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FAQ on the Epi proColon reimbursement initiatives

Below you will find answers to frequently asked questions regarding current developments at Epigenomics AG. A major topic is the initiatives related to the reimbursement decision of the U.S. Centers for Medicare and Medicaid Services (CMS) for the blood test Epi proColon. The Company’s initiatives to achieve reimbursement focus on (1) the National Coverage Determination (NCD), (2) a legislative initiative and (3) inclusion in one of the guidelines of the various guideline groups.

What is the status of the NCD CMS review process?
The CMS opened the NCD of Epi proColon on 28 February 2020. Epigenomics AG has informed the public via ad hoc release and corporate news. The opening of the NCD means that according to the statutes, a decision on CMS’s reimbursement of Epi proColon must be made within a maximum period of nine months. A positive CMS reimbursement decision would represent a major breakthrough for the company in the commercialization of Epi proColon in the U.S. market.
What would a positive/negative reimbursement decision by CMS mean for Epigenomics AG?
A positive CMS reimbursement decision would mean an important breakthrough for the company in commercializing Epi proColon in the U.S. market. Colorectal cancer (CRC) remains a leading cause of cancer deaths in the U.S. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new CRC cases and about 76% of CRC deaths and the associated costs.

A negative reimbursement decision would undoubtedly mean a setback for the company. Nevertheless, even if CMS rejects the NCD, there are other ways to obtain a positive reimbursement decision in the U.S., such as the legislative initiative or inclusion in one of the guideline groups’ guidelines.

Epigenomics hopes that the findings of the microsimulation model developed by experts at Harvard Medical School along with the key studies supporting FDA-approval of the product will result in CMS making a positive reimbursement decision. The microsimulation model demonstrates that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer nearly equivalent or better than other approved methods. Additionally, when adherence is included as a variable in the model, the blood test can outperform all other CRC screening strategies in terms of long-term benefits including the reduction in CRC incidence and mortality rates.

What is the current status of the legislative initiative on reimbursement of a blood test for colorectal cancer screening?
The legislative initiative under the title “Donald Payne Sr. Colorectal Cancer Detection Act” for reimbursement of our blood test for colorectal cancer screening must be introduced in both the Congress and the Senate. This was done in Congress in March 2019. A reintroduction to the Senate is still pending. One reason for the delay is presumably that political activity in Washington has been severely restricted in recent months, partly due to the Impeachment. The management assumes that after the recent conclusion the day-to-day political business will now continue.
What can you tell us about the work of the guideline groups? What are the prospects of Epi proColon being included in one of these groups’ guidelines?
In general, the Company believes that the Guideline Groups recognize the benefit of Epi proColon in contributing to a significant increase in colorectal cancer screening rates. However, there are no official dates on which the various Guideline Groups update their guidelines. Epigenomics is in regular communication with the groups and will promptly inform its stakeholders about significant developments.
FAQ on the status quo of scientific studies

What is the current status of the prospective liver cancer (HCC) detection study? When will the results be published?
The study has been completed and the data are currently being evaluated. The results are to be published in a scientific journal and are within the responsibility of the scientists. No results can be announced until they are published in a journal. Furthermore, Epigenomics has no further capacity to take the next steps in the further development of the liver cancer test for the time being due to limited financial resources.
What is the current status of the U.S. Department of Veteran Affairs study? When will the results be published?
The study, which aimed to assess the potential of a blood-based test as an acceptable alternative for screen-resistant individuals, has now been completed. The publication of the results is the responsibility of the U.S. Department of Veterans Affairs. Epigenomics anticipates that they will submit the study to a scientific journal for publication and therefore does not expect the U.S. Department to announce the results until they are published by the journal.