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Autoimmune disease patients' challenge to access medicines

Individually, autoimmune conditions do not attract as much attention from healthcare administrators or funders as infectious diseases like HIV and TB, and other non-communicable diseases, but the figures are concerning: it’s estimated that 2.5m people in this country are affected, many of them denied access to life-saving help.

Now, thanks to a proactive and tenacious local mother, an alliance has been formed that will help South Africans living with these potentially devastating diseases to have improved access to treatments to control autoimmune conditions and allow them to live their lives to their full potential.

In the early 20th century, German physician Paul Ehrlich coined the term “horror autotoxicus” to describe a condition of the body’s immune system turning on itself, and in 1938 the first autoimmune condition, haemolytic anaemia, was described, whereby the immune system attacks and destroys normal red blood cells.

Since then, write David Epstein, Catherine McCormack and Karin Davidson in Daily Maverick, more than 100 autoimmune diseases have been identified.

An autoimmune disease is characterised by the activation of the body’s immune system against one or many organs, causing inflammation which, if left unchecked, causes permanent damage. Common autoimmune diseases include rheumatoid arthritis, juvenile arthritis, ankylosing spondylitis, scleroderma, “lupus” (systemic lupus erythematosus), Grave’s disease, psoriasis, multiple sclerosis, type I diabetes, coeliac disease, Crohn’s disease and ulcerative colitis.

Autoimmune diseases cannot be cured, they affect all age groups and tend to be more common in women than in men.

Numbers ares increasing

One in five Americans live with an autoimmune disease and the numbers are swelling annually.

In South Africa, where numbers are also rising, data from the Inflammatory Bowel Disease Africa (IBD Africa) registry show an exponential increase in newly diagnosed Crohn’s disease and ulcerative colitis patients over the past 50 years.

Why the increase?

This is one of the intriguing medical questions of the 21st century. Our immune systems evolved over millennia to protect us against infections that were the major cause of death among our ancestors.

During the 20th century, advances in modern living – improved hygiene, vaccinations and widespread use of antibiotics – resulted in the eradication and prevention of many, previously fatal, infectious diseases.

One could argue that a highly evolved and efficient immune system is now “rendered idle” and turns inward to “keep busy”. This theory, called the hygiene hypothesis, is supported by the fact that autoimmune diseases are less prevalent in impoverished rural communities where hygiene is poor and access to primary healthcare limited.

By comparison, in populations where there is rapid economic development and migration from rural to urban areas, there is an attendant increase in autoimmune disease.

Other factors important in the development of autoimmune diseases include a genetic predisposition and other environmental triggers, like pollution, stress and diet.

Treatment complications

South African patients with autoimmune diseases face enormous challenges in obtaining an accurate diagnosis and accessing effective treatment to control their condition, thus preventing permanent damage and disability, be it to their joints, brain or gut.

Diagnosis is difficult, due to poor doctor awareness, lack of standardisation of diagnostic tests, such as autoantibody assays, and limited access to expensive diagnostic tests, like CT and MRI scans.

Individually, autoimmune conditions do not attract much attention from healthcare administrators or funders and are often overshadowed by infectious diseases, such as HIV and TB, and other non-communicable diseases, such as heart disease and cancer. However, collectively they represent a significant health problem in the country.

Successful treatment, termed sustained remission, requires targeted suppression of a component of the immune system, thereby controlling the autoimmune disease. In addition, drugs need to be easily administered, have low toxicity and be affordable.

For most of the 20th century, steroids (cortisone or corticosteroids) were the only treatment available for autoimmune diseases.

Steroids have a shotgun effect on the immune system controlling the autoimmune disease but compromising it at the same time, increasing the risk of both mild and severe infections. They also have wide-ranging side effects and are devastating if used long-term in children, stunting growth, among other problems.

Steroid-sparing immune suppressants for the treatment of autoimmune diseases, such as azathioprine, ciclosporin and methotrexate, prevent the reliance on steroids but have their own side effects and long-term toxicity issues.

Medical advances and pathways

In 1979 a brief article appeared in The New York Times regarding a US firm, Hybritech, which developed a laboratory-produced antibody with the potential to treat disease, heralding the therapeutic monoclonal antibody (MAB) industry.

Therapeutic monoclonal antibody drugs or biologics have become an important modality to treat autoimmune diseases, cancers, organ transplant rejection and even high cholesterol. Biologics are large protein molecules, similar to our own protective antibodies produced in response to an infection or vaccination, but designed to target and inactivate an important component in the pathway of a specific autoimmune condition.

For example, one of the first biological drugs developed targeted the chemical messenger, TNFα, an important immune system co-ordinator, and is used to treat rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease and psoriasis.

In 2000, infliximab (Revellex), an intravenous biological drug, was approved to treat Crohn’s disease and rheumatoid arthritis in South Africa.

Currently, various other biologics covering a range of autoimmune conditions are registered by the South African Health Products Regulatory Authority (Sahpra). In recent years the registration of biosimilars (the equivalent of a biologic generic) has made these drugs more affordable and prices will continue dropping as more biosimilars become available.

