Government, experts wary of new Covid-19 drug

SA is taking a cautious approach to a specialised coronavirus drug which is being tested in the country, choosing not to commit until its efficacy is proven.

Last month, during the health portfolio committee hearings on the National Health Insurance scheme, Zwelethu Bashman, the South African managing director of US drugmaker Merck & Co (MSD), told MPs they were in talks with the health department over the antiviral drug molnupiravir, which they anticipate will be available for pre-licence use towards the end of the year.

SA is one of 18 countries where the drug, which has shown promising signs of stopping the progression of the Covid-19 disease and preventing hospitalisation, is undergoing its third phase of clinical trials before it is submitted for approval to the South African Health Products Regulatory Authority (Sahpra). Bashman said trials were being conducted at 12 sites in six provinces.

“MSD has engaged the government on progress related to our clinical development programme … We believe that … an effective treatment, in addition to vaccination and all the other safety measures, could prove to be a critical component … to combat Covid-19 by reducing pressure on our health-care system,” he said.

In June, the US government agreed to pay about $1.2bn (about R18bn) for 1.7-million courses of the drug, which translates to $705 or more than R10,000 a course. In its second phase of trials in India, molnupiravir was found to have resulted in fewer hospital admissions, a faster recovery and a swifter negative test.

However, SA could find itself in a similar position to the one it was in when trying to source vaccines, which were snapped up as early as July last year by wealthy countries that were able to spend money on jabs that had by then not yet been fully tested. To be in the front of the queue for molnupiravir, the country would have to sign an early agreement with MSD, which it has not yet done.

Health department spokesperson Popo Maja said the department had been in discussions with MSD but it was too early to commit. “We will get to such agreements upon approval by Sahpra,” said Maja.

“Resource allocation decisions cannot be taken lightly, especially given that the drug is still undergoing investigation in clinical trials. In addition, making a financial commitment for a medicine still undergoing investigation is difficult to motivate for when the robust data required to make such decisions with a certain degree of comfort is not available.

“Once there is clear evidence of benefit in terms of efficacy and safety will cost be considered.”

Bashman told the Sunday Times that “an early, non-binding supply agreement could assist countries with the highest need to secure early access to the antiviral candidate, if approved for use”.

“We currently do not have a set price, however, we do plan to implement a tiered pricing approach based on World Bank data that recognises countries’ relative ability to finance their health response to the pandemic,” he said.

Dr Jeremy Nel, head of the division of infectious diseases at Helen Joseph Hospital and the University of the Witwatersrand, agrees that the government should take a cautious approach considering its financial constraints.

“We just don’t yet know whether or not molnupiravir is effective in reducing rates of hospitalisation or death, which are the things we care about.

“Results are only expected from the trial around September or October of this year at the earliest. In my opinion, any commitment to buy the drug at this stage is therefore premature, at least for a cash-strapped middle-income country like South Africa,” he said.