CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pregabalin and Gabapentin Products Prior Authorization and Step Therapy

Defines initial step therapy and prior authorization criteria for Lyrica (pregabalin), Lyrica CR, Gralise (gabapentin ER), and Horizant (gabapentin enacarbil) for members under a CVS Caremark-administered prescription benefit; affects prescribers and pharmacies processing PA/step edits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPregabalin and Gabapentin Products Prior Authorization and Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionIf the patient has not filled a ≥30-day supply of gabapentin IR (or specified comparator) within the past 120 days, submit a prior authorization; approvals are generally issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDOA

>=30 daysPrior fill

120 daysLookback

MultipleIndications

Coverage Criteria

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Indication-specific coverage and step/P A criteria

Covered with prior authorization when the following grouped criteria are met (logic preserved below):

Lyrica immediate-release indications: 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 patients from 1 month up to 3 years of age; (D) cancer-related neuropathic pain; (E) cancer treatment-related neuropathic pain.

Lyrica oral solution: If request is for Lyrica oral solution, the patient must either have difficulty swallowing oral solid dosage forms (e.g., capsules) or require a dose that cannot be obtained using the commercially available capsules.

Lyrica additional indications requiring prior trial of gabapentin IR for new therapy: For Lyrica prescribed for: (A) adjunctive therapy for partial-onset seizures in patients ≥3 years old, (B) management of postherpetic neuralgia (PHN), or (C) management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) — IF the request is NOT for continuation of therapy, the patient must have experienced an inadequate treatment response, intolerance, or have a contraindication to gabapentin immediate-release prior to initiation. For continuation requests, the patient must have achieved or maintained a positive clinical response.

Extended-release gabapentin/pregabalin for PHN: Lyrica CR (pregabalin extended-release), Gralise (gabapentin extended-release), or Horizant (gabapentin enacarbil extended-release) prescribed for postherpetic neuralgia require that, for new therapy (request NOT for continuation), 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.

Lyrica CR for DPN: For Lyrica CR prescribed for diabetic peripheral neuropathy (DPN): IF the request is NOT for continuation of therapy, the patient must have experienced an inadequate treatment response, intolerance, or have a contraindication to TWO of the following prior therapies: (A) gabapentin immediate-release, (B) pregabalin immediate-release, (C) duloxetine, (D) venlafaxine, or (E) a tricyclic antidepressant. For continuation requests, the patient must have achieved or maintained a positive clinical response.

Horizant for RLS: For Horizant (gabapentin enacarbil extended-release) prescribed for Restless Legs Syndrome (RLS): IF the request is NOT for continuation of therapy, the patient must have experienced an inadequate treatment response, intolerance, or have a contraindication to ANY of the following: (A) pramipexole immediate-release, (B) ropinirole immediate-release. For continuation requests, the patient must have achieved or maintained a positive clinical response.

Recommendation: Horizant (gabapentin enacarbil) is not recommended for patients who are required to sleep during the daytime and remain awake at night. This guidance reflects the product-specific recommendation in the prescribing information and should be applied when considering coverage for members whose sleep schedule is primarily daytime sleep and nocturnal wakefulness.

Coding & Lookback

Prior fill lookback

Lookback windowPatient must have filled at least a 30-day supply within the past 120 days under a CVS Caremark-administered prescription benefit.

ApplicationIf the prior fill criterion is met, the requested extended/brand product will be paid under that prescription benefit.

System behavior if unmetIf the patient does not meet the initial therapy (prior fill) criteria, the system will reject the claim with a message indicating a prior authorization is required.

Prior trial	Required for
At least a 30-day fill of gabapentin immediate-release within the past 120 days under a CVS Caremark-administered prescription benefit
For Horizant: a prior trial of ropinirole immediate-release or gabapentin immediate-release within the past 120 days under a CVS Caremark-administered prescription benefit

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required when the initial step therapy criteria are not met. Typical approval duration is 12 months.

Duration of approval: 12 months

Step Therapy

Step Therapy / System Rejection

If the patient has NOT filled at least a 30-day supply of gabapentin immediate-release (or, for Horizant, ropinirole immediate-release or gabapentin immediate-release where specified) within the past 120 days under a prescription benefit administered by CVS Caremark, the system will reject the request with a message indicating that a prior authorization (PA) is required. Providers should submit a PA request for evaluation by the PA unit when rejection occurs.

Initial step therapy requirement: ≥30-day supply of gabapentin IR (or specified comparator) filled within past 120 days under CVS Caremark prescription benefit
System rejection message will instruct to seek prior authorization

Documentation Required

Oral Solution Documentation Required

Requests for oral solution formulations (e.g., pregabalin oral solution) require documentation supporting medical necessity. Acceptable justification includes difficulty swallowing oral solid dosage forms (e.g., capsules) or a clinical need for a dose that cannot be achieved with commercially available capsule strengths.

Oral solution justification examples: documented dysphagia or inability to swallow capsules; required dose not available in capsule formulation

Initial Therapy / Step Requirements

Initial therapy / step

Initial therapy rules and step therapy requirements for new starts.

Step therapy - gabapentin IR prior fill: 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 extended/brand product will be paid under that prescription benefit. If the patient does not meet this initial therapy criterion, the system will reject the claim with a message indicating that a prior authorization is required and PA criteria will be applied.

Horizant comparator requirement: For Horizant, prior trial of ropinirole immediate-release or gabapentin immediate-release within the past 120 days under a CVS Caremark-administered benefit may satisfy step requirements; if not met the system will reject and PA criteria will be applied.

Oral solution exceptions: Oral solution requests require documentation that the patient has difficulty swallowing oral solid dosage forms (e.g., capsules) or requires a dose that cannot be obtained from commercially available capsules.

Continuation of Therapy Criteria

Continuation therapy

Continuation of therapy approvals require documentation that the patient has achieved or maintained a positive clinical response.

Continuation requirement: For requests for continuation of therapy, the patient must have achieved or maintained a positive clinical response to the requested drug.

Continuation evidence by indication: Continuation approvals apply across indicated products and indications (e.g., Lyrica, Lyrica CR, Gralise, Horizant) when clinical benefit is documented; specific prior-trial requirements apply only to new therapy as outlined in the indication-specific criteria.

Step Therapy Details

Indication	Step / prior trial requirement
Postherpetic neuralgia (PHN) — Lyrica CR, Gralise, or Horizant
Diabetic peripheral neuropathy (DPN) — Lyrica CR: inadequate response/intolerance/contraindication to TWO of: gabapentin IR; pregabalin IR; duloxetine; venlafaxine; tricyclic antidepressant
Restless Legs Syndrome (RLS) — Horizant: inadequate response/intolerance/contraindication to ANY of: pramipexole IR; ropinirole IR (or gabapentin IR per step logic)
Other Lyrica immediate-release indications (fibromyalgia, neuropathic pain due to spinal cord injury, adjunctive therapy for partial-onset seizures, cancer-related neuropathic pain) — prior to new therapy, patient must have had inadequate response/intolerance/contraindication to gabapentin immediate-release

OpenPayer