In the commercialisation and commissioning phase, NHSE and NICE evaluate a medtech product’s affordability and sustainability. This focuses on need and volume, long-term purchasing, ease of implementation, projected costs and benefits, and market competition.
Planning for the commercialisation of a digital therapy in the NHS should begin from the very start, during the Pre-authorisation phase. Early commercial activities typically focus on identifying NHS needs and demonstrating the value of the digital therapy to the health system and patients. When developers are building their evidence plan (see Authorisation phase for details on the Evidence Standard Framework), they need to start thinking about collecting early economic data through the initial pilots.
Over time, the emphasis shifts towards evaluating different approaches for procuring and funding a digital therapy as it transitions from pilot to wider real-world implementation. This includes how the product is purchased (ideally through frameworks agreed between government and suppliers), who is responsible for payment (e.g., NHS England, Integrated Care Boards (ICBs)) and the type of contract used (e.g., subscription-based, pay-per-use).
As the pilots are conducted in one or more NHS Trusts, developers can begin building their business cases and procurement plans. A robust business case is essential for demonstrating the value proposition, which allows the NHS to make an investment decision. Value-based procurement focuses on different metrics rather than just cost, such as patient outcomes, system efficiency, whole-pathway care and long-term benefits for taxpayers. Robust business cases assess different types of benefits (see figure).
| Cash-releasing | Financial, non-cashable | Non-financial | Qualitative |
| Resulting in 'cash in bank' through avoided spend | Benefits that can be monetised but don't result in 'cash in bank' | Benefits that can be counted but are very difficult to monetise | Benefits that cannot be monetised but are often a significant driver of change |
|
Reduced headcount Reduced cost per test |
Value in £ of hours saved that will be dedicated to frontline duties |
Improved patient satisfaction Faster turnaround time for a diagnostic test |
Improved patient safety |
Procurement and Reimbursement
One of the key challenges developers face is that the procurement of digital therapies is largely localised and depends on Integrated Care Board (ICB) funding.
Further work is needed to incorporate digital therapies into national reimbursement frameworks, such as the Drug Tariff in England and Wales. Having a centralised procurement system for digital therapies has become a priority as more of these solutions are developed to support mental and physical well-being. There are some initiatives underway to enable a more streamlined procurement approach:
- The Dynamic Purchasing System (DPS) is an electronic platform managed by the London Procurement Partnership (LPP) that enables digital therapies to be listed. One of its aims is to help small and medium-sized companies to provide services to the NHS.
- A specific health and social care DPS, run in partnership with ORCHA, provides access to condition-specific apps. ORCHA offers an accreditation process for digital therapies that covers regulatory and compliance requirements to ensure the credibility and trustworthiness of these programmes.
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Example of procurement challenges for digital therapies - Sleepio In 2022, NICE recommended the national adoption of Sleepio, a digital therapeutic that delivers cognitive behavioural therapy for insomnia. While it is available nationally in Scotland and in certain Integrated Care System (ICS) regions in England in 2025 it has still to be adopted across England and Wales. |
Required Outputs
- The business cases should provide a clear picture of the objectives and benefits (clinical, operational, economic) against the estimated costs and risks. It should clearly show that the digital therapy addresses a specific problem for the NHS, produces clear benefits and offers value for money. It should include a detailed breakdown of costs and the expected return on investment, such as financial savings and reduced NHS staff time. The Five Case Model can help to create strong business cases and the Health Innovation Network has guidance and examples on how to write your NHS business case.
- Another critical component of the business case is demonstrating that implementation will not introduce too much risk or burden on staff (this will be covered in more detail in Phase 5).
- A Budget Impact Analysis (BIA) is a modeling exercise that estimates the short- to medium-term financial consequences of introducing the digital therapy. The BIA is mainly focused on the direct costs and any savings that might accumulate. It evaluates affordability (but not value for money). The government has more information on how to use a BIA to evaluate a digital health product.
Tips & Resources
- Adopting a multidisciplinary approach early in the process, including working with commercial experts, enables proactive planning of commercial activities, which are likely to evolve based on data and insights gained from previous phases. This iterative process involves developers and NHS stakeholders.
- It is essential to identify who will be willing to pay for the digital therapy. It can be helpful to reach out to a Health Innovation Network to start building relationships with champions and supporters, who can advocate for the digital solution to senior stakeholders.
- Participating in initiatives such as the Early Value Assessment (EVA ) and the Innovative Devices Access Pathway (IDAP) offers an opportunity to generate real-world evidence, as discussed in Phase 3 (Evaluation and Guidance), and it can also help identify appropriate payment models and funding mechanisms.
- Navigating the procurement frameworks in the NHS can be complex. There are procurement hubs available that provide support.
- If the developers decide to work with an external company to produce the health economics report, it is key to communicate openly from the start to confirm their plans align with the information and metrics needed for the business case.
- Understanding the NHS financial year, which runs from April to March, helps to optimise commercial opportunities.
Moving towards a national reimbursement route for digital therapies will allow developers to offer clinically validated and cost-effective solutions to patients via the NHS. The recent Department of Health and Social Care 10-Year Health Plan will support the commercialisation and adoption of digital therapies by building more robust decision pathways. A new “HealthStore” will allow patients to access approved therapy apps, which will be procured and funded centrally, likely providing funding guarantees similar to those for medicines. This should dramatically reduce the burden that developers of digital therapies currently face when commercialising their innovations for the NHS.
