Pharmacy Prior Authorization Criteria

Corlanor (ivabradine)

Indications for Prior Authorization

Corlanor (ivabradine)

• For diagnosis of Chronic Heart Failure
  Indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic, chronic heart failure with left ventricular ejection fraction less than or equal to 35%, who are in sinus rhythm with a resting heart rate greater than or equal to 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.

• For diagnosis of Heart Failure due to Dilated Cardiomyopathy (DCM)
  Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

• For diagnosis of Inappropriate Sinus Tachycardia (IST)
  Has been used for the treatment of inappropriate sinus tachycardia (IST). [7]

Criteria

Brand Corlanor, generic ivabradine

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Heart Failure

• Diagnosis of chronic heart failure [3, 5]
AND
• Patient has New York Heart Association (NYHA) Class II, III, or IV symptoms [3, 5, A]
AND
• Patient has a left ventricular ejection fraction of less than or equal to 35% [3, 5]
AND
• Patient is in sinus rhythm [3, 5]
AND
• Patient has a resting heart rate that is greater than or equal to 70 beats per minute [3, 5, E]
AND
• Trial and failure, contraindication, or intolerance to all of the following at a maximally tolerated dose: [10]
• One of the following:
• Angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril)
• Angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan)
• Angiotensin receptor-neprilysin inhibitor (ARNI) [e.g., Entresto (sacubitril and valsartan)]
AND
• One of the following: [3, 5, 10, B-F]
• bisoprolol
• carvedilol
• metoprolol succinate extended-release
AND
• Sodium-glucose co-transporter 2 (SGLT2) inhibitor [e.g., Jardiance (empagliflozin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformn)]
AND
• Mineralocorticoid receptor antagonist (MRA) [e.g., eplerenone, spironolactone]
AND
• Patient has been hospitalized for worsening heart failure in the previous 12 months [3]
AND
• Prescribed by or in consultation with a cardiologist

Brand Corlanor, generic ivabradine

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Heart Failure due to Dilated Cardiomyopathy

• Diagnosis of heart failure due to dilated cardiomyopathy
AND
• Patient has New York Heart Association (NYHA) Class II, III, or IV symptoms [6]
AND
• Patient is in sinus rhythm
AND
• Patient has an elevated heart rate
AND
• Trial and failure, contraindication, or intolerance to one of the following: [1, 4, 6]
• Beta blocker (e.g., bisoprolol, metoprolol succinate extended release)
• Angiotensin-converting enzyme (ACE) inhibitor (e.g., captopril, enalapril)
• Diuretic Agent (e.g., spironolactone, furosemide)
AND
• Prescribed by or in consultation with a cardiologist

Brand Corlanor, generic ivabradine

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Inappropriate Sinus Tachycardia (IST) [off-label]

• Diagnosis of inappropriate sinus tachycardia (IST) confirmed by both of the following: [7]
• Sinus heart rate greater than 100 beats per minute at rest
• A mean 24 hour heart rate greater than 90 beats per minute
AND
• Other causes of sinus tachycardia have been ruled out (e.g., hyperthyroidism, anemia, illicit stimulant drug use, caffeine, etc.) [7]
AND
• Provider attests that symptoms of IST are causing significant functional impairment or distress (e.g., palpitations, light-headedness, syncope, chest pain, dyspnea, etc.) [8, 9]
AND
• Prescribed by or in consultation with a cardiologist

Brand Corlanor, generic ivabradine

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-07-31, 2023-09-29, 2022-08-01, 2021-08-04, 2021-05-20, 2020-07-23, 2019-12-10, 2019-08-20

References

1. Corlanor Prescribing Information. Amgen Inc. Thousand Oaks, CA. April 2019.
2. Ivabradine (Corlanor) for heart failure. Med Lett Drugs Ther. 2015 May 25; 57 (1469): 75-6.
3. Swedberg K, Komajda M, Bohm M, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomized placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85.
4. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): Thomson Reuters (Healthcare) Inc; Updated periodically. Available by subscription at: http://www.thomsonhc.com/. Accessed June 25, 2020.
5. Yancy CW, Jessup M, Bozkurt B, et al. 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. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803.
6. Bonnet D, Berger F, Jokinen E, et al. Ivabradine in children with dilated cardiomyopathy and symptomatic chronic heart failure. J Am Coll Cardiol. 2017 Sep 5;70(10):1262-1272.
7. Page RL, Joglar JA, Caldwell MA, et al. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2016 Apr 5;67(13):e27-e115.
8. Cappato R, Castelvecchio S, Ricci C, et al. Clinical efficacy of ivabradine in patients with inappropriate sinus tachycardia: a prospective, randomized, placebo-controlled, double-blind, crossover evaluation. J Am Coll Cardiol. 2012 Oct 9;60(15):1323-9.
9. Sheldon RS, Grubb BP 2nd, Olshansky B, et al. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63.
10. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Journal of Cardiac Failure. Published online April 2022.

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Revision History

• 2024-07-31: 2024 Annual Review - addition of generic ivabradine and minor updates, no changes to clinical intent
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2022-08-01: 2022 Annual Review - Addition of SGLT2 and MRA as step requirements to chronic heart failure indication.
• 2021-08-04: Annual review
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-23: Annual Review
• 2019-12-10: Guideline updated to add approval criteria for IST.
• 2019-08-20: added new indication and new formulation

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