ModifiedWashington State Health Care AuthorityPolicy 99.39.20-2
Immune Modulators - Thalidomide Analogs
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Medicaid fee-for-service coverage and prior authorization for lenalidomide, pomalidomide, and thalidomide for specified oncology and non-oncology indications, including medical-necessity criteria, reauthorization, preferred-drug requirements, and dosage and quantity limits.
Policy Summary
PayerWashington State Health Care Authority
PolicyImmune Modulators - Thalidomide Analogs
Policy CodePolicy 99.39.20-2
Change TypeModified
Effective DateJun 1, 2026
Next Review DateN/A
Key ActionFor a non-preferred agent, document inadequate response or intolerance to at least two preferred agents, or to the single preferred agent when only one is available.
The policy updated the approved dose and quantity limits for thalidomide (Thalomid).
3Thalidomide analogs covered
6 monthsStandard authorization period
2 agentsPreferred-agent trials generally required
60 daysPomalidomide progression window
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400 mg/day
Maximum listed thalidomide dose
Covered Indications
Erythema Nodosum Leprosum (ENL)
Covered when all criteria are met:
ENL initial therapy
ALL of the following
Thalidomide is prescribed by or in consultation with an infectious disease specialist.
The patient has erythema nodosum leprosum (ENL).
ONE of
ALL of the following
If moderate to severe neuritis is present
The medication is used in combination with corticosteroids.
Corticosteroids are not tolerated or are contraindicated.
The medication is used as maintenance therapy to prevent and suppress recurrence of the cutaneous manifestations of ENL.
Follicular Lymphoma (FL)
Covered when all criteria are met:
Follicular lymphoma initial therapy
Lenalidomide is prescribed by or in consultation with an oncologist or hematologist.
The patient has follicular lymphoma (FL).
ONE of
If used as first-line treatment, lenalidomide is used in combination with another medication such as rituximab or obinutuzumab.
The patient previously received at least one prior regimen for follicular lymphoma.
Kaposi Sarcoma
Covered when all criteria are met:
Kaposi sarcoma
Pomalidomide is prescribed by or in consultation with an oncologist, dermatologist, or infectious disease specialist.
The patient has Kaposi sarcoma.
The patient has progressed on at least one prior systemic treatment, such as liposomal doxorubicin or paclitaxel, unless contraindicated.
If HIV-positive
The patient remains on highly active antiretroviral therapy.
Mantle Cell Lymphoma (MCL)
Covered when all criteria are met:
Mantle cell lymphoma
Lenalidomide is prescribed by or in consultation with an oncologist or hematologist.
The patient has mantle cell lymphoma (MCL).
Lenalidomide is used in combination with rituximab.
Marginal Zone Lymphoma (MZL)
Covered when all criteria are met:
Marginal zone lymphoma initial therapy
Lenalidomide is prescribed by or in consultation with an oncologist or hematologist.
The patient has marginal zone lymphoma (MZL).
ONE of
If used as first-line treatment, lenalidomide is used in combination with another medication such as rituximab or obinutuzumab.
The patient previously received at least one prior regimen for marginal zone lymphoma.
Multiple Myeloma (MM)
Covered when all criteria are met:
Multiple myeloma
The requested drug is prescribed by or in consultation with an oncologist or hematologist.
The patient has multiple myeloma (MM).
ONE of the following drug-specific pathways
For lenalidomide: the medication is used with dexamethasone as part of a doublet or triplet regimen, or, if used as maintenance therapy, it may be used as monotherapy.
For pomalidomide: the patient has received at least two prior treatments for multiple myeloma, including lenalidomide and a proteasome inhibitor such as bortezomib; the patient has demonstrated disease progression on or within 60 days of completion of the last therapy; and pomalidomide is used with dexamethasone as part of a doublet or triplet regimen.
Myelodysplastic Syndromes (MDS)
Covered when all criteria are met:
Myelodysplastic syndromes
Lenalidomide is prescribed by or in consultation with an oncologist or hematologist.
The patient has myelodysplastic syndrome (MDS).
The patient has lower-risk disease, such as IPSS Low or Intermediate-1; IPSS-R Very Low, Low, or Intermediate; or WPSS Very Low, Low, or Intermediate.
The patient has transfusion-dependent anemia defined as 2 or more units of red blood cells in the previous 8 weeks.
ONE of
MDS has a del(5q) abnormality.
POEMS Syndrome
Covered when all criteria are met:
POEMS syndrome
Lenalidomide is prescribed by or in consultation with an oncologist or hematologist.
The patient has POEMS syndrome.
The patient has disseminated disease, such as more than 3 bone lesions, and is not a candidate for radiation-only therapy.More than 3 bone lesions
The provider attests that the patient is not a candidate for autologous hematopoietic cell transplantation (HCT).
Lenalidomide is used in combination with dexamethasone.
Reauthorization
Reauthorization requires all criteria to be met:
Continuation response
Documentation of response to treatment, defined as improvement or stabilization of disease or symptoms.
Initial Therapy Requirements
Thalidomide for ENL
Thalidomide may be approved when all criteria are met:
ENL
Thalidomide is prescribed by or in consultation with an infectious disease specialist.
