BMJ Open Developing a national framework for health technology assessment in Iran: a mixed-methods Delphi consensus study
Meysam Behzadifar,1 Ahad Bakhtiari,2 Saeed Shahabi,3 Samad Azari,4
Aidin Aryankhesal,5 Masoud Behzadifar Β1

To cite: Behzadifar Μ, Bakhtiari A, Shahabi S, et al. Developing a national framework for health technology assessment in Iran: a mixed-methods Delphi consensus study. BMJ Open 2025;15:e100662. doi:10.1136/ bmjopen-2025-100662
► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/1O.1136/ bmjopen-2025-100662).
Received 13 February 2025 Accepted 24 October 2025

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© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
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Correspondence to
Dr Masoud Behzadifar;
masoudbehzadifar@gmail.com

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ABSTRACT
Objectives To develop a context-specific health technology assessment (HTA) framework tailored to the healthcare needs and system of Iran, to improve evidence-based decision-making, optimise resource allocation and support progress towards universal health coverage.
Design A mixed-methods Delphi consensus study conducted using a three-phase, sequential approach: document review, qualitative focus group discussions and Delphi consensus rounds. The study reporting follows the Accurate Consensus Reporting Document guideline to ensure transparent reporting of consensus methods.
Setting A national-level study conducted in Iran’s healthcare system between January 2023 and March 2024, including perspectives from public and academic institutions, policy bodies and patient organisations. Participants The study involved 18 purposively selected stakeholders in three focus group discussions, including policymakers, healthcare professionals, researchers and patient representatives. Subsequently, 20 HTA experts participated in three iterative Delphi rounds to refine and reach consensus on the framework components. Outcome measures Identification of core components and operational steps required to develop and implement a comprehensive HTA framework in Iran.
Results The final HTA framework includes nine core components: (1) establishing a national HTA body; (2) engaging stakeholders; (3) building capacity through training and research; (4) developing standard HTA methodologies; (5) implementing prioritisation and evaluation processes; (6) ensuring sustainable funding; (7) enhancing transparency and accountability; (8) promoting continuous improvement and (9) fostering innovation. Detailed operational steps and micro-activities were developed for each component. The framework achieved an 84% consensus among Delphi panellists, indicating strong agreement on its content and applicability. Conclusions This tailored HTA framework provides a structured roadmap to institutionalise evidencebased decision-making in Iran’s healthcare system. Its implementation can strengthen the efficiency, equity and sustainability of healthcare planning and policy. Pilot testing is recommended to assess feasibility and scalability, with potential to serve as a model for other low- income and middle-income countries.
STRENGTHS AND LIMITATIONS OF THIS STUDY
=> A rigorous three-phase methodology was used, combining a comprehensive literature review, focus groups and Delphi consensus.
=> Stakeholders from diverse backgrounds were purposively selected to ensure broad representation across policymaking, clinical, academic and patient domains.
=> The use of qualitative content analysis ensured systematic identification and synthesis of themes.
= > Although designed for Iran, the framework may have relevance for other low- and middle-income countries with contextual adaptation.
=> The study did not include pilot testing of the framework, which should be addressed in future research to evaluate real-world applicability.
INTRODUCTION
Health technology assessment (HTA) is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient and high-quality health system.1 By supporting evidence-based decision-making, HTA helps ensure that healthcare interventions are safe, effective and cost-efficient, particularly in settings where resources are constrained.2
In many low-income and middle-income countries (LMICs), the integration of HTA into national health policy remains fragmented and inconsistent.3 4 Iran is one such setting, where HTA-related activities have been introduced in both academic and policy contexts but remain limited in scope and coordination.5 The country’s healthcare system operates under a mixed model, combining a dominant public sector with a growing private sector involved in both service provision and innovation.6 The Ministry of Health and Medical Education (MoHME) is responsible for governance, financing and public service delivery, while universities and

