The National Institute for Health and Care Excellence (NICE) is the health technology assessment (HTA) body for NHS England and NHS Wales. To note, NHS Wales has its own HTA process (All Wales Medicines Strategy Group (AWMSG) for those treatments that are not included on the NICE work program but will be made commercially available in Wales.
While NICE does not directly get involved in price setting, it focuses on clinical and cost effectiveness, based on quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Therefore, price negotiations could affect approval. NICE continues to monitor drugs after approval, to ensure that the prices and patient access programs agreed match with real-world use.
NHS England and NHS Wales must legally allow access to all approved drugs that NICE recommends. National specialized commissioning, local clinical commissioning groups (CCGs) and hospital trusts make the final decisions to add drugs to formularies. There are over 200 CCGs, which can make the route to final market access slow.
For those treatments that are not included on the NICE HTA work program then the route to reimbursement is direct engagement with specialized commissioning bodies or CCGs and hospital trusts. In many cases decision making is undertaken amongst groups of CCGs in bodies often called Area Prescribing committees (APCs). Treatments that have been granted marketing authorization but have not received positive recommendations by NICE can still be made available to patients, and companies can support this through risk-sharing, patient access programs and payer discounts. However, not receiving a positive recommendation from NICE (& AWMSG) will make the market access process in England and Wales very challenging.
In Scotland, the role of the Scottish Medicines Consortium (SMC) is to recommend drugs, though the process is somewhat quicker and more streamlined than in England and Wales.
To guide you through the market access journey in the U.K., visit our U.K. Value, Access and Outcomes Planner.
Click on the graphic to enlarge
Essential reading to gain a greater understanding on strategies that are relevant to succeeding in the U.K.: