During a session at the Asembia 2019 Specialty Pharmacy Summit, Rhonda Cooper-DeHoff, PharmD, associate professor in the department of pharmacotherapy and translational research at the University of Florida College of Pharmacy, and Joseph Saseen, PharmD, professor and vice chair of the department of clinical pharmacy at the University of Colorado Anschutz Medical Campus, reviewed recent clinical data for PCSK9 inhibitors and analyzed recent cost-effectiveness data.
Dr Saseen kicked off the session with statistics from the American Heart Association HeartDisease and Stroke Statistics. He explained that cholesterol is one of the primary casual risk factors for atherosclerosis cardiovascular disease (ASCVD) development. He continued to explain that 28.5 million individuals, older than 20 years, have serum TC levels >= 240 mg/dL. Finally, he explained that familial hypercholesterolemia affects roughly 1 in 200 individuals.
According to Dr Saseen, based on these statistics, as well as the recently published 2018 Cholesterol Guideline, “statin therapy remains the cornerstone of therapy for most patients with hypercholesterolemia.” He also explained that based on recent trial findings, from both the FOURIER and ODYSSEY OUTCOMES, that alirocumab and evolocumab, two PCSK9 inhibitors, “have been proven to reduce the incidence of CV events in patients with clinical ASCVD and additional risk factors, when added to maximally tolerated statin therapy.”
Dr Saseen concluded his section of the session recommending that “PCSK9 inhibitor therapy should be considered in patients with clinical ASCVD and/or familial hypercholesterolemia that need additional LDL-C reduction while maximally tolerated statin therapy.
In the second half of the session, Dr Cooper- DeHoff dove into the economic considerations of PSCK9 inhibitors.
She explained both the pros and cons of PCSK9 inhibitor use. She said that although PCSK9 inhibitors do have many pros, it also has many cons—including the cost of treatment. She included the following in her list of cons:
- Overall cost of treatment;
- Restricted access;
- A complicated prior authorization process; and
- Prescription denials by payers.
Dr Cooper-DeHoff explained, “From 2011-2012, the estimated annual direct and indirect costs of CVD and stroke were more than $310 billion with annual costs projected to nearly triple from $273 billion to $818 billion.”
Despite a history of high costs associated with this treatment, she explained that cost for PCSK9 has gone down recently, they are still expensive. Originally, but they were priced at $14,000 per year.
Dr Cooper-DeHoff noted the recent move by Sanofi and Regeneron to reduce the list price of alirocumab to $5840 annually, which matches the price of evolocumab. Sanofi and Regeneron announced the lower price of treatment in February 2019, and Amgen reduced the price of evolocumab in October 2019.
Dr Cooper-DeHoff wrapped up the session by providing a checklist for “Clinician-Patient Shared Decision Making for Initiating Therapy.” Her checklist included:
- ASCVD risk assessment;
- Lifestyle modifications;
- Potential net-clinical benefit from pharmacotherapy;
- Cost considerations; and,
- Shared decision making.
She said that because patient adherence to all lipid lowering medications is critical to CV risk reduction, shared decision making allows patients to verbalize what they heard about treatment, and the health care provider and patient can collaborate to determine what plan is ultimately best.—Julie Gould