CurrentUnitedHealthcarePolicy 1 = 2024 P 1123-13

Valchlor (mechlorethamine) topical gel prior authorization

Prior authorization and notification criteria for Valchlor (mechlorethamine topical gel) coverage for UnitedHealthcare members, including eligible diagnoses and reauthorization rules. Applies to pharmacy benefit adjudication and prescribers seeking coverage.

Policy Summary

PayerUnitedHealthcare

PolicyValchlor (mechlorethamine) topical gel prior authorization

Policy CodePolicy 1 = 2024 P 1123-13

Change TypeNo material change

Effective Date1/1/2025

Next Review Date

Key ActionObtain prior authorization for Valchlor; approvals issued for 12 months (members under 19 process automatically).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

through 10/2024P&T approval

<19automatic processing

Coverage Criteria for Valchlor (mechlorethamine) Topical Gel

Initial Authorization - Eligible Diagnoses

Covered when ONE of the following diagnoses is present (Initial Authorization):

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Initial Authorization - LCH

Covered when BOTH criteria are met for Langerhans Cell Histiocytosis (LCH) initial authorization:

Initial Authorization - LCH: (1) Diagnosis of Langerhans Cell Histiocytosis (LCH); (2) Skin disease is unifocal and isolated

Authorization issued for 12 months

State mandates and compendium references may supersede this policy. Where a state law or a required compendium applies to an off‑label diagnosis or circumstance, that mandate takes precedence over the language in this document. Additionally, benefit plan terms and contract language may limit or alter coverage; providers should confirm member-specific plan provisions when determining coverage eligibility.

Initial Therapy Criteria

Initial therapy

Initial authorization criteria by diagnosis

Initial - general diagnoses: Diagnosis of one of the listed cutaneous lymphoid disorders (see Initial Authorization - Eligible Diagnoses)

Authorization for 12 months

Initial - LCH: Diagnosis of LCH with unifocal and isolated skin disease

Authorization for 12 months

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Valchlor except for members under 19 who process automatically. When applicable, authorization will be issued for 12 months.

Prior authorization required for Valchlor (automated processing for members < 19 years).
Authorizations, when required, are issued for a 12-month period.

Step Therapy

Provider Action — No Step-Therapy Required

No explicit step-therapy requirements are listed in this policy. Coverage is diagnosis-based and includes multiple eligible indications; providers should submit documentation supporting one of the covered diagnoses.

No step-therapy or failed-prior-therapy prerequisite specified.
Coverage criteria are diagnosis-driven (see diagnoses such as mycosis fungoides, Sezary syndrome, lymphomatoid papulosis with extensive lesions, primary cutaneous B‑cell lymphomas, LCH with unifocal isolated skin disease, and chronic/smoldering T‑cell leukemia/lymphoma).

Note

Authorization Basis and Supply Limits

Authorization decisions may be approved based on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Supply limits may apply and use of automated approval or re‑approval processes varies by program.

Authorization may be approved using prior claims/medication history, ICD-10 diagnosis codes, and claim logic alone.
Automated approval and re-approval processes vary by program and may be used.
Supply limits may be enforced; lack of demonstrated prior medication does not preclude approval if other automated/claim-based criteria are satisfied.

Step	Requirement
1	No specific step-therapy sequence is specified in this policy; coverage is diagnosis-based per NCCN-recognized indications.

Quantity Limits and Supply

Quantity limits and related rules for Valchlor (mechlorethamine) topical gel

Quantity limit statusSupply limits may be in place for Valchlor (mechlorethamine) topical gel

Authorization periodWhen approved, authorization is issued for 12 months

Approval basisApprovals may be based on prior claim/medication history, ICD-10 diagnosis codes, and/or claim logic

Automatic processing exceptionMembers under 19 years may be processed automatically without coverage review

Background

Valchlor (mechlorethamine) topical gel is a topical alkylating agent indicated for the treatment of certain cutaneous lymphoid disorders. This policy addresses prior authorization for Valchlor under the pharmacy benefit and specifies eligible diagnoses and reauthorization rules for coverage. For members under 19 years of age, prescriptions will automatically process without a coverage review; otherwise, prior authorization is required per the criteria in this document.

Definitions

Valchlor — key facts

Drug nameValchlor (mechlorethamine) topical gel

Drug class / indication summaryAlkylating topical antineoplastic indicated for topical treatment of stage IA and IB mycosis fungoides-type cutaneous T‑cell lymphoma; NCCN also recognizes topical mechlorethamine for other cutaneous lymphoid disorders and Langerhans Cell Histiocytosis

Site of careTopical application to affected skin as per prescribing information (home use)

Authorization considerationsPrior authorization required except where automated processing applies; supply limits may be applied and approvals can be based on claim/medication history or ICD-10/claim logic