Filsuvez Medical Drug Criteria
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Medical policy outlining prior authorization criteria, coding, and coverage rules for Filsuvez topical gel for treatment of partial-thickness wounds in patients with inherited epidermolysis bullosa for Blue Cross Blue Shield of Kansas members.
Removed additional testing requirements of IFM or TEM and updated diagnosis and genetic testing requirements.
Added disallowance requirement for combination therapy on the same wound of gene therapy product.
Moved/indented FDA age requirements to bypass continuation of therapy and standardized formatting.
Added HCPCS code J3490 to coding section.
Coverage Criteria for Filsuvez (birch triterpenes) topical gel
Initial Therapy
Covered when ALL of the following are met
Initial Authorization
Agent eligibility
- Continuation of therapy option: The requested agent is eligible for continuation of therapy AND ONE of: the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed.
- New use option: ALL of the following: (1) ONE of: a) diagnosis of dystrophic or junctional epidermolysis bullosa confirmed by genetic testing (medical records required) OR b) another FDA-labeled indication for the requested agent; (2) If the patient has an FDA-approved indication, then ONE of: the patient's age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient's age for the requested indication; (3) the patient does NOT have current evidence or a history of squamous cell carcinoma on the area to be treated; (4) the patient does NOT have an active infection on the area to be treated.
- Prescriber requirement: Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient's diagnosis.
- Combination therapy restriction: The patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated.
- Contraindications: The patient does NOT have any FDA labeled contraindications to the requested agent.
- Authorization duration: Length of Approval: 4 months.
Renewal / Continued Therapy
Renewal approved when ALL of the following are met
Renewal Authorization
Agent eligibility
- Continuation of therapy option: The requested agent is eligible for continuation of therapy AND ONE of: the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed.
- New use option: ALL of the following: (1) ONE of: a) diagnosis of dystrophic or junctional epidermolysis bullosa confirmed by genetic testing (medical records required) OR b) another FDA-labeled indication for the requested agent; (2) If the patient has an FDA-approved indication, then ONE of: the patient's age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient's age for the requested indication; (3) the patient does NOT have current evidence or a history of squamous cell carcinoma on the area to be treated; (4) the patient does NOT have an active infection on the area to be treated.
- Prescriber requirement: Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient's diagnosis.
- Combination therapy restriction: The patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated.
- Contraindications: The patient does NOT have any FDA labeled contraindications to the requested agent.
- Authorization duration: Length of Approval: 4 months (note: later renewal section indicates 12 months when previously approved and clinical benefit demonstrated).
Renewal After Initial Approval (Clinical benefit)
Covered when ALL of the following are met
Renewal after prior approval
- Prior approval: The patient has been previously approved for the requested agent through the plan's prior authorization criteria.
- Clinical benefit: The patient has had clinical benefit with the requested agent.
- Safety checks: No current evidence or a history of squamous cell carcinoma on the area to be treated AND no active infection on the area to be treated.
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient's diagnosis.
- Combination therapy restriction: The patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated.
- Contraindications: The patient does NOT have any FDA labeled contraindications to the requested agent.
- Authorization duration: Length of Approval: 12 months.
Use of the requested agent in combination with a gene therapy agent on the same treated area is disallowed. This prohibition applies to both initial and renewal approvals and is an explicit requirement for coverage.
For continuation of therapy, documentation must show the patient was treated with the requested agent within the past 90 days. Samples are not approvable evidence of prior use and cannot be used to establish prior treatment for continuation requests.
Requests that do not meet the plan's stated initial or renewal criteria will be considered not medically necessary. Examples of unmet criteria that would render a request not medically necessary include: lack of required diagnostic confirmation (for new use, absence of genetic testing confirming dystrophic or junctional EB when required or no alternate FDA-labeled indication documented); presence or history of squamous cell carcinoma on the area to be treated; an active infection on the area to be treated; or failure to show that the prescriber is a specialist in the patient’s diagnosis or has consulted one.
Other situations that may make a request not medically necessary include use of samples as the sole evidence of prior treatment for continuation (samples are not approvable) or any plan-requested combination therapy that includes a gene therapy agent applied to the same treated area.
Coding and Billing
| J3490 | Unclassified drug |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required; approval when clinical criteria met
Prior authorization is required. Initial approval is granted when all clinical criteria in the policy are met, including diagnosis/continuation options, prescriber specialty/consultation, absence of current or prior squamous cell carcinoma on the treated area, no active infection on the treated area, no FDA-labeled contraindications, and confirmation that the agent will not be used in combination with a gene therapy on the same treated area. Length of initial approval: 4 months.
- Codes: J3490 (HCPCS) may be used for billing.
No step therapy (fail-first) requirements listed
No fail-first or other step therapy requirements are specified in this policy; the document states that no specific step therapy (fail-first) requirements are listed.
Required medical record documentation
Provide medical records as documentation of required diagnostic and clinical information: genetic testing confirming dystrophic or junctional EB when applicable, or documentation of another FDA‑labeled indication; records showing prior use of the agent within the past 90 days for continuation requests (starting on samples is not approvable); documentation of specialist prescriber or consultation; and documentation that the treated area has no current or prior squamous cell carcinoma and no active infection.
- Genetic testing results confirming dystrophic or junctional EB (medical records required).
- If continuation: records showing patient treated with the requested agent within past 90 days (samples not approvable) or prescriber statement that patient was treated within past 90 days and is at risk if therapy changed.
- Documentation that prescriber is a specialist (e.g., dermatologist, geneticist) or has consulted one.
- Documentation that the treated area has no current evidence or history of squamous cell carcinoma and no active infection.
Denial triggers — missing documentation, safety risks, or disallowed combination therapy
Requests may be denied if required documentation or safety criteria are not met, including missing genetic confirmation when required, lack of documentation of prior use for continuation requests (or use only of samples), presence or history of squamous cell carcinoma on the area to be treated, active infection on the area to be treated, prescriber not a specialist and no specialist consultation documented, or if the requested agent will be used in combination with a gene therapy on the same treated area.
Background on Condition and Evidence
Epidermolysis bullosa (EB) comprises a group of rare inherited disorders characterized by skin fragility and recurrent blistering due to defects in proteins that mediate skin adhesion. Major subtypes include dystrophic and junctional EB, which are specifically referenced in the coverage criteria. Management is primarily supportive and may involve specialists such as dermatologists or geneticists.
Filsuvez (birch triterpenes topical gel) was evaluated for treatment of partial-thickness wounds in patients with inherited EB. Coverage requirements reference diagnostic confirmation (genetic testing for dystrophic or junctional EB when applicable), specialist involvement, and safety precautions including absence of current or prior squamous cell carcinoma and no active infection on the area to be treated. Initial approvals are limited in duration (4 months) with renewal pathways for patients demonstrating clinical benefit (renewal approvals up to 12 months).
Definitions and Operational Terms
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