The Council for Medical Schemes (CMS), South Africa’s medical scheme industry regulator, has declined a request from the Autoimmune Alliance of SA (AASA) to issue clear guidance on funding expensive biologic treatments for autoimmune diseases. CMS emphasized that each case must be assessed on its own merits, rejecting a blanket directive for funding.
The AASA has been actively lobbying the CMS to clarify how funders should cover the cost of biologics. These treatments, though expensive, are often necessary for patients with severe autoimmune conditions. The advocacy group argues that patients should not have to fight repeatedly for coverage already granted in similar cases.
At the core of the debate is the application of the Medical Schemes Act, which mandates that schemes cover chronic conditions classified as prescribed minimum benefits (PMBs). However, the obligation to cover these conditions is limited to the standard of care provided in the public healthcare sector, which frequently does not include costly treatments such as biologics or immunotherapy drugs.
Regulatory framework and exceptions for funding biologics
Under regulations 15H (c) and 15I (c) of the Medical Schemes Act, patients who do not respond to conventional treatments can apply for exceptions. These applications, while often rejected by medical schemes, are frequently overturned when complaints are lodged with the CMS, according to AASA founder Catherine McCormack.
The CMS responded, stating it could not issue a blanket ruling binding all medical schemes to fund biologics under regulation 15I (c) because each case must be considered based on its clinical merits.” It added that biologics are generally not considered the standard of care for autoimmune conditions and that clinical evidence, cost-effectiveness, and affordability must guide any decision.
CMS’s commitment to streamlining complaint handling
Despite rejecting a blanket directive, the CMS highlighted its commitment to resolving complaints efficiently. It defended its track record, stating that it had addressed 52 complaints from patients with autoimmune diseases since May 2021 and maintained a resolution rate above 90%.
McCormack, however, criticised the length of time it takes for patients to secure funding approval for biologics, even when clinical evidence is undisputed. She expressed frustration over the months-long process for predictable rulings, arguing that the system could be streamlined.
McCormack said the government and medical schemes have the power to change the prices paid for biologics, stressing that these treatments are a lifeline for many patients. However, they are often viewed as a financial burden by others.
The CMS remains firm in adjudicating each case individually, citing compliance with the Medical Schemes Act. However, advocacy groups like AASA continue to push for more streamlined processes and consistent rulings to prevent unnecessary delays in accessing life-saving treatments for autoimmune disease patients.