MAO-B Inhibitors Underused in PD, CMS Proposes Decision on Aducanumab Coverage, PREMIUM II Trial of gammaCore Published

Neurology News Network for the week ending January 15, 2022. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Data from the PD MED studyshowed that lower 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores and worse long-term motor outcomes occurred for patients with Parkinson disease (PD) who took COMT inhibitors as an adjunctive treatment compared with those on MAO-B inhibitors or dopamine agonists. Findings also showed a slightly worse patient-rated quality of life on MAO-B inhibitors compared with dopamine agonists, although the differences were not significant. These medications did, however, produce equivalent disease control, with the study authors concluding that MAO-B inhibitors may be underused as an adjuvant therapy. The primary end point was change in PDQ-39 mobility scores. Outcomes were assessed before study entry, at 6 and 12 months after randomization, and annually thereafter. After a median of 4.5 years (range, 0-13 years) of follow-up, PDQ-39 mobility scores were a mean of 2.4 points better for those in the dopamine agonist group compared with the combined MAO-B and COMT groups; however, this difference was not significant.

The Centers for Medicare and Medicaid Services (CMS) has proposed that the government’s health insurance program will cover the administration of aducanumab (Aduhelm; Biogen) in the treatment of Alzheimer disease (AD) only for those patients who are partaking in CMS-approved randomized controlled trials that satisfy its coverage criteria, and those in trials supported by the National Institutes of Health (NIH), according to a recently published proposed decision memo.1 The 100 mg/mL intravenous injection was approved for use in Alzheimer disease in June 2021 with the accelerated pathway based on biomarker data, driving much discussion in the field about its potential efficacy and costs. Authored by a group including Joseph Chin, MD, MS, deputy director, Coverage and Analysis Group, and 6 others, the conclusion reached as it pertained to the clinical evidence of the monoclonal antibody (mAb) class was that “to date, no trial of an antiamyloid mAb has confidently demonstrated a clinically meaningful improvement in health outcomes (i.e., cognition and function) for AD patients.

Findings from the double-blind, sham-controlled PREMIUM II trial further reinforced the efficacy and safety of gammaCore (electrocore), a noninvasive vagus nerve stimulation (nVNS) device designed as a portable, easy-to-use technology, for the prevention of migraine, and in particular, those who have migraine with aura. The newly published data in Cephalagia continued to build on the growing efficacy profile of gammaCore since its FDA approval for the treatment of cluster headache in 2018. The study was originally powered to be randomized to 400 patients with migraine, but was closed early due to COVID-19 after enrolling 231 individuals. Those included in the study completed a 4-week diary run-in period, followed by a 12-week double-blind period where they were randomized to gammaCore nVNS. At the end of the study period, patients who were treated with the device recorded a decrease of 4.6 monthly headache days, whereas those on sham showed an increase of 3.0 days per month (= .05). Furthermore, 44.87% of those on gammaCore demonstrated at least a 50% reduction in these days, compared with 26.81% of those in the sham group

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