CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Daratumumab (Darzalex and Darzalex Faspro) coverage for multiple myeloma

Defines medical necessity, supported regimens, substitution rules, exclusions, and review/approval authority for IV and subcutaneous daratumumab for members receiving care under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaratumumab (Darzalex and Darzalex Faspro) coverage for multiple myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSeptember 27, 2024

Next Review DateN/A

Key ActionSubmit prior authorization to Utilization Management; final approval is by the Utilization Management Committee and requests are processed by Evolent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1-3Relapsed/Refractory window

>=3Monotherapy threshold

16 mg/kgMax IV dose

1,800 mgMax SC dose

09/27/24Policy effective

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Coverage Criteria for Daratumumab

Multiple Myeloma - Supported and Not Supported Regimens

Covered when any one of the following regimen-specific conditions is met for multiple myeloma:

Newly diagnosed, transplant eligible: Daratumumab in combination with lenalidomide + bortezomib +/- steroid is supported for transplant-eligible newly diagnosed multiple myeloma.

See chunk 6

Newly diagnosed, transplant ineligible regimens: Daratumumab + lenalidomide +/- steroid, or daratumumab + bortezomib + thalidomide +/- steroid are supported for transplant-ineligible newly diagnosed multiple myeloma.

See chunk 6

Regimen not supported (newly diagnosed): Daratumumab + carfilzomib + lenalidomide +/- steroid is NOT supported for newly diagnosed multiple myeloma (transplant eligible or ineligible) except when the member is intolerant to or has a contraindication to bortezomib; alternative regimens should be considered.

See chunk 6 NOTE 2

Relapsed/Refractory after 1-3 prior therapies: Covered regimens include daratumumab + carfilzomib +/- steroid; daratumumab + pomalidomide +/- steroid; daratumumab + lenalidomide +/- steroid; daratumumab + bortezomib +/- cyclophosphamide +/- steroid.1-3 prior therapies

See chunk 6

Monotherapy criteria: Daratumumab monotherapy is supported for members who have failed 3 prior lines of therapy or are double refractory to a proteasome inhibitor and an immunomodulatory agent.>=3 prior lines or double refractory

See chunk 6 and policy definitions

Regimen not supported (relapsed/refractory): Daratumumab + selinexor +/- steroid is NOT supported per policy (insufficient Level 1 evidence compared to recommended alternatives).

See policy exclusions and not medically necessary sections

Coverage will be denied when any of the following exclusion criteria apply: disease progression that occurred while the member was receiving a daratumumab-containing regimen (IV or SC) or while on an isatuximab-containing regimen; dosing that exceeds the stated single-dose limits — Darzalex (IV) 16 mg/kg or Darzalex Faspro (SC) 1,800 mg; or use that is investigational or off-label without sufficient supporting evidence as defined by CMS-recognized compendia or acceptable peer‑reviewed literature. The policy outlines criteria for determining sufficiency of evidence, including representation of the patient population and regimen in published studies and clinically meaningful outcomes (e.g., ASCO-recommended thresholds).

Certain daratumumab combinations and indications are explicitly not supported by this policy. Examples include daratumumab + selinexor +/- steroid for relapsed/refractory multiple myeloma, which is not supported due to lack of Level 1 evidence. For newly diagnosed disease, daratumumab + carfilzomib + lenalidomide +/- steroid is not supported except when bortezomib is contraindicated or not tolerated; in those limited cases alternative regimens may be considered. Requests for regimens listed as not supported are considered not medically necessary under this policy.

