Drug Prior Authorization Guideline PCSK9 Inhibitors - REPATHA (evolocumab) PRALUENT (alirocumab) PA9911 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes-as shown below Additional Information: Prescribed and monitored by (or in consultation with) a cardiologist, lipidologist, or endocrinologist with prior authorization through Navitus Prevea360 Health Plan Approved Criteria: 1.0 Heterozygous familial hypercholesterolemia (HeFH): 1.1 As an adjunct to diet and maximally tolerated high-intensity statin therapy for the treatment of adults with HeFH as defined by the following criteria: 1.1.1 DNA-based evidence of mutation in the LDLR, Apo B, PCSK9 mutation; OR 1.1.2 Untreated LDL-C > 190 mg/dl Tendon xanthomas in patient or first/second degree relative; OR 1.1.3 Untreated LDL-C > 190 mg/dl either first degree relative <60 years of age or second degree relative <50 years of age with premature heart disease; OR 1.1.4 Untreated LDL-C > 190 mg/dl First or second degree relative with total cholesterol >290 mg/dl 1.2 Recent fasting lipid panel (within 3 months) provided; 1.3 Member meets ONE (1) of the following: 1.3.1 Member has failed an 8 week trial of high-intensity statin (atorvastatin 40 mg) in combination with ezetimibe; OR 1.3.2 Member has failed an 8 week trial of high-intensity statin (rosuvastatin 20 mg) in combination with ezetimibe 1 of 5
1.4 Prescriber attests the member was adherent to the high-intensity statin therapy; 1.5 Member meets ONE (1) of the following: 1.5.1 Member s LDL level remains > 100 mg/dl while on high-intensity statin therapy; OR 1.5.2 Member s LDL level remains > 70 mg/dl while on high-intensity statin therapy the member has diabetes; 1.6 Documentation of high-intensity statin trial attempt is submitted with the authorization request (including the trial dates and LDL levels before and after the trial) 2.0 Primary Hyperlipidemia-Clinical Atherosclerotic Cardiovascular Disease (ASCVD): 2.1 As an adjunct to diet and maximally tolerated high-intensity statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). ASCVD defined by ONE (1) of the following: 2.1.1 Acute coronary syndromes (ACS) 2.1.2 History of myocardial infarction (MI) 2.1.3 Prior coronary or other arterial revascularization 2.1.4 Ongoing angina (stable or unstable) 2.1.5 Prior stroke or transient ischemic attack (TIA) 2.1.6 Peripheral arterial disease of atherosclerotic origin 3.0 AVAILABLE FOR REPATHA ONLY: Homozygous Familial Hypercholesterolemia: As an adjunct to diet and other LDL-lowering therapies (e.g. statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. 3.1 Both biological parents diagnosed with HeFH OR presence of two (2) mutant alleles at the LDLR, Apo B, PCSK9 or ARH adaptor gene locus 3.2 Xanthomas since 10 years of age 3.3 Clinical atherosclerotic event by age 20 years 3.4 Untreated LDL-C > 190 mg/dl 3.5 Two recently completed (most recent no older than 3 months) lipid panels including APO-B performed at least 8 weeks apart 2 of 5
Comment(s): 1.0 General Policy Statement: This document contains the most current coverage criteria using guidance from experts and approved by the Prevea360 Health Plan Pharmacy and Therapeutics Committee. This document remains dynamic and will be updated from time to time as new evidence becomes available reflecting substantive changes in care. The most recent version of the medical coverage criteria can be found at http://www.prevea360.com/. 2.0 Additional Criteria for Initial and Renewal Period Requests 2.1 Patient is 18 years of age 2.2 Complete and submit the request form for initial and renewal authorizations. 2.3 Must include with submission of the request form legible copies of required lab reports, medication history, tobacco use status, and medical records. 2.4 Renewal authorization required after first 3 months and annually thereafter. The authorization period commences with the authorization request approval date. Lack of renewal authorization will result in claim denial. 2.5 Use in non-fda approved indication or non-approved dosage regimen is considered experimental and not approvable. 