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research institutions play a key role in health research and innovation.7 The private sector, although less regulated, contributes significantly to healthcare delivery and increasingly to the development and adoption of new health technologies.8
Despite these initiatives, Iran currently lacks a formal and institutionalised HTA structure to guide the systematic evaluation and prioritisation of health technologies.9 The absence of structured processes contributes to inefficiencies, inconsistent decision-making and inequitable access to high-value care.10
A tailored HTA framework that reflects Iran’s epidemiological profile, resource limitations and sociopolitical context is essential for improving policy decisions and advancing healtli system goals. By incorporating cost-effectiveness, safety and social implications into policy deliberations, HTA can serve as a strategic tool to rationalise expenditures, enhance transparency and improve healtli outcomes. This mixed-method consensus study aims to introduce a customised HTA framework for Iran, addressing existing system-level gaps and contextual needs. It is intended to support policymakers, healtli system managers and stakeholders in making informed, equitable and sustainable decisions about healtli technology adoption and use. Due to the diversity of content identified in the earlier phases of our study, a consensus exercise using the Delphi technique was conducted to refine the final framework into a clear and concise output tailored for the primary audience of this research—health system managers and policymakers across Iran and other nations with similar contexts.
METHODS
This study, registered witli the Iranian National Institute for Medical Researcli Development in 2022 (No.: 4021378), employed mixed-methods consensus techniques conducted between January 2023 and March 2024. The ACCORD (Accurate Consensus Reporting Document) guideline was used for the transparent reporting of consensus methods in biomedicine. All elements of the Delphi process, including study objectives, participant selection, round structure, consensus criteria and feedback procedures, are reported according to the ACCORD checklist. A completed checklist indicating the page and line references for each reporting item is provided in online supplemental appendix 1.
Framework development approach
The methodological structure used in this study was informed by established practices in framework development and consensus-building within health policy research. Specifically, we drew on a hybrid model combining literature review, qualitative stakeholder engagement and the Delphi technique, an approach commonly used in HTA and health systems research, to ensure comprehensive, context-specific and consensusbased outputs. This multiphase structure was designed to ensure rigour, stakeholder inclusiveness and alignment witli both international best practices and Iran’s specific healtli system context. For clarity, the framework development approach is described under three main phases (Review, Stakeholder Engagement and Delphi Consensus), each with clearly defined subsections to improve readability.
Phase 1: comprehensive review
This phase consisted of two subphases:
Subphase 1: international review
A comprehensive review was conducted to identify international frameworks, standards, methodologies and elements influencing HTA development in other countries. This review included an in-depth examination of scientific articles, organisational reports and official guidelines, alongside recommendations from the WHO. Relevant studies were retrieved using targeted searches in databases such as PubMed, Embase, Scopus and ISI Web of Science. The search strategy included keywords such as "HTA framework,” “health technology assessment,” "policy development,” “HTA model,” and “HTA institutionalization,” combined witli country names and regional terms (eg, “Europe,” “Asia,” “Africa,” “LMICs”). The search was designed to capture a diverse and representative set of frameworks from multiple regions and income levels, including examples from countries sudi as the UK, Canada, Thailand, Brazil and South Africa. The search range extended up to December 2024. Inclusion criteria focused on documents that addressed the structure, components, implementation and governance of HTA systems. Documents not directly related to HTA frameworks (eg, clinical guidelines, cost-effectiveness analyses unrelated to policy development) were excluded. Only studies published in English or Persian were considered. Two independent reviewers screened the titles and abstracts, followed by full-text reviews for eligible documents. Discrepancies were resolved through discussion. Data extraction was guided by a structured form capturing key elements sucli as governance structures, methodological standards, stakeholder involvement, funding mechanisms and implementation strategies.
Subphase 2: national review
All available documents, guidelines, regulations and articles published in Iran related to HTA were reviewed. Additionally, websites of the MoHME, the government, the parliament and the Food and Drug Administration were examined. Key items necessary for developing HTA in Iran were identified and extracted through a synthesis of findings from both subphases.
Phase 2: focus group discussions
To identify HTA framework items specific to national conditions, the focus group method was employed. This approach incorporated perspectives from key stakeholders in HTA, offering deeper insights into their experiences and opinions. This component of the study
was qualitative in design, with participants purposively selected based on the following inclusion criteria:
►		Experience in HTA or familiarity with health policy-making.
►		Willingness to participate in the study.
Three virtual focus group sessions were conducted with a total of 18 participants. The participants were divided into three sessions based on stakeholder roles as follows:
1. Session 1: Health policymakers and public healtli professionals.
2.		Session 2: Clinical professionals, including physicians and pharmacists, along with researchers and insurance experts.
3.		Session 3: Patient representatives and civil society stakeholders.
Each session lasted approximately 85 min and was attended by six participants. The distribution was preplanned to ensure balanced representation across categories, and actual attendance matched the intended structure. Sessions were moderated by a trained facilitator witli expertise in qualitative methods. At the start of each session, the study’s purpose and significance were explained, and informed consent was obtained.
The focus group discussions were guided by a semistructured interview guide (pretested beforehand), which included the following sample questions:
►		What factors should be considered in designing the HTA framework in Iran?
►		What challenges currently exist in developing and implementing HTA in the country?
►		What roles should various stakeholders (eg, policymakers, patients, private-sector actors) play in the HTA process?
►		How can stakeholder engagement in tlie assessment process be enhanced?
Sessions were audio-recorded, and field notes were taken by the facilitator. Collected data included direct quotes and observations.
Data analysis
A content analysis method was employed to identify primary and secondary themes. The process included:
1. Familiarisation with data: Transcribing audio files and repeatedly reviewing transcripts.
2.		Initial coding: Identifying relevant text segments using initial codes.
3.		Categorisation: Organising codes into conceptual categories.
4.		Theme development: Reviewing categories to identify final themes.
To ensure reliability and validity, two independent researchers coded the data, resolving disagreements through: discussion and consensus. Preliminary findings were shared with participants for feedback, and investigator triangulation was used during data analysis. Themes such as Έquity and Inclusiveness in Decision-Making’ were explicitly identified and subsequently integrated into the Delphi process to ensure that these values were reflected in the final framework.
Phase 3: Delphi consensus process
The Delphi method involved three iterative rounds witli structured feedback and refinements to achieve consensus on the HTA framework.
► Round 1: In round 1, the initial Delphi questionnaire was developed based on findings from the literature review and focus group discussions (phases 1 and 2). It consisted of botli open-ended and closed-ended questions designed to evaluate the relevance, clarity and comprehensiveness of the proposed framework components. Twenty experts received the questionnaire via email, and all responded (response rate: 100%). Participants rated each item on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and provided qualitative comments to justify their responses. Items that achieved >70% agreement were retained for the next phase, while those witli less than 50% agreement were excluded. Statements witli moderate agreement (50%-69%) were revised and carried forward to round 2 for further consideration. This initial round aimed to gather diverse expert opinions and identify areas requiring clarification or modification.
► Round 2: Based on the results of round 1, the questionnaire was revised to address items with moderate agreement (50%-69%) and integrate qualitative feedback from participants. Revised statements were redistributed to the same 20 experts for re-evaluation, witli all experts responding (response rate: 100%). During this round, participants received anonymised summary statistics from round 1, including median scores and key comments, to guide their reassessment. Items maintaining or exceeding 70% agreement were considered accepted, while those below 50% were removed. This round promoted convergence of expert opinions and refinement of framework components requiring further clarity.
► Round 3: In the final round, only items that had not yet reached the 70% consensus threshold were re-evaluated. Experts reviewed these items witli the benefit of consolidated group feedback, and 75% agreement was set as the final threshold for inclusion. All 20 experts completed this round (response rate: 100%), and an overall consensus level of 84% was achieved across all framework components. This final round confirmed strong expert agreement on the validity, relevance and applicability of the proposed HTA framework. Following the Delphi process, the finalised framework was independently reviewed and validated by five additional HTA and policy experts not involved in the Delphi rounds.