The patient has erythema nodosum leprosum (ENL).
ONE of
The medication is used for acute treatment of the cutaneous manifestations of moderate to severe ENL; when moderate to severe neuritis is present, it is used in combination with corticosteroids unless corticosteroids are not tolerated or contraindicated.
The medication is used as maintenance therapy to prevent and suppress recurrence of the cutaneous manifestations of ENL.
Reauthorization Requirements
All Covered Indications
For reauthorization, all criteria must be met:
Response to treatment
Documentation of response to treatment, defined by improvement or stabilization of disease or symptoms.
Preferred-Agent Sequencing
Step
Requirement for a non-preferred agent
Documentation needed
1
Document an inadequate response or intolerance due to a severe adverse reaction or contraindication to at least two preferred agents. If only one preferred agent exists in the class, document an inadequate response or intolerance to that one agent.
Preferred agents tried and the inadequate response or documented intolerance, severe adverse reaction, or contraindication.
Authorization and Documentation Guidance
Prior Authorization
Prior Authorization for Non-Preferred Drugs
New-to-market drugs in this class listed as non-preferred on the Apple Health Preferred Drug List require prior authorization before dispensing.
Check the current Apple Health Preferred Drug List (AHPDL) for preferred status: https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx
Prior Authorization
Six-Month Indication Authorization
When the applicable indication criteria are met, initial authorization is generally issued for 6 months. A new FDA-approved indication is reviewed case by case according to FDA labeling.
ENL: thalidomide for acute moderate-to-severe cutaneous manifestations, with corticosteroids for moderate-to-severe neuritis unless not tolerated or contraindicated, or for maintenance prevention of recurrence.
FL: lenalidomide with rituximab or obinutuzumab for first-line treatment, or after at least one prior FL regimen.
Kaposi sarcoma: pomalidomide after progression on at least one prior systemic treatment unless contraindicated; patients with HIV must remain on highly active antiretroviral therapy.
Clinical Thresholds and Disease Definitions
Pomalidomide multiple myeloma progression
ConditionMultiple myeloma
Prior treatmentAt least two prior treatments, including lenalidomide and a proteasome inhibitor such as bortezomib
Progression requirementDisease progression on or within 60 days of completion of the last therapy
Transfusion-dependent anemia2 or more units of red blood cells in the previous 8 weeks
Disease pathway
Drug-Specific Quantity Limits
Lenalidomide (Revlimid)
DrugLenalidomide (Revlimid)
Strength2.5 mg capsules
Quantity limit28 capsules per 28 days
Thalidomide (Thalomid)
DrugThalidomide (Thalomid)
50 mg capsule limit28 capsules per 28 days
100 mg capsule limit112 capsules per 28 days
Policy Definitions
Erythema nodosum leprosum (ENL)
DefinitionAn immunologic reaction to leprosy, a mycobacterial infection
Systemic manifestationMay cause fever
Neurologic manifestationMay cause neuritis
Skin manifestationsMay cause skin ulceration, pain, and redness
Myelodysplastic syndromes (MDS)
DiseaseMyelodysplastic syndrome (MDS)
Lower-risk diseaseExamples include IPSS Low or Intermediate-1; IPSS-R Very Low through Intermediate; and WPSS Very Low through Intermediate
Clinical Background
Lenalidomide, pomalidomide, and thalidomide are immunomodulatory drugs used for several oncology and selected non-oncology indications. Lenalidomide is commonly used in first-line treatment for some conditions, including myelodysplastic syndromes, and in relapsed or refractory disease for other indications such as follicular, marginal zone, and mantle cell lymphoma. Pomalidomide is generally used for relapsed or refractory disease, including multiple myeloma and Kaposi sarcoma. Thalidomide is used less often because newer second-generation agents are available, but it remains an option for multiple myeloma and erythema nodosum leprosum (ENL).
Policy Summary
PayerWashington State Health Care Authority
PolicyImmune Modulators - Thalidomide Analogs
Policy CodePolicy 99.39.20-2
Change TypeModified
Effective DateJun 1, 2026
Next Review DateN/A
Key ActionFor a non-preferred agent, document inadequate response or intolerance to at least two preferred agents, or to the single preferred agent when only one is available.
For thalidomide: the medication is used with dexamethasone or prednisone.
MDS does not have a del(5q) abnormality and serum erythropoietin is less than 500 mIU/mL, with a history of inadequate response to an erythropoiesis-stimulating agent with or without G-CSF.
MDS does not have a del(5q) abnormality and serum erythropoietin is greater than 500 mIU/mL, with a history of failure, contraindication, or intolerance to immunosuppressive therapy or demethylating agents.
MDS does not have a del(5q) abnormality and the patient has a verified SF3B1 mutation.
Oncology Indications
The requested drug may be approved when all applicable criteria are met:
Covered disease-specific pathways
Follicular lymphoma: follow the follicular lymphoma criteria.
Kaposi sarcoma: follow the Kaposi sarcoma criteria.
Mantle cell lymphoma: follow the mantle cell lymphoma criteria.