2.6 Concurrent use with another PCSK-9 inhibitor, mipomersen, or lomitapide is considered experimental and not approvable. 2.7 Must be filled and agree to monitoring by network specialty pharmacy 2.8 Hyperlipidemia and ASCVD under current and active management by cardiologist, lipidologist, or endocrinologist. 2.9 Medication adherence measure by objective means including but not limited to pharmacy claims, proportion of days covered (PDC), e-prescribing messaging. 2.9.1 A minimum adherence threshold of 80% is used to define medication adherence for lipid-lowering therapies not including PCSK9s. 2.9.2 A minimum adherence threshold of 100% to define adherence to PCSK9s. 2.10 Adherence to a low fat diet as determined by the requesting provider. 2.11 Not actively using tobacco products or currently enrolled in a nicotine addiction program like Quit for Life if currently using tobacco products. 2.12 Current rosuvastatin or atorvastatin combination regimen Ineffective 2.13 Adherence to current regimen 80% measured by Rx claims and other means 2.14 Documentation supporting patient meeting definition for Statin Intolerance 2.15 Patient tobacco free or enrolled in program 3 of 5
3.0 Renewal Criteria (Patient must meet ALL of the following at each renewal period): 3.1 Initial coverage criteria continues to apply to patient 3.2 LDL-C level 50% lower than LDL-C measured prior to (within 3 months) before starting therapy 3.3 Adherence rate of 100% using prescription claims or other means 3.4 Ongoing lipid therapy adherence rate of 80% using claims or other means 4.0 Definition of ASCVD: Specific Conditions Qualifying as ASCVD prior myocardial infarction prior non-cardiogenic thromboembolic stroke peripheral arterial disease due to atherosclerotic origin stable or unstable angina transient ischemic attack history of coronary stenting or other coronary revascularization acute coronary syndrome 5.0 Definition of Ineffective Therapy and Statin Intolerance Definitions of Ineffective Therapy and Statin Intolerance (while on maximum statin dose) Ineffective Therapy Trial of ezetimibe 10 mg /day with rosuvastatin 20-40 mg/day or atorvastatin 40-80 mg/day. After 8 weeks of adherent therapy to either statin combination regimen, LDL-C remains 100 mg/dl. Lower doses justified in lieu of statin intolerance. LDL-C level must reflect the most recent adherent drug therapy regimen (within the most recent 3 months). Statin Intolerance Symptoms not caused by hypothyroidism, interacting drugs, concurrent illness, changes in physical activity, or underlying muscle disease. Symptoms of muscle cramps, stiffness, soreness and tenderness persisting for 2 weeks during statin use and resolve 2 weeks of discontinuing the statin. Symptoms recur or persist despite restarting same statin at lowest starting daily dose of statin. Symptoms recur despite trial of one other statin alternative. 6.0 Quantity Limits: FDA indication guides the limits on coverage. 6.1 Two (2) prefilled syringes or auto-injectors per 28 days. 6.2 Individuals with Homozygous Familial Hypercholesterolemia (HoFH) may receive one additional prefilled syringe or auto-injector every 28 days. 6.3 For individuals without HoFH, requests for a greater quantity will be reviewed on a case by case basis. 4 of 5
7.0 Approval Duration: 7.1 Initial Period: 3 months commencing on coverage request approval date and subject to member eligibility, benefits, and medical certificate of coverage. 7.2 Renewal Period: 12 months duration commencing on the renewal request for coverage approval date and subject to member eligibility, benefits, and medical certificate of coverage. 8.0 NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. Committee/Source Date(s) Originated: Medical Director Committee/Quality and Care Management Division/Pharmacist 12/16/2015 Revised: Management/Pharmacy Services November 16, 2016 June 21, 2017 September 20, 2017 May 16, 2018 Reviewed: Management/Pharmacy Services November 16, 2016 June 21, 2017 September 20, 2017 May 16, 2018 Effective: 06/01/2018 Published: 06/01/2018 5 of 5