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Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
AUG 0 I20t6
ADMINISTRATIVE ORDER
No. 2016-__lDlg!L

SUBJECT: The New Imnlementine Guidelines of the Philinnine National

Formularv Svstem (PNTS)

I. RATIONALE

The 1987 Philippine Constitution mandates the right of every Filipino to health. It enunciates
the policy that "the State shall protect and promote the health of the people and instill health
consciousness among them" (Article II Section 15). Moreover, it provides the adoption by the State of
an "integrated and comprehensive approach to health development which shall endeavor to make
essential goods, health and other social services accessible to all the people at affordable cost"
(Article XII Section 15).

To support these goals, several policies and laws have been passed. These include Republic
Act No. 6675 known as the Generics Act of 1988 that was enacted to "ensure the adequate supply of
drugs with generic names at the lowest possible cost." It further states that "in the promotion of the
generic names for pharmaceutical products, special consideration shall be given to drugs and
medicines which are included in the Essentiat Drugs List to be prepared within one hundred eighty
(180) days from approval of this Act and updated quarterly by the Department of Health on the basis
of health conditions obtaining in the Philippines as well as on internationally accepted criteria."

Executive OrderNo. 49 (dated2l Jamary 1993, entitled "Directing the Mandatory Use of the
Philippine National Formulary Volume I as the Basis for Procurement of Drug Products by the
Government") strengthened the advocacy of the Generics Act by ensuring that only essential
medicines identified in their generic names will be procured by all government instifutions.

Administrative Order No. 163 s. 2002 (entitled "Implementing Guidelines and Procedures in
the Procurement and Requisition of Drugs and Medicines by the Department of Health pursuant to
Executive Order No. 49") provides the procedural bases that ensure requisition of essential medicines
by the Government sector and the decision system for the inclusion and deletion of medicines in the
Philippine National Drug Formulary (PNDF).

The Philippine Health Insurance Corporation (PHIC) Board Resolution No. 265 (dated 15
July 1999) and the National Health Insurance Act of 2013 (Republic Act No. 7875 as amended by
R.A. No. 9241 and R.A. No. 10606) provide that the PNDF Volume I shall be the basis for claims
reirnbursements for medicines both in the private and public sectors for equitable and efficient use of
limited resources.

The more recent RA 9502 enacted in 2008 provides additional power to the President of the
Philippines to impose, upon the recommendation of the Secretary of Health, maximum retail prices
over medicines that include, among others, the "drugs and medicines that are included in the
Philippine National Drug Formulary Essential Drug List."

The Philippine National Formulary continues to serve as the national reference for cost-
effective and rational selection of the medicines which are vital in achieving optimal population
health outcomes. Given the importance of the PNF in the attainment of universal access to quality
essential medicines, the systems, procedures and processes to formulate and update the previous
issuances, Administrative Order 2012-0023 (Revised Implementing Guidelines for the Philippine
National Formularv Svstem) and its addendum AO 2012-0023-4 need to be reviewed and enhanced.

Bldg.l San Lazaro Compound, Rizal Avenue, Sla. Cruz, 1003 Manila . Trunk Line 651-7800 . Fax 743-1829. URL:
htto://www.doh. gov.oh; e-mail: [email protected]

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TI. OBJECTIVES
This issuance aims to:

A. Describe the new systems and procedures for:

l. the selection of medicines to be included in or deleted from the Essential Drug List hereafter
referred to as the National Essential Medicines list;
2. the development of the PNF manual which integrates the Essential Medicines List and
Formulary monographs; and
3. the promotion of the use of the Formulary among the different levels of healthcare managers
and providers and the consumers.

B. Reconstitute the Formulary Committee and describe the implementation arrangements of the
Philippine National Formulary System (PNFS).

ilI. SCOPN

This Order shall be applicable to all health facilities, units and offices of the entire
government sector as a basis t"-i arug procurement. It shall also be applicable to the entire health
sector (both government and private) as a reference guide for rational use of medicines and as a basis
for reimbursement of medicines by the PHIC.

IV. DEFINITION OF TERMS

A. Essential Medicines- These are medicines that satisfy the priority health care needs of the
population and which are selected based on the evidence of their efficacy, safety and comparative
cost-effectiveness. The DOH shall endeavor to make these available and affordable at all times.
B. Affordability- refers to the cost implications of including the drug in the Formulary expressed as
total treatment cost per patient and budget impact to the government.
C. Budget Impact Analysis- estimates the financial consequences of the adoption and diffusion of a
new health-care intervention such as drugs/medicines within the local specific health-care setting
context given inevitable resource constraints.
D. Conflict of Interest- a situation created when persons or entities in the public and/or private
sectors that have personal, financial, or any other interest in the pharmaceutical and/or medical
device industry, such as but not limited to, having existing ownership or investment therein, being
an officer or a member of the Board of Directors of a corporation of a corporation (including its
subsidiaries, affiliates and branches) or a partner in a partnership engaged therein, and receiving
any contribution there from. This includes receiving or accepting any offer or contribution there
from.
E. Cost- effective- a term that is applied to a drug or health technology when its overall health gain
to the health system outweighs the opportunity costs of funding that drug or technology.
F. Evidence Review Group- composed of content and methods experts who shall evaluate
medicines that are proposed to be included into or deleted from the PNF.
G. Health Technology Assessment- the systematic evaluation of properties, effects, and/or impacts
of health technology to inform policy decision making.
H. Methods Manual- provides the principles and methods of health technology assessment that shall
be undertaken to assess medicines that will be included into or deleted from the Formulary.

I. National Health Program (NHP) - health programs and disease control strategies developed and
funded by the Department of Health for the prevention and management of diseases that are of
public health importance.

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J. Pharmaceutical Establishment- a sole proprietorship, a partnership, a corporation, an institution,

an association, or an organization engaged in the manufacture, importation, exportation, sale,
offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship
of health products including the facilities and installations needed for its activities.
K. Scoping- a process of determining the scope of drug review with relevant stakeholders in terms of
the population who will benefit, the comparator or the current standard of care and the relevant
health outcomes to be considered.
L. Systematic Review- a systematic search of all empirical evidence that would meet pre-specified
eligibility criteria in order to answer a specific research question. It involves an explicit
reproducible methodology to assess the validity of the findings of the included studies.
M. Urgent health situation- requiring immediate action to prevent death, permanent disability or a
major or irreversible organ dysfunction and for concerns that are of public health importance upon
decision and endorsement of the Secretary of Health.

