CurrentUnitedHealthcarePolicy N/A

Immune Modulators: Thalidomide Analogues prior authorization form

This document governs prior authorization requests for thalidomide analogues (immune modulators) and collects member, provider, diagnosis, prior therapy, and indication-specific information to support coverage decisions. It affects providers requesting new or continued therapy for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Modulators: Thalidomide Analogues prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the prior authorization form to 866-940-7328 and allow at least 24 hours for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

sectioned formsections

10+indications

chart notesrequired docs

faxsubmission

Indication and Coverage Criteria

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Indication-specific coverage criteria

Coverage evaluation is based on indication-specific criteria; requests are assessed as continuation or new therapy with required supporting answers per diagnosis.

General requirements: Provider must submit completed sections A–E, medication details, ICD-10 code, chart notes, prescriber signature/specialty/date; if continuation, document clinical response (improvement or stabilization).

See chunks 1,3,4,13

Indication selection: Request must indicate one or more of listed diagnoses (Erythema nodosum leprosum, Mantle cell lymphoma, Follicular lymphoma, Marginal zone lymphoma, Kaposi sarcoma, Multiple myeloma, POEMS syndrome, Myelodysplastic syndrome, Other).

See chunk 5

Erythema nodosum leprosum (ENL) specific: For ENL, indicate whether medication is for acute treatment of cutaneous manifestations of moderate–severe ENL, presence of moderate–severe neuritis, and whether used as maintenance to prevent/suppress recurrence.

See chunk 6

Follicular Lymphoma (FL): Indicate if the requested medication is being used as first-line treatment for follicular lymphoma.

See chunk 7

Kaposi Sarcoma: Patient must have progressed on at least one prior systemic treatment (e.g., liposomal doxorubicin or paclitaxel) unless contraindicated; indicate HIV status and if HIV-positive whether patient will remain on HAART.

See chunk 8

Marginal Zone Lymphoma (MZL): Indicate if the requested medication is being used as first-line treatment for marginal zone lymphoma.

See chunk 9

Multiple Myeloma (MM): Specify agent requested (lenalidomide or pomalidomide), indicate if used as maintenance therapy, and document whether patient demonstrated disease progression on or within 60 days of completion of last therapy.

See chunk 10

Myelodysplastic Syndrome (MDS): Document lower-risk disease per IPSS/IPSS-R/WPSS, transfusion dependence (two or more units RBCs in the previous eight weeks), del(5q) status, serum erythropoietin level considerations, prior inadequate response to ESAs, intolerance/failure of immunosuppressive or demethylating agents, and SF3B1 mutation status.

See chunk 11

POEMS Syndrome: Document disseminated disease (e.g., >3 bone lesions) and not a candidate for radiation-only therapy, or document not a candidate for autologous hematopoietic cell transplantation (HCT).

See chunk 12

For Kaposi sarcoma, the form requires documentation that the patient has progressed on at least one prior systemic treatment (for example, liposomal doxorubicin or paclitaxel) unless a contraindication is documented. The form also asks the provider to indicate the patient’s HIV status and, if HIV-positive, whether the patient will remain on highly active antiretroviral therapy (HAART). Requests without documentation of prior progression or a stated contraindication to prior systemic therapy may not meet coverage criteria.

If the request does not include the indication‑specific responses or required prior therapy documentation requested on the form, the request will not meet medical necessity requirements. The form explicitly asks whether the request is for continuation of therapy and, for continuation requests, for documentation that the patient has a clinical response (defined as improvement or stabilization of disease or symptoms). Missing these condition‑specific answers or the associated chart notes and prescriber signature/date can result in denial or delay.

Initial Therapy Considerations

Initial therapy considerations

For some hematologic malignancies the form asks whether the requested medication is being used as first-line therapy.

First-line use — Follicular Lymphoma: Provider must indicate if the agent is being used as first-line treatment for follicular lymphoma.

See chunk 7

First-line use — Marginal Zone Lymphoma: Provider must indicate if the agent is being used as first-line treatment for marginal zone lymphoma.

