Digital therapeutics are evidence-based therapeutic interventions often developed in combination with a device and/or therapeutic agent, that are designed to prevent, manage, or treat a variety of medical conditions and address challenges such as medication adherence and poor disease control.1
In this update, taken from the free report “Digital Therapeutics: Value, Evidence, and Access insight,” we review some of the differences in reimbursement pathways and how some markets are leading the charge, defining and implementing clearer guidelines for the reimbursement of digital therapeutics.
Germany: guidelines for the reimbursement of digital therapeutics
In Germany, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) assessment procedure for digital health applications (Digitale Gesundheitsanwendungen, DiGAs) established a novel fast-track national assessment process for low-risk digital health applications (class I and IIa medical devices). In addition, pre-existing reimbursement routes exist regionally, through Statutory Health Insurance (SHI) providers and private insurers.
Successful assessment leads to a listing in the national directory of reimbursable digital health applications, enabling the digital health application to be prescribed by healthcare providers and to be reimbursed by SHI providers. If the manufacturer cannot provide sufficient evidence of a positive healthcare effect, but all other basic requirements are fulfilled, it is possible to apply for a provisional listing.2
A positive healthcare effect must be established for a DiGA to be granted national reimbursement in Germany.3
France: guidelines for the reimbursement of digital therapeutics
In France, digital health technologies are mainly funded through the standard national pricing and reimbursement procedure for medical devices – CNEDiMTS is the committee within the French National Authority for Health (Haute Autorité de Santé, HAS) that oversees medical device assessments and approvals for reimbursement by statutory insurers. CNEDiMTS assessment typically considers a technologies clinical benefit and likely value compared with currently available solutions.
CNEDiMTS opinion is used to determine reimbursement through national health insurance and is used to guide subsequent price negotiations between the manufacturer and the Economic Committee for Health Products (Comité économique des produits de santé, CEPS). Once a price for the device has been negotiated, the Ministry of Health includes it in the list of reimbursable products—the LPPR (used for secondary care outside of hospitals) and the T2A list (used for hospital products that are paid for out of DRG tariffs).4
Similarly to Germany, France has established its own national registry of approved digital health applications, the “Mon Espace Santé” mobile health platform. The Ministry of Health evaluates the technology (safety, efficacy, adherence to required standards) prior to inclusion on this register. Details of the national reimbursement framework are pending publication.5
Spain: guidelines for the reimbursement of digital therapeutics
In Spain, national reimbursement through the basic services portfolio of the Spanish national health system is required before assessment by the regions, but this does not guarantee local reimbursement. Specific processes of regional HTA agencies (autonomous communities, ACs) are not regulated by any national standards, but are administered directly from the ACs. As a result, there is a high level of disparity and inequality across different regions, as regional budget spend differs and is apportioned based on the prioritization criteria of that region.6
UK: guidelines for the reimbursement of digital therapeutics
There are multiple applicable assessment pathways for digital health technologies in the UK.7
NICE has developed a specific program to support the assessment of digital health technologies, called the Medical Technologies Evaluation Programme (MTEP). The program evaluates medical devices that can be deemed cost-saving or cost-neutral, and produces medical technologies guidance to encourage their adoption. However, a positive MTEP recommendation does not entail a funding mandate for NHS England.8
There are 3 types of guidance that are published by MTEP, each with different evidentiary requirements.
Diagnostics guidance covers the evaluation of innovative diagnostic technologies, measurements, and tests.
Medical technologies guidance covers the evaluation of medical devices, and is key to getting these recommended for reimbursement. Medtech innovation briefings set out available evidence for digital interventions that support NHS commissioners in deciding which technology to use, but are not recommendations for reimbursement. Digital health interventions are more likely to be funded at a regional level.
The Digital Technology Assessment Criteria (DTAC) set the national baseline framework for digital technologies entering the NHS in the UK, bringing together legislation and good practice to ensure digital health tools meet clinical safety, data protection, technical security, interoperability, usability, and accessibility standards.9
Procurement decisions are primarily made at a local level in the UK for digital therapeutics. In England, commissioning has been delegated to Integrated Care Systems (ICSs). In the absence of a national reimbursement pathway, there are regional disparities access to these innovations and inefficiencies in the path to reimbursement.
US: guidelines for the reimbursement of digital therapeutics
In the US, reimbursement refers to the means by which healthcare providers are paid by insurance plans (ie, payers) for providing medically necessary (ie, covered) healthcare services to patients. There are 3 required components for reimbursement, coverage (the type and number of healthcare services providing a product and the conditions), coding (language used to define healthcare diagnosis and procedures), and payment (fee paid to healthcare provider for covered service).7,10
The US has a mix of public and private payers, and reimbursement is critical for securing patient access to a new digital therapeutic; however, it does not determine the price. The price is subject to negotiations with providers and the digital therapeutic must demonstrate added value to the payer to increase coverage.7,10
In the US, digital health describes a range of services and is regulated by the Food and Drug Administration (FDA). There are multiple reimbursement models for digital health in the US, but commercial plans have been historically more agile in providing access to such digital services. Pandemic emergency provisions (2020) allowed certain low-risk digital health applications to be launched for use by patients without having to go through the FDA’s usual premarket notification requirement (510(5) process).7,10 Centers for Medicare and Medicaid Services (CMS) has developed policies for the reimbursement of remote patient monitoring and telehealth solutions but there is not a clear policy on reimbursement of digital therapeutics. Private health insurers have begun to develop evaluation frameworks for digital products and services.
Variations in reimbursement pathways for digital therapeutics across markets leads to disparities in access and inefficiencies in reimbursement pathways
There have been recent efforts in certain markets to integrate digital therapeutics, resulting in individual payer initiatives as seen in the US and Germany, for example, and a mix of national or regional funding mechanisms applied across other European markets. Each payer is likely to have its own guidelines and criteria for digital therapeutics adoption. In the absence of a definitive funding policy, public and private insurers generally reimburse for digital therapeutics only when there is a strong rationale for their use.
In summary, there are variations in the established reimbursement pathways for digital therapeutics across markets and differences in the evidence requirements to support pricing and reimbursement. This will lead to health inequity with regional disparities in access to these innovative technologies. There are many inefficiencies in the reimbursement pathway. Multiple regional and local stakeholders can be involved in procurement in the absence of national funding for digital therapeutics, leading to fragmented market access for manufacturers.
In the next section of the free report, we discuss evidence requirements for digital therapeutics. We also explore evidence requirements and highlight perspectives for access in the Asia-Pacific region and the US.
Digital Therapeutics Alliance. https://dtxalliance.org.
(2021). DiGA-Verzeichnis. Retrieved from https://diga.bfarm.de/de/verzeichnis.
National Commission for the Assessment of Medical Devices and Health Technologies: https://www.has-sante.fr/jcms/c_419486/fr/commission-nationale-d-evaluation-des-dispositifs-medicaux-et-des-technologies-de-sante.
Digital health reimbursement concepts: Discussion document: abhi.org.uk/media/3307/digital-health-reimbursement-concepts.pdf.
Medical Technologies Evaluation Programme: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-medical-technologies-evaluation-programme.
NHSX – Digital Technology Assessment Criteria (DTAC): https://www.nhsx.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac.
Remote Patient Monitoring (RPM) CPT codes for CMS: https://timedochealth.com/2021/04/23/rpm-billing-explained-billing-for-cpt-codes-99453-99454-99457-99458/.