Repatha Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

Repatha will be approved when ALL of the following are met:

1. The patient has ONE of the following:

   1. A diagnosis of heterozygous familial hypercholesterolemia (HeFH) AND ONE of the following:

      1. Genetic confirmation of one mutant allele at the LDLR, Apo-B, PCSK9, or 1/LDLRAP1 gene OR

      2. ONE of the following:

         1. The patient is 18 years of age or older AND has a pretreatment LDL-C greater than 190 mg/dL (greater than 4.9 mmol/L) OR
         2. The patient is between the ages of 10 and less than 18 years AND has a pretreatment LDL-C greater than 155 mg/dL (greater than 4.0 mmol/L) OR

      3. The patient has clinical manifestations of HeFH (e.g., cutaneous xanthomas, tendon xanthomas, corneal arcus, tuberous xanthoma, or xanthelasma) OR

      4. The patient has “definite” or “possible” familial hypercholesterolemia as defined by the Simon Broome criteria OR

      5. The patient has a Dutch Lipid Clinic Network criteria score of greater than 5 OR

      6. The patient has a treated low-density lipoprotein cholesterol (LDL-C) level greater than or equal to 100 mg/dL after treatment with antihyperlipidemic medications but prior to PCSK9 inhibitor therapy OR

   2. A diagnosis of homozygous familial hypercholesterolemia (HoFH) AND ONE of the following:

      1. Genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, Apo-B, PCSK9, or LDLRAP1 genes or greater than or equal to 2 such variants at different loci OR

      2. History of untreated LDL-C greater than 400 mg/dL (greater than 10 mmol/L) AND ONE of the following:

         1. Cutaneous or tendon xanthomas before the age of 10 years OR
         2. Untreated elevated LDL-C levels consistent with heterozygous familial hypercholesterolemia (HeFH) in both parents (or in digenic form, one parent may have normal LDL-C levels and the other may have LDL-C levels consistent with HoFH) OR

   3. A diagnosis of established cardiovascular disease [acute coronary syndrome (ACS), history of myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), peripheral artery disease (PAD) including aortic aneurysm] AND the requested medication will be used to reduce the risk of myocardial infarction, stroke OR

   4. A diagnosis of primary hyperlipidemia (not associated with HeFH, HoFH, or established cardiovascular disease) OR

   5. The patient has another indication that is supported in CMS approved compendia for the requested medication AND

2. ONE of the following:

   1. The patient has tried and had an inadequate response to a high-intensity statin (i.e., rosuvastatin 20-40 mg or atorvastatin 40-80 mg) OR
   2. The patient has an intolerance* to TWO different statins (*intolerance is defined as inability to tolerate the lowest FDA approved starting dose of a statin) OR
   3. The patient has an FDA labeled contraindication to a statin AND

3. The patient will NOT be using the requested medication in combination with another PCSK9 medication AND

4. The medication was prescribed by, or in consultation with, a cardiologist, an endocrinologist, and/or a physician who focuses in the treatment of cardiovascular (CV) risk management and/or lipid disorders AND

5. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit OR

   2. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Repatha will be approved when ALL of the following criteria are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria AND

2. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication AND

3. The patient has had clinical benefit with the requested medication AND

4. The patient will NOT be using the requested medication in combination with another PCSK9 medication AND

5. The medication was prescribed by, or in consultation with, a cardiologist, an endocrinologist, and/or a physician who focuses in the treatment of cardiovascular (CV) risk management and/or lipid disorders AND

6. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit OR

   2. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of approval: 12 months

Dutch Lipid Clinic Network criteria for diagnosis of HeFH