Abstract

Patient Access Schemes (PAS) have become an integral part of the UK pharmaceutical environment. The research seeks to investigate the historical role PAS have played in regard to Health Technology Appraisals (HTAs), how the mechanism interacts with other features of the UK funding environment, such as the Cancer Drugs Fund (CDF), and the PAS strategies employed by pharmaceutical companies to optimise funding recommendations. It also takes a forward look towards any role PAS might have in a value-based pricing system, which is potentially facing the UK from 2014. We reviewed NICE Technology Appraisals which included a PAS from 2002 up to June 2012. We then extracted the key information and compared and contrasted the advantages/disadvantages of different schemes as time has progressed. PAS have shifted from outcome-based schemes to financially-based discounts. It is clear from the results that as PAS have become more integral to the UK HTA environment, an acceptance of confidentiality and a requirement to prove that PAS reduce uncertainty to payers are two major developments. The research also highlights how the CDF may act as a potential disincentive for manufacturers to engage with PAS and provide the NHS with discounts to achieve cost-effectiveness. As there are set opportunities for manufacturers to submit PAS, it is vital that pharmaceutical companies consider a PAS for the purpose of a HTA as early as possible when bringing a new product or indication to market. The CDF, whilst expanding medicine access to patients, may act as a disincentive for pharmaceutical companies to engage with PAS. With a forward look to 2014, PAS are to remain a vital part of the UK HTA and payer environment.

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