RANEXA, ASPRUZYO (ranolazine)

RANEXA, ASPRUZYO (ranolazine)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of chronic angina.

Coverage Criteria:

For diagnosis of chronic angina:

• Dose does not exceed maximum FDA-recommended dose of 2000 mg (2 tablets) per day; AND

• Patient is 18 years of age and older; AND

• Prescribed by or in consultation with a cardiologist; AND

• Diagnosis of chronic angina; AND

• Patient meets one of the following:

  • Failure of concurrent use of a beta-blocker and long-acting nitrate at therapeutic doses for greater than or equal to 30 days within the previous 6 months

  • Failure of concurrent use of calcium channel blocker and long-acting nitrate at therapeutic doses for greater than or equal to 30 days within the previous 6 months

  • Patient has experienced inadequate response, intolerance, or contraindication to one of the following:

    • Both calcium channel blockers and beta blockers

    • Long-acting nitrates; AND

• Inadequate response, intolerance, or contraindication to generic ranolazine

Reauthorization Criteria:

For diagnosis of chronic angina:

• Dose does not exceed maximum FDA-recommended dose of 2000 mg (2 tablets) per day; AND

• Documentation of positive clinical response to therapy

   

Coverage Duration:

 
•    Initial: 1 year
•    Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing:

  • Initiate dosing at 500 mg twice daily and increase to 1000 mg orally

  • The maximum recommended daily dose is 1000 mg twice daily

Policy Updates:

•    11/15/2022 – New policy approved by P&T.

References:

1. Ranexa Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; October 2019.
2. Aspruzyo Sprinkle Prescribing Information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; February 2022.
3. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, et al. 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation 2012; 126:e354.
4. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, et al. 2014 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease. November 2014; 64(18):1929-49.