What is the Early Access to Medicines Scheme (EAMS)?
Introduced in 2014, EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines when there is a clear unmet need. The scheme is voluntary and does not replace the normal licensing procedures.
Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.
What are the stages?
The first stage of EAMS is a Promising Innovative Medicine (PIM) Designation, which is an early indication that a medicinal product is a likely candidate for EAMS. Three criteria must be fulfilled to gain a PIM designation. These are:
Once a PIM designation is granted, the company can apply for EAMS. The criteria for an EAMS application are the same as the criteria for a PIM designation, with the additional requirement that the applicant must be able to supply the medicine and manufacture it to a consistent quality standard. After submission, the MHRA will issue an EAMS scientific opinion on the benefit/risk of the medicine, based on the data available. Positive EAMS scientific opinions tend to be for products that have completed Phase III clinical trials, though in some instances they have been granted to products that have only completed Phase II trials.
The company will then provide the medicine free of charge to the NHS during the EAMS period until a marketing authorisation is granted. The scientific opinion lasts for one year and can be renewed, although there is an additional cost.
EAMS provides patients with seriously debilitating and life-threatening conditions access to a medicinal product before a marketing authorisation is granted. EAMS also provides the opportunity to generate real-world patient data, with the expectation that medicines with a positive EAMS scientific opinion could be made available to patients up to 18 months ahead of a marketing authorisation.
Opportunities and risks
EAMS opportunities include:
- A shorter time to achieve NHS funding. NHS England commissioners are expected to fund within 30 days of positive NICE guidance compared with 90 days normally. Achieving early funding means approximately 6 months of free-of-charge supply.
- NICE must consider the product to be innovative when a PIM designation is granted.
· Confidentiality, so no minutes are ever published and a positive designation is only published at the company’s discretion.
· No penalty if the company disengages from the EAMS process, even if the PIM is positive.
The company must make the product available free of charge until a UK marketing authorisation is granted, and MHRA expect regular updates on significant new data. Data collection must be carried out during the EAMS period, which will be agreed between NHS England and NHS Improvement (NHSE&I), NICE and the company.
An EAMS programme is typically only open for a few months; however, there is no fixed time limit on how long an EAMS can run before receiving a marketing authorisation. While this may appear short, patients who begin treatment within this period will continue to receive the product once enrolment closes, so data collection will continue beyond this point. In addition, there is potential for many patients to be enrolled in a short time unless enrolment is limited as part of the EAMS agreement. The company needs to be aware that if reimbursement is not agreed, then the company may potentially be responsible for supplying the product in perpetuity to any patients enrolled. If a PIM is positive, it does not guarantee a positive EAMS. MHRA will interrogate the product’s data and will focus on where there is no uncertainty; therefore, EAMS may be granted for a sub-group population only or not at all.
Key considerations and questions
Next steps for EAMS
MHRA has recently prepared a government response outlining the key legislative changes to EAMS. These changes will provide the UK with an opportunity to maximise the scheme’s impact by accelerating availability of medicines for patients, reduce the burden on companies and facilitate the collection of real-world data through a framework that could potentially be used as evidence to support regulatory decision making for future authorisations. This will help patients to benefit from important EAMS medicinal products and ensure that the UK remains internationally competitive in the pre-market access landscape.
MAP has experience in supporting companies with the EAMS process, please contact us today to find out what support we can provide you.