Loading...

mhn pregabalin Coverage & Prior Auth Update | OpenPayer

ModifiedmhnPolicy CP.PMN.33

Clinical Policy: Pregabalin (Lyrica, Lyrica CR)

Defines medical necessity criteria, prior authorization expectations, and coverage limits for pregabalin and pregabalin CR across multiple indications for health plans affiliated with Centene Corporation; applies to Commercial, Health Insurance Marketplace (HIM), and Medicaid line(s) of business.

Policy Summary

Payermhn

PolicyClinical Policy: Pregabalin (Lyrica, Lyrica CR)

Policy CodePolicy CP.PMN.33

Change TypeMaterial updates (dose, RLS criteria, state bypass)

Effective DateJan 1, 2007

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing required trials (e.g., 30-day gabapentin 1,800 mg/day trial) and that member meets indication-specific dose limits.

SourceLink

POLICY UPDATE CHANGES

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 legs syndrome (RLS).

Added step therapy bypass for Illinois Health Insurance Marketplace per IL HB 5395.

For partial onset seizures, revised maximum dose from 420 mg to 14 mg/kg/day for members weighing < 30 kg per prescribing information.

Clarified that the policy applies to generic pregabalin where applicable and revised brand-to-generic redirection language.

12 monthstypical approval duration

600 mg/daycommon maximum dose

Gabapentin 1,800 mg/day

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.

Coverage and Medical Necessity Criteria

Initial Therapy — Neuropathic Pain

Covered when ALL of the following are met

Neuropathic Pain Initial Approval: 1) Diagnosis of neuropathic pain due to one of: a) diabetic peripheral neuropathy (DPN), b) postherpetic neuralgia (PHN), c) treatment of cancer (immediate‑release only), or d) spinal cord injury (immediate‑release only); 2) Age ≥ 18 years; 3) Failure of a 30‑day trial of gabapentin at ≥ 1,800 mg/day unless contraindicated or intolerant; 4) Failure of a 30‑day trial of a tricyclic antidepressant (e.g., amitriptyline, nortriptyline, imipramine) at up to maximally indicated doses unless contraindicated, intolerant, or age ≥ 65; 5) Except for PHN, failure of a 30‑day trial of a formulary SNRI (e.g., duloxetine, venlafaxine) at up to maximally indicated doses unless contraindicated or intolerant; 6) For controlled‑release (CR) requests, prior use of immediate‑release pregabalin unless contraindicated or intolerant; 7) For brand Lyrica requests, prior use of generic pregabalin unless contraindicated or intolerant; 8) Dose must not exceed indication‑ and formulation‑specific maximums (see dosing limits).

Initial Therapy — Partial Onset Seizures

Covered when ALL of the following are met

Partial Onset Seizures Initial Approval: 1) Diagnosis of partial onset seizures; 2) Prescribed by or in consultation with a neurologist; 3) Age ≥ 1 month; 4) Request is for immediate‑release formulation; 5) Member meets one of: (a) treatment in a State with step therapy limitations (see Appendix E), OR (b) i) failure of gabapentin used as adjunctive therapy to other anticonvulsants unless contraindicated/intolerant, ii) failure of TWO anticonvulsants indicated for partial seizures unless contraindicated/intolerant, iii) for brand requests, prior use of generic pregabalin unless contraindicated/intolerant; 6) Pregabalin will be used as adjunctive therapy to other anticonvulsants; 7) Dose limits: for members <30 kg: ≤14 mg/kg/day; for members ≥30 kg: ≤600 mg/day.

Initial Therapy — Fibromyalgia

Covered when ALL of the following are met

Fibromyalgia Initial Approval: 1) Diagnosis of fibromyalgia; 2) Age ≥ 18 years; 3) Request is for immediate‑release formulation; 4) Failure of a 30‑day trial of gabapentin at ≥ 1,800 mg/day unless contraindicated or intolerant; 5) Failure of a 30‑day trial of duloxetine at up to maximally indicated doses unless contraindicated or intolerant; 6) Failure of a 30‑day trial of cyclobenzaprine or a tricyclic antidepressant at up to maximally indicated doses unless contraindicated, intolerant, or age ≥ 65; 7) For brand Lyrica requests, prior use of generic pregabalin unless contraindicated or intolerant; 8) Dose does not exceed 450 mg/day.

Initial Therapy — Generalized Anxiety Disorder (off‑label)

Covered when ALL of the following are met

GAD Initial Approval: 1) Diagnosis of generalized anxiety disorder (GAD); 2) Age ≥ 18 years; 3) Request is for immediate‑release formulation; 4) Failure of TWO of the following alternatives unless contraindicated or intolerant: escitalopram, paroxetine, venlafaxine ER, duloxetine, buspirone; 5) For brand Lyrica requests, prior use of generic pregabalin unless contraindicated or intolerant; 6) Dose does not exceed 600 mg/day.

