Conference Proceeding

A Formulary Management Group Consensus

Laila Carolina Abu Esba ,1,2,3 Hind Almodaimegh,1,2,3 Mansoor Ahmed Khan,3,4,5 Consuela Cheriece Yousef,3,6,7
Hana Al-Abdulkarim,8,9 Ali A. Al Aklabi,2,3,10 Mohammed Al Harbi2,3,11
1
Pharmaceutical Care Department, King Abdulaziz Medical City, Ministry of National Guard, Health Affairs,

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Jeddah, Saudi Arabia
2
King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia
3
King Abdullah International Medical Research Centre, Riyadh, Kingdom of Saudi Arabia
4
Pharmaceutical Care Department, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia
5
King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia
6
Pharmaceutical Care Department, Ministry of National Guard Health Affairs, Dammam, Saudi Arabia
7
King Saud bin Abdulaziz University for Health Sciences, Al Ahsa, Saudi Arabia
8
Doctoral School of Applied Informatics and Applied Mathematics, Óbuda University, Budapest, Hungary
9
Drug Policy and Economic Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
10
Internal Medicine Division, Department of Medicine, King Abdulaziz Medical City, Ministry of National Guard
Health Affairs, Riyadh, Saudi Arabia
11
Department of Anesthesia, King Abdulaziz Medical City, Ministry of National Guard, Riyadh, Saudi Arabia

Address correspondence to Laila Carolina Abu Esba ([email protected]).

Source of Support: None. Conflict of Interest: None.
Submitted: Sep 12, 2023; First Revision Received: Nov 20, 2023; Accepted: Jan 4, 2024
Abu Esba LC, Almodaimegh H, Ahmed Khan M, et al. A formulary management group consensus. Glob J Qual Saf Healthc. 2024; 7:
XXX–XXX. DOI: 10.36401/JQSH-23-26.
This work is published under a CC-BY-NC-ND 4.0 International License.

INTRODUCTION developed a set of principles. These principles serve as the

foundation for establishing essential components integral
In 2014, the very first event that marked a significant to a robust formulary system.[6]
milestone in the field of formulary management took Despite this, there is a notable lack of standardization
place in Riyadh, Saudi Arabia. The conference, organized and agreement among large healthcare systems globally
by King Faisal Specialist Hospital, brought together health- regarding the essential elements that need to be addressed
care experts and professionals from various national and within a formulary system. The American Society of Health-
international institutions. It was a momentous occasion, System Pharmacists, in its 2021 guidelines, has outlined
one that provided a platform for the exchange of invalu- some of the most important standards in formulary man-
able insights and sparked the interest of many in the field agement.[6] However, it is imperative not only to establish
of formulary management.[1] agreed-on practice standards but also to highlight emerg-
Since that historic gathering, no similar conference was ing and trending issues that formulary management sys-
organized, despite the rapid pace of evolvement of drug tems may encounter. These challenges can be regional,
discovery and the need for experts in the field of formu- local, or global in nature, affecting healthcare systems in
lary management. The need for continued dialogue, col- diverse ways. Collaborative efforts in sharing experiences
laboration, and knowledge sharing in this ever-changing and approaches are essential for institutions in managing
field has never been more apparent, and there has been a their formulary systems.
noticeable lack of research and standardization of prac- In this paper, we attempted to encapsulate some of the
tices.[2,3] Fortunately, as serendipity would have it, the for- most pivotal and enlightening thoughts shared by the
mulary team at the Ministry of National Guard Health speakers and attendees at that momentous conference.
Affairs (MNGHA) was granted the privilege of leading this Their insights, expertise, and dedication to advancing the
endeavor forward and was honored to organize the sec- field of formulary management have left an indelible mark
ond formulary management conference. on our collective understanding of this critical domain.
Several organizations have developed tailored policies,
outlining their formulary management and development METHODS
processes, some of which include unique elements tailored
to their specific population and services they provide.[4,5] Participants
Notably, in the year 2000, a collaborative working group Participants for the consensus-building process were
in the United States, consisting of various stakeholders, based on their expertise and experience in the field of

