Premera Bluecross pregabalin policy update Coverage

Coverage Criteria for Listed Agents

Lyrica (pregabalin) criteria

Lyrica (pregabalin) — Medical necessity for neuropathic pain, seizures, fibromyalgia, generalized anxiety disorder

Lyrica for neuropathic pain (adult): The individual is aged 18 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin AND has tried and had an inadequate response or intolerance to 1 of the following generic medications: tricyclic antidepressant (e.g., amitriptyline) or an SNRI (duloxetine, venlafaxine) AND has tried and had an inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release.age >= 18

From policy coverage criteria.

Lyrica for seizure disorder: The individual is aged 1 month or older AND has tried and had an inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release.age >= 1 month

From policy coverage criteria.

Lyrica for fibromyalgia (adult): The individual is aged 18 years or older AND (meets the policy step requirements for prior trial(s) of designated generic agents and intolerance or inadequate response as documented in the medical record).age >= 18

Criteria pattern follows Lyrica neuropathic pain and seizure indications per policy.

Lyrica for generalized anxiety disorder (adult): The individual is aged 18 years or older AND has tried and had an inadequate response or intolerance to a generic SSRI (e.g., citalopram, fluoxetine) AND has tried and had an inadequate response or intolerance to one of the following generics: benzodiazepine (e.g., alprazolam, clonazepam), buspirone, venlafaxine, hydroxyzine, or duloxetine.age >= 18

From policy coverage criteria.

Lyrica CR (pregabalin extended-release) criteria

Lyrica CR (pregabalin extended-release) and general drug coverage patterns

Lyrica CR for diabetic peripheral neuropathy or postherpetic neuralgia (adult): The individual is aged 18 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin AND has tried and had an inadequate response or intolerance to 2 of the following generic medications: a tricyclic antidepressant (e.g., amitriptyline), an SNRI (duloxetine, venlafaxine), cyclobenzaprine, or tramadol AND has tried and had an inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release.age >= 18

Managed under pharmacy benefit; follows step requirements described in policy.

Neurontin (gabapentin) criteria

Neurontin (gabapentin) — Medical necessity for neuropathic pain and seizures

Neurontin for neuropathic pain (adult): The individual is 18 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin AND has tried and had an inadequate response or intolerance to 1 of the following generic medications: tricyclic antidepressant (e.g., amitriptyline) or an SNRI (duloxetine, venlafaxine, desvenlafaxine) AND has tried and had an inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release.age >= 18

Policy applies similar step logic to Neurontin as to pregabalin.

Neurontin for seizure disorder (pediatric): The individual is aged 3 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin (per product labeling and documented trials) as appropriate for the seizure indication.age >= 3

From policy coverage criteria (partial text present).

Qutenza and Savella criteria

Qutenza (capsaicin) and Savella (milnacipran)

Qutenza for diabetic peripheral neuropathy or postherpetic neuralgia (adult): The individual is aged 18 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin AND has tried and had an inadequate response or intolerance to 1 of the following generic medications: tricyclic antidepressant (e.g., amitriptyline) or an SNRI (duloxetine, venlafaxine, desvenlafaxine).age >= 18

Qutenza is managed under the medical benefit per policy.

Savella for fibromyalgia (adult): The individual is 18 years or older AND has tried and had an inadequate response or intolerance to generic gabapentin AND has tried and had an inadequate response or intolerance to 2 of the following generic medications: tricyclic antidepressant (e.g., amitriptyline), an SNRI (duloxetine, venlafaxine), cyclobenzaprine, or tramadol.age >= 18

Savella is managed under the pharmacy benefit.

Evidence-based agent groups

Agents supported by clinical evidence for neuropathic pain and fibromyalgia:

SNRIs (duloxetine, milnacipran): Duloxetine demonstrated efficacy in DPN trials at doses of 60–120 mg once daily with responder definitions commonly ≥30% pain reduction; duloxetine also showed short-term efficacy in fibromyalgia. Milnacipran (Savella) showed greater efficacy than placebo at 3 months for fibromyalgia but less consistent data at 6 months and has safety concerns (elevated blood pressure, heart rate, and LFTs) making it unsuitable in individuals with liver dysfunction, substantial alcohol use, or uncontrolled BP/HR.duloxetine 60-120 mg

chunks 20,21

Anticonvulsants (pregabalin): Pregabalin (Lyrica) demonstrated modest efficacy versus placebo for neuropathic pain and fibromyalgia; responders often defined as ≥30% reduction in pain; greatest symptomatic relief observed at 450 mg/day though adverse events are common.pregabalin up to 450 mg/day

chunk 22

Topical capsaicin (Qutenza):

All uses of Lyrica (pregabalin), Lyrica CR (pregabalin extended‑release), Neurontin (gabapentin), Qutenza (capsaicin), and Savella (milnacipran) that are not specifically described in this policy are considered not medically necessary. Requests for indications, diagnoses, or treatment scenarios outside the named conditions and drug‑specific coverage criteria are therefore subject to denial.

