Efgartigimod Alfa (Vyvgart): CADTH Reimbursement Recommendation [Internet]

Excerpt

What Is the CADTH Reimbursement Recommendation for Vyvgart?: CADTH recommends that Vyvgart be reimbursed by public drug plans for the treatment of adult patients with generalized myasthenia gravis (gMG) if certain conditions are met.

Which Patients Are Eligible for Coverage?: Vyvgart should only be covered to treat patients who have a diagnosis of class II to IV gMG based on the Myasthenia Gravis Foundation of America (MGFA) system, tested positive for anti–acetylcholine receptor (AChR) antibodies, and have a Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score of at least 5. Vyvgart should only be covered to treat patients if their symptoms persist despite a stable dose of conventional therapy with acetylcholinesterase inhibitors (AChEIs), corticosteroids (CSs), and/or nonsteroidal immunosuppressants (NSISTs).

What Are the Conditions for Reimbursement?: Vyvgart should not be reimbursed when given during a gMG exacerbation (i.e., moment when patient experience weakness in some or all muscles, without needing assistance to breath) or crisis (i.e., moment when respiratory muscles are too weak, limiting air flow in and out of lungs, and as a result, patient is unable to breathe), or within 3 months of thymectomy (i.e., surgical removal of thymus gland). Vyvgart should only be reimbursed if prescribed by or in consultation with a neurologist with expertise in managing patients with gMG, and the cost of Vyvgart is reduced. Vyvgart should not be used concomitantly with rituximab or complement inhibitors.

Why Did CADTH Make This Recommendation?:

1. Evidence from a clinical trial (ADAPT) demonstrated that treatment with Vyvgart was associated with a meaningful improvement in gMG daily activity, reduction in disease activity, and improvement in health-related quality of life for patients whom symptoms persisted despite a stable dose of conventional therapy.

2. Vyvgart met some of the identified patient needs, including sustained efficacy benefit (based on the long-term open-label extension trial ADAPT+), with manageable side effects.

3. Based on CADTH’s assessment of the health economic evidence, Vyvgart does not represent good value to the health care system at the public list price. A price reduction is therefore required.

4. Based on public list prices, Vyvgart is estimated to cost the public drug plans approximately $379 million over the next 3 years.

What Is gMG?: Myasthenia gravis (MG) is a condition that causes muscle weakness. In some patients, symptoms remain exclusive to the eyes (ocular MG); however, most patients either are diagnosed with or progress within a few years to gMG, which affects the head, neck, and other muscles. Symptoms of gMG include eyelid drooping and double vision, altered facial expression, difficulty chewing and swallowing food, difficulty speaking, and, in patients with more severe disease, problems with limb movement and breathing.

Unmet Needs in gMG: Symptom control can be achieved with standard treatment for most patients with gMG; however, in some patients, symptom control cannot be achieved with any standard treatment. For these patients, fewer treatment options exist.

How Much Does Vyvgart Cost?: Treatment with Vyvgart is expected to cost approximately $63,200 to $94,800 per patient per course, or $298,304 to $447,456 per patient per year, depending on patient weight and assuming 4.72 courses per year.