Some positive news: We have learned of the existence of an FDA approved drug that would be effective for patients with COVID who are suffering from mild to moderate form.
During the first months of the COVID-19 pandemic, the widespread belief was that everything would be fine once vaccines were developed by experts, distributed in all countries, and administered to populations. Once that happened, life would resume its normal course.
It has been almost two years. Several brands of vaccines have been developed and deployed in many countries around the world. Different governments have had different successes in vaccinating their populations against the virus. There is also the continuing threat of cyclical surges following an easing of restrictions.
As a result, the recovery has been patchy, uncertain. It has been a terrifying roller coaster ride for ordinary people and health experts alike. The victims themselves have to go through the painful process of trying to recover (on their own in COVID services) and praying for an effective drug.
We now know that despite the availability of vaccines, the debilitating effects of COVID-19 on our health system and our economy. We need a more active strategy to vaccinate everyone.
What would allow us to step up our game in the fight against COVID-19? Access to innovative treatments approved by health authorities would be a good complement to a strong vaccination program.
On September 24, the World Health Organization updated its clinical care guidelines to include the monoclonal antibodies casirivimab and imdevimab (known as Ronapreve outside the US and UK) for treatment non-serious cases of COVID-19, which are most at risk. hospitalization. It is also ideal for patients with severe or critical illness who have not developed an antibody response.
In July 2021, Japan fully approved Ronapreve antibody therapy for patients with mild to moderate cases. A month later, in August 2021, UK regulators granted conditional marketing authorization to treat patients with confirmed acute infection with COVID-19. Other countries, including the United States, have authorized Ronapreve for emergency or temporary use. For example, it was used to treat former US President Donald Trump when he was hospitalized with COVID last year.
On October 1, the Food and Drug Administration of the Philippines issued an emergency use authorization for Ronapreve as a treatment for COVID-19.
Ronapreve is a cocktail of two monoclonal antibodies that studies have shown reduce the risk of hospitalization and death by up to 70% in patients with mild to moderate COVID-19. The two ingredients, casirivimab and imdevimab, work together to prevent the SARS-CoV2 virus from infecting cells that line the airways.
Ronapreve is used in patients 12 years of age and older who weigh at least 40 kilograms and do not require supplemental oxygen. It can be given as a single infusion into the vein [or an injection under the skin – based on clinical trials].
Developed by biotech companies Regeneron and Roche, Ronapreve is currently in use at St. Luke Medical Center and Makati Medical Center, which had previously received special compassionate permits from the FDA.
So what’s the next logical step? The Health Technology Assessment Council (HTAC) and Philippine COVID-19 Living Recommendations must first give a positive recommendation to the Department of Health before the government can purchase the drug. The assessment must be completed before hospitals can place an order through the government, the only entity that can purchase and distribute it.
A recent forum hosted by the Stratbase ADR Institute brought together health and policy experts who agreed that treatments like Ronapreve should run alongside the nationwide vaccination campaign.
Professor Dindo Manhit, Chairman of Stratbase ADRi, said: “We need an innovative, fast-track, cross-sectoral and cost-effective approach to healthcare if we are to tackle this persistent crisis decisively.
In the same discussion at the virtual town hall, Dr Rontgene Solante, head of the Adult Infectious Diseases and Tropical Medicine Unit at San Lazaro Hospital, stressed the need to move forward “because SARS-CoV-2 is not going to go away”.
Experts agree that administrative and bureaucratic roadblocks should be immediately lifted to allow as many COVID-19 patients as possible to access innovative treatments like Ronapreve. In fact, it should be part of PhilHealth’s benefits for COVID interventions and be available to all Filipinos, especially those who cannot afford hospitalization and expensive medication.
One can imagine the lives that could be saved and the resources that could be freed up for those who need them most. More importantly, imagine the reduction in pressure on primary care physicians and the health care system in general.
Melancholy thought or a “new” normal for all?
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