Virtual contract research organisation (VCRO) Curavit Clinical Research, has launched a Health Economics and Outcomes Research (HEOR) service for clinical trials.
Curavit said the inclusion of HEOR in clinical trials will give medicine manufacturers insight into product value and market potential.
Curavit stated that the services will especially focus on the health economics value of digital therapeutics, which the company will assess in both individual patients and population levels of care. HEOR will be incorporated into clinical trials and analysed at study close-out to quantify the financial impact of the digital therapeutic.
In a 31 October press release, the New York-based VCRO said it has connected its decentralised platform Stratus to claims and medical data networks, ensuring a HIPAA-compliant environment in which the data sets can be analysed.
Digital therapeutics is a type of digital health. It involves using software to treat a medical disorder or disease. Patients use the therapies over devices, including mobiles, virtual reality, and sensors. It can either be used as a standalone therapy or in conjugation with pharmacological medicines and is divided into prescription and non-prescription digital therapeutics. Their use in managing chronic diseases and neurological outcomes has been highlighted in particular.
Although there is evidence from studies that show digital therapeutics can drive down patient costs, their relative novelty and insufficient insurance coverage means they are not being extensively used as a treatment option. It is also in its infancy when it comes to clinical trial testing.
Digital Therapeutics Alliance CEO Andy Molnar said: "Real-world evidence is critical for DTx companies to achieve coverage and reimbursement by demonstrating to payors and providers the full impact of these innovations.”
MedRhythms, which is developing a neurorehabilitation system to improve walking in adults with chronic stroke walking deficits, is working with Curavit for a prospectively enrolled clinical trial. The study design focuses on generating data on the product’s financial impact on chronic stroke treatment.
MedRhythms president and co-founder Owen McCarthy said: "In conjunction with clinical outcomes, HEOR assessments are an indispensable part of the evidence package needed to 'speak the same language' with payers and gain traction with a new prescription-only product."
Curavit CEO and co-founder Joel Morse commented: "We are helping digital therapeutics companies by seamlessly incorporating HEOR into their clinical trials, enabling them to not only capture safety and efficacy data but also financial data. The goal is that this information will prompt broader insurance coverage and use for patients in need.
