Impact of an integrated clinical and specialty pharmacy service model on access to PCSK9 inhibitor therapy. (21st September 2018)

• Record Type: Journal Article
• Authors: Chinn, M.; Reynolds, V.; Jolly, J.; Zuckerman, A. D.
• Is Part Of: Journal of drug assessment. Volume 7(2018)Supplement 1
• Page Start: 7
• Page End: 7
• Publication Date: 2018-09-21
• Subjects: PCSK9 inhibitors -- lipid -- specialty medication; Jacob Jolly [e-mail]; Drugs -- Testing -- Periodicals; 615.1901
• DOI: 10.1080/21556660.2018.1521048
• Languages: English
• ISSNs: 2155-6660

Abstract

Abstract: Background: Despite the proven benefits of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in dramatically lowering low-density lipoprotein cholesterol (LDL-C) levels, access to these costly medications remains challenging. A recent nationwide report of over 51, 000 patients prescribed a PCSK9 inhibitor found that only 47% of patients gained insurance approval, with an average time to approval of 29 days. Vanderbilt Specialty Pharmacy (VSP) developed a model to streamline insurance approval and increase patient access to evolocumab and alirocumab. Objectives: To evaluate the time to PCSK9 inhibitor approval and factors that impact time to approval in an integrated specialty pharmacy model. Methods: A single-center, retrospective cohort study of patients prescribed a PCSK9 inhibitor by a Vanderbilt University Medical Center provider between 1 September 2015 and 1 December 2016 was conducted. The primary endpoint was days to treatment approval from first provider treatment request. Secondary endpoints were patient, prescriber, and clinical factors related to treatment approval. Descriptive statistics, univariate, and multivariable Cox regression analyses were performed to evaluate the impact of specified factors on the time to treatment approval. Results: VSP gained access to PCSK9 inhibitor treatment through insurers in 264 patients during the study period. The majority were male (52%) with a mean age of 62 (SD ±11) and mean baseline LDL-C of 162mg/dL (SD ±57). The median time to medication approval was 7 days, ranging of 0–266. Mean time to medication approval was 17 days (SD ±25). On univariate analysis, older patients (≥65) were significantly more likely to achieve approval earlier compared to those <65 years ( p = .031) as were patients prescribed PCSK9 therapy for atherosclerotic cardiovascular disease (ASCVD) ( p < .001). The time to medication approval was longer when a prior authorization (PA) was required (HR 0.17, SD ±0.5; p < .001) or a first level appeal was required (HR 0.28, SD ±0.04; p < .001). On multivariable analysis, older age, the requirement of a PA, and the requirement of a first level appeal remained significant predictors to the time to medication approval ( p < .001). Conclusions: The VSP model of an integrated clinical pharmacist and pharmacy technician expedited the time to PCSK9 inhibitor access and initiation. As expected, the need for a prior authorization or appeal increased the time to approval. However, age and diagnosis of ASCVD positively impacted time to approval.