Few Patients Prescribed PCSK9 Inhibitors Actually Receive the Therapy

Patients prescribed PCSK9 inhibitors (PCSK9i) often face challenges involving patient access, including low approval rates during the first year of availability, according to research.

In a study recently published in JAMA Cardiology, researchers investigated patient access to PCSK9i inhibitors through evaluated pharmacy transaction data from the Symphony Health Solutions database for individuals newly prescribed PCSK9i in the United States between August 1, 2015, and July 31, 2016. The study also considered the type of payer that was associated with each patient by categorizing them between commercial or government.

“In this analysis, we evaluated what proportion of patients prescribed PCSK9i ultimately received therapy and factors associated with both approval and dispensing in the first year after PCSK9i were approved by the US Food and Drug Administration,” the authors wrote. “Specifically, we calculated the proportion of patients who received a rejection initially (within 24 hours) as well as the proportion who ultimately received approval.”

Of the 45,029 patients in the study, 51.2% were women, 56.6% were 65 years or older, and 52.5% had government insurance. Of the individuals who were given a prescription, 20.8% received approval on the first day, and 47.2% eventually received approval. Furthermore, of those who were approved, 65.3% filled the prescription, meaning that 30.9% of those prescribed PCSK9i ever received the therapy.

Additionally, the prescription abandonment by patients was most associayed with high copay costs, as abandonment rates ranged from 7.5% for those with $0 copay to more than 75% for those with copays over $350.

“The high retail cost of PCSK9i therapy has led to significant debate about their cost-effectiveness and optimal price points. In response to these costs, payors have implemented various utilization management strategies including prior authorization requirements and patient cost-sharing (copays),” the authors wrote. “While these strategies have contained costs, our analysis suggests that these practices may be a blunt instrument to identify those at highest risk or those who may benefit the most.”

The investigators noted that their research was limited as it was challenging to consider all of the clinical factors used in various approval processes; however, the researchers were able to establish that a person’s likelihood of receiving the therapy is significantly dependent on the payer and approval policies.

"The high cost of PCSK9 therapy has led payors to institute rigorous prior authorization practices and often leads to high patient copays,” the authors concluded.