Global Journal on Quality and Safety in Healthcare 2024 | Volume 7 | Issue 2 | 1

jqsh.org
2 Abu Esba et al: Formulary management consensus

formulary management. A diverse group of professionals, incorporating their input, the final consensus was compiled
including physicians, pharmacists, and policymakers, was and is outlined as follows.
chosen to ensure a comprehensive perspective. A total of
eight panel members were included, all of whom had RESULTS
served an average of 8–10 years as pharmacy and thera-
peutics committee members and were involved in a vari- There are key features, concepts, and practices that a
ety of responsibilities related to formulary management. successful formulary system needs to adopt. In the follow-

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ing we highlight the themes that emerged during the
Preparation conference, where a consensus was reached regarding
The expert panel met regularly before the formulary their importance.
management conference held in Riyadh, Saudi Arabia,
to develop the agenda topics, selection of the expert The Role of Formulary Management in
speakers, and pressing issues for discussion. Although the Value-Based Healthcare
participants prepared during the conference preparatory Formulary management is a critical component of
phase, many provided feedback to the panel, which stim- the healthcare system. In our ever-changing landscape,
ulated important ideas to bring forth. ensuring the safe, effective, and cost-efficient use of medi-
cations is paramount. Value in healthcare is described as
Consensus-Building Process the measured improvement in a patient’s health out-
The consensus-building process took place during a comes for the cost of achieving that improvement.[7] For-
2-day in-person meeting at the conference venue where mulary management is pivotal in embracing value-based
topics were discussed, and constructive discussions took healthcare, guaranteeing patient access to the most effec-
place. The conference was divided into several sessions, tive and cost-efficient medications based on measurable
each focused on a specific aspect of formulary management, health outcomes. However, the concept of value-based
including committee formation, drug evaluation process, healthcare within formulary management faces challenges,
drug safety considerations, post-approval issues, regulatory such as defining value, measuring therapeutic outcomes,
and logistic factors, and the adoption of biosimilars and and incorporating patient-centered care into the decision-
[8]
generics. Each session followed a structured format: making processes.
The role of a formulary manager extends far beyond a
1. Presentation by an expert: A subject matter job; it is a calling demanding dedication, passion, and
expert presented the available evidence, research commitment to improving the lives of patients. It requires
findings, and best practices related to the specific ongoing learning and adaptation to new technologies,
topic under discussion. Each session was followed by medications, and practices. It calls for a profound under-
questions from the audience. standing of the healthcare system and collaborative work
2. Panel discussion: Participants engaged in open with healthcare professionals.
and facilitated discussions regarding the presented Every drug selected for the formulary has the potential
topics, with attendees from various institutions and to lead to life-changing outcomes for patients, and each
experts in the field. time cost savings are made in the selection process, there
3. Consensus building: The facilitator guided the are opportunities to invest in other technologies and ser-
participants to propose specific statements that rep- vices that enhance patient care. “Value,” as envisioned, is
resented the consensus view on the topic. about the outcomes that matter most to patients relative
4. Documentation: Detailed notes and minutes of to the cost of achieving them. Yet, the growing burden in
each session were recorded, including the key points pharmaceutical spending and its impact on all healthcare
of discussion and areas of consensus. All panel mem- systems challenges this equation. It is recognized that we
bers reviewed the key points and provided feed- are not living in a cost crisis in healthcare but rather we
back if they had any amendments. The final draft are living in a value crisis in healthcare.
was circulated by email and approved by all panel Incorporating value-based assessment tools developed
members. by various associations within the drug decision processes
has been described. Tools such as the National Compre-
Data Analysis hensive Cancer Network (NCCN’s Evidence Blocks) and
Following the consensus meeting, the recorded notes, the European Society for Medical Oncology-Magnitude of
recommendations, and minutes were analyzed to compile Clinical Benefit Scale can be useful for formulary decision-
a comprehensive report summarizing the consensus reached makers.[9,10] There have also been recent efforts shared on
on each topic. This report served as the basis for the devel- how to apply a multi-tier value-based formulary within a
opment of the final consensus document. health plans, and interest in such approaches is growing
The draft consensus document was circulated to all and supported.[11,12]
participants for review and feedback. Participants had The emergence of innovative contracting opportunities
the opportunity to suggest revisions or clarifications. After commonly known as managed entry agreements and their
 Conference Proceeding 3

