Adoption pathway

Adoption

The stage of getting your product through NHS procurement and into clinical use. Business cases and clinical evidence will need to be presented to the relevant decision makers.

Considerations

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Not all medical technologies will need to be considered by the Clinical Commissioning Group before local adoption can take place. The CCG only needs to consider the product where a change in commissioned services or tariff is required

Relevance:Devices and Diagnostics

Diagnostics and medical devices are procured and used by various providers across the NHS including GP surgeries, NHS Trusts and diagnostic laboratories (in-hospital or outsourced private labs). Local providers are able to choose the products that they use to deliver services commissioned by the local CCG (or NHS England for Specialised Services), provided they comply with any guidance published, therefore key stakeholders need to understand the clinical and cost-effectiveness benefits

Relevance:Devices and Diagnostics

If the device provides an upgrade to a procedure already commissioned and no changes to tariff are required, then it may be possible to go directly to the end-user and start pricing negotiation

Relevance:Devices and Diagnostics

If it is necessary to get CCG approval then a business case detailing the clinical and cost effective evidence supporting the device will be required

Relevance:Devices and Diagnostics

Each CCG is an independent decision- maker for services in that area, so you will need approval from each CCG and engagement processes may differ slightly

Relevance:PharmaceuticalDevices and Diagnostics

Devices may be bought through national, regional and local procurement routes, usually depending on the value, size and complexity of requirements: NHS Supply Chain / National Framework Tenders (national); Collaborative Procurement Hubs / Confederations (regional) and Individual Organisation Contracts (local)

Relevance:Devices and Diagnostics

Horizon scanning is carried out by national health bodies in order to gain advance information on new medicines for budget and service planning. Pharmaceutical company input into horizon scanning can begin as early as Phase I of the development process. It is an important precursor to the reimbursement process as it allows endorsement bodies such as NICE to be aware of your product in advance

Relevance:Pharmaceutical

Registering medicines on UK PharmaScan (and adding timely updates) increases visibility of new medicines to all the national horizon scanning organisations during development - NICE, NIHR HSRIC, UKMi, Scottish Medicines Consortium, All Wales Strategy Medicines Group, Northern Ireland Health and Social Care Board and NHS England Specialised Services

Relevance:Pharmaceutical

Data required across the horizon scanning process include general information on the medicine and indication, clinical trial information, regulatory information and cost and budget impact information. Information should be updated at least every three months with the exception of specified regulatory information which should be updated immediately

Relevance:Pharmaceutical

Vaccinations have a separate reimbursement process to other pharmaceutical products, usually taking 1+ years between market approval and vaccine availability in the NHS. Following marketing approval, the Joint Committee on Vaccines and Reimbursement (JCVI) reviews vaccines and provides a recommendation or advice around vaccine use. If recommended, the vaccine manufacturer enters central procurement negotiations with the Commercial Medicines Unit

Relevance:Pharmaceutical

The National Institute for Health and Care Excellence (NICE) conducts Health Technology Assessments (HTAs) on pharmaceutical products; if a drug is found to be both clinically and cost effective compared to a comparator, NICE will issue a positive recommendation. NICE HTAs are a common route to national endorsement for many products (some specialised products are evaluated by the Specialised Commissioning Evaluation). Positive recommendations indicate that the product should be reimbursed either by CCGs or NHS England (for Specialised or Highly Specialised products); medicines can also receive negative or “only in research” recommendations (for promising interventions not yet supported by sufficiently robust evidence). Patient Access Schemes, ways to improve the cost-effectiveness of a medicine, are also considered at this stage

Relevance:Pharmaceutical

NHS England commissions Specialised Services at a national level. Four factors determine whether NHS England classes a product under Specialised Commissioning:

  • The number of individuals who require the service (less than 500 nationally);
  • The cost of providing the service or facility;
  • The number of people able to provide the service or facility and
  • The financial implications for Clinical Commissioning Groups (CCGs) if they were required to arrange for provision of the service or facility themselves
Relevance:Pharmaceutical

Specialised Services Clinical Reference Groups (CRGs) decide which products to put forward for consideration by NHS England. In order for your product to be put forward for assessment, contact the relevant CRG. For products that are not recommended for routine use, Commissioning through Evaluation (launched in 2013) could be an alternative route to patient access

Relevance:Pharmaceutical

Early dialogue is most relevant for digital health products which are classed as a medical device; the main benefit is to boost their understanding around requirements for approval and relevant evidence for the payer, allowing a company to make strategic decisions around product development 


Relevance:Digital

Engage with external stakeholders including NICE Office for Market Access, NIHR, patient advocacy groups (e.g. charities) and providers. The NIHR Office for Clinical Research Infrastructure (NOCRI) can refer you to the relevant part of the NIHR. 


