Medicines regulator approves Pfizer’s Covid-19 pill

SA’s medicines regulator has approved Pfizer’s coronavirus treatment Paxlovid, but the drug is likely to be too expensive for all but a limited number of medical scheme patients.

Paxlovid has been shown to reduce the risk of hospitalisation and death in high-risk patients with mild to moderate Covid-19, and was given the green light by the SA Health Products Regulatory Authority (Sahpra) on Monday. Patients require a five-day course of tablets, taken morning and evening, and they must begin treatment as soon as possible soon after symptoms appear.

Paxlovid costs the US government $530 a course, but the price for private sector sales in SA has yet to be disclosed by Pfizer or the health department. An industry source said even at half the US price, it would be too expensive for the state.

The medical scheme administrator Discovery Health said it has been in discussions with Pfizer and expected its client schemes would cover Paxlovid for members at high risk of Covid-19 complications. Discovery Health counts SA's biggest open scheme, Discovery Health Medical Scheme among its clients.

The drug was a “very important” addition to the available treatments for high risk members, which included people over the age of 65, those with underlying health conditions such as diabetes or a compromised immune system, said Noluthando Nematswerani, head of the centre for clinical excellence at Discovery Health.

“Based on our discussions we will be able to fund it. The engagements [with Pfizer] were to make sure it is affordable and accessible to everyone who is clinically eligible,” she said.

However, the drug will not immediately be available to state patients as the health department’s experts last year recommended against its use until the price of cheaper generics was known. Pfizer signed an agreement with the Medicines Patent Pool last year that paves the way for 35 generic pharmaceutical manufacturers to make cheap copies of its tablets in 95 low- and middle-income countries, including SA. The agreement includes Indian generic giant Cipla, which has a factory in Durban, and restricts generic sales in SA to the state sector.

No generic versions of Paxlovid have yet been registered in SA.

The national essential medicines list committee on Covid-19 therapeutics has previously questioned the feasibility of providing Paxlovid in the public sector as patients must begin treatment as soon as possible and within five days of symptom onset. The state’s limited Covid-19 testing capacity means many patients get tested only once they have severe illness, by which stage it is too late to use Paxlovid.

The committee also expressed concern at the time about possible drug interactions with Paxlovid.

Paxlovid combines nirmatrelvir, developed by Pfizer, and an older drug, ritonavir, developed as an HIV treatment. Nirmatrelvir inhibits viral replication, while ritonavir boosts the concentration of nirmatrelvir by slowing its breakdown in the body. Ritonavir itself is well tolerated, but its mechanism affects the way other drugs in the body are metabolised, resulting in potential dangerous interactions between medications.

Sahpra CEO Boitumelo Semete-Makokotlela said the regulator was committed to fast-tracking the registration of all urgently needed products, including those for Covid-19, HIV/Aids, and cancer.

While SA’s confirmed Covid-19 cases, hospital admissions and deaths are now low, the World Health Organization said on Monday that the coronavirus pandemic remained a public health emergency of international concern, its highest alert level, due to the low vaccine uptake in some parts of the world and uncertainty about the evolution of future variants.

kahnt@businesslive.co.za

Correction: February 1 2023
A previous version of this story described Noluthando Nematswerani as the principal officer of Discovery Health Medical Scheme. This story has been updated to reflect her correct title and the fact that she was speaking on behalf of Discovery Health.