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| Category: | Managed Rx Coverage |
| Number: | J-0365 |
| Subject: | Bystolic (nebivolol) – Healthcare Reform Essential Formulary |
| Effective Date Begin: | January 1, 2017 |
| Effective Date End: | August 9, 2017 |
| Original Date: | September 7, 2016 |
| Review Date(s): | September 7, 2016 |
Policy Applies to
- Healthcare Reform plans with an Essential formulary
Drugs Addressed in this Policy
- Bystolic (nebivolol)
FDA-Approved Indications
- Treatment of hypertension
Background
- Bystolic (nebivolol) is a long-acting cardioselective beta-1 adrenergic antagonist. Possible antihypertensive mechanisms include decreased heart rate, decreased myocardial contractility, diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, suppression of renin activity, and vasodilation and decreased peripheral vascular resistance.
- This policy defines the criteria under which coverage of a non-preferred beta-blocker (Bystolic) will be considered.
Approval Criteria:
When a benefit, coverage for Bystolic (nebivolol) may be approved when all of the following criteria are met (1 & 2):
1. The member has a diagnosis of hypertension AND
2. The member has tried and failed at least 3 generic beta-blocker alternatives (e.g.; metoprolol, atenolol, timolol, labetolol).
- Coverage of nebivolol for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.
- For HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.
Automatic Approval Criteria:
Members who meet the criteria as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.
1. The member has at least one paid claim for three (3) different generic beta blockers within the past 720 days.
Authorization Duration
- HCR Plans: If approved, up to a lifetime authorization may be granted.
References
- DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2015. Accessed July 14, 2016.
- Bystolic [prescribing information]. St. Louis, MO: Forest Labs; February 2010.
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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.