Initial Therapy — Restless Leg Syndrome (off‑label)

Covered when ALL of the following are met

RLS Initial Approval: 1) Diagnosis of restless leg syndrome (RLS); 2) Age ≥ 18 years; 3) For controlled‑release requests, prior use of immediate‑release pregabalin unless contraindicated or intolerant; 4) For brand Lyrica requests, prior use of generic pregabalin unless contraindicated or intolerant; 5) Dose does not exceed: a) immediate‑release pregabalin 450 mg/day, or b) pregabalin CR 495 mg/day.

Initial Therapy — Other Indications

Covered when ONE of the following is met

Other Indications: 1) If the drug has undergone a recent label change (within last 6 months) not yet reflected in this policy, follow the applicable no‑coverage or non‑formulary policy for the line of business; OR 2) If the requested use is not listed in Section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid).

Continuation Therapy

Covered when ALL of the following are met

Continued therapy criteria

Receiving status: a. Currently receiving medication via Centene benefit or previously met initial approval criteria; b. Currently receiving medication and in continuity‑of‑care state/product
Clinical response: Member is responding positively to therapy
Dose increase requirement: Dose increase requests must not exceed specified maximums by indication and formulation (see Dose Limit Criteria block).

Dose Limit Criteria

Dose limits (applies when dose increase requested)

Immediate‑release dose limits: DPN: 300 mg/day; PHN, neuropathic pain associated with treatment of cancer, or spinal cord injury, and GAD: 600 mg/day; Partial‑onset seizures: <30 kg -> 14 mg/kg/day; ≥30 kg -> 600 mg/day; Fibromyalgia and RLS: 450 mg/day.

Controlled‑release (Lyrica CR) dose limits: DPN: 330 mg/day; PHN: 660 mg/day; RLS: 495 mg/day.

Lyrica CR (controlled‑release pregabalin) is approved for neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). Its efficacy has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial‑onset seizures, and requests for those uses should be evaluated against the applicable off‑label and coverage criteria in this policy.

Coverage is not authorized for the following indications: dental pain, essential tremor, and social phobia (social anxiety disorder). In addition, requests for non‑FDA approved indications not addressed in this policy will be denied unless the provider supplies sufficient supporting documentation of safety and efficacy per the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM, and CP.PMN.53 for Medicaid) or other evidence-of-coverage documentation.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the provisions of this clinical policy. Where there is a discrepancy between this policy and a state Medicaid manual, the state Medicaid rules govern; providers should consult the applicable state Medicaid manual for any state‑specific coverage decisions.

Dosing, Limits, and Required Trials

Dose limits — indication-specific maximums

DPN (immediate-release)Maximum 300 mg/day

PHN (immediate-release)Maximum 600 mg/day

DPN (controlled‑release, Lyrica CR)Maximum 330 mg/day

PHN (controlled‑release, Lyrica CR)Maximum 660 mg/day

Neuropathic pain associated with cancer or spinal cord injury (immediate‑release)Maximum 600 mg/day

Gabapentin trial requirement

Required trial30-day trial of gabapentin at ≥ 1,800 mg/day is required for several indications (unless contraindicated or intolerant)

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for pregabalin products per this policy. For Commercial and Health Insurance Marketplace (HIM) requests for immediate‑release pregabalin (Lyrica), review and apply applicable step therapy criteria (CP.CPA.83 for Commercial; HIM.PA.109 for HIM) unless the formulary explicitly requires prior authorization or a state-specific bypass applies.

Immediate‑release pregabalin (Lyrica) — evaluate using step therapy CP.CPA.83 (Commercial) or HIM.PA.109 (HIM) unless formulary prior authorization takes precedence.
Requests for continuation of therapy or dosing changes require prior authorization documentation as outlined below.
Failure to submit required documentation may result in denial.

Step Therapy

Step Therapy and Required Trials

Step therapy requirements apply to many indications for immediate‑release pregabalin. Required medication trials and sequencing (for example, trials of gabapentin, TCAs, SNRIs, and other specified agents) must be documented unless contraindicated or clinically significant adverse effects are experienced. For controlled‑release requests, members must generally trial immediate‑release pregabalin first unless contraindicated.

Definitions and Background

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma‑aminobutyric acid (GABA) and functions as an alpha2‑delta ligand at voltage‑gated calcium channels, producing antinociceptive and anticonvulsant effects. Both immediate‑release pregabalin (Lyrica) and a controlled‑release formulation (Lyrica CR) are referenced in this policy; the formulations have overlapping but distinct approved indications and different dosing limits. Clinical use is guided by indication‑specific criteria (for neuropathic pain, seizures, fibromyalgia, GAD, RLS) and by prior‑authorization and step‑therapy requirements described elsewhere in the policy.

Lyrica CR — controlled‑release formulation indications

Indications summarizedLyrica CR indicated for neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN)

Not establishedEfficacy of Lyrica CR has not been established for management of fibromyalgia or as adjunctive therapy for adult partial-onset seizures

Dosing range (examples)Lyrica CR dosing escalation described up to 330 mg/day (DPN) and up to 660 mg/day (PHN); RLS CR up to 495 mg/day