An international research team led by the Medical University of Vienna reports on a new treatment strategy that has made a kidney transplant possible for a patient with no realistic chance of receiving a suitable donor organ. As the case study demonstrates for the first time, the use of a new drug from the field of cancer medicine can achieve a substantial and sustained reduction in antibodies against potential transplants, a level not previously attained. This significantly improves the prospects of a successful organ transplant even in cases with a particularly unfavourable initial immunological profile. The results have recently been published in the New England Journal of Medicine and could open up new perspectives in transplant medicine.
The new drug Teclistamab is currently used to treat blood cancer (myeloma). It specifically eliminates those cells in the blood and bone marrow that produce antibodies against foreign structures. Due to this unique mechanism of action, the substance has now also come to the attention of transplant medicine: the research team led by Georg Böhmig and Martina Schatzl (Clinical Department of Nephrology and Dialysis, Department of Medicine III, MedUni Vienna) applied it for the first time as part of a case study in a dialysis-dependent patient with a highly unfavourable initial immunological profile.
The 37-year-old had developed particularly pronounced HLA sensitisation following two previous kidney transplants. In this process, the immune system produces antibodies against tissue markers of potential donor organs, known as HLA (Human Leukocyte Antigens). These antibodies significantly limit the availability of suitable organs. In the specific case of the study, the calculated probability (cPRA value) of ever finding a compatible donor kidney for the patient was actually zero. Consequently, the study participant’s name had been on the waiting list for more than twelve years, whilst his condition progressively deteriorated.
Successful transplant after 31 weeks of therapy
Treatment with teclistamab over a period of 31 weeks turned the tide: the drug achieved such a substantial and sustained reduction in antibodies against tissue antigens as is not possible with the methods currently available for HLA sensitisation. “During the course of therapy, HLA markers from donor kidneys, against which there had previously been strong antibody reactions, were gradually classified as acceptable,” reports lead author Martina Schatzl. Eventually, a suitable organ was found and successfully transplanted. “The patient is doing very well today; his kidney function is excellent, and he no longer needs dialysis,” adds study leader Georg Böhmig.
Further studies on benefits and risks needed
20 to 30 per cent of patients on the waiting list for donor kidneys are affected by significant HLA sensitisation, some of whom have no chance of receiving a suitable organ. Existing procedures for so-called desensitisation aim to reduce the number of antibodies prior to transplantation, but are only effective to a limited extent and for a short period. The treatment approach described in the case study, by contrast, directly intervenes in antibody production and sustainably reduces the immune response over a longer period. “This could herald a paradigm shift in transplant medicine and open up new prospects for a group of patients who have been particularly disadvantaged until now,” says Böhmig.
Detailed immunological results from the current case study also suggest that the new treatment strategy might also be applicable in xenotransplantation – that is, the transplantation of organs from genetically modified pigs – as well as in blood-group-incompatible transplants. “Looking ahead, an extension to other forms of organ transplantation, such as heart transplantation, as well as use in the post-transplant setting to treat antibody-mediated rejection reactions, also seems conceivable,” says Böhmig. However, before the new treatment strategy can be used in clinical practice, its benefits and risks must be systematically investigated. A study of this kind is already being planned at MedUni Vienna.
Through Cipla’s voluntary licensing agreement with Merck (MSD), Cipla may support potential future access to generic alimatravir, an investigational medicine being studied for HIV-1 pre-exposure prophylaxis (PrEP).
The announcement underscores Cipla’s role in supporting responsible partnerships at a critical moment for the global HIV response, as global leaders, researchers and healthcare professionals convene in Brazil this week for the world’s largest HIV and AIDS conference.
Through the agreement, Cipla may produce generic alimatravir following completion of development, applicable regulatory approvals, technology-transfer requirements and any other country-specific requirements. The voluntary licensing agreement builds on Cipla’s vertically integrated capabilities across the pharmaceutical value chain, enabling the company to support the development and manufacturing activities, under the terms of the agreement.
As one of Africa’s leading pharmaceutical companies, Cipla has contributed to improving access to critical HIV medicines and prevention-related public-health programmes across the continent. In the early 2000s, Cipla made quality, affordable antiretrovirals available at less than $1 per day, contributing to wider access to HIV treatment during a critical period in the global HIV response.