Supported Regimens and Indications

Regimen	Indication	Coverage status
Daratumumab + lenalidomide + bortezomib +/- steroid	Newly diagnosed multiple myeloma — transplant eligible	Covered

Regimen	Indication	Coverage status
Daratumumab + lenalidomide +/- steroid	Newly diagnosed multiple myeloma — transplant ineligible	Covered
Daratumumab + bortezomib + thalidomide +/- steroid	Newly diagnosed multiple myeloma — transplant ineligible	Covered

Regimen	Indication	Coverage status
Daratumumab + carfilzomib + lenalidomide +/- steroid	Newly diagnosed multiple myeloma (general)	Not covered except when bortezomib contraindicated/intolerant

Regimen	Indication	Coverage status
Daratumumab + carfilzomib +/- steroid	Relapsed/Refractory multiple myeloma after 1-3 prior therapies	Covered
Daratumumab + pomalidomide +/- steroid	Relapsed/Refractory multiple myeloma after 1-3 prior therapies	Covered
Daratumumab + lenalidomide +/- steroid	Relapsed/Refractory multiple myeloma after 1-3 prior therapies	Covered
Daratumumab + bortezomib +/- cyclophosphamide +/- steroid	Relapsed/Refractory multiple myeloma after 1-3 prior therapies	Covered

Regimen	Indication	Coverage status
Daratumumab monotherapy	Members who failed 3 prior lines of therapy or are double refractory to a proteasome inhibitor and an immunomodulatory agent	Covered

Regimen	Indication	Coverage status
Daratumumab + selinexor +/- steroid	Relapsed/Refractory multiple myeloma	Not covered

Line of Therapy Definitions and Rules

first-line | second-line | salvage

First-line (newly diagnosed): Specific daratumumab-containing combinations supported for transplant eligible and ineligible newly diagnosed multiple myeloma as listed in policy (see supported regimens for transplant-eligible and transplant-ineligible members).

Relapsed/Refractory (1-3 prior therapies): Specific daratumumab-containing regimens supported for relapsed/refractory disease after 1-3 prior therapies (including combinations with carfilzomib, pomalidomide, lenalidomide, or bortezomib +/- adjunct agents/steroids).

Late-line monotherapy: Daratumumab monotherapy is supported for members who have failed 3 prior lines of therapy or are double refractory to a proteasome inhibitor and an immunomodulatory agent.

Dose Limits and Coding Notes

Maximum single dose limits — daratumumab formulations

Daratumumab (IV) maximum single dose16 mg/kg per single IV administration

Darzalex Faspro (SC) maximum single dose1,800 mg per single subcutaneous administration

Policy consequence for exceeding limitsRequests exceeding these single-dose limits are listed in exclusion criteria and are subject to denial

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Darzalex (daratumumab IV) and Darzalex Faspro (daratumumab SC). All medication requests are reviewed by the Utilization Management (UM) Department; final approval authority resides with the Utilization Management Committee.

Review: Utilization Management Department
Final approval: Utilization Management Committee

Note

Continuation Exemption Criteria

Continuation (renewal) requests may be exempt from initial policy requirements when all of the following are met: the requested medication was used within the last year, the member has not experienced disease progression and has had no intolerance to the medication, and no additional medications are being added to the continuation request.

Key Definitions

Double refractory

DefinitionFailure to respond to or progression on both a proteasome inhibitor and an immunomodulatory agent

Proteasome inhibitor examplesBortezomib, carfilzomib, ixazomib

Immunomodulatory agent examplesLenalidomide, pomalidomide, thalidomide

Transplant eligible / ineligible

Purpose of designationClinical classification to differentiate recommended daratumumab-containing induction regimens for newly diagnosed multiple myeloma

Transplant-eligible regimensDaratumumab + lenalidomide + bortezomib +/- steroid (supported for transplant-eligible patients)

Background and Clinical Context

Daratumumab is an anti‑CD38 monoclonal antibody used in the treatment of multiple myeloma in both intravenous and subcutaneous formulations (Darzalex IV and Darzalex Faspro SC). It is used across newly diagnosed and relapsed/refractory settings as monotherapy and in combination regimens. The policy permits substitution of subcutaneous Darzalex Faspro for IV daratumumab for all listed indications and aligns coverage with FDA labeling and major oncology compendia and guidance.