The Early Access to Medicines Scheme (EAMS) is designed to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation where there is clear unmet medical need.
The Medicines and Healthcare products Regulatory Agency (MHRA) provides a scientific opinion on the benefit/risk balance of the medicine which lasts for a year or until marketing authorisation (MA) is granted. NICE draft guidance is scheduled to be published shortly after Marketing Authorisation is granted.
The MHRA's scientific opinion is provided after a two-stage evaluation process:
- The promising innovative medicine (PIM) designation
- The early access to medicine scientific opinion
More information about the scheme and how to apply is available on the MHRA website.
The MHRA shares the PIM designation and preliminary positive opinion on Day 45 (45 days from the start of the MHRA assessment for scientific opinion) confidentially with the NHS and appraisal bodies in the UK including AWTTC.
Pharmaceutical companies are encouraged to contact AWTTC ahead of the EAMS scientific opinion to discuss the implementation of an EAMS medicine in NHS Wales.
Frequently asked questions
When should a pharmaceutical company contact AWTTC?
Early engagement (ahead of positive opinion at Day 45) maximises the opportunity for AWTTC to facilitate EAMS uptake in NHS Wales. If no correspondence has been received at the time of the positive opinion at Day 45, AWTTC will contact the applicant company. Contact us by email at
awttc@wales.nhs.uk
What information will AWTTC request?
In order to keep duplication to a minimum AWTTC request a copy of the D45 checklist that is completed for NHS England.
How will AWTTC support implementation of EAMS medicines?
AWTTC works with health board formulary pharmacists, various clinical networks and the Medicine Value Unit (MVU) in Wales and will facilitate communication between the relevant stakeholders to encourage consideration and uptake of an EAMS medicine for patients in NHS Wales.
What if MA is granted before NICE HTA advice is published?
NICE will schedule the appraisal such that draft guidance (or final guidance in cases where there are no issues requiring consultation) is issued very shortly after Marketing Authorisation. On occasion it may be that NICE advice has been delayed or the consultation period extended; in such circumstances a winding down period may be agreed with the MHRA. The winding down period may be considered for existing and new patients for a maximum of one year.
What if NICE do not recommend use of an EAMS medicine?
In situations where the final NICE guidance does not recommend a medicine introduced through the EAMS, the company will agree a clear exit strategy for patients in Wales.