Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

Access

Performance-based Risk-sharing Agreements in Diagnostics: Part 2, Europe

Performance-based Risk-sharing Agreements in Diagnostics: Part 2, Europe

In our second part in this mini-series, today we look at the landscape, trends and challenges in Performance-Based Risk Sharing Agreements in Europe.

Performance-based Risk-sharing Agreements in Diagnostics: Part 1 USA

Performance-based Risk-sharing Agreements in Diagnostics: Part 1 USA

We look at the first systematic review of an ever-evolving diagnostic access pathway, performance-based risk-sharing agreements, in the United States. In our next blogpost, we will review the same trends in diagnostic patient access in Europe.

10 most exciting (digital) diagnostics news from 2019

10 most exciting (digital) diagnostics news from 2019

The top/best/most lists are always subjective, so is ours. Looking back to 2019 we enjoyed reading the following 10 news bites the most. This inventory is far from being comprehensive, yet they can point to broader trends.

3+1 Policy Initiatives That Will Influence Diagnostics (IVD) Access

3+1 Policy Initiatives That Will Influence Diagnostics (IVD) Access

The diagnostics industry is facing increasing policy attention. Policymakers push for broader access, better affordability and safer than ever solutions. Institutions, like the European Union (EU) and World Health Organization (WHO), are involved in introducing new regulations.

Find out what are the latest policy initiatives and how will they impact access for IVD solutions.

Five Diagnostics (IVD) Access Challenges & Potential Actions

Five Diagnostics (IVD) Access Challenges & Potential Actions

Five Diagnostics (IVD) Access Challenges & Potential Actions:

  1. Diagnostics are complex solutions

  2. Less clinical investment

  3. Cost-based reimbursement

  4. Lack of clear funding processes and guidelines

  5. Limited-use cases in digital diagnostics reimbursement

WHO Essential Diagnostics List (EDL) – 3 likely impacts to the diagnostics industry

WHO Essential Diagnostics List (EDL) – 3 likely impacts to the diagnostics industry

WHO Essential Diagnostics List (EDL) – 3 likely impacts to the diagnostics industry

The diagnostics industry is facing increasing policy attention. The In Vitro Diagnostic Device Regulation (IVDR) will newly regulate the European approval system, the new EU Health Technology Assessment (HTA) proposal is already on the table and World Health Organization (WHO) has just released the first Essential Diagnostics List (EDL).

Similar concept, Essential Medicines List (EML) has been around for 40 years. Looking at the history of EML what can the diagnostics industry expect?