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Centene Pomalidomide Coverage Update | OpenPayer

ModifiedCentenePolicy CP.PHAR.116

Pomalidomide (Pomalyst) Coverage Criteria

Defines medical necessity, prior authorization, and coverage criteria for pomalidomide (Pomalyst) across multiple indications (including multiple myeloma and Kaposi sarcoma) for Centene lines of business.

Policy Summary

PayerCentene

PolicyPomalidomide (Pomalyst) Coverage Criteria

Policy CodePolicy CP.PHAR.116

Change TypeMaterial updates to KS indications and approval durations

Effective Date07.01.13

Next Review Date

Key ActionSubmit prior authorization with documentation of prior therapy failure and specialist consultation as specified for the indication.

SourceLink

POLICY UPDATE CHANGES

For KS, added option for off-label use in KSHV-associated inflammatory cytokine syndrome if prescribed in combination with rituximab per NCCN.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for chronic conditions.

For all indications, added redirection to generic (applied then removed and reapplied per SDC and P&T actions in 2025-2026).

Modified commercial approval duration to '12 months or duration of request, whichever is less'.

1,2,3,4 mgproduct strengths available

≥18minimum age for coverage

4 mg/dayMM dose limit

5 mg/day

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Coverage Criteria

Initial Therapy - Multiple Myeloma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of multiple myeloma (MM).
Prescribed by or in consultation with an oncologist or hematologist.
Age >= 18 years.
Failure of an immunomodulatory agent (e.g., lenalidomide, Thalomid) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), unless clinically significant adverse effects are experienced or all are contraindicated. Prior authorization may be required for immunomodulatory agents and proteasome inhibitors.
Prior auth may be required for prior therapies.
Prescribed in combination with dexamethasone, unless contraindicated or clinically significant adverse effects are experienced.
For Pomalyst requests, member must use generic pomalidomide, unless contraindicated or clinically significant adverse effects are experienced.
Pomalyst is not prescribed concurrently with lenalidomide or Thalomid.
Request meets one of the following:
- a
  - Dose does not exceed both of the following on days 1-21 of repeated 28-day cycles:
  - 4 mg per day4 mg/day
  - 1 capsule per day
- b: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

ALL of the following

Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Kaposi Sarcoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Kaposi sarcoma (KS).
Prescribed by or in consultation with an oncologist, dermatologist, immunologist, or infectious disease specialist.
Age >= 18 years.
If disease is HIV-associated/AIDS-related, Pomalyst is prescribed in combination with antiretroviral therapy.
One of the following:
- a

Initial Therapy - Systemic Light Chain Amyloidosis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of systemic light chain amyloidosis.
Prescribed by or in consultation with an oncologist or hematologist.
Age >= 18 years.
Disease is relapsed or refractory to prior therapy.
Prescribed in combination with dexamethasone.

Initial Therapy - Primary CNS Lymphoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of primary central nervous system (CNS) lymphoma.
Prescribed by or in consultation with an oncologist or hematologist.
Age >= 18 years.
Prescribed as a single agent.
Request is for one of the following:
- a

Initial Therapy - POEMS Syndrome

Covered when ALL of the following are met:

ALL of the following

Diagnosis of POEMS syndrome.
Prescribed by or in consultation with an oncologist or hematologist.
Age >= 18 years.
Prescribed in combination with dexamethasone, unless contraindicated or clinically significant adverse effects are experienced.
Prescribed for one of the following:
- a

Initial Therapy Criteria and Dosing

inv-24: Initial Therapy Summary

Initial Therapy Summary — common initial requirements across indications.

Initial Therapy Summary: Refer to indication-specific initial approval criteria (MM, KS, systemic light chain amyloidosis, primary CNS lymphoma, POEMS). Common requirements: prescribed by or in consultation with an appropriate specialist; age ≥ 18 years; use generic pomalidomide unless contraindicated; do not prescribe concurrently with lenalidomide or Thalomid; dosing must meet indication-specific limits or be supported by guidelines/literature with submitted evidence.

inv-25: Initial Therapy Dosing

Initial Therapy Dosing — dosing and initial regimen by indication.

MM initial dosing: Multiple myeloma: 4 mg PO once daily on days 1-21 of repeated 28-day cycles; maximum 4 mg/day.

