February 2018
The increasing focus on the quality and cost of care, the growing emphasis on reimbursing for value, and evolution of the global healthcare environment has created an unprecedented set of dynamic and complex market conditions for innovators.

We understand these challenges, and serve as a global strategic thought partner throughout the decision-making process as our clients prepare their products and technologies for commercial success.
Boston Healthcare Leaders Showcase Evidence-Based Insights
During early February, we joined world leaders in the biotech and pharmaceutical industries and academia to explore cancer research and innovation at the Molecular Med Triconference in San Fransisco.
Joe Ferrara and Shivang Doshi , both presented in the Molecular Diagnostics and Devices track on designing test strategies for oncology and non-oncology applications, and the importance of real world evidence in advanced diagnostics adoption.
Robert Wenthold recently spoke at the Medtech Commercial Leaders Forum in Zurich on the role of market access in strategic business development processes.

A copy of the presentation is available on request.
Germany: Medical Device Policy Update
In previous years, healthcare reform in Germany has focused on containing pharmaceutical costs, with the aim of ensuring that pharmaceutical prices would be economically efficient while not inhibiting innovation.
 
More recently, the focus has shifted to the medical device industry, specifically coverage, evidence, and reimbursement for devices across the ambulatory, inpatient, and home care segments. 

The federal government has started initiatives for better quality in the provision of healthcare. This includes the newly established quality institute, ‘Institut für Qualitätssicherung und Transparenz im Gesundheitswesen’ (IQTIG). Currently the IQTIG is conducting 26 quality evaluations, which includes device related inpatient procedures, like carotid revasculation, implantable cardioverter defibrillators, aortic valve surgery, or hip-/knee-replacement surgery. It is expected, that this Institute will evaluate medical procedures, and develop quality metrics, which may affect payment of inpatient procedures in the future.
 
Since 2017, a benefit assessment is required for new notably invasive or active implants in risk classes IIb/III before being granted additional payment. The NUB - 'Neue Untersuchungs - und Behandlungsmethoden' – can support financially innovative devices in inpatient use if costs are exceeding the existing DRG payment. In the new process for notably invasive or active implants, the Federal Joint Committee (G-BA) will assess the benefit within three months of the hospitals’ application for NUB payment. Manufacturers must cooperate with the hospital during this process.
 
The experience in 2017 showed that the criteria regarding clinical evidence are extremely high. None of the eight products in this category (i.e., notably invasive or active implants) provided sufficient evidence to be reimbursed through the NUB process.
 
If you would like to discuss these developments with us, please email   our Berlin office for more information.
IN THE NEWS
Joe Ferrara spoke with 360Dx News about the proposed EU Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here .


UPCOMING EVENTS

  • Joe Ferrara to speak at the DxConference in Boston, 8-9 March.
  • Tom Goss, PharmD to present at the World Orphan Drug Congress, April 26, 2018.
  • ISPOR 23rd Annual International Meeting, May 19-23, 2018.
  • American Society of Clinical Oncology Annual Meeting, June 1-5, 2018.

Boston Healthcare is a global consulting firm that develops successful market access and value optimization strategies for emerging and established medical device, diagnostics and pharmaceutical companies seeking to commercialize specialized products and services that have the potential to transform standards of care and significantly improve health outcomes. We combine our multi-disciplinary consulting expertise and analytic rigor with a deep and current understanding of evolving market and sector dynamics and trends, enabling our global clients to implement value and access strategies across their product portfolio successfully.