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<p>The Government is committed to supporting timely patient access to clinically-
and cost-effective new drugs, including for metastatic breast cancer. The Medicines
and Healthcare products Regulatory Agency, the National Institute for Health and Care
Excellence (NICE) and NHS England are working closely together to ensure that there
is a joined-up, timely approach to supporting access to new medicines for National
Health Service patients, including those licensed through Project Orbis and the creation
of the Innovative Licensing and Access Pathway (ILAP). For example, average times
taken between licensing and the publication of NICE guidance for new medicines have
been reduced from 10.2 months for 2017/18 to 3.1 months for 2022/23. The proportion
of positive NICE recommendations increased from 79% in 2017/18 to 92% in 2022/23.</p><p>NICE
is also able to make recommendations through the cancer drugs fund (CDF), which has
benefitted over 88,000 patients as of March 2023. The CDF has allowed patients with
metastatic breast cancer to access new medicines like trastuzumab deruxtecan and palbociclib,
while allowing for the collection of further data on their clinical and cost effectiveness
to inform a final NICE recommendation.</p><p>NICE published a surveillance review
of its guideline on advanced breast cancer in January 2023. It concluded that the
recommendations on biological therapy, chemotherapy, psychological support and preventing
and managing complications will be updated. These updates will be scheduled into NICE’s
work programme and will include equality impact assessments and consultation with
stakeholders to ensure access issues are fully considered.</p><p>The NHS Cancer Programme
has commissioned five new cancer clinical audits, which will provide timely evidence
for cancer service providers of where patterns of care in England may vary, increase
the consistency of access to treatments and help stimulate improvements in cancer
treatment and outcomes for patients. The Royal College of Surgeons began work on this
audit in October 2022 with the first outcomes expected in 2023/24. One of the five
audits will cover primary and metastatic breast cancer.</p><p>The Department has not
had specific discussions with the Devolved Governments. However, the Welsh Government
and the Northern Ireland Department of Health have agreements in place with NICE to
use their technology appraisals and clinical guidelines. NICE will engage with them
to support implementation. Both NICE and the Scottish Medicines Consortium are permanent
partners in ILAP. Decisions on how guidance is implemented is a matter for each Government.</p>
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