CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ranolazine ER

Policy governs initial step therapy and post-step therapy prior authorization for ranolazine extended-release (Ranexa) for treatment of chronic angina under a CVS Caremark-administered prescription benefit. It defines step requirements, PA clinical criteria, and durations of approval.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRanolazine ER

Policy CodePolicy N/A

Change TypeReferences updated (no material changes)

Effective Date

Next Review Date

Key ActionIf patient has not filled at least a 30-day supply of any two specified agents within past 365 days under CVS Caremark, submit a prior authorization to the PA unit for evaluation.

SourceLink

POLICY UPDATE CHANGES

Policy references Ranexa ST, Post PA Policy 658-D UDR 05-2024 in references.

1Covered Indication (chronic angina)

2Step requirement (must have tried 2 agents)

12m / 36mDOA Initial / Continuation

Coverage Summary

Policy governs initial step therapy and post-step therapy prior authorization for ranolazine extended-release (Ranexa) for treatment of chronic angina under a CVS Caremark-administered prescription benefit. Coverage stance: covered_with_criteria. Policy identifiers: 658-D (Duration of Approval reference). Effective date: ; Last review: 2024-05; Next review: .

Initial Step Therapy

If the patient has filled a prescription for at least a 30-day supply of any two of the following within the past 365 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit.

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Step Therapy

Step Therapy Enforcement

Requests for ranolazine are subject to step therapy enforcement. If the initial step therapy requirement is not met, the claim will reject and a prior authorization (PA) is required; PA clinical criteria for chronic angina will then be applied.

Beta blocker — ≥30-day supply within the past 365 days
Calcium channel blocker — ≥30-day supply within the past 365 days
Long-acting nitrate — ≥30-day supply within the past 365 days

Post-Step Therapy Prior Authorization — Chronic Angina

Post Step Therapy Prior Authorization — Chronic Angina

Authorization may be granted when the requested drug is being prescribed for chronic angina when ONE of the following are met:

ANY of the following

The patient has experienced an inadequate treatment response to a combination of TWO of the following: beta blocker, calcium channel blocker, long-acting nitrateCombination of two agents
The patient has experienced an intolerance to a combination of TWO of the following: beta blocker, calcium channel blocker, long-acting nitrateCombination of two agents
The patient has a contraindication to a combination of TWO of the following: beta blocker, calcium channel blocker, long-acting nitrateCombination of two agents

Continuing therapy response: The patient has achieved or maintained a positive clinical response to treatment from baseline

Prior Authorization

Documentation Required for PA Approval

For PA approval for chronic angina, document one of the following reasons OR document that the patient has achieved or maintained a positive clinical response from baseline.

Inadequate treatment response to a combination of two of: beta blocker, calcium channel blocker, long-acting nitrate
Intolerance to a combination of two of: beta blocker, calcium channel blocker, long-acting nitrate
Contraindication to a combination of two of: beta blocker, calcium channel blocker, long-acting nitrate
Maintenance or achievement of a positive clinical response from baseline

Definitions

Positive clinical responseImprovement or maintenance of symptomatic control from baseline while on ranolazine (policy implies achievement or maintenance of response from baseline)

Inadequate treatment responseFailure to achieve adequate control of chronic angina after treatment with a combination of two agents (beta blocker, calcium channel blocker, long-acting nitrate)

Provider Actions & Billing Rules

Billing Rule

Duration of Approval

Initial therapy duration of approval = 12 months; Continuation of therapy duration of approval = 36 months.

Policy identifier: 658-D
Initial DOA: 12 months
Continuation DOA: 36 months

Prior Authorization

Prior Authorization Submission Requirement

If the prior-fill requirement (two agents, each ≥30-day supply within past 365 days) is not met, the claim will reject indicating a prior authorization is required. In that case, submit a PA to the PA unit for evaluation against the clinical PA criteria.

Claim will reject with message indicating PA required if step therapy not met
Submit PA to PA unit for evaluation of clinical criteria

Clinical Evidence & References

Evidence references include: Ranexa package insert (Gilead Sciences, Oct 2019); ranolazine package insert (Unichem Pharmaceuticals, Nov 2023); and the 2023 AHA/ACC Guideline for Management of Patients With Chronic Coronary Disease (Virani et al., Circulation 2023). Note: document changes list references including package inserts and guideline citations.

Background

Ranolazine is FDA-approved for the treatment of chronic angina. It may be used concomitantly with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, ACE inhibitors, and ARBs. This CVS Caremark policy defines the step-therapy requirement and prior authorization criteria that apply under the prescription benefit administered by CVS Caremark.

Revision History

2024-05revised

Document lists references including package inserts and guideline citations; no clinical policy statement changes explicitly indicated.

2024-05Last review

Last review

revised

Initial Step Therapy: patient must have filled a prescription for at least a 30-day supply of any two of the following within the past 365 days under a CVS Caremark-administered prescription benefit: beta blocker, calcium channel blocker, long-acting nitrate; otherwise claim rejects and PA required.

revised

Post Step Therapy Prior Authorization — Chronic Angina: authorization may be granted when the patient has an inadequate response, intolerance, or contraindication to a combination of two of (beta blocker, calcium channel blocker, long-acting nitrate), or has achieved/maintained a positive clinical response from baseline.

revised

Duration of Approval (658-D): Initial therapy DOA = 12 months; Continuation of therapy DOA = 36 months.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRanolazine ER

Policy CodePolicy N/A

Change TypeReferences updated (no material changes)

Effective Date

Next Review Date

Key ActionIf patient has not filled at least a 30-day supply of any two specified agents within past 365 days under CVS Caremark, submit a prior authorization to the PA unit for evaluation.

SourceLink

On This Page

OpenPayer

Ranolazine ER

Coverage Summary

Initial Step Therapy

Post-Step Therapy Prior Authorization — Chronic Angina

Provider Actions & Billing Rules

Policy Identifiers / Codes

Clinical Evidence & References

Background

Revision History