V. GENERAL GUIDELINES

A. The new edition of the Philippine National Drug Formulary shall be referred to as the Philippine
National Formulary GNF), with its inputs, processes and outputs collectively referred to as the
Philippine National Formulary System (PNFS).
B. The Formulary Committee shall be reconstifuted and hereafter referred to as the Philippine
National Formulary Executive Council (PNFEC).
C" The process by which the PNFEC evaluates medicines shall be guided by the principles under the
New Global Model for HTA Governance: (l)
ethically sound, (2) scientifically rigorous, (3)
transparent, (4) consistent, (5) independent, (6) contestable, and (7) timely and enforceable.

D. The PNFS shall be operationalized through the PNFEC with assistance from independent
evidence review groups (ERGs) and a pool of specialty experts. The Pharmaceutical Division
through its Policy, Planning, Program Development and Research Unit shall provide secretariat
support to the PNFEC.
E. The PNF shall be developed and updated using the Formulary Selection Algorithm as well as the
Methods Manual which shall describe the step-by-step selection procedure to be employed in
determining the medicines to be included in or deleted from the Formulary.
F. Declaration of conflict of interest (Annex A) shall be mandatory to all persons who will be
involved in any Formulary related activities (i.e., PNFEC members, Secretariat, ERG, consultees
from hospitals professional associations and patient groups).
G. Prioritization criteria (Annex B) shall be developed by the PNFEC to determine which medicines
will merit priority evaluation by the ERG.
H. Representatives from the pharmacy and therapeutics committee (PTC) of both public and private
hospitals and professional medical societies recognized by the Philippine Medical Association
(PMA) shall be convened to help in the updating and review of the Formulary.
I. Applications for inclusion in the PNF shall emanate from the PTCs, professional medical
societies, national health program (NHP) or Philhealth. For medicines disapproved for inclusion
in the PNF or deleted from the PNF, all application for reconsideration shall include new or
additional evidence-based data on the medicine. The PNFEC may consider holding a public
forum when deliberating on the reconsideration of an application.
J. The PNF Manual shall include the following: (1) Guidelines on the Rational Use of Medicines,
(2) National Essential Medicines List, and (3) Formulary Monographs.

1. The previously named PNDF Volumes 1-2 (Essential Medicines List and Formulary
Monographs) shall cease to exist as independent publications. Together with succinct
guidelines on the rational use of medicines, the content of these previous volumes shall be

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integrated into a concise PNF Manual. PNDF Volume 3 or the cross reference index shall no
longler be part of the new PNF, instead the Food and Drug Administration (FDA) website
shall serve as the reference for the available proprietary names of each drug molecule.
2. Two versions of the PNF Manual shall be published: (1) Essential medicines list (EML) for
the Bids and Awards Committee (BAC) and(2) EML with prescribing information for each
medicine which shall be classified whether it can be dispensed and administered at the (a)
primary healthcare or (b) general hospital level. A legend for restricted antimicrobials shall
also be specified in the manual.
3. The PNF Manual shall be published upon the recommendation of the Assistant Secretary or
Undersecretary of Health in charge of the Pharmaceutical Division and the approval of the
Secretary of Health in accordance with the prescribed timelines established in the Generics
Act of 1988 and the Cheaper Medicines Act of 2008. The Pharmaceutical Division shall be
responsible for the cost of publication and dissemination of the PNF Manual.
K. The PNF Manual shall be made available in downloadable format from the official websites of
the DOH, FDA, and the Pharmaceutical Division.
L. Only medicines listed in the PNF Manual shall be procured by all government entities in
accordance with Executive Order No. 49 s. 1993. However, exemptions may be granted upon
submission of the completed application form by the end user, e.g., DOH national programs and
government hospitals, with justifrcation and subject to the approval of the Pharmaceutical
Di rision Cluster Head upon the recommendation of the PNFEC based on the prescribed criteria.
All NHPs that will request exemption of non-PNF medicines in volumes exceeding Php
500,000.00 in cost shall be subject to the approval of the Secretary of Health.
M. Medicines that shall be used in the rural health units, city health offices, infirmaries and other
primary healthcare facilities shall be restricted to only those that are classified under the Primary
Healthcare category.
N. Medicines withdrawn from the Philippine market due to safety reasons shall be deemed delisted
from the PNF Manual effective on the date of the order for withdrawal by the FDA.

VI. SPECIFIC GUIDELINES

A. Philippine National Formulary Executive Council
l. Composition:

a. The Philippine National Formulary Executive Council (PNFEC) shall consist of

experrs representing the broad scientific and societal perspectives that may impact on
the judicious selection and use of medicines. It shall have as members respected
individuals whose collective expertise shall cover the fields of pharmacology,
toxicology, clinical epidemiology, pharmacy, clinical medicine, public health, law
and medicine, health economics.

b. The number of Council members shall be odd and is to be determined by the

Secretary of Health.

c. The members of the committee shall be co-terminus with the Secretary of Health
(maximum), subject to reappointment by the new Secretary of Health.

d. The PNFEC shall have a Chairperson selected by the Secretary of Health from the
members. The chair shall hold his/her position for a period not exceeding three (3)
years, unless he/she relinquishes hislher position for reasons beyond his/her control.

2. Qualifications:

a. Persons of moral and intellectual integrity.

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b. Recognized specialists in their field of expertise.

c. Willingness to disclose conflicts of interest.

3. Disclosure of Conflicts of Interests:

The PNFEC members shall conform with the principles of integrity and shall therefore
declare all circumstances with real or potential conflicts of interests and shall comply with
the policy set up for declaring and managing such (Annex A).

4. Specific Functions:

a. The PNFEC shall identify which medicines need to be included in the Formulary based
on a continuing review of local disease statistics from public and private hospitals and
other health facilities, advice from the different specialty societies and input from the
programs and offices of the Department of Health and other stakeholders.
b. The PNFEC shall prioritize which medicines to evaluate within the prescribed period
using a prioritization tool (Annex B).
a. The PNFEC shall determine the research question of each medicine that will be evaluated
by the ERG following the PICO format (population, intervention, comparator and
outcome).
d. The PNFEC shall recommend for official approval to the Secretary of Health the
medicines to be included into and deleted from the PNF.

5. The PNFEC shall meet at least once a month and shall follow a regular cycle of review for
drugs being considered for inclusion in the PNF (Drug nomination, Prioritization of drugs,
Scoping of Drug review, Evaluation/Assessment, Deliberation, Decision and Implementation).

6. The PNFEC shall conduct a continuous review of the Formulary with assistance from the ERG
and/or the specialty experts (i.e., specialists, subspecialists, members of Pharmacy and
Therapeutics Committee) as needed.

7. The PNFEC may recofirmend to the Pharmaceutical Division (PD) courses of action for a more
comprehensive dissemination, monitoring and evaluation of the PNF. Monitoring of the
dissemination and use of the Formulary Manual will be conducted regularly by the PD.

