DOH officials say PCV13 tender now under health technology assessment

The Department of Health (DOH) has placed the pneumococcal conjugate vaccine (PCV13) under health technology assessment to determine its safety and effectiveness after its procurement was postponed due to calls for an open and competitive bidding.

“Yes, it is up for review and will be elevated to the HTAC,” Health Secretary Francisco Duque III told GMA News Online on Thursday.

Created under Republic Act No. 11223 or the Universal Health Care law of 2018, the Health Technology Assessment Council (HTAC) is an attached agency of the Health department.

The DOH has postponed the bidding for P4.9 billion worth of PCV stocks for 2020 for a review of data raised by pharmaceutical company GlaxoSmithKline, Health Undersecretary Eric Domingo earlier said, noting that GSK asked for a reconsideration of its vaccine as a “viable option.”

“The bidding is on hold until the HTA review is completed. I believe he (Duque) directed them to finish in a month,” Domingo told GMA News Online in a separate text message on Thursday.

Domingo did not specify a definite date, beyond saying that the procurement of pneumococcal conjugate vaccines would begin immediately after the review.

While the DOH usually conducts open and competitive bidding, the PCV procurement process was questioned because it specified a single vaccine, the PCV13.

Composed of health experts tasked to facilitate the provision of financing and coverage recommendations for health technologies to be financed by the DOH and the state-run Philippine Health Insurance Corporation, the HTAC is mandated to oversee and coordinate health technology assessment within the DOH and PhilHealth and review and assess existing benefit packages.

Five years after its creation, the council will transition into an independent government entity.

“In the UHC law, the first two years of operation will focus on review and rationalization of existing DOH programs and PhilHealth benefits kasama na nga ang mga vaccines including PCV13 sa National Immunization Program (NIP) since lumaki ang budget requirement when DOH aimed to cover all infants,” Melissa Guerrero, program director of the DOH’s National Center for Pharmaceutical Access and Management (NCPAM), said in a separate text message.

“Since this is an existing vaccine under NIP, nire-review ano ang naging impact ng implementation including the existing serotypes of pneumococcus in the Philippines,” Guerrero said.

The review might take six to 12 months subject to availability of data, according to NCPAM.

“Then will see po if recommend pa rin ng HTAC na ituloy given the huge budgetary impact and mayroon ding priorities na iba for funding ang DOH like primary care,” she said.

Anna Ong-Lim, president of the Pediatric Infectious Disease Society of the Philippines, earlier said there are two types of PCVs in the global market that are both effective in protecting against pneumococcal diseases, the biggest vaccine-preventable cause of death in children under five. She was referring to PCV10 and PCV13.

The World Health Organization has said both PCV10 and PCV13 “have been shown to be safe and effective” against pneumococcal disease caused by vaccine serotypes when administered in three or four doses.

Some industry stakeholders were supposedly concerned by the Health department’s seeming preference for only one PCV type, the PCV13.

“There is new evidence on PCV vaccines that we need to consider and also revisit whether the vaccination has really led to reduced streptococcal disease,” Guerrero said.

Domingo, for his part, said the HTAC review will also cover the PCV10.

Health Assistant Secretary Maria Vergeire was quoted as saying in an earlier report that PCV10 is “still undergoing health technology assessment and not yet included in the Philippine National Formulary.”  —VDS, GMA News