CurrentCignaPolicy N/A

Zevaskyn gene therapy prior authorization coverage criteria

Form and criteria to request prior authorization for the gene therapy product Zevaskyn for members; governs documentation and clinical criteria required for Cigna coverage decisions and affects prescribing providers, infusion sites, and billing offices.

Policy Summary

PayerCigna

PolicyZevaskyn gene therapy prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the gene therapy prior authorization form and submit required clinical documentation, including genetic test results confirming pathogenic COL7A1 variants, to Fax# 833-910-1625.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 monthsminimum chronic wound duration required for target wound

1+open wound(s) required to be treated (target wounds)

both allelesCOL7A1 pathogenic variant requirement

Gene Therapy NetworkGene Therapy Network

833-910-1625Fax to submit form

Coverage and Medical Necessity

Medical necessity criteria

Zevaskyn is considered medically necessary when ALL of the following are met:

Genetic confirmation: Diagnosis confirmed by genetic testing showing a pathogenic variant in both alleles in the COL7A1 gene

Documentation required

Clinical features of RDEB: Patient has at least one clinical feature of recessive dystrophic epidermolysis bullosa (examples include blistering, wounds, and scarring)

Documentation required

Target wounds present: Patient has one or more open wound(s) that will be treated (target wound[s])1+ wound

Target wound characteristics

Policy Summary

PayerCigna

PolicyZevaskyn gene therapy prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the gene therapy prior authorization form and submit required clinical documentation, including genetic test results confirming pathogenic COL7A1 variants, to Fax# 833-910-1625.

SourceLink

On This Page

Initial Therapy Requirements

Initial therapy requirements

Initial coverage requires meeting ALL medical necessity criteria listed on the form.

Initial therapy criteria: See Medical necessity criteria: genetic confirmation, clinical features of RDEB, presence of target wound(s), target wound characteristics (clean/not infected; adequate granulation and vascularization; chronic ≥ 6 months; SCC has been considered), and prescriber specialty

Documentation required

Key Definitions

Target wound definition

DefinitionAn open wound(s) intended to be treated with Zevaskyn that is clean in appearance, not infected, has adequate granulation tissue and vascularization, has been present for ≥ 6 months, and for which squamous cell carcinoma has been considered.

Minimum number of woundsOne or more open wound(s) (≥ 1) required as target wound(s)

Required wound characteristics (summary)All of: clean/not infected; adequate granulation and vascularization; chronic (present ≥ 6 months); squamous cell carcinoma considered

Genetic confirmation definition

DefinitionGenetic testing showing a pathogenic variant in both alleles of the COL7A1 (collagen type VII alpha 1 chain) gene.

Documentation requirementDocumentation of genetic testing confirming pathogenic variants in both COL7A1 alleles is required for coverage consideration.

Related coverage criterionThis genetic confirmation is a prerequisite for medical necessity determination for Zevaskyn.

Coding and Related Metrics

Administration CPT codesCPT

No codes listed

Chronic wound duration

Minimum durationTarget wound(s) must be chronic: present ≥ 6 months.

ContextDuration is one element of required target wound characteristics assessed alongside infection status, granulation/vascularization, and consideration of squamous cell carcinoma.

Evidence requiredDocumentation supporting wound chronicity (e.g., chart notes, wound history) should be provided as part of the prior authorization submission.

Step	Requirement	Notes
1	No prior biologic or alternative therapy failure is required	Initial coverage focuses on meeting all medical necessity criteria: genetic confirmation of pathogenic COL7A1 variants in both alleles; clinical features of RDEB; presence of one or more target wounds; target wound characteristics (clean, not infected; adequate granulation and vascularization; chronic ≥ 6 months; squamous cell carcinoma considered); and prescriber specialty (dermatologist or wound care specialist). Documentation is required.

Provider Requirements and Submission

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zevaskyn gene therapy. Complete and fax the Gene Therapy Prior Authorization form along with all supporting clinical documentation to Fax# 833-910-1625. Questions may be directed to the Gene Therapy Program at 855.678.0051 or GeneTherapyProgram@Cigna.com.

Fax completed form and supporting documentation to 833-910-1625
Contact Gene Therapy Program: 855.678.0051 or GeneTherapyProgram@Cigna.com

Documentation Required

Required Documentation — Completed Form and Supportive Documentation

Failure to complete the authorization form in its entirety or to provide required supporting documentation may result in delayed processing or an adverse determination for insufficient information. Include chart notes, genetic test results, laboratory and medical test results, claims records, prescription receipts, and any other pertinent documentation.

Required documentation: completed authorization form and supporting clinical documentation (e.g., chart notes, genetic test results, lab results, medical test results, claims records, prescription receipts)
Incomplete submissions risk delayed processing or an adverse determination

Step Therapy

Step Therapy Not Specified

Step therapy is not specified for Zevaskyn in this policy. If provider believes treatment is medically necessary despite unmet criteria, submit detailed clinical rationale and supporting evidence with the authorization request.

No step therapy requirements listed for Zevaskyn
Provide clinical justification if criteria are not fully met

Denial Risk

Incomplete Submission Risk — Potential Delays or Adverse Determinations

Incomplete or missing information may lead to delays or adverse determinations. Ensure all elements of the medical necessity criteria are documented (diagnostic genetic testing confirming pathogenic COL7A1 variants, clinical features of recessive dystrophic epidermolysis bullosa, details about target wound(s), prescriber specialty) and include additional pertinent information such as recent history and physical, recent lab work, disease stage, prior therapy, performance status, and concurrent medications.

Document genetic test confirming pathogenic COL7A1 variants (both alleles)
Document clinical features of recessive dystrophic epidermolysis bullosa and target wound details (clean appearance, adequate granulation/vascularization, chronic ≥ 6 months, squamous cell carcinoma considered)
Prescriber must be dermatologist or wound care specialist, or include consult note
Include recent H&P, labs, disease stage, prior therapies, performance status, and concurrent agent details

Background

Zevaskyn is a gene therapy indicated for patients with recessive dystrophic epidermolysis bullosa due to pathogenic variants in the COL7A1 gene. Candidate patients typically present with blistering, wounds, and scarring and must have one or more target wounds that meet specified characteristics (clean, not infected; adequate granulation and vascularization; chronic, present for ≥ 6 months; and for which squamous cell carcinoma has been considered). Genetic confirmation by testing showing pathogenic variants in both COL7A1 alleles is required, and the medication must be prescribed by or in consultation with a dermatologist or wound care specialist.

OpenPayer

Zevaskyn gene therapy prior authorization coverage criteria

Coverage and Medical Necessity

Initial Therapy Requirements

Key Definitions

Coding and Related Metrics

Provider Requirements and Submission

Administration Location

Background