Foundation Medicine Announces Final National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (...
March 18 2018 - 10:19PM
Business Wire
-- Final NCD Significantly Expands Patient
Access Beyond the Preliminary NCD --
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the
Centers for Medicare & Medicaid Services (CMS) issued a final
National Coverage Determination (NCD) for patients who receive next
generation sequencing (NGS) testing with an assay that meets the
coverage criteria. Medicare and Medicare Advantage patients who
receive testing with FoundationOne CDx™, the first FDA-approved
comprehensive genomic profiling (CGP) assay for all solid tumors
incorporating a broad set of companion diagnostics, will be
eligible for coverage. Below is an outline of key changes made to
the final NCD that expand patient access to FoundationOne CDx:
Preliminary NCD Final NCD
Patient Eligibility Coverage for Stage IV
metastatic, recurrent cancers Coverage for Stage III
and Stage IV, metastatic, recurrent, relapsed, or refractory
cancers
Breadth of Coverage for FoundationOne
CDx
Coverage for companion diagnostic claims across five
tumor types including non-small cell lung, colorectal, breast,
ovarian cancers and melanoma. (Approximately 50% of solid tumors
based on Foundation Medicine’s volume). Coverage
across all solid tumors
Repeat Testing No
repeat testing included Repeat testing is covered
when a new primary cancer diagnosis is made by the treating
physician and the patient meets other clinical criteria
Coverage
with Evidence Development (CED) Included
Removed; Coverage for FoundationOne CDx is for all solid
tumors
Based on the final CMS coverage policy, FoundationOne CDx is the
first and only NGS assay that presently meets the requirements of
the policy, enabling national coverage for all solid tumors. For an
NGS diagnostic assay to be covered under the policy, the NGS
diagnostic assay must:
- be an FDA approved or FDA 510(k)
cleared test with a companion diagnostic claim;
- have a product label from FDA with an
indication for use in the patient’s cancer; and,
- report results to a treating physician
for management of the patient using a report template to specify
treatment options.
There are currently no NGS assays that have FDA 510(k) clearance
with a companion diagnostic claim.
“We applaud CMS for issuing this final National Coverage
Determination that significantly expands coverage beyond the
preliminary draft policy. Most notably, the NCD, as it applies to
FoundationOne CDx, will provide coverage for eligible patients
across all solid tumors,” said Troy Cox, chief executive officer at
Foundation Medicine. “The final NCD will significantly improve
access and coverage for Medicare beneficiaries to comprehensive
genomic profiling and biomarker-driven treatments. We look forward
to commercializing FoundationOne CDx by the end of March, providing
the oncology community with the only FDA-approved broad assay for
all solid tumors.”
Similar to the coverage available today via local Medicare
Administrative Contractors (MACs), the NCD coverage policy will
enable NGS assays, including those performed in CLIA-certified
laboratories, such as FoundationOne®, FoundationOne® Heme and
FoundationACT®, as well as FDA cleared or FDA approved assays
without companion diagnostic claims, to continue to seek local
coverage determinations (LCDs) through the MACs.
Please visit CMS.gov to view the final decision memo.
About FoundationOne CDx
FoundationOne CDx is indicated as both (i) a broad companion
diagnostic test for approved companion diagnostic claims including,
NSCLC, CRC, melanoma, breast and ovarian cancers and (ii) to be
used by qualified health care professionals in accordance with
professional guidelines in oncology for patients with solid
malignant neoplasms. FoundationOne CDx is a next-generation
sequencing based in vitro diagnostic device for detection of
substitutions, insertion and deletion alterations, and copy number
alterations in 324 genes and select gene rearrangements, as well as
genomic signatures including microsatellite instability (MSI) and
tumor mutational burden (TMB) using DNA isolated from
formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens.
For the complete intended use statement, including companion
diagnostic indications, please see the FoundationOne CDx Technical
Information, www.foundationmedicine.com/f1cdx.
About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information
company dedicated to a transformation in cancer care in which
treatment is informed by a deep understanding of the genomic
changes that contribute to each patient's unique cancer. The
company offers a full suite of comprehensive genomic profiling
assays to identify the molecular alterations in a patient's cancer
and match them with relevant targeted therapies, immunotherapies
and clinical trials. Foundation Medicine’s molecular information
platform aims to improve day-to-day care for patients by serving
the needs of clinicians, academic researchers and drug developers
to help advance the science of molecular medicine in cancer. For
more information, please visit http://www.FoundationMedicine.com or
follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine®, FoundationOne®, FoundationOne® Heme and
FoundationACT® are registered trademarks and FoundationOne CDx™ is
a trademark of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for
Foundation Medicine
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements regarding the
ability of certain Medicare patients who receive FoundationOne CDx
testing to receive Medicare coverage for costs associated with
FoundationOne CDx, the ability of the NCD, and FoundationOne CDx as
an assay covered under the NCD, to enhance access to comprehensive
genomic profiling and biomarker-driven treatments; whether the
changes contained in the final NCD as compared to the preliminary
NCD will expand the access to reimbursement for certain Medicare
beneficiaries; the interpretation of how the NCD will operate and
the potential access to Medicare coverage through LCDs from MACs
that may exist for certain Foundation Medicine products; the
benefits of our products to oncologists and patients in the
treatment of cancer and personalized cancer care; and the timing,
scope and potential benefits to the oncology community of a
commercial launch of FoundationOne CDx. All such forward-looking
statements are based on management's current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include the risks that the final NCD
will not significantly improve access to reimbursement for Medicare
beneficiaries; that Foundation Medicine has not correctly
interpreted the NCD or that CMS subsequently modifies the NCD; that
Foundation Medicine is not able to provide FoundationOne CDx for
commercial use in the manner or on the timeline currently
anticipated by management; and that the risks described under the
caption "Risk Factors" in Foundation Medicine's Annual Report on
Form 10-K for the year ended December 31, 2017, which is on file
with the Securities and Exchange Commission, as well as other risks
detailed in Foundation Medicine's subsequent filings with the
Securities and Exchange Commission. All information in this press
release is as of the date of the release, and Foundation Medicine
undertakes no duty to update this information unless required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20180318005086/en/
Media:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor:Kimberly
Brown, 617-418-2215ir@foundationmedicine.com
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