Pregabalin (Lyrica, Lyrica CR)

Coverage Summary

This policy's coverage stance is covered with criteria for pregabalin (both immediate‑release and controlled‑release formulations) across Commercial, HIM/ICHRA, Medicaid, and ICHRA lines of business. It defines initial and continued approval criteria, indication‑specific dosing maxima, excluded indications, and authorization durations as the scope of review.

I. Initial Therapy Criteria

I. Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. For Commercial and HIM/ICHRA immediate-release pregabalin requests, review step therapy CP.CPA.83 (Commercial) or HIM.PA.109 (HIM) unless formulary requires prior authorization.

Indication (one of)

Neuropathic Pain
- Diagnosis of neuropathic pain associated with one of: DPN; PHN; treatment of cancer (immediate-release only); spinal cord injury (immediate-release only)
- Age ≥ 18 years
- Failure of a 30-day trial of gabapentin at ≥ 1,800 mg/day, unless contraindicated or clinically significant adverse effects experienced30 days; ≥ 1,800 mg/day
- Failure of a 30-day trial of a tricyclic antidepressant (TCA) at up to maximally indicated doses, unless clinically significant adverse effects experienced, member age ≥ 65, or all are contraindicated30 days; up to maximally indicated doses
- For all requests except PHN: failure of a 30-day trial of a formulary SNRI (e.g., duloxetine, venlafaxine) at up to maximally indicated doses, unless clinically significant adverse effects experienced or all are contraindicated30 days; up to maximally indicated doses
- If request is for controlled-release formulation, member must use immediate-release pregabalin unless contraindicated or clinically significant adverse effects experienced
- If request is for brand Lyrica, member must use generic pregabalin unless contraindicated or clinically significant adverse effects experienced
- Dose limit (one of depending on indication)
  - DPN: pregabalin immediate-release ≤ 300 mg/day300 mg/day
  - DPN: pregabalin CR ≤ 330 mg/day330 mg/day
  - Neuropathic pain associated with treatment of cancer or spinal cord injury: pregabalin ≤ 600 mg/day600 mg/day
    immediate-release only for spinal cord injury per PI
  - PHN: pregabalin immediate-release ≤ 600 mg/day600 mg/day
Partial Onset Seizures
- Diagnosis of partial onset seizures
- Prescribed by or in consultation with a neurologist
- Age ≥ 1 month
- Request is for immediate-release formulation
- Redirection/step therapy bypass
  - Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix E)
  - Failure of gabapentin used as adjunctive therapy to other anticonvulsants, unless contraindicated or clinically significant adverse effects experienced; and failure of TWO anticonvulsants indicated for partial seizures (e.g., carbamazepine, phenytoin, valproic acid, oxcarbazepine, phenobarbital, lamotrigine, levetiracetam, topiramate, zonisamide, tiagabine, felbamate), unless clinically significant adverse effects experienced or all are contraindicated
Fibromyalgia
- Diagnosis of fibromyalgia
- Age ≥ 18 years
- Request is for immediate-release formulation
- Failure of a 30-day trial of gabapentin at ≥ 1,800 mg/day, unless contraindicated or clinically significant adverse effects experienced30 days; ≥ 1,800 mg/day
- Failure of a 30-day trial of duloxetine at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects experienced30 days; up to maximally indicated doses
Generalized Anxiety Disorder (off-label)
- Diagnosis of generalized anxiety disorder (GAD)
- Age ≥ 18 years
- Request is for immediate-release formulation
- Failure of TWO of: escitalopram, paroxetine, venlafaxine ER, duloxetine, buspirone, unless clinically significant adverse effects experienced or all are contraindicated
- If request is for brand Lyrica, member must use generic pregabalin unless contraindicated or clinically significant adverse effects experienced
- Dose does not exceed 600 mg per day600 mg/day
Restless Leg Syndrome (off-label)
- Diagnosis of restless leg syndrome (RLS)
- Age ≥ 18 years
- If request is for controlled-release formulation, member must use immediate-release pregabalin unless contraindicated or clinically significant adverse effects experienced
- If request is for brand Lyrica, member must use generic pregabalin unless contraindicated or clinically significant adverse effects experienced
- Dose limit (one of)
  - Pregabalin immediate-release: dose does not exceed 450 mg per day450 mg/day
Other diagnoses/indications
- If drug has recent label change not yet reflected in policy (within 6 months), refer to no coverage or non-formulary policy as applicable (CP.CPA.190, HIM.PA.33, CP.PMN.255 or HIM.PA.103, CP.PMN.16)6 months
- If requested use is not listed under section III and criterion above does not apply, refer to off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Prior Authorization

Prior authorization / step therapy review

For Commercial and HIM/ICHRA requests for immediate‑release pregabalin, review and apply the applicable step therapy criteria (CP.CPA.83 for Commercial; HIM.PA.109 for HIM/ICHRA) unless the formulary requires prior authorization. Note: Illinois HIM requests are exempt from these step therapy requirements as of 2026-01-01 per IL HB 5395. Step therapy applies to Commercial and HIM immediate‑release requests unless the formulary requires PA.