Building on this legacy, Cipla continues to strengthen its contribution to public health through the development, manufacture and distribution of high-quality, affordable medicines that support national and regional HIV priorities, where such medicines are appropriately authorised and supplied in accordance with local requirements.
Paul Miller, CEO of Cipla Africa, said: “Cipla’s vision has always been to make quality healthcare more accessible for patients who need it most. This licensing agreement reflects our long-standing commitment to supporting responsible innovation in HIV prevention for the patients and communities we serve. We believe that expanding future access, where permitted by applicable regulatory requirements, requires extensive manufacturing expertise, reliable supply chains and strategic partnerships that can translate scientific innovations into real-world impact.”
Investment in Local Manufacturing, Sustainable Access
Cipla’s manufacturing network and established presence across African markets position the company to support widespread, sustainable access to HIV medicines. Through decades of experience in producing and supplying medicines at scale, Cipla has helped strengthen healthcare systems and HIV treatment programmes.
The company also remains committed to supporting local healthcare priorities by investing in local manufacturing capabilities and working collaboratively with governments and healthcare professionals to improve access to life-saving medicines. Cipla has been supplying the South African government with equitable access to HIV medication for a number of years. These efforts align with broader ambitions to strengthen pharmaceutical manufacturing capacity on the continent, reinforcing Cipla’s commitment to secure and ensure reliable ARV supply.
Most recently for example, Cipla made significant investments in its local manufacturing facility, upgrading the capacity of the ARV production line with the installation of a new Countec bottle line and increased its tablet filing capacity by 190%. The company is able to locally produce 475 million ARV tablets annually and has upscaled its manufacturing capabilities to ensure sufficient capacity to meet current demand and support near‑term growth, ensuring continuity of supply. Cipla’s overall manufacturing capacity is 1,625 billion tablets annually.
“With a long history of leadership in HIV treatment and prevention, Cipla remains dedicated to helping shape a future where innovative healthcare solutions are accessible, affordable and available to communities across Africa. We want people to live a long and healthy life as part of our ethos of caring for life,” said Paul Miller, CEO of Cipla Africa.
*According to Statistics South Africa, the number of people living with HIV in the country is estimated to be approximately 8 million (12,7% of the population)[1].
Important regulatory notice: Alimatravir is an investigational medicine. It is not registered by the South African Health Products Regulatory Authority (SAHPRA), has not been approved for sale or supply in South Africa, and is not currently available in South Africa. Its safety, quality and efficacy have not been evaluated or approved by SAHPRA. This communication is a corporate announcement about a voluntary licensing agreement and is not intended to promote, recommend or encourage the use of any medicine.
Alimatravir remains investigational and no claims are made regarding its safety, efficacy or suitability. No availability in South Africa is implied by this announcement. Any future availability remains subject to successful completion of development, regulatory approval and applicable local authorization requirements.
Large-scale study results call for earlier cardiovascular screening for women who experience menopause before age 40
Photo by Hush Naidoo on Unsplash
Women who reach menopause before age 40 face a meaningfully higher risk of developing high blood pressure than those who go through menopause after age 45, according to a new study of more than 107 000 women. Risk peaked among women who reached menopause prematurely between the ages of 25 and 35 years. The results of the study are published online today in Menopause, the journal of The Menopause Society.
Hormone shifts during the menopause transition are known to influence a woman’s overall disease risk, and earlier menopause has previously been linked to higher rates of coronary heart disease and stroke. However, evidence connecting the timing of menopause directly to hypertension has been inconsistent, with some prior meta-analyses finding an association and others finding none.
A key challenge has been separating the direct hormone effects of menopause from indirect effects driven by weight gain, metabolic changes, and other cardiovascular risk factors that tend to accompany the menopause transition.
To address this gap, researchers analysed data from 107 836 postmenopausal women enrolled in the UK Biobank between 2006 and 2010, following them for a median of nearly 15 years through the end of 2003. The study classified women by age at menopause – normal (after age 45), early (ages 40 to 45), and premature (before age 40) – as well as by type of menopause (natural vs surgical) and tracked new diagnoses of high blood pressure over time.
