Pulmonary Hypertension – tadalafil 20 mg and sildenafil 20 mg Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

Tadalafil 20 mg or sildenafil 20 mg will be approved when ALL the following are met:

1. ONE of the following:

   1. BOTH of the following:

      1. ONE of the following:

         1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 90 days
            OR
         2. The prescriber states the patient is currently being treated with the requested medication within the past 90 days
            AND

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

   2. The patient has a diagnosis of pulmonary arterial hypertension (PAH), WHO Group 1 as determined by right heart catheterization AND ALL of the following:

      1. The patient’s World Health Organization (WHO) functional class is II or greater
         AND

      2. The patient has a mean pulmonary arterial pressure greater than 20 mmHg
         AND

      3. The patient has a pulmonary capillary wedge pressure less than or equal to 15 mmHg
         AND

      4. The patient has a pulmonary vascular resistance greater than or equal to 3 Wood units
         AND

      5. ONE of the following:

         1. The requested medication will be utilized as monotherapy
            OR

         2. The requested medication will be used in combination with an endothelin receptor antagonist (ERA) for dual therapy ONLY
            OR

         3. The requested medication will be utilized for add-on therapy to existing monotherapy (dual therapy) [except for dual therapy requests for a phosphodiesterase 5 (PDE5) inhibitor plus an endothelin receptor antagonist (ERA)], AND BOTH of the following:

            1. The patient has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy
               AND
            2. The requested medication is in a different therapeutic class
               OR

         4. The requested medication will be utilized for add-on therapy to existing dual therapy (triple therapy) AND ALL of the following:

            1. ONE of the following:

               1. A prostanoid has been started as one of the medications in the triple therapy
                  OR
               2. The patient has an intolerance or hypersensitivity to a prostanoid
                  OR
               3. The patient has an FDA labeled contraindication to a prostanoid
                  AND

            2. The patient has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy
               AND

            3. All three medications in the triple therapy are from a different therapeutic class
               OR

         5. The requested medication will be utilized as part of triple therapy in a treatment naive patient AND BOTH of the following:

            1. The patient is classified as WHO functional class IV
               AND
            2. The three medications being utilized consist of: ERA plus PDE5i plus prostanoid
               OR

   3. The patient has an indication that is supported in CMS approved compendia for the requested medication (erectile dysfunction is not a covered indication)
      AND

2. The patient is NOT concurrently taking another phosphodiesterase type 5 (PDE-5) inhibitor [tadalafil (Adcirca, Alyq or Cialis) or sildenafil (Revatio or Viagra)] with the requested medication
   AND

3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

4. 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

Tadalafil 20 mg or sildenafil 20 mg will be approved for renewal when ALL the following 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 is NOT concurrently taking another phosphodiesterase type 5 (PDE-5) inhibitor [tadalafil (Adcirca, Alyq or Cialis) or sildenafil (Revatio or Viagra)] with the requested medication
   AND

5. The patient does NOT have any FDA labeled contraindications to the requested medication
   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