CurrentCignaPolicy CNF557

Oncology – Thalomid Prior Authorization Policy - (CNF557)

Prior authorization policy for outpatient prescription benefit coverage of Thalomid (thalidomide capsules) across Cigna-administered health benefit plans, specifying covered indications, required criteria for approval, duration of approval, not-covered uses, and revision history.

Policy Summary

PayerCigna

PolicyOncology – Thalomid Prior Authorization Policy - (CNF557)

Policy CodePolicy CNF557

Change TypeRevisions and additions (material changes to indications and criteria)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document age, prior therapies, disease status, and combination therapy when required.

SourceLink

POLICY UPDATE CHANGES

Histiocytic Neoplasms: Added new approval condition and criteria; Langerhans Cell Histiocytosis moved under Histiocytic Neoplasms and option for relapsed/refractory disease added.

Kaposi Sarcoma: Requirement that patient is ≥ 18 years and has IRIS was added; requirement for relapsed/refractory disease removed; additional medication examples added.

Medulloblastoma indication and criteria added for pediatric recurrent/progressive disease as part of MEMMAT regimen.

Castleman Disease: renamed/clarified; previous HIV/HHV-8 negativity option removed.

Policy name changed to 'Oncology (Oral - Immunomodulator) - Thalomid PA Policy' on 04/08/2025.

9Covered Indications Listed

1Not Covered Category

2026-04-22Last Review Date

Coverage Summary

Scope: This prior authorization policy applies to outpatient prescription benefit coverage of Thalomid (thalidomide capsules) across Cigna-administered health benefit plans and specifies covered indications, required criteria for approval, duration of approval, not-covered uses, and revision history.

Coverage stance: Thalomid is covered with criteria. Thalomid (Thalomid®) is covered as medically necessary for FDA‑approved indications and for selected non‑FDA uses when the specific criteria in the policy are met. For FDA‑approved uses and approved other uses, authorizations are typically provided for 1 year. Thalomid is considered not medically necessary for any other uses not listed in the policy.

Policy Snapshot

Policy NumberCNF557

SubjectThalomid prior authorization

PayerCigna

StatusCURRENT

Last Review2026-04-22

Covered Indications Listed9

Not Covered Category1

FDA-Approved Indications (Medical Necessity)

FDA-Approved Indications

Thalomid is covered as medically necessary for FDA-approved indications when criteria below are met. Approvals provided for the durations noted.

Erythema Nodosum Leprosum (ENL)

Approve for 1 year.

Multiple Myeloma subcriteria

Patient is ≥ 18 years of age
Medication is used in combination with at least two other medications
Examples include bortezomib, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, etoposide, and Kyprolis (carfilzomib intravenous infusion).

Other Uses with Supportive Evidence

Thalomid is covered for selected non-FDA indications when the specific criteria listed below are met. Approvals provided for 1 year.

Castleman Disease subcriteria

Patient has relapsed/refractory or progressive disease
Patient has multicentric disease

Discoid Lupus Erythematosus or Cutaneous Lupus Erythematosus

Approve for 1 year if the patient has tried at least two other medications.

Histiocytic Neoplasms subcriteria

Patient is ≥ 18 years of age

Conditions Not Covered

Thalomid is considered not medically necessary for any other use(s) not listed above.

Any other use(s) not specified in the policy

Criteria will be updated as new published data are available.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Thalomid (thalidomide). Approvals are provided for the duration specified per indication (typically 1 year).

Policy: CNF557
Codes: []

Documentation Required

Documentation requirements

Providers must document the following in the medical record when requesting coverage: age criteria (e.g., ≥ 18 years where required); prior therapies attempted (for indications that require failure of other agents — e.g., discoid or cutaneous lupus erythematosus requires trial of at least two other medications); disease status (for example, relapsed/refractory or progressive disease, multicentric disease for Castleman disease, IRIS or KICS status for Kaposi sarcoma where applicable); and combination therapy when indicated (for example, multiple myeloma requires thalidomide used in combination with at least two other medications).

Applicable Codes

Drug (NDC)NDCCovered

No codes listed

Definitions

IRIS: Immune reconstitution inflammatory syndrome.

KICS: Kaposi sarcoma-associated herpesvirus (KSHV)-associated inflammatory cytokine syndrome; also known as Kaposi sarcoma inflammatory cytokine syndrome.

MEMMAT regimen: Combination regimen including thalidomide, celecoxib, fenofibrate, oral etoposide, cyclophosphamide, bevacizumab, and intraventricular etoposide.