See chunk 9

Coding and Defined Terms

Transfusion threshold

Transfusion thresholdTwo or more units of red blood cells (RBCs) in the previous eight weeks.

ContextUsed as a criterion for transfusion-dependent anemia on the prior authorization form for MDS.

Question mappingForm asks: 'Does patient have transfusion-dependent anemia defined as two or more units of red blood cells in the previous eight weeks?'.

Disease progression window for multiple myeloma

Disease progression windowPatient must have demonstrated disease progression on or within 60 days of completion of last therapy.

ApplicationSpecifically required for multiple myeloma requests (asked on the MM section of the form).

Answer optionsForm records a Yes/No response to whether progression occurred on or within 60 days of last therapy.

Transfusion-dependent anemia

DefinitionTransfusion-dependent anemia is defined on the form as two or more units of red blood cells in the previous eight weeks.

Use caseRequired documentation item for Myelodysplastic Syndrome (MDS) coverage evaluation.

Form promptQuestion 16 asks whether the patient meets this transfusion-dependent anemia definition (Yes/No).

Required Provider Actions and Submission

Prior Authorization

Submit completed PA form

Please complete the entire prior authorization form and fax it to: 866-940-7328. Allow at least 24 hours for review. If you have questions, call 800-310-6826.

Fax: 866-940-7328
Phone: 800-310-6826
Allow ≥ 24 hours for review

Documentation Required

Required submission documents

Include the following with your submission: member and provider details (member name, Member ID, DOB, contact information; provider name, NPI, specialty, phone), medication details (name, strength, directions, quantity, start date), diagnosis with ICD-10 code, indication specifics (e.g., ENL, MCL, MM, etc.), and prior treatment information. Refer to the patient’s PDL for preferred alternatives.

Member information: first/last name, Member ID, DOB, phone, address
Provider information: prescriber name, NPI, specialty, phone
Medication: name, strength, directions, quantity, start date
Diagnosis: specific diagnosis and ICD-10 code
Indication specifics: select from listed diagnoses or specify other

Documentation Required

Document prior medication trials

Document all prior medication trials on the form (medication name, strength, directions, dates of therapy) and include reason for failure or discontinuation for each. List other treatment regimens the patient has tried and check applicable prior agents (e.g., lenalidomide, proteasome inhibitors, bendamustine + rituximab, chemo regimens).

Provide dates of therapy for each prior medication
Provide specific reason for failure or discontinuation for each trial
Indicate prior regimens tried (see checklist on form)

Denial Risk

Required documentation missing

Chart notes are required with this request. Missing documentation (including chart notes), absent prescriber signature, missing prescriber specialty, or missing date may cause denial or delay of the request.

Required: chart notes documenting diagnosis and response to prior therapies
Required: prescriber signature, prescriber specialty, and date
Missing items may cause denial or delay

Medication name	Strength / directions	Dates of therapy	Reason for failure / discontinuation	Preferred alternative (PDL) referenced
(Provider-entered prior medication)
(Provider-entered strength and directions)
(Provider-entered dates of therapy)
(Provider-entered reason for failure or discontinuation)
Refer to patient’s PDL for preferred alternatives; provider must explain why preferred medications would not meet patient’s needs

Background

Thalidomide analogues are classified on the form as immune modulators and the document covers member and provider submission for these agents. The form lists multiple hematologic and related indications for these agents — including multiple myeloma, myelodysplastic syndrome (MDS), POEMS syndrome, follicular and marginal zone lymphomas, mantle cell lymphoma, erythema nodosum leprosum (ENL), and Kaposi sarcoma — and captures indication‑specific information such as use as first‑line therapy, prior systemic treatment history, transplant candidacy, and response or stabilization for continuation requests.

OpenPayer

Immune Modulators: Thalidomide Analogues prior authorization form

Indication and Coverage Criteria

Initial Therapy Considerations

Continuation of Therapy

Coding and Defined Terms

Required Provider Actions and Submission

Step Therapy and Prior Trials

Background

Definitions