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All Delphi rounds were directed by a senior HTA researcher (Masoud Behzadifar) who had expertise in both HTA and consensus-reaching techniques. The panellists included 20 HTA experts from various
universities, research centres and policy institutions across Iran. The inclusion criteria for panellists were: (1) at least 5 years of experience in HTA, health policy or healtli economics; (2) familiarity with national healthcare decision-making processes and (3) willingness to participate in multiple Delphi rounds. A total of 25 experts were initially contacted via email (n=25), and two reminder emails were sent to maximise participation. Those who declined participation were asked to nominate alternative qualified experts. Ultimately, 20 experts consented and participated in all three Delphi rounds. All Delphi rounds were conducted between August 2023 and March 2024.
Framework validation
To further ensure the validity and reliability of the framework, it was reviewed by five additional experts who had not participated in the Delphi rounds. These experts were selected based on their national-level expertise in HTA, policy analysis or healtli economics and were recruited through professional networks to provide an independent evaluation. A final virtual session was held to confirm and validate the framework, which was subsequently approved. Nevertheless, the steering committee of the research had no voting rights.
Patient and public involvement
Study participants were actively involved in this study through participation in one of the three focus group sessions conducted in phase 2 of the framework development process. The third focus group included patient representatives and civil society stakeholders who shared their experiences, expectations and concerns regarding the implementation of HTA in Iran. Their input contributed directly to identifying relevant framework components, such as stakeholder inclusiveness, transparency and equity considerations. These perspectives were incorporated into the design of the final framework and informed its focus on inclusivity and innovation. Participants’ input also influenced the development of items later assessed in the Delphi process, ensuring that end-user values were reflected in expert consensus-building.

