ADVERTORIAL – Sponsored by Alexion, AstraZeneca Rare Disease

^PrUltomiris^® (ravulizumab) now publicly reimbursed for adult anti-AQP4 antibody-positive NMOSD in Ontario, Quebec, Alberta, Nova Scotia, Saskatchewan, and NIHB

Alexion, AstraZeneca Rare Disease is pleased to announce that as of January 20^th, 2026, ravulizumab (Ultomiris) is now listed on the Ontario Drug Benefit program for the treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disease (NMOSD).

Ultomiris is a recombinant, humanized monoclonal antibody that binds to the complement protein C5, inhibiting cleavage to C5a (an anaphylatoxin) and C5b (initiating subunit of the membrane attack complex [MAC]). The presumed mechanism of action in NMOSD is inhibition of anti-AQP4 antibody induced complement C5b-9 deposition and C5a-dependent inflammation.

Eligibility criteria details are below. Public coverage is also available in Quebec, Alberta, Nova Scotia, Saskatchewan, 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 provincial formulary listings:

• Quebec (French; page 178)
• Alberta (page 36)
• Saskatchewan (page 3)
• Nova Scotia (page 90)
• NIHB (search term RAVULIZUMAB).

Ontario Exceptional Access Program reimbursement criteria

Ravulizumab may be initiated in adult patients with NMOSD who meet all the following criteria:

1. The patient is at least 18 years old; AND
2. The patient has a diagnosis of NMOSD that meets international diagnostic criteria; AND
3. The patient is seropositive for the AQP4 antibody; AND
4. The patient must have had at least one relapse of NMOSD in the previous 12 months despite an adequate trial of rituximab for NMOSD or, if the patient is not appropriate for rituximab, an adequate trial of another preventative treatment such as azathioprine or mycophenolate; AND
5. The patient has an EDSS score of <7 points; AND
6. The patient’s use of Ultomiris has been prescribed by a neurologist with expertise in the diagnosis and treatment of NMOSD.

Exclusion criteria:

• The patient is or will be using Ultomiris in combination with other biologics for NMOSD, such as rituximab, satralizumab, eculizumab, or inebilizumab
• The patient is or will be using Ultomiris for the acute treatment of an NMOSD relapse.

It should be noted that:

• Ravulizumab should not be initiated during a NMOSD relapse episode;
• Patients should be evaluated every 6 months; and
• Ravulizumab may be used alone or in combination with an immunosuppressant therapy.
• Case-by-case consideration will be provided for patients with EDSS score higher than 7, provided that the patient meets all other reimbursement criteria.

NMOSD is a rare, autoimmune disease with approximately 0.53-4.0 cases per million annually with a prevalence of <5 per 100,000; the estimated number of cases is 2,000 in Canada (Etemadifar et al. Mult Scler Int 2015;2015:174720). Relapses are the primary driver of disability, and attacks are often severe with incomplete recovery (Wingerchuk et al. Neurology 2007;68:603‑605). Within five years of diagnosis, substantial proportions of patients experience major, irreversible deficits, such as legal blindness and loss of ambulation, underscoring the disease’s impact (Jiao et al. Neurology 2013;81:1197‑1204).

Rapid recognition and treatment of acute attacks is essential to limit irreversible damage (Jiao et al. Neurology 2013;81:1197‑1204). A key treatment goal is proactive relapse prevention with effective maintenance therapy, initiated early and optimized to minimize breakthrough disease and the accumulation of disability (Wingerchuk et al. Neurology 2007;68:603‑605).

Clinical Evidence
Ultomiris received Health Canada authorization for NMOSD in October 2023 based on the results of the CHAMPION-NMOSD trial. The phase III open-label, multicentre trial evaluated ravulizumab in 58 patients with AQP4+ NMOSD for >50 weeks compared to an external comparator (Pittock et al. Ann Neurol 2023;93:1053-1068). The external comparator was the placebo group (n=47) from the PREVENT trial of eculizumab. Prior therapies included rituximab in 36% (n=21) of ravulizumab‑treated patients and 43% (n=20) of the PREVENT placebo cohort. At study entry, 52% (n=30) of patients received ravulizumab as monotherapy (no concomitant immunosuppressant therapy). All patients received prior vaccination against meningococcal infections ≥2 weeks before initiating ravulizumab.

No adjudicated on-trial relapse was observed in ravulizumab-treated patients during the median primary treatment period of 73.5 weeks. The observed proportion with adjudicated on-trial relapses was 42.6% in the external placebo arm. The proportion of relapse-free patients at Week 48 was 100% with ravulizumab versus 63.2% in the placebo arm. All ravulizumab-treated patients remained relapse-free at Week 72, including patients not on concomitant treatment. The most common adverse effects were COVID-19, headache, back pain, arthralgia and urinary tract infection. Two patients developed meningococcal infections; both recovered without sequelae.

Dosing and Administration
Ultomiris 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 2 weeks prior to initiating ravulizumab unless the risk of delaying treatment outweighs the risk of developing a meningococcal infection. Patients who initiate ravulizumab less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.

Full prescribing information is available here.

For more information on reimbursement navigation 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.