My Lords, I am grateful to all noble Lords who have spoken thus far in this debate. I also thank the noble Baroness, Lady Thornton, for expressing her confidence in my ability to understand these issues; I fear that she may be right.
Turning first to Amendment 29, it is firstly important to note that it is the MHRA, not NICE, that licenses these medicines in the UK. NICE makes recommendations on whether the price that the NHS pays for treatments represents value for money. Access to effective new treatments for NHS patients is a priority for the Government. That is why we have committed to maintain the funding requirement for NICE appraisal of recommended treatments.
The standard contract also stipulates that providers must ensure that formularies include all NICE appraisal-recommended treatments. NICE’s guidance on developing and updating local formularies also clearly states:
“When a NICE technology appraisal recommends a medicine, adopt the medicine into the local formulary automatically, if clinically appropriate and relevant to the services provided by the organisation. This process should take place within 3 months.”
I believe that this represents a robust legal framework for ensuring compliance with NICE’s appraisal decisions. A stronger legislative requirement to include all NICE-recommended treatments on formularies within 28 days of a NICE decision would remove any flexibility both to vary the timescale where there are barriers to implementation, or where a product was not relevant to a particular organisation.
Turning to Amendment 171, NICE rightly operates independently from the Government, and key to this is setting its own procedures for developing guidance and recommendations. This includes setting its own discount rate, taking into account the wider policy and fiscal implications. NICE recently carried out a comprehensive review of its methods and processes for making appraisal recommendations, and the changes that NICE is introducing will ensure that its processes are fairer, faster and more consistent. I assure noble Lords that NICE already aims, wherever possible, to make timely recommendations on new medicines with draft guidance around the time of licensing, and final guidance within three months of licensing. However, NICE’s ability to issue guidance depends on an evidence submission from the manufacturer. It would not therefore be appropriate to place a requirement in legislation for a specified timeframe when that is dependent on other organisations.
This amendment would also require NICE to take account of a company’s membership of the Voluntary Scheme for Branded Medicines Pricing and Access, or the statutory scheme, in making its recommendations on medicines. These schemes have a very different purpose from NICE appraisals, which ensure that new medicines are clinically and cost effective, and they are time-limited, so would create significant disparities between medicines launched at different times.
I turn now to Amendment 178. I hope I can assure the noble Lord that arrangements are already in place to regularly review and monitor delivery against priorities
and objectives, including through accountability meetings, engagement with external partners and public board meetings. The Government believe that regular monitoring through existing arrangements is the right approach and do not consider that a requirement to carry out a review is necessary. I assure the noble Lord that the changes recently introduced by NICE will make its methods and processes fairer, faster and more consistent, will ensure that they are suited to new and emerging types of technology, and will provide more equitable access for those with severe diseases. The vast majority of cancer medicines covered by the previous end of life flexibilities would also be covered by the severity modifier.
Placing requirements on NICE through primary legislation to use specified processes would fetter its independence to determine its own methods and processes, and it would be unfair to operate two different approaches at the same time. The amendment proposed by the noble Lord could also impact negatively on cancer medicines that were not eligible for the end-of-life flexibilities in their first appraisal but may be eligible for the severity modifier.
6 pm
I will now turn to a couple of specific questions, one of which was about the uptake of medicines in the UK. The NHS is legally required to fund NICE-recommended treatments, normally within three months, and this requirement will apply to ICBs once established. Differences in healthcare systems between different countries—in commissioning, disease prevalence and population demographics—make any direct comparison of uptake difficult, and the speed at which innovation is taken up is not the only effective measure of quality of care.
However, we are committed to making the UK one of the most pro-innovation healthcare systems in the world, and we have made some real progress in recent years. Noble Lords have mentioned the Accelerated Access Collaborative, which was established to support the appropriate uptake of NICE-recommended medicines and devices, as my noble friend Lord Lansley said. In 2019-20 alone, the AAC helped more than 2,500 innovators to develop their cutting-edge products and launch them in the NHS. Nearly 750,000 patients have benefited from access to these products, and they spent around 125,000 fewer days in hospital as a result.
I should add that NICE is the independent body responsible for methods and processes. NICE’s consultation stated that there is an evidence-based case for changing the discount rate to 1.5%, but it acknowledged the wider policy and fiscal implications and proposed to maintain the existing reference case discount rate while further data is collected on the likely effects of a change to the discount rate. NICE’s changes are in line with the department’s expectations for the review as set out in the VPAS agreed with industry. It is important to recognise that any changes to NICE’s methods could have financial impacts beyond the duration of the current VPAS.
On the postcode lottery, we have reporting tools at our disposal to monitor the use of innovative medicines and products. NHS Digital publishes a biannual report
on the use of innovative medicines by the NHS in England, known as the innovation scorecard. The latest publication, from June 2021, shows that uptake of more than 70% of NICE-approved medicines reported in the scorecard has increased over the past 12 months. We are committed to further strengthening these innovation metrics and to improving our understanding of the use of innovative medicines and medicinal products within the NHS.
It is for these reasons that I ask noble Lords not to press their amendments when they are reached.