Breast cancer chemopreventive drugs such as tamoxifen should be covered as a preventive service with no out-of-pocket cost for high-risk women, according to the Health and Human Services department. But it’s not clear if the HHS clarification of covered preventive benefits under the Affordable Care Act will encourage more primary care physicians to prescribe the medications and more women to take the drugs.

Dr. Jeffery Ward, an oncologist at the Swedish Cancer Institute, Edmonds, Wash., said that he did not think cost was a big obstacle, as tamoxifen is available generically. Concern about side effects and a lack of knowledge among primary care physicians are larger issues, said Dr. Ward, who is the immediate past chairman of the American Society of Clinical Oncology’s clinical practice committee.

The policy – clarified by HHS on Jan. 9 – would apply to group and individual health insurance policies that went into effect after the March 2010 enactment of the Affordable Care Act, as well as those that have been substantially changed since then.

The ACA mandates that services or therapies given an "A" or "B" rating by the U.S. Preventive Services Task Force be covered as preventive care by individual and group health plans and Medicare. States have the option to cover these benefits for Medicaid recipients.

Preventive benefits must be covered with no copayments, deductibles, or other out-of-pocket costs.

The breast cancer prevention coverage must start on or after Sept. 24, 2014, 1 year after the USPSTF first issued a "B" rating also, for use of the selective estrogen receptor modulators, tamoxifen, or raloxifene for women at high-risk for breast cancer and low risk for side effects. ASCO urged use of tamoxifen and raloxifene for breast cancer prevention in guidelines issued in July (J. Clin. Onc. 2013;31:2942-62).

Currently, tamoxifen and raloxifene are the only Food and Drug Administration–approved drugs for breast cancer prevention in high-risk women. Tamoxifen is approved for women aged 35 years and older; and raloxifene for postmenopausal women. The USPSTF backed the use of the FDA-approved therapies only. Likewise, the HHS policy applies to only FDA-approved drugs.

As many of 5% of U.S. women may be eligible for breast cancer chemoprevention, according to Dr. Mark H. Ebell, a USPSTF member and epidemiologist with the University of Georgia, Athens, who spoke with Frontline Medical News after the guidelines were issued. Few seem to be currently taking any of these prevention drugs, however, according to data compiled by the USPSTF. The task force cited surveys showing that, after being told of the risks and benefits, 50%-75% of high-risk women declined to accept a prescription for tamoxifen or raloxifene. Concerns about side effects seemed to be the main concern.

There is also a lag in prescribing. Only 96 of 350 primary care physicians – including ob.gyns – who responded to a survey, said that they had prescribed tamoxifen as a preventive, according to a study.

Dr. Ward said that primary care physicians may not understand who is an appropriate candidate or may be reluctant to refer healthy women to an oncologist. They also might not be comfortable prescribing a medication they regard as a cancer drug, he said. Many of the high-risk women referred to him ultimately end up taking a chemopreventive, he said, adding that for every patient who refuses, there are probably 4 who agree to try the therapy, but "15 after that who never hear about it," because of gaps in knowledge in the primary care setting.

While the HHS clarification will likely help many of his patients, he also sees it leading to some confusion. For instance, patients who already have breast cancer might think that their medications will now be covered without any out-of-pocket costs. "The consequences have not been well thought out," said Dr. Ward, of the coverage policy.

The coverage requirement also gave insurers pause. "We are concerned about the precedent of expanding the definition of prevention to now include some treatments that must be covered with no cost-sharing," said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans (AHIP). He said that while, "helping women with breast cancer get the care they need has long been a top priority for health plans," the cost of therapies that appear to be "free" are actually "reflected in the premiums consumers pay for coverage."

Dr. Ward noted, however, that it might be less expensive for insurers to cover the cost of chemopreventives than for the treatment of a woman with breast cancer.

aault@frontlinemedcom.com

On Twitter @aliciaault

Will 100% coverage spur more use of breast cancer chemopreventives?