NICE wants companies to alert it to possible candidates for the early access to medicines scheme
Pharmaceutical companies should inform the National Institute for Health and Care Excellence when a medicine has been deemed a possible candidate for the early access to medicines scheme (EAMS), even though the information will not be in the public domain, according to NICE.
Speaking at a joint meeting of the Association of the British Pharmaceutical Industry and the UK Bioindustry Association earlier this week (28 April 2014), Meindert Boysen, NICE programme director for technology appraisals, said that it is “absolutely vital” that NICE understands which technologies have been given “promising innovative medicines” (PIM) designation from the Medicines and Healthcare products Regulatory Agency.
The PIM designation is an early indication that a medicinal product is a possible candidate for the EAMS and is likely to be considered for step 2, the scientific opinion, explained Daniel O’ Connor, MHRA expert medical assessor. “The MHRA will not publish either positive or negative designation decisions. However, the MHRA may publish information on the number of designation meetings carried out.”
Mr Boysen explained: “We’re slightly surprised that it is not in the public domain, but we hope the companies will do their best to make sure that we understand, as well as their investors, that these drugs have PIM designation status.”
Paul Catchpole, value and access director at the ABPI, said that part of the process requires engagement on early scientific advice and, therefore, early dialogue with NICE may be important on a confidential basis, as determined by companies on a case-by-case basis.
He added: “We would expect companies to have confidential discussions with NICE as early as possible, but we would not expect them to put potentially commercially sensitive information in the public domain until the full assessment process had been completed for granting a medicine early access status.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11137987
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