subtypes, such as outcome-based agreements, in which a Committee members should voluntarily disclose any con-
specific efficacy outcome may be a rule for reimbursement, flicts of interest they may have before meetings, and chairs
mandates a better understanding of how to implement must play a pivotal role in recognizing and managing these
them and developing policies related to their execution. conflicts. Having clear, written policies and procedures
Formulary managers need to build awareness in negotiat- for conflict identification and management is essen-
ing skills, how to develop terms of such contracts, and tial. Some organizations choose to use multilayered com-
methods of implementing them, which can be very chal- mittees to enhance decision-making and mitigate conflict

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lenging; however, many workshops and learning opportu- of interest.[22]
nities are available.[13,14] Physicians within these committees serve a vital role in
advocating for practical and convenience-related aspects
Formulary Committee Formation of therapies, aligning with the principles of evidence-
Developing a value-based formulary hinges on several based practice that stress the importance of assessing the
key factors. First and foremost is the establishment of an applicability of the evidence to unique patient popula-
effective formulary committee, commonly referred to as the tions. In addition, physicians must ensure that research
pharmacy and therapeutics committee (P&T). This commit- findings are representative and beneficial to the patients
tee plays a central role in ensuring the alignment of the served by the committee and call to localize clinical trials
formulary with value-based principles; institutions have to reflect the diversity of their population.
recognized the importance of coordinating the processes
of these committees and organizing the streamlining of The Drug Evaluation Process
its responsibilities.[15–17] In addition, with the complex- The drug evaluation process is a crucial aspect of the
ity of new emerging extremely expensive therapies, large formulary decision-making process, aiming to ensure that
institutions have examined developing subcommittees all members have the resources available to make an
with more specialized members and focused tasks.[18] informed decision. The transition from evidence-based
Efficiency in formulary management development is medicine to value-based medicine emphasizes the impor-
contingent on the formulation and leadership of an adept tance of not only considering clinical evidence but also
team. This entails selecting individuals with the requisite the overall value that a drug provides to patients and health-
expertise, fostering collaboration, and providing clear care systems. Here are some key points and considerations
guidance on the committee’s objectives and decision- in this process:
making processes. Formulating comprehensive evaluations
To drive continuous improvement, benchmarking Evaluators must develop a systematic and comprehen-
against the practices and experiences of similar commit- sive approach to evaluating drugs. This includes evaluating
tees is invaluable. In addition, it is crucial to define the clinical trial data, real-world evidence, economic analyses,
role of each committee member within the process. In and patient-reported outcomes. A well-rounded assessment
essence, developing a value-based formulary necessi- provides a more holistic view of a drug’s value.
tates a well-structured committee, proficient leadership,
insights from best practices, and a defined role for each Literature search and data navigation
member in the decision-making journey. The first step in drug evaluation is a comprehensive
Efforts have been made to outline standards and practices literature search. Drug evaluators should be well-versed
of the P&T committee, describing the structure and func- in using advanced search tools and strategies to gather
tions of such committee.[6,19] The sophistication of these the best available evidence.
committees can vary widely based on the size of the institu- Interpreting statistics
tion and population it serves. The MNGHA’s formulary Understanding statistics is imperative for drug evalua-
committee described some of the features of its process and tors. They should be able to identify the strengths and limi-
structure in previous publications, which was also shared in tations of different study designs and statistical methods. It
detail during the conference.[20,21] is also important to recognize that statistical significance
Challenges faced by the committee, as described by does not always equate to clinical significance.
many members, include limited time allocated for phar-
macists to evaluate a drug and constraints on the time Comparative trials
allocated for P&T members to review the literature related When evaluating comparative trials, there must be a
critical assessment of the choice of comparators. Vigi-
to a drug discussion. In addition, there is a need for greater
lance is required to recognize irrelevant comparators or
higher management support in providing extra working
disadvantaged ones.
slots and/or compensation for overtime. Addressing these
challenges is crucial for ensuring the committee can make Composite endpoints
well-informed and timely decisions. Caution is needed when dealing with composite end-
Addressing conflicts of interest within drug formulary points in clinical trials. If the significance of a trial is pri-
committees is critical for maintaining transparency and marily driven by a less valuable component to patients,
safeguarding the best interests of patients and institutions. it may not reflect the true clinical benefit of the drug. In
4 Abu Esba et al: Formulary management consensus

