Drug Class Prior Authorization Criteria PCSK9 Inhibitors

Transcription

1 Drug Class Prior Authorization Criteria PCSK9 Inhibitors Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 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 Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Praluent (alirocumab), Repatha (evolocumab) Formulary Alternative: atorvastatin, ezetimibe Criteria: Praluent Diagnosis: Heterozygous Familial Hypercholesterolemia Criteria: Must meet all of the following requirements: a. Familial hypercholesterolemia (FH) as established by i. Presence of a mutation in LDLR, apolipoprotein B (ApoB), PCSK9, or ARH adaptor protein (LDLRAP1) gene. ii. Pre treatment LDL level greater than 190 mg per dl or total cholesterol greater than 290 mg per dl in an adult or pre treatment LDL level greater than 155 mg per dl or total cholesterol greater than 250 mg per dl in a child and tendon xanthomas in patient or a first or second degree relative. ii. iii. Patient has been adherent for 3 months (90 consecutive days) of the Patient has a labeled contraindication to all statins as documented in

2 iv. Patient has experienced rhabdomyolysis or muscle symptoms with CK ii.patient has a labeled contraindication or intolerance to Zetia. d. Documentation indicating 1 of the following treated LDL levels while on a lipid lowering therapy, dated within the last month (30 days): 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 Diagnosis: Clinical Atherosclerotic Cardiovascular Disease Criteria: Must meet all of the following requirements: a. Documentation of i. Acute Coronary Syndromes. ii. History of Myocardial Infarction (MI) iii. Stable or unstable Angina iv. Coronary or other Arterial Revascularization v. Stroke vi. Transient Ischemic Attack (TIA) vii. Peripheral Arterial Disease presumed to be of Atherosclerotic origin

3 ii. iii. iv. Patient has been adherent for 3 months (90 consecutive days) of the Patient has a labeled contraindication to all statins as documented in Patient has experienced rhabdomyolysis or muscle symptoms with CK ii. Patient has a labeled contraindication or intolerance to Zetia. d. Documentation indicating 1 of the following treated LDL levels while on a lipid lowering therapy, dated within the last month (30 days): 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 Repatha Diagnosis: Homozygous Familial Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia Criteria: Must all of the following requirements: a. Presence of a mutation in LDLR, apolipoprotein B (ApoB), PCSK9, or ARH adaptor protein (LDLRAP1) gene.

4 i. Pre treatment LDL level greater than 190 mg pr dl or total cholesterol greater than 290 mg per dl in an adult or pre treatment LDL level greater than 155 mg dl or total cholesterol greater than 250 mg dl in a child and tendon xanthomas in patient or a first or second degree relative. ii. Patient has been adherent for 3 months (90 consecutive days) of the iii. Patient has a labeled contraindication to all statins as documented in iv. Patient has experienced rhabdomyolysis or muscle symptoms with CK ii. Patient has a labeled contraindication or intolerance to Zetia. d. Documentation indicating 1 of the following treated LDL levels while on a lipid lowering therapy, dated within the last month (30 days): b. Patient continues concurrent use of the high intensity statin or the statin at the maximally tolerate dose, unless documentation of the inability to take statins is

5 Diagnosis: Clinical Atherosclerotic Cardiovascular Disease Criteria: Must meet all of the following requirements: a. Documentation of i. Acute Coronary Syndromes ii. History of Myocardial Infarction (MI) iii. Stable or unstable Angina iv. Coronary or other Arterial Revascularization v. Stroke. vi. Transient Ischemic Attack (TIA) vii. Peripheral Arterial Disease presumed to be of Atherosclerotic origin ii. Patient has been adherent for 3 months (90 consecutive days) of the iii. Patient has a labeled contraindication to all statins as documented in iv. Patient has experienced rhabdomyolysis or muscle symptoms with CK ii. Patient has a labeled contraindication or intolerance to Zetia. d. Documentation indicating

6 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 Change Control Date Change RPH 06/29/2018 Changed Format IK 02/21/2018 Added quantity limit CT Updated guidance of 2017 American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease