ModifiedUnitedHealthcarePolicy 2025 P 1108-13

Thalomid (thalidomide) prior authorization

Prior authorization policy for Thalomid (thalidomide) coverage and renewal criteria for UnitedHealthcare members; includes indications, age-based processing, and REMS considerations. Affects prescribers, pharmacists, and members under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyThalomid (thalidomide) prior authorization

Policy CodePolicy 2025 P 1108-13

Change TypeAdded pediatric medulloblastoma criteriaclarified reauthorization rules

Effective Date8/1/2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added criteria for pediatric central nervous system cancers based on NCCN recommendations.

Authorization period specified as 12 months for initial and renewals.

Reauthorization requires lack of progressive disease while on therapy.

2025-08-01policy effective date

Members <19 auto-processautomatic processing for under 19

12 monthsauthorization duration

recurrent/progressiveinitial approval disease state

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pediatric medulloblastomaexplicit initial approval diagnosis

Policy Header & Overview

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for Thalomid except when prescriptions are for members under 19 years of age, which are eligible for automated processing. Automated approval and re-approval processes may vary by program or therapeutic class and UnitedHealthcare may approve based solely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Supply limits may be in place.

Prior authorization required except auto-processing for members <19
Automated approvals may be based on prior claims/medication history or ICD-10 codes
Supply limits and program-specific automation may apply

Documentation Required

Provider Actions / Documentation Requirements

Provider action — Initial authorization requirements and acceptable documentation. Coverage for initial authorization requires documentation of the specific diagnosis and any condition-specific requirements below (for example: pediatric medulloblastoma must be recurrent or progressive). Not all NCCN-recommended indications are first-line; for Kaposi sarcoma, documentation must show it is not being used as first-line therapy and, for AIDS-related Kaposi sarcoma, that the patient is on antiretroviral therapy (ART). Acceptable documentation includes clinic notes, pathology or histology reports, operative reports, prior medication or chemotherapy records, and relevant imaging or lab results. Authorization durations when specified in criteria are 12 months.

Initial Authorization — pediatric medulloblastoma: diagnosis of pediatric medulloblastoma AND disease is recurrent or progressive; auth for 12 months (when criteria met)
NCCN recognition: policy acknowledges NCCN-recommended uses including histiocytic neoplasms, Castleman disease, pediatric medulloblastoma, and Kaposi sarcoma
Coverage requires meeting the listed criteria; states may supersede for off-label uses
Automated approval limitations: auto-processing applies only for members <19; other automated approvals depend on program-specific rules and prior claims/diagnosis logic
Acceptable documentation: clinic notes, pathology/histology reports, operative reports, prior chemotherapy/medication records, imaging, lab results
Not first-line requirements: Kaposi sarcoma approvals require it not be used as first-line therapy; AIDS-related cases require concurrent ART
Supply limits and program automation: supply limits may be enforced and some approvals may be handled automatically per program

Indications and Coverage Criteria

Patients less than 19 years of age

Covered when ALL of the following are met

Age criterion: Patient is less than 19 years of age

Authorization issued for 12 months

Multiple Myeloma

Initial Authorization and Reauthorization

Initial authorization: Diagnosis of multiple myeloma

Authorization issued for 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

Provider Responsibilities & Authorization Procedures

Prior Authorization

Initial authorization: pediatric medulloblastoma (recurrent/progressive)

Initial authorization for pediatric medulloblastoma requires both a diagnosis of pediatric medulloblastoma and that the disease is recurrent or progressive; authorization will be issued for 12 months when criteria are met.

Note

Reauthorization requires no progressive disease

Reauthorization is approved only if the patient does not show evidence of progressive disease while on Thalomid therapy; reauthorizations are issued for 12 months.

Documentation Required

Regimen must have NCCN recognition (Category 1, 2A, or 2B)

The treatment regimen should be recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B to support coverage decisions.

Initial Therapy — Per-Indication Requirements

Initial therapy

Initial authorization criteria per indication

Multiple myeloma: Diagnosis of multiple myeloma

Authorization issued for 12 months

ENL: Diagnosis of moderate to severe ENL AND used for acute treatment OR used as maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence

Authorization issued for 12 months

Castleman Disease: Diagnosis of Castleman Disease with either: not used as first line therapy OR all of: therapy is for active idiopathic multicentric CD with no evidence of organ failure; used in combination with cyclophosphamide and prednisone; patient is HIV-negative; patient is HHV8-negative

Authorization issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements across indications

General reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy (for ENL, documentation of positive clinical response may be acceptable)

Authorization issued for 12 months

Reauthorization / Continuation Therapy

Reauthorization/continuation criteria

Continuation: Patient must not show evidence of progressive disease while on therapy

Authorization period: 12 months

Step Therapy & Quantity Limits

Step	Requirement
1
Thalomid is not to be used as first-line therapy for Castleman disease and Kaposi sarcoma in specified scenarios. For Castleman disease: either Thalomid is not used as first-line therapy, OR all of the following are met — therapy is for active idiopathic multicentric Castleman disease with no evidence of organ failure; used in combination with cyclophosphamide and prednisone; patient is HIV‑negative; patient is HHV8‑negative. For Kaposi sarcoma: diagnosis of HIV‑negative Kaposi sarcoma OR AIDS‑related Kaposi sarcoma in a patient receiving antiretroviral therapy (ART), AND Thalomid is not used as first-line therapy.

