CurrentCignaPolicy N/A

Cardiology - Ranolazine Products Step Therapy Policy

Defines step therapy requirements for ranolazine products (generic ranolazine ER tablets, Aspruzyo Sprinkle, Ranexa) for Cigna-administered health benefit plans; affects prescribers and prior authorization reviewers.

Policy Summary

PayerCigna

PolicyCardiology - Ranolazine Products Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Step 2 ranolazine products unless the patient has trialed a Step 1 product or meets specified Aspruzyo Sprinkle exceptions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Step levels (Step 1 and Step 2)

1 yearApproval duration

2Products listed as Step 2

2Formulations referenced

Coverage Criteria for Ranolazine Products

Step Therapy Criteria

Covered when ALL of the following are met

Primary sequence requirement: Patient must have tried one Step 1 Product (generic ranolazine extended-release tablets) prior to use of a Step 2 product.trial of one Step 1 product

Approvals provided for 1 year

Aspruzyo Sprinkle exceptions

A: Patient requires administration by nasogastric or gastrostomy/gastric tube.
B: Patient is unable to swallow or has difficulty swallowing tablets or capsules.

Policy Summary

PayerCigna

PolicyCardiology - Ranolazine Products Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Step 2 ranolazine products unless the patient has trialed a Step 1 product or meets specified Aspruzyo Sprinkle exceptions.

SourceLink

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Prior Authorization, Step Therapy Sequence, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required when prescribing Step 2 products (Aspruzyo Sprinkle or Ranexa) unless the Step Therapy criteria are met. Approvals are provided for 1 year.

Step 1: generic ranolazine extended-release tablets
Step 2: Aspruzyo Sprinkle, Ranexa

Step Therapy

Step Therapy Sequence

Step Therapy Sequence: Step 1 requires trial of a generic ranolazine extended-release tablet. If the patient has tried one Step 1 product, a Step 2 product (Aspruzyo Sprinkle or Ranexa) may be approved.

Approval for Step 2 is contingent on documentation of trial of one Step 1 product.
If Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria.

Documentation Required

Required Documentation for Step 2 Approval

Required Documentation for Step 2 Approval: Documentation must demonstrate a trial of one Step 1 product (generic ranolazine ER tablets). For Aspruzyo Sprinkle, documentation must also show ONE of the following: (A) the patient requires administration by nasogastric or gastrostomy/gastric tube, OR (B) the patient is unable to swallow or has difficulty swallowing tablets or capsules.

Documented trial of one Step 1 product (generic ranolazine ER tablets).
For Aspruzyo Sprinkle: documentation of tube administration requirement OR documented swallowing impairment.

Denial Risk

Coverage Dependent on Step Therapy

Coverage Determination When Step Therapy Not Met: If the Step Therapy rule is not met at the point of service, coverage will be determined by the Step Therapy criteria; appeals and coverage determination processes apply.

All approvals are provided for 1 year in duration.

Formulation Definitions

inv-11: Aspruzyo Sprinkle — Ranolazine extended-release granules

Product descriptionRanolazine extended-release granules supplied in unit-dose sachets in strengths of 500 mg and 1,000 mg.

AdministrationCan be sprinkled on one tablespoonful of soft food (e.g., applesauce or yogurt) and immediately consumed.

Enteral tube useCan be administered via nasogastric or gastrostomy/gastric tube.

Regulatory/approval noteApproved via the 505(b)(2) pathway relying on existing ranolazine safety and efficacy data.

IndicationIndicated for the treatment of chronic angina, similar therapeutic intent to ranolazine ER tablets.

inv-12: Ranalazine ER tablets (Ranexa/generic) — Extended-release tablets

Product descriptionExtended-release tablets supplied in strengths of 500 mg and 1,000 mg.

Administration requirementTablets must be swallowed whole; do not crush, break, or chew.

AvailabilityAvailable as brand (Ranexa) and as generic ranolazine extended-release tablets.

IndicationIndicated for the treatment of chronic angina alongside Aspruzyo Sprinkle.

Background

Ranolazine products are indicated for the treatment of chronic angina and are available in different formulations with distinct administration requirements. Ranolazine ER tablets (500 mg and 1,000 mg) are extended-release tablets that must be swallowed whole and are available as brand (Ranexa) and generic formulations. Aspruzyo Sprinkle is ramolazine extended-release granules supplied in unit-dose sachets (500 mg and 1,000 mg) that can be sprinkled on soft food or administered via nasogastric/gastrostomy tube; this formulation supports specific exceptions to the Step 1 trial when a patient cannot swallow tablets or requires tube administration.

OpenPayer

Cardiology - Ranolazine Products Step Therapy Policy

Coverage Criteria for Ranolazine Products

Referenced Products and Billing Codes

Prior Authorization, Step Therapy Sequence, and Documentation

Formulation Definitions

Background