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<p>The National Institute for Health and Care Excellence (NICE) is the independent
body that makes evidence-based recommendations for the National Health Service on
whether medicines should be routinely funded by the NHS based on an assessment of
their costs and benefits. NICE ensures that the price that the NHS pays for medicines
represents value and it recommends the vast majority of medicines for use on the NHS,
often as a result of commercial arrangements proposed during the NICE evaluation process.
The NHS is legally required to fund medicines recommended by NICE.</p><p>Since 2019,
NHS patients have been able to access Orkambi, Symkevi and Kaftrio through an interim
access agreement between NHS England, the company (Vertex), NICE, and the UK Cystic
Fibrosis Trust. The agreement makes the medicines available for a limited time at
a reduced price, while further information has been collected to inform a NICE appraisal.
On 15 November 2023, the Medicines and Healthcare products Regulatory Agency approved
a new licence extension and children as young as two years old with cystic fibrosis
are now eligible to receive Kaftrio through the interim access agreement.</p><p>NICE
is currently consulting on its draft recommendations on the use of Orkambi, Symkevi
and Kaftrio and has not yet published its final recommendations. NICE continues to
work with stakeholders to address the issues highlighted by the committee in the draft
guidance. Under the terms of the interim access agreement for the cystic fibrosis
medicines, Orkambi, Symkevi and Kaftrio, eligible children and adults with cystic
fibrosis can continue to receive ongoing treatment and be initiated onto treatment
with these medicines, as clinically appropriate, while NICE concludes its evaluation.</p>
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