Cardiovascular disease cuts across ethnicities and demographics as the leading cause of death in the United States, explains a new white paper from the Institute for Patient Access. But access to innovative treatment for cardiovascular disease is something altogether less common.
“Improving Access to Cardiovascular Care” is the first white paper from the Alliance for Patient Access’ Physicians Cardiovascular Disease Working Group. It explores both the promise of new treatments and the challenges faced by physicians and patients trying to obtain them.
Promising Treatments, Challenging Barriers
For example, a new medication for heart failure reduced cardiovascular death by 20 percent and hospitalization by 21 percent in clinical trials. The FDA fast tracked the drug’s approval because of unmet medical need. The trial even ended early due to the treatment’s demonstrated and “overwhelming” benefit, the paper explains. Yet early projections suggest that most patients may have co-pays of $100 or more. Not surprisingly, the treatment’s sales reflect lower-than-expected uptake of the medication.
Breakthrough treatments for extremely high cholesterol also present access challenges. PCSK9 inhibitors are designed for patients with extremely high LDL, or “bad,” cholesterol – those for whom statins alone are not enough. In clinical trials, the drugs lowered LDL cholesterol by nearly 60 percent in some patients.
PCSK9 inhibitors are pricey and, as the paper’s authors acknowledge, appropriate prescribing according to the FDA label is important. But physicians are finding it difficult to get these treatments for patients even when they meet FDA’s indication. “Physicians can cite guidelines and label indications; we can be meticulous in our descriptions of the specifics, the statins that patients have taken previously and their doses, as well as pertinent side effects,” explains working group member Laurence Sperling, MD, “But still you get these capricious [prior authorization] denials from insurance companies.”
Due largely to prior authorization requirements, three out of every four patient prescribed a PCSK9 inhibitor by his or her doctor is denied covered by the health plan, the paper reports. Between 75 and 90 percent of patients can’t fill their prescriptions.
Prior authorizations and high cost sharing are becoming significant challenges for cardiovascular patients, the paper explains. Another issue is step therapy, whereby patients must first fail a medication preferred by the health plan before getting their doctor-recommended treatment. And the barriers aren’t just for innovative treatments, the paper notes. Traditional treatments such as statins can also be the target of health plan barriers.
The Way Forward
“Although cost-conscious healthcare decisions are important to the stability of our system,” the paper concludes, “price considerations shouldn’t come between the decisions made at the bedside between patients and doctors.” The authors applaud state-level legislation that targets access barriers and emphasize the importance of physician input in shaping policy.
To learn more, read “Improving Access to Cardiovascular Care.”