Some positive news: We learned of an FDA-approved medicine that is said to be effective for COVID patients who have it mild to moderate.
During the first months of the COVID-19 pandemic, the widespread belief was that everything would be all right once vaccines were developed by experts, distributed to all countries, and administered to populations. Once that happened, life would go back to normal.
It has been nearly two years. Several vaccine brands have been developed and rolled out to numerous countries around the world. Different governments have had differing success in inoculating their populations against the virus. There is also the perennial threat of cyclical surges following a loosening of restrictions.
As a result, recovery has been uneven, uncertain. It’s been a terrifying roller coaster ride for ordinary folks and health experts. The victims themselves have to go through the painful process of trying to get well (by themselves in COVID wards) and praying for an effective medicine.
We now know that despite the availability of vaccines, the debilitating effects of COVID-19 on our healthcare system and economy. We do need a more active strategy to vaccinate everyone.
What would allow us to step up our game in fighting COVID-19? A good complement to a robust vaccination program is access to innovative treatments that have been approved by health authorities would greatly help.
On Sept. 24, the World Health Organization updated its clinical care guidance to include the monoclonal antibodies casirivimab and imdevimab (known as Ronapreve outside the US and UK) for treatment of non-severe cases of COVID-19, who are at the highest risk of hospitalization. It is also ideal for patients with severe or critical illness who have not mounted an antibody response.
In July 2021, Japan fully approved Ronapreve antibody treatment for patients with mild to moderate cases. A month later, in August 2021, the UK regulators followed by granting a Conditional Marketing Authorization to treat patients with confirmed acute COVID-19 infection. Other countries including the US have authorized Ronapreve for emergency or temporary use. For example, it was used to treat former US President Donald Trump when he was hospitalized for COVID last year.
This Oct. 1, the Philippines’ Food and Drug Administration issued an emergency use authorization for Ronapreve as treatment for COVID-19.
Ronapreve is a cocktail of two monoclonal antibodies that, according to studies, reduces the risk of hospitalization and death by up to 70 percent in mild to moderate COVID-19 patients. The two ingredients, casirivimab and imdevimab, work together to prevent the SARS-CoV2 virus from infecting cells that line the respiratory tract.
Ronapreve is used in patients 12 years and older, weighing at least 40 kilograms, and not requiring supplemental oxygen. It may be given as a single infusion into the vein [or an injection under the skin – based on clinical trials].
Developed by biotech firms Regeneron and Roche, Ronapreve is currently being used at St. Luke’s Medical Center and Makati Medical Center that were earlier given a Compassionate Special Permit by the FDA.
So what is the next logical step? The Health Technology Assessment Council (HTAC) and Philippine COVID-19 Living Recommendations first have to give a positive recommendation to the Department of Health before the government can procure the drug. The assessment has to be concluded before hospitals can place an order through the government, the only entity that can procure and distribute it.
A recent forum by the Stratbase ADR Institute gathered health and policy experts who agreed that treatments such as Ronapreve should run parallel to the nationwide vaccination drive.
Prof. Dindo Manhit, Stratbase ADRi President, said: “We need an innovative, accelerated, cross-sectoral, and cost-effective approach to healthcare if we are to confront this lingering crisis decisively.”
In the same virtual town hall discussion, Dr. Rontgene Solante, chief of the Adult Infectious Diseases and Tropical Medicine Unit at San Lazaro Hospital, emphasized the need to move forward “because SARS-CoV-2 is not going away.”
The experts agree that administrative and bureaucratic roadblocks should be hurdled right away to allow as many COVID-19 patients access to innovative treatments like Ronapreve. In fact, it should be made part of PhilHealth benefits under the COVID interventions and be available to all Filipinos, especially those who cannot afford hospitalization and expensive medicines.
One can imagine the lives that could be saved and the resources that can be freed up for those needing them more. More important, imagine the reduced strain on medical front-liners and the healthcare system in general.
Wistful thinking or a “new “ normal for all?