Biologics can improve health outcomes and increase life span for people living with lupus, but timely access in Ontario remains limited.
Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease in which the body’s immune system attacks its own tissues and organs. Lupus can damage any organ in the body, leading to a variety of often debilitating symptoms. One in 1,000 people is diagnosed with lupus, many of whom find the pain, fatigue, and other symptoms to be disabling. Lupus patients are generally diagnosed between the ages of 15 and 45, with 9 out of 10 patients being women and 2 out of 3 patients identifying as people of colour. While there is no cure for lupus, early diagnosis and intervention with appropriate treatment can help manage the disease, improve quality of life, and increase a person’s life span.
Lupus’ impact on employment and education
Lupus Ontario was founded 48 years ago and is the largest provincial organization in Canada dedicated to improving the lives of people living with lupus and their families. Our mission is to provide support, education, awareness, advocacy, and research through the fundraising efforts of our staff and volunteer community, helping those affected by lupus live longer, healthier, and better lives.
A 2025/2026 survey conducted by Lupus Ontario indicates that lupus and the current medications and treatments to manage the disease remain a significant barrier to employment and education. More than one-third of 128 respondents (35.2 per cent) reported leaving the workforce or transitioning to disability because of their condition. Nearly 61 per cent experienced reduced income due to reduced work hours, career changes, or lost income. In addition, 7.8 per cent of respondents reported missing classes or having to change the educational program they were enrolled in because of lupus, highlighting that the disease can also disrupt educational goals and future career opportunities. Overall, only 25.0 per cent of respondents indicated that lupus had not resulted in major changes to their work or education.
A breakthrough in lupus treatment
New research and development in lupus biologic medications have led to major improvements in disease management and patient outcomes. A recent study found that early use of biologics1 was cost-effective, improved health outcomes, and increased life span. This new class of lupus-specific medications has been recognized by both the European Alliance of Associations for Rheumatology and the American College of Rheumatology as an important breakthrough in lupus treatment. Both associations have recommended that biologics be introduced in early stages of the disease to reduce the frequency and severity of flares and reduce organ damage.
Unlike older, non-specific drugs such as steroids and immunosuppressants, biologics work by intercepting specific disease pathways in the immune system to reduce inflammation and prevent joint and tissue damage. For those undergoing steroid treatment for lupus, biologics allow a faster and more effective tapering of corticosteroids and improvements in physical function and quality of life.
A burdensome route to access
Currently, three biologics are approved by Health Canada for the treatment of lupus: belimumab (Benlysta®), anifrolumab (Saphnelo®), and obinutuzumab (Gazyva®).
In order for eligible Ontario patients to receive public coverage for these medications, their prescribers must apply to the Ministry of Health through the Exceptional Access Program (EAP), which facilitates patient access to drugs not funded on the Ontario drug benefit formulary, or where no listed alternative is available.
The EAP process takes one to four months to receive a decision, causing additional damage to the patient’s organs and a needless administrative burden on health care professionals. Additionally, the EAP process needs to be repeated on an annual basis for the same patient requesting the same biologic.
Preventing patient access
The Ministry of Health restricts access to these medications for lupus patients by requiring an administratively burdensome submission to the EAP for the Ministry’s approval for physicians to prescribe the biologic. This process requires the prescribing physician to submit forms, including providing a medical history of all treatments, indicating that all other possible treatments have been tried before requesting approval for the biologic through the EAP. This process must be completed annually by the physician, even in circumstances where the patient is showing a positive response to the biologic.
By requiring physicians and lupus patients to go through this process, the Ministry of Health acts as an unnecessary gatekeeper, blocking timely access to proven therapies and superseding the expertise of the rheumatologists who are best positioned to determine appropriate treatment. As a result, lupus patients suffer from delayed or denied access to biologics.
Conversely, patients with other autoimmune diseases, such as rheumatoid arthritis, are able to access biologic medication using a simpler process involving a Limited Use (LU) code. Unlike the EAP, the LU code enables immediate access.
Advocating for better access
In May 2025, a petition relating to biologics for lupus patients was tabled by MPP France Gélinas on behalf of Lupus Ontario at the Ontario Legislature. The petition, which had over 500 signatures, requested a change in the access to biologics from the EAP to LU access, similar to the process for rheumatoid arthritis biologics.
A vague response was received from the Government of Ontario in November 2025, stating that funding decisions are made by “expert committee recommendations.” This response did not include information on who participated in the expert committee, or how those funding and approval decisions are made. This less-than-adequate response to the petition indicates a crass indifference to the well-being of lupus patients and a lack of understanding of the greater long-term value for health systems1 achieved by early initiation of biologics.
Addressing barriers to care
As a result of these barriers in access to care for lupus patients, rheumatologists in Ontario are unable to follow clinical guidelines recognized by rheumatology associations and tend to prescribe biologics only after using older, non-specific drugs such as steroids and immunosuppressants. Unfortunately, in recent cases, the Ministry of Health has declined to renew the request for biologic medication through the EAP unless a recent (less than six months) kidney biopsy is submitted for lupus nephritis patients. This is not a requirement under Health Canada but one instigated by the Ministry of Health. The kidney biopsy is an invasive procedure that is performed annually on a patient with lupus nephritis.
Undergoing a second painful biopsy within a 12-month period to meet EAP requirements is unjustifiable. These roadblocks to accessing medications must be addressed to ensure lupus patients have access to life-saving medical care.
A call for equitable access
Ontario’s current policies create clear and harmful inequities for lupus patients seeking biologic medications. Despite strong international guidelines and Health Canada approval, access remains bottlenecked in Ontario by the EAP — an outdated, slow, and burdensome process that delays treatment, increases organ damage, and undermines clinical judgment. Meanwhile, patients with rheumatoid arthritis receive biologics through a simple LU code, highlighting an unjustifiable disparity in care.
The government’s response to Lupus Ontario’s petition shows little urgency or recognition of the evidence: early biologic use improves outcomes, reduces long-term costs, and may extend a person’s life. Yet rheumatologists are forced to rely on older, less effective drugs while patients wait months for a decision — and in some cases are subjected to repeat invasive kidney biopsies solely to satisfy administrative requirements.
To ensure fair, timely, and evidence-based access to care, the Ontario government must allow access to biologics for lupus patients through LU codes. Until lupus patients have access to biologics, they will continue to face irreversible and avoidable harm as a result of inequitable access to care within Ontario’s health care system.
To learn more, visit lupusontario.org.