addition, the choice of each individual component of a drug regulatory body to address specific safety concerns
composite endpoint should be sound, and results of associated with certain drugs. For example, the Saudi Food
each component examined separately to conclude the and Drug Authority (SFDA) developed the regulatory frame-
overall benefit. work known as the Risk Minimization Measures (RMM).
This framework closely resembles the U.S. Food and Drug
Surrogate endpoints
Administration Risk Evaluation and Mitigation Strategy
Recognizing that surrogate endpoints, although often
program and the European Medicines Agency’s risk-man-

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used in clinical research, do not always translate into
agement plan. The purpose of RMMs is to introduce inter-
meaningful clinical value. Evaluators should consider
ventions aimed at preventing or mitigating the occurrence
whether the surrogate endpoint correlates with impor-
of adverse reactions associated with exposure to a medicine
tant patient outcomes. This may require examining
or to reduce their severity or impact on the patient. Com-
basic evidence related to disease pathophysiology and
ponents of the SFDA RMM may include patient cards,
quality of evidence linking the surrogate marker to an
patient guides, healthcare provider guides or checklists,
expected benefit.
and Dear Healthcare Provider letters. Implementation of
Common statistical misconceptions these measures requires collaboration between regulatory
Understanding common statistical misconceptions is agencies, the pharmaceutical industry, healthcare pro-
vital for drug evaluators. P values should not be used in viders, and patients. There is also a growing emphasis on
isolation to determine clinical importance, and they do digitalizing the RMM components to facilitate access to
not convey the size of the effect. Relative risk can exagger- the safety information.[24,25]
ate findings, and absolute risks provide a clearer picture.
Post-marketing surveillance
Moreover, it’s crucial to differentiate between correlation
Because randomized controlled trials are not powered
and causation.
to identify all safety concerns, post-marketing surveillance
The drug evaluation is a multifaceted process that
can help detect safety issues that have not been recognized
requires a combination of clinical expertise, statistical acu-
and that can shift the benefit versus risk ratio. The formu-
men, and a patient-centered approach. As healthcare sys-
lary committee has a significant role in monitoring and
tems are transforming to value-based care, drug evaluators
addressing new safety concerns and considering whether
play an important role in ensuring that the right drugs are
adjustments to formulary inclusion or utilization criteria
selected for formularies, taking into account not only
are necessary.[26]
their clinical efficacy but also their overall value. In addi-
tion, untraditional aspects of a drug evaluation, such as Medication use evaluations (MUEs)
the effect a pharmaceutical may have on the environ- MUEs can be a valuable tool for monitoring drug safety.
ment, indicates the multiple issues the committees may These evaluations involve a systematic review of the med-
need to address and incorporate into their evaluation.[23] ication’s safety and effectiveness, and can identify local
safety issues (e.g., higher risk groups based on genetic or
Drug Safety from a Formulary Perspective ethnic background, inappropriate practices resulting in
Drug safety is a vital aspect of formulary management, safety concerns, or cultural aspects influencing risk vs ben-
and it involves multiple stages, from pre-market assess- efit of a drug). The committee can help identify potential
ment to post-marketing surveillance. During the evalua- issues and inform decision-making.
tion of drugs for formulary inclusion, limited information
Managed entry agreements (MEAs) and risk sharing
is often available about their safety profiles, and commit-
agreements (RSAs)
tees might not discuss the safety profile thoroughly. There
When there is uncertainty surrounding the risk-benefit
is a need for greater standardization and guidance from
balance of a drug, the formulary committee can consider
committees concerning the management of risks associ-
incorporating specific drug safety concerns into MEAs or
ated with drugs at all stages.[2] Here are some key consider-
RSAs. These agreements can help to manage the financial
ations for evaluating and ensuring drug safety within a
risk associated with uncertain outcomes. [27]
formulary system.
Drug safety assessment upon formulary addition Formulary Post-Approval Process
consideration The formulary post-approval processes within formu-
Before a drug is approved and added to a formulary, thor- lary management are just as important as the initial
ough evaluation of the safety profile and assessing the safety evaluation. These processes ensure the continuity of care
data from available studies should be conducted. This within an institution. Here are some key aspects of post-
includes reviewing data from clinical trials and real-world approval formulary management.
studies and assessing the risk-benefit ratio.
Monitoring utilization
Risk mitigation strategies Continuously monitoring the use of drugs on the for-
The drug evaluating committee should be aware of mulary is essential to identify trends and to ensure formu-
any risk mitigation measures developed by the country’s lary committee members are informed of changes. This
 Conference Proceeding 5

