Rare Disease Day 2023 – Reflections on the second Rare Disease Action Plan.

Rare Disease Day 2023 – Reflections on the second Rare Disease Action Plan.

Today, on Rare Disease Day, the UK Department of Health and Social Care (DHSC) has published its second Rare Disease Action Plan (RDAP) for England.

In January 2021, the UK published its Rare Disease Framework, a national vision to improve the lives of the 3.5 million people in the UK living with a rare disease. Two years, three Prime Ministers and four health secretaries later, we want to take stock of the latest Rare Disease Action Plan and what it means for the rare disease community going forward.

The 2023 Action Plan highlights the progress that has been made to date across the actions outlined in the 2022 RDAP. There is welcome progress on early diagnosis through a broadened remit of the UK Newborn Screening Committee. A new digital educational toolkit for healthcare professionals has been rolled out to improve the coordination of care for patients and progress has been made on access to treatment through approval of a life-saving gene therapy for metachromatic leukodystrophy.

Whilst it is important to recognise the progress that has been made, there remains more to do.  Many people living with a rare disease still encounter poorer than average access, experience and outcomes in healthcare services.

What’s New?

It is positive to see that tackling health inequalities is at the forefront of the 2023 Action Plan through the ambition to include rare diseases within the NHS England’s Core20PLUS5 framework. Recognising rare diseases within this framework would raise the profile of health inequalities faced by people living with rare diseases at both national and system levels. This would enable ICSs to develop targeted actions to reduce health inequalities associated with rare diseases.

Another positive addition to the 2023 Action Plan is the commitments from the MHRA and NICE to publish and operationalise guidance on incorporating real world data into appraisals. The nature of small patient populations for rare diseases often means it may not be feasible to recruit enough participants into traditional randomised clinical trials and the use of real-world data to support decision making is one solution to ensure that innovative new treatments can reach rare disease patients in a timely manner.

Furthermore, the commitment laid out in the 2023 Action Plan to review the effectiveness of EAMS, ILAP and the IMF in improving access to treatments for people living with rare diseases will also be a welcome step in ensuring that patients in the UK can benefit from innovative new treatments. Over the coming year, NHS England, MHRA and NICE will review the impact of these initiatives to provide an understanding of how the schemes are working for rare diseases medicines and identify any potential gaps or improvements. The review is a welcome first step, however, the ultimate impact will depend on the actions that are put in place following the readout of the review.

Looking ahead

Following Rishi Sunak’s recent departmental re-shuffle and the creation of the new Department for Science, Innovation and Technology, there may be a short-term delay in progress whilst new teams and structures bed in. However, the short-term time lags may prove worthwhile in the long run with the rare disease and emerging technologies team now sitting in the NHS Policy Directorate of the DHSC, bringing them much closer to the policy levers for the healthcare system.

In what has been a year of political unpredictability, there is one thing for certain. With a general election looming in 2024, the progress made in 2023 will be vital for the rare disease community.

By Ollie George – Account Manager