DraftNeighborhood Health Plan of Rhode IslandPolicy N/A

Prior Authorization and Step Therapy for Pregabalin and Gabapentin Extended‑Release Products

Defines step therapy and prior authorization requirements for Lyrica (pregabalin), Lyrica CR, Gralise (gabapentin ER), and Horizant (gabapentin enacarbil) for indications including postherpetic neuralgia, neuropathic pain, and restless legs syndrome; applies to prescription benefit administration by CVS Caremark for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPrior Authorization and Step Therapy for Pregabalin and Gabapentin Extended‑Release Products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionConfirm patient has a ≥30-day supply of specified immediate‑release agent within the past 120 days to satisfy step therapy before requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval (DOA)

120Lookback period (days)

30 dayMinimum prior fill

Coverage and Medical Necessity Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Permitted indications: Lyrica (pregabalin immediate-release) is being prescribed for one of the following: adjunctive therapy for partial-onset (focal-onset) seizures (age ≥3 years for the indication listed in chunk 12; note chunk 9 includes ages down to 1 month for other seizure wording), management of postherpetic neuralgia, management of neuropathic pain associated with diabetic peripheral neuropathy, cancer-related neuropathic pain, or cancer treatment–related neuropathic pain.

(chunks 9,12)

Oral solution requirement: If the request is for Lyrica oral solution, patient must have difficulty swallowing solid dosage forms or require a dose not available in capsules.

(chunk 12)

Continuation vs new request: Either the request is for continuation of therapy OR the request is NOT for continuation of therapy; if continuation, the patient must have achieved or maintained a positive clinical response to the requested drug.

(chunk 11)

Non-continuation prerequisites (new requests for certain indications): For new (non-continuation) requests for Lyrica for listed neuropathic pain indications or seizure adjunctive use, the patient must have experienced an inadequate treatment response, intolerance, or have a contraindication to gabapentin immediate-release.

(chunks 12,14)

Lyrica CR, Gralise, Horizant coverage for PHN and RLS

Covered with prior authorization when criteria below are met:

PHN management: Lyrica CR, Gralise, or Horizant is being prescribed for management of postherpetic neuralgia AND for new requests the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release; for continuation requests the patient must have achieved or maintained a positive clinical response to the requested drug.

(chunk 14)

Diabetic peripheral neuropathy (Lyrica CR): For Lyrica CR prescribed for neuropathic pain associated with diabetic peripheral neuropathy, new requests require inadequate response, intolerance, or contraindication to TWO of the following: gabapentin immediate-release; pregabalin immediate-release; duloxetine; venlafaxine; a tricyclic antidepressant. Continuation requests require that the patient has achieved or maintained a positive clinical response.2 agents

(chunk 14)

Horizant for RLS: Horizant (gabapentin enacarbil extended-release) prescribed for Restless Legs Syndrome: for new requests the patient must have experienced an inadequate response, intolerance, or have a contraindication to ANY of pramipexole immediate-release or ropinirole immediate-release; for continuation requests the patient must have achieved or maintained a positive clinical response to the requested drug.

(chunk 14)

Provider Requirements, Prior Authorization, and System Rejections

Step Therapy

Initial step therapy lookback for gabapentin immediate-release

If the patient has filled a prescription for at least a 30-day supply of gabapentin immediate-release within the past 120 days under a prescription benefit administered by CVS Caremark, the requested drug will be paid under that prescription benefit. If the patient does not meet the initial step therapy criteria, the system will reject the request with a message indicating that a prior authorization (PA) is required. The prior authorization criteria will then be applied to requests submitted for evaluation to the PA unit.

Initial step therapy lookback: ≥30-day supply of gabapentin immediate-release within past 120 days under a CVS Caremark-administered prescription benefit

Step Therapy

Initial step therapy lookback for Horizant

For Horizant, prior use of ropinirole immediate-release or gabapentin immediate-release (≥30-day supply within the past 120 days under a prescription benefit administered by CVS Caremark) will satisfy the initial step. If the patient does not meet this initial step therapy criterion, the system will reject the request with a message that a prior authorization (PA) is required and the authorization criteria will be applied when submitted to the PA unit.