RESULTS
The characteristics of Delphi panellists are summarised in table 1.
The finalised framework was agreed on by panellists with a consensus rate of 84%, indicating strong agreement on the framework’s validity, relevance and applicability. The framework consists of nine core items, each representing a critical component necessary for effective implementation. The framework was reviewed and refined based on stakeholder input and is divided into the following strategic categories: Establishing Central Coordination and Leadership, Stakeholder Engagement and Inclusiveness, Capacity Building and Training, Developing HTA Methodologies and Processes, Implementing HTA Processes, Ensuring Sustainable Funding and Resource Allocation, Enhancing Transparency and Accountability, Monitoring, Evaluation and Continuous Improvement, and Promoting Innovation and Future Directions.
Establishing central coordination and leadership
The first component of the framework emphasised the formation of a national HTA body under the MoHME. Currently in Iran, HTA activities are dispersed across different departments within the Ministry of Health, without a centralised institutional body overseeing the process. Previous pilot efforts and research centres have carried out HTA studies, but there has not yet been a formal mandate or structure equivalent to national HTA agencies found in countries like the UK (The National Institute for Health and Care Excellence) or Thailand (The Health Intervention and Technology Assessment Program). The proposed framework recommends formalising a dedicated national body to consolidate efforts and provide unified leadership. This body would coordinate national HTA activities, advocate for evidence-based decision-making and ensure alignment witli national health priorities. The creation of a governance structure involving multisectoral representation ensures inclusivity and accountability.
Stakeholder engagement and inclusiveness

Table 1 Demographic and professional characteristics of experts involved in the Delphi consensus	
Category/description	Ν (%) or summary statistic	
Gender	Male/female	12 (60%)/8 (40%)	
Age (years)	Mean±SD (range)	44.6±6.8 (33-56)	
Education level	PhD/MD or MPH equivalent	16 (80%)/4 (20%)	
Sector of employment	Public/academic/private	13 (65%)/5 (25%)/2 (10%)	
Years of professional experience	Mean±SD (range)	17.2±5.9 (8-28)	
Field of expertise	Health technology assessment; health economics; public health; pharmacoeconomics; health policy and management	-	
Geographic distribution (by province)	Representation from seven provinces across Iran	-	

