Allogeneic Cultured Keratinocytes and Dermal Fibroblasts in Murine Collagen-dsat (StrataGraft) Form

Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (StrataGraft®) is an allogeneic cellularized scaffold product. FDA Approved Indication(s) StrataGraft is indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that StrataGraft is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Thermal Burns (must meet all):

1. Diagnosis of deep partial-thickness thermal burns containing intact dermal elements;
   2. Prescribed by or in consultation with a burn specialist;
   3. Age ≥ 18 years;
   4. Prescriber attestation that surgical intervention is clinically indicated;
   5. Member is not allergic to products of bovine or porcine origin;
   6. Request meets both of the following (a and b): a. Requested number of StrataGraft constructs does not exceed the size of the wound bed (number of constructs may be rounded up to the nearest whole number); b. Request is for a one-time application only. Approval duration: 3 months (one application only per thermal burn occurrence) B. Other diagnoses/indications (must meet 1 or 2):

2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Allogeneic Cultured Keratinocytes and Dermal Fibroblasts in
   Murine Collagen-dsat b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Thermal Burns
4. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable
   B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Page 2 of 5

   CLINICAL POLICY Allogeneic Cultured Keratinocytes and Dermal Fibroblasts in
   Murine Collagen-dsat Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known allergies to murine collagen or products containing ingredients of bovine or porcine origin • Boxed warning(s): none reported Appendix D: General Information • Deep partial-thickness burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin). V. Dosage and Administration
   Indication Thermal burns Dosing Regimen Apply topically to a surgically prepared wound bed. The number of StrataGraft constructs applied will vary depending on the size of the wound bed. StrataGraft constructs may be trimmed to accommodate the size and shape of the wound bed. It is not necessary to overlap the edges. Each StrataGraft construct is for application to a single patient only Maximum Dose Not applicable VI. Product Availability
   StrataGraft construct: off-white rectangular sheet of approximately 100 cm2 (approximately 8 cm by 12.5 cm), consisting of a viable, bioengineered, allogeneic cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts VII.