The virtual contract research organization (vCRO) says incorporating the HEOR practice will capture evidence of the health economics value of novel pharmaceutical products, particularly digital therapeutics striving to accelerate market momentum.
Curavit specializes in decentralized trials (DCTs) for digital therapeutics (DTx) and will assess the value of both individual patients and population health levels of care. It indicates that DTx products can drive better outcomes for patients living with chronic diseases – an area experts predict will contribute to up to 84% of the total global mortality figures by 2030.
Research shows that DTx products can drive better outcomes for patients living with chronic diseases – an area that experts predict will contribute to up to 84% of total global mortality by 2030.
In further research, Curavit found that DTx products have the potential to improve health outcomes, reduce clinician workloads, lower the costs of care, reduce health disparities based on geography or socioeconomic levels, and expand access to behavioral treatments for a range of conditions.
Getting treatments to patients 'slow'
Unfortunately, for several reasons, the company has found, that getting the treatments to patients has been slow. These include lack of clinician familiarity, administrative challenges, prescribing complications, and insufficient insurance coverage. Curavit says evidence that a DTx reduces economic impact can motivate government and private insurance coverage to pave the way for greater access.
Andy Molnar, CEO of Digital Therapeutics Alliance (DTA), 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.
“Curavit's HEOR services will produce the real-world data needed to unlock wider insurance coverage and availability for transformative digital treatments. Their decentralized trials rigorously demonstrating improved outcomes and reduced costs will be instrumental to driving comprehensive adoption of these breakthrough therapies.”
An early adopter of the practice, MedRhythms, is working with Curavit to investigate long-term patient adherence, response durability and healthcare economic value of its neurorehabilitation system to improve walking in adults with chronic stroke walking deficits.
Exploring product's impact
A study – known as OrcHESTRAS (Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation) – is a prospectively enrolled study, designed with a focus on evidence generation and exploration of a product’s impact on reducing financial impact on the US healthcare landscape.
“A cornerstone of our mission at MedRhythms is that our products must be accessible to patients. One way we do that is through furthering our evidence development," said Owen McCarthy, president and co-founder of MedRhythms.
“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.”
Quantifying the final impact
Curavit connected its Stratus platform to both claims and medical data networks, providing a single HIPAA-compliant environment for receiving, reviewing, and analyzing these data sets. When HEOR is part of the scope of a trial, Curavit’s clinical research coordinators confirm claims and medical data availability during the screening process to efficiently incorporate HEOR into the clinical trial. At study close-out, both HEOR and clinical data are then easily analyzed to quantify the financial impact of the therapeutic.
Joel Morse, CEO and co-founder of Curavit, said: “Payers are concerned with health outcomes and cost-effectiveness, especially as healthcare costs keep rising and when it comes to less-understood digital therapeutics.
“We are helping DTx 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. Digital medicines are here – let’s streamline the steps required to prescribe and implement them.”