Will your diagnostic significantly change the patient pathway or does it require a large investment?
Have you clarified the value proposition and is it relevant to all stakeholders?
Can you share, develop or refine a clear business case that can demonstrate to commissioners the clinical and health economic benefits to the local health economy?
Have you considered engaging with patients and clinical champions to disseminate information?
Do you understand the procurement route?
Do you need to revisit your clinical evidence development?
Have you engaged all stakeholders both clinical and financial?
Post-adoption, are you planning to monitor the impact of change to further develop the business case?
Have you registered the company on UK PharmaScan (if not already registered) and have you ensured relevant data is collected for the registered drug?
Have you added drug information and update in a timely manner?
If you are producing a vaccine: have you ensured it is entered onto relevant horizon scanning databases and held early dialogue with both regulators and JCVI where possible to ensure vaccine development and evidence generation (including post-authorisation data) will meet approval requirements and support cost-effectiveness?
Have you determined whether your product should be considered under Specialised Services for a target patient population? If so, have you engaged with the relevant Clinical Reference Group for advice and put the product forward for assessment? Are you aligned with the strategy for the relevant National Programme of Care? Have you ensured appropriate information and data is published in peer-review journals in order for evidence to be considered? Have you registered as a Clinical Reference Group stakeholder? Have you considered whether a parallel route to reimbursement is required for other target patient populations?
Have you considered entering the NIB Workstream 1.2 process?
Have you ensured you have sufficient clinical and economic effectiveness data – NICE are developing a guide to evidence collection for digital health technologies
Have you considered how your product will fit into the current system?