CurrentAvMedPolicy N/A

Filsuvez (birch triterpenes) topical gel prior authorization

Prior authorization / step-edit form and clinical criteria for coverage of Filsuvez topical gel for wounds associated with dystrophic epidermolysis bullosa (DEB), including initial and reauthorization requirements, prescribing/provider requirements, and specialty pharmacy dispensing notes.

Policy Summary

PayerAvMed

PolicyFilsuvez (birch triterpenes) topical gel prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must submit a completed prior authorization request with required documentation (molecular genetic testing confirming DEB, chart notes, wound measurements, Vyjuvek trial or contraindication if applicable) faxed to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

1Covered Indication (DEB)

JEBRequires medical necessity review (efficacy not proven)

3/6Authorization durations (months): initial/reauth

Coverage summary

Coverage stance: covered_with_criteria. Scope: Prior authorization / step-edit form and clinical criteria for coverage of Filsuvez (birch triterpenes) topical gel for wounds associated with dystrophic epidermolysis bullosa (DEB), including initial and reauthorization requirements, prescribing/provider requirements, and specialty pharmacy dispensing notes. Product: Filsuvez is a topical gel (birch triterpenes) used to treat wounds in epidermolysis bullosa and is dispensed via specialty pharmacy Proprium Rx.

Initial Authorization (3 months) — DEB

Initial Authorization (3 months) - DEB

All criteria must be met for approval. To support each line checked, documentation must be provided.

ALL of the following

Medication will be used for treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) in patients ≥ 6 months of age
Member has a diagnosis of DEB confirmed by molecular genetic testing
Must be prescribed by or in consultation with a dermatologist or wound care specialist
Application and wound characteristics
- Medication will be applied only to open partial-thickness wounds at dressing changes at least once every 4 days or up to once daily
- Target wound(s) must meet ALL
  - Target wound(s) is clean in appearance and does not appear to be infected
  - Target wound(s) is 10 cm2 to 50 cm2
  - Target wound(s) is ≥ 21 days and < 9 months old
  - Squamous cell and/or basal cell carcinoma has been ruled out for the target wound(s)
- Provider attests treatment will be discontinued until the infection has resolved, if a Filsuvez-treated wound becomes infected
Prior therapy requirement (one must be met)
- Member has had an unsuccessful 3-month trial of Vyjuvek (beremagene geperpavec-svdt) (medical benefit medication - requires prior authorization); medical chart notes must be submitted for documentation of therapy failure or clinical contraindication to therapy
- Member has a contraindication to use of Vyjuvek (beremagene geperpavec-svdt); medical chart notes must be submitted for documentation of clinical contraindication
Medication will NOT be used in combination with Vyjuvek (beremagene geperpavec-svdt)

Reauthorization and new/reopened wounds

Reauthorization (6 months)

All criteria must be met for approval. To support each line checked, documentation must be provided.

ALL of the following

Must be prescribed by or in consultation with a dermatologist or wound care specialist
Member is currently receiving Filsuvez on previously treated wound(s)
The target wound(s) remains open
The target wound(s) has decreased in size from baseline (must submit documentation)
If a Filsuvez-treated wound becomes infected, treatment will be discontinued until the infection has resolved

Initial Authorization - New or Reopened Wounds

If the member is treating a new wound(s) not previously treated with Filsuvez or a reopened recurrent wound(s), refer to the initial authorization criteria above.

ALL of the following

Target wound(s) remains open
Target wound(s) has decreased in size from baseline (must submit documentation)
If the member is treating a new wound(s) not previously treated with Filsuvez or a reopened recurrent wound(s), follow initial authorization criteria

Junctional Epidermolysis Bullosa (JEB) — special note

Junctional Epidermolysis Bullosa (JEB) note

Clinical caution and special requirement

ALL of the following

For treatment of JEB, efficacy of Filsuvez has NOT been proven to be better than placebo; in pivotal EASE trial JEB patients had higher closure with placebo vs Filsuvez
Medical necessity approval will be required for treatment of JEB

The pivotal trial did not demonstrate efficacy of Filsuvez in the JEB subgroup — complete wound closure at Day 45 was greater with placebo than with Filsuvez in JEB patients — and therefore treatment for JEB requires medical necessity review prior to approval.

Provider requirements & prior authorization

Prior Authorization

Prior authorization required

Prescriber must submit a completed prior authorization/step-edit request with the prescriber signature. Fax the signed request to 1-305-671-0200. Include required documentation: molecular genetic testing confirming DEB, relevant chart notes, wound measurements, and evidence of an unsuccessful 3-month Vyjuvek trial or documentation of a clinical contraindication to Vyjuvek when applicable.

Signed prescriber signature required (preprinted stamps not valid)
Fax to 1-305-671-0200
Include molecular genetic testing, chart notes, wound measurements, and Vyjuvek trial/contraindication documentation

Documentation Required

Wound documentation and measurements

Provider must document that the target wound(s) is open, clean (not appearing infected), size 10 cm2 to 50 cm2, and age ≥ 21 days and < 9 months. For reauthorization, the target wound(s) must remain open and have decreased in size from baseline; submit chart notes and diagnostics to support these findings.

Target wound open and partial-thickness (applied at dressing changes at least every 4 days up to once daily)
Target wound clean and not infected
Target wound size 10 cm2 to 50 cm2
Target wound age ≥ 21 days and < 9 months
For reauthorization: wound decreased in size from baseline (documentation required)
Submit chart notes and diagnostics

Documentation Required

Molecular genetic testing

Provider must submit molecular genetic testing confirming the diagnosis of dystrophic epidermolysis bullosa (DEB) as part of the documentation for approval.

Prior Authorization

Vyjuvek prior therapy requirement

Approval requires documentation of an unsuccessful 3-month trial of Vyjuvek (beremagene geperpavec-svdt) or a documented clinical contraindication to Vyjuvek. Vyjuvek is a medical benefit medication that requires prior authorization and Filsuvez must not be used in combination with Vyjuvek.

Either unsuccessful 3-month Vyjuvek trial (medical chart notes required) or documented contraindication
Vyjuvek requires prior authorization (medical benefit)
Do not use Filsuvez in combination with Vyjuvek

Billing Rule

Specialty pharmacy dispensing

Medication is dispensed by Specialty Pharmacy - Proprium Rx. Providers should route dispensing accordingly through the specialty pharmacy.

Medication being provided by Specialty Pharmacy - Proprium Rx

Denial Risk

Incomplete or illegible request may delay/deny authorization

Authorization may be delayed or denied if the request is incomplete, incorrect, or illegible, or if required documentation such as labs, diagnostics, or chart notes is not provided.

Incomplete, incorrect, or illegible requests can delay the authorization process
Required documentation (labs, diagnostics, chart notes) must be provided or request may be denied

Term	Definition
DEB
Dystrophic epidermolysis bullosa
JEB
Junctional epidermolysis bullosa

Policy Summary

PayerAvMed

PolicyFilsuvez (birch triterpenes) topical gel prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Filsuvez (birch triterpenes) topical gel prior authorization

Coverage summary

Initial Authorization (3 months) — DEB

Reauthorization and new/reopened wounds

Junctional Epidermolysis Bullosa (JEB) — special note

Provider requirements & prior authorization

Applicable codes

Clinical evidence

Background & definitions

Revision history