CurrentUnitedHealthcarePolicy N/A

Revlimid (lenalidomide) prior authorization

UnitedHealthcare prior authorization and notification rules for Revlimid (lenalidomide) covering indications, initial and reauthorization criteria, and REMS requirements for affected members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyRevlimid (lenalidomide) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization documentation showing the specific covered diagnosis and, for reauthorization, evidence of no disease progression or positive clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

<19 auto-approvepediatric processing rule

REMS requiredREMS

multiple hematologicdistinct diagnoses listed

patient responsereauthorization requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Pediatric automatic approval

Revlimid will be approved when the following is met:

Pediatric: Patient is less than 19 years of age

Authorization will be issued for 12 months

Multiple myeloma — Initial authorization

Revlimid will be approved when ALL of the following are met:

MM initial: Diagnosis of multiple myeloma

Authorization will be issued for 12 months

Multiple myeloma — Reauthorization

Revlimid will be approved when ALL of the following are met:

MM reauth: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Myelodysplastic syndromes (MDS) and MDS/MPN overlap — Initial authorization

Revlimid will be approved based on specified diagnostic and laboratory criteria; multiple alternative paths are allowed (OR logic).

MDS paths

MDS with del5q: Diagnosis of symptomatic anemia due to MDS associated with deletion 5q
Authorization will be issued for 12 months
MDS without del5q - path A: Sideroblasts >= 15% (or >= 5% with SF3B1 mutation) AND history of failure, contraindication, or intolerance to one of the following: luspatercept (Reblozyl) or imetelstat (Rytelo)
MDS without del5q - path B: Sideroblasts >= 15% (or >= 5% with SF3B1 mutation) AND used in combination with an erythropoiesis-stimulating agent (e.g., epoetin alfa, darbepoetin alfa) AND serum erythropoietin levels < 500 mU/mL>= 15% (or >= 5% with SF3B1 mutation); serum erythropoietin < 500 mU/mL

B-cell lymphomas — Initial authorization

Revlimid will be approved when one of the listed B-cell lymphoma diagnoses is present and other conditions apply for some diagnoses.

B-cell lymphoma initial: Diagnosis of one of the following: mantle cell lymphoma (MCL); extranodal marginal zone lymphoma (EMZL) of the stomach; extranodal marginal zone lymphoma of nongastric sites (noncutaneous); classic follicular lymphoma; splenic marginal zone lymphoma; nodal marginal zone lymphoma; diffuse large B-cell lymphoma (DLBCL); high-grade B-cell lymphoma; histologic transformation of indolent lymphomas to DLBCL; HIV-related B-cell lymphoma; post-transplant lymphoproliferative disorders

For specified diagnoses, therapy must be used as second-line and subsequent therapy where indicated; Authorization will be issued for 12 months

B-cell lymphomas — Reauthorization

Revlimid will be approved for reauthorization when ALL of the following are met:

B-cell lymphoma reauth: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Myelofibrosis-associated anemia — Initial authorization

Revlimid will be approved when ALL of the following are met:

Myelofibrosis anemia initial: (1) Diagnosis of myelofibrosis-associated anemia; (2) Presence of del(5q) mutation; and (3) No symptomatic splenomegaly and/or constitutional symptoms

Authorization will be issued for 12 months

Myelofibrosis-associated anemia — Reauthorization

Revlimid will be approved when documentation of positive clinical response is provided.

