Regulator urged to clarify cover for costly drugs

An advocacy group for patients with autoimmune diseases has called on SA’s medical schemes regulator to clarify the extent to which schemes are obliged to cover costly specialised treatments that are not routinely used in the public sector.

The Autoimmune Association of SA (AASA) says dozens of patients with conditions such as Crohn’s disease and rheumatoid arthritis are contesting virtually identical issues with different medical schemes. It wants the Council for Medical Schemes (CMS) to issue guidance so patients can benefit from the experience of those who went before them.

“Schemes are not shifting despite repeated CMS rulings,” said AASA executive director Catherine McCormack.

The AASA has since 2021 helped more than 70 patients lodge complaints with the CMS over their medical schemes’ refusal to fund specialised treatment. Complainants included members of Fedhealth, Bonitas, Profmed and Discovery Health, she said.

While the CMS had found in favour of every patient assisted by the AASA, some schemes had appealed and thus suspended rulings in their members’ favour, McCormack said.

The complaints centre on funding for expensive biologicals and biosimilars, such as ustekinumab for Crohn’s disease and adalimumab for treating rheumatoid arthritis.

The battle focuses on the application of regulations to the Medical Schemes Act that set out schemes’ obligations to cover treatment for prescribed minimum benefit (PMB) chronic conditions. Schemes are compelled to provide PMB cover for all beneficiaries, regardless of their benefit option. But this obligation is limited to the level of care provided in the public sector, and schemes may use designated service providers, treatment protocols and formularies to help manage costs.

Regulations 15H (c) and 15I (c) of the act contain provisions that enable patients to apply for an exception to these rules if they have failed to respond to conventional, PMB-level treatment.

These applications were regularly rejected by medical schemes but overturned when patients complained to the CMS, McCormack said. Complaints took months to resolve and patients could not get funding for the contested treatments while they waited.

“The CMS is failing patients. It is the regulator’s job to fight this fight: it is duty bound to protect members’ interests,” she said.

Fedhealth medical scheme principal officer Jeremy Yatt said the needs of individual members had to be balanced against the overall financial stability of scheme. Schemes faced growing demand for new and expensive treatments for a variety of conditions, including cancer, and could not afford to routinely provide them to all members on all plan types, he said.

“We are getting blamed for not funding drugs that could really change the life of a member, but no-one is pointing fingers at the pharmaceutical companies,” he said.

Applications for exceptional funding were considered on a case-by-case basis, as each one needed careful review, he said.

A review of the PMB benefits and the implementation of a risk-sharing mechanism between schemes had the potential to widen access to expensive treatments, he said.

Discovery Health CEO Ron Whelan expressed doubt at the prospect of the CMS issuing a blanket decision for the industry, saying the treatment of autoimmune conditions was complex and there were numerous clinical and health economic considerations.

“It is not possible to set standardised treatment criteria for these cases, and all cases must be considered on their own individual merits,” he said.

Discovery Health administers SA’s biggest open scheme, Discovery Health Medical Scheme and since 2021, 45 members with autoimmune disorders had lodged complaints with the CMS after their applications for specialised treatment were rejected, Whelan said.

The CMS generally ruled in favour of the member as it relied on regulations 15H (c) and 15I (c). But it failed to acknowledge the aspects of the regulations relating to cost-effectiveness and affordability, he said.

Discovery had not appealed against the majority of the CMS rulings, as most clinicians agreed to use reference-priced alternatives that enabled full funding for the affected members, he said.

The CMS had not responded to Business Day’s request for comment by the time of publication.