CurrentCentenePolicy HIMPA.17

Methoxsalen (Uvadex) for extracorporeal photopheresis in cutaneous T-cell lymphoma (CTCL)

Defines medical necessity and prior-authorization criteria for Uvadex (methoxsalen) administered with THERAKOS UVAR XTS or CELLEX photopheresis systems as palliative treatment of skin manifestations of CTCL for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyMethoxsalen (Uvadex) for extracorporeal photopheresis in cutaneous T-cell lymphoma (CTCL)

Policy CodePolicy HIMPA.17

Change TypeRevised continued therapy limitsupdated therapeutic alternatives

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) demonstrating the member meets all approval criteria including diagnosis, specialist involvement, prior therapies, dosing, and response.

SourceLink

POLICY UPDATE CHANGES

For continued therapy, total allowable courses of therapy revised from 7 to 20 per FDA labeling and consistent with approval duration.

Peginterferon alfa-2a was added as an alternative therapy option per NCCN.

6 monthsInitial approval duration

Up to 20Continued approval / max cycles

≥18Minimum age for coverage

Vol × 0.017

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Medical Necessity Criteria for Uvadex (methoxsalen)

Initial Approval Criteria

Uvadex is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of cutaneous T-cell lymphoma (CTCL).
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Failure of at least 2 of the following therapies (credit given if clinically significant adverse effects or contraindications exist):
- External beam radiation therapy
- Systemic retinoid
- PUVA/UVB phototherapy
- Interferon-alpha, interferon-gamma, or peginterferon alfa-2a (credit allowed for prior use of interferon-alpha/gamma though some are no longer commercially available)
- Methotrexate
- Mechlorethamine
- Istodax (romidepsin) or Zolinza (vorinostat)
- Adcetris (brentuximab vedotin)
- Poteligeo (mogamulizumab)
- Folotyn (pralatrexate)
- Gemcitabine
- Keytruda (pembrolizumab)
- Liposomal doxorubicin
- Alemtuzumab (credit allowed for prior use though not commercially available)
Dose requirement (one of):
- Dose does not exceed treatment volume (mL) × 0.017 per treatment.
- 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; off-label requires documentation per HIM.PA.154.

Approval duration: 6 months (approximately 7 treatment cycles) per initial approval criteria.

Continued Therapy Criteria

For members currently receiving Uvadex and seeking renewal—ALL of the following must be met:

ALL of the following

Member is currently receiving Uvadex via Centene benefit or documentation supports current receipt for a covered indication for at least 30 days.
Member is responding positively to therapy.
Member has not yet received a total of 20 treatment cycles.
If request is for a dose increase (one of):
- New dose does not exceed treatment volume (mL) × 0.017 per treatment.

Other Diagnoses/Indications

Requests for diagnoses/indications other than CTCL must follow formulary/non-formulary and off-label policies:

ANY of the following

If drug is on formulary/PDL, refer to the no coverage criteria policy for the relevant line of business (HIM.PA.33 for health insurance marketplace).
If drug is NOT on formulary/PDL, refer to the non-formulary policy (HIM.PA.103 for health insurance marketplace).
If requested use is not listed under Diagnoses/Indications for which coverage is NOT authorized and initial CTCL criterion does not apply, refer to the off-label use policy (HIM.PA.154).

Follow the referenced line-of-business policies for coverage determination and prior authorization requirements.

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

ALL of the following

Non-FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety is provided per off-label policy (HIM.PA.154).

Requests for non-FDA approved uses without adequate off-label supporting documentation will be denied in accordance with the off-label use policy.

Product and Administration Coding

Relevant product and administrationNDC|HCPCS

Uvadex (methoxsalen) single-use vial 20 mcg/mL in 10 mL

Product availability - used for photopheresis extracorporeal administration per THERAKOS systems (no specific NDC or HCPCS listed in policy text).

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization and documentation

Provider must submit documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria, including diagnosis of CTCL, that the drug was prescribed by or in consultation with an oncologist, prior therapies tried/failed, dosing (including treatment volume calculation), and evidence of response.

Office chart notes documenting diagnosis and oncologist involvement
Laboratory results relevant to disease status and treatment monitoring
Documentation of prior therapies (dates, agents, reasons for discontinuation)
Dosing details including treatment volume and calculated methoxsalen dose
Evidence of clinical response for continued therapy requests

Documentation Required

Supporting evidence for off-label doses/uses

Dosing and Treatment Limits

Dose calculation per treatmentTreatment volume (mL) × 0.017

Maximum number of treatment cycles (continued therapy)Up to a total of 20 treatment cycles

Initial approval duration6 months (approximately 7 treatment cycles)

Clinical Background

Methoxsalen (Uvadex) is a psoralen indicated for extracorporeal administration with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis System as a palliative treatment for the skin manifestations of cutaneous T‑cell lymphoma (CTCL) that are unresponsive to other therapies. Each treatment involves collection of leukocytes, photoactivation with methoxsalen, and reinfusion of the photoactivated cells using the THERAKOS photopheresis system.

The typical dosing schedule is 2 consecutive days every 4 weeks, with the usual initial course spanning approximately 6 months (about 7 treatment cycles). Dosage for each treatment is calculated based on treatment volume using the formula: treatment volume (mL) × 0.017 = mL of methoxsalen per treatment.

Labeling and guideline sources describe an accelerated schedule for patients with worsening skin scores at the fourth treatment assessment: this consists of 2 consecutive treatments every 2 weeks for a maximum of 20 cycles, with a return to the regular schedule if a 25% improvement in skin score is achieved after 4 weeks on the accelerated schedule. The FDA labeling and NCCN guidance are reflected in coverage and continuation criteria, including allowance of up to a total of 20 treatment cycles for continued therapy.

Defined Terms

CTCLCutaneous T-cell lymphoma.

Treatment cycleA course of photopheresis treatments as defined in dosing schedule (commonly 2 consecutive days = 1 cycle)

Policy Changes

2024-08-07material change (annual review)Latest

Continued therapy total allowable courses of therapy revised from 7 to 20 to align with FDA labeling and approval duration.

2024-08-07non-material change (annual review)

Peginterferon alfa-2a was added to Appendix B as an alternative therapy option per NCCN.

2018-12-01initial effective date

Methoxsalen (Uvadex) for extracorporeal photopheresis in cutaneous T-cell lymphoma (CTCL)

Medical Necessity Criteria for Uvadex (methoxsalen)

Product and Administration Coding

Authorization, Documentation, and Denial Risks

Dosing and Treatment Limits

Clinical Background

Defined Terms

Policies to Read With This Policy

Policy Changes