We can help you navigate through the early access to medicines scheme (EAMS) process. We do this by working with NHS England to offer engagement meetings.
EAMS allows important drugs to be used in clinical practice during the later stages of the regulatory process. If medicines have a positive scientific opinion, they could be made available to patients 12 to 18 months before formal marketing authorisation.
How we can help
We can organise an engagement meeting for you if your pharmaceutical product has a promising innovative medicines (PIM) designation through EAMS.
It can be challenging to prepare for the EAMS period or to submit for an EAMS scientific opinion. The engagement meeting can help you make sure you are ready for NHS patient access and our appraisal.
An EAMS meeting can:
- Provide expert feedback from NICE and NHS England on your data collection plans for the EAMS period.
- Help you to understand whether NHS England can accommodate your plans within the time available.
- Provide insights into flexible pricing options and managed access approaches that you may want to consider.
This is a not-for-profit service but we charge a fee to cover our costs.
Our EAMS process
To understand our involvement in the EAMS process, download our guide to EAMS procedures at NICE (PDF).
This includes:
- an introduction to the scheme and how to apply
- explanation of the key stages of EAMS and NICE's role
- a diagram of the process, including approximate timeframes
- detailed procedures for NICE EAMS meetings.
We also participate in the government - industry stakeholder task group supporting the EAMS scheme.
Timing of EAMS meetings
Engaging with us and NHS England at the right stage of the process can prevent delays between a positive scientific opinion and patients accessing the medicine.
We aim to hold the meeting before the MHRA issues the day 45 preliminary scientific opinion. See the MHRA's list of dates for more information.
To make the most of our EAMS meetings, contact us as soon as you have requested a pre-submission meeting with the Medicines and Healthcare products Regulatory Agency (MHRA).