Barriers and limited access in SA

More than 20 years since the first biologic was registered in South Africa, with overwhelming evidence to support their efficacy and safety, as well as consistent price reductions, these drugs remain unaffordable for most autoimmune patients in the country.

The devastating reality is that accessing a biologic in South Africa is too often unrelated to the severity of a patient’s illness, the degree of disability, or even the treating doctor’s decision.

In the public sector, financial constraints limit access to a minority treated in one of only a few centres around the country. Addressing this shortfall is the ongoing work of public, private, and non-profit organisations too extensive to describe here.

Private-sector access, on the other hand, hinges on three criteria:

• Is the autoimmune condition included in the Prescribed Minimum Benefit (PMB) list?
• Is the patient on one of the highest and most expensive medical plans? and
• Has the patient failed treatment included in the Department of National Health’s Treatment Algorithm, a minimum treatment standard, below which medical schemes may not fall?

The first hurdle, inclusion in the PMB list, is almost insurmountable for those unlucky enough to be diagnosed with a non-PMB disease. Some autoimmune conditions, like rheumatoid arthritis and Crohn’s disease, are included in the PMB chronic disease list, while other equally destructive conditions, like axial spondyloarthritis, are not.

The list itself defies logic. Juvenile arthritis, for example, is only classified as a PMB if diagnosed before 16 years of age. This collection of diseases loses its PMB status in anyone older than, not because the disease disappears but because of arbitrary distinctions between one kind of autoimmune inflammatory arthritis and another.

Medical aid schemes’ spurious obstruction

PMB status is significant because it obliges medical schemes to fund appropriate treatment and care, regardless of a member’s plan type, something of which most members are either unaware or unable to enforce. As a result, the medical scheme mantra that specialised treatments like biologics are only available on the highest tier plans is almost universally believed by members and doctors alike.

The final hurdle for the minority with the “right” plan type sees biological therapy prescriptions vetted by medical schemes to determine “appropriateness”, further hindering access to care and increasing doctors’ administrative burden.

Catherine McCormack, mother of a child with juvenile arthritis and executive director of the patient organisation Arthritis Kids South Africa, is very familiar with the bureaucratic and legal obstacles in accessing care for PMB conditions.

Having believed that specialised treatments were limited to high-end plans, McCormack was incredulous when she discovered medical schemes routinely reject PMB applications for biologics, despite regulations protecting access to appropriate treatment for members without viable options.

Having seen the life-changing impact of biologics on her daughter’s disease, McCormack launched her first case in early 2021 on behalf of another child with juvenile arthritis. Four months later, the Council for Medical Schemes (CMS) ordered the medical aid to fund the child’s biologic despite the family’s limited plan type.

By the end of 2021, McCormack had four more rulings and had resolved several more cases before a ruling became necessary. She was struck by the fact that no matter how often she reversed a funding decision or how many rulings were made in her favour, schemes continued to reject lawful applications for biological treatment.

She took her concerns to the CMS to reverse what she described as systemic issues in assessing legally protected applications for biologics.

To date, McCormack has represented almost 50 members and has succeeded every time in reversing funding decisions denying appropriate biological treatment, a testimony to the clarity of the relevant regulations despite protestations by schemes.

In theory, anyone can do what McCormack does, but patients and their families often lack the necessary time, confidence, or energy to challenge decisions by large corporates in the face of ubiquitous, jargon-filled misinformation.

The TV programme Carte Blanche featured her achievements in a recent segment highlighting the plight of medical scheme members for whom a plan upgrade is a financial impossibility.

Discovery Health, the country’s largest medical scheme by a significant margin, subsequently confirmed a change in PMB application processing to include the protective regulations, bringing members one step closer to accessing essential, legally protected treatment.

Hopefully, this change marks the start of a new era for medical aid members, one where knowledge of the law by the member is not a requirement for medical schemes to fulfil the law – but only time will tell.

In the background, the battle continues against schemes like Profmed and Medihelp that consistently rely on large legal retainers and spurious arguments to circumvent unambiguous regulations and statutory obligations. As a result, many of their clients living with autoimmune diseases are left stranded, suffering untold harm by being denied access to life-changing therapy.

McCormack has now joined forces with gastroenterologist Dr David Epstein, director of Inflammatory Bowel Disease Africa and specialist IBD nurse Karin Davidson to form the Autoimmune Alliance of South Africa, which will advocate for South Africans living with these potentially devastating diseases to improve access to treatments that can effectively control autoimmune diseases and allow patients to live life to their full potential.

Dr David Epstein is director of Inflammatory Bowel Disease Africa, Catherine McCormack is executive director of Arthritis Kids South Africa, and Karin Davidson is a specialist inflammatory bowel disease nurse


Daily Maverick article – Autoimmune disease in South Africa — increasing number of patients denied life-changing therapy (Open access)


See more from MedicalBrief archives:


Vitamin D and Omega-3 supplementation reduced autoimmune disease – VITAL trial


Inflammatory bowel disease biologic blunts immune response to COVID-19 — NHS study


Phase two clinical trials for promising lupus treatment


Hydroxychloroquine linked to less heart risk in rheumatoid arthritis and lupus


Collaborative lupus research uncovers two new findings




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