Limited coverage drugs – sacubitril-valsartan

Generic name

sacubitril-valsartan

Strength

24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg

Form

tablets

Special Authority criteria

Approval period

For the treatment of heart failure (HF) with reduced ejection fraction in patients with New York Heart Association (NYHA) class II or III HF, if all the following clinical criteria are met:

  • Reduced left ventricular ejection fraction (LVEF) ≤ 40%

AND

  • NYHA class II to III symptoms have persisted despite at least four weeks of treatment at the optimum stable doses of:
    • an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); AND
    • a beta blocker; AND
    • other recommended therapies, including an aldosterone antagonist (if tolerable)

Notes:

  • Coverage of sacubitril-valsartan for the treatment of HF is available only upon request by a cardiologist or an internal medicine specialist.
  • Sacubitril-valsartan should be administered in place of an ACEI or an ARB.

Indefinite

Practitioner exemptions

  • None

Special notes

  • None

Special Authority requests

Requests should be completed by a cardiologist or an internal medicine specialist.