Topic nomination

Topic nomination refers to the process of referring topics to HTAC for which technology appraisals may be produced and disseminated for the guidance of policy-makers, health providers and patients. For more details, view the Philippine HTA Process Guide here: Philippine HTA Process Guide.

Existing health technologies refer to those which are currently covered by DOH or PhilHealth. New health technologies are those that are not yet covered by DOH or PhilHealth.

You may download the Nomination forms from the file links in the table below:

NAME OF NOMINATION FORM DOWNLOADABLE FORM
Appeal Form For Topic Prioritization For Preliminary HTAC Recommendations
 Minor Inclusion Form Application Form  
 Clinical Equipment and Devices  Existing New 
 Drugs and Vaccines  Existing  New  
 Medical and Surgical Procedures  Existing  New  
 Other Health Technologies Existing New  
 Preventive and Promotive Health Services Existing New  
 Traditional Medicine Existing New   
 Any type of Health Technology for
Patient Groups Civil/Society/Public
 English Filipino
 Topic Nomination Submissions   Tracker

You may submit the accomplished topic nomination forms or any of the documents listed above via our official email, hta@doh.gov.ph, until 27 May 2022.

Stakeholders may also submit appeals once HTAC publishes its preliminary priority list of nominated topics. HTAC will also post its preliminary recommendations on prioritized topics for HTA subject to appeals.

We gently remind our stakeholders that HTA Philippines will not process incomplete or late submissions. 

FREQUENTLY ASKED QUESTIONS (FAQS)

Who can nominate during topic nominations?

Topic nominations may be submitted by the following proponents: 

  1. DOH Offices and national health programs (NHPs); 
  2. PhilHealth; 
  3. Hospital Pharmacy and Therapeutic Committee (PTC);
  4. Professional medical, paramedical, and scientific organizations; 
  5. Industry;
  6. Local government units (LGUs);
  7. Civil society organizations (CSOs) or patient groups; 
  8. Academe or research institutions; and 
  9. Research Laboratories (public or private).

Sinu-sino ang maaaring mag-nominate sa panahon ng topic nominations?

Maaaring magsumite ng topic nominations ang mga sumusunod:

  1. Mga DOH Office at national health programs (NHPs); 
  2. PhilHealth; 
  3. Ang Hospital Pharmacy and Therapeutic Committee (PTC);
  4. Mga professional medical, paramedical and scientific organizations
  5. Mga industriya;
  6. Mga local government units (LGUs);
  7. Mga civil society organizations (CSOs) o grupo ng mga pasyente;
  8. Mga taga-academe o research institution; at
  9. Mga laboratoryo para sa pag-aaral o pananaliksik (pampubliko o pribado).

When can we submit the topic nomination forms?

The topic nomination forms and complete documentary requirements may be submitted from 04 April to 13 May 2022.

Kailan namin puwedeng isumite ang mga topic nomination form?

Maaaring isumite ang inyong topic nomination form at kumpletong dokumento mula ika-04 ng Abril hanggang ika-13 ng Mayo 2022.

Where can we access the newly revised topic nomination forms?

You may access and download the topic nomination forms here: https://hta.doh.gov.ph/topic-nomination/

Saan namin puwedeng makuha ang mga bagong form para sa topic nomination?

Puwede niyong makuha ang mga topic nomination form sa link na ito: https://hta.doh.gov.ph/topic-nomination/

How and where do we submit the topic nomination forms and other documentary requirements?

You must submit an electronic copy and two (2) hardcopies of EACH of the required documents at the following:

Electronic copy: 

A Google Drive link must be submitted to hta@doh.gov.ph (required) and a flash drive (optional) to the Philippine Blood Center (see full address below),

Hardcopy (2 copies): 

HTA Division, 4th Floor, Philippine Blood Disease and Transfusion Center, Lung Center Compound, Quezon Avenue, Diliman, Quezon City

Proponents should provide hard copies of the complete topic nomination forms for documentation purposes. All attached studies and references  do not need to be printed in submitting the hard copies although these are required for the submission of the electronic copy.

Please ensure that all documents are complete to avoid resubmissions. Late and incomplete submissions will not be processed.

Paano at saan namin puwedeng isumite ang mga topic nomination form at ang iba pang mga kinakailangang dokumento?

Kailangang magsumite ng electronic copy at dalawang (2) hardcopy ng BAWAT isa sa mga kinakailangang dokumento sa mga sumusunod:

Electronic copy

Kailangang isumite ang link ng Google Drive sa hta@doh.gov.ph (required) at isang flash drive (optional) sa Philippine Blood Center (tingnan ang buong address sa baba).

Hardcopy (2 kopya):

HTA Division, 4th Floor, Philippine Blood Disease and Transfusion Center, Lung Center Compound, Quezon Avenue, Diliman, Quezon City

Kailangang magsumite ng kumpletong mga hard copy ng mga topic nomination form para ito ay madokumento. Hindi kailangang i-print ang lahat ng mga kalakip na pag-aaral at sangguinuan sa pagsumite ng mga hard copy ngunit ang mga ito ay kailangang isama sa pagsumit ng electronic copy

Siguraduhin lamang na kumpleto ang mga isusumiteng dokumento upang maiwasang magsumite muli. Hindi ipoproseso ang mga dokumentong hindi kumpleto at hindi ipinasa sa itinakdang panahon.

What are the requirements for nominating a topic?
The requirements for nominating a topic differ depending on the type of health technology that is being nominated. The specific requirements for each form for the different types of health technology are listed and can be found in the Letter of Request section (except for the form for patients / CSOs / public which is applicable for all types).

Ano ang mga requirement para sa pag-nominate ng topic?
Ang mga requirement o mga kinakailangang dokumento ay nakadepende sa uri ng health technology na planong i-nominate. Nakatala ang mga partikular na requirement sa Letter of Request ng topic nomination form ng health technology na inyong isusumite (maliban sa form para sa mga pasyente/ Civil Society/ pampubliko na puwedeng gamitin sa lahat ng uri).

How do I know if I am filling out the correct form?

The topic nomination forms are catered to different technologies (i.e., drugs and vaccines, clinical equipment and devices, medical and surgical procedures, preventive and promotive health services, traditional medicine, and other health technologies).

For guidance on the definitions of each HT, please refer to Section IV of Administrative Order No. 2020-0041:https://hta.doh.gov.ph/administrative-order-on-hta/

Paano ko malalaman na tama ang sinasagutan kong form?

May nakalaan na topic nomination form para sa iba-ibang uri ng health technology tulad ng mga bakuna at gamot, klinical na kagamitan, tradisyunal na gamot at iba pa na nais i-nominate

Para sa mga kahulugan ng mga ibat-ibang uri ng health technology, maaaring bisitahin ang Section IV ng Administrative Order 2020-0041 na matatagpuan sa link na ito: https://hta.doh.gov.ph/administrative-order-on-hta/

How do we know the status of our application?

The status of applications will be posted and will regularly be updated on the HTA websiteProponents may also directly inquire via email at hta@doh.gov.ph

 

Paano namin malalaman ang status ng aming aplikasyon

Ang status o katayuan ng iyong aplikasyon ay makikita at regular na i-uupdate sa aming website. Para sa inyong mga katanungan, maaari rin kayong magpadala ng mensahe sa aming email: hta@doh.gov.ph

What are the differences between the general track and the expedited track?

Both tracks require thorough HTA and review of evidence, according to the HTAC decision framework. This will  aid in crafting the recommendations of HTAC which will guide policy and decision-makers on which health technologies are for public financing. 

The differences between the general track and the expedited track (where COVID technologies are nominated) can be seen below:

  1. General track – this is the standard track that Philippine Food and Drug Administration (FDA)-approved health technologies intended for listing in the Philippine National Formulary (PNF) for government procurement will undergo HTA
  2. Expedited track – this track is for public health emergency technologies which are granted emergency use authorization (EUA) by the FDA which will undergo the prioritization of the Disease Prevention and Control Bureau (DPCB). This has a shorter timeline than the general track and health technologies under this track are not listed in the PNF, given that only EUAs are issued.

For further details, please refer to page 13 to 25 of the HTA Process Guide: https://hta.doh.gov.ph/philippine-hta-process-guide/

Anu-ano ang pagkakaiba ng general track sa expedited track?

Masusing HTA at panunuri ng ebidensya ang kinakailangan para sa parehong track, ayon sa decision framework ng HTAC. Tinutulungan nitong buuin ang mga rekomendasyon ng HTAC na magsisilbing gabay sa mga taga-gawa ng polisiya at mga desisyon kung anong mga health technology ang popondohan ng publiko.