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Mapping and engaging stakeholders were identified as vital steps for the framework's success. The stakeholders’ roles, interests and influence were categorised to ensure
alignment witli tlie HTA process. A national stakeholder network was proposed to facilitate regular dialogue and create inclusive committees. Building multidisciplinary HTA committees that include clinicians, economists, researchers and civil society actors was emphasised as essential to promoting transparency, equity and shared ownership of HTA decisions.
Capacity building and training
Capacity building through tailored training programmes was acknowledged as a significant requirement for the framework's implementation. Training programmes designed for policymakers, healthcare professionals and researchers were outlined, with a particular focus on HTA methodologies, economic evaluation and policy translation. Moreover, fostering researcli and development in HTA methods and strengthening collaborations with academic institutions were consistently highlighted during the focus group discussions. These measures aim to create a sustainable HTA workforce and strengthen institutional capacity across national and subnational levels.
Developing HTA methodologies and processes
Participants emphasised that defining decision criteria and topic-selection procedures should precede implementation. Transparent and evidence-based selection criteria, such as disease burden, cost-effectiveness, feasibility and ethical or social considerations, should be developed and applied to identify and prioritise technologies for assessment. Following this, standardised HTA guidelines must be developed to specify methodological requirements (eg, analytical models, clinical and cost-effectiveness standards, budget impact analysis and equity dimensions). These guidelines should also detail operational processes such as topic selection, evidence appraisal, stakeholder deliberation and reporting to promote consistency, transparency and reproducibility.
Implementing HTA processes
This phase focuses on applying the established HTA methodologies and processes within the national healtli system. Stakeholders emphasised that implementation should follow a systematic approach that integrates HTA findings into policy mechanisms including technology approval, reimbursement and pricing. The framework recommends developing clear pathways to show how HTA evidence informs decision-making, establishing coordination between HTA producers and policymakers, and monitoring the use of HTA results in real-world settings. By distinguishing implementation from development, the framework ensures that the translation of HTA evidence into policy decisions occurs efficiently and consistently.
Ensuring sustainable funding and resource allocation
Securing sustainable funding for HTA activities such as research, training and the implementation of evaluation processes was identified as a top priority. The alignment of HTA funding witli national health objectives was regarded as critical for ensuring that resources are directed toward o
high-impact technologies. Participants recommended establishing a dedicated budget line within the MoHME for HTA activities, supported by potential contributions from insurance organisations and public—private partnerships. This approach ensures both financial stability and long-term sustainability.
Enhancing transparency and accountability
Transparency and accountability were highlighted as essential features to build trust among stakeholders and the public. The framework promotes the publication of HTA criteria, methodologies and assessment outcomes and mandates disclosure of conflicts of interest among decision-makers. Additionally, oversight mechanisms such as independent audits, peer reviews and external evaluations are encouraged to ensure integrity and prevent undue influence in HTA decision-making. By adopting open governance principles, Iran’s HTA system can enhance credibility and legitimacy in national healtli policy.
Monitoring, evaluation and continuous improvement
A robust monitoring and evaluation (Μ&Ε) system was proposed to assess how effectively HTA processes and decisions are being implemented. The Μ&Ε component includes performance indicators for assessing the health, financial and policy impact of HTA recommendations. Participants also emphasised the need for feedback mechanisms to capture lessons learnt and refine methods over time. Continuous improvement should be supported through periodic reviews, integration of new evidence and adaptation to changing national health priorities.
Promoting innovation and future directions
The final component of the framework focuses on promoting innovation while ensuring that foundational HTA systems are firmly in place. This involves supporting tlie assessment and responsible adoption of novel technologies, including digital healtli interventions, diagnostics and pharmaceuticals. The framework encourages structured collaboration between public institutions and the private sector to strengthen innovation ecosystems and maintain alignment with national healtli priorities. Future directions include developing adaptive HTA models to evaluate emerging technologies more rapidly, ensuring the system remains responsive to global healtli and technological shifts.
Summary outputs from the process

