Joint Nordic HTA Bodies (JNHB): further collaborations for HTA in Europe
Background
On 3rd June 2024, a new collaboration, Joint Nordic HTA Bodies (JNHB), was announced, aiming to streamline health technology assessments (HTAs) in the Nordics through joint HTA assessment of medicinal products.[1] The JNHB replaces FINOSE and comprises HTA bodies from Denmark, Finland, Iceland, Norway, and Sweden.[1] JNHB joint assessments will evaluate both relative effectiveness and health economics; however, national decisions on pricing and reimbursement will be left at the discretion of individual countries.
This initiative illustrates the growing trend towards harmonising HTA procedures in Europe. The JNHB joint assessments will operate in parallel with the joint clinical assessments (JCAs) mandated by the new European HTA Regulation (EUHTAR)[2]; however, it is unclear how these processes will work together.
Development of the JNHB
JNHB replaces FINOSE, which originally launched in 2018 as a collaboration between Finland, Norway, and Sweden (Figure 1). JNHB participation has expanded to include HTA bodies from the five Nordic countries; the Danish Medicines Council (DMC), the Finnish Medicines Agency (FIMEA), Landspítali – The National University Hospital of Iceland, the Norwegian Medical Products Agency (NOMA), and the Swedish Dental and Pharmaceutical Benefits Agency (TLV).[1]
Figure 1: Timeline of the history of the JNHB collaboration [1]
Objective of the JNHB
The aim of JNHB is to enhance the efficiency, transparency, and quality of HTAs in the Nordics. The joint assessment allows for the sharing of resources and a harmonisation of evidence requirements, which will hopefully lead to increased efficiency and ultimately more timely and equal access to medicinal products.[1] Although Nordic countries have advanced healthcare systems and HTA assessment processes, they have comparatively low access to new medicines [3] and advanced therapy medicinal products (ATMPs). [4] The JNHB assessment is one factor among others that could facilitate equal access to medicines in the Nordic countries, and a JNHB assessment can facilitate Nordic price negotiations for relevant products.
The JNHB assessment
The JNHB joint assessment is a voluntary process limited to medicinal products, and Health Technology Developers (HTDs) sign a Waiver of Confidentiality to allow the sharing of information during the assessment. New active substances, indication extensions, and products for use in patient care are all considered suitable for joint assessment; however, they will typically only qualify if treatment patterns are sufficiently comparable in the Nordic countries. The process for JNHB assessment is outlined in Figure 2.
Figure 2: JNHB assessment process; adapted from Joint Nordic HTA-Bodies Process Guideline [5]
Horizon scanning: JNHB collaborates with Nordic horizon scanning initiatives and can contact HTDs directly to initiate an assessment. [5]
Note: HTDs and other relevant organisations can also recommend products for joint assessment directly.
PICOs and pre-assessment: HTDs are responsible for submitting the PICO proposal incorporating a Nordic perspective. The JNHB will conduct a pre-assessment of the PICO proposal to determine if a joint assessment is appropriate.
Scoping meeting: If the pre-assessment concludes that the product is suitable for a joint JNHB assessment, the HTD is invited to a scoping meeting to discuss timelines and submission.
Submission: The HTD is responsible for submitting a dossier containing the documents specified in the JNHB submission dossier template. For practical reasons, this is submitted to the TLV following TLV’s national procedure.
Assessment: The assessment is completed in two stages: a draft report is prepared and reviewed with input from clinical experts and suggestions for country-specific analyses (which are developed as national appendices). The final report contains the final efficacy estimates, the final base case with relevant scenarios and sensitivity analyses, and the finalised national appendices.
