Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary

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1 Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit-Through Preferred Agent(s) OBJECTIVE The intent of the PCSK9 inhibitor Prior Authorization (PA) with quantity limit program is to appropriately select patients for therapy according to the Food and Drug Administration (FDA) approved product labeling and/or clinical practice guidelines and/or clinical studies. This program will require the patient has a confirmed diagnosis of Homozygous Familial Hypercholesterolemia (HoFH), Heterozygous Familial Hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD). The criteria will require the patient is currently receiving maximally tolerated statin therapy and is compliant. The program will not require use of a statin if the patient has a history of intolerance to two different statins or an FDA labeled contraindication to a statin. If the client has preferred agent(s), a preferred agent may be approved for use once criteria has been met; a non-preferred agent may be approved if the patient is currently treated with the non-preferred agent or the prescriber has documented failure of, intolerance to, FDA labeled contraindication to, or hypersensitivity to the preferred agent(s). The criteria will limit all agents to the maximum FDA approved dose for any indication. TARGET DRUGS Preferred agent(s) Praluent (alirocumab) Repatha TM (evolocumab) QUANTITY LIMIT TARGET DRUGS- RECOMMENDED LIMITS Brand (generic) GPI Multisource Code Quantity Limit Praluent (alirocumab) 75 mg/ml pre-filled pen D0 M, N, O, or Y package of pens/8 days 75 mg/ml pre-filled syringe E50 M, N, O, or Y package of syringes/8 days 50 mg/ml pre-filled pen D30 M, N, O, or Y package of pens/8 days 50 mg/ml pre-filled syringe E530 M, N, O, or Y package of syringes/8 days Repatha TM (evolocumab) 40 mg/ml pre-filled syringe E50 M, N, O or Y syringes/8 days 40 mg/ml pre-filled autoinjector D50 M, N, O or Y pens/8 days 40 mg/3.5 ml single-use Pushtronex system (infusor with pre-filled cartridge) E30 M, N, O or Y Pushtronex system/30 days INITIAL PRI AUTHIZATION CRITERIA F APPROVAL Praluent (alirocumab) or Repatha TM (evolocumab) will be approved when ALL of the following are met:. The patient has ONE of the following: HCSC_CS_ PCSK9_PAQL_ProgSum_AR06_r047 Page of 5 Divisions of Health Care Service Corporation, a Mutual Legal Reserve Company, an Independent Licensee of the Blue Cross and Blue Shield Association

2 a. A diagnosis of heterozygous familial hypercholesterolemia (HeFH) confirmed by ONE of the following: i. Genetic confirmation of one mutant allele at the LDLR, Apo-B, PCSK9, or ARH adaptor protein /LDLRAP gene locus ii. BOTH of the following:. ONE of the following: a. Total cholesterol greater than 90 mg/dl (>7.5 mmol/l) (pretreatment or highest level while on treatment) b. LDL-C greater than 90 mg/dl (>4.9 mmol/l) (pretreatment or highest level while on treatment). History of tendon xanthomas in ONE of the following: a. The patient b. The patient s first degree relative (i.e. parent, sibling, or child) c. The patient s second degree relative (e.g. grandparent, uncle, or aunt) iii. The Patient has a Dutch Lipid Clinic Network Criteria score of greater than 8 (see scoring algorithm in Table below) b. A diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by ONE of the following: i. Genetic confirmation of two mutant alleles at the LDLR, Apo-B, PCSK9, or ARH adaptor protein /LDLRAP gene locus ii. Untreated LDL-C >500 mg/dl (>3 mmol/l) or treated LDL-C 300 mg/dl ( 7.76 mmol/l) with ONE of the following:. The patient had cutaneous or tendon xanthoma before age 0 years. Untreated elevated cholesterol levels consistent with heterozygous FH in both parents [untreated LDL-C >90 mg/dl (>4.9 mmol/l)) or untreated total cholesterol greater than 90 mg/dl (>7.5 mmol/l)] c. A diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) defined as having ONE of the following: i. Acute coronary syndrome ii. History of myocardial infarction iii. Stable or unstable angina iv. Coronary or other arterial revascularization v. Stroke vi. Transient ischemic attack vii. Peripheral arterial disease presumed to be of atherosclerotic origin. ONE of the following: a. BOTH of the following: i. ONE of the following:. The patient is currently (for the past 80 days) on high-intensity statin therapy (i.e. rosuvastatin 0-40 mg or atorvastatin mg). BOTH of the following: a. The patient has tried and is intolerant to high-intensity statin therapy (i.e. rosuvastatin 0-40 mg and atorvastatin 40 80mg) b. The patient is currently (for the past 80 days) on low or moderate intensity statin therapy HCSC_CS_ PCSK9_PAQL_ProgSum_AR06_r047 Page of 5