B. Evidence Review Groups

l. Compositions and Qualifications:

a. The evidence review goups (ERG) shall be composed of experts in clinical

epidemiology, pharmacology, toxicology, pharmacoeconomics, health economics, health
technology assessment (HTA), evidence-based medicine (EBM) and other related fields.
b. Qualifications of an evidence review expert include:
i. Active practice or teaching of evidence-based medicine;
ii. Willingness to declare and manage conflicts of interests; and
iii. Willingness to sign the contract of service.
iv. Trained on EBM, health economics, HTA, pharmacoepidemiology
v. At least masters or doctorate desree holder in the above fields.

2. Functions:
a. The evidence review experts are tasked as necessary by the PNFEC to systematically
review and analyze the results of benefit- risk and efficiency analysis of medicines
obtained from controlled clinical trials and sound epidemiologic studies.

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 b. Conduct economic evaluation as deemed necessary.
c. Develop evidence summary following the prescribed format set by the PNFEC.
d. Present the result of evaluation durins PNFEC meetings.

C. Specialty Experts

1. Composition and Qualifications:

a. Specialty experts from various clinical and related disciplines with relevant years of
experience and distinction in their fields.
b. Trained on EBM and/or epidemiology.
c. Willingness to declare and manage conflicts of interests.

2. Functions:
a. Provide expeft opinion regarding a particular medicine;
b. Review and assist in the formulation of relevant clinical guidelines;
c. Provide assistance in the formulation of systems and procedures; and
d. Recommend to the PNFEC items for inclusion or deletion from the PNF.

D. Specific Guidelines for the Formulary Selection Algorithm

l. The PNFEC shall ensure that any medicine considered for inclusion in the PNF shall be
assessed based on its benefit- risk assessment (efficacy and safety), cost-effectiveness
affordability and local public health relevance.
2. The FDA shall provide the initial necessary data to the PNFEC to this effect, i.e. records of all
medicines registered in the Philippine market covered with a Certificate of Product
Registration (CPR). The FDA shall likewise provide data on whether the medicine is available
in the Philippine market or is still in the process of being registered.
3. The PNFEC shall continuously review the list of medicines in the PNF. The PNFEC shall
submit to the Assistant Secretary or Undersecretary of Health in charge of PD the list of
recommended medicines for inclusion in or deletion from the PNF. Such shall be published in
the DOH-PD website, upon the approvalof the Secretary of Health.
4. The PNF adheres to the essential medicines list concept of the World Health Organization
(WHO) which states that "essential medicines are those that satisff the priority healthcare
needs of the population." As such, the major criteria for the selection of medicines in the
PNF are:

a. Local public health context- the drug addresses a priority disease or unmet health care
need as determined by the DOH in consultation with the stakeholders.
b. Burden of disease and avoidable burden of disease that shall be measured by its
frequency, as indicated by its prevalence or incidence, and by its severity, as indicated by
its quality-adjusted life years (QALY) or disability-adjusted life years (DALY) or, in their
absence, a consensus ofexperts;
c. Comparative efficacy and safety relative to the current standard of care or a medicine
listed in the PNF indicated for the same condition. This shall be based on
pharmacological studies including systematic reviews andlor meta-analysis of Phase III
clinical trials;
d. Comparative cost-effectiveness- as a rule of thumb, the FEC sets an arbitrary threshold of
less than or equal to one (1) GDP per capita per QALY gained or DALY averted when
evaluating potentially innovative treatments compared to the current standard of care
which include the medicines listed in the PNF:

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 e. Affordability of the drug to DOH and Philhealth- pertains not only to the unit cost of the
drug but also the treatment cost per patient and the overall potential budget impact if all
patients eligible for that treatment are funded by the national government; and
f. Equity- the drug addresses the disease that places a great burden on disadvantaged or
special populations such as the pooro disabled, children, elderly, women, indigenous
peoples that reflect the values that should be considered by DOH policymakers as
stipulated in existing DOH policies and national laws.

5. For medicines belonging to the same pharmacologic class, the following preferential
factors shall be used in choosing the best possible medicine:

a. The medicine is the most thoroughly investigated and therefore the best understood with
respect to its benefits and risks;
b. The medicine possesses clinical utility for the treatment of more than one condition or
disease;
c. The medicine has the most favorable pharmacokinetic properties, e.g., factors promoting
better compliance or leading to lesser risk in various pathophysiological states;
d. The medicine has dosage forms that are easy for the health staff to dispense or that are
easily and safely administered to the patient;
e. The medicine is easy for the patient to take or promotes better compliance among most
patients; and
f. The medicine and its dosage forms have favorable stability under the anticipated local
conditions in storage facilities.

6. The medicines should be formulated as single compounds. Fixed-dose combinations,

however, are acceptable only when:

a. The value of concomitant use of more than one medicine is rational and clinically
documented;
b. At least equally effective or more cost-effective. The combination product is less than or
does not exceed that of the sum of the individual products of the active ingredients of the
combination.
c. Plus any of the following:
i. The combination provides an additive, synergistic and/ or complementary
action;
ii. The combination has no additional adverse drug reactions; and
iii. The combination provides dosage convenience for better patient compliance.

7 . Criteria for the exclusion or deletion of medicines from the PNF are as follows:

a. The medicine has been withdrawn from the FDA registry due to safety reasons;
b. A more effective or equally effective but less toxic medicine becomes available;
c. In light of new data, the therapeutic efficacy of the medicine is found to be unsatisfactory;
d. Toxicity, suspected toxicity, potential for abuse and dangerous interactions outweigh the
medicine's therapeutic value;
e. The medicine is no longer deemed cost-effective compared to other therapies;
f' The medicine is a fixed-dose combination that does not satisfli the requirements of A'o'
96 s.1990 and the prescribed criteria of the PNFEC; or
g. Not affordable to the government (budget impact).

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 8. Exemptions

a. EO No. 49 s.7993 states that only medicines listed in the PNDF shall be procured bY all
government entities. Requests for exemptions will be considered provided that the
medicine proposed for exemption meets all the criteria for exemption. There shall also be
a simultaneous application frled by the proponent for inclusion of the medicine in the
PNF.

b. The application for exemption shall have the following as attached documents:

Accomplished proposal form that includes justification, a report on disease

burden and its ranking relative to the common diseases in the health facility or
communitv:

ii. Soft/electronic copies ofall cited studies and published articles; and
iii. Other relevant documents (e.g. peer-reviewed local Philippine clinical practice
guidelines which provides information on the indication or use of the product
(preferred), excerpts from WHO documents or other formularies, etc., including
photocopies ofsuch).