Myelofibrosis reauth: Documentation of positive clinical response while on Revlimid therapy

Hodgkin lymphoma — Initial authorization

Revlimid will be approved when ALL of the following are met:

Hodgkin lymphoma initial: Diagnosis of Hodgkin lymphoma

Hodgkin lymphoma — Initial Authorization

Covered when ALL of the following are met for Hodgkin lymphoma

Hodgkin lymphoma initial authorization: (1) Diagnosis of Hodgkin lymphoma; (2) Used for primary refractory disease or suspected relapse; (3) Patient is not a candidate for high-dose therapy and autologous stem cell rescue (HDTIASCR)

Authorization will be issued for 12 months

Hodgkin lymphoma — Reauthorization

Reauthorization criterion for Hodgkin lymphoma

Hodgkin lymphoma reauthorization: Documentation of positive clinical response while on Revlimid therapy

Authorization will be issued for 12 months

Systemic light chain amyloidosis — Initial Authorization

Covered when BOTH criteria are met for systemic light chain amyloidosis

Systemic light chain amyloidosis initial: (1) Diagnosis of systemic light chain amyloidosis; and (2) Used in combination with one of the following: dexamethasone; dexamethasone plus cyclophosphamide; dexamethasone plus ixazomib (Ninlaro); or dexamethasone plus daratumumab (Darzalex)

Authorization will be issued for 12 months

Systemic light chain amyloidosis — Reauthorization

Reauthorization for systemic light chain amyloidosis

Systemic light chain amyloidosis reauthorization: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

CLL/SLL — Initial Authorization

Covered when ALL of the following are met for CLL/SLL

CLL/SLL initial: (1) Diagnosis of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL); (2) Disease is relapsed or refractory; (3) Used after therapy with Bruton Tyrosine Kinase (BTK) inhibitor- and venetoclax-based regimens

Authorization will be issued for 12 months

CLL/SLL — Reauthorization

Reauthorization for CLL/SLL

CLL/SLL reauthorization: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

T‑cell lymphomas — Initial Authorization

Covered initial authorization criteria for T‑cell lymphomas (several subtypes)

Peripheral T‑cell lymphoma criteria: Diagnosis of peripheral T‑cell lymphoma AND either used as initial palliative intent therapy OR used as second-line and subsequent therapy

Authorization will be issued for 12 months

Adult T‑cell lymphoma criteria: Diagnosis of adult T‑cell lymphoma AND used as second-line and subsequent therapy

Authorization will be issued for 12 months

Hepatosplenic T‑cell lymphoma criteria: Diagnosis of hepatosplenic T‑cell lymphoma AND used for refractory disease after two first-line therapy regimens

Authorization will be issued for 12 months

T‑cell lymphomas — Reauthorization

Reauthorization for T‑cell lymphomas

T‑cell lymphomas reauthorization: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Primary CNS lymphoma — Initial Authorization

Covered when the following is met for primary central nervous system lymphoma

Primary CNS lymphoma initial: Diagnosis of primary central nervous system lymphoma

Authorization will be issued for 12 months

Primary CNS lymphoma — Reauthorization

Reauthorization for primary CNS lymphoma

Primary CNS lymphoma reauthorization: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Kaposi sarcoma — Initial Authorization

Covered when ALL of the following are met for Kaposi sarcoma

Kaposi sarcoma initial - HIV‑negative: Diagnosis of HIV‑negative Kaposi sarcoma

Authorization will be issued for 12 months

Kaposi sarcoma initial - HIV‑related: Diagnosis of HIV-related Kaposi sarcoma AND patient is currently treated with antiretroviral therapy (ART) AND disease has progressed or not responded to two different first-line systemic therapies (e.g., liposomal doxorubicin, sirolimus, paclitaxel)

Authorization will be issued for 12 months

Kaposi sarcoma — Reauthorization

Reauthorization for Kaposi sarcoma

Kaposi sarcoma reauthorization: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Histiocytic neoplasms — Initial Authorization

Covered when the following is met for histiocytic neoplasms

Histiocytic neoplasms initial: Diagnosis of one of the following histiocytic neoplasms: Langerhans cell histiocytosis OR Rosai‑Dorfman disease

Initial Therapy - Histiocytic Neoplasms

Covered when ALL of the following are met for histiocytic neoplasms:

Initial - histiocytic neoplasms: Diagnosis of one of the following histiocytic neoplasms: Langerhans cell histiocytosis OR Rosai-Dorfman disease

