Frequently asked questions (FAQs)
FAQ #1 What is health technology?
What is health technology?
Health technology is the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem, and to improve quality of life.
Ano ang health technology?
Ang health technology ay anumang kagamitang medikal, gamot, bakuna, pamamaraang medikal, mga patakaran, at sistemang binuo gamit ang sistematikong kaalaman at kasanayan upang tugunan ang isang problemang pangkalusugan tungo sa pagpapabuti ng kalidad ng buhay.
What is health technology assessment (HTA)?
Health technology assessment or HTA is the systematic evaluation of properties, effects, or impact of health-related technologies, which utilizes a multidisciplinary process to evaluate the clinical, economic, organizational, social, and ethical issues of a health intervention or health technology.
Ano ang health technology assessment (HTA)?
Ang health technology assessment o HTA ay tumutukoy sa sistematikong pagsusuri o pag-aaral ng mga katangian, at epekto ng mga health technology, kabilang ang mga aspektong klinikal, pang-ekonomiya, pang-organisasyon, panlipunan, at pang-etikal na bunga ng paggamit ng isang health technology.
What is the role of the Health Technology Assessment Council (HTAC) and who comprises them?
The Health Technology Assessment Council (HTAC) is the recommending body on which health technologies should be funded or covered by the Department of Health (DOH) and Philippine Health Insurance Corporation (PhilHealth). It is composed of a Core Committee and seven (7) Subcommittees. The members of the Core Committee include the following: ethicist, public health epidemiologist, health economist, sociologist/anthropologist, clinical trial/research methods expert, clinical epidemiologist/evidence-based medicine expert, medico-legal expert, public health expert and citizen’s representative. On the other hand, experts on medicines, vaccines, medical and surgical procedures, clinical equipment and devices, preventive and promotive health, traditional medicine and other health technologies constitute the Subcommittees. The HTAC is supported by the Health Technology Assessment Unit (HTAU).
Ano ang papel ng Health Technology Assessment Council (HTAC) at sinu-sino ang mga bumubuo nito?
Ang Health Technology Assessment Council o HTAC ay isang konseho ng mga eksperto na siyang nagbibigay rekomendasyon sa Department of Health (DOH) at Philippine Health Insurance Corporation (PhilHealth) ng mga health technologies na maaari nilang pondohan. Ang HTAC ay binubuo ng isang Core Committee at pitong Subcommittees. Ang Core Committee ay binubuo ng mga sumusunod: ethicist, public health epidemiologist, health economist, sociologist o anthropologist, clinical trial/research methods expert, clinical epidemiologist/evidence-based medicine expert, medico-legal expert, public health expert at citizen’s representative. Samantalang ang mga eksperto sa medicines, vaccines, medical and surgical procedures, clinical equipment and devices, preventive and promotive health, traditional medicine at other health technologies ang bumubuo sa Subcommittees. Kaagapay ng HTAC ang Health Technology Assessment Unit o HTAU upang magampanan nito ang mga tungkulin.
How does HTA contribute to achieving Universal Health Care (UHC) in the Philippines?
HTA contributes to the achievement of UHC by:
- Increasing transparency, accountability, and equity
- Institutionalizing priority setting mechanism on health technology coverage
- Improving efficiency in allocation of resources
- Negotiating better prices of health technologies
Paano nakatutulong ang HTA sa pagkamit ng Universal Health Care (UHC) sa ating bansa?
Ang HTA ay makatutulong sa pagkamit ng UHC sa pamamagitan ng:
- Pagbuo ng patas at malinaw na mga proseso
- Pagbuo ng sistematikong proseso sa pagtukoy ng mga health technologies na bibigyang prayoridad upang pondohan ng gobyerno
- Epektibong paggamit at paglalaan ng pondo ng gobyerno
- Pagkakasundo sa abot-kayang presyo ng mga serbisyo at ibang health technologies
What are the steps in the HTA process?
Ano ang proseso ng HTA?
What are the priorities of HTAC for review for the first two years?
According to the UHC Law, the HTAC should prioritize the review of existing health technologies within two years upon their creation (from October 2019 to October 2021). Existing health technologies are those which are currently funded by DOH and PhilHealth. In parallel, they will also accommodate the assessment of new health technologies which are proposed by the DOH and PhilHealth.