Only requests for exemption submitted by the PTC of the requesting facility or the DOH
National Health Program shall be accepted.

d. The request for exemption shall only be granted if it fuIfills ALL of the following criteria:

i. The medicine has proven safety and efficacy.

ll. There is no other medicine listed in the formulary which is indicated for the
same condition or appropriate for the current situation.
iii. The medicine will be used for an ursent health situation.

Potentially innovative medicines responding to a public health priority or where there are
no other strategies or treatment to address a disease which is of grave public health
importance may be granted an exemption provided that they have been tested in terms of
clinical performance and safety, and have a certiftcate of product registration from the
FDA.

The Undersecretary or Assistant Secretary in charge of PD shall approve or disapprove

the request based on the recommendation of the PNFEC. In cases where the procurement
would amount to Php 500,000 and above, the Secretary of Health shall be the approving
authority.

The validity ofthe exemption is good for a period ofone year or as prescribed, unless an
adverse decision has been rendered regarding the application for inclusion.

Medicines not registered in the Philippines may be considered for exemption or inclusion in
the PNF provided that they are needed to address a public health priority as determined by the
Secretary of Health upon the recommendation of the PNFEC. Provided also that the medicine is
registered in any stringent national regulatory authority (i.e., accredited by the Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme fiointly referred to as
Prc/s)).

E. Process for Inclusion or Deletion of Medicines in the PNF

1. Drug Nomination
a. The following individuals or parties, hereto referred as the proponents, may request for
application for inclusion or deletion of medicines; for additional indications, formulation,

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 route of administration, dosage strength, net content andl or immediate packaging; as well
as for exemptions: PNFEC; Units, Offices and Health Facilities directly under the
supervision of the DOH and Health Facilities under the Local Government Units (LGUs);
and professional medical societies recognized by the Philippine Medical Association
(PMA).

The following timeline for submission of application and scoping shall be followed:

i. January - submission period of a1l applications for the year;

ii. February - presentation of applications to PNFEC; and
iii. March - presentation of prioritized drugs and their corresponding research
questions to stakeholders through public consultation.

The proponents shall submit Letters of Requests and accomplish the appropriate Proposal
Forms prescribed by the PNFEC. These are the following forms:

i. PNF Form No.l (Letter of Request and Proposal Form for Inclusion) hereto
appended as Annex C.
ii. PNF Form No. 2 (Letter of
Request and Proposal Form for Deletion of
Medicine from the PNF) hereto appended as Annex D.
iii. PNF Form No. 3 (Letter of Request and Proposal Form for Exemption from
E.O. No. 49 s. 1993) hereto appended as Annex E.

The above forms may be downloaded from the PD website.

d. The proponents shall likewise submit two (2) hard and soft copies each of the following
documents required by the PNFEC, to wit:

i. Accomplished proposal form;

ii. SofVElectronic copies of all cited studies and published articles;
iii. Systematic Review (preferably Cochrane) or Meta-analysis or at least Phase III
Randomized Controlled Clinical Trials; and

iv. Other relevant documents (e.g. peer-reviewed local Philippine clinical practice
guidelines which provides information on the indication or use of the product
(preferred), excerpts from WHO documents or other formularies, etc., including
photocopies ofsuch).

Proposal Forms shall include the following:

General information on the medicine:

Specific request;
Summary of justification for request;
References for clinical efficacy and safety profile;
Details required for cost-effectiveness assessment; and
Copies of all cited scientific joumal articles, entries, other accepted legal
documents and other supporting publications.

f. Medicines deemed essential for a specific DOH health facility or are for specific DOH
program/project must be explicitly certified as essential by the DOH requesting unit.
These medicines shall be prioritized for evaluation by the PNFEC. The NHP shall be
required to submit the following documents in lieu of the abovementioned requirements:

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 (1) letter of request with justification; (2) local or international clinical practice guidelines
and (3) WHO recommendation, if available.

2. Prioritization of Drugs
a. The PNFEC, upon receipt of the Letter of Request and Proposal Form duly classified by
the Secretariat, shall proceed with the prioritization of the request following the tool
attached herein as Annex B. Only applications for inclusion shall undergo the
prioritization process.
b. Medicines classified as non-priority medicines shall be recommended for disapproval.

3. Scoping of Drug Evaluations/ Assessments

a. A research question shall be developed by the Council for each of the prioritized
medicine with regard to the appropriateness of the target population, comparator and
clinically relevant outcomes.
b. Public consultation shall be conducted to inform and elicit feedback on the list of
prioritized medicines and their corresponding research question.

4. Evaluation and Assessment

a. The Council shall follow the process flow with timelines as detailed in Annexes G and H.
b. The ERG shall develop an evidence summary together with an evidence table for each
evaluation. The evidence summary shall consist of the following parts: (1) burden of
disease; (2) clinical evidence; (3) cost analysis; (4) final recommendation; and (5)
references.
c. If deemed necessary by the Council, a pharmacoeconomic evaluation may be conducted.
This is defined as the comparative analysis of alternative courses of action in terms of
both costs (resource use) and consequences (outcomes, effects). This may pertain to (l)
cost minimization analysis, (2) cost utility analysis, (3) cost-effectiveness analysis and (4)
cost-benefit analysis.
d. A budget impact analysis shall be conducted especially for high cost medicines to guide
the PNFEC in making a recommendation on the feasibility and sustainability of financing
the drug through government procurement or Philhealth reimbursement.

5. Deliberation

a. The Council shall recommend the inclusion or deletion of a certain medicine based on the
aforementioned criteria under the Specffic Guidelines for the Formulary Selection
Algorithm.
b. The final recommendation shall be obtained through a majority (50% + 1) vote provided
that there is a quorum. In the absence of a quorum and in an urgent situation, votation
through ad referendum may be conducted.
c. A period of 30 working days shall be allowed for reconsideration on the
recommendations of the Council. All submissions shall still emanate from the PTC or
professional medical societies.
d. For appeals, the proponent shall submit a letter of justification for reconsideration based
on the following parameters: new evidence on safety, efficacy or price.

6. Decision

a. The recommendations of the Council shall be endorsed by the cluster head in charge of
the Pharmaceutical Division to the Secretary of Health.

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 b. The inclusion or disapproval of a medicine in the PNF shall be considered official once
signed with finality by the Secretary of Health.

7. Implementation

a. A coresponding Department Memorandum shall be drafted for all the decisions of the
Secretary of Health. This shall be signed by the cluster head in charge of the
Pharmaceutical Division.
b. The issuance shall be disseminated to all DOH Regional Offices, Philhealth, government
and private health facilities and other concerned institutions.
c. All evidence summaries. PNF-related issuances or announcements and the decisions of
the Secretary of Health shall be posted on the DOH-PD website and disseminated to the
stakeholders. PNF updates shall be presented during the quarterly meetings of the
Advisory Council.

