M4

• The HTAC recognizes that it should respond effectively, efficiently and in a timely manner to the decision needs of the DOH and PhilHealth particularly in situations of public health emergency as defined under Section 4.30 of the Universal Health Care Act, hence requiring an expedited process of evidence review to provide immediate guidance to public health authorities and health care providers on the use of a health intervention or technology
• A health technology can be considered to undergo an expedited process if it responds to the following public health emergencies:
• Public health emergencies


  • Bioterrorism
  • Appearance of a novel or previously controlled or eradicated infectious agent or biological toxin
  • Natural disaster
  • Chemical attack or accidental release
  • Nuclear attack or accident
  • Attack or accidental release of radioactive materials
• Criteria for public health emergency

  • High probability of a large number of deaths in the affected population
  • High probability of a large number of serious injuries or long-term disabilities in the affected population
  • Widespread exposure to an infectious or toxic agent that poses a significant risk of substantial harm to a large number of people in the affected population
  • International exposure to an infectious or toxic agent that poses a significant risk to the health of citizens of other countries
  • Trade and travel restrictions
• Steps for conducting HTA on health technologies for public health emergencies

  1. Topic nomination

  2. Topic prioritization

  3. Protocol development and assessment

  4. Evidence appraisal

  5. Recommendation

  6. Decision

  7. Dissemination
• Topic nomination


  The request for an expedited process must emanate from the Secretary of Health following the declaration of a public health emergency. Directors of the DOH national health programs shall submit the following documents to facilitate the review process as verified and endorsed by the Secretary of Health:
• Documents to be submitted for topic nomination

  • Accomplished proposal form that includes justification, a report on the public health emergency, disaster, or accident with pertinent information such as the estimated number of affected populations
  • FDA marketing authorization or WHO certification of prequalification for drugs and medicines
  • Other relevant documents (e.g. peer-reviewed local Philippine clinical practice guidelines which provides information on the indication or use of the product (preferred), excerpts from WHO documents or other formularies, etc., including photocopies of such)
• Topic prioritization


  The decision to use the expedited process is the responsibility of the HTAC which shall act on the request/petition of the SOH within seven (7) days of receiving the request for an expedited review of a health technology
• Protocol development and assessment

  The HTA office shall extend all assistance to HTAC through fast track evidence assessment supported by internal or external assessment teams which shall conduct a rapid review that should be completed within 2 to 12 weeks of the request/petition for an expedited review process
• Evidence appraisal


  Health technologies that have undergone expedited assessment shall be subject to full appraisal that includes evidence generated from the emergency use as soon as feasible
• Criteria for HTAC to evaluate and recommend the use of a health technology

  • The health technology has been approved for marketing and use by the Philippine FDA, when applicable
  • There is no other better or existing health intervention that can address the particular condition /situation
  • The health intervention shall be used for a current public health emergency or imminent health threat that could affect a sizeable population as defined in the UHC Act
• Recommendation


  Following the rapid appraisal process, the HTAC shall develop and submit its recommendation to the Secretary of Health to guide the final decision of the DOH on the use of the health technology
• Decision


  The Chair of the HTA Core Committee through the Secretariat shall transmit the recommendation of the Committee to the Secretary of Health for interventions which fall under the remit of specific health programs at the DOH and the PhilHealth Board of Directors for health interventions that are part of the benefit packages of PhilHealth for final decision-making
• Drugs and vaccines that are approved by the Secretary of Health and/or PhilHealth Board of Directors shall be listed in the Philippine National Formulary
• Dissemination


  The HTA Unit shall develop and publish the communication materials, policy briefs and evidence summaries for healthcare professionals, patients and policy makers on the appropriate use of health technologies based on the appraisal and recommendations of the HTA Core Committee
• The HTAC shall review and finalize the content of the communication materials before public dissemination
• The Assessment Teams shall draft the study protocol with the scope of the assessment through a review of literature on the specific health technologies, expert advice or contact of manufacturers/companies as necessary
• Feedback from contacted experts/ companies should be submitted within one week upon receipt of the official communication from HTAU
• The protocol development shall include scoping with relevant stakeholders to refine and validate the assessment methods and scope
• The HTAC Subcommittee and the methods expert/s in the Core Committee shall review the consistency of the protocol with the agreed methodological standards and set the prescribed timeline of assessment
• Topic prioritization


