Use of R models for HTA submission

This document is intended to be a living document for individual country guidance on the use of R models as evidence in HTA submissions. This consists of both available guidance from individual HTA websites, with references, but also correspondence with individual organisations. The correspondence with each HTA agency has been made via the ‘contact us’ information provided on each website.

Disclaimer: This document is a guide only; the author holds no responsibility for where information here differs from individual experiences. We encourage anyone interested in submitting to a HTA agency to follow the published guidance and reach out to the individual agencies to confirm acceptance based on your individual circumstance.

Notice something wrong or missing? Contact us at rhart@darkpeakanalytics.com with more information and we will try to incorporate it

Country	Agency	Available guidance from agency website	Reference	Additional guidance from correspondence
Australia	Pharmaceutical Benefits Advisory Committee (PBAC)	States that TreeAge Pro and Excel 2010 are the only software that can be used without pre-arrangement Requirements of submission: • Access to the electronic copy of the evaluation • Ensure that variables can be changed independently • Can produce results within ‘reasonable running times’	Link Version 5 (September 2016)	Awaiting reply
Austria	Austrian Institute for Health Technology Assessment (AIHTA)	States that the model should use ‘appropriate software’ and that this will depend on the model structure. It requests thorough testing by independent reviewers and prefers development to be carried out modularly so that invidivual modules can be tested independently	Link Version 1 - Section 8.3.2.5 translated using Google translate (March 2012)	Awaiting reply
Belgium	Belgian Health Care Knowledge Centre (KCE)	The guidance states that the intention is to find a balance between transparency and practical feasibility: “Different software packages for building economic models are available (e.g. Excel, DATA/Treeage, R or WinBUGs). While no specific software packages are prohibited, it is important to ensure that the assessors are practically able to validate the model. Therefore, either a generally applied package is used (e.g. Excel) or prior consultation with the assessors about which package can be used or how the model can be delivered to allow for validation is recommended.” Requirements of submission: • Routine submission of the model is not required. However, the assessor can always ask for a copy of the model	Link (May 2025)	No submissions in R have yet been made in Belgium (April 2025)
Canada	Canada’s Drug Agency (CDA)	States that the economic model must be programmed in Excel but the sponsor must contact CDA-AMC in advance if considering alternative program software to ensure that it is acceptable and whether additional requirements will apply. Requirements of submission: • The model must be able to function in a stand-alone environment that does not require access to a web-based platform. • The sponsor must provide the model in its entirety and be able to fully execute the model based on modifications to parameters of interest • CDA-AMC must be able to vary individual parameters, view the calculations, and run the model to generate results	Link (September 2024)	• Not yet received submission fully in R, but have received submissions where specific functionality is programmed in R (uncommon: around 5 instances in last 5 years) • Would accept R, but would expect there to be strong justification • Any submitted code must be clearly annotated and with minimal use of packages that need to be installed from CRAN • Would need to adhere to all specified guidelines (e.g. requires inclusion of Markov trace, ability to vary individual parameters and have locally executable model) (March 2025)
Czech Republic	CzechHTA	Software preference not specified	Not available	The Czech authority have received models in R although it is uncommon. They have also developed models internally in R and have based their recent analysis of HPV catch-up vaccination on this platform. The key thing that they look for is good documentation, especially surrounding the localisation of inputs and model structure (March 2025)
Denmark	Danish Medicines Council (DMC)	“The health economic analysis and budget impact analysis must be submitted in Excel format.”	Link (June 2022)	R is not currently accepted (March 2025)
England	National Institute for Health and Care Excellence (NICE)	NICE accepts fully executable economic models using standard software, that is, Excel, DATA/Treeage, R or WinBUGs Requirements of submission: • NICE must have access to the programming code of a fully executable model • No specifications on package preference or code guidelines	Link (October 2023)	Confirmed that R models have been submitted and accepted. There are no plans for developing guidelines/preferences on coding structure and packages to be used. (April 2025)
Finland	Pharmaceuticals Pricing Board	States that recommended softwares for executing the model are Microsoft Excel and R. It must be possible to view and edit the calculation formulas and initial data in the electronic document. The model needs to facilitate the addition of new scenarios and the model must not be password protected.	Link (June 2024)	The Pharmaceuticals Pricing Board has not yet received any R model as part of an application submission. R packages published on CRAN are recommended. Stated that all instructions for health economic evaluations currently available apply to R models. The model should be attached and the Pharmaceuticals Pricing Board should be able to view and edit the model code and data, including creating new scenarios. l it is also important to have comprehensive comments in the code to ensure smooth assessment process. (March 2025)
France	Haute Autorité de Santé (HAS)	Software preference not specified	Link (March 2014)	HAS confirmed that economic models relating to medicines and medical devices submitted to the HAS should be programmed in Excel. However, there are exceptions where programming using other software (including R) may be considered in certain specific cases, such as the economic evaluation of a vaccine based on a dynamic transmission model. The specific interest in using other software must be argued by the manufacturer sufficiently in advance of submitting the file to allow the HAS to specify the terms of acceptance of the software. (July 2025)
Germany	Institute for Quality and efficiency in Health Care (IQWiG)	Software preference not specified in English General methods guidance	Link Version 7 (September 2023)	IQWiG have stated that R is a recognized program and models developed with it will be accepted. They have confirmed that they have not yet received any models in R and that they have no current guidelines on how a model in R would need to be developed for submission. (February 2025)
