CurrentNeighborhood Health Plan of Rhode IslandPolicy 656-D

Pregabalin and gabapentin extended-release products step therapy and post-step prior authorization

Coverage and prior authorization rules for Lyrica, Lyrica CR, Gralise, and Horizant for members using Neighborhood Health Plan of Rhode Island (administered via CVS Caremark). Defines step therapy conditions, continuation criteria, and required prior trials for specific indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPregabalin and gabapentin extended-release products step therapy and post-step prior authorization

Policy CodePolicy 656-D

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization when step therapy criteria are not met and document required prior trials or clinical response as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4brand products covered

5indications listed

2required prior agents (RLS)

12 monthsDOA months

Refs 1-16references

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Coverage and Medical Necessity Criteria

inv-01: Covered with prior authorization - Indication-specific criteria

Covered with prior authorization when the following criteria are met (organized by indication and continuation status):

Lyrica - indications (group A): Lyrica (pregabalin immediate-release) is being prescribed for one of: A) management of fibromyalgia; B) management of neuropathic pain associated with spinal cord injury; C) adjunctive therapy for the treatment of partial-onset (focal-onset) seizures in a patient 1 month to up to 3 years of age; D) cancer-related neuropathic pain; E) cancer treatment-related neuropathic pain.

From initial criteria

Oral solution justification for Lyrica (group A): If the request is for Lyrica (pregabalin) oral solution, the patient has difficulty swallowing oral solid dosage forms (e.g., capsules) OR requires a dose that cannot be obtained using the commercially available capsules; the request is NOT for continuation of therapy.

See oral solution requirement

Continuation for group A indications: If the request is for continuation of therapy, the patient has achieved or maintained a positive clinical response to the requested drug.

Continuation requirement

Lyrica - indications (group B): Lyrica (pregabalin immediate-release) is being prescribed for one of: A) adjunctive therapy for the treatment of partial-onset seizures in a patient 3 years of age or older; B) management of postherpetic neuralgia; C) management of neuropathic pain associated with diabetic peripheral neuropathy.

From criteria set

Oral solution justification for Lyrica (group B): If the request is for Lyrica (pregabalin) oral solution, the patient has difficulty swallowing oral solid dosage forms OR requires a dose that cannot be obtained using the commercially available capsules; the request is NOT for continuation of therapy.

Oral solution requirement

Lyrica CR / Gralise / Horizant for PHN (initiation): Lyrica CR (pregabalin extended-release), Gralise (gabapentin extended-release), or Horizant (gabapentin enacarbil extended-release) is being prescribed for management of postherpetic neuralgia AND the request is NOT for continuation of therapy AND the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release.

PHN initiation requirement

Lyrica CR for diabetic peripheral neuropathy (initiation): Lyrica CR is being prescribed for management of neuropathic pain associated with diabetic peripheral neuropathy AND the request is NOT for continuation of therapy AND the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to TWO of: gabapentin immediate-release, pregabalin immediate-release, duloxetine, venlafaxine, a tricyclic antidepressant.

DPN initiation requirement

Horizant for Restless Legs Syndrome (initiation): Horizant (gabapentin enacarbil extended-release) is being prescribed for the treatment of Restless Legs Syndrome AND the request is NOT for continuation of therapy AND the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to ANY of: pramipexole immediate-release, ropinirole immediate-release.

Horizant initiation requirement

inv-02: COVERAGE CRITERIA — multiple OR branches for initiation or continuation; AND/OR conditions

Covered when the relevant AND/OR conditions below are met (document presents multiple OR branches for initiation or continuation):

General OR branches

Initiation requirement for Horizant: Horizant (gabapentin enacarbil extended-release) is being prescribed for the treatment of Restless Legs Syndrome.
Initiation - Horizant
New-start step requirement: If the request is NOT for continuation, the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to ANY of: pramipexole immediate-release, ropinirole immediate-release.
Step therapy for new starts
Continuation branch: If the request is for continuation of therapy, the patient has achieved or maintained a positive clinical response to the requested drug.
Continuation requirement

Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect administration frequency; providers should not substitute other gabapentin formulations for Gralise without consideration of these differences.

Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night; avoid prescribing Horizant for individuals whose sleep schedule would necessitate daytime sleep.

No explicit exclusion statements beyond those noted for specific products were identified in the referenced sections of the source document.

Requests for coverage may be considered not medically necessary if required prior trials are not completed or documented. Examples of required prior agents include trials of pramipexole immediate-release, ropinirole immediate-release, or gabapentin immediate-release where the policy specifies those agents as prerequisites for approval.

Prior Authorization, Step Therapy, and Documentation Requirements

Step Therapy

Step therapy fill requirement or system rejection

If the patient has not met the initial step therapy requirement of a 30-day gabapentin immediate‑release (IR) fill within the past 120 days under the prescription benefit administered by CVS Caremark, the system will reject the claim with a message indicating that prior authorization (PA) is required. A PA request will then be evaluated by the PA unit.

Applies to initial fills for Lyrica, Lyrica CR, Gralise, and Horizant as specified.
For Lyrica/Lyrica CR/Gralise: evidence of a 30‑day gabapentin IR fill within past 120 days satisfies initial step requirement.
For Horizant: evidence of a 30‑day fill of pramipexole IR, ropinirole IR, or gabapentin IR within past 120 days satisfies initial step requirement.

Documentation Required

Clinical response and prior trial documentation

Continuation requests must include documentation that the patient has achieved or maintained a positive clinical response to the requested drug. For continuation of therapy, the prior trial/step requirements that apply to new starts may not apply, but documentation of clinical benefit is required to support ongoing coverage.

Product Indications and Key Definitions

Gralise / Horizant / Lyrica / Lyrica CR indications

Gralise indicationManagement of postherpetic neuralgia (PHN)

Horizant indicationsTreatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults; management of postherpetic neuralgia (PHN)

Lyrica (pregabalin) indicationsManagement of neuropathic pain associated with diabetic peripheral neuropathy; management of postherpetic neuralgia; adjunctive therapy for partial-onset seizures (patients ≥1 month); management of fibromyalgia; management of neuropathic pain associated with spinal cord injury

Lyrica CR indicationsManagement of neuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia

Important interchangeability noteGralise is not interchangeable with other gabapentin products due to differing pharmacokinetic profiles affecting administration frequency.

Clinical and Product Background

Gralise and Horizant are extended-release formulations of gabapentin with distinct labeled indications. Gralise is indicated for management of postherpetic neuralgia. Horizant (gabapentin enacarbil) is indicated for treatment of moderate-to-severe primary Restless Legs Syndrome in adults and for management of postherpetic neuralgia. The products have different pharmacokinetic properties and labeled use considerations that inform coverage and substitution decisions.