Existing TM Topic Nomination Template For Existing Traditional Medicine 22 March 2022
Existing TM Topic Nomination Template For Existing Traditional Medicine 22 March 2022
Existing TM Topic Nomination Template For Existing Traditional Medicine 22 March 2022
The Topic Nomination Template for Existing Traditional Medicines* for Public Funding contains the
detailed information that the Health Technology Assessment Council (HTAC) requires from
proponents. Existing health technologies refer to those which are currently covered by DOH or
PhilHealth to proceed to HTA for rationalization or optimization.
The detailed information shall allow the determination as to whether the proposed traditional
medicine, practice, or product should be prioritized in the assessment process and the identification
of the potential role of the health technology in the management of the disease as well as the
resources needed for its deployment and use in the health system.
Nominations can be submitted by the following possible proponents: (1) DOH offices and national
health programs (NHPs); (2) PhilHealth; (3) hospital Pharmacy and Therapeutics Committees (PTCs);
(4) professional medical, paramedical, and scientific organizations; (5) industry; (6) local government
units (LGUs); (7) civil society organizations (CSOs) or patient groups and (8) academic or research
institutions.
*Based on Administrative Order No. 2020-0041 (Section IV. Definition of Terms), Traditional and
Complementary Medicines are defined as follows:
Traditional and Complementary medicine (T&CM) — merges the terms Traditional Medicine
(TM) and Complementary Medicine (CM), encompassing products, practices and practitioners.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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General instructions
● Topic proponents are requested to fill up the entire form. If the requested information is not
relevant to the health technology of interest, please state NA (not applicable).
● For those questions requiring evidence in the form of illustrations, attach the evidence as separate
items when submitting this form.
● All submitted evidence/documents are subject to review and appraisal of the HTAC.
Section Details
- Letter of Request
- Letter of Undertaking
- Executive Summary
6 Additional information
- References
Should you have any other queries or concerns or should you require assistance in accomplishing this
form, please contact the Technical Secretariat of the Health Technology Assessment Division (HTAD)
at telephone numbers (02) 8875-7734 local 260 or 8937-5314 or email at [email protected].
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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LETTER OF REQUEST
Date
Honorable ______________________
Secretary of Health
Department of Health
ATTENTION: ____________________
Chair, Core Committee
Health Technology Assessment Council
Respectfully yours,
PROPONENT’S NAME
Designation
Name of Health Facility/ Institution/ Organization/ Company
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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LETTER OF UNDERTAKING
Date
____________________
Chair, Core Committee
Health Technology Assessment Council
Dear ________________:
Furthermore, should I thereafter learn that new studies become available, I commit to
submit the same to the HTAC within 30 days from my knowledge.
I understand that any false or misleading information provided in this submission may lead to
appropriate legal actions by the Department of Health.
Lastly, I understand and agree that all disclosed information in this submission may be
included in the published report, in accordance with the existing laws and policies of the
country.
Truly yours,
PROPONENT’S NAME
Designation
Name of Health Facility/ Institution/ Organization/ Company
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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ADDITIONAL DOCUMENTARY REQUIREMENTS CHECKLIST
Valid Government Certificate/Permit issued by the Food and Drug Administration attesting
to the regulatory status of the technology
*Traditionally-used herbal products refer to preparations from plant materials whose claimed application/s is/are
based only on traditional experience of long usage which should be at least five (5) or more decades as
documented in medical, historical and ethnological literature. Such products have been evaluated to show
efficacy for the intended indication and are subject to regulatory provisions of the FDA Administrative Order No.
172 s. 2004 or the Guidelines on the Registration of Herbal Medicines.
**Herbal medicines refer to finished, labeled, medicinal products that contain as active ingredient/s serial or
underground part/s of plant or other materials or combination thereof, whether in the crude state or as plant
preparations. Such products have been evaluated to show efficacy for the intended indication and are subject to
regulatory provisions of the FDA Administrative Order No. 184 s. 2004 or the Guidelines on the Registration of
Traditionally Used Herbal Products.
