How the JCA may help to address medicine inequality across Europe
5 minute read
Patient access variation
The JCA follows European Commission recognition of problems with inequality across Europe when it comes to patients accessing innovative medicines. These access barriers are the result of numerous factors, including the wide variation in how long each country takes to manage the HTA process on a national and sub-national level, a lack of healthcare system resources in smaller EU countries, and a tendency by the industry to focus on larger markets in Europe.
According to the the European Federation of Pharmaceutical Industries and Associations (EFPIA) Patients Waiting to Access Innovative Therapies (W.A.I.T.) Indicator 2022 Survey, which includes data on 37 countries (27 EU and 10 non-EU)iii, medicine availability of 168 EU approved products differs vastly across the EU. As an example, in Germany, 87 percent of these products have full availability, while in Poland only 8 percent have full availabilityiv. Furthermore, the data finds that a patient in Poland has to wait an average of 725 days from marketing authorization to availability for a new medical solution versus 47 days for a patient in Germanyv.
With life-saving oncology products, the data is equally stark, according to Vintura and EFPIA’s Every Day Counts reportvi. The proportion of EU authorized oncology therapies that receive a positive reimbursement decision varies from 7 percent in Latvia to 98 percent in Germany, while time to market access ranges from an average of 86 days in Denmark to 981 days in Latvia.
Through a single submission and jointly conducted assessment process, the JCA seeks to address the issues posed by multiple country-specific clinical assessments and therefore to establish a more streamlined, transparent and less bureaucratic single market for health technologiesvii.
To achieve the objectives of the HTAR, the European Commission awarded a service contract to a group of 13 HTA agencies, referred to as the EUNetHTA 21 consortium, to “advance the development of HTA methodology to be used when carrying out joint work (e.g., joint scientific consultations, joint clinical assessments) and provide relevant input to the new legal framework on HTA being developed at that timeviii.”
However, there is a very real risk that the JCA might not solve all needs or questions from the different EU member states. Where that is the case, those member states will ask manufacturers to submit additional data or evidence while carrying out an additional assessment locally. This would add complexity and delay access to innovative medicine in those countries.
The EUNetHTA 21 consortium has yet to provide its proposal for the final framework for the JCA to the Commissioning Group from the European Commission. The JCA process will become mandatory for oncology drugs and advanced therapy medicinal products (ATMPs) in January 2025, followed by orphan drugs in January 2028, and for all drugs registered with the EMA by January 2030ix.
Support from largest markets
While there was some early uncertainly about the JCA process from Germany and France, which have well-established national systems in place, they have since thrown their weight behind the joint assessments. Since then, the Netherlands, Germany and France have demonstrated their full support and are in fact driving the JCA process to ensure it achieves the objectives of improving patient access.
Nevertheless, there remains some controversy over how the process should be run, how industry can impact it and ensure their feedback is heard, and whether the patient perspective will be included in the final framework.
In October 2022, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) issued a joint statement outlining their concerns about the direction of implementation, calling for the process for JCA to “seek an alignment on common European methodologies and information requirements and harmonized HTA criteria, rather than a mere amalgamation of national practices which would undermine the goals of the Regulationx”.
The final JCA framework is currently still unknown. However, as previous system implementations have shown, it takes time for the industry to become comfortable with a new process. Indeed, when new submission processes were introduced by the European Medicines Agency some years ago, many concerns were initially raised. Once the industry and other stakeholders become accustomed to the new JCA process, it could become as familiar as the EMA’s regulatory processes.
However, for it to achieve the objective of equitable access to medicine for all EU patients, all health care system stakeholders will need to make an effort to support a transparent and innovation-led JCA process. That includes striving to remove redundancies and aligning around the objectives of reducing inequality and improving speed to market.
iRegulation on Health Technology Assessment, European Commission, https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en
iiEFPIA-EURODIS Joint Statement on Patient Access to Medicines for Rare Diseases, June 2022, https://www.efpia.eu/media/637073/efpia-eurordis-joint-paper-on-access-to-medicines.pdf
iiiEFPIA Patients W.A.I.T. Indicator 2022 Survey, IQVIA, Published April 2023. https://www.efpia.eu/media/677311/efpia-patient-wait-indicator.pdf
ivBreakdown of availability (%, 2018-2021), W.A.I.T. Indicator 2022 Survey.
vMedian time to availability (2018-2021), W.A.I.T. Indicator 2022 Survey.
viEvery Day Counts: Improving Time to Patient Access to Innovative Oncology Therapies in Europe, Vintura, 2020. https://www.efpia.eu/media/578013/every-day-counts.pdf
viiJoint clinical assessment in the EU: Pan-European HTA for drugs and medical devices will become reality, February 2022, Kelp, W., et al, AmerisourceBergen/Xcenda. https://www.xcenda.com/insights/htaq-spring-2022-joint-clinical-assessment-eu
viiiEUnetHTA21 service contract, European Commission, https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment/eunethta21-service-contract_en
ixEUnetHTA 21 – Stakeholder Meeting, 13 July 2022. https://www.eunethta.eu/wp-content/uploads/2022/07/Stakeholder-meeting-13-07-2022-slides.pdf
xJoint Statement Pharmaceutical industry concerns over the implementation of the EU HTA Regulation, October 2022. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/joint-statement-pharmaceutical-industry-concerns-over-the-implementation-of-the-eu-hta-regulation/
Panel discussion – The EU JCA process
The EU JCA process, seeking to substitute multiple country-specific clinical assessments and establish a more streamlined, transparent and less bureaucratic single market for health technologies, will pose both a threat and an opportunity for getting innovative medicines to patients in Europe.
Watch our panel discussion to explore the ins and outs of the JCA and the next steps to best prepare.Moderator Tommy Bramley, SVP, Global Consulting, AmerisourceBergen, welcomes panelists Herbert Altmann, Head Commercialization and Access Solutions Europe, PharmaLex, Casper Paardekooper, Partner, Vintura, Mihai Rotaru, Senior Manager Market Access, EFPIA, and Jurgen Huismans, Global Director Access & HTA Strategy, MSD, for an hour-long discussion including Q&A with the audience.
Herbert Altmann, Ph.D.
Head Commercialization and Access Solutions Europe with PharmaLex, part of AmerisourceBergen