Shareholder Newsletter van deze morgen:
Welcome to the first MDxHealth newsletter for 2013. We have made a solid start to the year and have laid firm foundations for continued growth throughout the year.
Our fiscal year 2012 results, issued at the end of February, demonstrated again significant year over year revenue growth, attributable to both ClinicalMDx and PharmacoMDx products and services. In 2012, our revenue increased by 71% to more than €4.6 million in 2012, over 2011.
For a life science company, it is vital that research is supported by strong, peer-reviewed data. So it was with great pleasure that we announced additional positive data from studies with our ConfirmMDx™ for Prostate Cancer test in February. Clinical validation data from the MATLOC study was published in the current issue of the Journal of Urology, the official journal of the American Urological Society, and two additional scientific abstracts on the test were presented at the prestigious cancer symposium, American Society of Clinical Oncology for Genitourinary Cancers.
In addition, a pivotal health economics study for the ConfirmMDx for Prostate Cancer test was published in the American Health & Drug Benefits journal in February. This budget impact analysis demonstrates achievable cost savings using the test, which aids urologists in the identification of men who may avoid unnecessary repeat prostate biopsies, thereby reducing overall healthcare spending. The positive economic analysis, combined with the supplementary peer-reviewed scientific data, further supports reimbursement from payors and a positive coverage determination with Medicare. These publications are also important tools for MDxHealth sales force. Dr. Wade Aubry one of the co-authors of the budget impact study provides us with some more information about the importance of this publication in the Q&A section below.
We are looking forward to a successful 2013 and thank you for your continued interest and support in MDxHealth.
Sincerely,
Jan Groen
President & Chief Executive Officer
In January 2012, our licensing partner Exact Sciences Corp. (Nasdaq: EXAS) announced that it has submitted the second module of its premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its stool-based DNA colorectal cancer screening test, Cologuard™, which leverages an MDxHealth epigenetic biomarker together with MDxHealth's methylation-specific PCR (MSP) platform.
Wade Aubry, M.D.
Lead author of the ConfirmMDx Budget Impact Analysis published in American Health & Drug Benefits, Wade Aubry, M.D., is the Senior Medical Director for Quorum Consulting and Associate Clinical Professor of Medicine at the University of California, San Francisco
How does a health plan use a budget impact analysis?
A budget impact analysis is useful in assisting policymakers and financial managers to assess the affordability of new diagnostics, therapies or patient care strategies, such as the ConfirmMDx for Prostate Cancer test. Budget impact models (BIM) provide payers with a useful tool for forecasting the potential financial impact and uptake of a new diagnostic and patient care strategy.
As a medical director what do you typically look for in a budget impact analysis?
As a former health plan medical director I would give greater consideration to clinical and health economic data, including budget impact models, which have gone through expert review and published in credible peer-reviewed journals. My co-authors are accomplished experts in their respective fields, including urology, health economics, and medical policy development government agencies and commercial health plans. American Health & Drug Benefits is a credible peer-review publication, and the final published paper benefitted from the peer review process.
What was the impact/outcome of the budget impact analysis in the ConfirmMDx for Prostate Cancer study?
The BIM for ConfirmMDx demonstrates that a health care plan with 1 million members can achieve a cost savings of $588 per patient managed using ConfirmMDx on histopathologically negative men at risk for prostate cancer. The clinical utility of ConfirmMDx to distinguish men who may forgo a repeat prostate biopsy procedure from men who may be harboring undetected cancer reduces medically unnecessary repeat biopsies, complications associated with this invasive procedure, and the overall costs using conservative payment rates. By today’s standard of care, a large number of men are currently undergoing 2, 3 and even 4 repeat biopsy procedures. Until the emergence of ConfirmMDx, there were few alternatives to repeat biopsies to manage these men with better, less invasive, and less costly care. This BIM by design incorporates conservative costs for a prostate biopsy procedure and yields a cost savings of $530,801 to the plan or return on investment 1 year out.
How do you see the Budget Impact Analysis for ConfirmMDx for Prostate Cancer being utilized?
This budget impact analysis for ConfirmMDx is an important and timely contribution to the literature since stakeholders have a common goal: reducing unnecessary and costly healthcare costs without sacrificing appropriate patient care. With the introduction of ConfirmMDx and the publication of our study in a peer-reviewed publication, there is now emerging evidence for alternative and less invasive ways to manage patients at risk of prostate cancer. Payers that have evaluated the scientific evidence for ConfirmMDx may be more open to providing coverage for ConfirmMDx as a result of improved clinical benefit, reduced complications from repeat biopsies, and potential savings. Urologists may also be more open to utilizing this test for their at-risk patients knowing that they are providing improved patient care while reducing medically unnecessary tests and associated costs.
Based on the savings demonstrated in the ConfirmMDx budget impact model, how do you see this impacting coverage policy for ConfirmMDx?
A savings of $588 per patient managed with ConfirmMDx would come to my attention, and this would be likely to occur with other medical directors. Typically, health plan medical directors develop coverage policies by conducting a comprehensive evaluation of the entire body of scientific evidence and opinions of key opinion leaders and specialty societies. The diagnostic performance of ConfirmMDx along with its clinical utility and the Budget Impact Model results should provide the impetus for a health plan to consider a review of ConfirmMDx for Prostate Cancer. In the event a health plan does adopt a favorable coverage policy for ConfirmMDx, I would suggest that payers consider educational campaigns to inform urologists of coverage and criteria to augment appropriate use and enhance return on investment from downstream cost savings.
Jan Groen, CEO of MDxHealth, will be presenting at the following conferences:
March 16, 2013
MDxHealth Presents at the FlandersBio Beleggersdag Conference in Ghent, Belgium
March 19, 2013
MDxHealth Presents at the KBC Securities Healthcare Conference, Brussels, Belgium
April 17, 2013
MDxHealth to present at the BioCapital Europe 2013 Conference in Amsterdam, The Netherlands
April 23, 2013
MDxHealth Presents at the Kempen & Co Healthcare / Life Sciences Conference