Ultomiris (ravulizumab) now publicly reimbursed in gMG

April 7, 2026
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ADVERTORIAL – Sponsored by Alexion, AstraZeneca Rare Disease

PrUltomiris® (ravulizumab) now publicly reimbursed for adult anti-AchR-antibody-positive generalized myasthenia gravis in Ontario, Alberta, Nova Scotia, Saskatchewan, Newfoundland and Labrador, and NIHB

Alexion, AstraZeneca Rare Disease is pleased to announce that as of March 26, 2026, ravulizumab (Ultomiris) is listed in Ontario through the Exceptional Access Program (EAP) for the treatment of adult patients with anti-anticholinergic receptor (AChR) antibody-positive generalized myasthenia gravis (gMG).

Ultomiris is a monoclonal antibody that binds to the complement protein C5 with high affinity, inhibiting its cleavage into C5a (an anaphylatoxin) and C5b, preventing formation of the membrane attack complex (MAC).

Ontario EAP eligibility criteria details are below. Public coverage is also currently available in Alberta, Nova Scotia, Saskatchewan, Newfoundland and Labrador, and through the Non Insured Health Benefits (NIHB) program for First Nations and Inuit. Private insurance coverage for Ultomiris is also available; eligibility may vary by plan.

Click on the links to access the formulary listings:

The Ontario EAP reimbursement criteria are as follows:

Ravulizumab may be initiated in adult patients with gMG who meet ALL the following criteria:

  1. The patient is at least 18 years old;
  2. The patient has a positive serologic test for anti-acetylcholine receptor antibodies (anti-AChR-Ab+);
  3. The patient has been diagnosed with gMG that is class II to IV based on the Myasthenia Gravis Foundation of America (MGFA) scale;
  4. Prior to initiating therapy, the patient has a baseline Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score >6;
  5. The patient’s gMG symptoms persist despite an adequate use and stable dose of the following conventional therapies for anti-AChR-Ab+ MG in the 12 months preceding the request:
  • Acetylcholinesterase inhibitors (AChEIs), such as pyridostigmine; AND
  • One or more of the following:
    1. corticosteroids, such as prednisone;
    2. corticosteroids, such as prednisone, and the sequential or concomitant use of a regimen of nonsteroidal immunosuppressants (NSISTs), such as of azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus, as appropriate to manage the Patient’s gMG flare, symptoms, or both;
    3. a regimen of NSISTs, such as of azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus, as appropriate to manage the patient’s gMG flare, symptoms, or both; or
    4. a regimen of rituximab, provided that the patient did not respond or had a rapid relapse following response and is not able to use NSISTs or corticosteroids to treat their anti-AChR-Ab+ MG;
  1. The patient is not initiating therapy with ravulizumab while experiencing a gMG exacerbation or crisis;
  2. The patient is not initiating therapy with ravulizumab within 12 months of thymectomy, defined as the surgical removal of the thymus gland;
  3. Ravulizumab has been prescribed by a neurologist or by another prescriber who has consulted with a neurologist with expertise in the treatment of gMG.

Submission Requirements:

  • The request is submitted by an authorized prescriber in respect of a patient in accordance with section 16 of the ODBA;
  • The request includes the following information:
    (i) the patient’s baseline MG-ADL score results; and
    (ii) the patient’s medication history of treatments used for gMG, including the following information about each drug:
    a. name;
    b. dose;
    c. approximate timelines of use by month and year;
    d. duration of use; and
    e. the response to treatment or loss of effect.

Generalized myasthenia gravis (gMG) is a rare autoimmune disease that commonly presents as ocular weakness, with 88% of cases progressing to involvement of the muscles of the head, neck, trunk, limbs and respiratory system (Grob et al. Muscle Nerve 2008;37:141-149). Approximately  90% of gMG patients have autoantibodies targeting the acetylcholine receptor (AChR) (Ha et al. Biochim Biophys Acta 2015;1852:651-657). Autoantibody binding to the AChR results in activation of the complement cascade and formation of the membrane attack complex (MAC), leading to destruction of the neuromuscular junction and impaired neuromuscular transmission (Obaid et al. Neurol Neuroimmunol Neuroinflamm 2022;9:e1169). In Canada, the estimated incidence of gMG is 2.3 cases per 100,000 per year and the prevalence is 32.0 cases/100,000 (Breiner et al. Neuromuscul Disord 2016;26:41-46). The estimated number of Canadian cases is about 12,000-13,000.

Clinical Evidence
Ultomiris (ravulizumab for injection) received Health Canada authorization for the treatment of adults with anti-AChR antibody-positive gMG based on the results of the CHAMPION MG trial. The phase III double-blind trial compared ravulizumab with placebo in 175 gMG patients over a 26-week period (Vu et al. NEJM Evid 2022;1:EVIDoa2100066). All patients were required to have been vaccinated against meningococcal infections within the prior three years.

The proportion of clinical responders was consistently greater for ravulizumab compared to placebo for QMG ≥ 5-point improvement [30.0% vs. 11.3%; risk ratio (95% confidence interval [CI]): 2.7 (1.4, 5.3)] and MG-ADL ≥ 3-point improvement [56.7% vs. 34.1%; risk ratio (95% CI): 1.6 (1.2, 2.3)] endpoints. In patients treated with ravulizumab, favourable changes were observed in all domain scores of the MG-ADL and in the ocular, bulbar, and limb domain scores of the QMG. The onset of clinical benefit was seen within one week of ravulizumab initiation. The number of patients with adverse effects was similar in the two groups. There were no cases of meningococcal infection.

Clinical benefits were sustained on the long-term open-label extension (Vu et al. Eur J Neurol 2025;32:e70158). In the continuous ravulizumab group, the mean change in MG-ADL was -4.0 from baseline to week 164. No meningococcal infections were reported during long-term treatment.

Dosing and Administration
Ravulizumab is administered by intravenous infusion as a weight-based loading dose (2400-3000 mg), with a follow-up dose (3000-3600 mg) at week 2, and followed by maintenance dosing (3000-3600 mg) every eight weeks thereafter. All patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ravulizumab treatment unless the risk of delaying ravulizumab treatment outweighs the risk of developing a meningococcal infection. Patients who initiate ravulizumab treatment less than two weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until two weeks after vaccination.

Full prescribing information, including warnings and contraindications is available here.

For more information on reimbursement and support, contact the OneSource patient support program: 1‑888‑765‑4747.

Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases. It was created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. For more information, visit the company’s website at https://alexion.com/worldwide/canada.

This advertorial is intended for Canadian healthcare professionals. Please consult provincial program listings for exact coverage criteria and effective dates.

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