Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Darzalex (Daratumumab) and Darzalex Faspro require prior authorization.

2)    Darzalex is used to treat multiple myeloma.

3)    Darzalex is a specialty medication covered under the medical benefit.

Darzalex (Daratumumab) or Darzalex Faspro is considered medically necessary for patients meeting the following criteria:

A. Multiple Myeloma (must meet all):

1)    Diagnosis of MM;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Age ≥ 18 years;

4)    Darzalex or Darzalex Faspro is prescribed in one of the following ways (a or b):

a.    Primary therapy (i or ii):

                                          i.    Ineligible for ASCT (1 or 2):

1.    In combination with lenalidomide* and dexamethasone;

2.    In combination with bortezomib*, melphalan, and prednisone;

                                        ii.    Eligible for ASCT in combination with one of the following:

1.    bortezomib*, thalidomide*, and dexamethasone;

2.    bortezomib*, lenalidomide*, and dexamethasone;

3.    bortezomib*, cyclophosphamide, dexamethasone;

4.    carilzomib*, lenalidomide*, and dexamethasone;

b.    Subsequent therapy (I, ii, or iii):

                                          i.    In combination with dexamethasone and either lenalidomide*, bortezomib* (with or without cyclophosphamide), carfilzomib*, or Xpovio* after ≥ 1 prior

                                        ii.    In combination with pomalidomide* and dexamethasone after ≥ 1 prior therapies, including both of the following:

1.    An immunomodulatory agent (e.g., thalidomide*, lenalidomide*);

2.    A PI (e.g., ixazomib*, bortezomib*, carfilzomib*);

iii. As monotherapy after > 3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PA and an immunomodulatory agent;

5)    Request meets one of the following (a or b):*

a.    Dose does not exceed the FDA dosing limits.

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

B. Systemic Light Chain Amyloidosis (must meet all):

1)    Diagnosis of systemic light chain amyloidosis;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Age ≥ 18 years;

4)    Member meets one of the following (a or b):

a.    Darzalex Faspro is prescribed in combination with bortezomib*, cyclophosphamide, and dexamethasone;

b.    Darzalex or Darzalex Faspro is prescribed for relapsed or refractory disease after ≥ 1 prior therapy (e.g., bortezomib*, lenalidomide*) (off-label**);

5)    Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*

Continued Therapy

All Indications above (must meet all):

1. Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Darzalex of Darzalex Faspro for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed the maximum indicated;

b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

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

Approval duration: 12 months

1)    Darzalex Product Information. Janssen Biotech, Inc. Horsham, PA.  September 2019.

2)    Darzalex Faspro Product Information. Janssen Biotech, Inc. Horsham, PA. August 2020.

3)    Clinical Pharmacology. Accessed online 04-09-2021

4)    NCCN Drugs & Biologics Compendium. Accessed online 04-09-2021.

5)    Darzalex FasPro Prescribing Information. Horsham, PA: Janssen Biotceh, Inc.; January 2021.

6)    Kaufman GP, Schrier SL, Lafayette RA, et al. Daratumumab yields rapid and deep hematologic responses in patients with heavily pretreated AL amyloidosis. Blood. 2017; 130(7): 900-902.

7)    Palladini G, Kastritis E, Maurer MS, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020;136(1):71-80. doi: 10.1182/blood.2019004460.

Addendum:

1)    Effective 01/01/2017: added J9145 as appropriate code for Darzalex

2)    Effective 04/01/2020: Updated for additional coverage criteria for multiple myeloma.

3)    Effective 10/01/2020: Updated to include Darzalex Faspro (C9062) to coverage.

4)    Effective 01/01/2021: Updated code C9062 is being replaced by code J9144.

5)    Effective 06/01/2021: Updated multiple myeloma criteria, added systemic light chain amyloidosis.

6)    Effective 11/01/2023: Updated multiple myeloma criteria and added continued therapy criteria.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.