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As a result of the modified Delphi process, consensus was achieved on the final framework elements with an agreement rate of 84%. Eacli round helped refine or clarify specific components, especially concerning stakeholder participation, transparency and implementation strategies. From the focus groups, several key insights emerged: (a) the need to define selection criteria and topic-selection procedures before implementation; (b) tlie importance of capacity building and coordinated 
leadership; (c) the value of tailoring international models to the national context and (d) the centrality of equity and inclusiveness in decision-making. These themes were integrated into the final framework design.
For each item, a series of steps was defined to guide its operationalisation. These steps outline the strategic actions required to ensure the framework’s success in addressing the identified challenges and opportunities. Each step is further broken down into specific micro-activities, offering a practical roadmap for implementation. This hierarchical approach ensures that the framework is both comprehensive and actionable, allowing stakeholders to translate high-level strategies into practical initiatives.
The detailed micro-activities associated with each step are presented in table 2, providing a consolidated and systematic overview of the strategic actions required for each framework item.
The framework is visually represented in figure 1. which highlights the nine components and their interconnections. By illustrating the relationships between tliese strategic categories, the figure serves as a conceptual guide for understanding the comprehensive approach proposed for advancing HTA practices in Iran.
To provide greater transparency and detail regarding the data and processes underlying the framework, additional materials are included in two supplementary appendices. Online supplemental appendix 2 presents the qualitative and consensus-building results from all methodological phases, including (a) the semistructured interview guide used in the focus group discussions, (b) the key themes identified through qualitative analysis, (c) survey instruments used in Delphi rounds 1-3 and (d) a summary of the evolution of the framework components based on expert feedback. Online supplemental appendix 3 includes a comprehensive table of strategic actions and micro-activities for each of the nine framework components, offering a practical roadmap for implementation. Together, these appendices complement the main text by offering detailed evidence that supports the final framework design and operational strategy.
DISCUSSION
The proposed framework for developing HTA in Iran represents a crucial step towards institutionalising evidence-based decision-making within a resource- constrained healthcare system. By combining global best practices with the unique conditions of Iran’s healthcare system, this framework provides a structured approach to optimising resource allocation, enhancing transparency and promoting equity in healtli policymaking. It addresses key challenges within Iran’s healthcare system, while drawing on the successes of various developing countries, ensuring its relevance and credibility botli in content and methodology. While the framework includes strategic components that are adaptable to other countries, its development was rooted in Iran’s specific context, including the centralised structure of its healtli governance, the dual public-private system of service delivery, and existing gaps in HTA institutionalisation. For example, the emphasis on forming a national HTA body under the MoHME directly responds to the current fragmentation of HTA activities across different departments in Iran. Moreover, stakeholder engagement strategies and capacity-building components were informed by challenges identified in local policy documents and focus group discussions witli Iranian experts, ensuring contextual appropriateness.
One of the main findings of this study is tlie importance of establishing a central body for HTA under the MoHME, whicli will serve as the central authority for coordinating HTA activities. This body will be responsible for aligning HTA practices witli healtli priorities, similar to the central coordination seen in countries with mature HTA systems such as the United Kingdom, Germany, France and Thailand.11 These examples demonstrate that strong central governance is critical for ensuring sustainability and consistency of HTA activities.12
This framework also emphasises the critical role of stakeholder engagement in ensuring the success of HTA. Involving a broad range of stakeholders, including policymakers, healthcare professionals, researchers and patient representatives, helps build trust and ensures that the HTA process reflects diverse perspectives.1'’14 Experience from countries sucli as Thailand,1” India16 and Malaysia11 shows that inclusive stakeholder participation reduces resistance to policy change and increases acceptance of HTA-based decisions.18
A key component of this framework is capacity building and training. Developing local expertise in HTA methodologies is vital, as a skilled workforce is needed to conduct rigorous assessments and ensure long-term sustainability.19 Capacity-building efforts in Brazil,20 India21 and Malaysia22 have demonstrated how training programmes and collaboration with academic institutions can integrate HTA into national health systems despite resource constraints.2324
Another important component of this framework is the development of standardised HTA methodologies and guidelines. Adapting global HTA models to Iran's social, political and economic conditions will ensure that evaluation methods are both relevant and feasible.'” This approach aligns with WHO recommendations to customise HTA methods to local contexts. Examples from Malaysia, Thailand26 and several Latin American countries show how adapting global standards enhances both scientific validity and policy relevance.21 Standardising evaluation criteria sucli as safety, cost-effectiveness and equity will contribute to more reliable and comparable HTAs and improve transparency in decision-making.28