Relevance:PharmaceuticalDevices and DiagnosticsDigital

Currently there is no formal national endorsement model and associated funding direction for digital health products. The National Information Board (NIB) Workstream 1.2 Roadmap could partly address this for apps. The proposed NIB 1.2 assessment framework is split into the following stages, of which Stages 3 and 4 are relevant to this stage

  • Stage 1: Self-assessment against a set of questions around key quality dimensions, such as safety, privacy, data sharing, accessibility, usability, technical stability and interoperability 
 Some apps may be identified through the responses given as higher-risk apps (for example, classed as a medical device) and are required to follow external regulatory procedures (see previous page) 

  • Stage 2: Community evaluation through an engaged group of professionals, commissioners or end-users, giving opinions of usability, functionality and any early stories around impact 


  • Stage 3: Preparing a benefit case for a robust evaluation of evidence to support the app’s claims 



  • Stage 4: Independent impact evaluation by an NHS body- apps passing this final stage may be formally recommended by the 
NHS and receive adoption support mechanisms which could include reimbursement, commissioning support and NHS branding 





Few apps are expected to complete all the stages, but successful evaluation at any stage will be a positive indicator for 
commissioners and this process will interact with both the regulation and commissioning and adoption stages when complete. Other app endorsements are also being tested by a range of health organisations and networks 


Relevance:Digital

Commissioning is the process of planning, procuring and monitoring services, conducted at a primary and secondary care level by over 200 Clinical Commissioning Groups (CCGs) as well as regional / area / hospital trust prescribing committees and NHS England. Each CCG is an independent decision-maker for services in that area, so you will need to engage with and sell to each CCG if they are the buyer for your digital technology

Relevance:Digital

Unlike pharmaceutical products which typically receive a funding direction from NICE or NHS England, many digital health products may reach local commissioning stage without national reimbursement or endorsement; as a result, it is crucial to communicate the value proposition, business case and supporting evidence to relevant stakeholders within local health economies, including healthcare professionals, commissioners
– This will include clinical and economic evidence

Relevance:Digital

Many products will follow two key routes:

  • Competitive tendering: if you choose to undergo this route you must ensure your business meets tendering requirements 
(including financial accounts and evidence of where the product has been used elsewhere)
  • Framework contracts: these include the NHS G-Cloud

Relevance:Digital

Distribution platforms

  • Commercial app stores: Apple, Google, Microsoft Windows, Blackberry
  • NHS Choices did have an app store, but this has been discontinued pending a review of how medical apps are validated
  • Several NHS Trusts now run their own app stores giving them control over approval
  • In addition to the generic app store there are a number of credible online distribution platforms for mobile apps. Some of these are specific to a device manufacturer, some such as Happtique are focused on healthcare apps
Relevance:Digital

Commercialisation

  • The pace of app development targeting NHS services is growing at an exponential rate. In some instances these apps are addressing very specific patient or organisational needs, and that in itself is sufficient justification to commit funding and resources to the activity. In many other circumstances there may be a wider potential for use of the app, and there may be a requirement to pursue a commercial route as a means of generating income and / or offering some financial sustainability to the longer term use of the app.
  • Like other forms of commercially exploited software, potential income can be derived from:
  • The app product
  • Provision of a delivery service in conjunction with the use of the app; e.g. development of a telereferral service in conjunction with a mobile app for community based monitoring or reporting of a chronic health problem.
  • Provision of training and technical support associated with the app. (typically the domain of the software developer).

Revenue can be obtained from the app itself via:

  • Paid for apps
  • Freemium plus in app purchases
  • Advertising
  • Pay-per-click advertising
Relevance:Digital
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