Drug Class Monograph
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1 Drug Class Monograph Class: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Drugs: Praluent (alirocumab), Repatha (evolocumab) Line of Business: Medi-Cal Effective Date: February 17, 2016 Renewal Date: February 15, 2017 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic Subcommittee. Policy/Criteria: 1. PCSK9 inhibitor (Alirocumab or Evolocomab) is considered medically necessary and will be initially authorized for 6 months if ALL of the following criteria are met: (A through F) A. Confirmed diagnosis of ONE of the following: i. Dx: Familial hypercholesterolemia (FH) as established by ONE of the following: a. Presence of a mutation in LDLR, apolipoprotein B (ApoB), PCSK9, or ARH adaptor protein (LDLRAP1) gene b. Pre-treatment LDL level greater than 190 mg/dl or total cholesterol greater than 290mg/dL in an adult or pre-treatment LDL level greater than 155mg/dL or total cholesterol greater than 250mg/dL in a child AND tendon xanthomas in patient or a first-or second-degree relative c. World Health Organization (WHO)/Dutch Lipid Network Criteria with score of 8 or greater ii. Dx: Atherosclerotic Cardiovascular Disease (ASCVD), including ONE of the following (documentation must be provided): a. Acute coronary syndromes b. History of myocardial infarction (MI) c. Stable or unstable angina d. Coronary or other arterial revascularization e. Stroke f. Transient ischemic attack (TIA) g. Peripheral arterial disease presumed to be of atherosclerotic origin
2 B. Medical record documentation (e.g. laboratory test results, chart notes) indicating ONE of the following: i. Patient has been adherent for 12 consecutive weeks of high-intensity statin therapy and will continue to receive high-intensity statin therapy [e.g. atorvastatin 40 or higher, rosuvastatin 20 or higher] at the maximally tolerated dose ii. Patient has been adherent for 12 consecutive weeks of the maximally tolerated statin therapy [e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin at any dose] and will continue to receive the maximally tolerated dose AND patient is unable to tolerate high-intensity statin as evidenced by myalgia (muscle symptoms without CK elevations) or myositis (muscle symptoms with CK elevations <10 times ULN) iii. Patient has a labeled contraindication to all statins as documented in medical records iv. Patient has experienced rhabdomyolysis or muscle symptoms with CK elevations 10 times ULN C. Documentation indicating ONE of the following: i. Patient has been adherent for 12 consecutive weeks of Zetia (ezetimibe) concurrently with the statin ii. Patient has a labeled contraindication or intolerance to Zetia D. Documentation indicating ONE of the following treated LDL levels while on a lipid lowering therapy, dated within the last 30 days: i. LDL 100 mg/dl with ASCVD ii. LDL 130 mg/dl without ASCVD E. Prescribed by a cardiologist, endocrinologist or lipid specialist F. Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor or Juxtapid (lomitapide) or Kynamro (mipomersen)
3 Reauthorizations for PCSK9 inhibitor therapy will be approved for another 6 months if ALL of the following criteria are met: A. Patient is adherent to therapy since the initial authorization B. Patient continues concurrent use of the high-intensity statin or the statin at the maximally tolerated dose, unless documentation of the inability to take statins is provided C. Documentation of LDL reduction while on PCSK9 inhibitor therapy D. Prescribed by a cardiologist, endocrinologist or lipid specialist Note: This policy does not apply to the request for Praluent (alirocumab) for Medicare line of business. Please see CMS approved criteria for Praluent for Medicare. Clinical Justification: Comparison of FDA-Approved Indications Heterozygous familial hypercholesterolemia in adults on maximally tolerated statin therapy who requires additional lowering of LDL. Adjunct to diet modification. Clinical atherosclerotic cardiovascular disease in adults on maximally tolerated statin therapy who requires additional lowering of LDL. Adjunct to diet modification. Homozygous familial hypercholesterolemia in adults on other LDL-lowering therapies who require additional lowering of LDL. Adjunct to diet modification. Praluent (alirocumab) Repatha (evolocumab)
