Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy
Key result
Only 47.2% of patients prescribed a PCSK9 inhibitor received approval, and 30.9% ever received therapy, with prescription abandonment strongly associated with higher copay costs.
Why the study?
Do prior authorization and out-of-pocket costs limit patient access to PCSK9 inhibitor therapy in patients newly prescribed the medication?
Population
45,029 patients newly prescribed PCSK9 inhibitors in the United States between August 1, 2015, and July 31…
Design
Cohort
Authors
Discussion
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Member takes
Implication
High prior authorization denials and copay costs limit PCSK9i access; leaves open whether policy reforms increase real-world uptake.
Key Points
- To evaluate patient access to PCSK9 inhibitors among individuals who received a new prescription, focusing on authorization approvals and unfilled prescriptions.
- Analyzed pharmacy transaction records for 45,029 patients in the United States newly prescribed PCSK9 inhibitors between August 1, 2015, and July 31, 2016.
- Assessed proportions of prescriptions approved by insurers and abandoned by patients using multivariable regression adjusting for payer, copay, prescriber specialty, and clinical characteristics.
- Only 47.2% of prescribed patients ever received prior authorization approval (20.8% on the first day), and only 30.9% of all prescribed patients ultimately received therapy.
- Approval was more likely for government versus commercial insurance (OR, 3.3; 95% CI, 2.8-3.8) and specialty versus retail pharmacies (OR, 1.96; 95% CI, 1.66-2.33), but did not differ by statin use or LDL cholesterol levels.
- Prescription abandonment among approved patients was strongly linked to copay costs (C statistic, 0.86), escalating from 7.5% for a $0 copay to over 75% for copays exceeding $350.
Study Design
Type
Observational (n=45,029)
Multicenter
Yes
Structured PICO
Do prior authorization and out-of-pocket costs limit patient access to PCSK9 inhibitor therapy in patients newly prescribed the medication?
P
Population
45,029 patients newly prescribed PCSK9 inhibitors in the United States between August 1, 2015, and July 31, 2016. 51.2% women, 56.6% ≥65 years, 52.5% had governmental insurance.
I
Intervention
PCSK9 inhibitor prescription
O
Outcome
Proportion of PCSK9i prescriptions approved and abandoned (approved but unfilled)
High prior authorization rejection rates and high copay costs severely limit patient access to newly prescribed PCSK9 inhibitors, with only 30.9% of prescribed patients receiving therapy.
Cite This Study
Návar et al. (2017) conducted an observational in Patients newly prescribed PCSK9 inhibitors (n=45,029). PCSK9 inhibitors was evaluated on Proportion of PCSK9i prescriptions approved and abandoned. Only 47.2% of patients prescribed a PCSK9 inhibitor received approval, and 30.9% ever received therapy, with prescription abandonment strongly associated with higher copay costs.