CP.CPA.83
HIM.PA.109
IL HB 5395 (Illinois HIM step therapy bypass effective 2026-01-01)

II. Continued Therapy Criteria

Billing Rule

Authorization duration

Approval duration varies by line of business: Medicaid, HIM, and ICHRA approvals are for 12 months. Commercial approvals are for 12 months or for the duration of the request, whichever is less.

Denial Risk

Dose limit enforcement

Dose increases that exceed the indication‑specific maximums may be denied. Refer to the continued therapy and indication sections for the applicable dose limits when requesting dose increases.

III. Diagnoses/Indications Not Authorized

Documentation Required

Documentation required for approval

Providers must submit clinical documentation (office notes, lab results, or other clinical information) that demonstrates the member meets all approval criteria to support coverage determinations.

Provider Actions / What Clinicians Must Do

Step Therapy

Failure of alternative agents required

Specific failed trials and trial durations required before approval vary by indication. Document required prior trials and thresholds per the policy.

Gabapentin trial: 30-day trial at ≥ 1,800 mg/day (neuropathic pain, fibromyalgia)
TCA trial: 30-day trial at up to maximally indicated doses (neuropathic pain, fibromyalgia)
SNRI trial: 30-day trial at up to maximally indicated doses (neuropathic pain except PHN)
Partial-onset seizures: failure of gabapentin (adjunctive) and failure of TWO anticonvulsants indicated for partial seizures

Documentation Required

Brand-to-generic redirection

If the request is for brand Lyrica, the member must use generic pregabalin unless the brand is clinically contraindicated or causes clinically significant adverse effects.

Applicable Codes & Policy References

Relevant policy references / step therapy and off-label policiesmixed

CP.CPA.83	Commercial step therapy criteria (used for immediate-release pregabalin requests in Commercial line)
HIM.PA.109	HIM/ICHRA step therapy criteria (used for immediate-release pregabalin requests in HIM/ICHRA)
CP.CPA.190	No coverage criteria policy (commercial)
HIM.PA.33	No coverage criteria policy (HIM/ICHRA)
CP.PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (HIM/ICHRA)
CP.PMN.16	Non-formulary policy (Medicaid)
CP.CPA.09	Off-label use policy (Commercial)
HIM.PA.154	Off-label use policy (HIM/ICHRA)
CP.PMN.53	Off-label use policy (Medicaid)

Products (no billing codes provided in policy body)mixed

Lyrica (pregabalin)	Immediate-release pregabalin products; capsules and oral solution
Lyrica CR (pregabalin CR)	Controlled-release pregabalin tablets

Clinical Evidence & Background

Pregabalin is a structural derivative of gamma‑aminobutyric acid (GABA) and acts as a calcium channel alpha2‑delta ligand with antinociceptive and antiseizure effects. The policy aligns coverage with FDA‑approved indications (including neuropathic pain conditions, partial‑onset seizures, and fibromyalgia) and references evidence‑based alternatives. It specifies required step therapy redirections (e.g., use of gabapentin, TCAs, and SNRIs where applicable), step therapy application for Commercial and HIM/ICHRA immediate‑release requests, and indication‑based dosing maxima.

Lyrica Prescribing Information — April 2025 (reference used, accessed Jan 23, 2026).

Lyrica CR Prescribing Information — April 2025 (reference used, accessed Jan 23, 2026).

Definitions & Numeric Thresholds

Revision History

2Q 2024 (01.19.24 / P&T 05.24)clarified

For partial onset seizures, revised pediatric maximum dose from 420 mg to 14 mg/kg/day for members weighing < 30 kg per prescribing information; clarified immediate‑release pregabalin only for neuropathic pain associated with spinal cord injury; added generalized anxiety disorder (GAD) products and dosing to Appendix B.

2Q 2025 (04.04.25 / P&T 05.25)revised

For neuropathic pain associated with treatment of cancer, revised maximum dosage from 300 mg/day to 600 mg/day per NCCN; added off‑label criteria for restless leg syndrome (RLS) with dosing limits; added step therapy bypass for Illinois HIM per IL HB 5395. (This is a material change.)

09.23.25clarified