Nearly two-thirds of high-risk patients prescribed PCSK9 inhibitors to lower their risk of familial hypercholesterolemia (FH) and atherosclerotic cardiovascular disease (ASCVD) are rejected coverage for the drugs by their health insurers, a new study alleges. Those whose prescriptions were rejected or abandoned saw a 10% to 12% increased risk of adverse CV outcomes.
First approved in 2015 to treat FH and ASCVD in individuals with stubbornly high levels of LDL-cholesterol, proprotein convertase subtilisin kexin 9 inhibitors—or PCSK9is—have earned a reputation in the medical community as drugs that are at once safe and effective but too pricey for the average heart patient. Medications like alirocumab and evolocumab debuted with list prices that pushed $14,000, and recent efforts to lower out-of-pocket costs for PCSK9is have been met with some scrutiny.
The issue isn’t limited to unaffordable copays, though—in fact, many PCSK9i candidates consider themselves lucky if they receive any coverage for their injections. A good portion of insurers require patients to present with prior authorization, or proof from their cardiologist that their PCSK9i prescription is medically necessary, and can request anything from heavy paperwork to medical records to hard-to-locate documents before approving coverage.
One study published last year found that, on average, clinicians were required to meet 3 to 11 more demands for PCSK9i requests than for other medications, and rejection rates remained high.
In their study, published in Circulation: Cardiovascular Quality and Outcomes July 23, Kelly D. Myers, BS, and colleagues studied the cardiovascular outcomes of patients whose PCSK9i prescriptions were either covered, rejected or abandoned. In cases of abandonment, prescriptions were eventually approved by payers but remained unfilled by the patients in question.
Myers et al. identified 139,036 adults prescribed a PCSK9i between August 2015 and December 2017, all of whom had claims history info and an established date of exposure for either paid, rejected or abandoned status. Patients who received 168 days or more of paid PCSK9i medication within a 12-month period were considered “paid.”
The authors reported hazard ratios (HRs) for a composite CV events outcome of acute coronary syndrome, coronary intervention, stroke and cardiac arrest were 1.10 in rejected versus paid and 1.12 for abandoned versus paid prescriptions. In a more narrow analysis in which “paid” patients were defined as having received 388 days or more of paid medication within a year, HRs were 1.16 for rejected versus paid and 1.21 for abandoned versus paid status.
Individuals who were at the highest risk for adverse outcomes, including those diagnosed with FH and ASCVD, saw a PCSK9i rejection rate of 63.5%.
“For rejected prescriptions, rejection may be because of disagreement between the providers’ diagnoses and the payer policies for coverage, inadequate coding, or information submitted with the prescriptions or non-coverage for the prescribed condition,” Myers and her co-authors wrote in the journal. “Abandonment may be because of economic challenges.”
In a related editorial, Khurram Nasir, MD, MPH, and colleagues called the high rejection rates in spite of baseline risk “disappointing,” noting it’s hard to justify denying access to PCSK9is to two of every three familial hypocholesteromic patients with established ASCVD.
“As the market forces have led to significant reduction in PCSK9i prices, we think that the cardiovascular community is right to question these persistent obstacles in providing the right care for the right patient,” Nasir et al. wrote. “In its current form, there are clear unintended consequences of prior authorization that are not only having a toll on patient care and satisfaction but possibly on preventable outcomes as underscored by Myers et al. in the current study.
“At the same time, if our medical community truly aspires to overcome these blunt cost-containing instruments, it is critical that clinicians are mindful of limited available resources as well as broader societal cost opportunities in our prescribing practices. Status quo is not an option anymore for parties on both sides of the aisle.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.