The National Health Service in England (NHS) provides care to over 55 million patients, is free at the point of need and employs 1.3 million people.
Today it needs innovative medical technologies to help care providers to quickly treat a backlog of 5 million elective patients, who have been waiting over a year because of the effects of COVID-19.
Due to Brexit and the UK leaving the European Union, the new, faster UKCA mark will replace the CE mark, meaning a faster regulatory pathway as well.
The UK offers a competitive, business-friendly environment for companies thinking of incorporating their businesses here. This includes low corporation tax rates, research and development tax credit schemes, and a research-friendly environment with world leading university teaching hospitals, as well as the National Institute for Health Research (NIHR), the research part of the NHS which could even fund clinical research for your technology.
Currently if you have an existing CE marked medical device that is a ‘me too’ similar to existing technology, you are highly likely to able to sell your medical technology into an NHS Hospital, but this would depend on your selling price being competitive and allowing for any existing contracts with the existing supplier that the hospital may have in place.
This is because 99% of the time, the hospitals are paid for the treatments performed, so there’s not a device specific reimbursement code required. Under this arrangement, which is HRG (similar to the DRG in other countries) payment system, the hospital is reimbursed by the payer of care – currently the Clinical Commissioning Group (CCG).
The >1% exception is high-cost devices. This is an established list of around 30 devices, for example bespoke orthopaedic prosthesis, ICD with Cardiac Resynchronisation therapy capacity and bone anchored hearing aids, which are on a special list called “Device exclusion list”. This high-cost device exclusion list means excluded from the HRG payment tariff, so the provider of care would receive 2 payments, one for the care episode and the other for the high-cost device. Devices on this list are procured centrally by NHS England on a special contract.
To find out the reimbursement paid through HRG by the payer to the provider for established treatments, you would need to find the treatment code (OPCS code) that describes the treatment or therapy, and combine this with diagnosis of the patient code (ICD10) and the type of admission – i.e., emergency or planned elective. This would need to be grouped though NHS software to find the specific HRG code and payment amount. Furthermore, calculations are made on top of this payment, called Market Forces Factor (MFF), this is a top up depending on the hospital’s geographical location.
New products do go through Hospital New Product Committees, or Value Analysis Committees, so budget impact models and business cases for change help greatly in these hospital negotiations for approval.
If your device is involved in a brand-new treatment that does something interventional and involves going into the body cavity though an incision, then it would need to eventually be evaluated by The National Institute for Health & Care Excellence (NICE). NICE are the Health Technology Assessment (HTA) Body who evaluate technologies for safety, efficacy and cost effectiveness. They offer a range of evaluation programmes for MedTech – listed below.
The first part of this evaluation by NICE would be to demonstrate that the technology is safe and effective for use in NHS Patients. This generally takes around 12-18 months, and the results of this evaluation lead to the following conclusions and recommendations.
If you receive 1, 2, 3 above within the NICE IPG, then NICE issue specific OPCS codes describing the treatment that are combined with ICD10 codes to become a HRG Code. NICE IPG guidance would generically describe the intervention, and it does not mention the brand of the device or device name.
If you receive level 1 or 2 in the NICE IPG, or already have an established technology that can clearly demonstrate benefits to patients, hospitals and the NHS, this qualifies you to be considered for evaluation by the Medical Technologies Guidance Programme, or NICE MTG team. This is optional, and the sponsor (medical device company) would need to submit their technology to NICE through a portal, uploading their clinical and economic evidence to show the device is safe, effective and cost saving or cost neutral compared to the current standard of care. NICE currently evaluate around 15 devices a year through this programme. Similar programmes exist for diagnostic technologies through a programme called Diagnostic Assessment Programme or DAP.
Stage one – NICE MedTech Innovation Briefing or MIB
Once selected through this portal, devices and diagnostics are currently routed for a fast 15-week evaluation called the MedTech Innovation Briefing. This enables NICE to check the evidence and claims and ensure that they would withstand the scrutiny of formal NICE MedTech Guidance, stage 2 below.
A MedTech Innovation briefing is also known as NICE Advice, and help’s NHS Clinicians, Hospitals, commissioners and payers understand the level of evidence and where the device may benefit the NHS and patients. It is not formal guidance and can help the medical device company understand where they are in terms of evidence gaps required for selection to formal MedTech guidance. There are no legal or contractual reasons why the hospital would need to comply and use products under this briefing.
Stage 2 – Formal NICE MedTech Guidance – NICE MTG
Formal NICE MedTech Guidance takes around a year and requires a greater deal of work by the sponsor. The evidence requirements are that they must be peer reviewed, published or presented in English language and reflect the devices use into a similar care pathway that is used in the NHS today. Evidence generated in other countries can be used, so long as they conform to the above. The evaluation results in NICE announcing to the NHS that the specific branded device delivers clear benefits and should be adopted.
The sponsor will need to provide a cost consequence model, and systematic literature reviews of clinical and economic evidence, as well as compilation of a dossier required by NICE strict timescales throughout the evaluation.
MedTech Guidance has greater effect than a MedTech Innovation Briefing, as the Standard contract – a legal agreement signed between the payer and the provider of care – currently states that the provider of care should have regard to NICE Guidance issued. Non-compliance to this could result in contractual and reputational risk for the hospital. In addition, the financial savings and benefits of adopting the new technologies have been proven.
NICE MedTech Guidance has led to reimbursement and coverage in other global markets, especially the USA and commonwealth countries.
When engaging with NICE, the key starting point in describing the offering should be focussed around what’s known as the PICO framework
NICE require both clinical and economic evidence to be in English language, and be peer reviewed, published or presented. Data from outside the UK is acceptable so long as the care pathway is the same or similar to the NHS. Health economic analysis demonstrating cost saving or cost neutrality versus standard of care is also important.
We offer a service available to us via a licence provided by NICE called MedTech Early Technical Assessment (NICE META tool). This HTA gap analysis service helps our clients reduce the risk of going through evaluation too early, and to help identify gaps that you need to fill with evidence.
Since 2014 Device Access has had a licence from NHS England to access of over 1 billion electronic hospital individual patient records for researching specific care pathways and to help identify where new technologies would help patients, care providers and payers.
Our specialised services allow us to give you professional guidance about evidence gaps and requirements for successful NHS market access, NICE approval, as well as help understanding how patients are treated today the volumes of patients who would benefit from the introduction of new treatments, nationally and by each individual hospital.
Please reach out for a free consultation. Since 2010, Device Access has supported over 45 devices successfully through various NICE programs including MedTech Guidance.
Contact us today – firstname.lastname@example.org