FILSUVEZ (birch triterpenes gel)

FILSUVEZ (birch triterpenes gel)

Self-Administration – topical

Diagnosis considered for coverage:

• Diagnosis: Indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older

Coverage Criteria:

For diagnosis of epidermolysis bullosa:

• Diagnosis of one of the following:
  • Dystrophic epidermolysis bullosa (DEB)
  • Junctional epidermolysis bullosa (JEB), AND
• Disease is confirmed by one of the following:
  • Genetic testing confirms mutation in one of the following genes:
    • For Dystrophic epidermolysis bullosa (DEB), collagen type VII (COL7A1), OR
    • For Junctional epidermolysis bullosa (JEB), one of the following:
      • ITGA6
      • ITGB4
      • collagen type XVII (COL17A1)
      • LAMA3
      • LAMB3
      • LAMC2
      • ITGA3
      • LAMA3A, OR
  • Skin biopsy, AND
• Patient is 6 months of age or older, AND
• Medication is being used for the treatment of wounds, AND
• DEB or JEB associated wounds are present for at least 21 days, AND
• Patient does not have signs of infection for wound being treated, AND
• Patient has no evidence or history of basal or squamous cell carcinoma for wound being treated, AND
• Patient does not have history of stem cell transplant, AND
• Medication is not being used concurrently with other FDA approved therapies (e.g.,Vyjuvek) for the treatment epidermolysis bullosa, AND
• Standard wound care management not adequate in healing wounds (e.g., daily wound dressings, pain management, controlling infections), AND
• Prescribed by or in consultation with a specialist with expertise in wound care

Reauthorization Criteria:

For diagnosis of epidermolysis bullosa:

• Patient demonstrates positive clinical response to therapy as evidenced by wound is healing but not completely closed; AND
• Patient does not have signs of infection for wound being treated; AND
• Patient has no evidence or history of basal or squamous cell carcinoma for wound being treated; AND
• Prescribed by or in consultation with a specialist with expertise in wound care

Coverage Duration:

• Initial: 3 months
• Reauthorization: 6 months

Dosing:

For diagnosis of epidermolysis bullosa:

• Apply a 1 mm layer of Filsuvez to the affected wound surface only

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:

• Each tube of Filsuvez is for one-time use only. Once the tube is opened, use the product immediately
• Discard the tube after use in household trash or through a drug take back site, if available
• Subjects received topical treatment with either Filsuvez or a placebo gel on partial-thickness wounds every 1 to 4 days for a total of 90 days. Treated wounds were covered with non-adhesive dressings. Following completion of the double-blind phase, all subjects received FILSUVEZ for a total of 24 months during the open-label phase
• If a Filsuvez- treated wound becomes infected, discontinue treatment to that wound until the infection has resolved
• Apply Filsuvez to cleansed wounds with wound dressing changes until the wound is healed

Policy Updates:

• 9/1/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 8/20/2024) (P&T meeting date) 

References:

1. Filsuvez Prescribing Information. Lichtenheldt GmbH Pharmazeutische Fabrik. Wahlstedt Germany. December 2023.
2. Optum IPD Analytics. Available at: Dermatology: Epidermolysis Bullosa (ipdanalytics.com). Accessed March 25, 2024.
3. About EB. Available at: https://www.debra.org/about-eb. Accessed March 25, 2024.
4. Pfendner, E., and Lucky, A. Dystrophic Epidermolysis Bullosa. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1304/#:~:text=Dystrophic%20epidermolysis%20bullosa%20(DEB)%20is,dystrophic%20epidermolysis%20bullosa%20(DDEB). Accessed March 25, 2024.
5. Peraza, D. Epidermolysis Bullosa. Available at: https://www.merckmanuals.com/professional/dermatologic-disorders/bullous-diseases/epidermolysis-bullosa. Accessed March 25, 2024.
6. What is EB. Available at: https://www.debra-international.org/what-is-eb#:~:text=EB%20is%20a%20group%20of,with%20more%20than%2030%20subtypes. Accessed March 25, 2024.
7. ClinicalTrials.gov. Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE). Available at: https://www.clinicaltrials.gov/study/NCT03068780?cond=NCT03068780&rank=1#participation-criteria. Accessed March 25, 2024.
8. UptoDate. Diagnosis of epidermolysis bullosa. Available at: https://www.uptodate.com/contents/diagnosis-of-epidermolysis-bullosa. Accessed March 25, 2024.
9. UptoDate. Overview of the management of epidermolysis bullosa. Available at: https://www.uptodate.com/contents/overview-of-the-management-of-epidermolysis-bullosa?search=epidermolysis%20bullosa&source=search_result&selectedTitle=2%7E91&usage_type=default&display_rank=2. Accessed March 25, 2024.
10. UptoDate. Epidermolysis bullosa: Epidemiology, pathogenesis, classification, and clinical features. Available at: https://www.uptodate.com/contents/epidermolysis-bullosa-epidemiology-pathogenesis-classification-and-clinical-features?search=epidermolysis%20bullosa&source=search_result&selectedTitle=1%7E91&usage_type=default&display_rank=1. Accessed March 25, 2024.
11. Kern, J., Schwieger-Briel, A., Lowe, S., et al. Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560757/. Accessed March 26, 2024.