***Traditional medicine devices refer to any device used by T&CM practitioners for treatment, diagnosis and
management of disease
****Complementary medicine practices refer to a broad set of health care practices that are not part of the
country’s own tradition or conventional medicine and are not fully integrated into the dominant health care
system. Within these rules, complementary medicine shall be used interchangeably with the terms alternative
medicine and integrative medicine.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Executive Summary
Please include below the summarized major key points of the nominated Health Technology for HTAC
assessment. It must include the following information (maximum of 3 pages, 1.5 line spacing, Arial 12 ):
● Burden of disease
● Current standard of care and Place of the proposed intervention in the standard of care
● Summary of results for clinical impact (including the length of time in years the practice or product
has been used as a modality of intervention or complementation); economic evaluation; and
ethical, legal, social and health system impact
*Indications of burden of disease may include but not limited to prevalence, incidence, case fatality rate
(CFR), disability-adjusted life year (DALY), size of population at risk, distribution in the population (e.g.,
economic status)
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 1.
Proponent details and contact information
Name of Organization/
Company/Institution
Address
Name:
Affiliation:
Position/Designation:
Email address:
Landline no.:
Mobile no.:
Postal address:
Name:
Affiliation:
Position/
Designation:
Email address:
Landline no.:
Mobile no.:
Postal address:
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Brief description of the company / institution (e.g., number of years in the market, previous projects,
engagements with other local or international government agencies). Provide additional attachments
as necessary.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 2.
Description of the proposed health technology
For health technologies with multiple indications, kindly specify the dosage regimen for each respective indication or use a
separate form for each indication.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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2.2 Technical Characteristics and Requirements
How will the technology be used: ☐ Promotion of health and wellness
☐ Prevention of Disease
☐ Diagnosis of Disease
☐ Treatment of Disease
☐ Symptomatic Management of Disease
☐ Rehabilitation of Disease
☐ Others, please specify: _______________
Frequency and length of use of
the intervention
Expected provider/implementer of
the intervention
(Who will deliver or implement the proposed
health technology or intervention)
Is there additional training Yes, please specify:
required in addition to the
expected skill level of the
extended user?
If yes, please specify who delivered training,
the training tools, and the duration of training
required:
No training required
If Yes, kindly answer the following. If No, please write NA then proceed to Section 3.
Briefly describe the co-dependent technology in terms of achievement or enhancement of the intended clinical effect of either
health technology. Cite the mechanism of co-dependency.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Is the proposed health technology locally-developed, locally introduced or a foreign product?
locally-developed locally-introduced foreign product
*locally-developed – The product/practice is Filipino in origin
**locally-introduced- The product/practice has been used in the Philippines for more than 50 years.
***foreign-product – The product/ practice has been used in the Philippines for less than 50 years.
Section 3.
Background on the clinical or public health use of
the HT
Epidemiology
Disease frequency
Local data on prevalence or
incidence is recommended;
provide subgrouping by age
and sex, or geographical area,
if available.
Severity of disease
Cite quality of life studies if
available. Provide local
morbidity or mortality data.
Risk factors
Include related genetic
markers, if available
*If current clinical management guidelines are not available, cite an expert panel and/or a well-designed survey. Present
details of who the survey was sent to, who responded, and the survey questions and responses in an attachment to the
submission.
3.3. Relevant existing national government policy, programs and reimbursement
mechanisms on the use of the proposed technology.
Cite applicable Republic Acts, Administrative orders, or any other official government issuance.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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● Is there new evidence that prompts changes on the current use of the proposed HT? If yes, how so?
● What would be the potential impact to the current situation if the funding of proposed HT is continued or reallocated?
What clinically meaningful outcomes can be measured with the use of the proposed HT?
For disease-targeted technologies, briefly state the patient-relevant clinical effectiveness and safety outcomes. Outcomes
should be directly related to the quality (e.g., an estimate of the ICER, if available), and/or length of a patient’s life.
For disease-agnostic technologies, provide all outcomes (e.g., efficiency) that are used to evaluate the health technology.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 4.