Over the follow-up period, 18 508 women (17.2%) were diagnosed with hypertension. The risk climbed steadily as age at menopause dropped: 16.6% of women with normal age at menopause developed hypertension, compared to 18.8% of women with early menopause and 22.6% of women with premature menopause. After adjusting for more than 50 variables – including weight, lifestyle habits, family history, and lab values – women with premature menopause still had a 12.3% higher risk of developing hypertension than women who reached menopause after age 45.
A further analysis modelling age at menopause on a continuous scale found that risk peaks not at the traditional premature-menopause cutoff of age 40 but between the ages 25 and 35, suggesting the cardiovascular risk associated with premature menopause may be concentrated in an even younger group of women than previously defined. Surgical menopause was associated with higher hypertension rates in initial analyses, but that association did not hold once other risk factors were considered.
Based on these findings, the study authors recommend that clinicians treat age at menopause as a distinct cardiovascular risk factor, particularly for women who reach menopause before age 40. In addition to individualised counselling on hormone therapy, they point to earlier identification and management of high blood pressure as an opportunity to help reduce long-term cardiovascular risk in this group of women.
“The results of this study highlight the potential adverse long-term health outcomes associated with premature menopause, and in particular, the need to regularly screen for cardiovascular risk factors such as hypertension. Use of hormone therapy is also routinely recommended in women with premature menopause at least until the natural age of menopause unless contraindications exist,” says Dr Stephanie Faubion, medical director for The Menopause Society.
Dr Katlego Mothudi is the Managing Director of the Board of Healthcare Funders, an industry representative body for medical aid schemes, administrators and managed care providers.
By Katlego Mothudi
With plans in motion to roll out universal health coverage in South Africa, Dr Katlego Mothudi, of the Board of Healthcare Funders, argues that revising the compulsory prescribed minimum benefits that medical schemes must provide can be a tool to deliver meaningful improvements today while laying the foundations for a more sustainable healthcare system.
South Africa’s journey towards universal health coverage will not be defined by a single policy or piece of legislation, but by the practical reforms that make quality healthcare more accessible and affordable for more people. Achieving this goal requires, among other things, tackling structural barriers that continue to drive up the cost of medical scheme cover and place private healthcare beyond the reach of millions of people in South Africa. One of the most important, yet often overlooked, barriers is the outdated framework governing prescribed minimum benefits (PMBs).
PMBs are the set of conditions and services that every medical scheme is legally required to cover, regardless of the plan a member chooses. Their existence is critical, created with the intention of ensuring scheme members do not lose access to catastrophic care in the event of serious illness. PMBs ensure that members are not reliant on an over-burdened public sector during medical emergencies. And although this principle remains important, the framework has not kept pace with South Africa’s changing disease burden, evolving models of care, or the cost of delivering healthcare.
20 years of PMB limbo
Regulations made under the Medical Schemes Act require PMBs to be reviewed every two years. This must be carried out by the Department of Health together with the Council of Medical Schemes, provincial health departments and other stakeholders. In practice, this has happened only once, more than 20 years ago.
The current review process has been underway for close to a decade without conclusion. As a result, the outdated PMB framework has become one of the most significant contributors to medical scheme costs and thus an inefficient health policy. Actuaries advise that roughly 60% of a scheme’s budget goes towards funding PMBs before any other benefit is considered. This used to be approximately 40% when the PMB was amended in 2003.
The consequences of this laborious review process directly impact household budgets. The most basic scheme cover now costs a single beneficiary in the region of R1 600 a month, with a family of three facing around R4 000. For most working people in South Africa, that is simply unaffordable, and it is a significant reason why medical scheme membership has stagnated even as the population has grown. Furthermore, South Africa’s healthcare “missing middle” has grown to an estimated 8 million people who access private healthcare, paying out-of-pocket, without belonging to a medical scheme.
An out-of-date framework
If the PMB list were redesigned today, using current clinical evidence, the country’s evolving disease burden, and the realities of healthcare affordability, many of its benefits would likely look very different. The current framework no longer reflects what the system can sustainably provide. And because it consumes such a large portion of every scheme’s budget, it crowds out the very things that would make cover more affordable and more useful – primary care, early intervention and prevention.