Ireland	National Centre for Pharmacoeconomics (NCPE)	States that Microsoft Excel 2021 (or earlier versions) is the preferred software for NCPE submissions. Contact the NCPE in advance of submission if alternative software packages are to be considered for submission Requirements of submission: • A Technical Specification Document is required to be submitted alongside the model for how users should use and adapt the model • The model must be fully executable • Specifications of outputs are detailed in guidance and would need to be adhered to regardless of software used	Link Version 3.1 (March 2023)	The NCPE Will accept R with prior notification. No submissions have been made in R to date. All code would need to be provided. There is currently no guidance on preferred packages or code guidelines. (March 2025)
Italy	Italian Medicines Agency (AIFA)	“The data and models used must be made available at the same time in Excel or TreeAge format” (translated)	Link (January 2021)	Awaiting reply
New Zealand	PHARMAC	PHARMAC’s preferred software packages are TreeAge and Microsoft Excel. Models provided in other software packages will not be assessed unless by prior agreement Requirements of submission: • The model must be stand-alone, where PHARMAC can access all model materials for review and amend any relevant inputs • Economic models should not be unnecessarily complex, and should always be transparent, well described and reproducible	Link (accessed March 2025)	Awaiting reply
Norway	Norwegian Medicines Agency (NoMA)	States that normally it would be useful if the model is designed using Excel, but other alternatives can also be acceptable such as, TreeAge and R. Requirements of submission • NoMA must be able to change all relevant variables and parameters in the model • The model must not be locked, time limited, password-protected unless the password is made available, or have any hidden elements that are not described or cannot easily be changed. • The model must be fully executable and not in any non-transparent programmes and/or programming languages	Link (May 2020)	Awaiting reply on additional information request
Poland	Agency for Health Technology Assessment and Tariff System (AOTM)	“Except for justified situations, the models should be developed using commonly available tools - Software like MS Excel, TreeAge is often used.” (translated)	Link Version 3 (August 2016)	Awaiting reply
Portugal	Health Technology Assessment Committee (Infarmed)	The guidance states that a model software needs to be appropriate for the cost effectiveness model Requirements of submission • No specific guidance on model deployment • There is to be a specific focus on drivers and outcomes of paramenter uncertainty over time	Link Version 1 (December 2019)	Infarmed have confirmed that they will accept submissions in R code. However noted that specific particularities of the economic model may need to be replicated in Excel if the methodology is unclear. There is no current guidance on specific packages or coding structure. (March 2025)
Scotland	Scottish Medicines Consortium (SMC)	Software preference not specified Requires an executable electronic copy of the economic model with the submission, with full access to the programming code	Link Guidance on NPAF (November 2024)	SMC have not accepted, nor had the request to accept any models in R. There is concern that they would not be resources to make all the required checks within their very rapid assessment timelines. They have confirmed that their ability to accept would depend on the specifics of the case and the rationale for using R would need to be considered before deciding whether it was appropriate There is no current guidance on specific packages or coding structure. (March 2025)
Spain	Spanish Agency of Medicines and Medical Devices (AEMPS)	Software preference not specified	Not available	Awaiting reply
Sweden	Dental and Pharmaceutical Benefits Agency (TLV)	Software preference not specified	Link (February 2025)	The TLV requirement for models is that they are in electronic form - they confirmed R would therefore be accepted. They stated that the model must be fully executable and completely available to review the code and amend the inputs. There is no current guidance on specific packages or coding structure. (March 2025)
Switzerland	Federal Office of Public Health (FOPH)	Model not specifically required for when an application for reimbursement is made. Software preference not specified	Link (January 2025)	It was confirmed that if an applicant wishes to submit a model or if a model is asked for by FOPH, then Excel format is preferred but if the model is too complex for Excel and there is justification for the use of R then models in R will be accepted. There is no current guidance on specific packages or coding structure. (May 2025)
The Netherlands	National Health Care Institute (ZiN)	ZIN has provided a guideline specifically for the building of models in R Details of R model submission: • CE-models in R are required to include at least all functionalities that would otherwise be included in Excel (including the potential for end-to-end functionality with necessary data) • A recommended folder structure and code structure is provided • The code needs to be able to function stand-alone • Coding conventions and commenting guidance is described • ZIN requires the model to only use CRAN packages that are listed in the guidance • Unit testing is required	Link (December 2022)	Awaiting reply on additional information request
United States of America	Institute for Clinical and Economic Review (ICER)	Guidance on the reference model is agnostic to decision problem, but the software type and version needs to be clearly stated	Link (September 2024)	ICER commented that, as they are a not-profit organisation with no government mandate, they cannot rely on manufacturers to submit anything to them and any engagement is voluntary. Because of this, they build de novo models themselves or in collaboration with academic groups ICER additionally noted that nearly all their models were built in Excel because of their ICER Analytics platform, which is a subscription-only service that allows and users to view and interact with the models. The platform is currently not flexible to use R, so any R model would not currently be able to be shared on this platform - it is hoped that this will be updated in the future (May 2025)

Use of R models for HTA submission

Living document on individual country guidance

Rose Hart, Dark Peak Analytics Ltd.

Last updated: 22 July 2025