London — New drugs launched in the UK will soon face new, faster and more agile evaluations before they are approved for dispensing.
Consistently from pharmaceutical companies and patient groups to thoroughly rethink how the National Health Service drug gatekeeper decides which treatments to pay after years of unsuccessful attempts. Lobbying was done.
However, on Wednesday, the National Health Service Evaluation Organization (NICE) Board of Directors, a group of experts tasked with weighing the additional benefits of new treatments for patients against the additional costs of the NHS, drastically. We will approve any changes. For these evaluations.
Gillian Leng, Chief Executive Officer of NICE, said:
There will be no more timing. The UK has left the EU and is competing with its much larger neighbors for innovative and life-changing treatments. Not all companies have the resources to launch in the EU market and the UK at the same time, so faster valuation of the added value of medicines and more flexible pricing make them attractive.
Effective in early February, this change is designed in response to breakthrough advances in medicine, such as cell therapy and gene therapy, which bring therapeutic hope to some of the most devastating and life-threatening genes. it was done. sick.
Greater flexibility in cost-effectiveness decisions and broader evidence-based reviews gives patients early access to innovative therapies. NICE said in a statement that the new assessment will increase the predictability of the industry, increase patient transparency and enable rapid decision making by NICE’s independent committee.
One important addition is weighting the severity of the disease with the aim of providing more equitable access to treatment. A similar approach is currently being adopted and is only used for end-of-life medications, as long as higher price thresholds are offered.
NICE also considers more real-world evidence and considers uncertain benefits for the treatment of rare diseases and pediatric medicines, such as when evidence can be difficult to collect. NICE said it wants to ensure that valuable innovations are available in these areas while managing potential risks to patients. The decision applies to England and Wales and is often adopted in Northern Ireland.
In addition, for highly specialized treatments such as gene therapy, the NICE considers the broader impact of treatment — benefits not only to patients but also to their caregivers and the NHS. This is the approach that the industry has been campaigning for for a long time.
“These long-awaited changes mean that NICE’s methods and processes better reflect the amazing advances in drug discovery,” said Paul Catchpole, Director of Value and Access, UK Pharmaceutical Industry Association. Fairness of access to the latest medicines.
While many of the changes appear to be in response to the pharmaceutical industry’s call, NICE emphasized that changes and their impact on patients should always be assessed.
The group also said it would not take too long to update the assessment methods and processes again. From now on, we will review the process in a rolling format to keep pace with science.
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