Pharmacy Prior Authorization Criteria

Filsuvez (birch triterpenes) - PA, NF, QL

Indications for Prior Authorization

FILSUVEZ (birch triterpenes) topical gel

• For diagnosis of Wounds Associated with Dystrophic and Junctional Epidermolysis Bullosa
  Indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.

Criteria

Filsuvez

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [A,1]

• Diagnosis of one of the following:
• Dystrophic epidermolysis bullosa (DEB)
• Junctional epidermolysis bullosa (JEB)
AND
• Disease is confirmed by one of the following: [4-6, 10]
• 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 that require healing
AND
• Target wound(s) meets all of the following: [B, 1, 7]
• Present for at least 21 days
• No signs of infection
• No evidence or history of basal or squamous cell carcinoma
AND
• Patient does not have history of stem cell transplant [7]
AND
• Medication is not being used concurrently with other FDA approved therapies (e.g.,Vyjuvek) on the same target wound for the treatment of 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

Filsuvez

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by wound healing (e.g., reduction in number or size of wounds) [C, 1]
AND
• Wound(s) being treated continues to meet both of the following:
• No signs of infection
• No evidence or history of basal or squamous cell carcinoma
AND
• Medication is not being used concurrently with other FDA approved therapies (e.g.,Vyjuvek) on the same target wound for the treatment of epidermolysis bullosa
AND
• Prescribed by or in consultation with a specialist with expertise in wound care

Filsuvez

Non Formulary

Length of Approval: 3 months [A,1]

• Diagnosis of one of the following:
• Dystrophic epidermolysis bullosa (DEB)
• Junctional epidermolysis bullosa (JEB)
AND
• Submission of medical records (e.g., chart notes) documenting that disease is confirmed by one of the following: [4-6, 10]
• 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 that require healing
AND
• Target wound(s) meets all of the following: [B, 1, 7]
• Present for at least 21 days
• No signs of infection
• No evidence or history of basal or squamous cell carcinoma
AND
• Patient does not have history of stem cell transplant [7]
AND
• Medication is not being used concurrently with other FDA approved therapies (e.g.,Vyjuvek) on the same target wound for the treatment of epidermolysis bullosa
AND
• Submission of medical records (e.g., chart notes) confirming that 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

Filsuvez

*Clinician to confirm requested quantity is appropriate based on total BSA provided and frequency of administration (one tube covers up to 0.025m^2 surface area. A tube of Filsuvez is for one-time use and should be discarded once opened)

Quantity Limit Override

Length of Approval: 12 Month(s)

• Quantity limit restriction has been deemed insufficient in the treatment of the member's disease or medical condition
AND
• Submission of medical records (e.g., chart notes) documenting both of the following: [D]
• Patient total body surface area (m^2) to be treated
• Frequency of wound dressing changes
AND
• Requested quantity does not exceed one tube per 0.025m^2 surface area being treated*
AND
• Prescribed by or in consultation with a specialist with expertise in wound care

P & T Revisions

2024-09-05, 2024-07-31, 2024-07-18, 2024-05-17, 2024-04-11

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.
12. Filsuvez Prescription Form. Available at: https://resources.chiesiusa.com/Filsuvez/Filsuvez_Prescription_Form.pdf, Accessed July 24, 2024.

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End Notes

1. 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. [1]
2. If a Filsuvez- treated wound becomes infected, discontinue treatment to that wound until the infection has resolved. [1]
3. Apply Filsuvez to cleansed wounds with wound dressing changes until the wound is healed. [1]
4. One tube of FILSUVEZ covers up to 250 cm^2 surface area. A tube of Filsuvez is for one-time use and should be discarded once opened [1, 12]

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Revision History

• 2024-09-05: update guideline
• 2024-07-31: update guideline
• 2024-07-18: update guideline
• 2024-05-17: update guideline
• 2024-04-11: New UM PA program

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