CurrentCignaPolicy IP0795

Neurology – Tonmya - (IP0795)

Policy Summary

PayerCigna

PolicyNeurology – Tonmya - (IP0795)

Policy CodePolicy IP0795

Change TypeNew policy

Effective DateApr 15, 2026

Next Review Date

Key ActionPrior Authorization is required for Tonmya; approvals provided for 1 year when criteria are met and prescriber must document prior trials or positive response for continuation.

SourceLink

POLICY UPDATE CHANGES

New policy effective 04/15/2026 establishing coverage and step therapy for Tonmya.

1Covered Indication (fibromyalgia)

3Required prior therapies (duloxetine or milnacipran, plus pregabalin)

1Approval duration (years)

Coverage Summary & Scope

Prior authorization and step therapy requirements for Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for treatment of fibromyalgia in adults under Cigna benefit plans. Approvals are provided for 1 year. Coverage is for the FDA-approved indication of fibromyalgia in adults. Initial approval is granted when the patient meets the step therapy criteria (trial and inadequate efficacy or intolerance with one agent from duloxetine or milnacipran AND pregabalin) or for patients continuing therapy who have a documented positive response. Tonmya is considered not medically necessary for any other use.

Initial and Continuation Therapy Criteria

FDA-Approved Indication

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial therapy

i: Patient is ≥ 18 years of age and < 65 years of ageAge >= 18 and < 65 years
Age requirement
ii
- a: Duloxetine capsules (Cymbalta, generic)
- b: Savella (milnacipran tablets) [may require prior authorization]
iii: Patient has tried, and, according to the prescriber, has experienced inadequate efficacy or significant intolerance with pregabalin capsule or oral solution (Lyrica, generic)

B) Continuation therapy: Patient is continuing therapy with Tonmya. Approve if according to the prescriber, the patient is having a positive response to Tonmya therapy.

Conditions Not Covered

Not Medically Necessary: Tonmya for any other use is considered not medically necessary.

Prior Authorization, Step Therapy & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Tonmya; approvals provided for 1 year when criteria met.

Step Therapy

Step Therapy Requirements

Before approval of Tonmya (Step 2), patient must have tried one agent from duloxetine or milnacipran AND pregabalin (Step 1) with inadequate efficacy or significant intolerance per prescriber, except for patients continuing Tonmya with documented positive response.

Documentation Required

Prescriber Attestation of Prior Trials/Response

Prescriber must document that prior therapies (duloxetine or milnacipran, and pregabalin) were tried and resulted in inadequate efficacy or significant intolerance, or document positive response for continuation.

Background and Evidence

Tonmya™ (cyclobenzaprine hydrochloride sublingual tablets) is a sublingual formulation of cyclobenzaprine and is indicated for the treatment of fibromyalgia in adults. Cigna’s policy requires a Step Therapy component: before approval of Tonmya (Step 2), patients should try one agent from duloxetine or milnacipran and pregabalin (Step 1) unless continuing Tonmya with documented positive response. Clinical guidelines referenced note a multimodal, individualized approach with non-pharmacologic interventions as first-line therapy and list duloxetine and pregabalin among recommended pharmacologic options.

Evidence sources include the FDA prescribing information: Tonmya prescribing information, September 2025. Guideline and other FDA‑approved therapy references (duloxetine, milnacipran, pregabalin) are noted in the background and references.