 4.1 Out-of-Package Insert Use for Eight Common Chemotherapy Agents LEE MORTENSON Agent Unlabeled Diagnoses 1986 Projected Treatment Unlabeled Use 1986 Adriamycin G.I./digestive cancers Other malignancies 68,182 35,444 Cytoxan G.I./digestive cancers 5,972 Lung cancers 182,384 Other malignancies 30,200 22 Fluorouracil Lung cancers 33,310 Metastatic adenocarcinoma 12,584 Metastatic prostate cancer 28,650 4 Methotrexate G.I./digestive cancers 72,834 Ovarian cancers 18,912 Other malignancies 28,688 12 Mutamycin Rectal cancers 56,364 Lung cancers 16,782 Breast cancers 82,200 Ovarian cancers 3,420 Other malignancies 12,142 84 Oncovin G.I./digestive cancers 16,132 Breast cancers 133,348 Lung cancers 151,304 Other malignancies 71,900 41 Platinol G.I./digestive cancers 7,528 Lung cancers 38,344 Metastatic thyroid cancer 4,336 Malignant melanoma 2,580 Metastatic uterine cancer 3,432 Other malignancies 34,596 68 Vepesid G.I./digestive cancers 2,540 Ovarian cancers 4,556 Brain cancer 660 Hematologic malignancies 33,722 31 SOURCE: Association of Community Cancer Centers
From page 61...
... In addition, since the FDA is currently behind in reviewing regular NDAs, a flood of supplemental NDAs would easily cripple the system. Proposals to undertake massive FDA review of currently accepted therapies might also be unacceptable on the grounds cancer patients would needlessly die while providers waited for the review process to recognize the effectiveness of drugs that have been standard treatment for years.
From page 62...
... On the other hand, the Health Insurance Association of America has issued a more enlightened policy recommending that its over 300 member commercial payers recognize the three compendia for determining the legitimate use of drugs (10~. Payment for Investigational Therapies For years the medical benefits contracts of nearly all payers, public or private, contained clauses prohibiting reimbursement for patients receiving investigational or experimental therapies.
From page 63...
... DRGs are formulated to provide reimbursement for today's average treatment, not the potentially higher costs of experimental treatments given in clinical trials. Thus, major cancer centers have experienced major cost overruns for new therapies that hold significant promise for prolonged survivals and cures but that are far more expensive than today's average treatment (12,13~.
From page 64...
... There are 12 indications for interferon, but the pharmaceutical company went for its initial FDA labeling indication for a rare form of cancer called hairy cell leukemia because of impressive clinical evidence of efficacy for this cancer. Fewer than 500 people are diagnosed with hairy cell leukemia each year.
From page 65...
... Moreover, we should expect that treatments for many medium-size or small patient population clinical conditions will never be researched actively. The research and labeling process will be too expensive, and the return on the investment is likely to be small.
From page 66...
... Even rural outreach programs, providing oncology clinics in small communities, are being hit hard by the current reimbursement pressures. In addition, primary care physicians and general internists are increasingly reluctant to refer cancer patients to specialists because they perceive their job to include gatekeeping to mitigate against the use of specialists and costly technologies.
From page 67...
... We might try to remedy congressional schizophrenia on the issue and pass legislation that says that the HCFA should pay for the patient care costs associated with NIH and FDA clinical trials. It is also worth educating people that clinical trials offer the best care for current and future patients.
From page 68...
... Statement of the Blue Cross and Blue Shield Association before the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS, Washington, D.C., October 25, 1989.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.