Milnacipran (Savella) has demonstrated short‑term efficacy for fibromyalgia but the evidence at 6 months is less consistent. The agent is associated with safety concerns including elevated blood pressure, increased heart rate, and potential liver test abnormalities; use is not recommended in individuals with significant liver dysfunction, substantial alcohol use, or uncontrolled blood pressure or heart rate.

This policy document does not apply to Medicare Advantage members. Providers should consult the applicable Medicare Advantage plan documents or contact the plan directly for coverage determinations for those members.

For clarity, any proposed use of Lyrica, Lyrica CR, Neurontin, Qutenza, or Savella that is not explicitly covered by the criteria in this policy will be considered not medically necessary and is likely to be denied unless there is an approved exception supported by medical documentation.

Available evidence does not support the use of cannabidiol for fibromyalgia. Systematic reviews, including updated Cochrane analyses, report low to very low quality evidence for SNRI therapy in fibromyalgia and little evidence supporting combination pharmacotherapy; similarly, evidence does not support cannabidiol for this indication.

Initial and First-line Therapy Requirements

Initial therapy

Initial authorization criteria follow step/failure rules

Initial authorization general pattern: Requires documentation in the medical record of diagnosis, age meeting the indication, and documented trial with inadequate response or intolerance to specified generic alternatives (e.g., gabapentin; trial(s) of TCAs, SNRIs, cyclobenzaprine, tramadol) prior to approval of branded or non-generic formulations.

Applies across listed drugs in policy; chart notes/medical records must be provided per policy.

First-line therapy

First-line recommendations based on systematic reviews

First-line agents: Amitriptyline and gabapentin are recommended as first-line agents per guidelines and systematic reviews; SNRIs (e.g., duloxetine) and pregabalin have supportive evidence depending on the condition and trial data.

chunk 25; duloxetine/pregabalin evidence summarized in chunks 20 and 22.

Step Therapy and Required Trials

Step required	Required prior trials	Failure/intolerance documentation
Step 1	Documented trial and inadequate response or intolerance to generic gabapentin	Chart notes/medical records showing trial duration, dose, and reason for inadequate response or intolerance (e.g., lack of efficacy, adverse effects)
Step 2	Documented trial and inadequate response or intolerance to 1 (or condition-specific number) of the following generic agents: a tricyclic antidepressant (e.g., amitriptyline) or an SNRI (e.g., duloxetine, venlafaxine) — for some indications additional generics such as cyclobenzaprine or tramadol may be required	Chart documentation of trial(s) with agent name, dose, duration, and clinical response or intolerance
Step 3 (if applicable for brand pregabalin/Lyrica or Lyrica CR)	Documented trial and inadequate response or intolerance to generic pregabalin or generic pregabalin extended-release (when step-policy in effect) prior to coverage of brand formulation	Records demonstrating prior generic pregabalin trial and reason for failure or intolerance (or documentation of clinical justification if brand used without generic trial)

Requirement	Applies to	Notes / operational status
Trial of generic pregabalin or generic pregabalin extended-release required before coverage of brand Lyrica (pregabalin) or Lyrica CR when step policy is in effect	Brand Lyrica (pregabalin); Lyrica CR (pregabalin extended-release)	2021 update added the generic-first requirement; 2022 update removed prior authorization for the generics but the clinical step requirement remains as an operational criterion when applicable; documentation of generic trial and failure/intolerance required for brand coverage
Coverage or prior authorization may be denied if required generic pregabalin trial is not documented when applicable	Brand pregabalin formulations	Providers should submit chart notes showing trial details; exceptions require clinical justification

Policy requirement	Scope / affected products	Required evidence
Prerequisite medication tried must be a generic dosage form before coverage of certain branded or non-generic medications	All branded or non-generic formulations listed in this policy (e.g., brand Lyrica/Lyrica CR, Savella, Qutenza administration when medical necessity criteria reference prior generics)	Documentation of prior generic product trial (agent name, dose, duration, and reason for inadequate response or intolerance) must be submitted with prior authorization review
This generic-first requirement applies across indications and was added as a coverage criteria update	Drugs covered under this policy including pregabalin, pregabalin ER, gabapentin, milnacipran, and capsaicin (Qutenza) per their respective criteria	Chart notes or medical records demonstrating prior trials of generic dosage forms; clinical justification required for exceptions

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for branded agents listed in this policy (Lyrica, Lyrica CR, Neurontin, Qutenza, Savella) unless otherwise noted below. For branded pregabalin products (Lyrica, Lyrica CR), prior authorization decisions will require documentation of step/failure criteria and may be denied if required steps are not documented.