Authorization will be issued for 12 months when criteria met

Reauthorization

Reauthorization covered when the following is met:

Reauthorization - general: Patient does not show evidence of progressive disease while on Revlimid therapy

Authorization will be issued for 12 months

Initial Therapy - Multicentric Castleman Disease

Covered when ALL of the following are met for multicentric Castleman disease:

Initial - Castleman: (1) Diagnosis of multicentric Castleman disease; AND (2) One of the following: progressed following treatment of relapsed/refractory disease OR considered progressive disease

Authorization will be issued for 12 months

Compendia-supported Regimens

Covered when regimen is recognized by compendia:

NCCN/Biologics support: Drug recognized for the cancer indication by NCCN or Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Supports coverage per policy

State or federal mandates may override the coverage criteria listed in this policy. Where a state requires coverage for an off‑label use or mandates use of a specific compendium reference, that mandate supersedes the criteria and benefit language in this document.

Members under 19 years of age: prescriptions will automatically process without a coverage review, per the policy.

For the Hodgkin lymphoma initial authorization pathway, coverage is limited to patients with primary refractory disease or suspected relapse who are not candidates for high‑dose therapy and autologous stem cell rescue (HDTIASCR). This exclusion (candidate for HDTIASCR) must be documented to qualify for the Hodgkin lymphoma initial authorization criteria.

In addition to the per‑indication criteria in this policy, other UnitedHealthcare utilization management programs, site‑of‑care rules, quantity or supply limits, and benefit plan terms may affect coverage decisions. Approvals may also be governed by compendia or state mandates when applicable.

UnitedHealthcare may use automated approval logic based on prior claim or medication history, diagnosis codes, and/or claim logic; such program‑level processes can alter the review or authorization outcome.

Reauthorization of Revlimid may be denied if there is documentation of progressive disease while on therapy. Reauthorization generally requires documentation that the patient does not show evidence of disease progression or has demonstrated a positive clinical response.

Note that automated reauthorization processes based on claims or medication history may be used in some programs, but clinical evidence of progression remains a denial trigger where applicable.

Initial Therapy Criteria

inv-51: Initial authorization requirements

Initial authorization requirements — diagnosis-specific diagnostic, laboratory, and prior-treatment requirements

See coverage criteria: Refer to respective indication-specific initial authorization criteria (e.g., multiple myeloma; MDS and MDS/MPN overlap; B-cell lymphomas; myelofibrosis-associated anemia; Hodgkin lymphoma; systemic light chain amyloidosis; CLL/SLL; T-cell lymphomas; primary CNS lymphoma)

Authorization will be issued for 12 months where criteria met

inv-52: Initial therapy rules

Initial therapy rules — diagnosis-specific initial authorization criteria and typical approval duration

See per‑indication initial nodes: Refer to individual indication nodes (e.g., Hodgkin lymphoma; systemic light chain amyloidosis; CLL/SLL; T‑cell lymphomas; primary CNS lymphoma; Kaposi sarcoma; histiocytic neoplasms) for specific initial authorization requirements

Authorization usually 12 months

inv-53: Initial Therapy

Initial Therapy — consolidated initial authorization rules for covered indications

Initial authorization - general: Document the specific covered diagnosis per policy and meet indication-specific criteria such as prior progression for Castleman disease or prior therapies where required

Authorization duration typically 12 months

Continuation / Reauthorization Criteria

inv-54: Reauthorization requirements

Reauthorization requirements — evidence of lack of progression or positive clinical response required for continuation

General reauth: Patient does not show evidence of progressive disease while on Revlimid therapy OR documentation of positive clinical response (as specified by indication)

Authorization will be issued for 12 months

inv-55: General continuation/reauthorization

General continuation/reauthorization — demonstration of no disease progression while on Revlimid

General reauthorization node: Patient does not show evidence of progressive disease or has documented positive clinical response while on Revlimid therapy

Authorization typically renewed for 12 months

inv-56: Continuation Therapy / Reauthorization

Continuation Therapy / Reauthorization — reauthorization/continuation rules and required documentation

Continuation: Patient must not show evidence of progressive disease on Revlimid therapy to qualify for continuation; approvals typically for 12 months

Use of automated approval based on claims/medication history may occur

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Revlimid (lenalidomide) for members age 19 and older. Members under 19 years of age will automatically process without a coverage review and, when approved, authorizations are typically issued for 12 months.