At a recent Board of Healthcare Funders conference, Dr Fatima Hoosain, a specialist breast and endocrine surgeon, set out the numbers plainly: a mammogram and ultrasound cost in the region of R2 500. Left undetected until the disease has progressed, that same patient may require R100 000 in radiation therapy, R200 000 in chemotherapy, and, for HER2-positive cancers which typically can quickly spread from the breasts to other areas of the body, roughly R7 000 every three weeks for a year in targeted biological therapy. Early detection does not only save lives, but it is also, by a wide margin, the cheaper pathway. From a cardiology perspective, Dr Martin Mpe, president of the South African Heart Association, made the same point at the conference. He argued that the cheapest way to treat a heart attack is to prevent it, and that the system needs to start rewarding prevention rather than paying only for treatment after the fact.
Rather than expanding access, an outdated PMB framework has unintentionally limited it.
A PMB framework anchored in 1999-era diagnosis-and-treatment logic has little room for rewarding the prevention and early detection that would keep patients out of the expensive end of the system altogether. Importantly, reform does not mean stripping away protection. It means modernising the list so that mandatory cover reflects today’s clinical realities. It also means rethinking how the package is defined. The current approach is built around a long, condition-by-condition diagnostic list, a modern framework could instead focus on the essential health services people need most, including preventative care, primary healthcare services, medicines on an essential medicines list, and diagnostics on an essential diagnostics list. It could also emphasise the areas where the disease burden is greatest.
A core service package
This aligns closely with the Board of Healthcare Funders’ (BHF) recent commitment to explore a Core Service Package as a practical step towards universal health coverage. By focusing on the services that deliver the greatest health benefit within available resources, such an approach would place prevention and patients at the centre of the health system while creating greater flexibility to expand affordable access.
The BHF has previously worked to operationalise South Africa’s national Essential Medicines List (EML) within the private funding environment, partnering with MediKredit in 2021 to launch a NAPPI-coded mapping tool that helps funders align benefit design and claims systems with the EML, improve medicine access, and reduce out-of-pocket costs. This existing groundwork offers an affordable, prevention-oriented foundation on which a modernised PMB package could be built.
The evidence of where the current framework falls short is already available. Annually, the Council for Medical Schemes reports on out-of-pocket expenditure, which exceeded R40 billion last year. When people spend that much of their own money on healthcare, over and above their contributions, they are pointing directly to where their cover is failing.
A broader set of changes
PMB reform does not stand alone, and it will not by itself fix affordability. It is the entry point to a broader set of changes that reinforce one another. The most important of these is regulated tariff reform. South Africa currently lacks a transparent, predictable mechanism for setting provider prices, and this absence has driven costs upward for years. Allowing schemes and willing providers to negotiate fair tariffs, within a properly regulated framework, published for transparency, would bring discipline and predictability to pricing and give members clarity on what they are paying for.
Alongside this, permitting schemes to offer low-cost benefit options, a subset of the proposed revised PMBs and based on services rendered in the public sector clinics, would extend affordable, primary-care-based cover to millions of people in South Africa who currently fall outside the system and pay out-of-pocket for private care.
None of these reforms require new legislation or a wholesale restructuring of the health system. They can be pursued within the existing regulatory framework, and PMB modernisation is the logical place to begin, because it addresses the highest single cost in every member’s contribution and unlocks the room to fund better, more preventive care.
For members, this shift would be felt less as a change to their PMB entitlements and more as a change in what their contribution actually buys before a crisis ever occurs. Money currently locked into funding late-stage, high-cost treatment for conditions that could often have been caught earlier could instead support routine age- and risk-appropriate cancer screenings, cardiovascular risk assessments and blood pressure checks, diabetes screening and management support, and the kind of primary care consultations that catch problems while they are still cheap and simple to treat. None of this is about giving members less. It is about intervening earlier, so that fewer members ever need the R100 000 radiation course, the R200 000 chemotherapy regimen, or the cardiac admission that better screening or blood pressure control could have prevented.
There is an understandable reluctance to reopen the PMB framework, given how long the review has already taken and how contested the terrain can be. The longer reform is delayed, the greater the affordability pressures on households and the greater the strain on the broader health system.
Reforming prescribed minimum benefits is ultimately about far more than updating a list of conditions. It is about creating the flexibility to expand access, strengthen prevention and make medical scheme cover affordable for more people in South Africa.
*Mothudi is the Managing Director of the Board of Healthcare Funders, which represents around 45 medical aid schemes in South Africa, including GEMS and Bonitas.
*This piece was published by Spotlight – health journalism in the public interest. Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
