EFGARTIGIMOD ALFA-FCAB (VYVGART) AND EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC (VYVGART HYTRULO)
Efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) is are considered medically necessary and, therefore, covered for the treatment of adult individuals with generalized myasthenia gravis (gMG) when all of the following criteria are met:
EXPERIMENTAL/INVESTIGATIONAL
All other uses for efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo), are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.REQUIRED DOCUMENTATIONAn Individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.When coverage of efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
The safety, efficacy, and tolerability of VYVGART was demonstrated in the multicentre, randomized, placebo-controlled Phase 3 ADAPT trial. The ADAPT trial demonstrated that significantly more anti-AChR antibody-positive gMG individuals responded, based on the MG-ADL scale, following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle. Additionally, there were significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle. The most common adverse events in ADAPT trial were respiratory tract infection (33% vs 29% placebo), headache (32% vs 29% placebo), and urinary tract infection (10% vs. 5% placebo).
ADAPT trial established the effectiveness of efgartigimod alfa-fcab intravenous (IV) formulation for the treatment of AChR antibody positive generalized myasthenia gravis (gMG) in adult individuals. In trial (ADAPTsc), VYVGART HYTRULO demonstrated a comparable pharmacodynamic effect on AChR antibody reduction to the efgartigimod alfa-fcab IV formulation, which established the efficacy of VYVGART HYTRULO. This study enrolled110 individuals who were randomized and received one cycle of once weekly administrations for 4 weeks, of either VYVGART HYTRULO subcutaneously (n=55) or efgartigimod alfa-fcab intravenously (n=55).
The maximum mean reduction in AChR-Ab level was observed at week 4, with a mean reduction of 62.2% and 59.7% in the VYVGART HYTRULO SC and efgartigimod alfa-fcab IV arm, respectively. The decrease in total IgG levels followed a similar pattern.
Most common adverse events were injection site reactions occurred in 38% of individuals receiving VYVGART HYTRULO.
The primary endpoint was met, with a comparable mean reduction in total IgG with the subcutaneous versus the IV formulation. Secondary endpoints were met in 69.1% of individuals who responded on the MG-ADL score and 65.5% of individuals who responded on the QMG-score. From this study, individuals could enter an open label to receive VYVGART HYTRULO to evaluate the long-term safety and tolerability of subcutaneous formulation.
