Looking at the Potential Impact of JCA on Pharma

Landkarte *** Europa | Image Credit: © beugdesign - Stock.adobe.com

In December 2021, the European Parliament (EP) passed new legislation, European Union regulation 2021/2282, which amended directive 2011/24/EU and substituted the parallel evaluations of clinical data conducted by multiple country-specific health technology assessment (HTA) bodies with a single harmonized relative effectiveness assessment to reduce fragmentation and duplication (1).

The joint clinical assessment (JCA) is currently a voluntary collaboration, participation by member states is not mandatory, and non-EU countries can participate as observers or in specific collaborations (2). However, the process will be phased in for eligible health technologies starting with oncology products and advanced therapy medicinal products (ATMPs) in January 2025 (Figure 1, [3]). Once it is fully implemented in 2030, all drugs registered by the European Medicines Agency (EMA) via the centralized procedure will be subject to a JCA, and therefore, sponsors will need to prepare their new molecular entities (NMEs) for this process.

Figure 1: European Union joint clinical assessment (JCA) regulation will apply from 2025 onwards. [FIGURES COURTESY OF AUTHOR.]

The aim of JCA

The JCA enables EMA to run consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium. It aims to streamline the clinical assessment and cost-effectiveness of medicines to provide recommendations on pricing and reimbursement (P&R) decisions at the national level and improve patient access (4). Although the results of the JCA are currently non-binding, member states must give “due consideration” to the JCA report and can leverage the data to inform P&R decisions that remain under the jurisdiction of each member state (5).

Importantly, the JCA is designed to take into account the different member states’ requirements, for instance, regarding the standard of care (SoC) and patient preferences regarding clinical outcomes (2).

The main aspects covered by regulation (EU) 2021/2282 include:

• cooperation and exchange of information with EMA during JCAs
• deadlines and procedures for various stages, such as finalizing the assessment scope, submitting dossiers, preparing draft reports, and considering updates
• interaction and timing with the Coordination Group, its subgroups, health technology developers (HTDs), patients, clinical experts, and other relevant experts
• procedural rules for selecting and consulting stakeholders, patients, clinical experts, and other relevant experts
• provisions for confidentiality requests and processing of personal data
• requirements for correspondence and use of the HTA IT platform
• rules for handling changes to therapeutic indications, re-initiating assessments, and updating assessments
• templates and formats for dossiers, JCA reports, and summary reports (6).

Impact of JCA to date

Since the framework has been put in place, 68 JCA committees have occurred, but the use of JCA results remains limited by the member states (2). However, the JCA has established numerous guidance documents on procedures, methodology, the Scoping Process, direct and indirect comparisons, and report and dossier templates to help streamline the process (7).

According to OPEN Health analysis, pilot JCAs have considered a wider scope of clinical trials and product comparators compared with national HTAs. In addition, JCAs used a variety of safety endpoints and there was a good level of agreement in the use of efficacy endpoints by the JCA and national HTAs. The analysts concluded: “The new process will likely guarantee fairness in determining the true value and pricing of new technologies, but reimbursement decisions will ultimately rest at the national level” (8).

The JCA process is composed of four main steps:

1. the scoping phase, encompassing the development and validation of population, intervention, comparator, and outcomes (PICOs)
2. JCA dossier development phase
3. JCA dossier assignment phase
4. the publishing of the final JCA report (6).

The JCA directive aims to minimize the number of PICO elements; historically, at least five PICOs have been required. The assessment scope phase is around 90 days, which provides sponsors with limited time for evidence generation; therefore, sponsors must engage early with local affiliates and external stakeholders (9). Timelines for JCA dossier development are around six months, so, dossiers should be started at the time of EMA marketing authorization (MA) submission, to allow for sufficient preparation. The JCA dossier is required 45 days before the EMA’s Committee for Medicinal Products for Human Use (CHMP) opinion and will be published at the latest 30 days after approval of the medicine by EMA. The JCA report may influence country-specific HTA processes and procedures to start pricing negotiations (Figure 2, [6]).

Figure 2. Timeline for EMA and joint clinical assessment (JCA) dossier submission.

As of September 2023, the EUnetHTA 21 consortium was disbanded and all HTDs can now seek scientific advice from the national HTA body (HTAb) and EMA in parallel, via the Gemeinsamer Bundesausschuss/Federal Joint Committee, Germany (G-BA) (10).

