jmcp.org/doi/pdf/10.18553/jmcp.2016.22.10-a.s1
E43
Evaluation of Prior Authorization Requests for Alirocumab and Evolocumab at a PPO Health Plan
Bigness C, Tungol Lin A. 600 E Lafayette, #512C, Detroit, MI 48226; Blue Cross Blue Shield of Michigan
BACKGROUND: Alirocumab and evolocumab were FDA-approved in summer 2015 as adjunct treatment of familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease (ASCVD), based on their ability to significantly reduce low density lipoprotein cholesterol (LDL-C). Studies to support cardiovascular risk reduction are in progress. Guidelines recommend statins as first line therapy in FH and ASCVD since cardiovascular risk reduction is well documented, with ezetimibe and bile acid sequestrants (BAS) as options for adjunct therapy. While statins have been the mainstay, intolerance is highly reported in the community. Alirocumab and evolocumab could significantly impact health plans financially, despite lack of cardiovascular risk reduction data.
OBJECTIVE: To examine baseline treatment of members requesting prior authorization (PA) of alirocumab and evolocumab and effects on LDL-C among those approved for therapy.
METHODS: Retrospective review of commercially insured members with Blue Cross Blue Shield of Michigan pharmacy benefit requesting alirocumab and evolocumab from July 24, 2015 to June 30, 2016 was conducted. Member demographics, diagnosis, current medications and intolerances, lifestyle modifications, LDL-C, and PA approval status were analyzed using pharmacy claims data and PA requests submitted by prescriber offices. Approved PAs were reviewed for repeat LDL-C after two to three months of therapy.
RESULTS: A total of 284 PA requests were received, with 272 (95.8%) being denied initially. Ninety-six cases were appealed, with 63 (65.6%) denied. After a denied appeal, one case was escalated for external review, and the denial was upheld. Diagnoses included clinical ASCVD (55.6%), heterozygous FH (3.9%), and homozygous FH (0.4%). Off label use was requested among 40.1% of cases. Baseline therapy included maximal dose of high intensity statin (10.6%), ezetimibe (22.9%), and BAS (6.7%). Intolerances to statins (75.7%), ezetimibe (22.5%), and BAS (9.5%) were reported. Ninety-one members (32.0%) had documented lifestyle modifications. Forty-five members (15.8%) were initiated on therapy with samples. Average LDL-C was 160.5 mg/dL (range 38-357 mg/dL) among patients with a submitted LDL-C (n=228). A total of 25 approved cases had repeat LDL-C available (average 73.1 mg/dL, range 12-191.3 mg/dL), representing average LDL-C reduction of 60.2% (range 32.6-90.0%).
CONCLUSIONS: Guideline recommendations were not consistently followed among members requesting alirocumab and evolocumab. Documented LDL-C reductions were in accordance with package labeling.
SPONSORSHIP: Blue Cross Blue Shield of Michigan.
E43
Evaluation of Prior Authorization Requests for Alirocumab and Evolocumab at a PPO Health Plan
Bigness C, Tungol Lin A. 600 E Lafayette, #512C, Detroit, MI 48226; Blue Cross Blue Shield of Michigan
BACKGROUND: Alirocumab and evolocumab were FDA-approved in summer 2015 as adjunct treatment of familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease (ASCVD), based on their ability to significantly reduce low density lipoprotein cholesterol (LDL-C). Studies to support cardiovascular risk reduction are in progress. Guidelines recommend statins as first line therapy in FH and ASCVD since cardiovascular risk reduction is well documented, with ezetimibe and bile acid sequestrants (BAS) as options for adjunct therapy. While statins have been the mainstay, intolerance is highly reported in the community. Alirocumab and evolocumab could significantly impact health plans financially, despite lack of cardiovascular risk reduction data.
OBJECTIVE: To examine baseline treatment of members requesting prior authorization (PA) of alirocumab and evolocumab and effects on LDL-C among those approved for therapy.
METHODS: Retrospective review of commercially insured members with Blue Cross Blue Shield of Michigan pharmacy benefit requesting alirocumab and evolocumab from July 24, 2015 to June 30, 2016 was conducted. Member demographics, diagnosis, current medications and intolerances, lifestyle modifications, LDL-C, and PA approval status were analyzed using pharmacy claims data and PA requests submitted by prescriber offices. Approved PAs were reviewed for repeat LDL-C after two to three months of therapy.
RESULTS: A total of 284 PA requests were received, with 272 (95.8%) being denied initially. Ninety-six cases were appealed, with 63 (65.6%) denied. After a denied appeal, one case was escalated for external review, and the denial was upheld. Diagnoses included clinical ASCVD (55.6%), heterozygous FH (3.9%), and homozygous FH (0.4%). Off label use was requested among 40.1% of cases. Baseline therapy included maximal dose of high intensity statin (10.6%), ezetimibe (22.9%), and BAS (6.7%). Intolerances to statins (75.7%), ezetimibe (22.5%), and BAS (9.5%) were reported. Ninety-one members (32.0%) had documented lifestyle modifications. Forty-five members (15.8%) were initiated on therapy with samples. Average LDL-C was 160.5 mg/dL (range 38-357 mg/dL) among patients with a submitted LDL-C (n=228). A total of 25 approved cases had repeat LDL-C available (average 73.1 mg/dL, range 12-191.3 mg/dL), representing average LDL-C reduction of 60.2% (range 32.6-90.0%).
CONCLUSIONS: Guideline recommendations were not consistently followed among members requesting alirocumab and evolocumab. Documented LDL-C reductions were in accordance with package labeling.
SPONSORSHIP: Blue Cross Blue Shield of Michigan.