- After Merck's melanoma drug Keytruda was accepted into the UK's Early Access to Medicine Scheme (EAMS), 500 UK patients were granted access to the drug four months earlier than normal.
- In March 2015, Keytruda (pembrolizumab) became the first treatment to be accepted under EAMS, a program designed to give severely sick patients early access to new medicines.
- Keytruda eventually gained an EU license from the European Commission in July 2015. The UK's National Institute for Health and Care Excellence provided final cost guidance two months later in September.
In the world of oncology, four months can make a dramatic difference, especially in the case of patients with metastatic melanoma. The five-year life expectancy ranges from 10% in men to 25% in women. Five-hundred patients in the U.K. with metastatic melanoma were able to receive Keytruda before the drug was granted an EU license.
The EAMS system, which is administered through the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), is designed to help patients gain access to medications ahead of approval. There has been fairly strong demand, with 18 applications between April and December 2015. Overall, 13 of those 18 applications were granted EAMS access, while four were refused. One application is still pending.