Please enable JavaScript.

Coggle requires JavaScript to display documents.

HTA PRINCIPLES - Coggle Diagram

- - - - “The New Implementing Guidelines on Health Technology Assessment to Guide Funding Allocation and Coverage Decisions in support of Universal Health Care”
        
        Defines the overall framework to institutionalize and implement HTA as a priority setting mechanism that shall be recommendatory to guide DOH and PhilHealth on all coverage and funding allocation decisions
        
        objectives
        
        o provide the governance framework for HTA in the Philippines
        
        To provide the processes involved in the implementation and governance of HTA through the issuance of the HTA Process Guide
        
        To describe the methods of conducting assessments that will guide the generation of policy-informed recommendations through the issuance of the HTA Methods Guide
        
        To define the roles and responsibilities of stakeholders involved in HTA
        
        HTA council
        
        Supported by the HTA Division in its governance, management and operations
        
        HTAC Core committee: composed of nine voting members
        
        HTAC Subcommittees: seven subcommittees; each has three non-voting members
    - - “National Health Insurance Act of 1995”
        
        Adopts an integrated and comprehensive approach (National Health Insurance Program) to health development; to make essential goods, health and other social services available to all people at affordable cost.
        
        PhilHealth is the implementer of the National Health Insurance Program
        Presently: PhilHealth is planning to shift its provider-payment mechanism towards a blend of diagnosis-related groups (DRGs) and prospective global budget payments, supported by proper costing methodologies and explicit co-payment rules
        
        DRG: it is system that group the diseases together which afterwards set benefit packages for that group
        
        objectives
        
        Provide all citizens of the Philippines with the mechanism to gain financial access to health services;
        
        Create the National Health Insurance Program, hereinafter referred to as the Program, to serve as the means to help the people pay for health care services;
        
        Prioritize and accelerate the provision of health services to all Filipinos, especially that segment of the population who cannot afford such services; and
        
        Establish the Philippine Health Insurance Corporation, hereinafter referred to as the Corporation, that will administer the Program at central and local levels
    - - “National Health Insurance Act of 2013”
        
        Defined HTA and mandated the utilization of HTA in guiding the health services coverage of the PhilHealth
        
        relevant provisions
        
        The Corporation shall not cover expenses for health services which the Corporation and the DOH consider cost-ineffective through HTA”
        
        Has a component of economic assessment
        
        “Services and packages shall be reviewed annually to determine their financial sustainability and relevance to health innovations, with the end in view of quality assurance, increased benefits and reduced out-of-pocket expenditure.”
    - - Food and Drug Administration (FDA) Act of 2009
        
        objectives
        
        To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction
        
        To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction
        
        functions of FDA is to give LTO for establishment and CPR to health products
        
        To provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction
        
        “To conduct appropriate tests on all applicable health products prior to issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality”
    - - “Government Procurement Reform Act”
        
        States principles, scope and applications on government procurement
        
        procurement refers to the acquisition of goods, consulting services and the contracting for infrastructure projects by the procuring entity
        
        Creates the Government Procurement Policy Board
        
        All procurement shall be done through competitive bidding OR public bidding
        
        Open to participation by any interested party
        Consists of: advertisement, pre-bid conference, eligibility screening of prospective bidders, receipt and opening of bids, evaluation of bids, post-qualification, and award of contract
        
        instances that competitive and public bidding are not feasible
        
        limited source bidding
        
        direct contracting
        
        shopping
        
        negotiated procurement
    - - Collaboration among the DOH, the PhilHealth, and the DTI
      - Creates an independent Price Negotiation Board to centrally negotiate prices on behalf of the government.
      - Provides implementing guidelines on price negotiation for innovative, proprietary, patented and single-sourced health commodities
        
        Promote transparency in price setting for innovative, proprietary, patented and single-sourced health commodities;
        
        Improve efficiency in government spending on health commodities through centralized negotiation with respect to pooled volume of health commodities by consolidating the purchasing power of all health care providers under the DOH ‘ thereby strengthening its bargaining power;
        
        Guarantee access to affordable and quality health commodities by using the centrally negotiated price as leverage for a more homogenous and affordable price points for innovative, proprietary, patented and single-sourced health commodities.
    - - “New Implementing Guidelines of the Philippine National Formulary System”
        
        Established a new system and procedures for the selection of medicines, development of the Philippine National Formulary (PNF) and the promotion of its use.
        Required that any medicine considered for inclusion in the PNF shall be assessed based on:
        
        its benefit-risk assessment (safety and efficacy)
        
        cost-effectiveness
        
        affordability and
        
        public health relevance
    - - Universal Health Care Act
        
        Mandated the institutionalization of HTA as a fair and transparent priority setting mechanism that shall be recommendatory to the DOH and PhilHealth (i.e., positive recommendation is required for HTs to be adopted and reimbursed)
        
