Every year a large number of new medicines receive marketing authorisation. It is the National Health Service (NHS) responsibility to decide whether the additional cost of purchasing these medicines is justified by the likely benefit to patients. For this reason, a multi-disciplinary activity known as the health technology assessment (HTA) has been created. In the UK, HTA mainly focuses on the clinical and cost-effectiveness of new medicines.
In this essay it was discussed the processes through which HTA appraise new medicines and how the different policy makers within the UK use the most available evidence-based information to decide which technologies are most effective and appropriate for use.
Before a new medicine can be licensed for use in the UK, a long-lasting research (12 years) needs to be carried out. During this time each new medicine is assessed for its safety, quality and efficacy. A pharmaceutical company can apply for a marketing authorisation either through Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). MHRA is an authority in the UK that is responsible for the safety of medicines and medical devices while EMA evaluates the use of medicinal products across all member states within the European Union.
Once a medicine has been licensed, is being assessed for its clinical and cost-effectiveness for use in the NHS. In Scotland there is a national consortium of representatives of local drug and therapeutics committees known as the Scottish Medicines Consortium (SMC). SMC uses transparent decision making processes in order to assess the value of a new medicine. As soon as a medicine becomes available for use, SCM decides whether this medicine should be recommended in the NHS or not. This process can take up to 18 weeks and the decisions are made by a number of clinical experts, the pharmaceutical industry and patient representatives.
After a new medicine has been assessed, the SMC has to publish its advice on its website. Whether the medicine has been recommended for use or not, the NHS Boards must follow the SMC advice. Boards can consider individual patient treatment requests if the medicine has not been approved by the SMC.
On the other hand in England the clinical and cost-effectiveness of a new medicine is being assessed by the National Institute for Health and Clinical Excellence (NICE). NICE appraises those medicines referred to it by the UK ministers through two appraisal processes, Multiple Technology Appraisal (MTP) and Single Technology Appraisal (STA). MTA can take up to 18 months or more to complete and normally covers either more than one technology (drugs, medical devices and diagnostic tests) or one technology for more than one indication. NICE AMT suitability in Scotland is being reviewed by the NHS Quality Improvement Scotland (NHS QIS) and its advice is published on its website. If NICE MTA recommends a medicine for use, the NHS boards must make this medicine...