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  • Essay / Evaluation of the clinical and economic effectiveness of new...

    Each year, a large number of new drugs receive marketing authorization. It is up to the National Health Service (NHS) to decide whether the additional cost of purchasing these medicines is justified by the likely benefit to patients. It is for this reason that a multidisciplinary activity known as health technology assessment (HTA) was created. In the UK, HTA focuses primarily on the clinical and economic cost-effectiveness of new medicines. In this essay it was discussed the processes by which HTA evaluates new medicines and how different policy makers in the UK use the most available evidence-based information to decide which technologies are most effective and the most appropriate. Before a new medicine can be authorized for use in the UK, long-term research (12 years) must be carried out. During this period, each new drug is evaluated for safety, quality and effectiveness. A pharmaceutical company can apply for marketing authorization from either the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). The MHRA is a UK authority responsible for the safety of medicines and medical devices, while the EMA evaluates the use of medicines in all European Union member states. Once a drug has been authorized, its clinical effectiveness and cost are evaluated. -effectiveness for use in the NHS. In Scotland there is a national consortium of representatives from local medicines and therapies committees, known as the Scottish Medicines Consortium (SMC). SMC uses transparent decision-making processes to assess the value of a new drug. As soon as a drug becomes available, SCM decides whether that drug should be recommended in the middle of the document...... proposed by pharmaceutical companies and makes a recommendation to SMC before being accepted. or not. When PAS is approved for a drug, the SMC must take into account the reduction offered. On the other hand, when a PAS is not considered feasible, the SMC estimates the value of the medicine based on its standard cost. In this case, the pharmaceutical company has the right to resubmit a revised PAS for acceptance. Issues related to the complexity of PAS processes have been raised. Risk-sharing systems would be less inconsistent if a simpler process were implemented to provide a discount on expensive medicines. All of the above recommendations have been made in order to create an open and transparent system where everyone has the right to contribute. on the decision-making process regarding the clinical and economic profitability of newly approved drugs.