Ito ang mga pagkakaiba ng general track at expedited track:

  1. General track – ito ang karaniwang track na sinusundan kung saan daraan sa HTA ang mga health technology na aprubado ng Philippine Food and Drug Administration (FDA) 
  2. Expedited track – ito ang track para sa mga teknolohiya na sakop ng public health emergency na ipinagkaloob ng emergency use authorization (EUA) ng FDA at sasailalim sa pagbibigay prayoridad ng Disease Prevention and Control Bureau (DPCB). Mas maikli ang timeline nito sa general track at ang mga health technology na sakop ng track na ito ay hindi nakalista sa PNF dahil EUA lang ang binibigay.

Para sa karagdagang detalye, pumunta sa pahina 13 hanggang 25 ng HTA Process Guidehttps://hta.doh.gov.ph/philippine-hta-process-guide/

Does the opening of topic nominations include health technologies for inclusion in the Philippine National Formulary (PNF)?

Inclusion applications for health technologies that are already in the PNF which only apply for changes in dosage strength, immediate packaging, and pack size/ net volume may be submitted at any time (even after the topic nomination period).

Major applications for those not currently listed in the PNF will follow the April 2022 topic nomination opening.

Kasama ba sa pagbukas ng topic nominations ang mga health technology na balak isali sa Philippine National Formualry o PNF? 

Maaaring isumite ng anumang oras ang aplikasyon para sa karagdagang dosage strength, net volume, immediate packaging, at pack size o net volume ng mga health technology na kasama o nakalista na sa Philippine National Formulary (minor application).

Ang mga aplikasyon para mailista ang isang health technology sa PNF ay susunod sa iskedyul ng pagbubukas ng topic nomination sa ika-04 ng Abril 2022.

How does HTAC prioritze topics?

After the topic nomination period, HTAC prioritizes the nominated topics using the prioritization criteria that can be found in Section 7 of the topic nomination forms (Annex D for the form for patients / CSOs / public); The priority list will be then subjected to public consultation. Once finalized, the topics in the priority list will be assessed by HTAC.

HTAC will only be able to assess 5 – 20 priority topics (including those prioritized by DPCB and PhilHealth, especially those involving COVID) depending on the complexity of the assessments and considering limited available resources.

You may refer to the General HTA Process in  pages 13 to 24 of the HTA Process Guide for the timeline of the HTA process:https://hta.doh.gov.ph/philippine-hta-process-guide/

*Note: the forms in the Annexes of the HTA Process Guide are NOT UPDATED. Please refer to https://hta.doh.gov.ph/topic-nomination/ for the updated forms.


Paano pinipili ng HTAC kung alin ang mga topic na bibigyang prayoridad?

Pagkatapos ng panahon ng topic nomination, binibigyang prayoridad ng HTAC ang mga nominated na topic gamit ang kanilang prioritization criteria na puwedeng mahanap sa Section 7 ng mga topic nomination form (Annex D para sa form ng mga pasyente/ CSO/ publiko). Dadaan sa public consultation ang priority list. Kapag natapos na ang pagbuo ng priority list, susuriin ito ng HTAC. 

Nasa 5 – 20 na topic (kasama na ang mga isusumite ng DPCB at PhilHealth, lalo na ang mga kaugnay ng COVID) ang kayang suriin ng HTAC. Nakadepende ito sa uri ng pagsusuring kinakailangan, habang isinasaalang-alang ang limitadong resources ng HTAC.

Para makita ng timeline ng proseso ng HTA, tingnan ang General HTA Process sa pahina 13 hanggang 24 sa HTA Process Guide: https://hta.doh.gov.ph/philippine-hta-process-guide/

*Palatandaan: and mga form na makikita sa Annex ng HTA Process Guide ay HINDI UPDATED. Mahahanap ang mga updated na form sahttps://hta.doh.gov.ph/topic-nomination/

What is the timeline of the whole HTA process?

You may refer to the General HTA Process on pages 13 to 24 of the HTA Process Guide for the timeline of the HTA process: https://hta.doh.gov.ph/philippine-hta-process-guide/
*Note: the forms in the Annexes of the HTA Process Guide are NOT UPDATED. Please refer to the https://hta.doh.gov.ph/topic-nomination/  for the updated forms.

Ano ang timeline ng buong proseso ng HTA?

Para makita ng timeline ng proseso ng HTA, tingnan ang General HTA Process sa pahina 13 hanggang 24 sa HTA Process Guide: https://hta.doh.gov.ph/philippine-hta-process-guide/
*Palatandaan: and mga form na makikita sa Annex ng HTA Process Guide ay HINDI UPDATED. Mahahanap ang mga updated na form sa https://hta.doh.gov.ph/topic-nomination/

How is a health technology approved for PNF inclusion?

