Anthem Blue Cross California Darzalex (daratumumab) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj). Daratumumab is a human anti-CD38 monoclonal antibody that is FDA approved for newly diagnosed and relapsed/refractory multiple myeloma (MM). Darzalex is administered intravenously, with weight based dosing, over hours. Darzalex Faspro is a subcutaneous dosage form that allows for flat dosing and is administered over 3-5 minutes. The National Comprehensive Cancer Network® (NCCN) provides category 2A recommendations for the use of daratumumab. Approved and recommended uses are listed below. Newly diagnosed multiple myeloma: • Ineligible for stem cell transplant:     In combination with bortezomib, melphalan, and prednisone In combination with lenalidomide and dexamethasone In combination with cyclophosphamide, bortezomib, and dexamethasone (NCCN 2A) In combination with carfilzomib, lenalidomide, and dexamethasone (DP BIIa) • Eligible for stem cell transplant:     In combination with bortezomib, thalidomide, and dexamethasone In combination with bortezomib, lenalidomide, and dexamethasone (NCCN 2A) In combination with cyclophosphamide, bortezomib, and dexamethasone (NCCN 2A) In combination with carfilzomib, lenalidomide, and dexamethasone (NCCN 2A) Relapsed or refractory multiple myeloma: • • • In combination with lenalidomide and dexamethasone In combination with bortezomib and dexamethasone In combination with pomalidomide and dexamethasone in those who have received at least 2 prior therapies (or 1 prior line of therapy) including lenalidomide and a proteasome inhibitor (Label, NCCN 2A) • As a single agent in those who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent In combination with carfilzomib and dexamethasone In combination with cyclophosphamide, bortezomib, and dexamethasone (NCCN 2A) In combination with selinexor and dexamethasone (NCCN 2A) • • • Maintenance therapy for multiple myeloma: • As a single agent for transplant candidates after response to primary myeloma therapy (NCCN 2A) or for response or stable • disease following transplant (NCCN 1) In combination with lenalidomide for transplant candidates (high risk disease only) after response to primary myeloma therapy (NCCN 2A) or for response or stable disease following transplant (NCCN 1) Emerging data from prospective and retrospective studies indicate Darzalex and/or Darzalex Faspro produce clinically meaningful responses in patients with systemic light chain amyloidosis. Most recently, the FDA has approved Darzalex Faspro for the treatment of light chain amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. This indication is under accelerated approval and continued approval may be contingent upon confirmatory trials. It is not indicated and not recommended for treatment of light chain amyloidosis in individuals who have NYHA class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. There is also evidence to support Darzalex as a single agent or in combination with dexamethasone with or without bortezomib in relapsed or refractory systemic light chain amyloidosis (Kimmich 2020, Roussel 2020). Other Uses 1 The National Comprehensive Cancer Network® (NCCN) provides a category 2A recommendation for the use of daratumumab in combination with venetoclax and dexamethasone for patients with t(11;14) as useful in certain circumstances for previously treated multiple myeloma. Guidelines have not been updated with literature and discussion support for this recommendation to date. Definitions and Measures Line of Therapy: • First-line therapy: The first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy or a combination of these therapies. • Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression. • Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression. Multiple myeloma: A type of cancer that begins in plasma cells (white blood cells that produce antibodies). Plasma cell leukemia: A rare and aggressive form of multiple myeloma characterized by high levels of plasma cells in the peripheral blood. Proteasome inhibitors: A class of drugs used to treat multiple myeloma that work by blocking the action of proteasomes which are cellular complexes that break down proteins. Examples include bortezomib, carfilzomib and ixazomib. Refractory Disease: Illness or disease that does not respond to treatment. Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) Requests for Darzalex (daratumumab) or Darzalex Faspro (daratumumab and hyaluronidase-fihj) may be approved if the following criteria are met: I. II. Individual has a diagnosis of multiple myeloma, including plasma cell leukemia; AND Individual is using for one of the following: A. Newly diagnosed multiple myeloma for those who are ineligible for stem cell transplantation: 1. In combination with melphalan, prednisone and a proteasome inhibitor (PI) (for example, bortezomib); OR 2. In combination with lenalidomide and dexamethasone; OR B. Newly diagnosed multiple myeloma for those who are eligible for stem cell transplant, in combination with bortezomib, dexamethasone, and either thalidomide or lenalidomide (Label, NCCN 2A); OR C. Newly diagnosed multiple myeloma in combination with carfilzomib, lenalidomide, and dexamethasone; OR D. Newly diagnosed multiple myeloma in combination with cyclophosphamide, bortezomib, and dexamethasone; OR E. Relapsed or refractory multiple myeloma (Label, NCCN 2A): 1. As a single agent following therapy with at least two prior lines of therapy including a PI (for example, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (for example, thalidomide, lenalidomide, or pomalidomide); OR 2. In combination with cyclophosphamide, bortezomib, and dexamethasone; OR 3. In combination with selinexor and dexamethasone; OR 4. As combination therapy following treatment with at least one prior line of therapy when used with one of following: a. A PI (for example, bortezomib, carfilzomib, or ixazomib) and dexamethasone; OR b. An immunomodulatory agent (for example, thalidomide, lenalidomide, or pomalidomide) and OR dexamethasone; F. As single-agent maintenance therapy for multiple myeloma in transplant candidates (NCCN 2A); OR 2 G. In combination with lenalidomide for maintenance therapy of high-risk multiple myeloma in transplant candidates (NCCN 2A); OR III. IV. V. OR. VI. VII. Individual has a diagnosis of systemic light chain amyloidosis; AND Individual is using as a single agent (NCCN 2A); OR Individual is using in combination: A. Bortezomib, cyclophosphamide, and dexamethasone; OR B. Dexamethasone with or without bortezomib (DP B IIa); Individual has a diagnosis of pediatric Acute Lymphoblastic Leukemia (ALL), as T-ALL (NCCN 2A); AND Individual is using a daratumumab-containing regimen (e.g. daratumumab, vincristine, pegaspargase or calaspargase, doxorubicin, and prednisone or dexamethasone) for relapsed/refractory T-ALL. Requests for Darzalex (daratumumab) or Darzalex Faspro (daratumumab and hyaluronidase-fihj) may not be approved if the above criteria are not met and for all other indications not included above. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J9145 J9144 ICD-10 Diagnosis C90.00-C90.32 C91.00-C91.02 E85.0-E85.9 Z51.11-Z51.12 Z85.79 T86.5 Z94.84 Document History Injection, daratumumab, 10 mg [DARZALEX] Injection, daratumumab, 10 mg and hyaluronidase-fihj [Darzalex Faspro] Multiple myeloma and malignant plasma cell neoplasms Acute lymphoblastic leukemia Amyloidosis Encounter for antineoplastic chemotherapy and immunotherapy Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues Complications of stem cell transplant Stem cells transplant status Revised: 11/17/2023