The diagnostics industry (IVD) 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. From the WHO's Essential Diagnostics List (EDL) to the EU's Health Technology Assessment (HTA), diagnostic manufacturers shall plan now for coming change. These new policy initiatives will likely alter market access in the coming years. Consider three policy initiatives that are upon us now, plus one that is likely to be realized in the near future.
1. Essential Diagnostics List (EDL)
"It's clear that treatment of an illness will not be effective if it is not diagnosed correctly," stated Dr. Suzanne Hill , WHO Director of Essential Medicines and Health Products. With that philosophy in mind, WHO launched a committee in 2017 to create an Essential Diagnostics List (EDL) to compliment its List of Essential Medicines. The EDL was released last year with the goal of creating healthier populations by:
Providing guidance to Member States for local adaptation
Informing nongovernmental organizations to support provision of diagnostics
Informing the industry on global health priorities
The Essential Medicines List has been around since 1977, and has helped countries prioritize medicines that need to be available to their populations. The EDL could likely elevate the relative importance of diagnostics, potentially leading to pooled procurement, increased price controls, and certain in-focus disease areas might receive proportionally higher health care budgets. In fact, the EDL is already making a difference. Within half a year of its release, India drafted its own national EDL that addresses the unique diagnostic needs of its population. It's likely we will continue to see broadening global access to diagnostics as more nations follow WHO's example, especially in less resource-rich economies.
2. In-Vitro Diagnostics Regulation (IVDR)
In Europe, traditionally In-Vitro Diagnostics (IVD) were less regulated compared to pharmaceuticals. That is all changing under the new In-Vitro Diagnostic Regulations (IVDR). The IVDR went into effect in May 2017. However, companies have five years to comply. This new regulatory framework has major implications for IVD companies in wider scope of regulated IVDs and change in IVD classification. One significant change involves increasing clinical evidence requirements for access to and adoption of IVDs. The IVDR mandates that clinical data is collected at pre-registration and post-launch to prove clinical benefits and to meet safety standards. Read more about the implications of IDVR in this recent article.
3. EU-Health Technology Assessment (EU-HTA)
The European Commission started working on a proposal for Health Technology Assessment (HTA) in order to create a more systematic approach with more transparent methodologies. Under the existing framework, lack of common criteria meant that data and evidence requests vary between EU member states. Additionally, since national HTA bodies perform their own clinical assessments, costs and work are duplicated. The new EU-HTA could ensure continuity, improve predictability, enhance transparency and ultimately reduce costs. The result is greater access to innovative technologies for patients in the EU. Once it's fully certain, which innovative medical technologies will undergo future HTA assessments, and how the new system will be set up, diagnostic companies will be most likely need to generate more clinical data, demonstrating impact in practice. This will likely include further investments in clinical programs and launch preparation. Read more about the latest status of EU HTA here.
+1 Value of Diagnostics Information (VODI)
Value of Diagnostics Information (VODI) is more of a European concept right now, rather than a tangible policy. However, it's becoming part of policy discussion and will likely impact diagnostics in the near future. The idea behind VODI is to provide a comprehensive framework that captures the entire value of complex diagnostic solutions.
This European initiative is similar to Advanced Medical Technology Association’s (AdvaMed) Value Assessment Frameworks, which addresses four major components:
Clinical impact;
Non-clinical patient impact;
Care delivery revenue and cost impact
and Public/population impact
Based on these policy initiatives the IVD industry will most likely to experience:
broadening global access in less resource rich health care systems,
increasing clinical evidence requirements
and emerging, comprehensive value capture frameworks, supporting broader use of health technology assessments