UK patients with advanced melanoma were among the first in the world to access MSD’s Keytruda last year because of the country’s early access to medicines scheme.
Keytruda (pembrolizumab) was the first medicine to be awarded a positive scientific opinion and thus accepted onto the EAMS scheme back in March, offering patients with limited options a new treatment alternative ahead of a licensing decision in Europe.
The European Commission subsequently approved the drug in July, and in September final appraisal determination guidance from cost regulator the National Institute for Health and Care Excellence recommended its use at a shortened 30 day implementation, compared to the standard 90 days.
According to the MHRA’s case-study, the EAMS allowed more than 500 patients to access to the drug around four months earlier than they would have through the normal regulatory channel.
“EAMS undoubtedly accelerated access to pembrolizumab for patients with advanced melanoma and demonstrates a world-leading example of how healthcare agencies and industry can work together to get treatments to patients more quickly,” said Ben Lucas, Business Unit Director, Oncology, MSD.
“EAMS is an important step in ensuring patients gain access to innovative medicines as soon as possible, improving health outcomes in patients that urgently need new treatments,” noted Siu Ping Lam, Director of Licensing at the MHRA.
The MHRA received 18 applications for a Promising Innovative Medicine (PIM) status - the first stage in the two-step EAMS process - between April and December last year, of which 13 were granted, four were refused, and one is pending.