The first medicine to be approved through the UK’s Early Access to Medicine Scheme has been named as MSD’s PD-1 inhibitor pembrolizumab, an immunotherapy treatment for advanced melanoma.
The humanised antibody is different from other cancer drugs in that it boosts the immune system to launch an attack on cancer cells, rather than destroying cancer cells directly. The fact that it is humanised means it remains undetected by the body’s immune response.
The EAMS enables patients with life-threatening and seriously debilitating conditions to receive innovative and promising new drugs as soon as the Medicines and Healthcare products Regulatory Agency (MHRA) has signalled that the benefits outweigh the risks, through a two-stage evaluation process.
In stage one, if the MHRA considers a product to be a possible candidate for EAMS, it will issue a Promising Innovative Medicines (PIM) designation, based on early clinical data. In stage two, the Agency will issue an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value.
Medicines in EAMS will typically be commissioned by NHS England through its specialised commissioning arrangements, and MSD will be providing its medicine free of charge to the NHS while it is prescribed under the scheme.
According to the firm, a substantial number of people across the UK with advanced melanoma, who have limited remaining options, are expected to benefit from accelerated access to the drug, which has already been approved in the US as Keytruda and is currently being reviewed by European regulators.