4 2013 American College of Cardiology/American Heart Association Task Force Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults The Expert Panel makes no recommendation for or against specific LDL or non-hdl targets for the primary or secondary prevention of atherosclerotic cardiovascular disease (ASCVD) due to the absence of data on titration of drug therapy to specific goals Secondary Prevention: High-intensity statin therapy should be initiated or continued as first-line therapy in women and men 75 years of age who have clinical ASCVD, unless contraindicated Primary Prevention: High-intensity statin therapies are recommended for the following groups with risk 1) Individuals 21 years of age with LDL 190mg/dL; 2) Individuals years of age with diabetes, LDL mg/dl and 7.5% estimated 10-year ASCVD risk; 3) Individuals years of age with LDL mg/dl without clinical ASCVD or diabetes, and with an estimated 10-year ASCVD risk 7.5%. o Moderate-intensity statin therapy for the following groups with risk 1) Individuals years of age with diabetes and LDL mg/dL; 2) Individuals years of age, with LDL mg/dl without clinical ASCVD or diabetes, and with an estimated 10-year ASCVD risk of 5% to <7.5%; 3) Individuals years of age with LDL mg/dl without clinical ASCVD or diabetes, and with an estimated 10-year ASCVD risk 7.5% High-risk patients who have a suboptimal response to statins, who are unable to tolerate a less-than-recommended intensity of a statin, or who are completely statin intolerant, may consider the addition of a non-statin therapy Intensity of Statin Therapy High-Intensity Statin Therapy Lowers LDL 50% Atorvastatin 40-80mg Rosuvastatin 20-40mg Moderate-Intensity Statin Therapy Lowers LDL by 30-50% Atorvastatin 10-20mg Rosuvastatin 5-10mg Simvastatin 20-40mg Pravastatin 40-80mg Lovastatin 40mg Fluvastatin 80mg Pitavastatin 2-4mg Low-Intensity Statin Therapy Lowers LDL by <30% Simvastatin 10mg Pravastatin 10-20mg Lovastatin 20mg Fluvastatin 20-40mg Pitavastatin 1mg
5 National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III) 2001 Definition of Statin Intolerance, International Lipid Expert Panel 2015 Inability to tolerate at least 2 statins, with at least one started at the lowest starting daily dose Statin dose reduction is attempted for symptom and biomarker abnormality resolution, rather than discontinuation of statin therapy altogether Intolerable symptoms or abnormal biomarker changes are reversible upon statin discontinuation, but reproducible by re-challenge of statins; if clinically appropriate. Symptoms or biomarker abnormalities are not attributable to established predispositions such as drug-drug interactions and conditions recognized to increase the risk of statin intolerance such as: hypothyroidism, concurrent illness, significant changes in physical activity/exercise and/or underlying muscle disease
6 WHO/Dutch Lipid Network Criteria Simon-Broom Diagnostic Criteria
7 Clinical Studies for Praluent: ODYSSEY Program The efficacy of Praluent was evaluated in five double-blind placebo-controlled studies that enrolled 3499 patients, consisted of 36% patients with heterozygous familial hypercholesterolemia (HeFH) and 54% non-fh with clinical atherosclerotic cardiovascular disease. All patients enrolled were receiving a maximally tolerated statin dose. The Praluent study group received 75mg every 2 weeks followed by criteria-based up-titration to 150mg every 2 weeks at week 12 for patients with suboptimal response. The primary efficacy endpoint, mean percent change in LDL, was measured at week 24. In Study 1 and Study 2, which enrolled both non-fh patients with clinical atherosclerotic cardiovascular disease and HeFH patients, the overall average baseline LDL was 112 mg/dl. At week 24, the treatment differences between Praluent and