F. PNF Formats and Publication

1. The PNF Manual shall consist of the following:

a. National Essential Medicines List and

b. Formulary Monographs.

2. The Formulary lists the medicines according to Therapeutic Categories and the following
information will be provided for each medicine in the Manual:

a. Generic name;
b. Brief pharmacodynamic and pharmacokinetic data;
c. Acceptedindications;
d. Contraindications;
e. Precautions;
f. Adverse reactions;
g. Clinically significant drug interactions;
h. Weight and/or age specific dosage recommendations and dose adjustments for patients
with renal or hepatic disease;
i. Approved drug preparations; and
j Other recommendations regarding proper intake.

3. Succinct guidelines on the safe and rational use of medicines for the management of the
priority diseases shall be included.

4. A list of restricted antimicrobials identified by the Formulary Executive Council and the
National Antibiotic Guidelines Committee shall be part of the PNF manual.

5. PNF updates shall be posted on the DOH website and such shall be considered as an integral
part of the cunently published PNF. The EML for BAC and EML with full prescribing
information shall be printed annually and every three years, respectively, subject to the
availability of funds and the usual accounting and auditing rules and regulations.

6. An online version and mobile application of the PNF shall be made available. These shall
contain the abovementioned information together with the latest data of the Drug Price
Reference Index (DPRI).

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VII. IMPLEMENTATION ARRANGEMENTS

A. Roles and Responsibilities

1. Office of the Secretary

The Secretary of Health shall make the final review prior to the approval or disapproval of the
recommendations of the PNFEC through the Undersecretary or Assistant Secretary on the
PNF.

2. Undersecretary or Assistant Secretary

The Assistant Secretary or Undersecretary of Health in charge of PD shall provide oversight

functions to the PNFEC.

3. PharmaceuticalDivision
a. Chief
i. Shall assist the Undersecretary or Assistant Secretary in the provision of oversight
functions to the PNFEC;
ii. Shall undertake overall management of the PNFS Secretariat function including but
not limited to the planning, budgeting, controlling and monitoring processes; and
iii. Shall undertake overall coordination with intemal and extemal partners.

b. Head of the Policy, Planning, Program Development and Research Section

i. Shall undertake day to day management of the PNFS Secretariat function;
ii. Shall monitor implementation of the plan of the PNFS Secretariat and address
potential and actual delays in implementation; and
iii. Evaluates performance of the PNFS Secretariat.

c. The Policy, Planning, Program Development and Research Section staff:

i. Shall provide technical and administrative support to the PNFEC;
ii. Shall formulate the annual work and financial plan pertinent to the updating of the
PNFS; and
iii. Shall implement the above- mentioned plan, monitor implementation and formulate
catch-up plans in case of delay in implementation.

4. Formulary Executive Council

a. The PNFEC shall establish the systems and procedures of the PNFS.
b. The PNFEC shall review all applications submitted for inclusion in or deletion fiom the
PNF or exemption from E.O. No.49 s.1993 and make appropriate recommendations to
the Secretary of Health thru the concemed Undersecretary or Assistant Secretary.

5. Evidence Review Groups (ERGs) shall prepare the evidence summaries and perform
facllitatedlrapid reviews pertaining to the medicines under deliberation as requested by
PNFEC.

6. A pool of specialfy experts on various disciplines shall provide inputs during the
deliberations when called upon by the PNFEC.

7. A representative from the FDA, the Philippine Health Insurance Corporation (PHIC),
Research Institute for Tropical Medicine (RITM) and other agencies that may be deemed
necessary by the PNFEC chairperson or the Secretary of Health may be called upon to serve
as resource persons during PNFEC deliberations.

Av12
l
II
l\^b N
8. The following Bureaus and Centers of this Department are instructed to fully support the
PNFS and comply with the provisions stated in Executive Order No. 49 as applicable:

a. The Food and Drug Administration (FDA) shall provide the necessary technical input and
essential data requirements such as relative availability of drugs in terms of market
authorizations, as deemed necessary by the PNFEC. It shall also ensure that all drug
establishments have the latest edition of the PNF manual as part of licensing requirement.
b. Philippine Health lnsurance Corporation (PHIC) - shall use the PNF as the basis for
payments of in-patient and out-patient benefits schemes for medicines and in the
accreditation of health facilities and pharmacies for drug reimbursements; conduct price
negotiation; provide inputs on the capability of the govemment to fund medicines
(affordability); conduct prescription audit.
c. Research Institute for Tropical Medicine (RITM) - shall provide timely information on
the trends in resistance rates of microorganisms to antimicrobials and latest researches in
the prevention, diagnosis and treatment of tropical diseases including vaccines for the
control of vaccine-preventable diseases of public health importance.
d. Disease Prevention and Control Bureau (DPCB) - shall provide information on trends of
diseases being monitored. It shall likewise promote the use of PNF in all its progrcms
specifically ensuring that medicines used in the clinical practice guidelines (CPGs) or
standard ffeatment guidelines (STGs) are those listed in the PNF.
e. Health Facilities Development Bureau (HFDB) - shall ensure that public health facilities
through their Pharmacy and Therapeutics Committees (PTCs) comply with the mandatory
use of the PNF. It shall also assist in monitoring compliance with PNF use in health
facilities.
f. Health Facilities Services and Regulatory Bureau (HFSRB) - shall ensure that the tool in
licensing public and private health facilities include compliance with the mandatory use
of the PNF.
g. Health Human Resource Development Bureau (HHRDB) -shall advocate for a
transformative curriculum which shall include the use of PNF and rational management
of medicines by health professionals. They shall develop and provide continuing
professional education trainings that promote the use of the PNF.
h. Central Office Bids and Awards Committee/ Logistics Management Division
(COBAC/LMD) - shall ensure the use of PNF as basis for objective, transparent and
efficient processes in the DOH procurement and distribution of medicines.

i. DOH Regional Office - shall implement and monitor the mandatory use of PNF in its
procurement. It shall also report and give feedback on the status of PNF use in their areas
ofjurisdiction.
9. This Department shall closely coordinate with the Department of Interior and Local
Government (DILG) to ensure compliance with the mandatory use of PNF in the medicines
procurement of LGUs and to assist the DOH in the monitoring and evaluation of the PNF use.

t0. The Local Government Units (LGUs) shall comply with the use of PNF by their respective
Bids and Award Committees (BAC) in their medicines procurement and shall submit reports
to the DOH on the monitoring and evaluation of the use of the PNF in LGUs.

I l. Govemment entities including Government Owned and Controlled Corporations (GOCCs)

and those under public-private partnership arrangement with these agencies shall comply with
the mandatory use of PNF in procuring medicines.

r
 12. The Commission on Audit (COA) shall ensure the use of PNF as the basis for the
procurement of medicines by all government agencies and shall provide the necessary
sanctions if violations are committed.

