On 24 December 2021, the Secretary of Health approved and signed the Health Technology Assessment Council (HTAC) interim recommendation for the government not to finance casirivimab+imdevimab for the treatment of COVID-19.
The Philippine Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on 01 October 2021 (amended on 17 November 2021)1for casirivimab+imdevimab (120 mg/mL concentrate for solution for infusion), a dual monoclonal antibody designed to block infectivity of SARS-COV-2 and indicated for the treatment of confirmed mild to moderate COVID-19 in patients aged 12 years and older and weighing at least 40kg that do not require supplemental oxygen for COVID-19 and who are at risk of progressing to severe COVID-19. 2 In reaching its interim recommendation for the government, the HTAC considered the (a) rapid review of the Philippine COVID-19 Living Clinical Practice Guidelines for clinical efficacy and safety (as of 12 October 2021), (b) complexity of administration, and (c) the cost of the medication as follows:
A. Weak evidence of clinical benefit on the use of casirivimab+imdevimab for the treatment of mild to moderate COVID-19
For the evidence on clinical efficacy and safety of casirivimab+imdevimab, the HTAC considered the rapid review conducted by the Philippine COVID-19 Living CPG. At the time of the rapid review of the Philippine COVID-19 Living CPG, there were only two (2) studies on the efficacy and safety of the said drug, and the overall quality of evidence was rated moderate due to serious risk of bias. The HTAC noted that one (1) of the two (2) studies is a preprint study for hospitalized patients. he Philippine COVID- 19 Living CPG suggested the use of the drug for the treatment of non-hospitalized patients with at least one (1) risk factor based on weak recommendation; and, strongly recommended against the treatment of hospitalized patients. Currently, there are four (4) ongoing trials reported in the review of Philippine COVID-19 Living CPG.
B. Complex method of administration
The administration of casirivimab+imdevimab to non- hospitalized COVID-19 patients requires close supervision of a licensed physician and in a facility capable of monitoring and managing adverse reactions and will therefore need more resources and logistical considerations that may limit access to this medication.
C. Unaffordable cost of medication
Administration of casirivimab+imdevimab for non-hospitalized COVID-19 patients with at least one (1) risk factor will cost Php 25,551.00 per patient (total treatment cost). The government will need to spend Php 955.68 million to implement this medication to avert 840 cases of hospitalization which is significantly greater than the projected averted cost (Php 196.73 million) of hospitalization due to COVID-19 infection. The HTAC emphasized that the above recommendations are interim and will be revisited upon the release of new information. For more information on the current reviews and recommendations of the HTAC, please visit hta.doh.gov.ph.
1. Philippine Food and Drug Administration, Amended EUA for Casirivimab+Imdevimab,
2. Philippine Food and Drug Administration,Product informationon Casirivimab+Imdevimab, |