National decisions on pricing and reimbursement
The JNHB assessment report is agreed upon by all five HTA bodies and published according to their national procedures. However, the report is not a decision but is designed to support the countries in their national decisions on recommendations, pricing, and reimbursement. [6] The use of the report in these national decisions is dependent on the country:
Sweden: The report is used for decision-making in both outpatient (the Pharmaceutical Benefits Board makes the decision based on the report) and inpatient (the NT-council uses the report to make its recommendations) medicinal products. [6, 9]
Denmark: The report is used for decision-making in all medicinal products. For inpatient pharmaceuticals, the report is shared with Amgros for price negotiation. The DMC then makes its decision using both the report and the negotiated price. [6,10]
Finland: The report is only used for decision-making for inpatient medicinal products; it informs the Council for Choices in Health Care in Finland (COHERE) on its recommendation for use. [6, 7] The Pharmaceutical Pricing Board (Hila), which makes decisions on the price and reimbursement of outpatient pharmaceuticals, is not part of the JNHB collaboration.[6]
Norway: For inpatient pharmaceuticals, the report is used by the procurement body (Sykehusinnkjøp HF) for price negotiation, with the final recommendation made by the Nye Metoder Beslutningsforum. [6, 8]
In addition, JNHB has entered a collaboration with the New Expensive Drugs (NED) section of the Nordic Pharmaceutical Forum, which aims to support joint Nordic price negotiations for products assessed through JNHB, contingent upon mutual agreement between NED and the manufacturers. [11]
JNHB in the context of the EUHTAR
JNHB assessments are currently a voluntary process; however, they will operate in parallel with JCAs mandated by the new EUHTAR. [2] It is unclear how the JNHB process will be impacted by the rollout of the EUHTAR.
It is predicted that JNHBs will remain an important parallel process to JCAs for several years due to the phased rollout of the EUHTAR; products will be eligible for JNHBs several years before JCAs. [1, 2] In addition, there are several key differences between the processes that may necessitate indefinite parallel activities. Importantly, whilst JCAs include an assessment of relative effectiveness, the JNHB assessment includes both relative effectiveness and health economics. The JNHB assessment may act as a complement to JCAs, focusing on the health economics aspect; however, care should be taken not to duplicate work. In addition, considerations need to be given to Norway, who will not participate in the EU-level JCAs.
In any case, the JNHB initiative indicates that HTDs will need to prepare to manage national processes alongside regional collaborations (e.g. JNHB, Beneluxa) and EU-level JCAs for several years to come.
Reach out to us at Decisive Consulting to help your organisation seamlessly integrate these collaborative processes and simplify your HTA journey.
References:
FINOSE becomes Joint Nordic HTA-Bodies, JNHB; Available at: https://jnhtabodies.org/media/g4pjh2ig/june-3-jnhb-launch.pdf; Accessed 19th July 2024
Regulation (EU) 2021/2282 on health technology assessment; Available at: https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en; Accessed July 19th 2024
Ny rapport kortlægger adgangen til ATMP’er i 11 europæiske lande; Available at: https://www.lif.dk/23549-2/; Accessed 19th July 2024
EFPIA Patient W.A.I.T. Indicator 2023 Survey; Available at: https://efpia.eu/media/vtapbere/efpia-patient-wait-indicator-2024.pdf; Accessed 19th July 2024
Joint Nordic HTA-Bodies Process Guideline; Available at: https://jnhtabodies.org/media/mvbm1uke/jnhb-process-guideline.pdf; Accessed 19th July 2024
JNHB Help section; Available at: https://jnhtabodies.org/media/d5bpigpi/finose-qa-3-juni-2024.pdf; Accessed 19th July 2024
Choices in Health Care; Available at: https://palveluvalikoima.fi/en/council-for-choices-in-health-care-in-finland#:~:text=Council%20for%20Choices%20in%20Health%20Care%20in%20Finland%20(COHERE%20Finland,from%20public%20funds%20in%20Finland.; Accessed 19th July 2024
Sykehusinnkjøp HF; Available at: https://www.sykehusinnkjop.no/; Accessed 19th July 2024
TLV; Available at: https://www.tlv.se/in-english.html; Accessed 19th July 2024
Danish Medicines Council; Available at: https://medicinraadet.dk/om-os/in-english; Accessed 19th July 2024
JNHB – NED Collaboration; Available at: https://jnhtabodies.org/media/1j4badtw/jnhb-ned-collaboration-june-2024.pdf; Accessed 19th July 2024
Written by Sophia McGovern and Rosa Willock
Decisive Dialogue 12th August 2024
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