Request for Prior Authorization for PCSK9 inhibitor therapy Website Form Submit request via: Fax

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1 Request for Prior Authorization for PCSK9 inhibitor therapy Website Form Submit request via: Fax PCSK9 is a protein that reduces the hepatic removal of low-density lipoprotein cholesterol from the blood. All requests for medications that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) require prior authorization and will be screened for appropriateness using the criteria below. Initial Prior Authorization The prescribed medication is age appropriate based upon FDA-approved labeling. The prescriber is a cardiologist, endocrinologist, or lipid specialist or is prescribed in consultation with one of the listed specialists. Documentation of adherence or counseling to lipid-lowering lifestyle interventions, including exercise and a low fat, low cholesterol diet. Documentation of lipid panel results at baseline (pre-treatment), current LDL level with treatment (within the past month), and goal LDL level are provided. The dose and frequency requested is within FDA-approved labeling (dose optimization) and consistent with quantity limits. The member will not be taking the requested PCSK9 inhibitor concurrently with another PCSK9 inhibitor. All requests deemed medically necessary and approved will be referred to care management for review for assistance with disease state management, non-pharmacologic therapy, help with treatment of other modifiable risk factors to help decrease the risk of heart disease and other psychosocial issues. Certain criteria for each diagnosis must be met in order for approval to be granted: For the treatment of heterozygous familial hypercholesterolemia (HeFH): o Documentation of HeFH confirmed as definite by a score of > 8 using the Dutch Lipid Clinic Network criteria (all points added to calculate the total score must be documented) OR confirmed as definite by the Simon-Broome criteria. Clinical evidence and laboratory results must be provided to support the diagnosis. o The member will be taking a PCSK9 inhibitor concurrently with a maximally tolerated statin as indicated per the FDA-approved indication. o Pertaining to the member s current lipid-lowering treatment regimen: The member has had an adequate trial of at least two statins, both of which must be moderate or high-intensity at the maximally tolerated dose the member has been adherent to statin therapy as evidenced by consistent pharmacy claims over the past 6 months unless the member is new to the plan. If new to plan, documentation from prescribing physician and/or patient s pharmacy demonstrates adherence to therapy over the past 6 months. Documented therapeutic failure, intolerance, or contraindication to Zetia (available through the prior authorization process) in combination with statin therapy.

2 o Documentation, within the past month, that the member s LDL-C is >100 mg/dl (without ASCVD) or >70 mg/dl (with ASCVD) while adherent to a maximally tolerated dose of statin therapy alone and in combination with other lipid lowering therapy (Zetia) For the treatment of Clinical Atherosclerotic Cardiovascular Disease (ASCVD) requiring additional lowering of LDL-cholesterol: o Documentation of a diagnosis of clinical atherosclerotic cardiovascular disease defined as one of the following: Acute Coronary Syndrome History of Myocardial Infarction Stable or unstable Angina Coronary revascularization Other arterial revascularization Stroke Transient Ischemic Attack Peripheral Arterial Disease o The member will be taking a PCSK9 inhibitor concurrently with a maximally tolerated statin. o Pertaining to the member s current lipid-lowering treatment regimen: The member has had an adequate trial of at least two statins, both of which must be moderate or high-intensity at the maximally tolerated dose the member has been adherent to statin therapy as evidenced by consistent pharmacy claims over the past 6 months, unless new to the plan. If new to plan, documentation from prescribing physician and/or patient s pharmacy demonstrates adherence to therapy over the past 6 months. Documented therapeutic failure, intolerance, or contraindication to Zetia (ezetimibe), approved through the prior authorization process, in combination with statin therapy. o Documentation, within the past month, that the member s LDL-C is > 70 mg/dl while adherent to a maximally tolerated dose of statin therapy alone and in combination with Zetia (ezetimibe). For the treatment of homozygous familial hypercholesterolemia (HoFH)-Repatha (evolocumab) only: o Documented diagnosis of HoFH (clinical documentation and laboratory results must be provided to support the diagnosis) confirmed by: An untreated LDL-C >500 mg/dl or a treated LDL-C 300 mg/dl with at least one of the following: Presence of cutaneous or tendon xanthoma before 10 years of age Both parents have documented elevated LDL-C before lipid-lowering treatment (pretreatment) consistent with a diagnosis of heterozygous familial hypercholesterolemia [e.g. untreated LDL-C >190 mg/dl] OR Previous history of genetic confirmation of two mutant alleles in the LDLR, Apo-B, PCSK9, or LDLRAP1 gene locus o The member will be taking Repatha concurrently with other lipid lowering therapies as indicated in the FDA approved labeling.

