Multiple Myeloma denials in California external review

What the reviewers wrote

Where the denial was overturned

An enrollee has requested reimbursement and prospective authorization and coverage for Venclexta (venetoclax) 200 mg daily. A phase 1 study of Venclexta monotherapy in 66 patients with relapsed or refractory multiple myeloma with an average of five prior lines of therapy, reported an overall response rate in 21% of patients. In addition, the response rate was higher among the patients with t(11;14) genetic abnormality when compared with non-t(11;14) patients. The U.S. Food and Drug Administration (FDA) placed a hold on this study until adjustments, including the administration of prophylactic antibiotics, were instituted. Overall, Venclexta monotherapy exhibited an acceptable safety profile and evidence of single-agent activity in patients with heavily pre-treated relapsed or refractory multiple myeloma, predominantly in patients with t(11;14) abnormality.

Nature of Statutory Criteria/Case Summary: An enrollee has requested the combination of carfilzomib and daratumumab infusions for treatment of the enrollee’s multiple myeloma. Findings: The physician reviewer found that the combinations of carfilzomib and daratumumab infusions are medically necessary for treatment of the patient’s medical condition. Daratumumab (Darzalex) is a monoclonal antibody directed against CD38. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of myeloma in patients who have progressed on proteasome inhibitor or immunomodulatory agents. A phase I trial showed that daratumumab with bortezomib/dexamethasone was a safe combination (Moreau, et al).

Where the denial was upheld

Physician 1The patient is a 49-year-old woman who was discovered upon routine laboratory testing to have an elevated globulin level in mid 2003. Further workup revealed a monoclonal IgG gammopathy. Bone marrow analysis performed in August 2003 demonstrated that plasma cells comprised 40% to 50% of the cellular marrow elements. Bone series and beta2-microglobulin assay were normal, which were good prognostic factors. The patient was seen in oncologic consultation in August 2003, at which time various options were apparently discussed including the possibility of allogeneic or autologous stem cell transplant. Based upon the records submitted it does not appear that the patient has undergone treatment.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for the use of a power scooter. The records indicate that this patient has a history of multiple myeloma and degenerative disc disease. The patient initially underwent a mobility evaluation. At that time, the patient was able to ambulate in their home and in the community with the assistance of a cane or walker. The provider’s letter indicates that the patient was diagnosed with multiple myeloma and has experienced a decline in their ability to ambulate and perform daily activities. They are reported to experience increased falls. The patient has requested the use of a power scooter due to a decline in their level of mobility and function.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving multiple myeloma, then check the rights and deadlines that apply to your plan.