includes monitoring stocks, estimating initial stocks Institutional considerations

required, observing prescribing trends, and forecasting Each institution must assess the feasibility and signifi-
changes in the utilization of drugs being replaced.[28] cance of interchangeability and switching within their
specific healthcare setting. Understanding how product
Handling appeals and restrictions
Handling appeals from healthcare providers and the excipients can impact patient outcomes highlights also
industry, as well as implementing restrictions based on the need for a holistic approach to evaluation.

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the committee’s decisions, is an ongoing process. Thor- Appropriateness of extrapolation
ough discussions should take place regarding the justifi- Deciding whether to extrapolate data from one indi-
cations behind restriction decisions, whether rooted in cation to another should be based on robust scientific
high costs, safety concerns, or abuse potential. Clear evidence and clinical judgment. In some cases, main-
methods for implementing these restrictions should taining both the reference and biosimilar products may
also be decided on.[29] be necessary to ensure adequate treatment options for
Leveraging automation specific patients (e.g., pediatrics).
Automation tools can streamline formulary decisions, Manufacturer’s history
including automated prior authorization systems, elec- Reviewing the track record of the biosimilar manufac-
tronic prescribing information, enforcement of restric- turer and history of recalls and shortages are key in ensur-
tions, building customized alerts and system monitoring ing a reliable and consistent supply chain.
tools, and utilization management tools that help ensure
compliance with formulary policies.[30] Pharmacoeconomic impact
Assessing the impact of biosimilar adoption is funda-
Procurement issues mental to justify the switch. It involves analyzing the
Collaborating closely with procurement teams is cru- potential savings and overall financial implications for
cial to ensure the availability of drugs on the formulary.
the institution.
Formulary committees need to communicate with pro-
curement experts to address supply chain issues, manage Stakeholder engagement
drug shortages, and ensure medications are consistently Engaging various stakeholders, including healthcare
available while minimizing wastage. providers, and patients, is essential to ensure a smooth
transition to biosimilars or generics. Open communica-
Drug regulations and compliance
tion and addressing concerns are critical to gain support
Staying up-to-date with drug regulations and compli-
and trust.
ance requirements is essential. For example, in Saudi
Arabia, adherence to multiple bodies is expected within Pharmacovigilance requirements
the procurement process, such as Expenditure & Project Implementing robust pharmacovigilance measures is
Efficiency Authority, the Local Content and Govern- necessary to monitor the safety and efficacy of biosimi-
ment Procurement Authority, and the National Unified lars or generics post-switch.
Procurement Company. [31–33]
Post-switching education
Comprehensive education and support to healthcare
Biosimilars and Generics
Optimizing pharmaceutical spending through strate- professionals and patients is vital. It helps them understand
gic implementation of biosimilars and generics is a key the reasons for the switch, manage expectations, and use
role in formulary management.[34] Exploring the oppor- the new products effectively. Various means of education
tunities and expectations associated with biosimilar/ can be approached such as in-services or emails.
generic switching at an institutional level is therefore Real-world evidence studies in extrapolated
