UK government thinking on the introduction of an Early Access to Medicines scheme is now “at an advanced stage,” with “active discussion across Whitehall,” Department of Health Minister Earl Howe has said.
The discussions concern the introduction of a new “promising innovation medicine” designation, the Minister added, speaking at a meeting of the Empower Access to Medicines campaign in London. The government recognises the success of the “breakthrough therapy” designation which has been available in the US for the last 18 months, and hopes that the proposed “promising innovation medicine” designation would provide a similar boost for such products developed in the UK, he told the meeting.
The Minister’s words have been welcomed by Steve Bates, chief executive of UK industry group the BioIndustry Association (BIA), who also attended the meeting and points out that his Association has long called for such a scheme.
“I think that such a ‘promising innovation medicine’ designation would enable companies to signal in a straightforward way to potential patients and investors that they were adopting the speediest and most efficient regulatory process and had mapped out and would utilise the most appropriate route to work with NHS centres of excellence and Academic Health Science Networks [AHSNs] to ensure timely adoption and usage of a new therapy,” Mr Bates writes on the BIA website.
Such a designation is also likely to have a positive effect on the companies developing these products and also on the investment community’s perception of those companies, he adds.
Mr Bates also suggests that the proposed “promising innovation medicine” designation could prove to be more valuable than the US Food and Drug Administration (FDA)’s “breakthrough therapy” because it is likely to be linked with a process that delivers reimbursement via an Early Access to Medicines scheme; combining the designation and the scheme should enable NHS patients to be among the first in the world to benefit from new therapies, he says.
Medicines receiving the proposed designation “will be on the fast track for the most efficient regulatory engagement with the Medicines and Healthcare products Regulatory Agency [MHRA], using all the existing flexibilities available, and then given VIP access into the NHS system through the appropriate centres of excellence,” he writes.
- The US FDA received 92 requests for “breakthrough therapy” designation during October 1 2012-September 30, 2013, and so far,it has approved three such products - Genentech’s Gazyva (obinutuzumab), Pharmacyclics’ Imbruvica (ibrutinib) and Gilead Science’s Sovaldi (sofosbuvir).