Anu-ano ang mga prayoridad na susuriin ng HTAC sa kanilang unang dalawang taon?
Ayon sa UHC Law, sa unang dalawang taon ng pagkakabuo ng HTAC (simula October 2019 hanggang October 2021), prayoridad nilang suriin ang mga health technology na kasalukuyang pinopondohan ng DOH at PhilHealth. Bukod dito, prayoridad din nilang suriin ang mga bagong health technology na isusumite ng DOH at PhilHealth.
Who can participate in the HTA process?
Different stakeholders are involved in the HTA process, including the healthcare providers, the patients, industry, civil society organizations (CSOs), and other private sector members, academe and researchers, implementers and policymakers, among others.
Sinu-sino ang maaaring lumahok sa proseso ng HTA?
Kasama sa HTA ang iba’t ibang stakeholders kabilang na ang mga healthcare professionals, mga pasyente, mga miyembro ng pribadong sektor, mga mananaliksik at miyembro ng akademya, mga mambabatas, at iba pa.
Who can submit topics for HTA?
For the first two years of the HTA process implementation (from October 2019 to October 2021), the HTAC shall accept topic nominations from DOH and PhilHealth for the priority assessments in accordance with the UHC Law.
After this period, individuals, such as clinicians, healthcare professionals, patients, program managers, or institutions (i.e., public or private health facilities), professional societies, relevant DOH and PhilHealth offices/units, industry, can nominate a specific health technology for public funding or coverage.
Sinu-sino ang mga maaaring magsumite ng mga paksa para magsagawa ng HTA?
Sa unang dalawang taon ng proseso (mula October 2019 hanggang October 2021), tatanggap ang HTAC ng nominasyon mula sa DOH at PhilHealth para sa mga prayoridad na health technologies na kanilang susuriin.
Simula 2022.ang mga indibidwal tulad ng mga mediko, tagapangalaga ng kalusugan, pasyente, program managers o institusyon (hal., pampubliko o pribadong pasilidad), professional societies, opisinang may kaugnayan sa DOH at PhilHealth, industriya, ay maaaring magsumite ng mga health technology na maaaring pag-aralan kung dapat pondohan ng gobyerno.
What health technologies can be submitted for assessment?
Health technologies classified as drugs, vaccines, medical devices, traditional and alternative healthcare products and practices, medical and surgical procedures, and other health technologies (e.g., physical therapy, psychosocial therapy, speech therapy) may be submitted for HTA provided that mandatory documentary requirements, as specified in the HTA Process Guide, are fulfilled.
Anu-anong mga health technologies ang maaaring sumailalim sa HTA?
Ang mga health technologies na naaayon sa klasipikasyon ng drugs, vaccines, medical devices, traditional and alternative healthcare products and practices, medical and surgical procedures, and other health technologies (hal., physical therapy, psychosocial therapy, speech therapy) ay maaaring isumite para sa HTA basta’t napunan ang mga mandatory documentary requirements na nakasaad sa HTA Process Guide.
When can I apply for topic assessment?
The HTA Unit will only accept topic nominations within the month of September of each year.
Kailan maaaring magpasa ng topic assessment?
Tatanggap lamang ang HTA Unit ng mga aplikasyon para sa HTA sa buong buwan ng Setyembre bawat taon.
How do I apply for topic assessment?
Applications for a topic assessment are done by accomplishing this form.
Paano mag-apply para sa topic assessment?
Ang application form para sa topic assessment ay makikita rito.
Do I need to submit hard copies of the dossier?
Yes, two (2) hard copies of the following documents have to be submitted:
- Accomplished proposal form, including all appropriate tables;
- Copies of all cited studies and published articles;
- Other relevant documents (e.g. Philippine FDA regulatory certifications*, clinical practice guidelines, excerpts from WHO documents or other formularies, etc., including photocopies of such)
Electronic copies of the documents should be sent to firstname.lastname@example.org
Kailangan ko bang magpasa ng hard copy ng mga dossier?