placebo in mean LDL percentage change were -58% (p <0.0001), and -43% (p <0.0001), respectively. In Study 3, 4 and 5, which exclusively included HeFH patients with overall mean baseline LDL of 170 mg/dl, at week 24, the treatment differences between Praluent and placebo in mean LCL percentage change were -54% (p <0.0001), and -43% (p <0.0001). In the ODYSSEY LONG TERM trial, a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL of 70 mg/dl or more and were receiving maximum tolerated statin dose, the Praluent group had a lower rate of post hoc cardiovascular events (1.7% vs. 3.3%, HR 0.52, CI ). Adverse effects were similar between Praluent and placebo group (81% vs. 82.5%), as were serious adverse events (18.7% vs. 19.5%). Clinical Studies for Repatha: LAPLACE-2, RUTHERFD-2, OSLER-1 & OSLER-2 In the LAPLACE-2 multicenter, double-blind, randomized controlled trial, 296 patients with atherosclerotic cardiovascular disease received an open label statin regimen and a 4-week lipid stabilization followed by random assignment to subcutaneous Repatha 140mg every 2 weeks, Repatha 420mg once monthly or placebo for 12 weeks. The mean baseline LDL after 4 weeks of maximum-dose statin therapy was 108 mg/dl. The difference between Repatha group and placebo in mean percentage change in LDL at week 12 was -71% (p< ) and -63% (p< ) for the 140mg every 2 weeks and 420 mg once monthly dosages, respectively. In the RUTHERFD-2 multicenter, double-blind, randomized placebo-controlled, 12 weektrial, 329 patients with heterozygous familial hypercholesterolemia (HeFH) on statins with or without other lipid lowering therapies were randomized to receive subcutaneous Repatha 140mg every 2 weeks, 420mg once monthly or placebo. The average baseline LDL was 156 mg/dl with 76% of patients on high-intensity statin therapy. The differences between Repatha and placebo in mean percent change in LDL at week 12 was -61% (p< ) and -60% (p< ) for the 140mg every 2 weeks and 420mg once monthly, respectively. In two open-label, randomized trials, OSLER-1 and OSLER-2, 4465 patients who had completed one of twelve phase 2 or phase 3 trials were randomly assigned to Repatha, either 140mg every 2
8 weeks or 420mg monthly plus standard therapy, or standard therapy alone. The study population included those on statin therapy (70%), high-intensity statin therapy (27%), as well as those who were statin-intolerant or who were on no other lipid lowering therapy. The median duration of follow-up was 11.1 months. In contrast to the standard therapy alone, the Repatha study group reduced the LDL by 61% (p< 0.001) from a median of LDL 120mg/dL to 48 mg/dl. The rate of cardiovascular events at 1 year including death, myocardial infarction, unstable angina, coronary revascularization, stroke, transient ischemic attack and heart failure, was reduced from 2.18% on standard therapy alone to 0.95% (p= 0.003, HR 0.47). The risk of adverse events were similar in both groups (69% vs. 64%) as were serious adverse events (7.5% in each group). References 1. Sabatine MS, Giugliano RP, et al. N Engl J Med. 2015;372(16): Banach M, Rizzo M, Toth PP, et al. Statin intolerance an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci. 2015; 11(1): Robinson JG, Farnier M, et al. N Engl J Med. 2015;372(16): Stone NJ, Robinson JG, Lichtenstein AH, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014; 129(25 Suppl 2):S1- S Praluent [Product Information], Tarrytown, NY. Regeneron Pharmaceuticals, Inc. July Repatha [Product Information], Thousand Oaks, CA. Amgen Pharmaceuticals, Inc. August ATP III Final Report PDF. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. Circulation. 2002;106: ND Guides for Physicians. The Physician s Guide to Homozygous Familial Hypercholesterolemia (HoFH): nordphysicianguides.org/homozygous-familialhypercholesterolemia 12. Cuchel et al. Homozygous familial hypercholesterolemia: new insights and guidance for clinicians to improve detection and clinical management. European Heart Journal: June 2014
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