VERQUVO (vericiguat)
Self Administration – Oral
Diagnosis considered for coverage:
- Chronic Heart Failure - indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%.
Coverage Criteria:
- For diagnosis of Chronic Heart Failure:
- Dose does not exceed 10 mg once daily, and
- Prescribed by or in consultation with a cardiologist, and
- Patient has an ejection fraction less than 45 percent; and
- Patient has New York Heart Association (NYHA) Class II, III, IV symptoms; and
- One of the following:
- Patient was hospitalized for heart failure within the last 6 months, or
- Patient used outpatient intravenous (IV) diuretics (e.g., bumetanide, furosemide) for heart failure within the last 3 months.
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Beta-blocker (e.g., bisoprolol, carvedilol)
- One of the following:
- Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril), or
- Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan), or
- Angiotensin receptor-neprilysin inhibitor (ARNI) [e.g., Entresto (sacubitril and valsartan)].
Reauthorization Criteria:
For diagnosis of Chronic Heart Failure:
- Dose does not exceed 10 mg once daily, and
- Documentation of a positive clinical response to therapy.
Coverage Duration:
- Initial: up to 12 months.
- Reauthorization: up to 12 months.
Additional Information:
- The recommended starting dose of Verquvo is 2.5 mg orally once daily with food. Double the dose of Verquvo approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.
Policy Updates:
- 06/15/2021 – New policy approved by P&T
References:
- Armstrong PW, Pieske B, Anstrom KJ, et al; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928.
- Food and Drug Administration. Verquvo integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214377Orig1s000IntegratedR.pdf. February 17, 2021. Accessed March 26, 2021.
- Hollenberg SM, Warner Stevenson L, Ahmad T, et al. 2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized With Heart Failure: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2019 Oct 15;74(15):1966-2011. doi: 10.1016/j.jacc.2019.08.001.
- Maddox TM, Januzzi JL Jr, Allen LA, et al. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021 Feb 16;77(6):772-810. doi: 10.1016/j.jacc.2020.11.022.
- Verquvo [package insert], Whitehouse Station, NJ: Merck & Co., Inc.; January 2021.
- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2013 Oct 15;62(16):e147-239.
- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Journal of the American College of Cardiology. 2017 Aug 8;70(6):776-803.