  Selection of topics through a standard set of criteria by HTAC to ensure that the appraisal process responds to the priority health care needs of the country and that the topics address conditions that are important to patients, health care providers, PhilHealth and DOH program managers, hospitals and local health system administrators
• The objective of this specific step in the process is to ensure that topics are subjected to a standard selection process in deciding which health technologies undergo assessment and appraisal to maximize the use of available resources
• Through this step, it is also aimed that all relevant stakeholders are properly consulted in a transparent, inclusive and predictable manner
• All topics with complete evidentiary requirements submitted or referred to the HTA Technical Secretariat shall undergo the standard selection process using a validated prioritization tool used by HTAC in selecting topics
• Criteria for prioritizing existing health technologies already being financed by DOH and PhilHealth

  • Budget impact to DOH and PhilHealth
  • Total users of health technology
  • Cost-effectiveness
  • Severity of disease
  • Equity, ethical and social implications
• Criteria for prioritizing new health technologies

  • Total users of health technology
  • Severity of disease
  • Estimated household financial impact
  • Equity, ethical and social implications
  • National health service needs
• The topics shall be ranked based on their scores and from this, the shortlist of topics for evaluation shall be developed by the HTAC
• The HTA Internal Assessment Team shall conduct independent literature review of the shortlisted topics with regard to their current or potential place in clinical therapy, the likely populations who will benefit from the intervention, the existing literature on its clinical and cost-effectiveness in the local setting or other relevant settings, the associated costs with the use of the intervention and other legal, social and ethical considerations
• Topic nomination


  The process of referring topics to HTAC for which technology appraisals may be produced and disseminated for the guidance of policy-makers in healthcare coverage decisions and to health providers and patients on the optimal and appropriate use of health technologies
• The HTA Unit, through the Technical Secretariat, manages the process of accepting potential topics for assessment and appraisal by HTAC from health technologies referred by the different Offices of the Department of Health and PhilHealth, by other stakeholders such as professional health organizations, industry, patient/civil society organizations, public and private hospitals through the therapeutic committees (i.e., for medicines) and local government units through their provincial and/or city health officers
• New and potentially innovative health technologies which respond to unmet or priority health care needs in the local Philippine context may also be submitted for HTAC appraisal by relevant industries with the required clinical, social and economic evidence
• For existing health technologies, a reassessment may be triggered by the emergence of new clinical evidence that may have an impact on the previous recommendation of HTAC
• A call for topic nomination shall be issued by the HTA Technical Secretariat through website announcement and through electronic mail to all stakeholders once a year
• Mandatory documentary requirements for topic nomination

  • Certificate of Product Registration (CPR) from FDA for drugs and vaccines
  • Certificate of Free Sale (CFS) for medical devices exempted from current FDA process
  • Certification for Traditional Medicine Practices from PITAHC
  • Certification for Traditional Medicine Devices from FDA
  • Certification for herbal medicines and traditionally used herbal products from FDA
  • Certificate of impact on clinical practice from the concerned professional society/ies for medical and surgical procedures
• Proponents with deficiencies in their submissions may comply within the prescribed period of topic nomination. Incomplete submissions will not proceed to the prioritization process
• The implementation of HTA follows a standard process that will be detailed in the next sections. The General HTA Process will be applicable to all health technologies except in public health emergencies (PHEs). Meanwhile, the Expedited HTA Process will be applicable for health technologies during PHEs
• PICOT


  The research question should be delineated across five (5) elements: Population, Intervention, Comparator, Outcome, Timeframe
• The research question should be delineated across five (5) elements (PICOT): P: Population of interest, I: Intervention/s, C: Comparator/s, O: Outcome, T: Timeframe
• Not all policy questions are answerable by HTA. HTA questions, in our context, aim to respond to national-level service coverage or investment and optimization decisions to ensure proper allocation of resources
• Questions HTA attempts to answer

  • Does the technology work? Is it safe and effective for the clinical purpose or indication it is intended?
  • Is there meaningful improvement in health status relative to its cost?
  • Which patients or subgroups of the population benefit the most?
  • Can the government through DOH and PhilHealth afford to pay for all people who might need the technology?
  • What other considerations make this technology important in the local context?