For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
At the end of June 2022, the European Commission organized a meeting about the Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) with all stakeholders in the European healthcare space: member state authorities, HTA bodies, industry representatives, health professionals, and patients. This is the much-anticipated Regulation on the EU-wide HTA framework that was adopted in 2021 and will come into force in 2025. However, practical details as to its implementation remain scarce. So, what do you need to know?
So far, under the Cross-Border Healthcare directive 2011/24, only the regulatory part of the process giving drugs access to the European market was successfully unified under the European Medicines Agency (EMA) umbrella. HTA, pricing, and reimbursement were the prerogative of member states (EU countries). This resulted in headaches for the pharmaceutical industry when launching a new drug, vaccine, medical device, or medical test in the 27 member states, with 27 different regulations, 27 different reimbursement dossiers, 27 different appraisal techniques, and requirements, 27 different negotiations, etc.
The European Commission recognized these inefficiencies and adopted a long-awaited Regulation on HTA in December 2021, amending once more the Cross-Border Healthcare Directive 2011/24. The key principle of this EU Regulation on HTA is to have a common scientific assessment of clinical aspects of HTA for new treatments and health technologies. This assessment will be driven by the member states' authorities to produce high-quality and timely reports for national HTA processes.
The European Commission is currently in a preparatory phase, during which will see the setup of a Coordination Group (overseeing assessments and joint works), a Stakeholder Network (regrouping patients, healthcare professionals, the industry, payers), and will draft guidance documents. This is expected to be completed by 2025 when the first oncology assessments are due to take place.
This Coordination Group will benefit from the work from EUnetHTA21, a service contractor working on high-quality HTA collaboration in Europe for the European Commission since 2006. Through several iterations (Joint Actions 1/2/3), EUnetHTA established the foundation of collaborations between European HTA agencies, drafted assessment documents, and conducted several dozen common HTA assessments. EUnetHTA21, the last EUnetHTA iteration, will support the future EU Regulation on HTA by developing methodology, templates, guidelines, and other elements fit-for-purpose to be used by the Coordination Group. Public consultations (some already ongoing), Joint Clinical Assessments (JCA), and Joint Scientific Consultations (JSC) will also shape these developments.
In 2025, when the EU Regulation on HTA will be implemented, it will start by assessing oncology drugs and advanced therapies (e.g., gene therapies). Orphan drugs will start being assessed in 2028. Timelines for the assessment of medical devices, medical tests, and vaccines are still being drafted by the Coordination Group.
The European Commission presented its plans for implementing this new legal framework at the June conference. Ample time was provided for discussions between member states' authorities, HTA bodies, industry representatives, health professionals, and patients. While the additional information and the productive discussion were highly appreciated, many questions still need to be resolved.
During the conference, the European Commission insisted that member states will keep their rights to perform an additional or independent assessment using their established frameworks. The JCA will only assess the clinical benefits of new treatments, leaving member states to maintain their principles over pricing and reimbursement decisions (including health economics evaluations). This poses two challenges for companies launching new treatments in Europe:
While the shape of the JCA is beginning to appear, key questions that will impact realizing the value of new assets remain to be answered to support investment decisions, particularly around phase 3.
As EUnetHTA21's work will at least inform the Coordination Group in their decision regarding the common assessments in 2025, Parexel actively participates in their public consultations and follows up with guidelines and templates. This allows our partners to present aligned HTA evidence as much as possible with the future of HTA in Europe.
In recent years, Parexel has helped companies develop dossiers using the Model D5.1 Guidance submission dossier and other assessment documents aligned with EUnetHTA21's Joint Clinical Assessments methodologies and guidelines. Parexel has also supported many early interactions with EUnetHTA21, using the joint scientific advice interactions to ensure clinical trial programs are designed to meet the JCA requirements.
Parexel offers unique strength in market access. Our staff of subject matter experts, including former HTA agency employees, is trained in the latest evolutions of market access and HTA regulations. We cover everything from global Pricing & Market Access (P&MA) strategy to local market access planning and HTA submission through HTA and early payer engagement, evidence optimization, and value communication. We can thereby assist your subject-matter experts in preparing your evidence package.
With deep experience in European HTA and a growing understanding of the future EU Regulation, we can help you prepare – and give you a better chance of getting your product appropriate market access and pricing.
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