Mangyari lamang na magsumite ng mga sumusunod na dokumento:
- Kumpletong proposal form, kabilang ang lahat ng mga angkop na talahanayan?
- Kopya ng lahat ng kabilang na mga pagsusuri at nailathalang pag-aaral
- Iba pang nararapat na dokumento (e.g. Philippine FDA regulatory certifications*, clinical practice guidelines, excerpts from WHO documents or other formularies, etc., including photocopies of such)
Ang mga electronic na kopya ng mga dokumentong ito ay kailangang ipadala sa email@example.com
Are there any mandatory documentary requirements prior to submitting topic nomination?
Mayroon bang mandatory documentary requirements na kinakailangan sa pagsumite ng mga paksa para magsagawa ng HTA?
The following documents shall be required prior to the acceptance of the application:
Ang mga sumusunod ay kinakailangan bago matanggap ang aplikasyon:
Mandatory documentary requirement
Drugs and Vaccines
Certificate of Product Registration (CPR) from the Philippine Food and Drug Administration
* The HTAC will only consider the use of these health technologies within the approved marketing authorization of the product in the Philippines as certified by the FDA
For medical devices that are exempted from the current FDA process of granting marketing authorization, the technology sponsor shall submit a Certificate of Free Sale (CFS) issued by the regulatory authority from the source country or other stringent regulatory authority, which shall be validated by the Philippine FDA
Traditional and alternative healthcare products and practices
Certification from PITAHC for Traditional medicine practices
Certification from FDA for Traditional Medicine devices
Certification from FDA for herbal medicines and traditionally used herbal products
Medical and surgical procedures
Certificate of impact on clinical practice from the concerned professional society/ies.
Other health technologies
Who performs the assessment of health technologies?
The assessments can be performed by either the internal assessment team (i.e., HTA unit) or an external assessment team that is a part of the HTA research network that will be created by the DOH and DOST (Department of Science and Technology).
Sinu-sino ang mga sumusuri sa mga health technologies?
Ang gumagawa ng mga assessment ay maaaring ang internal assessment team (hal., HTA unit) o ang external assessment team na bahagi ng HTA research network na bubuuin ng DOH at ng DOST (Department of Science and Technology).
FAQ # 15 What are the decision criteria considered by HTAC when making a recommendation for a health technology?
What are the decision criteria considered by HTAC when making a recommendation for a health technology?
Anu-ano ang mga decision criteria na dapat isaalang-alang ng HTAC sa paggawa ng rekomendasyon para sa isang health technology?
The HTAC should be considering the following criteria when making a recommendation:
Kailangan isaalang-alang ng HTAC ang mga sumusunod na bagay sa paggawa ng rekomendasyon tungkol sa isang health technology:
Responsiveness to disease magnitude, severity and equity
The health intervention 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 the disease such as death, handicap, disability or pain and conditions of the poorest and most vulnerable populations
Kung ang health intervention ay tumutugon sa mga laganap na sakit sa bansa kasama na ang mga sumusunod na konsiderasyon: (1) dami ng taong apektado ng problemang pangkalusugan; (2) paglala ng kondisyon ng sakit na maaaring magdulot ng disability o humantong sa kamatayan; at (3) mga karamdaman na karaniwang nararanasan ng mga nangangailangan at vulnerable populations
Safety and effectiveness
The intervention must be shown to be safe and effective as shown by systematic reviews and/or meta-analysis or the best source of available clinical evidence. For drugs, the clinical benefit and safety must be demonstrated through Phase IV clinical trial (which may not necessarily be from the Philippines). For non-drug interventions where clinical trials are not practical to conduct, sources of evidence may be observational studies and real world evidence.
The intervention must not pose any harm to the users and health care providers that would outweigh the benefits they provide.
Kung ang health technology ay mabisa at hindi nakakasama sa kalusugan
Household financial impact
The intervention must reduce out-of-pocket expenses. Interventions must have economic studies and cost of illness studies.
Kung ang pagpondo ng health technology ay makakabawas sa mga gastusin na mula sa bulsa ng mga Pilipino
The intervention must provide overall health gain to the health system and outweigh the opportunity costs of funding other health technologies. It must represent a more efficient use of health care resources compared to the alternative health technologies.