Prior authorization required for Lyrica, Lyrica CR, Neurontin, Qutenza, Savella unless a specific update removes PA status.
Branded pregabalin products require documented step/failure trials as described in coverage criteria.

Step Therapy

Pregabalin Prior Authorization and Step Therapy Changes

Effective updates in 2021–2024 modified prior authorization and step therapy for pregabalin products: generic pregabalin and generic pregabalin extended‑release were added to the policy in 2021 with a generic‑first requirement; in 2022 prior authorization was removed for generic pregabalin and generic pregabalin extended‑release (these generics are no longer on the PA list). Coverage and PA requirements for branded pregabalin formulations (Lyrica, Lyrica CR) were updated to require prior trials of the generic pregabalin or pregabalin ER before authorizing brand.

Coding, Approval Length, and Dosing Notes

Medical benefit HCPCS for QutenzaHCPCSCovered

J7336

Capsaicin 8% patch (Qutenza), per sq cm

Length of approval

Initial approval lengthInitial authorizations may be approved up to 12 months.

Re-authorization lengthRe-authorizations may be approved up to 12 months if drug-specific criteria are met and chart notes show continued positive clinical response.

Non-formulary exceptionNon-formulary exception reviews may be approved for up to 12 months.

Responder thresholds and dosing

Responder definitionResponders commonly defined as ≥30% reduction in pain from baseline in clinical trials.

Duloxetine dosingDuloxetine studied for DPN at 60–120 mg once daily; 60 mg commonly provides benefit with no clear added benefit >60 mg.

Re-authorization and Continuation Rules

Re-authorization

Re-authorization requirements: May be approved up to 12 months if drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response to therapy.

Length of approval and re-authorization guidance per policy.

Benefit Assignment and Site of Care

Note

Qutenza = medical benefit; others = pharmacy benefit

Qutenza (capsaicin 8% patch) is managed under the medical benefit (administration billed on the medical benefit); all other drugs in this policy are managed under the pharmacy benefit.

Definitions and Trial/Responder Terms

Neuropathy / Neuropathic pain

DefinitionNeuropathy (neuropathic pain) = problems with one or more nerves causing abnormal sensations such as electric shock, burning, or knifing; may include dysesthesia and allodynia.

Common sensory descriptorsPatients often describe neuropathic pain as electric shock, burning, knifing, coldness, pins and needles, numbness, or itching.

Allodynia and dysesthesiaNeuropathic pain may include dysesthesia (abnormal sensations without stimuli) and allodynia (painful response to normally nonpainful stimuli, e.g., clothing touching skin).

Responder (in trials)

Common responder thresholdClinical trials often define a responder as an individual achieving ≥30% reduction in baseline pain (example: pregabalin trials used ≥30%).

Duloxetine responder endpoint

Background and Clinical Context

Neuropathy, fibromyalgia, and seizure disorders are distinct clinical entities addressed by this policy. Neuropathic pain arises from nerve dysfunction and includes conditions such as postherpetic neuralgia and diabetic peripheral neuropathy; fibromyalgia is a chronic centralized pain disorder; seizure disorders reflect abnormal brain electrical activity. This policy aligns available pharmacologic options (anticonvulsants, SNRIs, topical capsaicin, and selected analgesics) with the evidence base and agent‑specific indications to guide coverage decisions.

Policy Revision History and Material Changes

2024-07-04added

Added coverage criteria for Qutenza (capsaicin) for treatment of postherpetic neuralgia and diabetic peripheral neuropathy; effective July 4, 2024.

2022removed

Removed generic pregabalin and generic pregabalin extended-release from prior authorization requirements (prior authorization no longer required for these generics).

2021revisedLatest

OpenPayer

Pharmacologic Treatment of Neuropathy; Fibromyalgia, and Seizure Disorders (Pharmacy Medical Policy)

Coverage Criteria for Listed Agents

Initial and First-line Therapy Requirements

Step Therapy and Required Trials

Provider Actions, Prior Authorization, and Documentation

Coding, Approval Length, and Dosing Notes

Re-authorization and Continuation Rules

Benefit Assignment and Site of Care

Definitions and Trial/Responder Terms

Background and Clinical Context

Policy Revision History and Material Changes