Highlights on EMA’s focus to advance patient-centred access to medicines in partnership with healthcare systems
In EMA’s Regulatory Science Strategy to 2025, the EMA presents initiatives to advance not only the patient-centred drug development but ALSO the patient-centred access to medicines.
The EMA wants to advance the patient-centred access to medicines through partnerships with healthcare systems – e.g. by further developing the structured interaction between the EMA and the Health Technology Assessment (HTA) bodies and payers as these are key decision makers determining the use and availability of medicines in the EU healthcare systems.
As part of the EMA’s Regulatory Science Strategy to 2025, the EMA also highlights its intention to improve the communication with HTAs and payers regarding therapeutic contexts, comparison vs. placebo/active-control, and the patient perspective. Especially related to the patient perspective, the EMA aims to foster input of patients/patient representatives and caregivers in the regulatory process. Furthermore, the EMA wants to enhance multi-stakeholder advice in collaboration with patients, health care professionals (HCPs), HTAs and payers.
The EMA also emphasizes its aim to provide regulators, HTAs and payers with better evidence to underpin regulatory assessment and decision-making in order to ensure that patients gain access to beneficial treatments while being protected from medicines whose benefits do not outweigh their risks.
In addition, the EMA wants to contribute to HTAs’ preparedness and downstream decision-making for innovative medicines by implementing the following actions:
- Ensure the evidence needed by HTAs and payers is incorporated early in drug development plans, including requirements for post-licensing evidence generation.
- Enable information exchange with HTAs to support bridging from benefit-risk to relative effectiveness assessment.
- Discuss with HTAs guidance and methodologies for evidence generation and review.
- Collaborate with HTAs on the identification of priority products and technologies.
- Monitor the impact of decision-maker engagement through reviews of product-specific experience.
- Further develop the structured interaction between EMA and HTA bodies, respecting the respective remits.
Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf
Click here to learn more about the core recommendations presented in EMA’s Regulatory Science Strategy to 2025.
Patients are experts in their own experiences
Patients are experts in their own experiences and it can be very beneficial to bring their voices into the drug development process. This can be done by interviewing patients participating in clinical trials.
Interviewing patients as part of the drug development process can provide a clearer picture of the patients’ experiences and preferences for a new treatment. In this way, by obtaining feedback directly from the end-users of a treatment, patient access to medical care can be done in an even more informed way. In addition, enhancing patient engagement in drug development can produce more meaningful and applicable outcomes that can help produce better treatments more closely aligned with the patients’ needs. It all starts with the incorporation of the patients’ voices in your clinical trial program.
Click here to learn about how Clinigma® supports pharmaceutical companies in capturing patient feedback in clinical trials.
