Early access to medicines scheme (EAMS)

Working with NHS England and NHS Improvement (NHSE&I), we offer engagement meetings to help companies navigate through the early access to medicines scheme (EAMS) process.

The scheme provides an opportunity for important drugs to be used in clinical practice in parallel with the later stages of the regulatory process. Medicines with a positive scientific opinion could be made available to patients 12 to 18 months before formal marketing authorisation.

Set up an engagement meeting

How we can help

We facilitate engagement meetings for developers of pharmaceutical products granted a promising innovative medicines (PIM) designation through EAMS.

Preparing for the EAMS period or to submit for an EAMS scientific opinion can be challenging. The joint NICE and NHSE&I meeting can help to ensure you are ready for NHS patient access and NICE appraisal.

An EAMS meeting can:

  • Provide expert feedback from NICE and NHSE&I on your data collection plans for the EAMS period.
  • Help you to understand whether NHSE&I 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.

EAMS and NICE

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 NHSE&I at the right stage of the process can prevent delay between a positive scientific opinion and patients accessing the medicine.

To get the most value from our EAMS meetings, contact us as soon as you have requested a pre-submission meeting with the Medicines and Healthcare products Regulatory Agency (MHRA).

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.

We are preparing to submit for an EAMS scientific opinion. We're not sure whether the data we want to collect will be useful for HTA purposes or whether our plan could be accommodated within the NHS. We're also unsure about the suitability of different flexible pricing or managed access approaches for this particular technology.