The patient journey with proprotein convertase subtilisin/kexin type 9 inhibitors in community practice

Abstract

BACKGROUND: Trials have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective as an adjunct to statin therapy, but access and cost issues have limited their use in community practice. OBJECTIVE: The aim of the study was to better understand patients' experiences when trying to obtain, fill, and use PCSK9 inhibitor therapy in community practice. METHODS: We conducted a patient survey to evaluate patient experiences with PCSK9 inhibitors including medication initiation, indication for treatment, insurance approval status, medication persistence, and reason for discontinuation. The survey was emailed to 4740 adults who used a patient access support program. RESULTS: Overall, 1327 of 4740 adults completed the survey (28.0% response rate). Of those, 75.0% were aged .60 years, 52.8% were male, and 92.4% were White. At the time of PCSK9 inhibitor prescription, 70.2% were not on a statin (with 84.4% of those not on a statin reporting statin intolerance). Overall, 74.6% of patients found the drug approval process to be ''somewhat'' or ''very'' burdensome. Among n 5 1216 patients who initiated treatment, 33.7% discontinued by the time of the survey, with 50.0% taking the drug for 1 to 6 months. Patient out-of-pocket costs were the leading reported reason for discontinuation. CONCLUSIONS: Most PCSK9 inhibitor users in community practice were not on a statin, presumably because of statin intolerance. The drug approval process and costs continue to be strong reasons for lower initiation of PCSK9 agents, as well as higher discontinuation rates.

Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

“…Even though one of the most frequently reported adverse reactions in trials was injection site reactions, the subcutaneous administration of PCSK9 inhibitors was well accepted by patients [22]. In addition, multiple studies evaluating PCSK9 inhibitors treatment acceptance suggested a high level of drug acceptance and tolerability [23][24][25]. In the present OLE study, two (0.4%) participants had at least one device-related TEAE, including injection site hematoma in one (0.7%) participant and injection site reaction and application site pruritus in one (0.7%) participant.…”

Perceptions and Barriers on the Use of Proprotein Subtilisin/Kexin Type 9 Inhibitors in Heterozygous Familial Hypercholesterolemia (From a Survey of Primary Care Physicians and Cardiologists)

“…Of those who initiated treatment, 34% had discontinued treatment by the time of the survey with half taking the drug for 6 months or less, citing out-of-pocket costs as the leading reason for discontinuation. 24 Other impediments to insurance authorization include insistence on the patient failing ezetimibe on top of a statin in achieving adequate LDL-C reduction, refusing to accept documentation of statin intolerance, the absence of staff with the needed time or expertise to work through the authorization process, as well as the absence of nursing or other staff who can take the needed time to teach patients on the use of PCSK9i.…”

Impact of list price changes on out-of-pocket costs and adherence in four high-rebate specialty drugs

“…The date of the first alirocumab or evolocumab claim identified during the selection window was the index date. Given the known access hurdles for PCSK9is, [ 25 ] the cohort was restricted to prevalent patients (those with at least one filled prescription prior to the index date) to minimize the effect of interrupted or discontinued use due to prior authorization hurdles during first treatment initiation, and to isolate the effect due to list price change more effectively (rather than other access hurdles).…”