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Sustainable financing mechanisms are also essential for the success of the framework. Dedicated funding for HTA, as demonstrated in the UK29 and Colombia,30 is critical for ensuring continuity of activities. Iran should align HTA financing with national health objectives and
Items	Steps	Summary of microactivities	
Establishing central coordination and leadership	1.1 Form a national HTA body	Identify key organisations and legal mechanisms for establishing the national HTA agency; define its mandate, structure and resource allocation.	
	1.2 Appoint HTA leadership	Select qualified national HTA leaders, define roles and responsibilities, and create communication channels between the HTA body and MoHME.	
	1.3 Define governance structure	Develop a multisectoral governance model with advisory boards, clear workflows and mechanisms for transparency and accountability.	
Stakeholder engagement and inclusiveness	2.1 Map key stakeholders	Conduct stakeholder analysis to identify and categorise actors by influence and interest, developing detailed stakeholder profiles.	
	2.2 Establish stakeholder networks	Create forums and digital platforms for regular dialogue; hold national symposia to promote collaboration.	
	2.3 Build inclusive HTA committees	Establish multidisciplinary HTA committees and subcommittees (clinical, economic, social); provide orientation and training.	
Capacity building and training	3.1 Invest in training programmes	Develop tailored training curricula and workshops in HTA methods, cost-effectiveness analysis and evidence-based decision-making.	
	3.2 Foster research and development	Promote partnerships between academia, HTA bodies and policymakers to strengthen research and create a national HTA database.	
Developing HTA methodologies and processes	4.1 Develop standardised HTA guidelines	Review international models (eg, NICE, WHO, CADTH), tailor them to Iran’s context, and publish national HTA guidelines outlining evaluation criteria.	
	4.2 Define selection criteria and topic selection	Establish explicit decision criteria for selecting HTA topics (eg, disease burden, costeffectiveness, health impact) and create a transparent prioritisation mechanism.	
Implementing HTA processes	5.1 Conduct comprehensive evaluations	Design standardised templates, assign multidisciplinary teams and conduct evaluations covering safety, efficacy and equity.	
	5.2 Incorporate HTA in decision-making	Integrate HTA evidence into national pricing, reimbursement and procurement processes; monitor implementation outcomes.	
Ensuring sustainable funding and resource allocation	6.1 Secure dedicated financial resources	Establish budget lines within MoHME for HTA, identify funding sources (eg, grants, insurance), and publish annual financial reports.	
	6.2 Align funding with national health priorities	Ensure HTA financing supports national priorities and evaluate the return on investment for funded HTA projects.	
Enhancing transparency and accountability	7.1 Develop transparent HTA processes	Publish HTA criteria, methods and reports; facilitate open access and stakeholder feedback.	
	7.2 Promote accountability	Establish independent oversight committees and external audits to evaluate HTA performance and ensure ethical standards.	
Monitoring, evaluation and continuous improvement	8.1 Monitor implementation of HTA decisions	Track health and financial impacts of ΗΤΑ- informed policies and collect implementation data from providers.	
	8.2 Foster continuous improvement	Conduct periodic reviews of HTA methodologies, pilot innovative approaches and integrate new evidence into ongoing practices.	
Promoting innovation and future directions	9.1 Support evaluation of innovative health technologies	Develop criteria for evaluating emerging and digital health technologies; establish innovation support funds.	
Table 2 Strategic items, steps and activities for developing a national HTA framework in Iran
Continued
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Items	Steps	Summary of microactivities

9.2 Foster collaborative research

HITAP, The Health Intervention and Technology Assessment Program; HTA, health technology assessment; MoHME, Ministry of Health and Medical Education; NICE, The National Institute for Health and Care Excellence.

Establishing central coordination and leadership

Steps

Figure 1 Conceptual framework for developing and implementing a national HTA system in Iran. HTA, health technology assessment.

				
			N	I Map Key Stakeholders	
- 		Stakeholder Engagement and Inclusiveness		Steps—•	2. Establish Stakeholder Networks	
			3. Build Inclusive HTA Committees	

N I Form a National HTA Body λ 2. Appoint ΠΤΑ Leadership
I3. Define Governance Structure

3	==	Capacity building and training		1		Invest in Training Programs
2		. 1-ostcr Research and Development	
			Steps 	>		

1		. Develop Standardized ΗΤΑ Guidelines
2		Define Selection Criteria and Topic Selection	

>	2.	Conduct Comprehensive Evaluations Incorporate HTA in Decision-Making	

Ensuring sustainable funding and resource allocation		Steps —>	

===	Enhancing transparency and accountability	Steps	

1	Secure Dedicated Financial Resources	
2.	Align Funding with National Health Priorities	

1	Develop Transparent HTA Processes	
2.	Promote Accountability	

	Steps 	•	1.		Monitor Implementation of IITA Decisions
2.		Foster Continuous Improvement	

	Steps 	•	1.		Support Evaluation of Innovative Health Technologies
2.		foster Collaborative Research	

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Table 2 Continued
prioritise cost-effective interventions with the greatest population healtli impact.31
Transparency and accountability are critical for building trust in HTA processes.26 The framework recommends making HTA criteria, methods and results publicly available, as well as disclosing conflicts of interest and documenting decision-making processes.18 Oversight mechanisms such as external audits are necessary to safeguard the credibility of the system.’2
The framework supports innovation and collaboration, whicli are essential to keeping pace with rapid advancements in healtli technologies. Public-private partnerships and international collaboration, as demonstrated in Thailand33 and South Korea,34 can accelerate the adoption of beneficial technologies while maintaining cost-effectiveness.
This study significantly contributes to the growing body of literature on HTA implementation in LMICs and provides a comprehensive framework specifically

