This information has been provided by the Pan UK Pharmacy Working Group for ATMPs and will be useful to clinical trials sponsors, ATMP developers and manufacturers, organisations aspiring to hold ATMP marketing authorisations, as well as to NHS group members and beyond.
Horizon Scanning is the systematic process of identifying new medicines or technologies in development.
Horizon scanning is important for the NHS. It helps manage the entry of new medicines into the NHS. It allows the NHS to:
- plan medicines budgets more effectively.
- implement new services, or re-design existing services.
- incorporate new medicines into treatment guidelines.
- train staff on how to prescribe or administer new medicines.
- begin to review trial evidence, to determine if it will be clinically and cost effective.
Horizon scanning outputs are used in:
- NICE technology appraisal and other health technology appraisal (HTA) planning
- Budget planning at all levels from directorate level through to commissioned services level
- Specialised commissioning and Regional Medicines Optimisation Committee work planning
- Formulary committee/ Drug and therapeutics committee planning
- Secondary care directorate level or specialist service planning e.g mental health, respiratory
- Infrastructure planning/updates/changes (e.g. High cost drugs list (Tariff) development, service delivery model changes, new dm+d coding)
- Updating resources that support delivery of patient care (e.g. SPS website)
Horizon scanning expertise is provided by several organisations in the UK. Their remit differs according to their funding source and stakeholder requirements.
- Specialist Pharmacy Service provides horizon scanning services to NHS customers at all levels
- NIHR Innovation Observatory provides horizon scanning expertise to NICE for HTA planning, academia, and the Accelerated Access Collaborative, for example
- Scottish Medicines Consortium provides horizon scanning support for HTA and budget planning in Scotland
- All Wales Medicine Strategy group focuses on providing horizon scanning expertise to support HTA and budget planning in Wales
Resources used in horizon scanning include UK PharmaScan, a secure horizon scanning database populated by manufacturers with information on new medicines in their company pipeline. In addition, commercial horizon scanning databases, clinical trial registries, news feeds, licensing authority websites, industry websites and personal contacts are all used to provide additional data.
Horizon scanning data and how it is used
Staff with horizon scanning experience and knowledge of the therapeutic area, regulatory processes and infrastructure in which the new product/technology will be introduced, use these data to estimate the likelihood of the new product/technology launching in the UK, the anticipated date of availability and its potential impact on the NHS. This is presented in a variety of outputs targeted at customer and stakeholder needs.
Medicines development is a rapidly changing environment that requires constant review, update and re-evaluation, which means there are limitations to horizon scanning methodology that need to be understood. Data and predictions are only valid at any one point in time. The following factors impact on the actual availability of a medicine on the UK market:
- clinical trial results,
- regulatory discussions and decisions,
- company presence in the UK, mergers and acquisitions, commercial decisions,
- HTA outcomes,
- reimbursement negotiations,
- commissioning decisions including treatment pathway decisions.
Any of these factors could, at any point in time, alter the anticipated launch date and availability on the UK market of a new product, licence extension or new formulation.
Horizon scanning for ATMPs compared with conventional medicines
The process of horizon scanning for all technologies is the same but there are differences that make horizon scanning for ATMPs more difficult.
Firstly, the field of ATMPs is an emerging and rapidly evolving science. Products move from phase II study through to NHS availability much faster than conventional medicines, especially if they can deliver a transformative or curative option. However, because of the complex nature of the products, there is also more likely to be a higher attrition rate in the number of ATMP products that actually reach the market. Evidence of effectiveness is also usually limited to small numbers of patients which poses a challenge for health technology appraisal processes.
Horizon scanning for ATMPs is arguably more critical for the NHS than for conventional medicines. As well as the high acquisition cost of these products which impacts on commissioning decisions, they also have significant and complex infrastructure delivery costs and mechanisms. From the perspective of patient identification, treatment and follow-up, existing NHS clinical systems and processes, including staff training, are currently not mature enough to deal with ATMPs. Beyond the individual patient level, healthcare services are not currently configured to commission and provide these therapies as routine treatment. These factors need to be understood and effectively managed prior to ATMP market availability.
Finally, the developers of ATMPs are largely smaller biotech companies, often working in collaboration with academia, neither of whom have the traditional infrastructure to engage with the NHS in advanced planning activities.
For these reasons, and because of the disruptive nature of ATMPs, it is important that those likely to reach the UK market are within the sight of commissioners, policy makers and providers as early as possible. The horizon scanning mechanisms to facilitate this are already in place, but a wider understanding of the need for, and importance of, horizon scanning by the developers of ATMPs is required.
Finding out more about ATMPs in the pipeline
Go to the New medicines pages on the SPS website and filter to see Advanced therapy medicinal products. We include lots if information about how development of each ATMP is progressing. Or if you know the name of an ATMP, type it into the search box.
If you work for the NHS, check out Prescribing Outlook, our annual horizon scanning publication. This includes a list of the ATMPs expected to become available in the UK in the next three years and signposts you to more detailed information on the ATMP Horizon Scanning Information Portal. But you will need to login.
Once you are logged in, you will also find that there is more detail to be seen on the new medicines ATMP pages.
Want to know more
Please send comments on our ATMP website pages and horizon scanning documents so we can improve the information we provide email@example.com