Prior authorization required for members ≥19 years
Members <19 auto-process without coverage review
Typical authorization duration: 12 months

Note

Coverage Conditional on Meeting Listed Criteria

Coverage is conditional on meeting the diagnosis-specific and program criteria listed in this policy. State mandates, federal regulatory requirements, and the member's benefit plan may supersede or modify coverage for certain off-label uses; other utilization management programs and supply limits may also apply.

Coverage contingent on listed criteria and applicable mandates
Other policies or supply limits may affect coverage

Denial Risk

Reauthorization Denial Risk

Reauthorization may be denied if documentation does not demonstrate a positive clinical response or if there is evidence of progressive disease while on Revlimid therapy. Lack of required reauthorization documentation risks claim denial.

Reauthorization may be denied for lack of documentation of positive clinical response
Evidence of progressive disease while on therapy may prevent reauthorization

Documentation Required

Reauthorization Documentation Required

For reauthorization, providers must document the patient is not showing evidence of progressive disease or must document a positive clinical response while on Revlimid therapy, per the indication-specific reauthorization criteria. When met, reauthorizations are generally issued for 12 months.

Reauthorization requires documentation of no progressive disease or evidence of positive clinical response
Authorization length on reauthorization: typically 12 months

Step Therapy

MDS Step / Failure Requirements

For myelodysplastic syndromes (MDS) paths, prior failure, contraindication, or intolerance to specified therapies (or meeting the alternative laboratory/clinical criteria such as ring sideroblast percentage and SF3B1 mutation status, use with ESA, and serum erythropoietin thresholds) is required before approval in certain MDS indications.

MDS: history of failure/contraindication/intolerance to specified agents may be required
Alternative pathway requires ring sideroblasts ≥15% (or ≥5% with SF3B1 mutation) and other lab/therapy criteria

Step Therapy

Step Requirement for CLL / SLL

For chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), Revlimid is positioned after specific targeted regimens; approval is consistent with use after BTK inhibitor– and venetoclax-based regimens per the step requirements in the clinical criteria.

CLL/SLL: use after BTK inhibitor– and venetoclax-based regimens per policy step requirements

Step Therapy

Step / Sequence Requirement

Some indications require progression after prior relapsed/refractory treatment or documented progressive disease before Revlimid will be approved (for example, multicentric Castleman disease). Providers must document prior lines of therapy and disease progression where specified.

Certain indications require progression after relapsed/refractory treatment
Document prior therapies and progression per indication-specific criteria

Coding and Clinical Thresholds

Ring sideroblasts — laboratory threshold

Ring sideroblasts threshold>= 15% (or >= 5% with SF3B1 mutation)

Alternative threshold contextFor some MDS paths, sideroblasts threshold may be paired with additional requirements (e.g., prior therapy failure or combination with an ESA)

Use in criteria logicThreshold applies to initial authorization pathways for symptomatic MDS and MDS/MPN overlap as specified in policy

Serum erythropoietin — laboratory threshold

Serum erythropoietin — low threshold< 500 mU/mL (used when Revlimid is given in combination with an ESA)

Serum erythropoietin — high threshold>= 500 mU/mL (used with alternative MDS path requiring prior failure of hypomethylating agents)

Role in authorizationErythropoietin level is a required laboratory element in specified MDS authorization pathways

Step Therapy Requirements

Required prior failure/contraindication/intolerance
History of failure, contraindication, or intolerance to listed agents (examples cited in policy: luspatercept [Reblozyl], imetelstat [Rytelo])

