NEW YORK (GenomeWeb) – The Center for Medical Technology Policy has released initial health insurance coverage guidelines for next-generation sequencing cancer tests. The CMTP's Green Park Collaborative developed the guidelines in a multi-stakeholder process that included industry, medical professional societies, patient advocacy groups, and a number of health plans.
"NGS testing methods are potentially important new tools to enable clinical genomics and the realization of personalized medicine," Donna Messner, VP and senior research director at CMTP, who led the GPC guideline development effort, said in a statement. "However, there is currently substantial uncertainty over future health plan coverage policy for genomics and how to accelerate evidence development for this testing, which we hope to clarify through this effort."
The draft guidelines recommend that payors cover NGS panels consisting of five to 50 genes when such panels include at least five genes that are considered to be standard-of-care and medically necessary.
"The lack of predictable coverage and reimbursement policies that anticipate the rapid emergence of new genomic tools could become a hindrance to cancer care," Sean Tunis, CMTP's CEO, said in a statement. "Getting agreement on guidelines for coverage of targeted NGS gene panels is a crucial first step towards more comprehensive and forward-looking policies for genomics in clinical medicine."
In addition, the guidelines recommend that payors rely on the College of American Pathology accreditation program and proficiency testing to ensure analytic validity of NGS panels. They also include proposals to incentivize data sharing among labs and clinicians; to promote patient participation in clinical trials and registries; and to support robust, well-curated repositories and clinical research initiatives.
For panels larger than 50 genes, the authors noted that payors should "consider" covering such panels for certain patients, including those with newly diagnosed stage IV lung adenocarcinoma, newly diagnosed carcinoma of unknown primary origin, newly diagnosed stage IV rare or uncommon tumor for which no standard treatment exists, newly diagnosed stage IV tumors with a median overall survival of less than two years, stage IV solid tumors who have exhausted established guidelines for treatment, or newly diagnosed hematologic malignancies with limited established treatment guidelines.
Providers of comprehensive panels have so far had mixed results obtaining reimbursement. Foundation Medicine receives an average of $3,400 per test, and Grand Rapids, Michigan-based Priority Health has said it would cover Foundation's tests, while Google said that its employees would have access to them. On the other hand, the company recently had to lower its expectations of number of tests it would run in 2015 due to a delay in local coverage determination from its Medicare Administrative Contractor.
Exome and whole-genome sequencing are considered investigational and are not recommended for coverage.
The guidelines also seek to address an issue that has repeatedly been voiced as a major hindrance by providers of clinical cancer sequencing panels — access to drugs. Often an NGS panel will identify a targetable mutation for which there is a drug, but that is approved for a different indication. Clinicians have so far had difficulty gaining access to such drugs for their patients.
One potential workaround the GPC proposed is that payors could "cover off-label variant-directed drugs or biologics for individual patients who have already demonstrated a benefit after three months of treatment" with the drug. For the first three months, the GPC suggests it may make sense to ask the drug company to provide the drug for free.
However, "substantive additional discussion is needed to achieve a framework acceptable to patients, payers, and drug-makers," the report authors noted.
Over the next year, the GPC plans to continue to meet with stakeholders to address questions raised, including discussing future conditions under which comprehensive cancer panels, as well as exome and whole-genome sequencing, may be covered.