Daratumumab (Darzalex)

Section: Injections
Effective Date: December 01, 2019
Revised Date: May 19, 2020
Last Reviewed: May 19, 2020

Description

Daratumumab (Darzalex™) is an immunoglobulin G1 kappa (IgG1k) human monoclonal antibody against CD38 antigen indicated for the treatment of individuals with multiple myeloma.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Daratumumab (Darzalex) may be considered medically necessary for the treatment of multiple myeloma in individuals 18 years of age or older who meet ANY of the following criteria:

Food and Drug Administration (FDA) Indications

  • As combination therapy with lenalidomide and dexamethasone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
  • As combination therapy with lenalidomide and dexamethasone in individuals with relapsed or refactory disease who have received at least one prior therapy; or
  • As combination therapy with bortezomib, melphalan and prednisone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
  • As combination therapy with dexamethasone and bortzomib in individuals who have received at least one prior therapy; or
  • As combination therapy with pomalidomide and dexamethasone in individuals who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; b
  • As monotherapy, in individuals who have received at least three (3) prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent; or

National Comprehensive Cancer Network (NCCN) Indications

  • Primary therapy for active (symptomatic) myeloma in combination with bortezomib, melphalan, and prednisone for non-transplant candidates;or
  • Therapy for previously treated myeloma for relapse or for progressive disease:
    • In combination with dexamethasone and bortezomib; or
    • In combination with dexamethasone and lenalidomide; or
    • As a single agent in individuals who have received at least three prior therapies, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent; b
    • In combination with pomalidomide and dexamethasone in individuals who have received at least two prior therapies including an immunomodulatory agent and a proteasome inhibitor.

The use of daratumumab (Darzalex) for and other indication is considered experimental/investigational, and therefore not covered. The safety and effectiveness cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J9145

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

C90.00C90.02C90.10C90.12C90.20C90.22C90.30
C90.32Z85.79

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-19 added 18 years of age or older to criteria, updated references

Internal Medical Policy Committee 5-19-20 Changing J9145 to per-certification drug

Links

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.