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Keytruda is UK's first early-access medicine

Merck’s melanoma therapy accepted under the UK’s EAMS


Merck & Co's melanoma therapy Keytruda has claimed the distinction of being the first drug to be accepted under the UK's Early Access to Medicines Scheme (EAMS).

Merck - which operates as MSD outside North America - said PD-1 inhibitor Keytruda (pembrolizumab) was accepted into the scheme "based on the significance of … early study findings and unmet medical need."

The EAMS system was introduced last year in order to provide a way for patients with serious diseases to get access to new therapies more quickly, before a European license had been granted but after the Medicines and Healthcare Products Regulatory Agency (MHRA) has determined the benefits outweigh the risks.

The scheme also means that new therapies can be made available in advance of a cost-effectiveness assessment by the National Institute for Health and Care Excellence (NICE).

Medicines in EAMS will typically be commissioned by NHS England through its specialised commissioning arrangements, and MSD will provide Keytruda free of charge to the NHS while it is prescribed under the scheme.

Commenting on the development, Minister for Life Sciences George Freeman said that in recent years, "too many NHS patients have had to wait too long to access new treatments and slow uptake also threatens life science industry investment."

The rivalry between Merck and Bristol-Myers Squibb - which makes rival melanoma therapy Opdivo in the same PD-1 inhibitor class - has also spilled into this fast-track mechanism. 

In January, BMS claimed Opdivo was the first PD-1 inhibitor to be awarded Promising Innovative Medicine (PIM) status - the first stage in the EASM process - although MSD has beaten it to the finishing line by claiming the first EAMS Scientific Opinion, the final hurdle.

The news was welcomed by medical charity Melanoma UK. Founder Gillian Nuttall, said: "There are limited options for advanced melanoma patients, the majority of whom are in difficult positions which simply means they cannot afford to play any kind of waiting game.

"There is clearly an unmet need and we are delighted such progress is being made."

Article by
Phil Taylor

12th March 2015

From: Sales



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