Initial step therapy lookback for Horizant: prior fill of ropinirole IR or gabapentin IR within 120 days may satisfy step

Denial Risk

Requests will be rejected by the system when initial step therapy criteria are unmet

System-level rejections will occur when initial step therapy criteria are not met. Requests that do not meet the specified lookback requirements will be rejected by the system with instructions that a prior authorization (PA) is required; such requests must be routed to the PA unit for evaluation against the authorization criteria.

System rejection for unmet initial step therapy criteria — requests rejected and PA required when criteria not met
Similar operational rejection logic applies for Horizant when prior step criteria are not met

Documentation Required

Documentation required for Lyrica oral solution

If requesting Lyrica (pregabalin) oral solution, documentation must show either: A) the patient has difficulty swallowing oral solid dosage forms (e.g., capsules), or B) the patient requires a dose that cannot be obtained using the commercially available capsules.

Documentation required for Lyrica oral solution requests: swallowing difficulty OR dose not available in solid forms

Documentation Required

Non-continuation requests — required documentation

For non-continuation requests for Lyrica, Lyrica CR, Gralise, or Horizant, documentation must show the patient has experienced an inadequate treatment response, intolerance, or a contraindication to the required immediate-release agents (e.g., gabapentin immediate-release; for Horizant, pramipexole IR or ropinirole IR as applicable). When the initial step therapy criteria are not met, the request will be rejected by the system and a PA is required.

Non-continuation requests must document inadequate response, intolerance, or contraindication to specified agents
For Horizant non-continuation: inadequate response, intolerance, or contraindication to pramipexole IR or ropinirole IR

Clinical Background

Pregabalin (Lyrica and Lyrica CR) and gabapentin formulations (including Gralise and Horizant) are used to manage neuropathic pain conditions such as postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy; Horizant is also indicated for moderate-to-severe primary restless legs syndrome. Extended-release formulations differ pharmacokinetically from immediate-release gabapentin, which can affect dosing frequency and interchangeability.

When evaluating coverage, note that Gralise is specifically indicated for PHN and is explicitly not interchangeable with other gabapentin products due to its distinct pharmacokinetic profile. Lyrica CR and Lyrica are indicated for PHN and certain neuropathic pain conditions, but Lyrica CR’s efficacy is not established for fibromyalgia or as adjunctive therapy for adult partial-onset seizures, which may limit coverage for those indications.

Definitions and Product Notes

Postherpetic neuralgia (PHN)

DefinitionPostherpetic neuralgia (PHN): chronic neuropathic pain following herpes zoster

Gralise indicationGralise is indicated for the management of postherpetic neuralgia

Other products indicated for PHNLyrica and Lyrica CR and Horizant are indicated for management of postherpetic neuralgia

Coverage noteUse of Lyrica CR, Gralise, or Horizant for PHN requires prior authorization when criteria (e.g., prior inadequate response/intolerance to gabapentin IR) are met

Restless Legs Syndrome (RLS)

IndicationHorizant is indicated for treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

Usage caveatNot recommended for patients who are required to sleep during the daytime and remain awake at night

Step therapy implicationPrior fill of ropinirole IR or gabapentin IR within the past 120 days may satisfy initial step for Horizant; otherwise PA required

Product interchangeability

StatementGralise (gabapentin ER) is not interchangeable with other gabapentin products

ReasonDiffering pharmacokinetic profiles affect frequency of administration

Dosing implicationDosing frequency for Gralise differs from immediate‑release gabapentin formulations

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPrior Authorization and Step Therapy for Pregabalin and Gabapentin Extended‑Release Products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionConfirm patient has a ≥30-day supply of specified immediate‑release agent within the past 120 days to satisfy step therapy before requesting prior authorization.

SourceLink

On This Page

OpenPayer

Prior Authorization and Step Therapy for Pregabalin and Gabapentin Extended‑Release Products

Coverage and Medical Necessity Criteria

Step Therapy Lookback and Coding Notes

Provider Requirements, Prior Authorization, and System Rejections

Clinical Background

Definitions and Product Notes