B. Mandatory Use of the PNF

1. Allgovernment pharmaceutical establishments and health facilities must have a copy of the
PNF Manual. The PNF Manual shall be the basis of the drug establishment's in-patient
counseling and shall be used in giving consumer advice when information about essential
medicines is demanded.
2. Only those reflected in the PNF Manual can be requisitioned in the procurement of medicines
by all government agencies, i.e. national govemment agencies and the health facilities under
their supervision, government health facilities under the supervision and control of the DOH,
devolved health facilities under the Local Government Units and GOCCs.
3. Every Requisition and Issue Slip (RIS) and Procurement Request (PR), including purchases in
times of emergency and authorized under the General Appropriations Act, shall be
accompanied by a certification from the requisitioning officer or by the duly authorized
officer indicating that the products fall within and conform with the latest edition of the PNF
Manual.
4. Medicines not reflected in the printed PNF Manual may still be procured as long as these are
approved by the Secretary of Health for inclusion in the upcoming edition of the PNF and if
such products are already posted in the PD website. Medicines approved for inclusion in an
upcoming edition of the PNF Manual must be covered with the appropriate Department
Memorandum and other instruments of announcements, which shall be disseminated to all
public and private health facilities as well as other government drug procuring entities.
5. Only medicines listed in the PNF Manual shall be considered for reimbursement or subsidy
by the Philippine Health Insurance Corporation (PHIC) for the entire health sector -
government and private.
6. Restricted antimicrobials may only be procured by health facilities that satisfy any of the
following conditions: (1) presence of an Infection Control Committee whose chairperson is a
physician and DOH-trained on Antimicrobial Stewardship; or (2) presence of a board
certified infectious disease specialist who shall authorize the use of the drug as clinically
needed.

7. Medical practitioners and all potential end-users shall avail of a copy of the PNF Manual or
. download it from the DOH or PD website.

C. Coordinating Instructions
1. The PD shall coordinate with the Commission on Audit so that auditorslheads of auditing
units shall monitor compliance thereto and shall disallow claims/reimbursements either from
regular budget, local/trust funds covering the procurements of drugs and medicines which are
not within the latest edition of the PNF.
2. The PD shall conduct an Information, Education and Communication (IEC) campaign
targeting all drug establishments, patients, doctors/ prescribers, dispensers, and government
procuring entities within one (l) year from the effectivity of this Order to ensure smooth
compliance.
3. Any violation in the compliance of this Order may be subject to the penalties provided in
Section 12 ofRA 6675 as amended bv RA 9502.

VIII. TRANSITORY PROVISION

There are still a substantial number of drug applications pending review from the previous years,
hence, the timeline provided under Section E of the Specific Guidelines shall take effect in2017.

74
 Submission of applications shall commence in January 2017. However, for medicines that have
no alternative in the Formulary or if there is an urgent need as determined by the PNFEC,
applications therefor may be accepted. All other provisions shall take effect pursuant to the
Effectivity provision.

IX. SEPARABILITY CLAUSE

If any provision in these Guidelines, or application of such provision to any circumstance, is held
invalid, the remainder of these Guidelines shall not be affected thereby.

X. REPEALING CLAUSE
AO 2012-0023 and AO 2012-0023-A are hereby repealed by this Order. All other issuances
inconsistent with the provisions of this Order are hereby repealed/rescinded and modified
accordingly.

XI. EFFECTIVITY
This Order shall be effective within fifteen (15) days from publication in the Official Gazette.

PAULYN
lLuu l/A
B. ROSBLL-UBIAL. MDo MPrl . CESO II
^/-

l5
 Annex A
Fs*ct on* o-"n
$?ffiTifii'*ff
DECLARATION OF CONFTICT OF INTEREST

1. CURRENT FINANCIAL INTERESTS

To your knowledge, do 1) you, your spouse, minor child, general partner, 2) organization in which you serve as an officer,
director, trustee, general partner, or employee and/or 3) entity with whom you are negotiating or have any arrangement
concerning prospective employment have any current involvement or financial link with the meeting/task issues (including
competing companies)?
a. INVESTMENTS (e.g. stocks, bonds, retirement plans, trust, sector funds, etc.) n NONE "none", to item b.)
ESTABLISHMENT TYPE OF NUMBER OF CHECK % NET WORTH
INVESTMENT SHARES MORE THAN 15%

b.EMPLOYMENT Full or Part Time or Under tr NONE (lf "none", ski to item c.
ESTABLISHMENT RELATIONSHIP POSITION IN FIRM DATE EMPLOYMENT OR
NEGOTIATIONS BEGAN

c. CONSUITANT/ADVISOR (Current or Under n NONE (lf "none", to item d.

ESTABLISHMENT AMOUNT RECEIVED RELATED TO LISTED
PRO DU CTS/I N DI CATIO NS/ISSU ES

PRODUCT UNDER AMOUNT OF RELATED TO

STUDY AND REMUNERATION LISTED

INDICATIONS TO PRODUCTS/
rNDrcATroNS/
ISSUES

*Government, Establishment, Institution, Individual

** Site Investigator, Principal Investigator, Co-lnvestigator, Employee, Partner, No Involvement, orOther
IF MORE SPACE 1S NEEDED, PLEASE ATTACH ADDITIONAL PAGES.
 CURRENT FINANCIAL INTERESTS (Continued)
e. PATENTS/ROYALTIES/TRADEMARKS n
U NONE (lf "none", skip to item
FOR ESTABLISHMENT RELATED TO LISTED IF'YES", EXPLAIN BELOW AND INDICATE INCOME
PRODUCTS/ RECEIVED
rNDrcATroNS/ NUMBER OF SHARES
ISSUES

gYES
trNO
aYES
nNO
aYES
trNO
f. EXPERT WITNESS (Last 12 Months or Under Negotiation) ! NONE (lf "none", skip to item f.)
I appeal ed for or asainst the followine listed and issue(s).
FIRM AND ISSUE AMOUNT RELATED TO LISTED IF "YES", EXPLAIN BELOW
RECEIVED PRODUCTS/
l INDICATIONS/
ISSUES

gYES
trNO
aYES
r-r NO
aYES
trNO

AMOUNT RECEIVED RELATED TO LISTED

PRODUCTS/
rNDrcATtoNS/
ISSUES

2. PAST FINANCIAL INTERESTS

a. To your knowledge, do 1) you, your spouse, minor child, general partner, 2) organization in which you serve as an
officer, director, trustee, ggneral partner, or employ5re have any past involvement with the meeting/task issues:
U YES " NO U NOT TO MY KNOWLEDGE
b. ll "Yes" , describe involvement.
FIRM/PRODUCT FINANCIAL ROLE DATES RELATED TO LISTED
INVOLVEMENT PRODUCTS/
rNDrcATroNS/
ISSUES
gYES
trNO
6YES
t]NO
IF MORE SPACE IS NEEDED. PLEASE ATTACH ADDITIONAT PAGES.
 3.
OTHER INVOLVEMENTS (Other Kinds of Relationships) tr ruOruf (lf "none", skip to item 4.)
Using the list of products/firms/issues/, identify anything that would give an "appearance" of a conflict which has not been
disclosed above (e.g. involvement in a lawsuit, researcher initiated study, gift of research materials, etc.).

