Neighborhood Health Plan RI pregabalin/gabapentin Prior Auth

Coverage Criteria for Pregabalin and Gabapentin Products

Initial authorization: Lyrica specific indications (1 month to up to 3 years)

Authorization may be granted when ALL of the following criteria are met:

Lyrica indications - initial: The request is for Lyrica (pregabalin immediate-release) AND the requested drug is being prescribed for ONE of: adjunctive therapy for the treatment of partial-onset seizures (i.e., focal-onset seizures) in a patient 1 month to up to 3 years of age; cancer-related neuropathic pain; cancer treatment-related neuropathic pain; management of fibromyalgia; management of neuropathic pain associated with spinal cord injury. If the request is for Lyrica (pregabalin) oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules), or requires a dose that cannot be obtained using the commercially available capsules.

Initial authorization: Adjunctive therapy for partial-onset seizures (≥3 years)

Authorization may be granted when ALL of the following criteria are met:

Adjunctive therapy ≥3 years: The request is for Lyrica (pregabalin immediate-release). If the request is for Lyrica (pregabalin) oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules), or requires a dose that cannot be obtained using the commercially available capsules. The patient has experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release.

Initial authorization: Neuropathic pain associated with diabetic peripheral neuropathy

Authorization may be granted when ONE of the following criteria are met:

DPN - Lyrica IR path: The request is for Lyrica (pregabalin immediate-release) AND if the request is for Lyrica oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules), or requires a dose that cannot be obtained using the commercially available capsules; AND the patient experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release.

DPN - Lyrica CR path: The request is for Lyrica CR (pregabalin extended-release) AND the patient experienced an inadequate treatment response, intolerance, or has a contraindication to TWO of the following: gabapentin immediate-release; pregabalin immediate-release; duloxetine; venlafaxine; a tricyclic antidepressant.

Initial authorization: Postherpetic neuralgia

Authorization may be granted when ALL of the following criteria are met:

Postherpetic neuralgia: The request is for Lyrica (pregabalin immediate-release), Lyrica CR (pregabalin extended-release), Gralise (gabapentin extended-release), or Horizant (gabapentin enacarbil extended-release). If the request is for Lyrica (pregabalin) oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules), or requires a dose that cannot be obtained using the commercially available capsules. The patient experienced an inadequate treatment response, intolerance, or has a contraindication to gabapentin immediate-release.

Initial authorization: Restless Legs Syndrome

Authorization may be granted when ALL of the following criteria are met:

Restless Legs Syndrome: The request is for Horizant (gabapentin enacarbil extended-release) AND the patient has experienced an inadequate treatment response, intolerance, or has a contraindication to ANY of the following: pramipexole immediate-release; ropinirole immediate-release.

Continuation of therapy

Authorization may be granted for continuation when ALL of the following criteria are met:

Continuation - Lyrica indications: The request is for Lyrica (pregabalin immediate-release) for one of the listed indications (adjunctive seizure therapy in specified age groups, cancer-related neuropathic pain, cancer treatment-related neuropathic pain, management of fibromyalgia, management of neuropathic pain associated with spinal cord injury) AND if the request is for Lyrica oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules) or requires a dose that cannot be obtained using the commercially available capsules; AND the patient has achieved or maintained a positive clinical response to the requested drug.

Continuation - DPN: The request is for Lyrica or Lyrica CR for neuropathic pain associated with diabetic peripheral neuropathy AND if the request is for Lyrica oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules) or requires a dose that cannot be obtained using the commercially available capsules; AND the patient has achieved or maintained a positive clinical response to the requested drug.

Continuation - PHN: The request is for Lyrica, Lyrica CR, Gralise, or Horizant for postherpetic neuralgia AND if the request is for Lyrica oral solution, the patient meets ONE of the following: has difficulty swallowing oral solid dosage forms (e.g., capsules) or requires a dose that cannot be obtained using the commercially available capsules; AND the patient has achieved or maintained a positive clinical response to the requested drug.

The policy notes that the efficacy of Lyrica CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial-onset seizures. For other indications listed in this policy (e.g., neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia), coverage criteria differ by product and may require documented prior inadequate response, intolerance, or contraindication to specified comparator agents before authorization.

Gralise is specifically indicated for the management of postherpetic neuralgia and is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect dosing frequency; this difference underlies product-specific criteria and step edits in the policy.

This document contains confidential and proprietary information of CVS Caremark and cannot be reproduced, distributed, or printed without written permission from CVS Caremark. It includes references to brand-name prescription drugs that are trademarks or registered trademarks of manufacturers not affiliated with CVS Caremark.

When using the policy text for clinical or administrative purposes, cite the policy number (656-D) and consult the referenced package inserts and guidelines listed in the document for drug‑specific prescribing information and evidence.

Provider Authorization, Documentation, and Processing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required when initial step therapy criteria are not met. The system will reject requests that do not meet the initial step therapy criteria and display a message indicating a prior authorization (PA) is required; those requests must be submitted to the PA unit for review.

If the patient does not meet the initial step therapy criteria the electronic adjudication system will reject the claim and require PA submission to the PA unit.
Requests that do not meet initial step therapy criteria will not be auto-routed for benefit payment and must undergo PA review.

Billing Rule

Billing / Benefit Routing for Lyrica and Gralise

For Lyrica (pregabalin) and Gralise (gabapentin extended-release), benefit/payment routing depends on prior fills under the prescription benefit administered by CVS Caremark. If the patient has a qualifying prior fill (at least a 30 day supply of gabapentin immediate‑release within the past 120 days for Lyrica/Gralise), the request will be paid under the prescription benefit. If not, the system will reject and require PA.

Clinical Background

Pregabalin and gabapentin formulations are used for a range of neurologic and pain indications covered by this policy, including neuropathic pain (such as diabetic peripheral neuropathy), postherpetic neuralgia, restless legs syndrome, adjunctive therapy for focal (partial-onset) seizures, fibromyalgia, and spinal cord injury–related neuropathic pain.

Some marketed formulations are immediate‑release (e.g., pregabalin immediate‑release/Lyrica, gabapentin immediate‑release) while others are extended‑release or prodrug forms (e.g., Gralise, Horizant, Lyrica CR). Because of differing pharmacokinetic profiles and dosing schedules, these products are not considered interchangeable, and the policy applies product‑specific step edits and prior‑authorization requirements.

Product Differences and References

Not interchangeable — pharmacokinetic and dosing differentiation

Key statementGralise and other gabapentin products have differing pharmacokinetic profiles that affect dosing frequency and are not considered interchangeable.

Clinical implicationDo not substitute Gralise for immediate‑release gabapentin on a milligram‑for‑milligram basis due to differences in absorption and dosing regimen.

Formulation noteSome gabapentin formulations (Gralise, Horizant) and pregabalin extended‑release products (Lyrica CR) have distinct release profiles compared with immediate‑release gabapentin.

Package insert and reference list cited

Primary manufacturer inserts citedCymbalta; Gralise; Horizant; Lyrica; Lyrica CR; Pramipexole; Ropinirole; Neurontin (see full reference list).

Clinical resources

OpenPayer

Pregabalin and Gabapentin Prior Authorization and Step Therapy

Coverage Criteria for Pregabalin and Gabapentin Products

Provider Authorization, Documentation, and Processing Requirements

Clinical Background

Product Differences and References