Step

Requirement

Thalomid is not to be used as first-line therapy for Castleman disease and Kaposi sarcoma in specified scenarios. For Castleman disease: either Thalomid is not used as first-line therapy, OR all of the following are met — therapy is for active idiopathic multicentric Castleman disease with no evidence of organ failure; used in combination with cyclophosphamide and prednisone; patient is HIV‑negative; patient is HHV8‑negative. For Kaposi sarcoma: diagnosis of HIV‑negative Kaposi sarcoma OR AIDS‑related Kaposi sarcoma in a patient receiving antiretroviral therapy (ART), AND Thalomid is not used as first-line therapy.

Process	Notes
Automated approval
Use of automated approval and re-approval processes varies by program and therapeutic class; UnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes (ICD‑10) and/or claim logic.
Supply limits
Supply limits or other utilization management programs may be in place and may limit quantity dispensed per month or per course.

Quantity limits: Thalomid (thalidomide)

Quantity limitsSupply limits may be in place for Thalomid (thalidomide)

Unit/periodPer month (pack or course) — program-specific

AutomationUse of automated approval and re-approval processes varies by program and/or therapeutic class

Definitions and Background

Thalomid (thalidomide) is a synthetic glutamic acid derivative and an immunomodulatory/antineoplastic agent. It is labeled for use in combination with dexamethasone for newly diagnosed multiple myeloma and for the acute treatment and maintenance suppression of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). The manufacturer requires participation in the Thalomid REMS program because of high teratogenic risk; patients, prescribers, and dispensing pharmacies must be registered with the REMS prior to dispensing. The NCCN also recognizes Thalomid for selected uses in histiocytic neoplasms, Castleman disease, pediatric medulloblastoma, and Kaposi sarcoma, as noted in this policy.

ENL definition and indication summary

TermErythema nodosum leprosum (ENL)

Indication summaryThalomid indicated for acute treatment of cutaneous manifestations of moderate to severe ENL and as maintenance therapy to prevent and suppress recurrence

LimitationNot indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis

Site of Care & Program Restrictions

Note

Site‑of‑care utilization management may vary (infusion center)

Utilization management and site‑of‑care rules may vary by program and therapeutic class; site‑of‑care restrictions (e.g., infusion center policies) may apply depending on the program.

Site‑of‑care restrictions are possible and depend on utilization management programs.

Revision History & References

2025-05annual review - material changeLatest

Added criteria for pediatric central nervous system cancers (including pediatric medulloblastoma) per NCCN recommendations; updated background and references.

2025-05clarification

Standardized authorization period to 12 months for initial approvals and reauthorizations.

2025-05clarification

Clarified reauthorization requirement that continued coverage is contingent on lack of progressive disease while on Thalomid therapy.

Policy Summary

PayerUnitedHealthcare

PolicyThalomid (thalidomide) prior authorization

Policy CodePolicy 2025 P 1108-13

Change TypeAdded pediatric medulloblastoma criteriaclarified reauthorization rules

Effective Date8/1/2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals issued for 12 months when criteria are met.

SourceLink

On This Page

Erythema Nodosum Leprosum (ENL)

Initial Authorization and Reauthorization

Initial authorization: (1) Diagnosis of moderate to severe erythema nodosum leprosum (ENL) AND (2) One of: used for acute treatment OR used as maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence

Authorization issued for 12 months

Reauthorization: Documentation of positive clinical response to Thalomid therapy

Authorization issued for 12 months

Castleman Disease

Initial Authorization and Reauthorization

Initial authorization option 1: Diagnosis of Castleman Disease AND not used as first line therapy

Authorization issued for 12 months

Initial authorization option 2: Diagnosis of Castleman Disease AND all of: therapy is for active idiopathic multicentric Castleman disease with no evidence of organ failure; used in combination with cyclophosphamide and prednisone; patient is HIV-negative; patient is HHV8-negative

Authorization issued for 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

Kaposi Sarcoma

Initial Authorization and Reauthorization

Diagnosis options: HIV-negative Kaposi Sarcoma OR (AIDS-related Kaposi Sarcoma AND patient is currently being treated with antiretroviral therapy [ART])

Additional initial requirements: Not used as first line therapy AND patient has immune reconstitution inflammatory syndrome (IRIS)

Authorization issued for 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

Langerhans Cell Histiocytosis and Rosai-Dorfman Disease

Initial Authorization and Reauthorization

Initial authorization: Diagnosis of Langerhans cell histiocytosis OR diagnosis of Rosai-Dorfman Disease

Authorization issued for 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

Pediatric Medulloblastoma

Initial Authorization and Reauthorization

Initial authorization: Diagnosis of pediatric medulloblastoma AND disease is recurrent or progressive

Authorization issued for 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

Initial Authorization

Covered when ALL of the following are met

Initial Authorization for pediatric medulloblastoma: (1) Diagnosis of pediatric medulloblastoma AND (2) Disease is recurrent or progressive

Authorization issued for 12 months

Reauthorization

Covered when ALL of the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Thalomid therapy

Authorization issued for 12 months

NCCN Recommended Regimens

NCCN recognition: Drug regimen is recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Supports coverage decisions

For reauthorization, Thalomid will not be supported if there is clinical evidence that the patient has progressive disease while receiving Thalomid therapy. Continued coverage requires documentation that the patient does not show evidence of disease progression on therapy; authorizations are issued for 12 months when renewal criteria are met.