3 o Repatha will not be used concomitantly with Juxtapid (lomitapide) or Kynamro (mipomersen). o Pertaining to the member s current lipid-lowering treatment regimen: The member has had an adequate trial of at least two statins, both of which must be moderate or high-intensity at the maximally tolerated dose the member has been adherent to statin therapy as evidenced by consistent pharmacy claims over the past 6 months, unless new to the plan. If new to plan, documentation from prescribing physician and/or patient s pharmacy demonstrates adherence to therapy over the past 6 months. Documented therapeutic failure, intolerance, or contraindication to Zetia (ezetimibe), approved through the exceptions review process, in combination with statin therapy. o Documentation, within the past month, that the member s LDL-C is > 100 mg/dl (without ASCVD) or >70 mg/dl (with ASCVD) while adherent to lipid lowering therapies. Length of initial approval: three (3) months Reauthorization Criteria The member is adherent to PCSK9 inhibitor therapy as evidenced by consistent pharmacy claims. Documentation the member is adherent to statin treatment in combination with Praluent or Repatha. For a diagnosis of HoFH, documentation the member is adherent to lipid lowering therapies (e.g. statins, ezetimibe) in combination with Repatha. PCSK9 inhibitor therapy is continuously prescribed by a specialist or in consultation with a specialist (cardiologist, endocrinologist, lipid specialist). The dose requested is within FDA-approved labeling and frequency of administration, in alignment with the package insert (dose optimization) and consistent with quantity limits. For a dose increase, the prescriber submits supporting documentation such as peer reviewed medical literature supporting the dose increase in order to achieve LDL-C goal specified at initial request. LDL-C drawn after treatment initiation with a PCSK9 inhibitor demonstrates improvement while on maximized therapy. Length of reauthorization: six (6) months

4 PCSK9 Inhibitor INITIAL REQUEST PRIOR AUTHORIZATION FORM Please complete and fax all requested information below including any progress notes, laboratory test results, or chart documentation as applicable to Health Options Pharmacy Services. FAX: If needed, you may call to speak to a Pharmacy Services Representative PHONE: PROVIDER INFORMATION Requesting Physician: NPI: Physician Specialty: Office Address: Patient Name: Health Options ID: Office Contact: Office Phone: Office Fax: MEMBER INFORMATION DOB: DRUG INFORMATION Medication: Strength: Frequency: Duration: MEDICAL HISTORY: Please answer all questions and provide supporting documentation Baseline LDL-C: Current LDL-C: Goal LDL-C: Date: Date: Lifestyle Modifications Please list dietary and exercise therapies/programs that have been implemented to assist with cholesterol management: Please indicate the member s diagnosis (Chart documentation must be attached to support the diagnosis): Heterozygous Familial hypercholesterolemia (HeFH) Has the diagnosis been confirmed as definite by one of the following? Yes No Dutch Lipid Network criteria, please list total score and factors contributing to the total: Simon Broome criteria, please list factors leading to definite diagnosis: Homozygous Familial hypercholesterolemia (HoFH) Has the diagnosis been confirmed by any of the following (check all that apply)? Yes No Untreated LDL-C levels consistent with heterozygous FH in both parents [untreated LDL-C >190mg/dL] Presence of cutaneous or tendon xanthoma before 10 years of age Previous genetic confirmation of two mutant alleles in the LDLR, Apo-B, PCKS9 or LDLRAP1 gene locus Clinical Atherosclerotic Cardiovascular Disease (ASCVD) Has the patient been diagnosed with one of the following: Yes No Acute Coronary Syndrome History of Myocardial Infarction Stable or unstable Angina Other arterial revascularization Stroke Transient Ischemic Attack Peripheral Arterial Disease Coronary revascularization Will the requested drug be used in combination with other lipid lowering therapy (please specify dose/frequency)? None Statin Zetia (ezetimibe) Other (please list):

5 PREVIOUS THERAPY **Please list all medications the patient has previously tried and failed to treat this diagnosis** Drug Name Strength/Frequency Dates of Therapy Status (Discontinued & Why/ Current) Has the patient/caregiver been adequately educated on self-administration and storage of medication? Yes No SUPPORTING INFORMATION or CLINICAL RATIONALE *** SUBMIT ADDITIONAL SUPPORTING INFORMATION OR CLINICAL RATIONALE IN THE FORM OF CHART DOCUMENTATION LABS WITH THIS REQUEST AS NEEDED*** Prescribing Physician Signature Date

6 PCSK9 Inhibitor REAUTHORIZATION REQUEST PRIOR AUTHORIZATION FORM Please complete and fax all requested information below including any progress notes, laboratory test results, or chart documentation as applicable to Health Options Pharmacy Services. FAX: If needed, you may call to speak to a Pharmacy Services Representative PHONE: PROVIDER INFORMATION Requesting Physician: NPI: Physician Specialty: Office Address: Patient Name: Health Options ID: Office Contact: Office Phone: Office Fax: MEMBER INFORMATION DOB: DRUG INFORMATION Medication: Strength: Frequency: Duration: MEDICAL HISTORY: Please answer all questions and provide supporting documentation Diagnosis: Heterozygous FH Homozygous FH Clinical ASCVD Other: Current LDL-C on PCSK9 inhibitor: Date lab drawn: Is there documentation of improvement shown while on PCSK9 inhibitor therapy? Yes No If No, please explain clinical rationale for continued use of a PCSK9 inhibitor: Is this request for a dose increase? Yes No If yes, please provide clinical rationale and evidence supporting the dose increase: Has the patient been adherent to the PCSK9 inhibtor? Yes No Has the patient been adherent to adjunct lipid-lowering therapy? Yes No Will the patient continue to take a PCSK9 inhibitor in combination with lipid-lowering therapy? Yes No Please list medication including dose and frequency: *** SUBMIT ADDITIONAL SUPPORTING INFORMATION OR CLINICAL RATIONALE IN THE FORM OF CHART DOCUMENTATION LABS WITH THIS REQUEST AS NEEDED*** Prescribing Physician Signature Date