T-Cell Lymphoma Agents: Beleodaq, Istodax, Lymphir, Poteligeo, and Romidepsin
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This clinical policy governs prior authorization for Istodax and related T-cell lymphoma agents under the MassHealth unified preferred product list and the medical benefit for members with cutaneous or peripheral T-cell lymphoma and related hematologic malignancies.
Lymphir injection was added to the medical-benefit policy.
Beleodaq criteria were revised to define relapsed or refractory disease and place in therapy.
Poteligeo criteria were revised to specify stage IB to IV mycosis fungoides and clarify place in therapy.
The initial approval duration was changed from 2 months to 6 months.
The required trial of a generic equivalent was removed because it does not apply to the medical benefit.
Medical Necessity Criteria
Istodax (Romidepsin) Initial and Off-Label Therapy
Coverage may be authorized when the applicable criteria below are met.
ONE of the following
Istodax (romidepsin lyophilized) — CTCL
- Diagnosis of cutaneous T-cell lymphoma (CTCL)
- Received at least one prior systemic therapy
Istodax or romidepsin — off-label PTCL
- Diagnosis of peripheral T-cell lymphoma (PTCL)
- Prescriber is an oncologist or hematologist
- Inadequate response or adverse reaction to ONE second-line treatment option, or contraindication to ALL second-line treatment options, referring to the latest NCCN guideline
- Appropriate dosing
Romidepsin (Non-Lyophilized)
Coverage may be authorized when ALL of the following criteria are met:
ALL of the following
- Diagnosis of cutaneous T-cell lymphoma (CTCL)
- Prescriber is an oncologist, hematologist, or dermatologist
- Appropriate dosing based on current weight and height
Poteligeo (Mogamulizumab)
Coverage may be authorized when ALL of the following criteria are met:
ALL of the following
ONE of the following diagnoses
- Sézary syndrome
- Stage IB to IV mycosis fungoides
- Prescriber is an oncologist or hematologist
- Appropriate dosing
Beleodaq (Belinostat)
Coverage may be authorized when ALL of the following criteria are met:
ALL of the following
- Diagnosis of peripheral T-cell lymphoma (PTCL)
- Prescriber is an oncologist or hematologist
- Disease is relapsed or refractory
- Inadequate response or adverse reaction to ONE second-line treatment option, or contraindication to ALL second-line treatment options, referring to the latest NCCN guideline
- Appropriate dosing
Lymphir (Denileukin Diftitox-cxdl)
Coverage may be authorized when ALL of the following criteria are met:
ALL of the following
- Diagnosis of relapsed or refractory (R/R) stage I–III cutaneous T-cell lymphoma (CTCL)
- Prescriber is an oncologist or hematologist
- Inadequate response or adverse reaction to at least ONE prior line of systemic therapy, referring to the latest NCCN guideline
- Appropriate dosing
Continuation of Therapy
Reauthorization may be granted when the treating physician documents ongoing therapy with a positive response.
ALL of the following
- Member has demonstrated a positive response to therapy
- Continued treatment is clinically appropriate
- Reauthorization is requested by the treating physician
Reauthorizations are granted for 6 months.
For members new to the plan, defined as having a coverage effective date of less than or equal to 90 days, medical records must document that the member is currently receiving treatment with the requested drug. This requirement does not apply when the product was obtained as samples or through a manufacturer’s patient assistance program.
Initial approvals are granted for 6 months. Reauthorizations are granted for 6 months.
Authorization and Documentation Requirements
Medical-Benefit Prior Authorization Required
Prior authorization is required for T-cell lymphoma agents under the MassHealth Unified Preferred Product List (UPPL) when billed under the medical benefit.
- Medical benefit pharmacy: phone 833-895-2611; fax 888-656-6671.
Use the New-Member Transition Pathway
For a member whose coverage effective date is 90 days or less, request authorization through the new-member transition pathway by submitting medical records showing that the member is currently receiving the requested drug.
- The requested product must be the drug for which authorization is being sought.
- Treatment obtained as samples or through a manufacturer patient assistance program does not qualify for this pathway.
Document New-Member Continuation
For new members with a coverage effective date of 90 days or less, include records that establish current treatment with the requested drug. Do not rely on samples or manufacturer patient assistance program records to establish continuation of coverage.
- Submit medical records with the authorization request.
- Records must support active treatment with the requested drug as of the member’s plan enrollment.
Submit Current Weight and Height for Dosing
When dosing depends on body size, submit the member’s current weight and height with the authorization request so the plan can verify appropriate dosing.
- Current weight and height are specifically required for romidepsin (non-lyophilized).
- Appropriate dosing is also required for Poteligeo, Beleodaq, Lymphir, and the listed off-label indications.
