Bad News for Health Plans: MRIs Gain in Breast Cancer Detection
A study from the University of Washington Medical Center, Seattle, has confirmed what the American Cancer Society already recommends: In women at high risk, magnetic resonance imaging (MRI) better detects breast cancer than mammography or ultrasound alone. The problem is that MRI costs more than the other two methods, and with the weight of the guideline behind it, managed care plans will be hard pressed to deny the prescribed imaging.
This study of 171 women (avg age, 46 yr) at high risk but without symptoms revealed six tumors, all of them caught by MRI. Only two were recognized by mammography, and one was identified by ultrasound. A woman at high risk was defined as possessing either the BRCA 1 or 2 genes or with a strong family history of breast cancer.
Although the percentage of premenopausal women at high risk is estimated at 2%, MRI might also be utilized in the many women in whom mammography is not helpful because of high-density breast tissue, for example. Furthermore, the researchers believe that MRI may be useful in annual screening exams for postmenopausal women and recommend that studies be undertaken to determine if this indeed the case. If so, the health plans may have an additional significant, routine budgetary expense.
A separate study, utilizing the databases of multiple managed care organizations, found that in patients older than 65 years who are breast cancer survivors, more frequent screening may be beneficial. The investigators found that “each additional surveillance mammogram was associated with a 0.69-fold decrease in the odds of breast cancer mortality.” A greater problem may be that not all older patients who are breast cancer survivors are receiving annual mammograms.
Lash TL, Fox MP, Buist DSM, et al: Mammography surveillance and mortality in older breast cancer survivors
. J Clin Oncol 2007;25:3001-3006.
Lehman CD, Isaacs C, Schnall MD, et al: Cancer yield of mammography, MRI, and ultrasound in high-risk women: Prospective multi-institution breast cancer screening study
. Radiology 2007;244:381-388.
Do Terminally Ill Patients Have a Right to Receive Unproven Drugs?
Health plans and other payers have struggled for many years with the question of whether they should have to pay for investigational treatments for patients with terminal disorders, such as advanced metastatic cancer. The Fox v. HealthNet case in the early 1990s cast a pall on the managed care industry, when a health plan was forced to pay an $87 million jury award to the survivors of a patient with advanced breast cancer who was denied payment for a bone marrow transplant.
A federal appeals court has handed down a decision that will help managed care plans and insurers defend against lawsuits in these cases. The Court’s ruling, that patients who are terminally ill do not have the Constitutional right to expect access to unapproved therapies that may be potentially lifesaving. The justices indicated that this was a problem with the Food and Drug Administration’s approval system, and that it was up to Congress to change it.
In this case, Abigail Alliance v. McClellan, a suit was brought against the Food and Drug Administration and the Department of Health and Human Services for not providing access to investigational drugs for the terminally ill. Abigail Burroughs was a 21- year-old woman who died in 2001 and was denied the use of two investigational oncology agents recommended by the oncologist (and which were later approved by the FDA). If the FDA approves the medication, then insurers will have far greater difficulty denying access to it.
The central issue was whether the basic rights granted under the Fifth Amendment actually included the right to potentially lifesaving investigational drugs. The Court voted 8-2 that it did not.
Savage DG: Court denies test drugs to dying patients.
Los Angeles Times August 8, 2007.
Benefits of HPV Vaccine Still Unclear, but Time Will Tell
States continue to ponder the issue of making vaccination for the human papilloma virus (HPV) mandatory for girls, but researchers have not yet reached a conclusion on the overall societal benefit of the vaccine. Canadian population health scientists have contributed to the discussion by performing an economic analysis.
Assuming that the HPV vaccine is given to girls at 12 years of age, and it has an efficacy of 95% that does not wane over time, the number of girls who need to be vaccinated to prevent one episode of genital warts is eight. The number needed to be vaccinated to prevent one case of cervical cancer is 324, according to their study.
However, by varying their assumptions, the case for mandatory vaccination becomes less clear, assert these authors from the Center Hospital of the University of Quebec. For instance, if the vaccine protection wanes at a rate of 3% per year, the predicted numbers needed to vaccinate to prevent a case of genital warts or cervical cancer increase to 14 and 9,080, respectively. The use of a booster dose would help a great deal in this measure, lowering both figures to nine and 480, respectively.