Study Set Content:
Critical appraisal of the whole dossier with complete assessment conductedandsubmittedby the proponent (including evidence on clinical, economic, ethical, legal, social and healthsystemimpact)
Option 1
Assessment team conducts its own assessment which can be a combinationof oneclinicalanalysis and one cost analysis
Option 2
Critical appraisal of synthesized clinical evidence or systematic Review on clinical evidence
Clinical analysis
CMA, Budget Impact Analysis, Ethical, Legal, Social Impact and Health System Implications
Cost-Minimization Analysis
(CEA/CUA)+Budget Impact Analysis+ ELSI and HSI
Cost-effectiveness Analysis/ Cost-Utility Analysis
Cost-Minimization Analysis, Cost-effectiveness Analysis/ Cost-Utility Analysis
Cost Analysis
The Subcommittees shall be responsible for ensuring that: (1) the assessment was conductedfollowingthePhilippine HTA (); (2) all pertinent pieces of evidence are considered in the ();and (3) the evidence presented in the report answers the() and will be sufficient inarriving at a recommendation/decision.
Methods Guide, technical report, research question
refers to the process by which the HTAC evaluates and makes a judgement on thevalueofahealth technology in the Philippine context using its established criteria based on the evidencepresentedby the Subcommittees supported by the HTA output of the Assessment Teams.
Evidence Appraisal
The Assessment Team must present first its output to the Subcommittees which shall conduct aninitial deliberation and
appraisal
The preliminary output of the Assessment Team shall undergo peer review by experts identifiedbythe ()
DOST
Unsatisfactory reviews may require additional() from the proponents.
evidence
A () public consultation shall be conducted
face-to-face
shall conduct quality assurance of the final assessment output, whichshall beappraised by the ()
HTAC subcommitte, HTAC Core Committee
Once the output of the Assessment Team is approved, they shall develop an evidence summarytobepresented to the HTA Core Committee for final deliberation and
recommendation
The Chair of the Subcommittee or another designated Committee member with the support of theAssessment Team shall present to the HTA Core Committee the evidence summary for the assessedhealthtechnology, highlighting the important pieces of evidence considered as well as the
Subcommittee conclusions
shall deliberate on the evidence presented arriving at a judgment andrecommendation on the public funding and use of the health technology in the health system.
HTA Core Committee
The decision of the majority (i.e., one half plus one) of the members of the HTA Core Committeepresentduring the votation shall be considered as the decision of the Committee. Recommendations of theHTACore Committee may be one of the following
Approve Approve with restrictions/conditions of use Disapprove
Resolution
An appeal may be submitted to the HTA Technical Secretariat within () working days frompostingofthe HTAC Core Committee recommendation, if there is new data that was not part of the initial submissionand may impact the recommendation of the HTAC.
10
The Chair of the HTA Core Committee through the Secretariat shall transmit the recommendationoftheCommittee to the Secretary of Health for interventions which fall under the remit of specific healthprograms at the () and the () Board of Directors for health interventions that arepart of thebenefit packages of ()for final decision-making.
DOH, PhilHealth, PhilHealth
Drugs and vaccines that are approved by the Secretary of Health and/or PhilHealth Board of Directorsshallbe listed in the
Philippine National Formulary