Details of supporting evidence on the use of the proposed existing health
technology versus currently used HT (detailed description)
Proposed indication:
Disease, Stage of Disease, Population
Fill in the blanks, when applicable. This section is only applicable to those HTAs with WHO recommendation (e.g., public health program-related health
technologies). Quote the specific recommendation and indicate the page number in the document being referred to. Comparator may be one of the following,
in order of priority:
Proposed Research Current national DOH WHO treatment Systematic Review Issues
Question program guidelines that was referenced in
(e.g. DOH actual
implementation policy the WHO treatment implementation does not
guidelines match the DOH issuance, no
supporting SR for the
included guidelines)
References DOH issuance number, Title Title and Year Title, Author and Year Leave blank
Leave blank
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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POPULATION
INTERVENTION
existing HT that is being
proposed for HTA Leave blank
COMPARATOR
HT that will likely replace the
existing HT being proposed
Leave blank
for HTA
OUTCOME
Reference
[Digital Object Identifier (DOI) if
Author Year Study Design Population Intervention Comparator Outcome published, and indicate specific page
and headings of the reference]
1.
2.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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3.
4.
5.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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4.3. Costing data
Annual direct costs per patient will only be considered. Costs should be in Philippine pesos. Add more rows as necessary.
References
(DOI if published, and
Parameter Proposed HT Comparator indicate specific page
and headings of the
reference)
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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(G) Total number of users of the HT
Possible References:
● Burden of disease
1.
2.
3.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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4.
5.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 5.
Ethical, Legal, Social, and Health System Impact
Describe the possible implications of the proposed HT on ethical, legal, social aspects, as well as, the foreseen health system
impact. Refer to the guide questions stated and provide no more than 300 words for each question..
Give basis for your answers (e.g., focus group discussion, specific contact person, or other references, published or
unpublished)
❏ No
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 6.
Additional information
Please include any additional information you believe would be helpful to the HTA Council and assessors.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Section 7.
Data inputs on Prioritization Criteria
The number of health technologies needing assessment far outweighs available
resources.Thus, there is a need to set priority topics to efficiently manage these demands.
kindly provide information on the excel files (Sheets are arranged by criteria):
The proponents are asked to accomplish the self-scoring sheet so that they will become familiar with
how HTAC prioritizes topics for assessment. This exercise aims to help the proponents gauge the
likelihood that their nominated health technology will be prioritized, based on the total scores.
The HTAC will conduct its own prioritization of nominated topics for HTA. The Council reserves the right
to make the decision on the final recommendation based on the HTAC prioritization matrix, and a
holistic and judicious assessment of the impact of the inputs of the proponents and the general public
upon subjecting the list of priority topics to appeals.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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References
Australian Government Department of Health - Medical Services Advisory Committee.
Technical Guidelines for preparing assessment reports for the Medical Services
Advisory Committee – Service Type: Investigative (Version 3.0). 2017 July; 230 p.
Medical Services Advisory Committee, Australian Government Department of Health.
Avaihttps://www1.health.gov.au/internet/msac/publishing.nsf/Content/
9C7DCF1C2DD56CBECA25801000123C32/$File/InvestigativeTechnicalGuidelines-
December-2016-Version-3.0.pdf
Philippine Statistics Authority. 2018 Family Income and Expenditure Survey (FIES),
National and Regional Estimates. 2019 Dec 04; 1 (1): 1-80. Available from:
https://psa.gov.ph/sites/default/files/FIES 2018 Final Report.pdf
Republic Act No. 11223. An Act Instituting Universal Healthcare for all Filipinos,
Prescribing Reforms in the Health Care System, and Appropriating Funds Therefore
also known as the Universal Health Care Act. 2019 Feb 20; 18p. Available from:
https://doh.gov.ph/sites/default/files/health_magazine/RANo11223_UHC.pdf
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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11-117: Available from: https://www.who.int/health_financing/documents/lancet-
catastrophic_expenditure.pdf. DOI: 10.1016/S0140-6736(03)13861-5.
Topic Nomination Template of Existing Traditional Medicine version 2 (as of March 2022)
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Annex. LIST OF ACRONYMS USED
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