Faster access to drugs scheme to launch in UK this year
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will this month begin a 12-week public consultation on the feasibility of introducing a scheme to make new drugs available to patients before they are formally licensed, with the aim of introducing a scheme later this year.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will this month begin a 12-week public consultation on the feasibility of introducing a scheme to make new drugs available to patients before they are formally licensed, with the aim of introducing a scheme later this year.
The proposed Earlier Access Scheme would enable patients with life threatening or seriously debilitating conditions for which there are limited treatment options access to potentially life saving medicines around one year earlier than is currently the case, said the MHRA. However, it warns that the proposed scheme could still result in "a certain amount of variation" in the uptake and availability of such treatments as funding will have to be provided from existing Primary Care Trust (PCT) budgets.
The Scheme would operate within the existing regulatory framework and not amount to "conditional licensing", the MHRA added.
The Ministerial Industry Strategy Group (MISG) originally asked the Association of the British Pharmaceutical Industry (ABPI) with the BioIndustry Association (BIA) and the MHRA to explore the desirability of introducing an Earlier Access Scheme and in December 2009 the MISG approved the framework for such a scheme.
Under the proposals the Scheme will be available for medicines that have completed Phase III trials, although in exceptional circumstances an earlier authorisation may be possible based on Phase II data.
The drug developer will decide whether to apply for inclusion in the Scheme. The MHRA will review the drug with input from an independent expert advisory group and charge a fee for this service. The review is expected to take a maximum of 75 days to complete, including a 30-day initial assessment period with a possibility of a single round of questions to the drug developer, 15 days for their response, plus a further 30 days to review. Approval will last for one year and would be renewable if necessary.
The drug developer would set the price of the medicines supplied under the Scheme and no National Institute for Clinical Excellence (NICE) would be involved. There would be no central mandate for funding, as applies to NICE approved products, nor any additional funding for medicines supplied under the Scheme. A UK-wide exit strategy, which is specific to each medicine, must be stated upfront, the proposal said.
Patients must also understand the risk trade-offs that are at stake in accepting treatment with an unlicensed medicine, as well as the potential benefit. An essential element of the scheme will therefore be good quality information, the MHRA said.