CurrentNeighborhood Health Plan of Rhode IslandPolicy 2368-A

Thalidomide (Thalomid) coverage

Defines medical necessity and authorization parameters for thalidomide (Thalomid) for FDA-approved and selected compendial oncology and non-oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyThalidomide (Thalomid) coverage

Policy CodePolicy 2368-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvider must document that the requested use is an FDA‑approved indication or a listed compendial use and that the member has no exclusions to the prescribed therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration (typical)

multiplecompendial uses (examples)

1reference count

Coverage Criteria for Thalidomide (Thalomid)

Covered indications

Covered when the requested indication is either an FDA-approved indication or a listed compendial use and approval criteria are met

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyThalidomide (Thalomid) coverage

Policy CodePolicy 2368-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvider must document that the requested use is an FDA‑approved indication or a listed compendial use and that the member has no exclusions to the prescribed therapy.

SourceLink

On This Page

Experimental / Not medically necessary

Not medically necessary

Experimental/Investigational: All other indications not listed under FDA-approved or compendial uses are considered experimental/investigational and not medically necessary.

May be denied as not medically necessary.

Coverage for Thalomid (thalidomide) is limited to FDA‑approved indications and listed compendial uses when the approval criteria are met and there are no exclusions to therapy. Covered uses include FDA‑approved treatment of newly diagnosed multiple myeloma in combination with dexamethasone and treatment/prevention of erythema nodosum leprosum, as well as specified compendial indications such as multiple myeloma, multicentric Castleman disease, aphthous stomatitis, Kaposi sarcoma, chronic graft‑versus‑host disease, Crohn’s disease, histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai‑Dorfman disease), and pediatric medulloblastoma.

Limitations apply to certain clinical scenarios; for example, Thalomid is not indicated as monotherapy for treatment of erythema nodosum leprosum (ENL) when moderate to severe neuritis is present, and an alternative clinical approach should be considered in that setting.

Regimen name	Drugs included	Indication	Authorization duration	Coverage status
MEMMAT	Thalidomide, celecoxib, fenofibrate, etoposide, cyclophosphamide, bevacizumab	Recurrent or progressive pediatric medulloblastoma as part of the MEMMAT regimen	Authorization of 12 months may be granted when approval criteria are met	Covered with criteria

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests may be approved for up to 12 months for covered indications when all other policy criteria are met.

Authorization of 12 months may be granted for treatment of multiple myeloma.
Authorization of 12 months may be granted for treatment and prevention of erythema nodosum leprosum.
Authorization of 12 months may be granted for treatment of Crohn's disease.
Authorization of 12 months may be granted for treatment of Kaposi sarcoma as subsequent therapy.
Authorization of 12 months may be granted for treatment of chronic graft-versus-host disease.
Authorization of 12 months may be granted for treatment of multicentric Castleman disease.
Authorization of 12 months may be granted for treatment of AIDS-related and recurrent aphthous stomatitis in immunocompromised members.
Authorization of 12 months may be granted for treatment of histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai-Dorfman disease) as a single agent.
Authorization of 12 months may be granted for treatment of recurrent or progressive pediatric medulloblastoma as part of the MEMMAT regimen.

Documentation Required

Provider Documentation Required

Provider must document the FDA-approved indication or a compendial use and confirm the member has no exclusions to the prescribed therapy.

Include supporting documentation of the diagnosis and prior therapies tried/failed when applicable.
For reauthorization, document clinical benefit or improvement and absence of unacceptable toxicity or disease progression.

Denial Risk

Non‑Covered Indications

Indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary.

All other indications are considered experimental/investigational and not medically necessary.

Note

Reauthorization / Continued Therapy

For members requesting continued therapy: 12‑month authorizations may be granted when criteria below are met; specific exceptions apply for certain indications (see prior authorization items).

Continued treatment approvals (12 months) may be granted for multiple myeloma, multicentric Castleman disease, histiocytic neoplasms, Kaposi sarcoma, or pediatric medulloblastoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
For other covered indications in the criteria section, continued treatment approvals (12 months) may be granted when there is documented improvement in symptoms and no unacceptable toxicity.

Line of Therapy Definitions

first-line | subsequent

Line-specific notes: Thalomid in combination with dexamethasone is indicated for newly diagnosed multiple myeloma; Kaposi sarcoma is authorized as subsequent therapy; pediatric medulloblastoma use is authorized for recurrent or progressive disease as part of the MEMMAT regimen.

Authorization durations are generally 12 months when criteria are met; see prior authorization guidance for specifics.

Definitions and Compendial Uses

Compendial uses

DefinitionUses supported by cited compendia (NCCN, DRUGDEX, AHFS, Lexicomp) that are considered covered if approval criteria are met.

Compendial uses includedMultiple myeloma; multicentric Castleman disease; aphthous stomatitis; Kaposi sarcoma; chronic graft-versus-host disease; Crohn's disease; histiocytic neoplasms (Langerhans cell histiocytosis; Rosai-Dorfman disease); pediatric medulloblastoma.

Relation to FDA indicationsCompendial uses supplement FDA-approved indications (e.g., multiple myeloma, ENL) and may be covered when approval criteria are met.

Coverage conditionA compendial use is considered covered only if the provider documents the use is listed in a cited compendium and the member meets the policy's approval criteria and has no exclusions to therapy.

Non-covered statementIndications not listed in the FDA-approved or compendial uses are considered experimental/investigational and not medically necessary.

Background

Thalidomide (Thalomid) is an oral immunomodulatory agent with approved and compendial oncology and immunologic uses. It is indicated in combination with dexamethasone for newly diagnosed multiple myeloma and for treatment and prevention of erythema nodosum leprosum, and it is used in a variety of compendial settings including multiple myeloma, multicentric Castleman disease, aphthous stomatitis, Kaposi sarcoma, chronic graft‑versus‑host disease, Crohn’s disease, histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai‑Dorfman disease), and pediatric medulloblastoma. The policy distinguishes FDA‑approved indications from compendial uses and limits coverage to those indications when the stated approval criteria are satisfied.