Which assets are in scope for the HTAR?
Jan 2025: Medicinal products for cancer and ATMPs
Jan 2028: Orphan medicinal products
Jan 2030: All newly approved EMA products (including certain medical devices and IVDs) and extensions of indications where there is already a JCA available
Note that assets that are launching before January 2025 will not go through JCA.
Reference: European Union Regulation on Health Technology Assessment (2021/2282) Article 1
Demystifying the EU HTA Regulation: what you need to know about its impacts
Is your asset in scope for the HTAR in January 2025?
Yes
No
Acronyms
What YOU need to know
My asset will not go through JCA in Jan 2025
Monitor if local processes, methods and timelines will change as each Member State prepares for implementation of the EU HTAR as well as future implications
Understand the competitive landscape for your asset and include post-2025 considerations as you prepare your launch strategy
Lobby locally to ensure sufficient time/resources are allocated to existing process to avoid any delay to launch of products not in scope of HTAR
Monitor regulatory timelines to ensure products with planned filing in Q4 2024 do not become eligible for JCA
Monitor evolution of HEOR methods and acceptability as HTA bodies adjust methods in preparation of HTAR implementation (e.g. patient relevant endpoints, PRO, ITC, RWE etc).
Assess value of engaging in joint or parallel scientific advice with HTAs (JSC or other)
Map access pathway to understand implications on evidence generation activities
Keep in mind that whether your asset is in the scope of the EU HTA Regulation or will be subject to it as of 2028, now is the time to act!
All functions
What YOU need to know
All functions
Brand
Market access
Regulatory
Medical affairs and RWE
HEOR
Affiliates
Reset
ATMP - Advanced Therapy Medicinal Product
CADTH - Canada’s Drug and Health Technology agency
EMA - European Medicines Agency
ESA – Early Scientific Advice
EU - European Union
HEOR – Health Economics and Outcomes Research
HTA - Health Technology Assessment
HTAB - Health Technology Assessment Body
HTAR - Regulation on Health Technology Assessment
ITC - Indirect Treatment Comparison
IVD - In Vitro Diagnostic product
JCA - Joint Clinical Assessment
JSC - Joint Scientific Consultation
KOL - Key Opinion Leader
MS - Member States
NCE – New Chemical Entity
NICE - National Institute for Health and Care Excellence
PICO - Patent Intervention Comparator Outcome
PRO - Patient Reported Outcomes
ROW - Rest of World
RWE - Real World Evidence
Abbreviation
My asset will go through JCA in Jan 2025
Work cross-functionally to understand how HTAR implementation will impact launch strategy in different MS (including timing and priority) across portfolio and plan accordingly
Assess impact of PICO framework on target population size across MS to inform launch forecast
Assess impact of public availability of evidence package and particularly choice of comparator on price negotiations
Determine impact of JCA process on pricing (e.g. price may decrease due to less favourable HTA outcomes/international reference pricing dynamics; price may increase due to more favourable HTA outcomes/acceptance of JCA methods and process)
Brand (product launch and lifecycle)
My asset will go through JCA in Jan 2025
Work cross-functionally to understand how HTAR implementation will impact launch strategy in different MS (including timing and priority) across portfolio and plan accordingly
Assess quality of evidence and its relevance to EU HTA requirements to ensure clinical benefits are demonstrated in JCA process
Ensure upfront participation of local teams to understand local requirements, identify key hurdles, and devise mitigation strategy
Assess impact of public availability of evidence package and particularly choice of comparator on price negotiations
Assess impact of HTAR implementation on international reference pricing networks to ensure MS pricing and reimbursement processes do not inadvertently prevent target prices in EU markets from being achieved
Market access
My asset will go through JCA in Jan 2025
Understand how regulatory timelines and imperatives will impact activities relating to HTAR implementation as well as how the implications of JCA requirements will impact cross-functional activities involving the regulatory team
Engage with brand, market access and HEOR teams to: • Better understand implications of label discussions with EMA on evidence generation requirements • Assess opportunities and risks of closer collaboration between EMA and HTA bodies and implications on information sharing
Determine implications of early access programmes and regulatory pathways (e.g. accelerated access for orphan drugs)
Assess value of engaging in joint or parallel scientific advice with HTAs (JSC or other) in addition to regulatory advice
Understand relationship between EU HTA and other EU regulatory changes which may further compress timelines (e.g. manufacturers may be mandated to launch within 24 months in all EU markets to maintain/increase patent protection)
Regulatory
My asset will go through JCA in Jan 2025
Identify and partner with external groups (e.g. KOLs, patients) to support HTAR alignment, understand how these groups will contribute to the process, and help define potential PICOs by understanding what constitutes standard of care at a pan-EU level as well as cross country variations
Engage with HEOR to ensure there is a clear understanding of what will be considered standard of care across the different countries
Develop an integrated evidence generation strategy for addressing anticipated PICOs where feasible in light of the evolving HTA landscape (EU and ROW) including RWE requirements (particularly for ITC)
Medical affairs and RWE
My asset will go through JCA in Jan 2025
Align teams, processes, and templates to ensure Global HEOR can support JCA and national submissions
Consolidate organisational knowledge of the HTAR, stay up to date on changes, and create a feedback loop of learning based on experience with JCA/JSC processes to improve efficiency and/or outcomes over time
Collaborate with regulatory to ensure EMA label and HTA strategy are aligned and understand the implications on evidence generation needs
Seek JSC or ESA where possible to better inform clinical trial development and real-world evidence generation plans (Please note that scientific advice on RWE activities is currently only possible with NICE [England] and CADTH [Canada])
Anticipate evidence requirements by simulating what PICOs will be required, what evidence generation will be feasible, and mitigation strategies (e.g. clear rationale of why the PICO cannot be addressed)
HEOR
My asset will go through JCA in Jan 2025
Understand how local processes, methods, and timelines will change to integrate pan-EU JCA timelines and methods
Engage with the local HTAB and payers (where applicable) to understand the differences in the evidence requirements and JCA dossier development vs local submissions and the impact on pricing and negotiations (if any)
Connect with KOLs and the local clinical and patient community to encourage involvement in pan-EU HTA processes as well as local HTA processes (where applicable)
Collaborate with the Global team to understand what evidence will be included in the JCA dossier and to identify opportunities, mitigate risks, and plan evidence generation activities
Affiliates
Reset
Acronyms
Yes
No
My asset will go through JCA in Jan 2025
Implementation of the EU HTAR will begin on 12 January 2025 but Member States will still be responsible for reimbursement (Article 1 of HTA Regulations, European Union)
Although the JCA will likely increase the opportunity for new chemical entities (NCEs) to launch earlier than planned in new EU markets, it may affect local HTA processes (including timelines and other operations) resulting in possible delays to launch
Not all drugs will be affected by the new process in the same way. The impact will depend on whether a particular drug is in scope of the HTAR, how the HTAR affects the competitive landscape, and how HTA bodies revise their processes and methods (HPR59: Who Is Ready for Joint EU HTA?, IQVIA)
Given that the HTAR will lead to more pressure on the global organisation, it will be important to raise awareness on the implications of the HTAR (The Future of EU HTA, IQVIA)
Cross-functional collaboration will be required to ensure internal readiness. This will entail earlier collaboration with affiliates and clinical and regulatory teams Internal discussion about the implications of the HTAR on the overall portfolio, individual products, investment decisions, and evidence generation strategy will also be required (HTA97: Impact of Additive PICOs in a European Joint Health Technology Assessment, IQVIA) The ability to demonstrate benefits under new HTA scheme will have immediate knock-on effect across wider group of EU MS