CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY

Cigna prior authorization policy governing coverage of Sofdra (sofpironium 12.45% topical gel) for treatment of primary axillary hyperhidrosis, including medical necessity criteria for approval, non-covered uses, and supportive guideline context.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision (No criteria changes)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document functional impact and exclusion of secondary causes, and document prior trial or intolerance to a prescription-strength aluminum chloride topical antiperspirant.

POLICY UPDATE CHANGES

Annual Revision, Review Date = 05/14/2025 with 'No criteria changes.'

1Covered Indication (Primary Axillary Hyperhidrosis)

2Not Covered Uses (Other sites, concurrent Qbrexza)

Coverage Summary

This policy governs prior authorization coverage of Sofdra (sofpironium 12.45% topical gel) for the FDA‑approved indication of primary axillary hyperhidrosis. The product is a topical anticholinergic approved for patients aged ≥ 9 years and is applied to each underarm once daily at bedtime. Coverage is approved with criteria (covered_with_criteria) for a duration of 1 year when the policy’s medical necessity requirements are met. Per the International Hyperhidrosis Society algorithm, topical antiperspirants (aluminum/zirconium salts) are considered first‑line therapy and Sofdra is positioned as a second‑line option after topical antiperspirants.

Medical Necessity Criteria

FDA-Approved Indication - Primary Axillary Hyperhidrosis (Approval for 1 year)

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

ALL of the following

Patient is ≥ 9 years of age>= 9 years
Hyperhidrosis is significantly interfering with the ability to perform age-appropriate activities of daily living
The prescriber has excluded secondary causes of hyperhidrosis
ONE of
- Patient has tried one prescription strength aluminum chloride-containing topical antiperspirant for at least 4 weeks and experienced inadequate efficacy>= 4 weeks
  Examples include aluminum chloride 20% topical solution (Drysol, generics)
- According to the prescriber, the patient has experienced significant intolerance with an aluminum-containing topical antiperspirant

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Evidence sources informing this policy include the Product Prescribing Information: Sofdra topical gel, 12.45% (Botanix), August 2024, and the International Hyperhidrosis Society primary axillary hyperhidrosis treatment algorithm (updated February 2025). The guideline context specifies that topical antiperspirants are first‑line and that Sofdra (along with Qbrexza and botulinum toxin A) is a second‑line treatment option.

Conditions Not Covered / Not Medically Necessary

Sofdra is considered not medically necessary for any other use(s) including but not limited to:

ANY of the following

Hyperhidrosis other than Primary Axillary (Sofdra is not intended for application to areas other than the axillae)
Concurrent use with Qbrexza (glycopyrronium 2.4% cloth) due to unestablished safety and efficacy

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Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Sofdra; approvals provided for 1 year when criteria are met.

Documentation Required

Document functional impact and exclusion of secondary causes

Provider must document that hyperhidrosis significantly interferes with age-appropriate activities of daily living and that secondary causes have been excluded.

Documentation Required

Document prior treatment or intolerance

Provider must document either a trial of a prescription-strength aluminum chloride topical antiperspirant for at least 4 weeks with inadequate efficacy, or significant intolerance to such an antiperspirant per prescriber.

Background

Background: Sofdra is a topical anticholinergic indicated for primary axillary hyperhidrosis in patients aged ≥ 9 years. It is applied using the single‑actuation pump to clean, dry underarm skin once daily at bedtime (two pumps total per day). Guideline placement: topical antiperspirants (aluminum/zirconium salts, typically aluminum chloride hexahydrate 20% solution) are first‑line, and Sofdra, Qbrexza (glycopyrronium 2.4% cloth), and botulinum toxin A injections are recommended as second‑line options per the International Hyperhidrosis Society algorithm.