CurrentCignaPolicy IP0703

Sofdra

Defines prior authorization and medical necessity criteria for coverage of Sofdra (sofpironium 12.45% topical gel) for treatment of primary axillary hyperhidrosis in Cigna-administered plans; affects prescribers, providers, and pharmacy/utilization review for Cigna members.

Policy Summary

PayerCigna

PolicySofdra

Policy CodePolicy IP0703

Change TypeNew policyannual review

Effective Date7/15/2025

Next Review Date

Key ActionObtain prior authorization and submit documentation showing age ≥9, primary axillary hyperhidrosis, exclusion of secondary causes, trial or intolerance to prescription-strength aluminum chloride topical antiperspirant, and preferred product criteria.

SourceLink

POLICY UPDATE CHANGES

New policy created for Sofdra (sofpironium 12.45% topical gel).

Annual revision performed with no criteria changes noted.

≥9min age (years)

1 yearinitial auth

12.45%concentration

2 pumps/dayapplication

Coverage Criteria for Sofdra (sofpironium topical gel)

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FDA-Approved Indication (Initial Authorization)

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

FDA-Approved Indication: A) Patient is ≥ 9 years of age; AND B) Hyperhidrosis is significantly interfering with the ability to perform age-appropriate activities of daily living; AND C) The prescriber has excluded secondary causes of hyperhidrosis; AND D) Patient meets ONE of the following (i or ii): i. Patient has tried one prescription strength aluminum chloride-containing topical antiperspirant for at least 4 weeks and experienced inadequate efficacy (examples include Xerac AC [aluminum chloride 6.25% topical solution], Drysol [aluminum chloride 20% topical solution]); OR ii. According to the prescriber, the patient has experienced significant intolerance with an aluminum-containing topical antiperspirant; AND E) Preferred product criteria is met for the product(s) as listed in the below table(s).

Authorization duration = 1 year when criteria met

Sofdra (sofpironium 12.45% topical gel) is considered not medically necessary for any use other than treatment of primary axillary hyperhidrosis. The product is not intended for application to areas other than the axillae.

Concurrent use of Sofdra with Qbrexza (glycopyrronium 2.4% cloth) is not covered. The safety and efficacy of using Sofdra and Qbrexza together have not been established, and such combination therapy is therefore excluded from coverage.

Use of Sofdra for forms of hyperhidrosis other than primary axillary is not medically necessary and excluded from coverage. Sofdra should be applied only to the axillae when used for the covered indication.

Initial Therapy Criteria

Initial therapy criteria

Initial authorization criteria

Initial authorization: See FDA-Approved Indication criteria: age ≥9, hyperhidrosis significantly interferes with age-appropriate activities of daily living, prescriber has excluded secondary causes, patient has tried a prescription-strength aluminum chloride topical antiperspirant for at least 4 weeks with inadequate efficacy OR has documented significant intolerance to such a product, AND preferred product criteria is met.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Sofdra. Approvals are provided for 1 year when the FDA‑approved indication criteria are met (patient ≥9 years old, hyperhidrosis significantly interferes with age‑appropriate activities, secondary causes excluded, and required trial or intolerance of prescription aluminum chloride antiperspirant).

Approve for 1 year when ALL FDA‑approved indication criteria are met (see policy criteria).
Receipt of sample product does not satisfy criteria requirements for coverage.

Step Therapy

Formulary Step for Employer Plans

Employer plans may require a formulary step before coverage of Sofdra. For Standard/Value/Legacy Drug Plans, the prescriber must document that the patient tried and had inadequate efficacy or significant intolerance with Qbrexza (topical glycopyrronium) prior to Sofdra; Qbrexza may itself require prior authorization per the employer plan.

Affected product: Sofdra (sofpironium 12.45% topical gel).
Required step: Trial and inadequate efficacy OR significant intolerance with Qbrexza, per prescriber documentation.
Note: Qbrexza may require prior authorization under some employer plans.

Documentation Required

Required Documentation for Prior Authorization

Requests for prior authorization must include documentation supporting the diagnosis, age, exclusion of secondary causes, prior treatment attempts or intolerance (including details of trial duration and outcome), and the prescriber's rationale when applicable.

Documentation should confirm patient is ≥9 years of age and that hyperhidrosis significantly interferes with age‑appropriate activities of daily living.
If relying on trial of prescription aluminum chloride antiperspirant, include product name, strength, duration (≥4 weeks), and outcome; if documenting intolerance, include clinical details.
If step therapy with Qbrexza is required, include documentation of inadequate efficacy or significant intolerance to Qbrexza.

Denial Risk

Coding / Claims Denial Risk

Claims submitted without covered diagnosis or procedure codes as required by the Coverage Policy will be denied as not covered.

When billing, providers must use the most appropriate codes as of the date of service.
Services billed for conditions or diagnoses not covered under this Coverage Policy will be denied.

Definitions and Background

Primary axillary hyperhidrosis definition

DefinitionFocal excessive sweating affecting the axillae that is not caused by an underlying secondary condition and that significantly interferes with age-appropriate activities of daily living.

Common first-line therapy contextTopical antiperspirant therapy (aluminum and zirconium salts) is considered first-line treatment; aluminum chloride hexahydrate 20% topical solution is commonly prescribed.

Sofdra application noteSofdra is applied topically to the underarm areas once daily at bedtime (2 pumps/day) and is not intended for use on other body areas.

First-line therapy

Standard first-line therapyTopical antiperspirant therapy (aluminum and zirconium salts)

Commonly prescribed agentAluminum chloride hexahydrate 20% topical solution

Role in treatment algorithmConsidered first-line; topical anticholinergics (e.g., Sofdra, Qbrexza) and botulinum toxin A are second-line options

Sofdra (sofpironium topical gel) is a topical anticholinergic indicated for treatment of primary axillary hyperhidrosis. This policy limits coverage to the axillary application and excludes other anatomic uses. Concurrent administration with other topical anticholinergic products such as Qbrexza (glycopyrronium 2.4% cloth) is not covered because combined safety and efficacy have not been demonstrated.

Step Therapy Requirements

Step	Requirement	Employer plan variances
Trial of prescription-strength aluminum chloride-containing topical antiperspirant for at least 4 weeks	Patient experienced inadequate efficacy after the trial
Or documented significant intolerance to a prescription-strength aluminum chloride-containing topical antiperspirant (per prescriber)	Documentation of intolerance must be provided with the prior authorization request
Employer plans may require trial and inadequate efficacy or significant intolerance with Qbrexza (glycopyrronium 2.4% cloth) prior to Sofdra for Standard/Value/Legacy drug plan tiers	This requirement applies to certain employer-sponsored formularies and may necessitate prior authorization for Sofdra	Receipt of sample product does not satisfy any criteria requirements for coverage