KS initial dosing:

Continued / Maintenance Therapy Criteria

inv-06: Continued Therapy — All Indications in Section I

Continued Therapy — All Indications in Section I (must meet all):

Continued Therapy: 1. Member is currently receiving Pomalyst via Centene benefit or documentation supports at least 30 days of prior use; 2. Member is responding positively to therapy; 3. Member must use generic pomalidomide unless contraindicated; 4. Pomalyst is not prescribed concurrently with lenalidomide or Thalomid;>=30 days prior therapy

Continued Therapy - dose increase: 5. If request is for a dose increase, one of the following must be met: (a) For KS only: new dose does not exceed both i. 5 mg per day and ii. 2 capsules per day on days 1-21 of repeated 28-day cycles; (b) New dose does not exceed both i. 4 mg per day and ii. 1 capsule per day on days 1-21 of repeated 28-day cycles; (c) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with prescriber submission of supporting evidence.

inv-26: Continuation Therapy

Continuation Therapy — requirements for ongoing authorization and approval duration.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required. For commercial members, approval duration is 12 months or the duration of the request, whichever is less. For Medicaid and HIM (Health Insurance Marketplace/ICHRA), initial approval duration has been extended to 12 months for this maintenance medication for chronic conditions. Provider must document that the member meets all approval criteria and submit supporting clinical documentation (e.g., office chart notes, lab results).

Commercial approval duration: 12 months or duration of request, whichever is less.
Medicaid and HIM initial approval duration: 12 months (maintenance medication for chronic conditions).
Prior authorization required; prescriber must document that all approval criteria are met.

Documentation Required

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications are not authorized by default. Coverage for non‑FDA indications requires sufficient documentation of efficacy and safety in accordance with the off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace/ICHRA), and CP.PMN.53 (Medicaid). Prescribers must submit supporting evidence (peer‑reviewed literature, NCCN compendium, or other clinical justification) with the prior authorization request.

Step Therapy Requirements

Requirement

Details

Requirement to document prior therapy failure or contraindication

For Multiple Myeloma and Kaposi sarcoma, member must have documented failure of the specified prior therapies (e.g., for MM failure of an immunomodulatory agent such as lenalidomide or Thalomid and a proteasome inhibitor such as bortezomib, Kyprolis, or Ninlaro), unless clinically significant adverse effects or contraindications exist. Documentation of prior therapy or contraindication must be provided with the request.

Requirement	Details
Prior trial required	For non‑AIDS Kaposi sarcoma, prior trial and failure or inadequate response to liposomal doxorubicin and paclitaxel (unless clinically significant adverse effects or both are contraindicated) is required per NCCN before Pomalyst may be authorized.

Coding and Dose Limits

Dose limits — coding summary

MM coding-friendly summary4 mg/day and 1 capsule/day (days 1–21 of 28‑day cycle).

KS coding-friendly summary5 mg/day and 2 capsules/day (days 1–21 of 28‑day cycle).

Cycle noteDose limits specified correspond to days 1–21 of repeated 28‑day cycles unless otherwise specified.

Definitions

HAART definition

TermHAART: highly active antiretroviral therapy

ContextContinued HAART is required in AIDS‑related Kaposi sarcoma when Pomalyst is prescribed in combination with antiretroviral therapy per initial approval criteria.

Abbreviation expansionHAART = highly active antiretroviral therapy (per Appendix A).

KS (abbreviation)

AbbreviationKS: Kaposi sarcoma

Clinical noteKS diagnosis criteria appear in initial approval requirements for Kaposi sarcoma; if HIV‑associated, Pomalyst is prescribed with antiretroviral therapy.

Background

Pomalidomide is an oral thalidomide analogue used primarily in adults for relapsed/refractory multiple myeloma—commonly administered in combination with dexamethasone—and is also used for Kaposi sarcoma. The clinical evidence and prescribing considerations in this policy reflect these principal indications as well as specified off‑label hematologic and oncologic uses with defined combination regimens and dosing limits.

Revision History

2013-07-01policy_effective

Policy effective date recorded in document metadata.

2024-02-02annual_review

2Q 2024 annual review: updated terminology (Revlimid to lenalidomide) and references reviewed; P&T approval recorded May 2024.

2025-02-14annual_review

2Q 2025 annual review: revised dosing regimens in Appendix B per Clinical Pharmacology and references reviewed; P&T approval recorded May 2025.