The process of including a health technology in the PNF has the following major steps:

  1. Topic nomination and prioritization
  2. Topic assessment
  3. Initial recommendation
  4. Appeals period
  5. Final recommendation
  6. Decision by the Secretary of Health (SOH)
  7. Dissemination (including listing in PNF if positive HTAC recommendation is approved by SOH)

It should be noted that complete documentary and regulatory requirements for each type of health technology must be submitted before it is accepted as an official nomination. 

For further guidance on the steps of the General HTA Process please refer to pages 13 to 24 of the HTA Process Guide: https://hta.doh.gov.ph/philippine-hta-process-guide/

*Note: the forms in the Annexes of the HTA Process Guide are NOT UPDATED. Please refer to the https://hta.doh.gov.ph/topic-nomination/ for the updated forms.

Paano naaaprubahan ang paglilista ng isang health technology sa PNF?

Ang proseso ng paglista ng health technology sa PNF ay may sumusunod na mga hakbang:

  1. Topic nomination and prioritization
  2. Topic assessment
  3. Initial recommendation
  4. Appeals period
  5. Final recommendation
  6. Decision by the Secretary of Health (SOH)
  7. Dissemination (kasama na rin ang paglilista sa PNF kung ang positibong rekomendasyon ng HTAC ay naaprubahan ng SOH)

Kailangang tandaan na kailangang isumite ang kumpletong mga dokumento at mga regulatory na requirement para sa bawat uri ng health technology bago ito matanggap ilang isang opisyal na nomination.

Upang mabigyang gabay sa mga hakbang ng General HTA Process, pumunta sa pahina 13 hanggang 24 ng HTA Process Guide:https://hta.doh.gov.ph/philippine-hta-process-guide/

*Palatandaan: and mga form na makikita sa Annex ng HTA Process Guide ay HINDI UPDATED. Mahahanap ang mga updated na form sa https://hta.doh.gov.ph/topic-nomination/

Is HTAC under the DOH? How do we ensure that there is no conflict of interest (COI) in the prioritization of topics for HTA?

The HTAC is an independent recommendatory body with support staff affiliated with DOH; The objective evaluation criteria  (i.e, C1: responsiveness to magnitude & severity; C2: clinical efficacy, effectiveness & safety; C3: affordability and viability; C4: household financial impact; C5: social impact; C6: responsiveness to equity) of HTAC are followed in crafting their recommendations.

HTAC and its support staff discloses and manages its COI for every topic that is assessed.

Nasa ilalim ba ng DOH ang HTAC? Paano namin masisigurado na walang conflict of interest (COI) o salungatan ng interes ang prioritization ng mga topic para sa HTA?

Ang HTAC ay isang independent recommendatory body na may mga sumusuportang tauhan na kaakibat ng DOH. Ang objective evaluation criteria (ibig sabihin, C1: responsiveness to magnitude & severity; C2: clinical efficacy, effectiveness & safety; C3: affordability and viability; C4: household financial impact; C5: social impact; C6: responsiveness to equity) ng HTAC ay sinusunod sa paggawa ng kanilang mga rekomendasyon.

Ipinapahayag at pinamamahalaan ng HTAC at ng kanilang support staff ang kanilang COI sa bawat topic na kanilang sinusuri.

May pharmaceutical companies submit their own HTA?
Yes, pharmaceutical companies may submit their own HTA provided that they follow the HTA Methods Guide, but this will undergo the appraisal of the HTAC.

Maari bang magsumite ang mga kumpanya ng gamot o medisina ng kanilang sariling HTA?
Oo, maaaring isumite ng mga kumpanya ng gamot o medisina ng kanilang sariling HTA, kapag sinunod nila ang HTA Methods Guide, ngunit ito ay sasailalim pa rin sa pagsusuri ng HTAC.

May we submit an appeal if our nominated health technology is not part of the HTAC priority list?

Yes, appeals will be entertained for as long as they are submitted within the prescribed period (2 weeks from the release of the initial priority list). 

Maaari bang mag-apela kung ang ipinasang aplikasyon ay hindi nasama sa prioritidad ng HTAC?

Oo, tatanggapin ang mga apela kung naipasa sa itinakdang panahon (dalawang linggo pagkatapos mailabas ang pangunahing priority list)