4. CERTIFICATION STATEMENT
l, (name) (position and company or specialty)
of the Republic of the Philippines, do hereby declare on my
honor that the above information is true and complete, to the best of my knowledge. lf there are any changes, I will notify you
before the meeting/task.

My response contains pages.

SIGNATURE DATE

CON FI DENTIATITY STATEMENT

The primary use of this information is for review of the Food and Drug Administration, to determine compliance with applicable
conflict of interest laws and regulations.

This confidential report will not be disclosed to any requesting person unless authorized by law.

Falsification of information or failure to file or report of information required to be reported is subject to disciplinary action by
thc FDA.

FOR FDA USE ONLY

SIGNATURE OF REVIEWING OFFICIAL DATE

COMMENTS OF REVIEWING OFFICIAL

IF MORE SPACE IS NEEDED, PLEASE ATTACH ADDITIONAT PAGES,-

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ANNEX C.

PNF FORM NO. 1. LETTER OF REOUEST AND PROPOSAL FORM F'OR INCLUSION

LETTER. OF'REQUEST

Date

Honorable
Secretary
Department of Health

ATTENTION:

Chief
Pharmaceutical Division
Department of Health

SUBJECT: Proposal for INCLUSION of: (indicate if: new medicine or new indication,
formulation, or route of administration for a medicine currently listed in the formulary)

Dear Secretarv

The (indicate name of hospital/society/organization/facility/unit/office) proposes the inclusion of

(indicate name of new medicine or new indication, formulation or route of administration for a
listed medicine ) in the Philippine National Formulary.

Please find attached two (2) hard and soft copies each of the following documents:

1. Accomplished proposal form, including all appropriate tables;

2. Copies of all cited studies and published articles;
3. Other relevant documents (e.g. clinical practice guidelines, excerpts from WHO
documents or other formularies, etc., including photocopies of such).

We understand that incomplete submissions will not be processed.

(Indicate any additional remark)

Respectfully yours,

PROPONENT'S NAME
Designation
Name of Health Facility
Indicate email address, telephone and facsimile number
 PROPOSAL FORM FOR INCLUSION

A. GENERAL INFORMATION ON PROPOSED INCLUSION

GENERIC NAME
THERAPE UTIC CLASSIFICATION
(followine the ATC classification)
FOR NEW MEDICINES:
o Indication (primary indication where
drug is expected to have the most use)
o DosaqeFormulation/Streneth
o Route of Administration
o Dos€r Frequency and Duration of
Administration
FOR LISTED MEDICINES:
tr Proposed Indication
o Current Indication

tr Proposed New Dosage Formulation

o Current Dosage Formulation

n Proposed New Route of

Administration

. Current Route of Administration

tr Proposed Dosage Strength

r Current Dosage Strength

D Proposed Net Content

o Current Net Content

tr Proposed Immediate Packaging

. Current lmmediate Packaging

B. SUMMARY OF JUSTIFICATON F'OR INCLUSION

Please tick appropriate box/es: Concise Justification Comparing New Medicine

and Listed Medicine in the PNF
n Medicine is for a condition not yet covered
in the existing formularv:
tr New medicine, proposed indication,
formulation, dosage strength, route of
administration or net content has a risk-
benefit profile better than or comparable
to a currentlv listed medicine :
tr New medicine. oronosed indication.
al

formulation, dosage strength, route of

administration or net content has a cost-
effectiveness profile better than or
comnarable to a currentlv listed medicine
tr New medicine, proposed indication,
formulation, dosage strength, route of
administration or net content will improve
comnliance.

C. DETAILS OF CLINICAL EFFICACY AND SAFBTY PROFILE

Instruction: Compare the proposed medicine for inclusion to the (1) currently listed
medicine for the same indication OR (2) standard of care, based on the given
parameters. For each item please indicate all references used.

1. Efficacy: clinical performance (preferably final patient outcomes), outcome of medical

condition
2. Safety and tolerability
3. Quality of life (if available)

D. DETAILS REQUIRED FOR COST-EFFECTIVENESS ANALYSIS

Instruction: Please gather data on the price of the proposed medicine from the
pharmaceutical company. For the comparator drug, please refer to the Drug Price
Reference Index (DPRI).

PARAMETBR NEW MEDICINE CURRENTLY

(Indicate information for OR PROPOSED LISTED REFERENCES
intended recipient)r NEW MEDICINE FOR
INDICATION/ SAME
INTENDED RECIPIENT: FORMULATION/ INDICATION IN
ROUTE OF THE PNF
ADMINISTRATION
LINIT COST OF MEDICINE
(A)

NUMBER OF DOSAGE
LINITS PERTREATMENT
COURSE (R)
DURATION OF
TREATMENT (C)
TREATMENT COST PER
PATIENT (D)
{.'*e:eruia: ,4 v F} x C

OTHER MEDICAL COSTS

ASSOCIATED WITH THE
USE OF THE DRUG:(E)
a. Implementation costs: -
cost of drug
administration (e.g..
syringe, diluent)
monitoring (.e.g, PT,
PTT), additional
diagnostic services (e.g.,
Xray, CT scan),
additional equipment
 b. Intervention costs:
(management of adverse
drug reaction treatment)

TOTAL TREATMENT COST

PER PATIENT(I')

F:clc'r:a&ia; fi + g,

EXPECTED NUMBER OF
PATIENTS WHO WILL USE
THE DRUG (G)
Possible references:
o Burden of Disease
o If no local epidemiological
study, current volume of use
in the Philippines based on
market data
ESTIMATED BUDGET
IMPACT

:n-*rcra**e: *J x C
tt. ' ,t ,

ANNEX D.

PNF FORM NO.2. LETTER OF'REOUEST AND PROPOSAL FORM FOR DELETION

LETTER OF REQUEST

Date

Honorable
Secretary
Deparlment of Health

ATTENTION:

Chief
Pharmaceutical Division
Department of Health

SUBJECT: Proposal to delete medicine listed in the formulary.

