CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ranexa (ranolazine) — Step Therapy and Prior Authorization for Chronic Angina

This policy governs Step Therapy and Prior Authorization requirements for ranolazine (Ranexa) for treatment of chronic angina under a CVS Caremark-administered prescription benefit; it affects prescribers and members whose pharmacy benefit is managed by CVS Caremark.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRanexa (ranolazine) — Step Therapy and Prior Authorization for Chronic Angina

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionIf initial step therapy criteria are not met, submit a prior authorization with documentation of inadequate response, intolerance, or contraindication to a combination of two antianginal classes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2required background therapy classes for step therapy

30 daysprior fill supply per agent

12 moinitial approval DOA

36 mocontinuation approval DOA

Coverage Criteria for Ranexa (ranolazine)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRanexa (ranolazine) — Step Therapy and Prior Authorization for Chronic Angina

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Chronic Angina — Authorization Criteria

Authorization may be granted for chronic angina when ONE of the following is met:

Primary authorization conditions: Any ONE 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 nitrate; OR the patient has experienced an intolerance to a combination of TWO of the following: beta blocker, calcium channel blocker, long-acting nitrate; OR the patient has a contraindication to a combination of TWO of the following: beta blocker, calcium channel blocker, long-acting nitrate

Combination means two distinct classes from the listed three.

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

This is an additional standalone criterion allowing authorization based on demonstrated benefit.

Initial Step Therapy and DOA

Initial step therapy and duration:

Initial step therapy: Patient must have filled at least a 30-day supply of any two of the following within the past 365 days under the CVS Caremark prescription benefit: beta blocker; calcium channel blocker; long-acting nitrate30 days per agent; 365 days lookback

If initial step therapy is not met the claim will reject indicating prior authorization is required; if approved, see DOA below.

Duration of approval (DOA): Initial therapy DOA: 12 months; Continuation of therapy DOA: 36 months

Codes: 658-D references DOA durations as specified.

Provider Actions, Prior Authorization, and Documentation

Denial Risk

Step therapy rejection trigger

If the patient does not meet the initial step therapy criteria (see below), the claim will reject with a message indicating a prior authorization (PA) is required. Claims will not pay at point-of-sale and must be submitted to the PA unit for review under the authorization criteria.

Affected fills: must have filled at least a 30-day supply of any two agents (beta blocker, calcium channel blocker, long-acting nitrate) within the past 365 days under a prescription benefit administered by CVS Caremark.
Operational effect: claim rejection triggers PA review; do not submit as immediate payable claim.

Step Therapy

Initial Step Therapy requirement

If the patient has filled a prescription for at least a 30-day supply of any two of the following agents within the past 365 days under a prescription benefit administered by CVS Caremark, the requested drug will be paid under that prescription benefit. If this initial step therapy requirement is not met, the claim will reject and require prior authorization.

Required agents (examples): beta blocker; calcium channel blocker; long-acting nitrate.
Required fill: ≥ 30-day supply of any two agents within the last 365 days.

Prior Authorization

Prior authorization criteria — Prior authorization is required if initial step therapy criteria are not met; summarizes authorization allowance for chronic angina

Authorization for chronic angina may be granted when the requested drug is being prescribed for chronic angina and documentation shows ONE of the following: inadequate response, intolerance, or contraindication to a combination of TWO of the following agents: beta blocker, calcium channel blocker, long-acting nitrate. Documentation that the patient has achieved or maintained a positive clinical response from baseline may also support authorization.

Clinical reasons accepted: inadequate response, intolerance, or contraindication to two-agent combination (beta blocker + calcium channel blocker; beta blocker + long-acting nitrate; calcium channel blocker + long-acting nitrate).
Supportive outcome: documentation of positive clinical response or maintenance of response from baseline.

Documentation Required

Required clinical documentation — Documentation supporting inadequate response, intolerance, contraindication, or comparative clinical benefit

Submit clinical documentation supporting inadequate response, intolerance, contraindication, or that the member has achieved/maintained a positive clinical response from baseline. This documentation should include prior medication names, dosing, dates of trials, reasons for discontinuation, and objective clinical outcomes when available.

Include medication history showing two-agent trials (agent names, dates, days supply, and reasons for failure/intolerance/contraindication).
Include clinical notes or test results demonstrating response or lack of response where applicable.

Background on Ranexa

Ranexa (ranolazine extended‑release) is an FDA‑recognized product used for the treatment of chronic angina. The policy frames ranolazine as a later‑line antianginal agent that is commonly used in combination with other cardiovascular therapies such as beta blockers, nitrates, and calcium channel blockers. The coverage approach requires trials of, or intolerance/contraindication to, combinations of other antianginal classes before authorization is granted without PA, and notes that filled treatment history (e.g., 30‑day supplies of other agents within a 365‑day lookback) is used to determine step‑therapy satisfaction.

Definitions

Chronic angina — Indication definition for ranolazine

FDA-approved indicationTreatment of chronic angina

Clinical definition used in policySymptomatic coronary disease causing recurrent chest pain managed with antianginal therapy (ranolazine used as later-line agent)

Use with other therapiesMay be used with beta-blockers, nitrates, calcium channel blockers, and other cardiovascular therapies

Authorization basisAuthorization may be granted when inadequate response, intolerance, or contraindication to a combination of two classes (beta blocker, calcium channel blocker, long-acting nitrate) is documented, or when patient has achieved/maintained positive clinical response to ranolazine from baseline

OpenPayer

Ranexa (ranolazine) — Step Therapy and Prior Authorization for Chronic Angina

Coverage Criteria for Ranexa (ranolazine)

Coding and Operational Parameters

Provider Actions, Prior Authorization, and Documentation

Background on Ranexa

Definitions