CurrentNeighborhood Health Plan of Rhode IslandPolicy 2368-A

Thalomid

Defines coverage, authorization durations, and approved indications (FDA and compendia) for thalidomide (Thalomid) across referenced products; includes continuation criteria and states that other indications are investigational/not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyThalomid

Policy CodePolicy 2368-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests for Thalomid; approvals are typically for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material changes — has_material_change = false

12 monthsTypical authorization duration

FDA + CompendiaBasis of covered indications

Multiple listedCovered indications

Coverage Summary & Scope

Thalomid (thalidomide), including brand and generic products, is covered with criteria. Coverage includes FDA-approved uses — multiple myeloma (Thalomid in combination with dexamethasone) and erythema nodosum leprosum (ENL) (acute treatment and maintenance to prevent recurrence; not indicated as monotherapy in the presence of moderate to severe neuritis) — as well as multiple compendial uses (e.g., Crohn's disease, Kaposi sarcoma, chronic graft-versus-host disease, multicentric Castleman disease, aphthous stomatitis, histiocytic neoplasms, pediatric medulloblastoma, POEMS syndrome, plasma cell-related MIDD and MGRS).

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Covered Indications and Authorization Durations

The following indications are considered covered when all approval criteria are met and the member has no exclusions to the prescribed therapy. Authorization durations are noted per indication.

ANY of the following

Multiple Myeloma — Thalomid in combination with dexamethasone for treatment of patients with newly diagnosed multiple myeloma (FDA-approved).
Authorization of 12 months may be granted for treatment of multiple myeloma.
Erythema Nodosum Leprosum (ENL) — Acute treatment of cutaneous manifestations of moderate to severe ENL and maintenance therapy for prevention/suppression of recurrence (FDA-approved). Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Authorization of 12 months may be granted for treatment and prevention of ENL.
Kaposi Sarcoma — Covered when any of the following are met:
- ONE of: The requested medication will be used in combination with antiretroviral therapy for treatment of HIV-related relapsed or refractory advanced Kaposi sarcoma.
- Member is HIV-negative and the requested medication will be used as a single agent for relapsed or refractory advanced Kaposi sarcoma.
- The requested medication will be used in combination with rituximab for the treatment of Kaposi-sarcoma associated herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS).
Crohn's Disease — Compendial use (covered).
Authorization of 12 months may be granted for treatment of Crohn's disease.
Chronic Graft-versus-Host Disease — Compendial use for refractory disease.
Authorization of 12 months may be granted for treatment of refractory chronic graft-versus-host disease.
Multicentric Castleman Disease — Compendial use.
Authorization of 12 months may be granted for treatment of multicentric Castleman disease.
Aphthous Stomatitis — Compendial use for AIDS-related aphthous stomatitis and recurrent severe aphthous stomatitis.
Authorization of 12 months may be granted for treatment of AIDS-related aphthous stomatitis and recurrent severe aphthous stomatitis.
Histiocytic Neoplasms (including Langerhans cell histiocytosis and Rosai-Dorfman disease) — Compendial single-agent use.
Authorization of 12 months may be granted for treatment of histiocytic neoplasms, including Langerhans cell histiocytosis and Rosai-Dorfman disease, as a single agent.
Pediatric Medulloblastoma — For recurrent or progressive pediatric medulloblastoma as part of MEMMAT regimen (thalidomide, celecoxib, fenofibrate, etoposide, cyclophosphamide, bevacizumab).
Authorization of 12 months may be granted for treatment of recurrent or progressive pediatric medulloblastoma as part of MEMMAT regimen.
POEMS Syndrome, plasma cell-related Monoclonal Immunoglobulin Deposition Disease (MIDD), and plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS) — Compendial use.
Authorization of 12 months may be granted for treatment of POEMS syndrome, plasma cell-related MIDD, and plasma cell-related MGRS.

Initial / Approved Indications

The following indications are considered covered when all approval criteria are met and the member has no exclusions to the prescribed therapy. Authorization durations are noted per indication.

Covered Indications (Initial Criteria / Duplicate Display)

The covered indications are rendered in the COVERAGE section above. For UI flows that display initial criteria separately, the same indications and associated 12-month authorization notes apply.

