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<p>The National Institute for Health and Care Excellence (NICE) is able to take into
account the commercial terms offered by a manufacturer during a NICE appraisal through
a mechanism known as a commercial access agreement. On two occasions NICE has issued
optimised recommendations to make rare disease medicines routinely available for the
appropriate group of National Health Service patients that are conditional on it being
supplied in accordance with the terms of the commercial access arrangements. These
were Sorafenib, for advanced hepatocellular carcinoma, and ibrutinib for relapsed
or refractory mantle cell lymphoma.</p><p> </p><p>This is different from the process
of a conditional recommendation for use within the Cancer Drugs Fund (CDF) for oncology
drugs, where there is significant remaining clinical uncertainty which needs more
investigation through data collection. In these cases funding is provided from the
CDF for a time-limited period to allow patient access whilst this data is collected,
before guidance is then reviewed again for routine commissioning.</p><p> </p><p>NICE
does not have any particular criteria to determine whether treatments are eligible
for conditional recommendations. However, the process guide for patient access schemes
and commercial access agreements and the CDF can be found at the following link:</p><p><a
href="https://www.nice.org.uk/process/pmg19/chapter/patient-access-schemes-commercial-access-agreements-and-flexible-pricing"
target="_blank">https://www.nice.org.uk/process/pmg19/chapter/patient-access-schemes-commercial-access-agreements-and-flexible-pricing</a></p>
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