vital. Biosimilar switching provides a key opportunity indications of biosimilars
in cost savings; however, issues that institutions should Generating real-world studies of biosimilars in the extrap-
consider when contemplating a switch to a biosimilar olated indication is encouraged to improve the confi-
include the following. [35–38] dence and trust of health care professionals and patients
Thorough product evaluation on biosimilars.
Rigorous evaluation of biosimilar products is essential.
This involves reviewing regulatory approval, examining evi- Pharmacoeconomics and Defining Value
dence on efficacy and safety from approval trials, switching Pharmacoeconomics and defining value are crucial
studies, and post-marketing experiences. In addition, fac- aspects of formulary management. Policymaking, local
tors such as dosage form differences and patient conve- industry development, health technology assessment
nience that may vary between the reference and biosimilar (HTA), and cost-effectiveness assessments all play a role
products should be taken into account. Some large health- in defining value and influencing the decisions made
care institutions may consider forming a biosimilar regarding which pharmaceuticals to include in the for-
subcommittee to streamline the work.[38–41] mulary. These factors are integral to ensuring access to
6 Abu Esba et al: Formulary management consensus

effective and cost-efficient healthcare interventions for herein include the importance of defining value, the role
the population. of effective formulary committees, and transition from
The evolving healthcare landscape in Saudi Arabia, evidence-based to value-based medicine.
driven by the Saudi Vision 2030 goals,[42] has profound The rapidly evolving healthcare landscape has under-
implications for formulary management. Here are some scored the importance of formulary management in ensur-
of the key points that shape this landscape. ing access to cost-effective and high-quality medications.
Challenges such as enhancing the drug evaluation process,

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PESTEL indicators
Improvement in Saudi Arabia’s ranking across PESTEL drug safety, conflict of interest, regulatory and logistic con-
indicators signifies the nation’s commitment to progress in siderations, and the adoption of biosimilars and generics
various dimensions, including politics, economics, society, are among the specific fields that formulary commit-
technology, environment, and legal aspects. These improve- tee members need to continue working in to improve
ments can influence healthcare policies and investments, patient outcomes.
affecting formulary management decisions.
Acknowledgment
Regulatory updates
Regulatory updates focusing on privatization, patient- The authors thank all of the speakers who contributed their
centric care, and digital transformation are shaping the valuable time and expertise at the formulary management
healthcare landscape in Saudi Arabia. These changes may conference: Ahmad Jazeri, Ahmed Al Jedai, Esraa Al
impact the availability of healthcare services, technolo- Tawil, Ghada Mardawi, Hussain Al Omar, Johara Al
gies, and pharmaceuticals, thereby influencing formu- Koraishi, Mashael Alaskar, Mathew Grissinger, Mohammed
lary management strategies. Abdelshafy, Murtada Haleem, Sakra Balhareth, Samar Al
Maximizing local content Moaiseib, Tariq Al Hawassi, Waad Al Ghamdi, Wafaa Al
Efforts to maximize local content in healthcare, includ- Suwairi, Yazed Al Ruthia.
ing pharmaceuticals, reflect a move toward self-reliance
and sustainability. This can have implications for drug References
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