Corlanor - NC Standard

Restriction applies to brand and generic products 

• Corlanor® (ivabradine) tablets 
• Corlanor® (ivabradine) oral solution

• To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.
• For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. 

Initial Coverage Criteria: 

1. The patient has stable, symptomatic chronic heart failure; AND
2. The patient has a heart failure classification of NYHA class II, NYHA class III, or NYHA class IV; OR
   1. The patient’s age limits the ability to formally assess NYHA functional Class; AND
3. ONE of the following:
   1. ALL of the following:
      1. The patient has heart failure due to dilated cardiomyopathy (DCM); AND
      2. The patient is a pediatric patient aged 6 months and over; AND
      3. The patient is in sinus rhythm with an elevated heart rate; OR 
   2. ALL of the following:
      1. The patient has a baseline OR current left ventricular ejection fraction of ≤ 35%; AND
      2. Prior to initiating therapy with the requested agent, the patient is in sinus rhythm with resting heart rate ≥ 70 beats per minute; AND
      3. ONE of the following:
         1. The patient will use the requested agent in combination with a maximally tolerated dose of beta-blocker (e.g. atenolol, bisoprolol, carvedilol, metoprolol); OR
         2. The patient has an FDA labeled contraindication to ALL beta-blockers (e.g. atenolol, bisoprolol, carvedilol, metoprolol); AND
4. The patient does NOT have any FDA labeled contraindication(s) to the requested agent; AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of approval: 365 days (1 year)

Continuation Coverage Criteria:

1. The patient was approved through Blue Cross NC initial coverage criteria or would have met initial criteria for approval at the time they started therapy; AND
2. The patient has had clinical benefit with the requested agent; AND
3. If the requested agent is being used for heart failure (not due to DCM), ONE of the following:
   1. The patient will use the requested agent in combination with a maximally tolerated dose of beta-blocker (e.g. atenolol, bisoprolol, carvedilol, metoprolol); OR
   2. The patient has an FDA labeled contraindication to ALL beta-blockers (e.g. atenolol, bisoprolol, carvedilol, metoprolol); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval: 1 year (365 days) 

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

July 2024: Criteria update: Added statement that Restriction applies to brand and generic products.

April 2023: Criteria update: Addition of continuation coverage criteria.

Jan 2021: Criteria change: Quantity Limits applied to all products. Updated duration of approval to 1 year.

Aug 2019: Criteria update: Added Corlanor oral solution to the policy; Change duration of approval from indefinite to 1095 days (3 years)

May 2019: Criteria change; Added coverage for pediatric patients with heart failure due to dilated cardiomyopathy in response to expanded FDA approval

Oct 2018: Annual review; No change