CurrentNeighborhood Health Plan of Rhode IslandPolicy 2234-A

Pomalidomide (Pomalyst) coverage

Defines medical benefit coverage criteria and authorization requirements for pomalidomide (Pomalyst) for Neighborhood Health Plan of Rhode Island members, including FDA-approved and compendial uses and continuation/reauthorization rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPomalidomide (Pomalyst) coverage

Policy CodePolicy 2234-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; up to 12 months may be granted when coverage criteria for the specific indication are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration for approved indications

>=2 prior therapiesrequired prior therapies for FDA multiple myeloma indication

Compendial uses listedadditional covered indications beyond FDA labeling

2234-Adocument identifier

Coverage Criteria

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Covered Indications and Regimen-Specific Criteria

Covered when ALL of the following are met for the specific indication:

General

Indication: Multiple myeloma (FDA pathway and alternative regimens), AIDS-related or HIV-negative Kaposi sarcoma, systemic light chain amyloidosis, primary central nervous system lymphoma, POEMS syndrome

Multiple Myeloma - FDA pathway

Allowed regimens after >=2 prior therapies: In combination with elotuzumab and dexamethasone; in combination with ixazomib and dexamethasone if lenalidomide- or anti-CD-38 refractory; in combination with cyclophosphamide and dexamethasone; in combination with isatuximab-irfc and dexamethasone if bortezomib- or lenalidomide-refractory; in combination with dexamethasone; in combination with selinexor and dexamethasone; as a single agent
Authorization of up to 12 months may be granted

Multiple Myeloma - alternative regimens

Allowed regimens after >=1 prior regimen: In combination with carfilzomib and dexamethasone; in combination with bortezomib and dexamethasone if lenalidomide- or anti-CD-38 refractory; in combination with carfilzomib, daratumumab, and dexamethasone; in combination with daratumumab and dexamethasone if an immunomodulatory agent and a proteasome inhibitor were previously given and the disease is bortezomib- or lenalidomide-refractory
Authorization of up to 12 months may be granted

Systemic Light Chain Amyloidosis: Relapsed or refractory systemic light chain amyloidosis when used in combination with dexamethasone

Authorization of up to 12 months may be granted

Kaposi Sarcoma: Requested medication used in combination with antiretroviral therapy for HIV-related Kaposi sarcoma, or for HIV-negative Kaposi sarcoma

Authorization of up to 12 months may be granted

Primary CNS Lymphoma: Treatment of primary central nervous system lymphoma as a single agent

Authorization of up to 12 months may be granted

POEMS Syndrome: Treatment of POEMS syndrome in combination with dexamethasone

Authorization of up to 12 months may be granted

Continuation of Therapy: Reauthorization for up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

Covered Regimens and Indications

Indication	Allowed regimens / combinations	Coverage status
Multiple myeloma (after >=2 prior regimens including an immunomodulatory agent and a proteasome inhibitor with disease progression)
In combination with elotuzumab and dexamethasone; in combination with ixazomib and dexamethasone if lenalidomide- or anti‑CD38 refractory; in combination with cyclophosphamide and dexamethasone; in combination with isatuximab‑irfc and dexamethasone if bortezomib‑ or lenalidomide‑refractory; in combination with dexamethasone; in combination with selinexor and dexamethasone; as a single agent
Multiple myeloma (after >=1 prior regimen)
In combination with carfilzomib and dexamethasone; in combination with bortezomib and dexamethasone if lenalidomide‑ or anti‑CD38 refractory; in combination with carfilzomib, daratumumab, and dexamethasone; in combination with daratumumab and dexamethasone if prior IMiD and proteasome inhibitor were given and disease is bortezomib‑ or lenalidomide‑refractory

Indication	Regimen	Coverage status
Systemic light chain amyloidosis (relapsed or refractory)
Pomalidomide in combination with dexamethasone

Indication	Regimen	Coverage status
Kaposi sarcoma
Pomalidomide used in combination with antiretroviral therapy for HIV‑related Kaposi sarcoma, or for HIV‑negative Kaposi sarcoma

Indication	Regimen	Coverage status
Primary central nervous system lymphoma
Single‑agent pomalidomide

Indication	Regimen	Coverage status
POEMS syndrome
Pomalidomide in combination with dexamethasone

Line of Therapy Requirements

second-line

FDA multiple myeloma prior therapy requirement: At least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on or within 60 days of completion of last therapy

Applies to FDA-approved multiple myeloma indication

later-line

Alternative multiple myeloma prior therapy: At least one prior regimen for multiple myeloma with use limited to specified combinations (carfilzomib + dexamethasone; bortezomib + dexamethasone if lenalidomide- or anti-CD-38-refractory; carfilzomib + daratumumab + dexamethasone; daratumumab + dexamethasone if prior immunomodulatory agent and proteasome inhibitor were given and disease is bortezomib- or lenalidomide-refractory)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for pomalidomide (Pomalyst). Authorization of up to 12 months may be granted when coverage criteria for the specific indication are met (see coverage criteria for details). For continuation of therapy, authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Prior authorization required
Authorization duration: up to 12 months

Prior Authorization

Prior Regimen Requirements for Multiple Myeloma

For multiple myeloma, members must meet prior regimen requirements. Authorization of 12 months may be granted when either: the member has received at least two prior regimens including an immunomodulatory agent and a proteasome inhibitor and the requested regimen is one of the allowed combinations (e.g., with elotuzumab+dexamethasone; ixazomib+dexamethasone if lenalidomide- or anti‑CD38‑refractory; cyclophosphamide+dexamethasone; isatuximab‑irfc+dexamethasone if bortezomib‑ or lenalidomide‑refractory; dexamethasone; selinexor+dexamethasone; or as a single agent), or the member has received at least one prior regimen and the requested regimen is an allowed combination (e.g., carfilzomib+dexamethasone; bortezomib+dexamethasone if lenalidomide‑ or anti‑CD38‑refractory; carfilzomib+daratumumab+dexamethasone; daratumumab+dexamethasone if prior immunomodulatory agent and proteasome inhibitor were given and disease is bortezomib‑ or lenalidomide‑refractory).

Documentation Required

Drug and Reference Documentation

Prescribed drug must be pomalidomide (Pomalyst). Reference documentation required/used includes the FDA package insert for Pomalyst (Bristol Myers Squibb; March 2023) and the NCCN Drugs & Biologics Compendium (© 2024 National Comprehensive Cancer Network).

Drug: pomalidomide (Pomalyst)
References: Pomalyst package insert (March 2023); NCCN Drugs & Biologics Compendium (2024)

Denial Risk

Experimental/Investigational Exclusions

All other indications beyond the listed compendial and coverage indications (multiple myeloma, systemic light chain amyloidosis, Kaposi sarcoma, primary central nervous system lymphoma, POEMS syndrome) are considered experimental/investigational and not medically necessary and will be denied.

Background and Definitions

Pomalidomide is an immunomodulatory agent with FDA-approved and compendial indications that include multiple myeloma and Kaposi sarcoma, and compendial uses such as systemic light chain amyloidosis, primary central nervous system lymphoma, and POEMS syndrome.

Pomalyst

Generic namepomalidomide

Brand namePomalyst

Dosage forms/strengthsAll dosage forms and strengths (brand and generic) unless otherwise stated

ScopeIncludes both brand and generic pomalidomide for covered indications in this policy

ReferenceProduct listing as provided in policy (Pomalyst, Generic Name = pomalidomide)