Required prior therapy sequence for CLL/SLL
Revlimid must be used after prior therapy with Bruton Tyrosine Kinase (BTK) inhibitor- and venetoclax-based regimens (for relapsed or refractory CLL/SLL)

Progression criteria required for initial multicentric Castleman disease approval
Documentation of disease progression defined as either: progressed following treatment of relapsed/refractory disease	OR considered progressive disease as specified in the clinical record

Provider Action Highlights

Billing Rule

Quantity/supply limits may apply to Revlimid

Supply limits for Revlimid may be in place; UnitedHealthcare notes that supply limits may apply as part of additional clinical rules.

Note

Site‑of‑care and other programs may affect approvals; no specific restrictions listed

Other utilization management programs and site‑specific rules may apply (for example, infusion center/site‑of‑care programs), though no site‑of‑care restrictions are specified in this policy segment.

Definitions and Background

Lenalidomide (Revlimid) is an immunomodulatory agent (a thalidomide analogue) used across multiple hematologic and oncologic indications including multiple myeloma, myelodysplastic syndromes (including del(5q)), mantle cell lymphoma and various B‑cell and T‑cell lymphomas. Because lenalidomide is highly teratogenic, enrollment in the lenalidomide REMS program is required and prescribers, patients, and dispensing pharmacies must be registered.

Prior authorization is required for Revlimid except for prescriptions for members under 19 years (which process without coverage review); typical authorizations are issued for 12 months. Coverage for specific indications (initial and reauthorization) is subject to the diagnosis‑specific criteria in this policy and may be supported when the regimen is recognized by NCCN/Biologics Compendium with Category 1, 2A, or 2B evidence.

UnitedHealthcare may approve initial or reauthorization requests based solely on previous claim/medication history, diagnosis codes, and/or claim logic in certain programs; supply limits and other utilization management rules may also apply.

REMS

REMS requirementEnrollment in the lenalidomide REMS program is required due to teratogenic risk; patients, prescribers, and dispensing pharmacies must be registered

Purpose of REMSImplemented because lenalidomide can cause serious malformations in pregnancy

Reference guidancePolicy notes an extensive risk management program requiring registration of patients, prescribers, and pharmacies

High-dose therapy and autologous stem cell rescue (HDTIASCR)

Term / AbbreviationHDTIASCR = high-dose therapy and autologous stem cell rescue

Context of useReferenced as an exclusion criterion for Hodgkin lymphoma initial authorization when patient is a candidate for HDTIASCR

Authorization implicationPatients who are candidates for HDTIASCR are not eligible under the Hodgkin lymphoma initial authorization pathway

Histiocytic neoplasms / Castleman disease — examples of covered diagnoses

Covered histiocytic diagnosesLangerhans cell histiocytosis; Rosai-Dorfman disease

Multicentric Castleman diseaseCovered when diagnosis of multicentric Castleman disease is present and one of the progression criteria is met (e.g., progressed following treatment of relapsed/refractory disease or considered progressive disease)

Authorization duration/contextWhen criteria met, authorizations for these diagnoses are typically issued for 12 months

Policy Summary

PayerUnitedHealthcare

PolicyRevlimid (lenalidomide) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization documentation showing the specific covered diagnosis and, for reauthorization, evidence of no disease progression or positive clinical response.

SourceLink

On This Page

Alternative MDS path: Sideroblasts >= 15% (or < 5% with SF3B1 mutation) AND history of failure/contraindication/intolerance to hypomethylating agents (e.g., azacitidine, decitabine) AND serum erythropoietin >= 500 mU/mLsee text

MDS/MPN overlap: Diagnosis of MDS/MPN overlap neoplasm (including features such as SF3B1 mutation with thrombocytosis or ring sideroblasts with thrombocytosis - MDS/MPN-RS-T)

Authorization will be issued for 12 months