Dear Secretary

The (indicate name of hospital/society/organization/facility/unit/office) DELETION

request/s for the
of the following medicine (indicate medicine's generic name) from the Philippine National
Formulary.

Please find attached two (2) hard and soft copies each of the following documents:

1. Accomplished proposal form;

2. Copies of all cited studies and published articles;
3. Other relevant documents (e.g. clinical practice guidelines, excerpts from WHO documents
or other fbrmularies, etc., including photocopies of such).

We understand that incomplete submissions will not be processed.

(Indicate any additional remark )

Respectfully yours,

PROPONENT'S NAME
Designation
Name of Health Facility
lndicate email address, telephone and facsimile number
 t
t , ,t ,

PNF FORM NO. 2:

PROPOSAL FORM FOR DELETION OF MEDICINB FROM THE PNF

A. GENBRAL INFORMATION ON PROPOSED DELETION

GENERIC NAMB
THERAPEUTIC CLASSIFICATION
TNDICATION
DOSAGE F'ORM/STRENGTH
ROUTE OF ADMIN ISTRATION

B. SUMMARY OF JUSTIFICATON FOR DBLETION

Please tick appropriate box/es: Concise Justification and References

tr A more effective or equally effective

but less toxic medicine becomes
available:
tr lts therapeutic efficacy is found to be
unsatisfactorv:
tr Toxicity, suspected toxicity, potential
for abuse, dangerous interactions
outweigh its therapeutic value;
tr It is no longer cost-effective;
tr It is a fixed-dose combination that does
not satisfy the requirements of A.O. 96
s. 1990.

C. DETAILS OF RISK-BENEFIT ANALYSIS

lnstruction: Provide justification for the proposed deletion of a medicine from the PNF based on
the given parameters. For each item please indicate all references used.

Comparator medicine (alternative medicine

that can replace the proposed drug for
deletion)

1. Efficacy: clinical performance (preferably final patient outcomes), outcome of medical

condition
2. Safety and tolerability
3. Others
| ,, )

D. DETATLS REQUIRED FOR COST-EFFECTTVENESS ANALYSN

PROPOSED
PARAMETER COMPARATOR
MEDICINE FOR RBFERENCBS
MEDICINE
DELETION
COST PER DOSAGE UNIT
(in PhP)
NUMBER OF DOSAGE
UNITS PER UNIT COURSE

OTHER MEDICAL COSTS

ASSOCIATED WITH THE
USE OF THE DRUG: (in PhP)

a. lmplementation costs:
n cost of drug
administration (e.g.,
syringe, diluent)
tr monitoring (.e.g, PT,
PTT).
tr additionaldiagnostic
selices (e.g., Xray,
CT scan)
n additional equipment

b. Intervention costs:
tr management of
adverse drug
reaction treatment
.l ,' t

ANNEX E.

PNF FORM NO.3. LETTER OF REOUEST AND PROPOSAL FORM FOR EXEMPTION

LETTER OF REQUBST

Date

Honorable
Secretary
Department of Health

ATTENTION:

Chief
Pharmaceutical Division
Department of Health

SUBJECT: Proposal to EXEMPT the medicine from E.O. No.49 s. 1993 that states that only
medicines listed in the PNF shall be procured by government entities.

Dear Secretarv

The (indicate name of DOH Unit/other parties) is requesting for the EXBMPTION of the
following medicine (indicate generic and brand name) from E.O. No. 49 s.1993.

Please find attached two (2) hard and soft copies each of the following documents:

1. Accomplished proposal form, including all appropriate tables;

2. Copies of all cited studies and published articles;
3. Other relevant documents (e.g. clinical practice guidelines, excerpts from WHO
documents or other formularies, etc., including photocopies of such).

We understand thatjggqlqplglg submissions will not be processed.

(Indicate any additional remark)

Respectfully yours,

PROPONENTOS NAME
Chair, Pharmacy and Therapeutics Committee
Name of Health Facility
Indicate email address, telephone and facsimile number
PNF FORM NO. 3:

PROPOSAL FORM FOR EXEMPTION FROM E.O. No.49 s. 1993

A. GENERAL INFORMATION ON PROPOSED EXEMPTION:

GENERIC NAMB
BRAND NAME (if any)

THERAPEUTIC CLASSIFICATION
INDICATION
DOSAGE FORM/ STRENGTH
ROUTE OF' ADMINISTRATION

DOSE, FREQUENCY AND

DURATION OF ADMINISTRATION
MANUFACTURER
IMPORTER/ TRADER
DISTRIBUTOR

B. SUMMARY OF' JUSTIFICATION FOR EXEMPTION:

The proposed medicine should fulfill ALL of

the followins criteria: JUSTIFICATION AND REFERENCES
tr It has proven safety III clinical trial
Please attach at least a Phase

tr It has proven efficacy

tr There is no other medicine listed in the
formulary which is indicated for the
same condition.
tr It will be used for an urgent health 1. Why is the situation urgent?
situation defined as immediatelY 2. What is the ranking of the disease relative
requiring treatment to prevent death, to other disease conditions in the health
permanent disability or major or facility?
permanent organ dysfunction. (specify 3. What is the potential for spread of the
situation); disease?
C. DETAILS REQUIRED FOR COST-EFFECTIVENESS ANALYSIS

Instruction: Please gather data on the price of the proposed medicine from the pharmaceutical
company. For the comparator drug, please refer to the Drug Price Reference Index (DPRI).

PARAMETER NEW MEDICINE CURRENTLY

(Indicate information for OR PROPOSED LISTED MEDICINE REF'ERENCES
_. i
Intended recrprent) NEW INDICATION/ FOR SAME
FORMULATION/ INDICATION IN
INTENDED RECIPIENT: ROUTE OF THE PNF
ADMINISTRATION

UNIT COST OF MEDICINE ('\)

NUMBER OF DOSAGE UNITS

PER TREATMENT COURSE ('')
DURATION OF TREATMENT
(()
TREATMENT COST PER
PATIENT (D)
ils:"::-lxl*;,AxBaC

OTHER MEDICAL COSTS

ASSOCIATED WITH THE USE
OF THE DRUG:(L)
a. Implementation costs: -
cost of drug administration
(e.g., syringe, diluent)
monitoring (.e.g, PT, PTT),
additional diagnostic
selices (e.g., Xray, CT
scan). additional equipment

b. Intenrention costs:
(management of adverse
drug reaction treatment)

TOTAL TREATMENT COST

PER PATIENT(F)

F-ormaala: {} t E
EXPECTED NUMBER OF
PATIENTS WHO WILL USE
THE DRUG (C)
Possible references:
o Burden of Disease
o lf no local epidemiological
study, current volume of use
in the Philippines based on
market data
ESTIMATED BUDGET
IMPACT

F-ox.e*acela: F' xC
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