Genentech is focused on realizing the promise of personalized healthcare by working with health care advocates to educate policymakers on the value of patient access to and insurance coverage of biomarker testing.
Biomarkers are an essential part of “personalized” or “precision” medicine that provide necessary information for appropriate therapeutic intervention.
Biomarkers (short for “biological markers”) are characteristics of the body that can be objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. Biomarkers include, but are not limited to, gene mutations or protein expression.
Genetic variations play an increasingly important role in personalized healthcare because they can help healthcare professionals identify which patients may benefit from specific treatments.
With biomarker testing, patients can receive the specific treatment best suited to combat their specific disease. A growing majority of new trial results and FDA approvals in cancer, for instance, are for targeted therapies with associated biomarkers.
The scope of precision medicine is growing rapidly. Where today testing is used mainly in cancer diagnosis, prognosis, and treatment, several other disease areas are showing actionable biomarkers. The FDA has approved more than 430 medicines for targeted therapies in more than a dozen disease areas, and many of those therapies have associated biomarkers.1
At Genentech, we believe that comprehensive biomarker testing is critical to advancing personalized healthcare. Our goal is to provide patients with better care, leading to better health outcomes at lower costs. Biomarker testing is paramount to achieving this goal.
Currently, many commercial health plans and state Medicaid programs lack coverage or restrict coverage of biomarker testing, preventing patients and physicians from making fully informed treatment decisions. Specifically, many payers in the state-regulated, fully-insured commercial market are not covering biomarker testing consistently with clinical guideline recommendations.
But access to biomarker testing is a solvable challenge. We can dramatically improve the outlook for patients and ensure that more people benefit from targeted medicines if we work together across the whole community.
To address these concerns, Genentech is engaging with the healthcare advocacy community to help educate state legislators and regulators on the importance of biomarker testing to ensure that coverage is commensurate with scientific evidence and clinical guidelines.
Specifically, Genentech supports state policies that align access to biomarker testing with national clinical practice guidelines, consensus statements, FDA-approved, -cleared and/or -labeled tests, and Centers for Medicare and Medicaid Services National and Local Coverage Determinations. These aim to eliminate delays in coverage of and access to biomarker testing, and enable payers to keep coverage policies up-to-date with scientific advancements.
Barriers still exist that prevent patients from benefiting from the full potential of personalized healthcare. Barriers include, but are not limited to: inadequate coverage of biomarker testing by public payers and commercial insurance, out-of-date coverage policies, and low provider and patient awareness of innovation and scientific advancements in both precision medicine and biomarker testing.
Research has confirmed that there are inequalities in our healthcare system for disadvantaged patients who have poorer health outcomes as a result. Access to biomarker testing helps to ‘level the playing field’ for all people regardless of age, race, and socioeconomic status and ensures more patients can access precision medicines.
While there is broad coverage for many biomarker tests under Medicare, this is an evolving space that requires continuous review to ensure medically-appropriate, equitable access.
Despite the clear advantages of biomarker testing, many health insurers and Medicaid programs do not provide appropriate access to these critical tests. Policymakers can help change the landscape by making biomarker testing more widely available for patients.
As state lawmakers have realized the importance of access to and coverage of biomarker testing, many are taking action. State legislation is starting to be introduced and signed into law. Genentech is excited to partner with stakeholders and policymakers to support broad access to biomarker testing. Since 2021, more than a dozen states have enacted new legislation to require coverage of comprehensive biomarker testing when supported by clinical guidelines and other medical and scientific evidence by state-regulated commercial plans and/or Medicaid. This landmark legislation paves the way for more patients to benefit from the promise of precision medicines and help improve health outcomes.
1. Table of Pharmacogenomic Biomarkers in Drug Labeling. https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling