CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Lyrica CR (pregabalin ER)

Defines step therapy requirements for coverage of Lyrica CR (pregabalin ER) tablets for members covered under the payer's pharmacy clinical programs; applies to providers requesting authorization for this medication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Lyrica CR (pregabalin ER)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization and document diagnosis, dates and reasons for required prior medication trials to meet step therapy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

2 alternativesprior medication trials

requiredpregabalin IR trial

typically excludedcoverage stance

2025-07-01effective

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Initial Therapy — Neuropathic pain

Covered when ALL of the following are met for neuropathic pain:

Neuropathic pain criteria: Diagnosis of neuropathic pain and history of failure, contraindication, or intolerance to two of the following medications (document date of trial and drug name): (1) gabapentin; (2) one SNRI (e.g., duloxetine); (3) one tricyclic antidepressant (e.g., amitriptyline).two agents

Document dates and reasons for trials/failures

Pregabalin IR requirement: History of failure, contraindication, or intolerance to pregabalin (generic Lyrica) immediate release capsules or solution (document date of trial and reason for failure).pregabalin IR failed

Document date and reason

Initial Therapy — Other diagnoses

Covered when ALL of the following are met for diagnoses other than neuropathic pain:

Other diagnoses criteria: History of failure, contraindication, or intolerance to BOTH of the following (document the diagnosis and date of trial): a. gabapentin; b. pregabalin immediate release capsules or solution.both agents

Any diagnosis associated with nerve pain should be reviewed as neuropathic pain

Lyrica CR (pregabalin ER) is typically excluded from coverage. The formulation is not FDA‑approved for some indications and the payer requires meeting specific step therapy criteria and prior authorization before any approval is considered. Prior authorization is issued for 12 months when criteria are met; state mandates, federal requirements, and the member’s benefit plan may affect coverage.

Requests that do not document the required prior medication trials, dates, and reasons for failure, contraindication, or intolerance may be denied. For neuropathic pain this includes documentation of trials of alternative agents and immediate‑release pregabalin as specified in the coverage criteria.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be issued for 12 months when step therapy criteria are met. State mandates and member-specific benefit plans may affect coverage. Lyrica CR is typically excluded from coverage.

Authorization duration: 12 months
Lyrica CR typically excluded

Step Therapy

Step Therapy Requirements

Step therapy requirements described below must be met prior to coverage. For neuropathic pain: both of the following must be documented — (a) diagnosis of neuropathic pain and history of failure, contraindication, or intolerance to two of: gabapentin; one SNRI (e.g., duloxetine); one TCA (e.g., amitriptyline); AND (b) history of failure, contraindication, or intolerance to pregabalin (immediate release) with dates and reasons. Alternatively, for other diagnoses associated with nerve pain, there must be documented failure, contraindication, or intolerance to BOTH gabapentin and pregabalin (immediate release).

Neuropathic pain pathway: document two prior agents + pregabalin trial (dates and reasons)
Other nerve pain diagnoses: document trials of gabapentin and pregabalin (dates and reasons)

Documentation Required

Document the diagnosis, dates of trials, drug names, and reasons for failure, contraindication, or intolerance for each prior medication trial. Include specific dates and clinical rationale for why prior agents were ineffective or not tolerated.

Required documentation: diagnosis, drug names, dates of trials, and reason for failure/contraindication/intolerance

Denial Risk

Prior Therapy Not Met — Risk of Denial

Requests may be denied if the member does not have documented trials (with dates and reasons) of the required prior agents. Ensure complete documentation for each required prior therapy before submission to avoid denial.

Denial risk: missing documented prior trials, dates, or reasons

Required Prior Trials Before Coverage

Step	Prior trial(s) required	Notes
{"text":"1","status":""},{"text":"Diagnosis of neuropathic pain AND documented failure, contraindication, or intolerance to two of the following: (1) gabapentin; (2) one SNRI (e.g., duloxetine); (3) one tricyclic antidepressant (e.g., amitriptyline)","status":""},{"text":"Document date of trial and drug name for each agent; requirement applies when treating neuropathic pain","status":""}
{"text":"2","status":""},{"text":"History of failure, contraindication, or intolerance to pregabalin immediate‑release (Lyrica) capsules or solution","status":""},{"text":"Document date of trial and reason for failure","status":""}
{"text":"Alternative pathway (non‑neuropathic diagnoses)","status":""},{"text":"Documented failure, contraindication, or intolerance to BOTH gabapentin AND pregabalin immediate‑release","status":""},{"text":"Any diagnosis associated with nerve pain should be reviewed as neuropathic pain; document diagnosis and date of trial","status":""}

Drug Definition and Background

Lyrica CR — Key facts

Generic namepregabalin (extended‑release, Lyrica CR)

Brand nameLyrica CR

FDA‑approved indicationsNeuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia

Not FDA‑approved forPartial onset seizures and fibromyalgia (clinical trials failed to demonstrate efficacy)

Drug classAnticonvulsants / neuropathic pain agents

Lyrica CR (pregabalin ER) tablets are FDA approved for neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Clinical trials did not demonstrate efficacy for partial onset seizures or fibromyalgia, and those uses are not FDA‑approved.

Clinical guidance recognizes anticonvulsant agents such as gabapentin and pregabalin for certain neuropathic pain conditions (for example, chemotherapy‑induced peripheral neuropathy per NCCN), but FDA‑approved indications for Lyrica CR are limited to the neuropathic pain conditions noted above.