WHA

SOFDRA (sofpironium)

Self-Administration-topical gel

Diagnosis considered for coverage:

Primary axillary hyperhidrosis: Indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

Coverage Criteria:

For diagnosis of primary axillary hyperhidrosis:

  • Diagnosis of primary axillary hyperhidrosis; AND

  • Patient has experienced symptoms of disease for a duration of at least 6 months; AND

  • Patient is 9 years of age or older; AND

  • Provider attests other causes of axillary hyperhidrosis have been ruled out (e.g., menopause, medications); AND

  • Disease frequently interferes with daily activities (e.g., lower productivity at work, lower psychosocial wellbeing); AND

  • Trial and failure (minimum 6 weeks supply), contraindication, or intolerance to BOTH of the following: 

    • A topical prescription strength drying agent [e.g., Drysol, Xerac AC (aluminum chloride hexahydrate)] 

    • Qbrexza; AND

  • Prescribed by or in consultation with a dermatologist 

Reauthorization Criteria:

For diagnosis of primary axillary hyperhidrosis:

  • Patient demonstrates positive clinical response to therapy (e.g., improvement in productivity, improvement in psychosocial wellbeing)

Coverage Duration:
  • Initial: 6 weeks
  • Reauthorization: 6 months
Dosing:

For diagnosis of primary axillary hyperhidrosis:

  • Apply 1 pump of SOFDRA per underarm once a day at bedtime. 

  • Allow to dry completely (5 minutes) before putting on clothing.

  • Do not shower or wash underarms for at least 8 hours after application.

Authorization is not covered for the following:

  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

  • Hyperhidrosis Disease Severity Scale • The HDSS is a 4-point scale designed to assess the severity of hyperhidrosis in everyday clinical practice or in clinical research and the effectiveness of treatment. • The HDSS can be administered by an interviewer or self-completed by the patient. • The HDSS assess disease severity based on the extent of sweating-related impairment of daily activities 1) Question - My (underarm) sweating is never noticeable and never interferes with my daily activities, Score - 1; (2) Question - My (underarm) sweating is tolerable but sometimes interferes with my daily activities, Score - 2; (3) Question - My (underarm) sweating is barely tolerable and frequently interferes with my daily activities, Score - 3; (4) Question - My (underarm) sweating is intolerable and always interferes with my daily activities, Score – 4 The safety and effectiveness of Botox for hyperhidrosis in areas other than the axillae have not been established. 

  • Consult | 6 week trial of alternatives is sufficient. Examples of positive clinical response to therapy: patient reports fewer clothing changes or a positive impact on daily life or improvement in psychosocial well-being. 

  • Contraindications include medical conditions that can be exacerbated by the anticholinergic effect of SOFDRA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren’s syndrome). 

Policy Updates:

  • 12/01/2024 – New policy for Sofdra approved by WHA P&T Committee. (P&T, 11/21/2024)

References:
  1. Sofdra Prescribing Information. Botanix SB Inc., Wayne, PA . June 2024. 

 

Last review date: December 1, 2024