In Europe, the European Network for Health Technology Assessment (EuNetHTA), is the one tool, driving the conduct of health technology assessment (HTA) process. The Joint Clinical Assessment (JCA) is the central activity in this evaluation, that compares the relative clinical effectiveness and safety of emerging health technologies. As a way of arriving at a comprehensive and transparent assessment, the Population, Intervention, Comparison, Outcome, Study Design (PICOS) framework is widely employed. This, in turn, structured the approach so all critical aspects of the assessment are covered in a systematic way.[1]

EuNetHTA is a network of collaboration between various HTA organizations spread across the EU member states. The principle objectives of EUNetHTA include streamlining and harmonizing the HTA process to ensure consistency, transparency, and efficiency in the health technology evaluation. It lists JCA as its core feature, providing robust evidence of safety and clinical efficacy for new health technologies compared with available alternatives. These are important assessments to be used at the national level to inform decision-making processes on the reimbursement and eventual adoption of these technologies by different healthcare systems. The JCA process is well organized, from formulating the research question all the way through to finalizing it with clarity and precision. This research question is fundamental to the entire assessment process and is directly informed by the PICOS framework.[2]

The correlation between EuNetHTA and the PICOS framework is evident in the structured approach used to formulate the JCA research question. Each element of PICOS directly informs the corresponding aspects of the JCA. The JCA specifies the patient population for which the new technology is intended, aligning with the population component of PICOS. For instance, a JCA might focus on the effectiveness of a new drug for treating heart failure in patients with a specific genetic profile. The health technology being assessed is clearly defined in the JCA, reflecting the intervention component of PICOS. This could be, for instance, a novel surgical technique against some form of cancer or a new gene therapy for a type of genetic disorder. The JCA identifies the most appropriate comparator for the new technology, aligning with the comparison component of PICOS. This could be the current standard of care, a placebo control, or another alternative intervention. The JCA defines relevant clinical outcomes for assessing the impact of the new technology, corresponding to the outcome component of PICOS. Outcomes could include mortality rates, prevention of specific events, improvements in symptoms, disease progression, or cost-effectiveness measures. The JCA ensures that the assessment is based on rigorous and scientifically sound study designs, reflecting the study design component of PICOS.[2,3]

The integration of the PICOS framework within the JCA process offers several significant benefits. PICOS ensures a clear and well-defined research question, promoting transparency and facilitating efficient communication among stakeholders involved in the JCA. PICOS provides a structured and systematic method for defining the scope of the assessment and identifying relevant evidence for evaluation. By establishing a standardized framework, PICOS allows for comparisons between different JCA reports across Europe, promoting consistency and harmonization. The structured nature of PICOS enhances the reproducibility of the JCA, allowing for easier replication of the assessment by other researchers or healthcare institutions.[2,3]

Aligning with EuNetHTA’s PICOS is crucial for pharmaceutical companies developing new health technologies.  A well-defined PICOS framework during the HTA or SLR conducted by the company ensures a smooth transition to the JCA process.  By mirroring the PICOS elements used by EuNetHTA, companies can streamline the assessment process, anticipate potential information requests, and ultimately expedite regulatory approval.  Furthermore, considering the PICOS framework during the design of pivotal clinical trials allows companies to gather the most relevant data required for a successful JCA. This proactive approach minimizes the need for additional data collection during the JCA stage, saving time and resources for both companies and regulatory bodies.[3]

Despite its advantages, implementing the PICOS framework within EuNetHTA presents several challenges. Disparities among nations regarding expected endpoints and comparators can result in a high number of PICO parameters. Harmonizing these parameters is essential but challenging, requiring collective efforts across diverse healthcare systems. Different countries may have different requirements and preferences for the exact same PICO question, complicating the scoping phase of EuNetHTA process. Reaching a consensus on these research questions is crucial for a holistic assessment approach. Pharmaceutical companies often face hurdles due to limited early engagement opportunities in the centralized HTA process. Early engagement is critical for aligning the assessment with industry expectations and ensuring comprehensive evaluations. The lack of a requirement for consolidated advice engagement can lead to inconsistencies in the assessment process. Consolidated advice is essential for maintaining a harmonized approach and ensuring all relevant aspects are considered. There is often a lack of consensus on appropriate methodologies, with existing guidelines sometimes viewed as insufficiently flexible for novel or pragmatic approaches. This can hinder the implementation of innovative assessment methods.[4]

Multiple strategies can be utilized to tackle these like, ensuring the JCA process Involves early participation of all relevant stakeholders, including healthcare professionals, patient cohorts, and technology manufacturers, in order to guarantee a comprehensive understanding of healthcare needs. Extensive literature reviews and evidence synthesis, applying elements of the PICOS criterion represent a solid foundation for the assessment. Maintaining flexibility in the PICOS framework allows for adjustments based on new information or insights, enhancing the accuracy of the assessment. Developing standardized approaches and best practices for applying PICOS in JCAs contributes to consistency and facilitates knowledge sharing among EuNetHTA member states.[4]

The EuNetHTA JCA is a very vital tool for efficient and harmonized health technology assessments across the European Union. The PICOS framework allows a structured approach, providing the investigation with greater clarity, transparency, and robustness. Despite the existing issues with implementing PICOS in the context of EuNetHTA, results from strategic directions to come up with a more effective and consistent JCA framework could be promising. Ultimately, this synergy between EuNetHTA and the PICOS framework will contribute to better-informed healthcare decisions and improved health outcomes for patients across Europe.

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References

1. Desmet T, Brijs M, Vanderdonck F, Tops S, Simoens S, Huys I. Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks. Frontiers in Pharmacology. 2024 Apr 10;15:1369508.
2. Konstanski M, Gehrman J, Martinez JS, Schmidt K, Wissinger E, Altmann H. HTA229 PICO Criteria Applied in Joint Action 3 Differ From National HTA Requirements: A Review of Oncology Drug Assessments in Denmark, France, Germany, and Sweden. Value in Health. 2023 Dec 1;26(12):S363-4.
3. Chamoux C, Outteridge G, Berto P. PT29 Predicting PICOs for EU Joint Clinical Assessment: Lessons from PICOs in Relative Effectiveness Assessments (REA) from EUnetHTA Joint Action 3 Project. Value in Health. 2023 Dec 1;26(12):S392.
4. Schuster V. EU HTA Regulation and Joint Clinical Assessment—Threat or Opportunity?. Journal of Market Access & Health Policy. 2024 May 13;12(2):100-4.