From PICO anxiety to PICO strategy: planning for EU HTA success
In this interview, Ruairi O'Donnell, EU HTA Lead at Cencora, delves into the intricacies of the Joint Clinical Assessment (JCA) process and its impact on health technology developers (HTDs), particularly concerning the challenges of predicting and addressing PICOs (Population, Intervention, Comparator, Outcome).
Q&A on the latest guidelines for statistical analysis in EU Health Technology Assessment
The European health technology assessment (HTA) landscape is evolving, with new guidelines on statistical analysis set to impact biopharmaceutical companies starting in January 2025. Dr. Michael Hennig, Senior Director, Expertise Line Head HTA Statistics, at Cencora PharmaLex, delves into the details of the guidelines, their evolution, stakeholder involvement, challenges in implementation, promising approaches, adaptability to emerging trends, and their potential influence on decision-making processes within healthcare systems across Europe.
Forging ahead with US and EU healthcare policy changes: balancing sustainability, innovation and patient access in the era of IRA and EU HTA
The Inflation Reduction Act (IRA) is set to introduce significant reforms aimed at controlling drug prices and reducing out-of-pocket expenses for patients. The EU Health Technology Assessment (HTA) Regulation is about to be increasingly adopted to streamline and enhance efficiency within decision-making for the clinical value of new health technologies. But what are the implications of these policies for stakeholders, including biopharma companies, healthcare providers, payers, and patients?
Q&A Interview: Navigating the launch of ATMPs in Europe
Considering the imminent impact of the EU Health Technology Assessment (HTA) on ATMPs and oncology drugs, starting January 2025, Cencora experts Lung-I Cheng, Vice President and Head of Cell and Gene Therapy, and Herbert Altmann, Vice President of Market Access and Healthcare Consulting, shed light on the upcoming shifts in regulation and the strategies essential for successful navigation.
Embarking on the EU HTAR realization journey: Key insights from the first of six implementing acts
Less than one year before the implementation of the European Union Health Technology Assessment Regulation (EU HTAR), industry and national HTA bodies are still missing clarity on the Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA) procedures. The first implementing act of JCA has now been published, but does it address the stakeholders’ concerns?
Webinar on demand: Implications of the EU JCA on patient access and engagement
The Joint Clinical Assessment (JCA) aims to improve patient access to innovative medicinal products, however, there are concerns about how effectively the JCA will recognize the patients’ voice. Watch on demand to hear from experts from Cancer Patients Europe, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and Cencora.
Does the EU HTAR really put patients at the center?
There is widespread agreement across healthcare that the Joint Clinical Assessment (JCA) has good intentions – to accelerate the process of bringing innovative medicinal products to patients, strive for equal access, and reduce bureaucracy1. The more pertinent question, however, is how will the new process, which is a key pillar of the European Union’s Regulation on Health Technology Assessment (HTAR), truly impact patients across the EU?
Navigating the way to the new EU JCA—Are biopharma companies, HTA bodies, patients, and clinicians sufficiently prepared?
The interim period between the closure of the European Network for Health Technology Assessment 21 (EUnetHTA 21) and the full application of the Health Technology Assessment Regulation (HTAR) has begun. Is sufficient guidance available for biopharma companies, health technology assessment (HTA) bodies, patients, and clinicians, or do uncertainties remain?
Exploring the Implications of Differing PICO Criteria for Oncology Drug Assessments in Europe
The European Union’s Joint Clinical Assessment (JCA), relies on the definition of consolidated population, intervention, comparators, and outcomes (PICO) criteria to guide assessments. However, as we discovered through our research presented at the ISPOR Europe 2023 conference, national differences in healthcare systems and treatment guidelines can significantly impact the application of PICO criteria in drug assessments.
The EU JCA process: Opportunities and challenges in bringing innovative medicines to patients in Europe
During this panel discussion healthcare system experts from Cencora, the European Federation of Pharmaceutical Industries and Associations (EFPIA), MSD, PharmaLex, and Vintura, explore the JCA process and efforts to ensure timely access to innovative healthcare products within this new framework.
Unlocking the Potential of Joint Clinical Assessment (JCA) in Europe: Insights from Industry Leaders and Experts
In the ever-evolving landscape of healthcare, ensuring timely access to innovative therapies is a top priority. One promising approach that holds the potential to expedite patient access is the Joint Clinical Assessment (JCA). JCA aims to harmonize the evaluation and decision-making processes for new interventions across European member states, streamlining the path from development to market.
Q&A – Preparing for the EU Joint Clinical Assessment (JCA) process
During a recent panel discussion on the European Joint Clinical Assessment (JCA) process market access and healthcare system experts offered their perspectives on the challenges and opportunities pharmaceutical and biotechnology companies are likely to encounter.
Multistakeholder perspectives on Joint Clinical Assessment in Europe
What are the opportunities and challenges for improving patient access to new treatments? In an interview with The Evidence Base, our experts discuss the JCA framework, how it will streamline the HTA process and help address health inequalities in Europe, what are the risks and opportunities ahead, and the key requirements to meet the needs of the different EU member states.
Panel explores insights and implications of the game-changing EU JCA
In a recent panel discussion led by Tommy Bramley, Senior Vice President, Global Consulting and Market Access, Cencora, market access and healthcare system experts shared their insights on what the JCA will mean, and the challenges and the opportunities pharmaceutical and biotechnology companies will face.
