CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Revlimid (lenalidomide) coverage and authorization criteria

Defines covered FDA-approved indications and compendial uses for lenalidomide (Revlimid), authorization durations (typically 12 months), and continuation criteria for reauthorization. Specifies that other indications are investigational/not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRevlimid (lenalidomide) coverage and authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization (typically for 12 months) for treatment of indications listed in the policy; approvals are granted when indication-specific criteria are met.

POLICY UPDATE CHANGES

No material clinical/coverage changes

6FDA-approved indications listed

14+Compendial uses listed

12Standard authorization duration (months)

Coverage Summary & Indications

This policy defines coverage for FDA-approved and compendial indications for lenalidomide (Revlimid). Listed FDA-approved and compendial uses are considered covered when all indication-specific approval criteria are met and the member has no exclusions to the prescribed therapy. The policy reflects a mixed coverage stance—certain indications are explicitly covered when criteria are satisfied while indications not listed are considered investigational/not medically necessary. Authorizations and reauthorizations are typically granted for 12 months when approval criteria and continuation requirements are met.

Indications considered covered when approval criteria are met

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

Top-level coverage condition: Indication is one of the listed FDA-approved or compendial uses; All specific approval criteria for the indication are met (as detailed per indication); Member has no exclusions to the prescribed therapy

FDA-Approved Indications (covered)

Any of the following FDA-approved indications

Multiple myeloma (MM) in combination with dexamethasone.
Multiple myeloma maintenance: Multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
MDS with del(5q): Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Previously treated follicular lymphoma (FL), in combination with a rituximab product.
Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Authorization, Duration & Provider Requirements

Prior Authorization

Authorization required for listed indications

Authorization is required for treatment of indications listed in this policy. Approvals are granted when the indication-specific criteria are met. Typical authorization durations granted are 12 months.

Authorization durations and indication-specific criteria

Multiple myeloma: Authorization of 12 months may be granted for treatment of multiple myeloma.12 months
T-cell Lymphomas
- Peripheral T-Cell Lymphomas NOS: Peripheral T-Cell Lymphomas not otherwise specified — initial palliative or subsequent therapy.12 months
- Angioimmunoblastic T-cell lymphoma — initial palliative or subsequent therapy.12 months
- Enteropathy-associated T-cell lymphoma — initial palliative or subsequent therapy.12 months
- Monomorphic epitheliotropic intestinal T-cell lymphoma — initial palliative or subsequent therapy.12 months
- Nodal peripheral T-cell lymphoma with TFH phenotype — initial palliative or subsequent therapy.12 months
- Follicular T-cell lymphoma — initial palliative or subsequent therapy.12 months
- Adult T-cell leukemia/lymphoma — subsequent therapy.12 months
- Hepatosplenic T-cell lymphoma — subsequent therapy.12 months
Primary CNS lymphoma: Authorization of 12 months may be granted for treatment as a single agent or in combination with rituximab.12 months
CLL/SLL: Authorization of 12 months may be granted for treatment as a single agent or in combination with rituximab.12 months
B-Cell Lymphomas: Authorization of 12 months may be granted for treatment for listed B-cell lymphoma subtypes, generally as subsequent therapy.12 months
See policy for detailed B-cell lymphoma subtypes
Myelodysplastic syndrome (lower risk with symptomatic anemia): Authorization of 12 months may be granted for treatment when defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), or WPSS (Very Low, Low, Intermediate) for those with symptomatic anemia.12 months
Definition: lower risk myelodysplastic syndrome
Myelofibrosis-associated anemia: Authorization of 12 months may be granted when ALL of the following are met: the requested medication will be given in combination with prednisone; the member has serum erythropoietin (EPO) levels of either: 500 mU/mL or greater OR less than 500 mU/mL and no response or loss of response to erythropoiesis-stimulating agents.12 months; EPO criteria
EPO threshold: >= 500 mU/mL or <500 mU/mL with no response or loss of response to ESAs
Systemic light chain amyloidosis: Authorization of 12 months may be granted for treatment.12 months
Classic Hodgkin lymphoma: Authorization of 12 months may be granted for treatment that is refractory to at least 3 prior lines of therapy, as a single agent.12 months; refractory to >=3 prior lines
POEMS Syndrome: Authorization of 12 months may be granted for treatment in combination with dexamethasone.12 months
Myelodysplastic/myeloproliferative neoplasms: Authorization of 12 months may be granted for treatment as a single agent or in combination with a hypomethylating agent.12 months
Kaposi Sarcoma: Authorization of 12 months may be granted for treatment as subsequent therapy.12 months
Smoldering Myeloma: Authorization of 12 months may be granted for treatment of asymptomatic high-risk smoldering myeloma.12 months
Langerhans Cell Histiocytosis: Authorization of 12 months may be granted for treatment as a single agent.12 months

Documentation Required

Document EPO and prior therapy history where required

Document serum erythropoietin (EPO) level and planned combination with prednisone when requesting treatment for myelofibrosis-associated anemia. For myelofibrosis-associated anemia the policy requires either EPO ≥ 500 mU/mL or EPO < 500 mU/mL with no response or loss of response to erythropoiesis-stimulating agents. For classic Hodgkin lymphoma document that disease is refractory to at least 3 prior lines of therapy.

Denial Risk

Denial for unlisted indications

Claims for indications not listed in Sections I.A (FDA-approved) or I.B (Compendial Uses) are considered experimental/investigational and not medically necessary, and are therefore at risk of denial.

Continuation / Reauthorization Criteria

Continuation of Therapy (Reauthorization)

Continuation of Therapy (Reauthorization): Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II; There must be no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

Indication must be listed in Section II (FDA or compendial lists)

Surface thresholds

Authorization duration12 months

Myelofibrosis-associated anemia EPO threshold>= 500 mU/mL OR < 500 mU/mL with no response or loss of response to erythropoiesis-stimulating agents

Classic Hodgkin lymphoma prior therapiesRefractory to at least 3 prior lines of therapy

Not Covered / Investigational

Not covered / Investigational

Not covered / Investigational: Any indication not listed in Sections I.A (FDA-approved) or I.B (Compendial Uses); All other indications are considered experimental/investigational and not medically necessary.

Applicable Codes

Drug identifiers (generic/name)NDCCovered

lenalidomide

Revlimid (lenalidomide) — policy addresses coverage for lenalidomide products

Clinical Evidence & References

Primary supporting references for the indications and criteria include the Revlimid (lenalidomide) package insert (Celgene) May 2022 and generic lenalidomide package information. Compendia cited as primary evidence sources are the NCCN Drugs & Biologics Compendium, Lexicomp, and DRUGDEX.

Evidence items

Primary referenceRevlimid package insert (Celgene) May 2022

Compendia - NCCNNCCN Drugs & Biologics Compendium

Compendia - LexicompLexicomp

Compendia - DRUGDEXDRUGDEX

Definitions

Lower risk myelodysplastic syndrome: Defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), or WPSS (Very Low, Low, Intermediate) when the patient has symptomatic anemia.