ANY of the following

Multiple Myeloma — Thalomid in combination with dexamethasone for treatment of patients with newly diagnosed multiple myeloma (FDA-approved).
Authorization of 12 months may be granted for treatment of multiple myeloma.
Erythema Nodosum Leprosum (ENL) — Acute treatment of cutaneous manifestations of moderate to severe ENL and maintenance therapy for prevention/suppression of recurrence (FDA-approved). Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Authorization of 12 months may be granted for treatment and prevention of ENL.
Kaposi Sarcoma — Covered when any of the following are met:
- ONE of: The requested medication will be used in combination with antiretroviral therapy for treatment of HIV-related relapsed or refractory advanced Kaposi sarcoma.
- Member is HIV-negative and the requested medication will be used as a single agent for relapsed or refractory advanced Kaposi sarcoma.
- The requested medication will be used in combination with rituximab for the treatment of Kaposi-sarcoma associated herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS).
Crohn's Disease — Compendial use (covered).
Authorization of 12 months may be granted for treatment of Crohn's disease.
Chronic Graft-versus-Host Disease — Compendial use for refractory disease.
Authorization of 12 months may be granted for treatment of refractory chronic graft-versus-host disease.
Multicentric Castleman Disease — Compendial use.
Authorization of 12 months may be granted for treatment of multicentric Castleman disease.
Aphthous Stomatitis — Compendial use for AIDS-related aphthous stomatitis and recurrent severe aphthous stomatitis.
Authorization of 12 months may be granted for treatment of AIDS-related aphthous stomatitis and recurrent severe aphthous stomatitis.
Histiocytic Neoplasms (including Langerhans cell histiocytosis and Rosai-Dorfman disease) — Compendial single-agent use.
Authorization of 12 months may be granted for treatment of histiocytic neoplasms, including Langerhans cell histiocytosis and Rosai-Dorfman disease, as a single agent.
Pediatric Medulloblastoma — For recurrent or progressive pediatric medulloblastoma as part of MEMMAT regimen (thalidomide, celecoxib, fenofibrate, etoposide, cyclophosphamide, bevacizumab).
Authorization of 12 months may be granted for treatment of recurrent or progressive pediatric medulloblastoma as part of MEMMAT regimen.
POEMS Syndrome, plasma cell-related Monoclonal Immunoglobulin Deposition Disease (MIDD), and plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS) — Compendial use.
Authorization of 12 months may be granted for treatment of POEMS syndrome, plasma cell-related MIDD, and plasma cell-related MGRS.

Reauthorization / Continuation Criteria

Continuation of Therapy

Criteria for reauthorization of continued treatment.

ALL of the following

Indication is one of: Multiple Myeloma, Multicentric Castleman Disease, Histiocytic Neoplasms, Kaposi sarcoma, Pediatric Medulloblastoma, POEMS Syndrome, plasma cell-related MIDD, or plasma cell-related MGRS.
There is no evidence of unacceptable toxicity while on the current regimen.
There is no evidence of disease progression while on the current regimen.
Authorization of 12 months may be granted for continued treatment when the above are met.

Continuation for Other Listed Indications

Reauthorization criteria for other indications listed in coverage criteria (excluding those in the previous continuation tree).

ALL of the following

Indication is listed in the coverage criteria section (but is not one of: multiple myeloma, multicentric Castleman disease, histiocytic neoplasms, Kaposi sarcoma, pediatric medulloblastoma, POEMS syndrome, plasma cell-related MIDD, or plasma cell-related MGRS).
Member has improvement in symptoms while on current therapy.
There is no unacceptable toxicity while on current therapy.
Authorization of 12 months may be granted for continued treatment when the above are met.

Prior Authorization & Documentation Requirements

Prior Authorization

Authorization required for covered indications

Authorization (prior authorization) is required for covered indications. When approved, authorization is typically granted for 12 months per the specific covered indication.

Documentation Required

Clinical evidence for continuation

For reauthorization, documentation must show either (1) for the specified set of indications (multiple myeloma, multicentric Castleman disease, histiocytic neoplasms, Kaposi sarcoma, pediatric medulloblastoma, POEMS syndrome, plasma cell-related MIDD, or plasma cell-related MGRS) there is no unacceptable toxicity and no disease progression while on the current regimen, or (2) for other listed indications there is symptomatic improvement and no unacceptable toxicity while on current therapy. When these criteria are met, reauthorization of up to 12 months may be granted.

Background

Background: This policy defines coverage, authorization durations, and approved indications (FDA and compendia) for thalidomide (Thalomid), covering brand and generic products and all dosage forms unless otherwise stated. FDA-approved indications include treatment of newly diagnosed multiple myeloma (in combination with dexamethasone) and treatment/maintenance of erythema nodosum leprosum. Multiple compendial uses are included as covered when criteria are met. Typical authorizations are for 12 months. All other indications not listed as FDA-approved or compendial uses are considered investigational/not medically necessary.

Key Coverage Stats

Typical authorization duration12 months

Basis of covered indicationsFDA-approved indications + Compendia (listed compendial uses)

Covered Indications Count (approx)Multiple listed indications (FDA: multiple myeloma, ENL; Compendia: Crohn's, Kaposi sarcoma, chronic GVHD, multicentric Castleman disease, aphthous stomatitis, histiocytic neoplasms, pediatric medulloblastoma, POEMS, MIDD, MGRS, etc.)

OpenPayer

Thalomid

Coverage Summary & Scope

Initial / Approved Indications

Reauthorization / Continuation Criteria

Not Medically Necessary / Experimental Indications

Prior Authorization & Documentation Requirements

Applicable Codes

Evidence & References

Background

Revision History