mAbs: Gamechangers for this pandemic — and beyond

Dr Elin Hoffmann Dahl, Infectious Diseases Medical Advisor, MSF Access Campaign

Recently the World Health Organization (WHO) approved several biological drugs to treat COVID-19 disease. This is the first time that the organisation has moved so quickly to list monoclonal antibodies, popularly called mAbs, for the treatment of a disease. But will they reach the patients who need them?

I’m a hospital doctor, living and working in Norway, and usually when I want to prescribe a drug for my patients in the infectious diseases ward, I don’t have any difficulty accessing it.

For the new therapeutics for people with COVID-19, however, the situation is turning out differently.

Even though the global stock of these new medicines has been largely bought up by rich countries, including Norway, I am still facing the situation in my hospital of having to ration the medicines, because of the limited doses available globally. This means health care workers like myself — even in rich countries — must prioritise these medicines among the patients most in need.

I’m a medical doctor from Norway working in Infectious diseases in Haukeland University Hospital, Bergen, Norway. Before joining the Access Campaign in 2021, I worked for MSF in Pakistan treating people with hepatitis C, and in an Ebola project in the Democratic Republic of Congo during the 2019 outbreak.

While I struggle to get hold of these drugs, there are fortunately only a few Norwegian patients who may actually need them. Why? Because in Norway the vast majority of people particularly vulnerable to the virus have been vaccinated and therefore have a much-reduced risk of progressing to severe disease in the first place. In addition, should anyone need hospitalisation, we have a near free-of-charge first-class health system with a good capacity to treat them.

This is not the reality for many people in low- and middle-income countries (LMICs) where MSF works.

We have already seen the stark global inequality in distribution of COVID-19 vaccines, where more than 80% of them have been given in high-income countries. Currently, only about 6% of the population in low-income countries have received their first vaccine dose. This inequality has been gaining much wider public recognition in recent months. But now, the inequality in access to vaccination is matched and exacerbated by the less publicised lack of access to drugs such as mAbs.

Monoclonal what?

So, what are these new lifesaving medicines and what are the access barriers around them?

The two therapies that have recently been recommended by WHO are both mAbs. This is a class of medicines that has been used for years already to treat cancer and autoimmune diseases. mAbs have a number of advantages over other classes of drugs, including that some can be targeted towards a specific disease or pathogen. The mAbs pipeline is growing, and they are proposed as treatment for more and more diseases, including infectious diseases like Ebola, rabies and now COVID-19.

In early September, WHO recommended two interleukin-6 inhibitors, the mAbs tocilizumab and sarilumab, for people with severe COVID-19. These drugs work by trying to stop our immune system — faced with the COVID-19 virus — from overreacting in a way that can damage the tissue in the lungs.

© Sonis Photography/Shutterstock.com

Then, some weeks later, WHO added a recommendation for a combination of two ‘neutralising’ mAbs, casirivimab and imdevimab, to prevent progression from mild or moderate cases to severe disease for people with the highest risk, such as those who are unvaccinated, older people, and people with immunodeficiencies or underlying chronic diseases such as diabetes. The drug is also recommended for use in severe or critical disease cases among specific groups of people who are vaccinated but for whom the vaccine has not been effective.

These medicines directly ‘neutralise’ the virus by preventing it from entering the human cells and could be a gamechanger in the areas where people in high-risk groups are still waiting to be vaccinated. While these new drugs may not be used as a replacement for vaccines, they provide an important additional tool in the fight against severe COVID-19 disease.

Profits not people first

WHO recommendations should mean that these drugs will be made affordable and accessible to people in need, but this is not the reality.

Tocilizumab is not a new drug — it is already widely used to treat rheumatoid arthritis, but is now repurposed for treating COVID-19 as well. Roche has set the price for tocilizumab at between US$510 to $3,383 per treatment, despite the fact that nearly all of the research for the drug as a treatment for COVID-19 has been funded by governments and other non-industry institutions, and that the true cost of production could be as low as $56.

So, Roche has already made billions of dollars out of this drug, even before the pandemic started. Now, the corporation is set to make billions more from it. It’s time to call a halt to this profiteering.

Inadequate supplies and suppliers

The global shortage of tocilizumab is also affecting the other patients who need it — patients with rheumatoid arthritis who have used it for years are now struggling to get hold of it because the global stock is being bought up for use in COVID-19 patients.

WHO have asked Roche to broaden access to this drug by ensuring other suppliers can make the drug through technology and knowledge transfer and data sharing. They have also called for competent manufacturers to come forward in order to prequalify them for production of the drug so that availability will increase. Yet, these appeals have fallen on deaf ears. Roche remains silent.

The same is happening for other mAbs as well. All around the world, people whose lives could be saved by mAbs do not have access to these treatments, whether it’s for cancer, Ebola or COVID-19.

We must raise the alarm now about the access barriers around these drugs and seek solutions to overcome those barriers. It’s an exciting time for science and for medicine, but we need to ensure the benefits are made available to everyone, not just the fortunate few like the handful of patients in my hospital in Norway. The issue of lack of access to treatment will only intensify for the future if we don’t act now.

Together we must overcome the barriers for access to mAbs. They are needed for this pandemic and beyond.

****
What you can do: Support our campaign to overcome monopolies on all COVID-19 medical tools and open up access to everyone through the adoption of the TRIPS Waiver at the World Trade Organization.

This blog is a place to reflect on our experiences working for access to medicines. For the official MSF Access Campaign website please visit msfaccess.org.