Background & Clinical Evidence

Background: Thalomid (thalidomide) is an immunomodulatory agent with FDA‑approved indications for erythema nodosum leprosum (ENL) and multiple myeloma (newly diagnosed, in combination with dexamethasone). Multiple off‑label and supportive‑evidence uses are addressed in this policy, including Castleman disease (multicentric, relapsed/refractory or progressive), histiocytic neoplasms (including Langerhans cell histiocytosis and Rosai‑Dorfman cutaneous disease), Kaposi sarcoma (including KICS), discoid or cutaneous lupus erythematosus, prurigo nodularis, recurrent aphthous ulcers/stomatitis, and pediatric medulloblastoma as part of the MEMMAT regimen.

Guideline alignment: Coverage criteria in the policy align with cited NCCN guideline recommendations for several of these uses (see evidence block for specific guideline versions).

NCCN Recommendations: Multiple NCCN guideline citations are cited to support specific uses of Thalomid: Castleman Disease (NCCN v1.2026), Histiocytic Neoplasms (NCCN v2.2025), Kaposi Sarcoma (NCCN v2.2026), Multiple Myeloma (NCCN v5.2026), and Pediatric Central Nervous System Cancers (NCCN v1.2026) recommending Thalomid in the scenarios described in the policy.

Revision History

05/29/2024revised

Histiocytic Neoplasms: Added new approval condition and criteria; Langerhans Cell Histiocytosis and Rosai‑Dorfman entries consolidated under Histiocytic Neoplasms (Langerhans Cell Histiocytosis approval condition deleted; Rosai‑Dorfman approval condition deleted).

04/08/2025revised

Administrative policy name change: policy name changed from 'Oncology - Thalomid PA Policy' to 'Oncology (Oral - Immunomodulator) - Thalomid PA Policy.'

05/14/2025revised

Castleman Disease wording updated/clarified (previous 'Castleman's Disease' naming changed; option requiring HIV/HHV‑8 negativity was removed).

Policy Summary

PayerCigna

PolicyOncology – Thalomid Prior Authorization Policy - (CNF557)

Policy CodePolicy CNF557

Change TypeRevisions and additions (material changes to indications and criteria)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document age, prior therapies, disease status, and combination therapy when required.

SourceLink

On This Page

One of (i or ii)

i. Langerhans cell histiocytosis
- a or b (Langerhans options)
  - Patient has single-system multifocal skin disease
  - Patient has relapsed or refractory disease
ii. Rosai-Dorfman: Patient has Rosai-Dorfman cutaneous disease

Kaposi Sarcoma subcriteria

Patient is ≥ 18 years of age
Patient has immune reconstitution inflammatory syndrome (IRIS)
Kaposi one of (i or ii)
- Patient has tried at least one medication
  Examples include liposomal doxorubicin, paclitaxel, sirolimus, pomalidomide, lenalidomide, imatinib, Opdivo (nivolumab intravenous infusion), and Keytruda (pembrolizumab intravenous infusion).
- Patient has Kaposi sarcoma-associated herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS)

Medulloblastoma subcriteria

Patient is < 18 years of age
Patient has recurrent or progressive disease
Medication is being used as part of the MEMMAT regimen (thalidomide, celecoxib, fenofibrate, oral etoposide, cyclophosphamide, bevacizumab, and intraventricular etoposide)

Prurigo Nodularis

Approve for 1 year if the patient has tried at least two other medications.

Recurrent Aphthous Ulcers or Aphthous Stomatitis

Approve for 1 year if the patient has tried at least two other medications.

05/14/2025revised

Kaposi Sarcoma: Added requirement that patient is ≥ 18 years and has immune reconstitution inflammatory syndrome (IRIS); requirement for relapsed/refractory disease removed; additional medication examples (including sirolimus, nivolumab, pembrolizumab) added; KSHV‑associated inflammatory cytokine syndrome (KICS) added as an approval option.

05/14/2025added

Medulloblastoma: Indication and criteria added for pediatric (<18 years) recurrent/progressive medulloblastoma when used as part of the MEMMAT regimen (approval for 1 year).

04/22/2026revisedLatest

Annual revision: Documentation notes that Histiocytic Neoplasms includes Langerhans cell histiocytosis options (including relapsed/refractory disease) and other updates consistent with NCCN guidance; history records recent changes and review date 04/22/2026.