CurrentUnitedHealthcarePolicy N/A

Tonmya (cyclobenzaprine sublingual) prior authorization for fibromyalgia

Defines medical necessity and prior authorization requirements for Tonmya (cyclobenzaprine sublingual tablet) for treatment of fibromyalgia in adults; applies to UnitedHealthcare benefit plans subject to state mandates and member-specific coverage.

Policy Summary

PayerUnitedHealthcare

PolicyTonmya (cyclobenzaprine sublingual) prior authorization for fibromyalgia

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of fibromyalgia meeting ACR criteria, records of nonpharmacologic measures, failure/intolerance to generic cyclobenzaprine, and failure/contraindication/intolerance to two listed alternatives.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Tonmya (cyclobenzaprine sublingual tablet) for fibromyalgia.

12 monthsauthorization duration

2required failed alternatives (minimum)

3 monthsminimum symptom duration for diagnosis

WPI ≥7 & SSS ≥5 or WPI ≥4 & SSS ≥9diagnostic thresholds (ACR)

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Coverage Criteria for Tonmya (cyclobenzaprine sublingual)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization for Tonmya: 1) Diagnosis of fibromyalgia.

Fibromyalgia meets ACR diagnostic criteria: 2) Fibromyalgia diagnosed based on American College of Rheumatology criteria: generalized pain in ≥4 of 5 regions; symptoms present at a similar level for ≥3 months; diagnosis valid irrespective of other diagnoses and does not exclude other clinically important illnesses; and meeting one of the WPI/SSS thresholds (WPI ≥ 7 and SSS ≥ 5 OR WPI ≥ 4 and SSS ≥ 9).

Nonpharmacologic measures implemented: 3) Patient has implemented all of the following nonpharmacologic measures: patient education (e.g., sleep hygiene); physical activity and exercise; and cognitive therapy (e.g., meditation/relaxation, cognitive-behavioral therapy, mindfulness-based stress reduction).

Documentation of prior cyclobenzaprine: 4) Submission of medical records (e.g., chart notes) documenting failure or intolerance to cyclobenzaprine (generic Flexeril) that could not be resolved with attempts to minimize adverse effects (e.g., dose reduction).

Must document in medical record

Required failed alternatives: 5) History of failure, contraindication, or intolerance to two of the following: amitriptyline, duloxetine, gabapentin, pregabalin, or Savella.

Document trials, reasons for discontinuation, or contraindications

Continuation Therapy / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization for Tonmya: 1) Documentation of a reduction in pain intensity with Tonmya use.

Authorization will be issued for 12 months

Coverage may be modified by state mandates and the member’s specific benefit plan; any applicable federal regulatory requirements also apply. Other UnitedHealthcare policies and utilization management programs may affect coverage determination for Tonmya.

Use of Tonmya is not supported if documentation does not include the required diagnostic criteria, treatment history, nonpharmacologic measures, or required medical records. Specifically, initial approval requires a diagnosis of fibromyalgia meeting the American College of Rheumatology criteria, documentation that the patient has implemented nonpharmacologic measures (education, physical activity/exercise, and cognitive therapy), submission of medical records showing failure or intolerance to generic cyclobenzaprine that could not be resolved with measures such as dose reduction, and a history of failure, contraindication, or intolerance to two of the listed alternatives (amitriptyline, duloxetine, gabapentin, pregabalin, or Savella).

Coding and Diagnostic Thresholds

No specific CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

Symptom duration and diagnostic thresholds

Minimum symptom durationSymptoms present at a similar level for at least 3 months

WPI/SSS threshold option 1WPI ≥ 7 AND SSS ≥ 5

WPI/SSS threshold option 2WPI ≥ 4 AND SSS ≥ 9

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tonmya (initial and reauthorization). Initial approval requires documentation of fibromyalgia per American College of Rheumatology (ACR) criteria, implementation of nonpharmacologic measures, submission of medical records showing failure or intolerance to cyclobenzaprine, and history of failure, contraindication, or intolerance to two listed agents.

Initial authorization requires: ACR fibromyalgia criteria documentation; nonpharmacologic measures attempted; medical records documenting failure/intolerance to cyclobenzaprine; and failure/contraindication/intolerance to two agents from the required list.
Authorization duration: 12 months (reauthorization requires documentation of pain reduction with Tonmya).

Step Therapy

Step Therapy / Prior Failures Required

Requires prior failure, contraindication, or intolerance to two of the following therapies before Tonmya will be approved.

Amitriptyline (generic Elavil)

Initial Therapy Criteria

Initial Therapy — Initial coverage criteria (duplicate/alternate placement for clarity)

Covered when ALL of the following are met

Initial Authorization for Tonmya: 1) Diagnosis of fibromyalgia.

Continuation / Reauthorization Criteria

Reauthorization — Reauthorization requirements

Reauthorization requirements

Reauthorization: 1) Documentation of a reduction in pain intensity with Tonmya use.

Approvals issued for 12 months

Step Therapy Requirements

Required step therapy alternatives (must have tried and failed, or have contraindication/intolerance to)	Coverage requirement
amitriptyline (generic Elavil)	Must have failure, contraindication, or intolerance to two of the listed alternatives prior to Tonmya
duloxetine (generic Cymbalta)
gabapentin (generic Neurontin)
pregabalin (generic Lyrica)
Savella

Background

Tonmya (cyclobenzaprine sublingual tablet) is approved for the treatment of fibromyalgia in adults. Fibromyalgia diagnosis for coverage purposes must meet the American College of Rheumatology diagnostic criteria, which include generalized pain in ≥4 of 5 regions and symptoms present for at least 3 months, with required threshold scores on the Widespread Pain Index and Symptom Severity Scale.

Definitions

Fibromyalgia (ACR diagnostic criteria)

Generalized pain requirementGeneralized pain defined as pain in at least 4 of 5 regions

Symptom durationSymptoms present at a similar level for at least 3 months

ACR scoring thresholdsMeets one of: WPI ≥ 7 and SSS ≥ 5 OR WPI ≥ 4 and SSS ≥ 9

Diagnosis considerationsDiagnosis valid irrespective of other diagnoses and does not exclude other clinically important illnesses