Strengthen public-private partnerships and cross-sectoral research on innovative health interventions and technologies.
designed for Iran’s healtli system. Future studies should focus on pilot testing this framework in real-world settings to assess its feasibility and scalability. By testing in different settings, researchers can identify challenges and refine methods for broader implementation. Ultimately, the proposed HTA framework for Iran is a transformative step toward integrating evidence-based health policymaking into the country’s healthcare system. Its successful implementation will require strong leadership, sustained financing and ongoing stakeholder collaboration. Witli continued commitment, this framework can pave the way for a transparent, equitable and effective healthcare system in Iran, ultimately supporting progress towards universal healtli coverage.
Limitations
This study has several limitations that should be acknowledged. First, the framework was developed based on expert consensus obtained through the Delphi method,
which, while robust, may introduce subjective bias. The reliance on expert opinions may limit the generalisability of findings, particularly in contexts beyond Iran’s healthcare system. Second, the study primarily focused on Iran’s unique healthcare challenges and priorities, potentially limiting the framework’s applicability to other LMICs with differing health system structures and resource constraints. Third, the availability and quality of healtli data in Iran remain a critical challenge. Inconsistencies in data collection and reporting may affect the robustness of evaluations. Finally, although this study did not include a pilot implementation of the framework, this was beyond the scope of the current research. Future research should focus on piloting the framework in specific settings to assess its operational feasibility, scalability and effectiveness in improving healthcare decision-making.
CONCLUSIONS
The development of a tailored HTA framework represents a significant step forward in optimising Iran’s healthcare system. By integrating global best practices with a deep understanding of the country’s unique challenges, this framework offers a structured approach to improving evidence-based decision-making, resource allocation and healthcare outcomes. The framework emphasises critical components such as central coordination, stakeholder engagement, capacity building, standardised methodologies, sustainable funding and transparency. Each element is designed to address gaps in the current system, ensuring that healthcare interventions are evaluated systematically for their safety, efficacy, cost-effectiveness and societal impact. By addressing existing gaps and aligning witli national priorities, it can enhance the efficiency, equity and sustainability of healtli sector planning and resource allocation. Despite potential limitations, including resource constraints and data quality issues, the proposed framework provides a comprehensive foundation for integrating HTA into Iran’s healtli policy landscape. Its successful implementation will require strong leadership, collaborative stakeholder efforts and sustained commitment to overcoming challenges. Future studies should focus on piloting the framework in real-world settings to validate its practicality and scalability. By doing so, Iran can pave the way for more informed, transparent and equitable healthcare decisions, contributing to improved health outcomes and the sustainable development of its health system.
Author affiliations
1Social Determinants of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran (the Islamic Republic of)
2Health Equity Research Center (HERC), Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
3Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of)
4Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
5School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
Acknowledgements The research team would like to express gratitude to all the organizations and individuals who contributed to developing HTA in Iran. This study was done with the support of the National Institute for Medical Research Development (NO: 4021378).
Contributors MeB, MaB, AB, SS, SA and AA made substantial contributions to the conception and design of the study, data acquisition, analysis and interpretation. MeB, MaB, AB and AA drafted the manuscript and revised it critically for important intellectual content. All authors approved the final version of the manuscript to be published and agreed to be accountable for all aspects of the work in ensuring the accuracy and integrity of any part of the manuscript. MaB is the guarantor. We used artificial intelligence to revise certain sentences.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not applicable.
Ethics approval The ethics committee of Lorestan University of Medical Sciences (IR.LUMS.REC.1402.310) approved this study, ensuring adherence to ethical guidelines throughout the research process. This study was conducted in full compliance with the principles outlined in the Declaration of Helsinki, which emphasises the protection of participants’ rights, confidentiality and well-being. Ethical considerations were prioritised at every stage, including obtaining informed consent from all participants, ensuring voluntary participation and safeguarding their privacy. Furthermore, all data were handled with strict confidentiality and anonymity considerations, and participants were given the option to withdraw from the study at any time without facing any consequences. All participants and experts were based in Iran and had substantial knowledge of the national health policy and HTA landscape, ensuring that the process was grounded in relevant contextual understanding. This commitment to ethical standards ensured that the study was conducted responsibly, with the utmost integrity and respect for all participants.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. Data are available on reasonable request. This includes raw data extracted from reviewed literature, as well as anonymised transcripts from focus group discussions and Delphi survey responses. All data supporting the findings of this study can be obtained from the corresponding author on reasonable request, in accordance with ethical approvals and participant consent.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.0rg/licenses/by-nc/4.0/.
ORCID iD
Masoud Behzadifar https://orcid.org/0000-0002-0271-4360
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