Insurers reject PCSK9 inhibitors at a higher rate vs. other cardiometabolic prescriptions
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Key takeaways:
- PCSK9 inhibitor prescriptions are rejected by insurers at a higher rate vs. other guideline-indicated cardiometabolic drugs.
- This was despite expanded labeling in 2017 and lowered manufacturer cost in 2018.
PCSK9 inhibitors are rejected by insurance providers at a higher rate compared with other guideline-indicated cardiometabolic drugs despite expanded labeling and reduced manufacturer cost, researchers reported.
Additionally, the proportion of paid PCSK9 inhibitor prescriptions remained lower compared with other cardiometabolic therapies despite a more than twofold increase in paid prescriptions, according to a study published in Circulation: Cardiovascular Quality and Outcomes.
“Based on recent research from the Family Heart Foundation in 38 million high-risk Americans, less than 30% are achieving adequate LDL control and the use of combination lipid-lowering therapy is very limited,” Diane E. MacDougall, MS, vice president of science and research at the Family Heart Foundation, told Healio. “Prior authorization barriers and high out-of-pocket costs for therapies such as the PCSK9 inhibitors can serve as significant disincentives for patients and their health care practitioners to achieving a safe level of LDL cholesterol, which in turn may increase their risk of suffering a CV event.
“This real-world evidence shows a gap in care that limits cholesterol management and perpetuates the societal burden of atherosclerotic CVD,” she said. “Our biggest takeaway is that access barriers to PCSK9 inhibition, though somewhat improved, have persisted over time and appear greater than those of other comparable cardiometabolic drugs. Current access barriers to PCSK9 inhibition cannot be accounted for by lack of CV outcomes trials data, guideline recommendations, a limited label or cost.”
After 2017, the label of PCSK9 inhibitors was expanded to include indications for reduction of events in patients with ASCVD and lower elevated LDL in patients with primary hypercholesterolemia, and in October 2018, manufacturers reduced prices of PCSK9 inhibitors, making them more similar in price to other guideline-indicated cardiometabolic therapies such as apixaban (Eliquis, Bristol Myers Squibb/Pfizer), sacubitril/valsartan (Entresto, Novartis), dapagliflozin (Farxiga, AstraZeneca), empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) and liraglutide (Saxenda, Novo Nordisk).
Using U.S. health care claims data sourced from Symphony Health, representing more than half of the U.S. census, MacDougall and colleagues conducted a retrospective study to assess changes in PCSK9 inhibitor prescription, rejection or abandonment from July 2015 to December 2021.
Coverage for new prescriptions was classified as paid — covered by the insurer and retrieved by the individual; rejected by the insurer; or abandoned — covered by the insurer and not retrieved by the individual.
Rejection of PCSK9 inhibition by insurers
From 2015 to 2018, 238,704 patients were newly prescribed a PCSK9 inhibitor, which increased to 470,018 patients from 2019 to 2021.
The rate of rejected initial PCSK9 inhibitor prescriptions declined from 45.86% in 2015-2018 to 30.95% in 2019-2021, yet rejection remained higher compared with the other cardiometabolic therapies, according to the study. Rejection rates for the other cardiometabolic therapies ranged from 4.97% to 14.69% in 2015-2018 and from 3.53% to 14.61% in 2019-2021.
“We were not surprised that nearly 31% of prescriptions were not covered by insurance because we had shown in a 2019 publication that rejection rates were even higher several years earlier,” MacDougall told Healio. “The higher rate of rejection for PCSK9 inhibitors vs. other cardiometabolic drugs was striking. It is not clear from these data why the rates are different.”
Despite a 2.7-fold increase in paid prescriptions from 85,215 in 2015-2018 to 234,703 in 2019-2021, the rates of paid prescription for initial PCSK9 inhibitor coverage — ranging from 35.7% to 49.93% — were lower compared with other guideline-recommended cardiometabolic drugs, which ranged from 68.49% to 84.45%.
In addition, the proportion of PCSK9 inhibitor prescriptions abandoned by patients was similar from 2015 to 2018 through 2019 to 2021 and remained slightly higher compared with other guideline-indicated cardiometabolic drugs.
Prior authorizations ‘need to be simplified’
“Prior authorization criteria for PCSK9 inhibitors need to be simplified, harmonized and based on national cholesterol management guidelines, such as those from American College of Cardiology/American Heart Association. Additionally, streamlining the process through wider adoption of electronic prior authorization would be helpful,” MacDougall told Healio. “As outlined in our recent policy paper, the Family Heart Foundation supports common sense prior authorization reform based on the AMA principles, such as what was included in the recent CMS rule, although this guidance from CMS needs to be extended to cover medications as well.”
For more information:
Diane E. MacDougall, MS, can be reached at dm@familyheart.org.
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MacDougall DE, et al. Circ Cardiovasc Qual Outcomes. 2024;doi:10.1161/CIRCOUTCOMES.123.009988.
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