For nearly a decade, Dendrite Clinical Systems and Device Access UK have been combining their expertise in clinical registries and market access and reimbursement, respectively, to expedite the regulatory processes for MedTech companies to get their technologies to patients.  Working in conjunction with small, medium and large multinational companies, the partnership has enabled clients to record, collect and analyse real-world evidence and present data that adheres to the necessary regulatory guidance and requirements. 

“The UK regulatory process for reimbursement requires peer-reviewed published data from a number of sources including randomised controlled trials (RCTs) and clinical registries,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “Clinical registries are main source of observational large-scale evidence-based data and can be specifically designed to examine the effectiveness of pharmaceuticals, medical devices, treatments or procedures.”

Achieving regulatory and reimbursement approval can be long, exhaustive and expensive. In England, the National Institute for Health and Care Excellence (NICE) is responsible for producing evidence-based guidance and publishes regular appraisals that make recommendations on the use of new and existing medicines and treatments within the NHS. The NHS is legally obliged to fund and resource medicines and treatments that NICE has recommended.

As part of appraisal evaluations, NICE requires peer reviewed, published or presented data, demonstrating treatment from a UK care pathway. In addition, they also require patient-reported outcome measures (PROMs) to examine the impact the technology or treatment has on the patient’s quality of life (mental health, lifestyle etc).

“Gathering, analysing and presenting robust data is a key element in gaining approval from NICE and clinical registries are a proven approach to collecting and interpreting real-world evidence for MedTech companies,” explained CEO of Device Access UK, Michael Branagan-Harris. “In addition, far longer-term PROMS data is fast becoming a very desirable element of the NICE Interventional Procedure (NICE IPG) appraisals evaluation process, and Dendrite are one of the few companies who are able to incorporate a PROMS module as part of their bespoke clinical registry software package.”

Over the years, Dendrite Clinical Systems and Device Access have worked together across an array of specialities including interventional radiology, urology and vascular surgery to guide numerous companies through the reimbursement and NICE evaluation processes by developing registries that have informed NICE about a product's use, treatment patterns (standards of care), benefits and cost effectiveness, and helped them gain market access.

“In our experience, collecting data needs to be a finely tuned process, and it is crucial companies understand exactly what data NICE requires,” added Dr Peter Walton. “Device Access has unparalleled experience in guiding clients through the reimbursement minefield and it has been a great pleasure to work with them over the years,” added Dr Peter Walton. “Our two companies have a shared ethos - helping our clients to get their technology to the market to improve outcomes for patients.  Our partnership has opened up new opportunities for both our companies and we look forward to many more successful collaborations in the future.”

About the companies

For nearly 30 years, Dendrite Clinical Systems’ specialist clinical databases have enabled the international healthcare community to gather evidence-based medicine to improve patient outcomes and professional practice. The company has developed more than 200 local, national and international registries that have collected data on patients, procedures, devices, pharmaceuticals and therapeutics, and their flexible “Intellect-Web” software can be adapted to any clinical scenario.

Established in 2010, Device Access UK is a dedicated medical technology reimbursement consultancy providing support for MedTech companies entering the UK National Health Service. The company enables the efficient adoption of medical technologies into healthcare systems by demonstrating their true value to the patient, the provider and the payer. To date Device Access has supported over 40 companies though NICE Evaluations.

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As part of the larger IGES MedTech group, they are also able to support MedTech companies into European markets.

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