        Stipulated creation of the HTA Council
        
        Stipulated support of a secretariat and a unit with evidence generation and policy capacity to HTAC
        
        clauses
        
        “Within two (2) years from the effectivity of this Act, PhilHealth shall implement a comprehensive outpatient benefit, including outpatient drug benefit and emergency medical services in accordance with the recommendations of the HTA Council”
        
        “The DOH and the local government units shall endeavor to provide a health care delivery system that will afford every Filipino a primary care provider
        
        highlights the importance of primary care; health is not only the responsibility of the DOH, but also the LGU
        
        there should be a healthcare provider in primary care level
        
        “Investments on any health technology or development of any benefit package by the DOH and PhilHealth shall be based on positive recommendations of the HTA”
        
        “Despite having undergone the HTA process, all health technology, intervention or benefit package shall still be subjected to periodic review”
        
        “An HTA may be conducted as new evidence emerges, which may have substantial impact on the initial coverage decision by the DOH or PhilHealth”
        
        criteria to observed in conduct of HTA
        
        Responsiveness to magnitude, severity, and equity: must address the top medical conditions that place the heaviest burden on the population
        
        Safety and Effectiveness: must have undergone Phase IV clinical trial; evidence must be readily available
        
        Household Financial Impact: must reduce out-of-pocket (OOP) spending
        
        Cost-effectiveness: must provide overall health gain, outweigh the opportunity costs of funding the drug and technology
        
        opportunity cost: outcome of the next best alternative
        
        ex. you 100 pesos, that 100 pesos can be used for this type of health technology. the 100 pesos I used for this kind of health technology could actually outweigh the other healthcare technology that could have been funded by this money
        
        Affordability and Viability: must be affordable and the cost must be viable to the financing agents
  - - - DOH Pharmaceutical Division
        
        Policy development: crafting appropriate policies, guidelines, laws to the effective implementation of the PNF
        
        Price interventions: introducing and enforcing price regulation and monitoring mechanism as containment measure
        
        Interpretation: renders opinion on matters surrounding the PNF implementation
    - - list of drugs prepared and periodically updated by the DOH based on the country's health condition, as well as internationally accepted criteria
    - - DOH Pharmaceutical Division
  - - - Endeavors to provide broad guidelines in:
        
        The conduct of HTA and its domains in assessing the clinical, economic, ethical, legal, social and health systems implications of a specific health technology
        
        The production of standard HTA reports for healthcare decision makers and other target audiences in the health system
  - - - Provide structure, transparency and clarity in the processes followed by the HTA committee and its subcommittees when undertaking a health technology appraisals
      - Ensure that the HTAC and the HTA Unit are properly guided in the effective discharge of their functions and responsibilities
- - - - FDA: evaluate health technologies for safety, efficacy, quality, & purity
      - HTA Council: evaluate HTs based on clinical efficacy/effectiveness, cost effectiveness, and ethical, legal, social and health systems impact; provide recommendations to the DOH and the PhilHealth
      - in other countries, before the drug is in the market, the pharmaceutical company can gain reimbursement from their government
      - HTA is also applicable for existing health technologies
  - - - Selection was previously conducted by the Formulary Executive Council (FEC)
        Presently, there is a transitory FEC within the HTAC (Department Order No. 2020-0567, Feb 3, 2020)
        
        appraise the outputs of the Evidence Review Group [ERG] on drug topics left by the former FEC prior to the creation of the HTAC
        
        discuss and make recommendation to the HTAC on the aforecited appraised drug topics
    - - responsible for the prices: cheaper medicines act (2008)
    - - HTA can be used to guide clinical decisions on how to rationally prescribe, dispense, administer, and use HTs to ensure the maximization of their intended effects
  - - - monitoring is done during while the impact is done on the en
    - - Ensure that HTA findings are delivered on a timely basis to inform decision-making
      - Promote collaboration and transfer of knowledge and skills across jurisdiction
      - Assess the HTA processes and programs’ efficiency, consistency, and sustainability over time
    - - How are decisions implemented?
        What are the results of the recommendation?
    - - Who is being impacted?
        What is a relevant measure of impact?
        What is the decision-making procedure?
        What are the decision outputs? (e.g., yes/no)
    - - Review of mandate and identification of stakeholders
      - Establishment of a logic model and priorities for monitoring and evaluation
      - Selection of qualitative & quantitative indicators for monitoring annual and multi-year target
        
        The HTA mechanism (e.g., HTA funding, legislation on HTA, quality and transparency of HTA implementation)
        
        The procedural aspects of HTA (e.g., use of local data)
        
        The outputs or HTA reports (e.g., equity: on coverage, distribution of resources, access, resource utilization; effectiveness and quality: technical and perceived quality; efficiency: in resource allocation and in resource management; sustainability; social participation and control)
    - - The impact of HTA can occur in an interrelated series:
      - Awareness -> Acceptance -> Policy process -> policy decision -> practice -> outcome
      - One important factor influencing the impact of HTA reports is directness of the relationship among the HTA program, policy-making bodies and health care decisions
      - factors affecting the impact of HTA reports
        
