CurrentNeighborhood Health Plan of Rhode IslandPolicy 656-D

Pregabalin and gabapentin ER/EN step therapy and prior authorization policy (Lyrica, Lyrica CR, Gralise, Horizant)

Defines initial step therapy and post-step prior authorization criteria for Lyrica (pregabalin immediate-release), Lyrica CR (pregabalin ER), Gralise (gabapentin ER), and Horizant (gabapentin enacarbil ER) including indications (PHN, diabetic neuropathy, RLS, fibromyalgia, adjunctive therapy for partial-onset seizures, spinal cord injury, cancer-related neuropathic pain) and continuation criteria. Duration of approval is 12 months.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPregabalin and gabapentin ER/EN step therapy and prior authorization policy (Lyrica, Lyrica CR, Gralise, Horizant)

Policy CodePolicy 656-D

Change TypeNo material change

Effective Date

Next Review Date

Key ActionIf the patient has not met step therapy (e.g., prior fill of 30-day supply within 120 days of required agent), the system will reject and a prior authorization is required; PA criteria will be applied for evaluation.

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

12 monthsDuration of Approval

MultipleCovered Indications

AppliesPrior Step Therapy / PA

Coverage Summary & Scope

Scope: This policy defines initial step therapy and post-step prior authorization criteria for branded pregabalin and gabapentin ER/enacarbil products — specifically Lyrica (pregabalin immediate-release), Lyrica CR (pregabalin extended‑release), Gralise (gabapentin extended‑release), and Horizant (gabapentin enacarbil extended‑release).

Covered indications and criteria summary: Products are covered with prior authorization when used for listed indications and meeting step/PA requirements. Covered indications include postherpetic neuralgia (PHN) (Lyrica, Lyrica CR, Gralise, Horizant), diabetic peripheral neuropathy (DPN) (Lyrica, Lyrica CR per specific criteria), Restless Legs Syndrome (RLS) (Horizant), fibromyalgia (Lyrica), adjunctive therapy for partial‑onset seizures (Lyrica; age‑specific), neuropathic pain associated with spinal cord injury (Lyrica), and cancer‑related and cancer treatment‑related neuropathic pain (Lyrica).

Step therapy and PA approach: Initial step requirements apply (e.g., prior fill of a ≥30‑day supply within 120 days of the required agent will satisfy the step and result in payment under that benefit). For non‑step‑compliant requests the system will reject and require prior authorization; PA review requires documentation of inadequate response, intolerance, or contraindication to required prior agents (specific numbers of prior agents apply for some indications, e.g., TWO prior agents required for Lyrica CR in DPN).

Initial Therapy Criteria

Overall Coverage Criteria

The requested drug will be covered with prior authorization when the following criteria are met:

Lyrica for select indications (age-specific for seizures and other listed indications)

Lyrica (pregabalin immediate-release) is being prescribed for one of the following: A) Management of fibromyalgia, B) Management of neuropathic pain associated with spinal cord injury, C) Adjunctive therapy for the treatment of partial-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
Oral solution exception
- If the request is for Lyrica (pregabalin) oral solution, the patient has difficulty swallowing oral solid dosage forms (e.g., capsules)
- If the request is for Lyrica (pregabalin) oral solution, the patient requires a dose that cannot be obtained using the commercially available capsules
The request is NOT for continuation of therapy

Lyrica for other indications (older children/adults)

Lyrica (pregabalin immediate-release) is being prescribed for one of the following: 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
Oral solution exception
- If the request is for Lyrica (pregabalin) oral solution, the patient has difficulty swallowing oral solid dosage forms (e.g., capsules)
- If the request is for Lyrica (pregabalin) oral solution, the patient requires a dose that cannot be obtained using the commercially available capsules
The request is NOT for continuation of therapy

Lyrica CR / Gralise / Horizant for PHN

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

Lyrica CR for diabetic peripheral neuropathy (DPN)

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

Horizant for Restless Legs Syndrome (RLS)

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

Continuation criteria (general)

The request is for continuation of therapy
The patient has achieved or maintained a positive clinical response to the requested drug

Continuation Therapy Criteria

Continuation Criteria

Lyrica continuation

The request is for continuation of therapy
The patient has achieved or maintained a positive clinical response to the requested drug

Continuation criteria (general)

The request is for continuation of therapy
The patient has achieved or maintained a positive clinical response to the requested drug

Lyrica continuation / general continuation

The patient has achieved or maintained a positive clinical response to the requested drug
The patient has experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release

Continuation (other repeats)

The request is for continuation of therapy
The patient has achieved or maintained a positive clinical response to the requested drug

Exceptions, Non-coverage Notes, and Definitions

Exclusions / interchangeability notes: Gralise is not interchangeable with other gabapentin products due to differing pharmacokinetic profiles that affect dosing frequency.

Indication specificity: Horizant is indicated for moderate‑to‑severe primary Restless Legs Syndrome in adults and is also indicated for management of postherpetic neuralgia in adults; Horizant is not recommended for patients who must sleep during the daytime and remain awake at night.

Continuation of therapy definition: Continuation of therapy is defined as requests for refill/ongoing therapy where the patient has already been receiving the requested drug and has achieved or maintained a positive clinical response.

Prior Authorization, Step Therapy & Documentation Requirements

Prior Authorization

Prior Authorization required for non-step-compliant fills

If the patient did not meet step therapy (for example, did not have a required prior fill as described below), the claim will reject and a prior authorization is required; PA criteria will then be applied for evaluation.

Step Therapy

Initial step therapy fill requirements

Initial step therapy requirement: for Lyrica and Gralise, payment will be made under the prior prescription benefit if the patient filled at least a 30‑day supply of gabapentin immediate‑release within the past 120 days; for Horizant, payment will be made if the patient filled at least a 30‑day supply of pramipexole IR, ropinirole IR, or gabapentin IR within the past 120 days. If these step fills are not met the claim will reject and a prior authorization is required.

Documentation Required

Documentation of inadequate response/intolerance/contraindication

For non-first-line or ER/CR agents, the provider must document an inadequate treatment response, intolerance, or a contraindication to the required prior agents. Note: for certain indications (for example, Lyrica CR for diabetic peripheral neuropathy) documentation must show inadequate response/intolerance/contraindication to TWO of the listed prior agents.

Prior Authorization

Duration of approval

Approved duration of authorization is 12 months.

Evidence and Reference Materials

Evidence sources referenced by the policy include package inserts and clinical guidelines: Gralise [package insert] (March 2023), Horizant [package insert] (April 2020), Lyrica [package insert] (June 2020), Lyrica CR [package insert] (June 2020), and clinical guideline references including the American Academy of Neurology (AAN), American Diabetes Association (ADA), National Comprehensive Cancer Network (NCCN), and the RLS practice guideline (Winkelman et al., Neurology 2016).

Background & Policy Notes

Background: This policy establishes CVS Caremark step therapy and post‑step prior authorization criteria for branded pregabalin (Lyrica, Lyrica CR) and gabapentin extended/enacarbil products (Gralise, Horizant).

The policy specifies covered indications, step requirements (including prior fills of specified agents to meet step criteria), and PA requirements for non‑step‑compliant or non‑first‑line uses. It also notes that Gralise is not interchangeable with other gabapentin products and that Horizant has specific adult indications for moderate‑to‑severe primary RLS and PHN.