Recommendation 16

HM Government Acknowledged

The Government is committed to supporting timely access for NHS patients to clinically and cost-effective new drugs. The 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), agreed with industry, commits the National Institute for Health and Care Excellence (NICE) to publishing its draft guidance on all new medicines, including cancer medicines, around the time of licensing wherever possible. NICE has consistently delivered on this commitment in the vast majority of cases and expects to continue to be able to do so. NICE does this by aligning its guidance development timelines so that they run in parallel to the regulatory approval process. In 2021-22, NICE issued guidance within 90 days of marketing authorisation being received for 100% of new active substances where timelines were within NICE’s control. Topics falling outside of this timeframe were impacted by factors outside of NICE control. For example, where the companies request a delay to the NICE evaluation. Despite the pressures of the pandemic, the average time from marketing authorisation to first NICE output in 2020/21 for new cancer medicines was under a month. For some appraisals, NICE guidance was ready, but could not be published until the marketing authorisation had been received. NICE is able to recommend the vast majority of cancer medicines it appraises, often as a result of commercial deals struck between the NHS and companies. In 2020-21 and 2021-22 92% of recommendations on cancer drugs were positive. This includes recommendations through the Cancer Drugs Fund which supports patient access to the most promising new cancer medicines while further real-world evidence is collected on their effectiveness. In just over five years, more than 80,000 patients have benefitted from faster access to one of more than 90 different cancer drugs through the Cancer Drugs Fund. To date 21 treatments have completed their period of managed access within the CDF. Of these 18 have subsequently been approved for routine use. The NHS in England is legally required to fund all medicines NICE recommends, and cancer drugs are funded through the Cancer Drugs Fund immediately after NICE issues positive draft guidance. We have existing reporting tools at our disposal to monitor the uptake of NICE- approved treatments in the NHS; NHS Digital publish a bi-annual report on the use of innovative medicines by the NHS in England, known as the Innovation Scorecard. The latest publication from October 2021 shows that uptake of over 99% of NICE-approved medicines reported in the Scorecard has increased over the past 12 months. Through our Life Sciences Vision, we have committed to further strengthening innovation metrics and to improve our understanding regarding the use of innovative medicines to further enhance the Accelerated Access Collaboratives (AAC’s) crucial work to spread proven innovations across the NHS in England. The UK’s participation in Project Orbis and the creation of the Innovative Licensing and Access Pathway (ILAP) is enabling the more rapid review and approval of promising new cancer treatments. The scheme has already given the green light to ground-breaking new treatments for patients suffering from conditions such as breast cancer, lung cancer, liver cancer, endometrial cancer, and chronic lymphocytic leukaemia. An example of this is osimertinib (brand name Tagrisso), a post-surgery treatment for lung cancer that was the first to receive an authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis in May 2021. The accelerated licensing process through Project Orbis has, in some instances, meant NICE has not been able to publish guidance in line with its standard timeframes. NHS England (NHSE) and NICE have, however, agreed a set of principles to allow potential interim access ahead of NICE guidance where timely guidance is not anticipated. In deciding whether Project Orbis products are eligible for interim funding ahead of NICE guidance, NHSE and NICE consider, amongst other things, how long the gap between licensing and guidance is expected to be, and whether the treatment will make a fundamental change to the existing treatment pathway. For most cancer medicines licensed through Project Orbis, NHSE and the companies have been able to reach agreements under these principles that have made their products available to NHS patients in the interim period before NICE guidance. MHRA, NICE and NHSE&I are working closely together to ensure that there is a joined- up, timely approach to supporting access to new products licensed through Project Orbis, and are taking specific actions to facilitate this. For example, MHRA has recently created a proposal for industry to address existing legislation that restricts its ability to share information with partners. By obtaining the explicit consent of companies to share information, all partners involved in licensing and appraisal will be able to work in