Industry concerns about the JCA

The JCA is viewed by many in the industry as a good “starting point” to harmonize EU regulation and to accelerate and broaden equitable access to medicines across all member states. However, some patient organizations have raised concerns regarding the involvement of patient representatives in the JCA process. At a webinar held by Cencora Pharma, Antonella Cardone, CEO, of Cancer Patient Europe Cancer, noted it is unclear when, where, and how the patient voice will be incorporated into this process, and further work is needed to increase transparency and establish best practices, standards, and the selection of comparators and outcomes to maximize market access (11).

Future considerations for pharma before JCAs are compulsory

The future success of the JCA relies on significant coordination and cooperation between different stakeholders, including regulatory agencies, healthcare providers, and patient groups. To date, the JCA has reviewed a limited number of products due to restricted resources; therefore, additional funding and resources may be required to meet future demands. In the meantime, the JCA needs to continue to monitor and accommodate the needs and preferences of different regions and countries and to work closely with manufacturers and local stakeholders to ensure that drugs are accessible and affordable to patients in different regions and countries (12).

Moving forward, JCAs will have a considerable impact on market access and how pharma interacts with the EMA and HTA bodies. As the joint EU HTA process evolves, stakeholders will need to monitor how EU countries implement the EU HTA into their legislation and processes particularly given that each EU member state will vary in treatment patterns, patient populations, and equitable access to medicines. Pharma should seek early engagement with EU HTA assessors, to gather information and gain insights on pivotal trial designs, and any additional evidence requirements that may be needed for the effective assessment of pipeline assets.

In the meantime, pharma companies will need to think ahead, establish internal processes, and develop the skillset needed to respond to EU HTA at the country level. According to Alex Gee, senior director, Market Access, at Parexel, “Pharma needs to act to reduce their internal uncertainty and prepare for future success … This may require them to review processes, responsibilities, and capabilities to optimize for the new environment” (13).

The consultation closed on 2 April 2024, and it will be interesting to see how stakeholders’ views have been taken onboard and used to help refine the process to ensure that it is fit for purpose for future use.

References

1. European Parliament. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU. OJEU 2021, 64, 1–32.
2. Kulp, W.; Martel, M.; Billig, S.; Schmidt, K.; Martinez, J. Joint Clinical Assessment in the EU: Pan-European HTA for Drugs and Medical Devices Will Become Reality. HTA Quarterly. 21 Jan. 2022.
3. Lightning Health. European Joint Clinical Assessment. Article, 4 May 2022.
4. EUnetHTA. Joint Scientific Consultations (JSC). EUnetHTA.eu (accessed 21 March 2024).
5. JCA.EU, The JCA Process. JCA.eu (accessed 21 March 2024).
6. Remap Consulting. What is the Joint Clinical Assessment and What Does it Entail? Article, 3 March 2024.
7. JCA.EU. EUnetHTA Guidance. JCA.eu (accessed 21 Mar 2024).
8. Jose, R. Coming Soon: Joint Clinical Health Technology Assessments. OPEN Health, 20 March 2023.
9. Jose, R. Arca, E. European Health Technology Assessment Regulation: Implications for the Industry and 5 Key Areas for Successful Implementation. OPEN Health, March 2024.
10. Gemeinsamer Bundesausschuss. European Consultations: G-BA Acts as Coordination Contact for Parallel Consultations by EMA and HTA Agencies in Europe in the Interim Period until the Full Implementation of the EU HTA Regulation. G-BA.de (accessed 21 March 2024).
11. Cencora Pharma. Implications of the EU JCA on Patient Access and Engagement. Webinar. (accessed 21 March 2024).
12. Vesic, N. EU Joint Clinical Assessments: Theory vs Practice. PharmaBoardroom, 19 June 2023.
13. Gee, A. Joint Clinical Assessments: Manage What You Can Control. LinkedIn. 20 Oct. 2023.

About the author

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 4
April 2024
Pages: 7–8

Citation

When referring to this article, please cite it as Barton, C. Looking at the Potential Impact of JCA on Pharma. Pharmaceutical Technology Europe, 2024, 36 (4), 7–8.