Kung ang health technology ay sulit
Affordability and viability
The intervention must be affordable and the cost thereof must be viable to the financing agents. The intervention must be feasible to implement and adopt given existing health care resources at the local or national level.
Kung ang health technology ay kayang pondohan ng DOH o PhilHealth
The HTAC also looks into the ethical, legal, social and health systems implications of a health technology.
Tinitingnan din ng HTAC kung ang implementasyon ng isang health technology ay may etikal, sosyal, health system at legal na implikasyon.
Is there a venue for appeals in the HTA process?
Yes, appeals may be submitted (a) after topic prioritization, and (b) after the initial HTAC recommendation.
Mayroon bang pagkakataong umapela sa proseso ng HTA?
Oo, maaaring magsumite ng apela (a) pagkatapos ng topic prioritization at (b) pagkatapos ng pangunang rekomendasyon ng HTAC.
What is considered a public health emergency?
A public health emergency (PHE) refers to an occurrence or imminent threat of an illness or health condition that:
- is caused by any of the following: (i) bioterrorism; (ii) appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; (iii) a natural disaster; (iv) a chemical attack or accidental release; (v) a nuclear attack or accident; or (vi) an attack or accidental release of radioactive materials; and,
- poses a high probability of any of the following: (i) a large number of deaths in the affected population; (ii) a large number of serious injuries or long term disabilities in the affected population; (iii) 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; (iv) international exposure to an infectious or toxic agent that poses a significant risk to the health of citizens of other countries; or, (v) trade and travel restrictions.
Ano ang public health emergency?
Ang public health emergency (PHE) ay isang pangyayari o papalapit na banta ng isang sakit o health condition na:
- Sanhi ng mga sumusunod: (i) bioterrorism; (ii) paglitaw ng isang novel o dati nang nakontrol o naburang nakakahawang biological toxin; (iii) sakuna; (iv) chemical attack o accidental release; (v) nuclear attack o aksidente; o kaya nama’y (vi) atake o accidental release ng radioactive materials
- Nagbabanta ng mga sumusunod: (i) mataas na death rate sa apektadong populasyon; (ii) mataas na numero ng mga lubhang masasaktan o magkakaroon ng long-term disabilities sa apektadong populasyon; (iii) laganap na pagkalantad sa isang nakakahawa o isang toxic agent na nagbabanta ng malaking pinsala sa napakaraming tao sa apektadong populasyon; (iv) international exposure sa isang nakakahawa o isang toxic agent na nagbabanta sa kalusugan ng mga banyaga; (v) trade at travel restrictions.
What is the process for health technology review during public health emergencies?
Review of health technologies during public health emergencies shall undergo the expedited or rapid review route.
Ano ang proseso ng panunuri ng health technologies na gagamitin sa public health emergencies?
Ang pagsusuri ng health technologies sa tuwing may public health emergency ay sasailalim sa rapid review.
How will I know the status of my submission?
You may go to the Status of Health Technologies tab to check for the status of your submission or you may contact us at 8-875-7734 loc. 260 or 258.
Paano ko malalaman ang kalagayan ng aking aplikasyon?
Maaaring pumunta sa bahagi kung nasaan ang Status of Health Technologies tab para makita ang kalagayan ng inyong aplikasyon, o di kaya’y maaaring tumawag sa 8-875-7734 loc. 260 or 258.
As proponents, are we allowed to submit our own Systematic Reviews (SR)/Meta-Analyses (MA)/Economic Evaluations (EE)?
Yes, proponents may submit evidence and their own SR/MA/EE provided that they abide by the HTA Methods Guide; however, these shall still be appraised by the internal assessment team (i.e., HTA unit) or an external assessment team that is a part of the HTA research network.
Bilang proponents, maari ba kaming magsumite ng sarili naming SR/MA/EE?
Oo, maaaring magsumite ng ebidensya o sariling SR/MA/EE ang mga proponents; gayunpaman, lahat ng ito ay kikilatisin ng internal assessment team (i.e., HTA unit) o ng external assessment team na bahagi ng HTA research network.