Meet Agent-Specific Criteria
Authorization may be denied when the requested agent’s diagnosis, prescriber specialty, disease status, prior-treatment history, or dosing criteria are not met.
- Romidepsin (non-lyophilized): cutaneous T-cell lymphoma; prescriber must be an oncologist, hematologist, or dermatologist; appropriate dosing is required.
- Poteligeo: Sézary syndrome or stage IB-IV mycosis fungoides; prescriber must be an oncologist or hematologist; appropriate dosing is required.
- Beleodaq: peripheral T-cell lymphoma; prescriber must be an oncologist or hematologist; disease must be relapsed or refractory; inadequate response or adverse reaction to one, or contraindication to all, second-line treatment options per the latest NCCN guideline; appropriate dosing is required.
- Lymphir: relapsed or refractory stage I-III cutaneous T-cell lymphoma; prescriber must be an oncologist or hematologist; inadequate response or adverse reaction to at least one prior line of systemic therapy per the latest NCCN guideline; appropriate dosing is required.
- Istodax or romidepsin (non-lyophilized) for the listed off-label peripheral T-cell lymphoma indication: prescriber must be an oncologist or hematologist; inadequate response or adverse reaction to one, or contraindication to all, second-line treatment options per the latest NCCN guideline; appropriate dosing is required.
Insufficient Transition Records May Result in Denial
If the new-member transition request does not include records establishing that the member is currently receiving the requested drug, the transition pathway may not be available and authorization may be denied.
- The coverage effective date must be 90 days or less for this pathway.
- Records from samples or a manufacturer patient assistance program do not establish qualifying current treatment.
Clinical Background
Istodax (romidepsin) is a histone deacetylase inhibitor used for cutaneous T-cell lymphoma (CTCL) in members who have received at least one prior systemic therapy. The policy also addresses non-lyophilized romidepsin and related agents used in CTCL and peripheral T-cell lymphoma; coverage requirements vary according to lymphoma type, disease stage or relapse status, prior therapy, prescriber specialty, and dosing.
Key Clinical Definitions
Treatment-Line Requirements
Second-line: Istodax and romidepsin for PTCL
Second-line treatment is supported when the following criterion is met:
ALL of the following
- For CTCL, the member has received at least one prior systemic therapy.At least 1 prior systemic therapy
Applies to the Istodax labeled CTCL pathway.
- For PTCL, the member has inadequate response or an adverse reaction to one second-line treatment option, or a contraindication to all second-line treatment options.
Refer to the latest NCCN guideline; applies to the Istodax or romidepsin off-label PTCL pathway.
Second-line: Beleodaq
Second-line treatment is supported when the following criterion is met:
ALL of the following
- The member has relapsed or refractory peripheral T-cell lymphoma (PTCL).
- The member has inadequate response or an adverse reaction to one second-line treatment option, or a contraindication to all second-line treatment options.
Refer to the latest NCCN guideline.
Second-line: Lymphir
Second-line treatment is supported when the following criterion is met:
ALL of the following
- The member has relapsed or refractory stage I-III cutaneous T-cell lymphoma (CTCL).Stage I-III
- The member has inadequate response or an adverse reaction to at least one prior line of systemic therapy.At least 1 prior systemic therapy
Refer to the latest NCCN guideline.
Covered Drugs and Treatment Pathways
| Product | Covered indication | Coverage |
|---|---|---|
| Istodax (romidepsin) | Cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy | Covered |
| Product | Covered indication | Coverage |
|---|---|---|
| Istodax (romidepsin lyophilized) or romidepsin (non-lyophilized) | Off-label peripheral T-cell lymphoma (PTCL) when there is an inadequate response or adverse reaction to one second-line treatment option, or a contraindication to all second-line treatment options; refer to the latest NCCN guideline. | Covered |
| Product | Covered indication | Coverage |
|---|---|---|
| Beleodaq (belinostat) | Relapsed or refractory peripheral T-cell lymphoma (PTCL) with an inadequate response or adverse reaction to one second-line treatment option, or a contraindication to all second-line treatment options; refer to the latest NCCN guideline. | Covered |
| Product | Covered indication | Coverage |
|---|---|---|
| Lymphir (denileukin diftitox-cxdl) | Relapsed or refractory stage I-III cutaneous T-cell lymphoma (CTCL) after an inadequate response or adverse reaction to at least one prior line of systemic therapy; refer to the latest NCCN guideline. | Covered |
| Product | Covered indication | Coverage |
|---|---|---|
| Poteligeo (mogamulizumab-kpkc) | Sézary syndrome or stage IB to IV mycosis fungoides | Covered |
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