ModifiedCignaPolicy IP0588

Botulinum Toxins - Daxxify

Defines Cigna's coverage policy, prior authorization expectations, clinical criteria, dosing limits, excluded indications, and coding for Daxxify (daxibotulinumtoxinA) under medical benefit plans.

Policy Summary

PayerCigna

PolicyBotulinum Toxins - Daxxify

Policy CodePolicy IP0588

Change TypeRevised dosing, criteria, title, coding

Effective DateJul 15, 2025

Next Review Date

Key ActionPrior Authorization is recommended; ensure documentation supports diagnosis and physical findings and that Daxxify is prescribed by or in consultation with an appropriate specialist.

POLICY UPDATE CHANGES

Policy title updated from 'DaxibotulinumtoxinA-lanm' to 'Botulinum Toxins - Daxxify'.

Cervical dystonia criteria updated to require patient is at least 18 years of age, documentation for diagnosis, documentation of head torsion with limited range of motion, and specialist requirement.

Dosing updated from maximum 300 units to maximum 250 units, administered not more frequently than once every 3 months.

Conditions Not Covered section updated to only include cosmetic uses.

CPT code 64616 added to coding information.

1Covered Indications (FDA-approved)

250Max dose (per administration)

3 monthsMin interval

Cosmetic usesNot covered examples

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines Cigna's coverage policy, prior authorization expectations, clinical criteria, dosing limits, excluded indications, and coding for Daxxify (daxibotulinumtoxinA) under medical benefit plans. Subject: Daxxify (daxibotulinumtoxinA) for cervical dystonia. Effective date: 2025-07-15. Last review: 2025-07-15. Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Key thresholds and policy dates

Policy numberIP0588

StatusMODIFIED

Policy effective date2025-07-15

Last review date2025-07-15

Age threshold>= 18 years

Maximum dose per administration250 units

Minimum interval between administrations>= 3 months

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication: Cervical Dystonia

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has a diagnosis of cervical dystonia
[documentation required]
C: Patient has sustained head torsion and/or tilt with limited range of motion in the neck
[documentation required]

Continuation Therapy Criteria

Continuation/authorization duration: Approvals are provided for 1 year when criteria are met. Prior Authorization is recommended for prescription benefit coverage; all approvals are provided for the duration noted (approvals noted in policy as 1 year).

Continuation / operational points

Approval duration (operational)1 year

Operational reminder - minimum dosing interval>= 3 months (not more frequently than once every 3 months)

Conditions Not Covered / Exclusions

Conditions Not Covered

Daxxify for any other use is considered not medically necessary, including but not limited to:

ANY of the following

Cosmetic uses (examples: facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platysmal bands, rejuvenation of the periorbital region)

Daxxify for any other use is considered not medically necessary, including but not limited to cosmetic uses (examples: facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platysmal bands, rejuvenation of the periorbital region).

Applicable Codes

Covered CPTCPTCovered

64616

Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis)

Covered J-code for drugHCPCSCovered

J0589

Injection, daxibotulinumtoxina-lanm, 1 unit

Provider Actions / Authorization & Documentation

Prior Authorization

Prior authorization recommended

Prior Authorization is recommended for prescription benefit coverage of Daxxify. Approvals are provided for the durations noted in the policy and require appropriate prescriber expertise or consultation.

Documentation Required

Documentation required for diagnosis and physical findings

Documentation must support the diagnosis of cervical dystonia and the physical finding of sustained head torsion and/or tilt with limited neck range of motion. Acceptable documentation includes chart notes, tests, claims records, and other relevant information. Receipt of sample product does not satisfy documentation requirements.

Clinical Evidence & References

Prescribing information reference: Daxxify injection [prescribing information], Revance; January 2024. Background indication: Daxxify (daxibotulinumtoxinA-lanm) is indicated for cervical dystonia in adults.

Background and Definitions

Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for cervical dystonia in adults. Coverage decisions consider the terms of the applicable benefit plan, any applicable laws and regulations, and required clinical documentation; approvals require appropriate documentation and specialist prescribing or consultation.

Term	Definition
Cervical dystonia	Also known as spasmodic torticollis.

Revision History

7/15/2025title_changeLatest

Policy title updated from 'DaxibotulinumtoxinA-lanm' to 'Botulinum Toxins - Daxxify'.

7/15/2025criteria_revisionLatest

Cervical dystonia criteria updated to require patient is ≥ 18 years of age, documentation of diagnosis, documentation of sustained head torsion and/or tilt with limited neck range of motion, and that Daxxify be prescribed by or in consultation with a pain medicine specialist, neurologist, or physical medicine and rehabilitation physician.

7/15/2025

Policy Summary

PayerCigna

PolicyBotulinum Toxins - Daxxify

Policy CodePolicy IP0588

Change TypeRevised dosing, criteria, title, coding

Effective DateJul 15, 2025

Next Review Date

Key ActionPrior Authorization is recommended; ensure documentation supports diagnosis and physical findings and that Daxxify is prescribed by or in consultation with an appropriate specialist.

On This Page

D: Prescribed by or in consultation with a pain medicine specialist, neurologist, or physical medicine and rehabilitation physician

Dosing and Frequency

Coverage dosing limits and frequency:

ALL of the following

Approve up to a maximum dose of 250 units250 units
Administration not more frequently than once every 3 months>= 3 months

Documentation Required

Specialist prescribing or consultation required

Daxxify must be prescribed by or in consultation with a pain medicine specialist, neurologist, or physical medicine and rehabilitation physician. Documentation of the specialist prescriber or consultation should be included in the medical record.

Billing Rule

Use appropriate codes

When billing for Daxxify, providers must use the most appropriate codes as of the effective date. Claims submitted without covered code(s) under this policy will be denied as not covered.

64616
J0589

Denial Risk

Use for non-covered indications

Use of Daxxify for indications other than cervical dystonia (including cosmetic uses) is considered not medically necessary and may be denied.

Dosing updated: maximum dose per administration reduced from 300 units to 250 units; administration not more frequently than once every 3 months.

7/15/2025coverage_exclusion_updateLatest

Conditions Not Covered section updated to specify that Daxxify for other uses is not medically necessary, with cosmetic uses listed as excluded.

7/15/2025coding_addedLatest

CPT code 64616 added to coding information; J0589 listed as the HCPCS drug code for daxibotulinumtoxinA (1 unit).