
202106-138698
2021
CVS Caremark
Self-Funded
Central Nervous System/ Neuromuscular Disorder
Pharmacy/ Prescription Drugs
Medical necessity
Upheld
Case Summary
Diagnosis: Multiple Sclerosis
Treatment Gammagard liquid to treat MS [multiple sclerosis]
The insurer denied coverage for Gammagard liquid to treat MS
The denial is upheld
The patient has a past medical history of multiple sclerosis. The patient was being seen for the evaluation of his multiple sclerosis. The patient reported that his balance has been worse. The patient was using a cane and had not been having walking difficulties. Fear of falling was an issue for him. The patient had been utilizing Gammagard. The provider recommended continuing of Gammagard, Copaxone, and considering hand controls. The patient was also to be treated with physical therapy.
Gammagard (immune globulin infusion) is not appropriate for this patient. In a recent review of the role of immune globulin for multiple sclerosis (MS), Up to Date states "Although data are equivocal, there is no compelling evidence that intravenous immune globulin (IVIG) is effective for patients with RRMS [relapsing and remitting multiple sclerosis]. Some [206-209], but not all [210] early clinical trials reported beneficial effects for IVIG in RRMS. However, these trials generally involved small numbers of patients, lacked complete data on clinical and MRI [magnetic resonance imaging] outcomes, or used questionable methodology [211]. A later multicenter placebo-controlled trial of 127 patients with RRMS found that IVIG treatment conferred no benefit for reducing relapses or new lesions on MRI."
The patient is taking Copaxone with symptoms of disease progression. There are close to 20 effective DMT [disease modifying treatments] on the market. If the patient has failed Copaxone, they should be switched to a different DMT. The choice of the new DMT would be based on specific patient situation, as these meds are not interchangeable.
The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient.
Based on the above, the medical necessity for the Gammagard liquid to treat MS is not substantiated. The insurer's denial is upheld.