        Target clinician characteristics
        
        Specialty and affiliation of the clinician
        
        Target provider organization characteristics
        
        Target patient characteristics
        
        Environmental characteristics
        
        Characteristics of HTA findings/recommendation
        
        Regulatory policy (e.g., market access of a technology)
        
        Third-party payment policy (e.g., coverage, pricing, reimbursement of a technology)
        
        Rate of use of a technology
        
        Clinical practice guidelines
        
        Stakeholders’ awareness and behavior
        
        Acquisition, adoption, or diffusion of a technology
        
        Marketing of a technology
        
        Organization or delivery of care
        
        R&D priorities and associated spending levels
        
        Data collection (e.g., to fill evidence gaps identified by HTA reports)
        
        Allocation of local, regional, national, or global health care resources
        
        Investment decisions (e.g., by industry, investors)
        
        incentives to innovate
      - Ways in which HTA programs can increase the likelihood of achieving impacts: What to do to make sure HTA is effective
        
        Conduct a transparent, credible, unbiased, rigorous, and well-documented HTA process
        
        Gain prior commitment, where feasible, from decision makers to use HTA findings
        
        Ensure that assessments are designed to address decision makers’ questions
        
        Sinasagot dapat ang pinakaimportanteng tanong
        
        Seek to establish formal links between producers and users of HTA
        
        Involve key stakeholders throughout the HTA process (e.g., in priority setting, determination of assessment questions) in a transparent, well-managed manner
        
        Gain input of representatives of anticipated target audiences and communication experts in planning knowledge transfer strategies, including different formats, languages, media, and related messaging of HTA findings to different target audiences, as appropriate
        
        Anticipate the resource requirements, incentives, delivery system characteristics, and other diverse factors that will influence the feasibility of implementing HTA findings
        
        Ensure that HTA findings are delivered on a timely basis to inform decision making
        
        Promote collaboration and transfer of knowledge and skills across jurisdictions (e.g., across nations, regions, localities)
  - - - A multi-dimensional entity comprising the answers to three questions:
        
        What can go wrong?
        
        How likely is it?
        
        What are its consequences?
      - Involves: identifying, assessing, addressing, and reviewing and reporting risks; each stage being integrated with a communication and learning process
      - types
        
        Risks to the HTA program that are generated externally
        
        Risks to the HTA program that are generated internally
        
        Risks to organizations, individuals & general community that may be caused by the HTA program
    - - an action plan for identifying and managing risks, the probability of risk, the level of risk and strategies for avoidance should be drawn up
        
        Unrealistic expectations about the size and mandate of the organization
        
        Presence of conflicts of interest, data and confidentiality
        
        Unclear boundaries between the technical function of generating HTA evidence, the function of formulating recommendations and final decision-making
        
        Priorities that change according to political priorities & pressures or changes of governments
      - the risk management strategy could include
        
        Communication strategy to sensitize decision-makers and other stakeholders about the time required to develop an HTA mechanism,
        
        Number of staff required and their capacity to perform at the level expected by stakeholders
- - - - Delays in making the decision
    - - When the opinion of the champions/powerful proponents prevails even the absence of evidence supporting the use of HT
    - - Lobbying and opposition groups
    - - Lack of access to HTA reports, complex and technical formats of HTA reports, questionable data quantity and quality, absence of real-world applications, and narrow focus
      - When adopting a new technology requires a particular environment professional training, or other resources that are unavailable in a particular facility.
    - - increasing need and demand for HTA
        
        to design a tailored and transparent mechanism using HTA
      - lack of infrastructure and technical capacity to cope with the increasing demand
        
        to focus on building on existing capacity, that is, HTA public goods and network, and creating a better wheel (not to relevant one)
      - inadequate involvement of a broad range of stakeholders, including public authorities, healthcare providers, payers, academic, industry, citizens and patients and media
        
        to enhance the understanding of HTA among the public and stakeholder involvement in HTA process
  - - - develop standards and guideline and databases
        
        develop methods, standards, and guidelines to further institutionalize and develop HTA in the country
        
        develop databases that will collate all local- or context-specific data needed for HTA evidence generation
      - disseminate currenltly available guidance government
        
        Effectively communicate and disseminate the currently available HTA guidance documents (Process Guide and Methods Guide) published by the HTA Council.
      - create opportunites and platforms for education
        
        Create opportunities and platforms to educate all relevant stakeholders on HTA and EEs, and their utility and significance to policy decision-making processes. These include webinars, training courses, MS & PhD degrees.
      - strengthen stakeholder engagement and participate
        
        Engagement and participation of all stakeholders across all levels of the health system should be fostered, facilitated, and strengthened. These include the industry, patient groups, and the local government units.
      - capacitate stakeholders on HTA and EE
        
        Capacitate researchers on how to appropriately generate HTA evidence, and policy-makers on how to apply them in decision-making processes.
      - monitor and evaluate the impact of the HTA process
        
        Monitor and evaluate the process of HTA, including the impacts of the decisions and recommendations, towards ensuring quality practice and universal health coverage.