Section 34Sec./Art. 34

Health Technology Assessment (HTA). -

(a) The HTA process shall be institutionalized as a fan and transparent priority setting mechanism that shall be recommendatory to the DOH and PhilHealth for the development of policies and programs, regulation, and the determination of a range of entitlements such as drugs, medicines, pharmaceutical products, and other devices, procedures and services as provided for under this Act: Provided, That investments on any health technology or development of any benefit package by the DOH and PhilHealth shall be based on the positive recommendations of the HTA: Provided, farther, That despite having undergone the HTA process, all health technology, intervention or benefit package shall still be subjected to periodic review: Provided, furthermore, That a health technology assessment may be conducted as new evidence emerges which may have substantial impact on the initial coverage decision by the DOH or PhilHealth: Provided, finally, That the HTA process shall adhere to the principles of ethical soundness, inclusiveness and preferential regard for the underserved, evidence-based and scientific defensibility, transparency and accountability, efficiency, enforceability and availability of remedies, and due process.

(b) The following criteria must be observed in the conduct of HTA:

(1) Responsiveness to Magnitude, Severity, and Equity. - The health interventions must address the top medical conditions that place the heaviest burden on the population, including dimensions of magnitude or the number of people affected by a health problem, and severity or health loss by an individual as a result of disease, such as death, handicap, disability or pain, and conditions of the poorest and most vulnerable population;

(2) Safety and Effectiveness. - Each intervention must have undergone Phase IV clinical trial, and systematic review and meta-analysis must be readily available. The interventions must also not pose any harm to the users and health care providers;

(3) Household Financial Impact. - The interventions must reduce out-of-pocket expenses. Interventions must have economic studies and cost-of-illness studies to satisfy this criterion;

(4) Cost-effectiveness. - The interventions must provide overall health gain to the health system and outweigh the opportunity costs of funding drug and technology; and

(5) Affordability and Viability. - The interventions must be affordable and the cost thereof must be viable to the financing agents.

(c) The HTAC, to be composed of health experts, shall be created within the DOH and supported by a Secretariat and a Technical Unit for Policy, Planning and Evaluation with evidence generation and validation capacity. The HTAC shall: (1) facilitate provision of financing and/or coverage recommendations on health technologies to be financed by DOH and Philhealth; (2) oversee and coordinate the HTA process within DOH and PhilHealth; and (3) review and assess existing DOH and PhilHealth benefit packages. Within five (5) years after the establishment and effective operation of the HTAC, it shall transition into an independent entity separate from the DOH, attached to DOST.

(d) The HTAC shall conduct the HTA in accordance with the principles, criteria and procedures of this Act and ensure that its process is transparent, conducted with reasonable promptness, and the result of its deliberations is made public. The HTAC shall consist of a core committee and subcommittees.

The core committee, which shall elect from among themselves its Chairperson, shall be composed of nine (9) voting members, namely: a public health epidemiologist; a health economist; an ethicist; a citizens representative; a sociologist or anthropologist; a clinical trial or research methods expert; a clinical epidemiologist or evidence-based medicine expert; a medico-legal expert; and a public health expert.

The subcommittees to be constituted shall include, among others: Drugs, Vaccines, Clinical Equipment and Devices, Medical and Surgical Procedure, Preventive and Promotive Health Services, and Traditional Medicine. Each subcommittee shall have a minimum of one (1) and maximum of three (3) non-voting members for each subcommittee.

The HTAC may call upon technical resource persons from the PhilHealth, Food and Drug Administration (FDA), patient groups and clinical medicine experts as regular resource persons; and representatives from the private sector and health care providers as by-invitation resource persons.

(e) The HTACs core committee and subcommittee members shall be appointed by the Secretary of Health for a term of three (3) years except for the medico-legal expert, ethicist, and the sociologist or anthropologist who shall serve for a term of four (4) years: Provided, That no member shall serve for more than three (3) consecutive terms: Provided, further, That the members of the HTAC shall receive an honorarium in accordance with existing policies: Provided, furthermore, That the DOH shall promulgate the nomination process for all HTAC members with a clear set of qualifications, credentials and recommendations from the sectors concerned: Provided, finally, That the Secretary of the DOST shall appoint the members of the HTAC upon its transition into an attached agency under DOST.