Background
Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical aspect that often gets overlooked is market access planning, which includes (but is not limited to) considerations related to the competitor landscape, coding, market share, estimated price, and reimbursement. Defining a market access strategy early in the development process, even before proof of concept, can significantly contribute to the success and adoption of a Medical Device in clinical practice.
Understanding the value of market access planning, its place in the development of MDs, including IVDs, and the importance of incorporating the market access strategy early in your MD development plan is critical. This will not only enhance the success of your MD development but will also facilitate meeting the upcoming requirements from the new European Health Technology Assessment (HTA) Regulation for high-risk MDs and IVDs.
The HTA Regulation (HTAR Regulation (EU) 2021/2282) aims to ensure faster patient access to new treatments by enabling collaboration among national HTA bodies to support a joint perspective on the clinical aspects of the development of medical products (starting in 2025) and of in vitro diagnostics (IVDs) and high-risk medical devices (starting in 2026). One of the key elements of the HTAR is the mandatory preparation and submission of a Joint Clinical Assessment (JCA) in parallel with the health technology developer's CE-mark approval of their MDs and IVDs in Europe.
Market Access & Reimbursement Strategy for Medical Devices and IVDs Defined
A market access and reimbursement strategy aims to ensure your product obtains reimbursement and will have a good market uptake. It encompasses every step from drafting an evidence generation plan and advocating for novel coding in the early development phase, to submitting HTA dossiers and managing the review and evaluation for payment.
Why is it Important to have a Market Access and Reimbursement Strategy for Medical Devices and IVDs?
The market access and reimbursement path depend on the type of MD and IVD and may be impacted by local regulations and requirements. Effective market access strategies will increase the speed to market, can ensure that Health Technology Developers (HTDs) will receive the best reimbursement possible for their product and that patients will have access to new medical products as soon as possible by providing those data that address a medical need. Proper planning will result in lower budget requirements and encourage further growth and development. With the upcoming mandatory submission of a JCA as per HTAR in parallel with the HTDs CE-mark approval of their MDs and IVDs in Europe, it is even more important to have the market access and reimbursement strategy in place in the design input stage of product development (ISO13485, clause 7.3.2).
Failure to plan and execute a high-quality market access and reimbursement strategy can result in a cascade of non-coverage decisions by payers leading to poor market acceptance by clinicians or patients not having access to health improving technologies. Ultimately non-coverage could be very costly for HTDs and may delay the product launch or even lead to complete loss of opportunity of much needed Medical Devices and Diagnostic Products.
Impact of HTAR on Market Access and Reimbursement Strategy for Medical Devices and Diagnostic Products in Europe
At a European level, cooperation in the field of HTA has been ongoing for years through European joint actions, such as with EUnetHTA, and the regional HTA Networks to which ProPharma has actively participated. As of end of 2021, those joint actions have been replaced by a Regulation introducing newly defined cooperation in the field of HTA (HTAR).
The HTA Regulation (HTAR) aims to foster innovation and ensure faster patient access to new treatments by enabling a common framework, and to encourage collaboration among national HTA bodies to support a joint perspective on the clinical aspects of the development of medical products, in vitro diagnostics (IVDs), and high-risk medical devices. As such, a streamlined HTA process is expected to enhance market access for healthcare technologies throughout Europe.
One of the key elements with the HTAR is the mandatory preparation and submission of a Joint Clinical Assessment (JCA) in parallel with the health technology developer's CE-mark approval of their MDs and IVDs in Europe.
The HTAR will designate a subset of MDs and IVDs to systematic JCAs at the EU level, in which the device will be compared to other health technologies or solutions. These products must have undergone prior CE marking in the framework of the European Medical Device Regulation (MDR) or In-Vitro Diagnostic Device Regulation (IVDR). Such joint clinical assessments will look specifically at the clinical aspects of new products, i.e. safety and performance data, from regulatory documents generated under the MDR and IVDR. Clinical assessments are typically based on global evidence derived from worldwide clinical trials in the case of medicinal products and multi-national clinical trials for Medical Devices and IVDs.
Joint clinical assessments will cover relative safety assessment and performance and outline diverging scientific opinions but will not give recommendations on the added value or reimbursement, which remains the mandate of the European Member States (MS).
For medical devices, the JCA will only be mandatory to certain classes of MDs and IVDs:
- Medical Devices classified as class IIb or III according to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion, and subject to a selection process*.
- In vitro diagnostic medical devices classified as class D according to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views, and subject to a selection process*.
* E.g., unmet medical need; first in class; potential impact on patients, public health or healthcare systems; incorporation of software using artificial intelligence, machine learning technologies or algorithms; significant cross-border dimension; major union-wide added value.
At this time, ProPharma has particular focus on the HTAR implementation and development of processes and methodologies/guidance, in support of MD and IVD development space.
When is the Best Time to Develop a Market Access and Reimbursement Strategy for Medical Devices and Diagnostic Products?
In many ways it is never too early to start thinking about a good market access and reimbursement strategy for your MD and IVD. As explained, in the diagnostic and medical device space, it is often critical to consider market access and reimbursement strategies while still in the product design phase. By developing the MD and IVD market access strategy early and also incorporate it as part of the medicinal product development (as relevant), time and money will be saved pre-registration, but also likely reduce the need for evidence generation in the post-approval setting.
Thus, market access and reimbursement strategy planning conducted in parallel with regulatory planning can ensure that a product successfully meets regulatory requirements and payer approval within a streamlined timeline. This is also the aim of the new HTAR, where one of the key elements with the HTAR is the mandatory preparation and submission of a Joint Clinical Assessment (JCA) in parallel with the health technology developer’s CE-mark approval of their MDs and IVDs in Europe.
How can a Consultant Support in Developing Your Market Access Strategy for Medical Devices and Diagnostic Products?
There are many areas of focus when developing your market access and reimbursement strategy, apart from the timing that is of particular importance considering the implementation of the HTAR. ProPharma is convinced that good market access planning is a critical component in the development of medical products.
With this in mind, ProPharma has developed a support paradigm, that can not only support you with the technical aspects of your MD and IVD development, but also with evaluating market viability, guiding the timing of evidence generation, shaping pricing strategies, facilitating positive coverage and reimbursement decisions, and instilling stakeholder confidence. Such reimbursement analysis will set the stage for successful commercialization and enhance patient impact.
In addition, ProPharma can support you with the preparatory steps for the JCA and the JCA submission for your product in line with the European HTA Regulation requirements.
Lastly, the implementation of the HTAR may lead to additional clinical or economic evidence requirements to support adoption by payers on a national level. If such additional evidence will be needed, it is important to also consider whether additional resources are needed. ProPharma can help you to determine whether additional evidence will be needed and support you with additional resource planning.
Expert Market Access and Regulatory Affairs Consultants
ProPharma is your trusted partner in navigating the intricacies of regulatory and market access for your MD and IVD. Our MD and IVD regulatory and market access consultants can help companies navigate the demands of European and local product launches. We believe that there is no partner better equipped to maximize your MD and IVD regulatory and reimbursement potential.