Marginal zone lymphoma: follow the marginal zone lymphoma criteria.
Multiple myeloma: follow the multiple myeloma criteria.
Myelodysplastic syndromes: follow the myelodysplastic syndromes criteria.
POEMS syndrome: follow the POEMS syndrome criteria.
MCL: lenalidomide with rituximab.
MZL: lenalidomide with rituximab or obinutuzumab for first-line treatment, or after at least one prior MZL regimen.
Multiple myeloma: document the required drug-specific regimen, including dexamethasone or prednisone, prior therapies and progression requirements for pomalidomide, and maintenance monotherapy when applicable.
MDS: document lower-risk disease, transfusion-dependent anemia, del(5q) status or applicable non-del(5q) pathway, and the required ESA, immunosuppressive, demethylating-agent, or SF3B1 evidence.
POEMS: document disseminated disease, ineligibility for autologous HCT, and use with dexamethasone.
Step Therapy
Sequence Preferred Agents First
Before requesting a non-preferred agent, document an inadequate response or intolerance due to a severe adverse reaction or contraindication to the required preferred agents.
Document failure or qualifying intolerance to at least two preferred agents when two or more preferred agents are available.
If only one preferred agent is available in the class, document inadequate response to that one agent.
Unsupported block type: documentation
Documentation Required
Submit Indication-Specific Documentation
Submit indication-specific clinical documentation supporting the requested drug, including the diagnosis, prescriber specialty or consultation, regimen, prior therapies, and relevant disease characteristics.
ENL: infectious-disease specialist involvement; diagnosis; acute versus maintenance use; cutaneous manifestations; neuritis and corticosteroid rationale when applicable.
Lymphoma and multiple myeloma: oncology or hematology involvement, diagnosis, line of therapy, prior regimens, combination or maintenance regimen, and progression details where required.
MDS: risk category, transfusion history, del(5q) status, serum erythropoietin level, ESA or other treatment history, or verified SF3B1 mutation.
POEMS: hematology or oncology involvement, disseminated disease, radiation-only suitability, transplant candidacy, and dexamethasone regimen.
Kaposi sarcoma: oncology, dermatology, or infectious-disease involvement, diagnosis, prior systemic treatment and progression, HIV status, and antiretroviral therapy.
Documentation Required
Document Response for Reauthorization
For reauthorization, document that treatment produced improvement or stabilization of the disease or symptoms. When criteria are met, reauthorization is generally issued for 6 months.
Submit an updated clinical assessment describing the response to the requested agent.
Apply the response requirement to thalidomide, lenalidomide, and pomalidomide continuation requests.
Denial Risk
Indication Criteria Must Be Met
Requests may be denied when the applicable indication, prescriber specialty, regimen, prior-treatment, disease-characteristic, or response documentation is missing or does not meet the policy criteria.
Initial requests must support all criteria for the requested indication.
Continuation requests must include documented improvement or stabilization of disease or symptoms.
A request without the required indication-specific evidence is not eligible for the six-month authorization.
Denial Risk
Insufficient Preferred-Agent History
A non-preferred agent may be denied when the request does not document qualifying failure, inadequate response, severe adverse reaction, or contraindication to the required preferred agents.
Listing preferred agents without outcomes or a qualifying reason they were ineffective or not tolerated is insufficient.
Use the current AHPDL to determine which agents are preferred.
Billing Rule
Thalidomide REMS Required
Thalidomide must be dispensed in accordance with the thalidomide Risk Evaluation and Mitigation Strategy (REMS) program because of its teratogenicity.
Confirm REMS enrollment and required dispensing safeguards before dispensing thalidomide.
MDS with del(5q) abnormality, or MDS without del(5q) abnormality meeting an applicable treatment pathway
MDS serum erythropoietin
Lower erythropoietin pathwaySerum erythropoietin less than 500 mIU/mL, with an inadequate response to an erythropoiesis-stimulating agent with or without G-CSF
Higher erythropoietin pathwaySerum erythropoietin greater than 500 mIU/mL, with failure, contraindication, or intolerance to immunosuppressive therapy or demethylating agents
Alternative pathwayVerified SF3B1 mutation
POEMS disseminated disease
DiseasePOEMS syndrome
Disseminated diseaseMore than 3 bone lesions
Radiation-only therapyThe patient is not a candidate for radiation-only therapy
Lenalidomide (Revlimid) for FL or MZL
DrugLenalidomide (Revlimid)
IndicationsFollicular lymphoma (FL) or marginal zone lymphoma (MZL)
Treatment limitUp to 12 cycles
Transfusion-dependent anemiaDefined as 2 or more units of red blood cells in the previous 8 weeks
Disease classificationThe policy distinguishes disease with and without a del(5q) abnormality
POEMS syndrome
SyndromePOEMS syndrome
Disseminated diseaseMore than 3 bone lesions, for example
Radiation-only therapyThe patient is not a candidate for radiation-only therapy
Transplant candidacyThe patient is not a candidate for autologous hematopoietic cell transplantation
Combination treatmentLenalidomide is used in combination with dexamethasone