Creating a structured approach to the authorization, launch and use of digital therapeutics has the potential to improve healthcare across Europe, empower patients and bring significant financial benefits to healthcare systems, according to a new report out today by the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA is today publishing a number of policy recommendations which aims to improve access to these technologies across all Member States.

Digital therapeutics (DTx) deliver software driven, evidence-based therapeutic interventions to patients to prevent, manage, alleviate or treat a medical disorder or disease, either independently or in combination with medications or devices. Their potential for improving care came into the spotlight during the COVID-19 pandemic, when health systems frequently had to adapt to the challenges of treating patients outside of traditional clinical settings.

They can be used across a wide range of areas: Delivering cognitive behavioural therapy (CBT) for patients with depression, treating insomnia, the self-management of diabetes or remote surgical rehabilitation, for example for hip and knee or obesity surgery. Digital interventions have also been found to improve the survival rate of cancer patients.

Despite the extent of their potential benefits, the use of DTx in Europe is limited to only a handful of Member States. While there has been some progress in integrating DTx into market access and care pathways, only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and UK.

As a result, DTx face unpredictable requirements or standards for much of the development and commercialisation pathway, including authorisation, value assessment, reimbursement, and pricing. Specifically, the report highlights four key challenges:

1. Despite being governed by the EU Medical Device Regulations, there is a lack of harmonization in regulatory requirements due to differences in interpretation in individual Member States.
2. Challenges in the evidence requirements and lack of a value assessment processes. Due to lack of specific frameworks, it is unclear what evidence DTx requires for positive value assessments.
3. No standardised or specific reimbursement pathway for DTx in most countries: This means that DTx may not be reimbursed, be subject to long delays, or be reimbursed by individual providers, resulting in uncertainty over requirements for reimbursement.
4. Inadequate funding: DTx do not receive adequate funding and distinct reimbursements pathways so not guarantee uptake in practice. Even with adequate funding, there are further challenges due to a lack of readiness from physicians and patients to use them.

While EFPIA welcomes the initiatives already made in promoting access to DTx in some countries, there is a clear opportunity for both policy change within the individual Member States and for some harmonisation across the EU. 
EFPIA is making nine policy recommendations to be considered at the national and European level to improve authorisation, launch and use of DTx across the EU.

1. Harmonized regulatory requirements with clear guidance are required to ensure streamlined access.
2. Value assessment requirements should be tailored and fit-for-purpose, predictable and consistent, and involve a portfolio of evidence that can include real-world evidence.
3. Member States and the European Commission should consider supporting collaboration between countries to enable harmonisation of clinical evidence requirements.
4. Member States and the European Commission should collaborate to support data sharing and infrastructure building, to realise the potential of data generated by DTx.
5. Clear and transparent national pathways for DTx pricing and reimbursement in all Member States.
6. Payers should permit flexible approaches allowing provisional access while additional data is generated.
7. Payers should be willing to implement novel payment models to manage evidence uncertainties.
8. Adequate funding which should be explicit and budgeted for DTx, with no financial burden on patients.
9. Increasing DTx uptake will require collaborative efforts between policymakers, HCPs, and companies.                                   
   
   • Developing trust in DTx will require stakeholders to work together to enhance the knowledge and experience of HCPs and patients.

EFPIA believes that these recommendations in combination will help improve access to these therapies so that many more patients can benefit from these increasingly important new advances in medical technologies.

Nathalie Moll, Director General, EFPIA, said:

“The emergence of COVID-19 meant healthcare systems had to adapt and work in a more flexible and pragmatic way to ensure patients continued to receive treatment. This saw a dramatic surge in the use of digital technology across many disease areas. We must now take on board the lessons learned in the pandemic to improve and update health services - across a number of therapy areas - for patients throughout Europe.

From the treatment of mental health conditions to managing Cancer and Diabetes to surgical rehabilitation, the potential of these therapies is vast. In order to reap the benefits we need a coherent and harmonised approach to the implementation and use of these therapies across Member States. I hope this report can help to kickstart the process.”