Mechlorethamine Gel (Valchlor) Form

Mechlorethamine (MCH) gel (Valchlor®) is an alkylating drug also known as nitrogen mustard.
FDA Approved Indication(s) Valchlor is indicated for the topical treatment of Stage IA and IB mycosis fungoides (MF)-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. 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 Valchlor is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Mycosis Fungoides/Sezary Syndrome (must meet all):

1. Diagnosis of one of the following (a, b, or c): a. MF, stage IA-III; b. Sezary syndrome (SS), stage IV; c. Large cell transformation (associated with MF and SS);
2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Failure of at least one skin-directed therapy (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for skin directed therapy

3. Request meets one of the following (a or b): a. Dose does not exceed one application per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. NCCN Recommended Uses (off-label) (must meet all):

   1. Diagnosis of one of the following (a, b, c, or d): a. Primary cutaneous B-cell lymphoma (subtype i or ii): i. Marginal zone lymphoma; Page 1 of 6

   CLINICAL POLICY Mechlorethamine Gel ii. Follicle center lymphoma; b. Primary cutaneous CD30+ T-cell lymphoproliferative disorder (the following subtype only: lymphomatoid papulosis); c. Adult T-cell leukemia/lymphoma (chronic or smoldering subtype); d. Langerhans cell histiocytosis (LCH) with isolated skin disease;

4. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Failure of at least one skin-directed therapy (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for skin directed therapy
5. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
6. 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
7. 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. All Indications in Section I (must meet all):
8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Valchlor for a covered indication and has received this medication for at least 30 days;

9. Member is responding positively to therapy;

   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed one application per day; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
      Page 2 of 6

   CLINICAL POLICY Mechlorethamine Gel Approval duration: Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

10. 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

11. 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 CTCL: cutaneous T-cell lymphoma
    FDA: Food and Drug Administration LCH: Langerhans cell histiocytosis MCH: mechlorethamine
    MF: mycosis fungoides NCCN: National Comprehensive Cancer Network SS: Sezary syndrome Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies Skin-Directed Therapies • Topical corticosteroids (e.g., betamethasone, clobetasol) • Local radiation Varies Page 3 of 6

    CLINICAL POLICY Mechlorethamine Gel Drug Name Dosing Regimen Dose Limit/ Maximum Dose • Topical retinoids (Targretin® [bexarotene], tazarotene [Avage®, Fabior®, Tazorac®]) • Phototherapy (UVB, NB-UVB, PUVA) • Topical imiquimod (Aldara®) • Total skin electron beam therapy Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): severe hypersensitivity to mechlorethamine
    • Boxed warning(s): none reported Appendix D: General Information The Valchlor pivotal trial was designed to assess non-inferiority of Valchlor (0.02% MCH gel) versus 0.02% MCH as a compounded ointment (historically used for MF in the absence of FDA labeled topical MCH alternatives). Inclusion criteria included persistent or recurrent stage IA, IB and IIA disease. Prior skin-directed therapies included but were not limited to topical corticosteroids, phototherapy, topical and oral bexarotene and other retinoids, interferons, methotrexate, radiation, and topical MCH (the latter not within two years prior to study enrollment). Non-inferiority was confirmed. V. Dosage and Administration
    Indication Stage IA/IB MF Dosing Regimen Thin film QD to affected areas of the skin Maximum Dose One application QD VI. Product Availability
    Gel: 0.016% w/w (equivalent to 0.02% mechlorethamine HCl), 60g tube VII.