Launched in April 2014, the UK’s Early Access to Medicines Scheme has delivered pre-approval patient access to many treatments for life-threatening and seriously debilitating conditions. But after 10 years of the EAMS, the pharmaceutical industry wants new guidance and says the scheme should evolve so that companies can make the most of the opportunity it offers in the future.

The UK’s Early Access to Medicines Scheme celebrated its tenth birthday in April. In the first of two articles on experience with the scheme, the Pink Sheet looks at how far the inclusion of a product on the EAMS affects its chances of securing a positive HTA recommendation from NICE.

As the UK government implements a new rebate system for older medicines as part of the new pricing deal, industry trade bodies and experts suggest that exceptions will have to be made, such as higher prices or lower rebate levels for specific products.

With the clock ticking on UK drug pricing negotiations, it is still unclear whether even high-level terms of a new voluntary deal will be agreed in time.

The pharmaceutical industry says financial uncertainties are a key reason why the English Innovative Medicines Fund (IMF) – offering the potential for time-limited funding for promising non-cancer treatments where benefits are uncertain at launch - has still not been used a year after it was put in place. Industry wants the National Health Service to share the financial risk of taking part in the fund.

Ipsen and other experts have criticized proposals from the UK government on changes to the statutory scheme for the pricing of branded medicines. Plans for differential rebates are seen as too complex, meaning their impact is difficult to predict and they could end up costing the government more.