CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Thalomid (thalidomide) coverage and authorization criteria

Policy defines covered FDA-approved and compendial indications for thalidomide (Thalomid), criteria for initial authorization (generally 12 months), continuation/reauthorization criteria, and notes that other indications are investigational/not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyThalomid (thalidomide) coverage and authorization criteria

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months for covered indications and document required criteria (e.g., serum EPO level and prior ESA response for myelofibrosis-associated anemia).

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this brief.

9Covered Indications Listed

1Excluded/Investigational

Coverage Summary & Covered Indications

This policy governs coverage of thalidomide (Thalomid), referencing the product label and standard drug compendia. Covered uses include FDA-approved indications and selected compendial uses as detailed in the policy and supporting references (Thalomid package insert and standard compendia).

When the specified criteria are met, the policy allows coverage of FDA-approved and compendial indications with authorizations of 12 months.

Covered Indications and Authorization Durations

Thalomid is covered for the FDA-approved and compendial uses below provided all applicable criteria are met; authorizations are for 12 months when criteria satisfied.

ANY of the following

Multiple myeloma: Thalomid in combination with dexamethasone for newly diagnosed multiple myeloma - Authorization of 12 months may be granted
Erythema nodosum leprosum (ENL): Acute treatment of cutaneous manifestations of moderate to severe ENL - Authorization of 12 months may be granted
Thalomid not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis
ENL maintenance: Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL - Authorization of 12 months may be granted
Myelofibrosis-associated anemia
- Myelofibrosis criterion - combination: Requested medication will be given in combination with prednisone
- Myelofibrosis criterion - EPO
  - EPO >=500: EPO 500 mU/mL or greater>= 500 mU/mL
  - EPO <500 with ESA failure: EPO less than 500 mU/mL AND no response or loss of response to erythropoiesis-stimulating agents< 500 mU/mL with documented no response or loss of response to ESAs
    Provider must document serum EPO level and prior ESA response
Crohn's disease - Authorization of 12 months may be granted
Kaposi sarcoma (as subsequent therapy) - Authorization of 12 months may be granted
Chronic graft-versus-host disease - Authorization of 12 months may be granted
Multicentric Castleman disease - Authorization of 12 months may be granted
Aphthous stomatitis (AIDS-related and recurrent in immunocompromised members) - Authorization of 12 months may be granted
Histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai-Dorfman disease) as a single agent - Authorization of 12 months may be granted

Initial Therapy Criteria

Initial-therapy criteria for covered indications and any required baseline documentation or combination therapy requirements.

ANY of the following

Multiple myeloma (initial): Thalomid in combination with dexamethasone for newly diagnosed multiple myeloma - Authorization of 12 months may be granted
Myelofibrosis-associated anemia (initial)
- Combination with prednisone: Requested medication will be given in combination with prednisone
- EPO threshold
  - EPO >=500: EPO 500 mU/mL or greater>= 500 mU/mL
  - EPO <500 with ESA failure: EPO less than 500 mU/mL AND no response or loss of response to erythropoiesis-stimulating agents< 500 mU/mL with documented no response or loss of response to ESAs
Erythema nodosum leprosum (ENL) - initial: Acute treatment of the cutaneous manifestations of moderate to severe ENL - Authorization of 12 months may be granted
Thalomid not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis
ENL maintenance (initial): Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL - Authorization of 12 months may be granted

Continuation Therapy (Reauthorization) Criteria

Continuation of Therapy (Reauthorization)

Criteria for continued treatment/reauthorization for previously approved indications

Reauthorization rules

No progression/unacceptable toxicity indications: For multiple myeloma, multicentric Castleman disease, histiocytic neoplasms, and Kaposi sarcoma: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen
Document absence of unacceptable toxicity and disease progression for these indications
Improvement required indications: For all other listed indications: Authorization of 12 months may be granted for continued treatment when there is improvement in symptoms and no unacceptable toxicity
Document improvement in symptoms and absence of unacceptable toxicity

Prior Authorization & Documentation Requirements

Prior Authorization

Authorization required

Prior authorization of 12 months is required for covered indications. Approval is contingent on meeting the specific indication criteria (for example, thalidomide must be given in combination with prednisone and meet the EPO threshold criteria for myelofibrosis-associated anemia).

Authorization period: 12 months
Approval requires meeting the listed indication-specific criteria

Documentation Required

EPO level and prior treatment documentation for myelofibrosis-associated anemia

Provider must document the member's serum erythropoietin (EPO) level. If EPO is less than 500 mU/mL, provider must also document no response or loss of response to erythropoiesis-stimulating agents.

EPO ≥ 500 mU/mL OR
EPO < 500 mU/mL with documented no response or loss of response to erythropoiesis-stimulating agents

Documentation Required

Toxicity / disease status documentation for reauthorization

For reauthorization, document there is no unacceptable toxicity. For multiple myeloma, multicentric Castleman disease, histiocytic neoplasms, and Kaposi sarcoma, also document absence of disease progression while on the current regimen. For other listed indications, document improvement in symptoms and no unacceptable toxicity per the continuation criteria.

Document absence of unacceptable toxicity
For MM, multicentric Castleman disease, histiocytic neoplasms, Kaposi sarcoma: document no disease progression
For other indications: document symptom improvement and no unacceptable toxicity

Background

This policy governs coverage of thalidomide (Thalomid) for FDA-approved indications and selected compendial uses. The policy explicitly covers Thalomid in combination with dexamethasone for newly diagnosed multiple myeloma and for treatment and maintenance of erythema nodosum leprosum (ENL), with a noted limitation that Thalomid is not indicated as monotherapy for ENL in the presence of moderate to severe neuritis.

In addition to FDA-approved uses, the policy lists compendial uses considered covered when criteria are met, including myelofibrosis-associated anemia, multicentric Castleman disease, aphthous stomatitis, Kaposi sarcoma, chronic graft-versus-host disease, Crohn's disease, and histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai-Dorfman disease). The policy references the Thalomid package insert and standard compendia (AHFS, NCCN, DRUGDEX, Lexicomp) as sources for these determinations.