According to a recent survey, health plan pharmacy and medical directors remain skeptical about the value of obesity drugs. But drug companies are undeterred: The prevalence of obesity, and its dangerous comorbidities, encourage a demand by doctors for an effective drug.
"Pharmacy directors believe the current available drugs have demonstrated a limited degree of efficacy," says Donny Wong, PhD, an analyst at Decision Resources, an international research organization. The company recently conducted an in-depth study of the attitudes of endocrinologists, primary care physicians, and HMO pharmacy and medical directors toward drugs used to treat obesity. "As a result, obesity drugs have not found wide acceptance among HMO pharmacy and medical directors, who continue to view obesity as a lifestyle issue," he says. "And most health plans follow a general policy of excluding lifestyle drugs and weight-loss agents from pharmacy benefits."
One problem is health plan officials' perception that weight-reduction drugs are often not used to treat a medical condition, says Susan Z. Yanovski, MD. "Drugs used to treat obesity differ from medications for other chronic diseases in how they are used. A drug that appears to be efficacious in reducing body weight will also be used not only to reduce medical risk among those who are obese but to improve appearance," she wrote in an editorial in the New England Journal of Medicine. "And although weight loss in obese persons ... might be anticipated to reduce cardiovascular morbidity and mortality, no study has yet demonstrated conclusively that any weight-loss treatment has such an effect, although research is ongoing."
"Lifestyle changes remain the first approach for nearly all physicians and plans," says Zhaoping Li, MD, of the West Los Angeles Veterans Affairs Medical Center. Li and several other researchers conducted a meta-analysis of the pharmacologic treatment of obesity, published in the April 5, 2005, issue of the Annals of Internal Medicine. Her review of the published results of 79 clinical trials led her to conclude that "the effectiveness of pharmacologic therapy in the treatment of obesity is unclear. Those considering pharmacologic treatment for obesity should understand that these drugs can lead to modest weight loss at one year, but data on long-term effectiveness and safety are lacking."
The primary goal of physicians and health plans is to lower BMI, say experts, primarily through diet and exercise. Their belief is that lower weight reduces the threat of diabetes, heart disease, and a host of other life-threatening and expensive medical problems, including cancer. Implicit is the assumption that obesity is not a disease.
"Most health plans do not view obesity itself as a disease, but a causal factor of other diseases," says Stephanie Krebs, also an analyst at Decision Resources. "Plans reimburse for the treatment of those comorbidities, but hesitate to pay for direct treatment of obesity."
That attitude may be changing, however, according to Decision Resources officials, in part because of a changing attitude toward obesity in our country. An October 2004 decision by the Centers for Medicare & Medicaid Services removed barriers to the coverage of obesity therapies (including drugs) when "scientific and medical evidence demonstrate their effectiveness in improving Medicare beneficiaries' health outcomes." Before that ruling, the Medicare Coverage Issues Manual explicitly stated that obesity was not an illness.
According to the Decision Resources survey, 70 percent of endocrinologists and 63 percent of primary care physicians reported that the change by CMS will somewhat or significantly increase their prescribing of obesity drugs and 60 percent of managed care pharmacy and medical directors surveyed reported that these changes will eventually "somewhat or significantly affect" their coverage patterns.
But a majority of surveyed managed care officials (55 percent) also stated that any changes in reimbursement patterns will be slow in coming, taking several years. They cited several reasons: lack of scientific or pharmacoeconomics outcomes data supporting the use of obesity drugs, no government mandates or changes in legislation affecting obesity coverage on the horizon, and current policies treating weight-loss drugs as a benefit exclusion.
The expected arrival of rimonabant (Acomplia) this year could be a turning point, if reports of its promise in terms of efficacy and reduced negative side effects are correct.
"The attitudes of health plan officials are slowly changing," Wong says. "We believe reimbursement patterns will improve if novel agents demonstrate a level of efficacy greater than what's on the current market."
"We believe reimbursement patterns will improve if novel agents demonstrate a level of efficacy greater than what's on the current market," says Donny Wong, PhD, an analyst at Decision Resources.