3 ii. The patient is adherent^ (for the past 80 days) to statin therapy as prescribed b. The patient has documented intolerance* to TWO different statins (*intolerance is defined as inability to tolerate the lowest FDA approved starting dose of a statin) c. The patient has an FDA labeled contraindication to a statin 3. ONE of the following: a. The patient has not achieved a 50% reduction in LDL-C from baseline while on a maximally tolerated statin b. The patient has an LDL-C 00 mg/dl (.59 mmol/l) evaluated within the past 90 days 4. Praluent (alirocumab) and Repatha (evolocumab) will not be used concurrently with each other 5. The agent is being prescribed by a specialist in the area of practice related to the patient s diagnosis (e.g. cardiologist or endocrinologist) or in consultation with a specialist in the area of practice related to the patient s diagnosis 6. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent 7. ONE of the following: a. The quantity requested is less than or equal to the program quantity limit b. The quantity (dose) requested is within FDA approved labeling and the prescribed dose cannot be achieved using a lesser quantity of a higher strength that does not exceed the program quantity limit ^Adherence is defined as filling 80% of therapy as prescribed in the past 80 days Length of Approval: 6 months Renewal Evaluation Praluent (alirocumab) or Repatha TM (evolocumab) will be approved for renewal when ALL of the following criteria are met:. The patient has been previously approved for therapy with the requested agent through Prime Therapeutics PA process. ONE of the following: a. The patient has shown a percent change of 45% in LDL-C from baseline (LDL-C before PCSK9 therapy) b. The patient has a current (within the past 30 days) LDL-C 00 mg/dl (.59 mmol/l) 3. The patient is adherent ± (for the past 80 days) to therapy with the requested agent 4. ONE of the following: A. ALL of the following: i. ONE of the following:. The patient is currently (for the past 80 days) on high-intensity statin therapy (i.e. rosuvastatin 0-40 mg or atorvastatin mg). BOTH of the following: a. The patient has tried and is intolerant to high-intensity statin therapy (i.e. rosuvastatin 0-40 mg and atorvastatin 40 80mg) HCSC_CS_ PCSK9_PAQL_ProgSum_AR06_r047 Page 3 of 5

4 b. The patient is currently (for the past 80 days) on low or moderate intensity statin therapy ii. The patient is adherent^ (for the past 80 days) to statin therapy as prescribed B. The patient has documented intolerance* to TWO different statins (*intolerance is defined as inability to tolerate the lowest FDA approved starting dose of a statin) C. The patient has an FDA labeled contraindication to a statin 5. Praluent (alirocumab) and Repatha (evolocumab) will not be used concurrently with each other 6. The agent is being prescribed by a specialist in the area of practice related to the patient s diagnosis (e.g. cardiologist, lipidologist, or endocrinologist) or in consultation with a specialist in the area of practice related to the patient s diagnosis 7. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent 8. ONE of the following: a. The prescribed dosage is within the program limit (FDA approved labeled dosage) b. The quantity (dose) requested is within FDA approved labeling and the prescribed dose cannot be achieved using a lesser quantity of a higher strength that does not exceed the program quantity limit ^Adherence to standard therapy is defined as filling 80% of therapy as prescribed in the past 80 days ± Adherence to PCSK9 therapy is defined as filling 80% of the PCSK9 therapy at an FDA approved dose in the past 80 days Length of approval: months Non-Preferred Agent(s) will be approved when ONE of the following additional criteria are met: A. The patient is currently being treated with the non-preferred agent B. The patient has an FDA labeled contraindication, documented intolerance, or hypersensitivity to the preferred agent(s) C. The prescriber has submitted documentation in support of the use of the non-preferred agent(s), for the intended diagnosis which has been reviewed and approved by the Clinical Review pharmacist Table Agent(s) Praluent (alirocumab) Repatha (evolocumab) Contraindication(s) History of a serious hypersensitivity reaction to Praluent (alirocumab) History of a serious hypersensitivity reaction to Repatha (evolocumab) Table : Dutch Lipid Clinic Network criteria for diagnosis of heterozygous familial hypercholesterolemia 3 Group : Family history First-degree relative with known premature (<55 years, men; <60 years, women) coronary heart disease (CHD) First-degree relative with known LDL cholesterol >95th percentile by age and gender for country First-degree relative with tendon xanthoma and/or corneal arcus Children <8 years with LDL cholesterol >95th percentile by age and gender for country HCSC_CS_ PCSK9_PAQL_ProgSum_AR06_r047 Page 4 of 5

5 Group : Clinical history Subject has premature (<55 years, men; <60 years, women) CHD Subject has premature (<55 years, men; <60 years, women) cerebral or peripheral vascular disease Group 3: Physical examination Tendon xanthoma 6 Corneal arcus in a person <45 years 4 Group 4: Biochemical results (LDL-C) >8.5 mmol/l (>35 mg/dl) mmol/l (5 35 mg/dl) mmol/l (9 50 mg/dl) mmol/l (55 90 mg/dl) Group 5: Molecular genetic testing (DNA analysis) Causative mutation shown in the LDLR, APOB, or PCSK9 genes 8 Use and Interpretation Assign only one score, the highest applicable, per group then add the points from each group to achieve the total score Definitive FH diagnosis: > 8 points Probable FH diagnosis: 6 to 8 points Possible FH diagnosis: 3 to 5 points Unlikely FH diagnosis: 0 to points HCSC_CS_ PCSK9_PAQL_ProgSum_AR06_r047 Page 5 of 5