Step Therapy

Not to be used as first‑line therapy in specified Castleman and Kaposi sarcoma scenarios

Thalomid must not be used as first‑line therapy in the specified scenarios for Castleman disease and Kaposi sarcoma; other required combination or prior therapies must be met per the criteria before approval.

Castleman disease: approval requires either not first‑line or meeting the combination/serology criteria (e.g., combination with cyclophosphamide and prednisone and HIV/HHV8 negative).
Kaposi sarcoma: initial criteria include HIV‑negative or AIDS‑related on ART and not used as first‑line therapy (plus IRIS where specified).

Billing Rule

Supply limits and automation may apply

Supply limits or other utilization management programs may apply and use of automated approval and re‑approval processes varies by program and therapeutic class.

Supply limits may be in place.
Automated approval processes vary by program/therapeutic class.

Documentation Required

REMS registration required for patients, prescribers, and pharmacies

Because of Thalomid's teratogenic risk, patients, prescribers, and dispensing pharmacies must adhere to the Thalomid REMS program per the manufacturer.

See Thalomid REMS ® for registration requirements.

Documentation Required

Acceptable documentation: claims, medication history, ICD‑10, or claim logic

UnitedHealthcare may approve initial or reauthorizations based on prior claim/medication history, diagnosis codes (ICD‑10) and/or claim logic as acceptable documentation for coverage decisions.

Claims or medication history and ICD‑10 coding may be used to support automated approvals.

Note

Reference documents for reviewer consultation

Reviewers may consult the Thalomid package insert, the Thalomid REMS program resources, and the NCCN Drugs and Biologics Compendium when assessing coverage requests.

Thalomid package insert (Bristol‑Myers Squibb; Dec 2022).
Thalomid REMS website.
NCCN Drugs and Biologics Compendium.

Denial Risk

Denial triggers for initial authorization and reauthorization

Initial authorizations may be denied if the diagnosis is not pediatric medulloblastoma or the disease is not recurrent/progressive; reauthorization may be denied if there is evidence of progressive disease while on Thalomid.

Denial Risk

Automated approval limited by missing claims or coding

Automated approval may be used where permitted, but lack of required prior claims/medication history or appropriate diagnosis coding/claim logic can prevent automated approvals and require manual review.

Absence of claims or medication history or missing/incorrect coding may block automated processing.

Kaposi Sarcoma: One of: HIV-negative Kaposi Sarcoma OR (AIDS-related Kaposi Sarcoma AND patient is on ART); AND not used as first line therapy; AND patient has immune reconstitution inflammatory syndrome (IRIS)

Authorization issued for 12 months

Histiocytic neoplasms: Diagnosis of Langerhans cell histiocytosis OR diagnosis of Rosai-Dorfman Disease

Authorization issued for 12 months

Pediatric medulloblastoma: Diagnosis of pediatric medulloblastoma AND disease is recurrent or progressive

Authorization issued for 12 months

Initial Therapy

Initial authorization criteria for oncology indication

Initial pediatric CNS cancer criterion: Diagnosis of pediatric medulloblastoma AND disease is recurrent or progressive

Authorization issued for 12 months

REMS — definition and reference

DefinitionRisk Evaluation and Mitigation Strategy (REMS) — a manufacturer program to manage serious safety risks associated with a drug

Thalomid REMSAn extensive REMS due to teratogenic risk requiring registration of patients, prescribers, and dispensing pharmacies

ReferenceSee Thalomid REMS website (http://www.thalomidrems.com/) and Thalomid package insert

NCCN recognition (Category 1, 2A, or 2B)

DefinitionNCCN recognition indicates the regimen is listed in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

PurposeSupports coverage decisions for cancer indications when regimen is NCCN-recognized

ReferenceNCCN Drugs and Biologics Compendium (www.nccn.org) — accessed April 10, 2025

REMS — Manufacturer reference

Manufacturer REMSThalomid REMS is maintained by the manufacturer and requires enrollment of patients, prescribers, and dispensing pharmacies due to teratogenicity

AccessAdditional information available at http://www.thalomidrems.com/

Supporting docsREMS procedures referenced in Thalomid package insert and REMS materials in the policy references

2024-05annual review

Annual review; removed criteria for myelofibrosis-associated anemia and updated background based on NCCN recommendations; renamed section D to Castleman disease and updated Kaposi sarcoma criteria.

2018-05annual review - addition

Added coverage criteria for AIDS-related Kaposi sarcoma and removed systemic light chain amyloidosis and Waldenstrom macroglobulinemia per NCCN guidelines.