Public and private hospitals, local government units (LGUs) and relevant government agencies may now procure investigational coronavirus disease (COVID-19) drugs under emergency use authorization (EUA) such as antibody cocktail Ronapreve.
The Department of Health (DOH) on Nov. 8, 2021 issued Administrative Order 2021-0053, providing the guidelines for the procurement, distribution and rational use of COVID-19 drugs with EUA.
DOH Undersecretary Maria Rosario S. Vergeire, in a press conference Monday, Nov. 15, 2021, said the issuance of AO 2021-0053 decentralizes procurement of medicines used to treat COVID-19.
Under Food and Drug Administration (FDA) Circular 2020-036, only the DOH and the National Task Force (NTF) Against COVID-19 are authorized to procure investigational drugs with EUA.
“It’s a general prescription wherein we are already giving authority to our hospitals and local governments to procure these drugs. Hindi na kailangang DOH pa ang bumili tapos mag-a-allocate pa to the hospitals…This AO serves to provide that authority to all our implementing units so they can procure on their own,” Vergeire said.
The drugs that may be procured are only those included in the Philippine COVID-19 Living Recommendations and must come with positive recommendation from the Heath Technology Assessment Council.
Health facilities and LGUs that will procure these drugs must also comply with reportorial requirements.
The DOH directive also specified that the unit cost or the Approved Budget for the Contract must not be lower nor higher than the maximum wholesale price if the drug is included in the maximum drug retail price. If not, the procuring entities must be guided by the drug price reference index.
Ronapreve, which was developed by Roche and Regeneron, is a combination of human-made antibodies casirivimab and imdevimab.
It was developed to treat COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis).
This investigational drug has been approved for use in Japan and conditionally in Australia and the United Kingdom, and is authorized for emergency or temporary pandemic use in additional territories such as the United States, India and Canada. It has also been conditionally recommended by the World Health Organization (WHO).
A statement by Roche last week said Ronapreve is available in nearly 50 countries via bilateral purchase agreements, including upper-middle-income and lower-middle-income countries.
In the Philippines, the FDA released the EUA for the drug on Oct. 1, 2021.
Under the Philippine EUA, the drug is authorized for confirmed mild to moderate COVID-19 patients aged 12 and above with a minimum weight of 40 kilograms who do not need supplemental oxygen and are at high risk of progressing to severe cases.
An EUA, however, is not a marketing authorization, which means that the drug covered by such a permit may not be sold commercially. (Marites Villamor-Ilano)