CurrentCignaPolicy N/A

Oncology (Oral - Immunomodulator) - Pomalidomide Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of pomalidomide (Pomalyst and generic) for oncology indications under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - Immunomodulator) - Pomalidomide Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevisions include broadened prior-regimen language and clarified CNS lymphoma criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are granted for 1 year when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

Multiple myeloma requirement revised from 'received at least one lenalidomide-containing regimen' to 'tried at least one other regimen' with examples added.

Primary CNS lymphoma approval language clarified to include patients not candidates for high-dose methotrexate or intolerant to it.

Policy name changed from 'Oncology - Pomalyst PA Policy' to 'Oncology (Oral - Immunomodulator) - Pomalyst PA Policy'.

Generic pomalidomide was added to the policy with the same criteria as Pomalyst and policy name was changed to 'Oncology (Oral - Immunomodulator) - Pomalidomide PA Policy'.

1 yearapproval duration for covered indications

≥18minimum age requirement

FDA + other usescoverage scope

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.

Medical Necessity & Coverage Criteria

FDA-Approved Indication: Kaposi Sarcoma

Covered when the following criteria are met for FDA-approved indications:

Kaposi Sarcoma: Approve for 1 year if BOTH A and B are met

A) Patient is >= 18 years of age; AND B) Patient meets ONE of: i) Patient is HIV-negative; OR ii) BOTH a) Patient is HIV-positive AND b) patient continues to receive highly active antiretroviral therapy (HAART).

FDA-Approved Indication: Multiple Myeloma

Covered when the following criteria are met for FDA-approved indications:

Multiple Myeloma: Approve for 1 year if BOTH A and B are met

A) Patient is >= 18 years of age; AND B) Patient has tried at least one other regimen (examples provided).

Other Use: POEMS Syndrome

Covered when the following criteria are met for other uses with supportive evidence:

POEMS Syndrome: Approve for 1 year if BOTH A and B are met

A) Patient is >= 18 years of age; AND B) The medication is used in combination with dexamethasone.

Other Use: Primary CNS Lymphoma

Covered when the following criteria are met for other uses with supportive evidence:

Primary Central Nervous System Lymphoma: Approve for 1 year if patient meets ONE of the following

A) Patient has relapsed or refractory disease; OR B) According to the prescriber, the patient is not a candidate for high-dose methotrexate; OR C) Patient has had intolerance to high-dose methotrexate.

Other Use: Systemic Light Chain Amyloidosis

Covered when the following criteria are met for other uses with supportive evidence:

Systemic Light Chain Amyloidosis: Approve for 1 year if ALL of A, B, and C are met

A) Patient is >= 18 years of age; AND B) The medication is used in combination with dexamethasone; AND C) Patient has tried at least one other regimen (examples provided).

Pomalidomide (Pomalyst and generic pomalidomide) is considered not medically necessary for any uses not specifically listed in this policy. Coverage is limited to the indications and clinical criteria detailed elsewhere in this document; criteria will be updated as new published data become available.

Any other uses beyond those specified in this policy are considered not medically necessary. Requests for indications not described in the policy will be denied unless and until supportive evidence is added and the policy is revised.

Example Prior Regimens to Satisfy Prior Therapy Requirement

Example prior regimen
Darzalex (daratumumab) or Darzalex Faspro + lenalidomide + bortezomib + dexamethasone
Bortezomib / lenalidomide / dexamethasone
Kyprolis (carfilzomib) + lenalidomide + dexamethasone
Sarclisa (isatuximab) + bortezomib + lenalidomide + dexamethasone
Darzalex or Darzalex Faspro + lenalidomide + dexamethasone
Bortezomib + cyclophosphamide + dexamethasone
Kyprolis (carfilzomib) + cyclophosphamide + dexamethasone
Lenalidomide + dexamethasone
Melphalan +/- bortezomib + dexamethasone
Daratumumab (Darzalex or Darzalex Faspro) + cyclophosphamide + bortezomib + dexamethasone

Product & Coding Information

Covered productsNDC | drugCovered

Pomalyst / pomalidomide

Pomalyst (pomalidomide capsules) and generic pomalidomide (drug products referenced for prior authorization)

Age requirement (inv-09)

Minimum patient age≥ 18 years for most covered indications (Kaposi sarcoma, multiple myeloma, POEMS, systemic light‑chain amyloidosis)

Applies to which indicationsKaposi sarcoma; Multiple myeloma; POEMS syndrome; Systemic light chain amyloidosis; (Primary CNS lymphoma has separate criteria)

Approval durationApprovals are granted for 1 year when coverage criteria are met

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of pomalidomide. Typical approvals are issued for a 1-year duration; requests should specify the requested duration and expected treatment plan.

Prior authorization required for all FDA‑approved and supported off‑label indications listed in this policy
Standard approval duration: 12 months (1 year)

Step Therapy

Prior Regimen Requirement

For indications that require prior treatment, the prescriber must document that the patient has tried at least one other appropriate regimen before starting pomalidomide. Examples of acceptable prior regimens are provided in the Covered Regimens section and include combination therapies such as daratumumab (Darzalex or Darzalex Faspro)‑containing regimens, bortezomib/lenalidomide/dexamethasone, carfilzomib (Kyprolis)‑based combinations, and cyclophosphamide‑containing regimens.

Multiple Myeloma: patient must have tried ≥ 1 other regimen (examples: Darzalex ± lenalidomide/dexamethasone combos; bortezomib/lenalidomide/dexamethasone; Kyprolis/lenalidomide/dexamethasone)

Line of Therapy Specifications

second-line | subsequent

Second-line | Subsequent Therapy: Patient has tried at least one other regimen

Examples of other regimens are provided in policy (e.g., daratumumab-containing regimens, bortezomib/lenalidomide/dexamethasone, carfilzomib-containing regimens).

Key Definitions

POEMS definition (inv-15)

AcronymPOEMS = polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes

Context in policyRecognized indication: pomalidomide + dexamethasone is listed as an induction/management option for POEMS syndrome

Use criteriaCoverage: approve for 1 year if patient is ≥ 18 years and medication is used in combination with dexamethasone

Clinical Background

Pomalidomide is an oral immunomodulatory agent and a derivative of thalidomide that is used in oncology to treat selected hematologic malignancies and related syndromes. Its antineoplastic activity is mediated by multiple mechanisms including immune modulation, anti-angiogenic effects, and direct anti-tumor activity. In clinical practice pomalidomide is used for FDA-approved indications such as Kaposi sarcoma and multiple myeloma (typically in combination with dexamethasone after prior therapies), and it is also employed for select non‑FDA‑approved hematologic conditions supported by guideline or literature evidence (for example, POEMS syndrome, primary CNS lymphoma in certain situations, and systemic light chain amyloidosis).