Protecting Medical Innovation in New Jersey

New Jersey’s innovative life sciences industry develops groundbreaking treatments and cures that Patients everywhere depend on. Medical innovation also supports a healthy New Jersey economy. But a threat is looming. Patients and innovation itself may be endangered by the Institute for Clinical and Economic Review (ICER) and other organizations that use questionable, one-size-fits-all methods to determine drug value and access. Join BioNJ in our efforts to advocate for policies and solutions that help Patients access the medicines they need and promote a thriving life sciences industry in New Jersey and beyond.

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Why Patients and Medical Innovation May Be Under Threat?

In an effort to control the cost of care, health plans and policymakers are actively exploring the use of drug value assessments to determine whether or not a certain treatment should be covered. Health plans use value assessments – sometimes called “cost-effectiveness” reviews – to assess whether a drug’s price is justified by how effectively it treats a condition or disease. Payers use that information to decide if a new treatment will be covered for Patients.

But most drug value assessment frameworks are subjective, based on a one-size-fits-all equation, and could limit Patient access to innovative treatments.

What is ICER?

The Institute for Clinical and Economic Review (ICER) is a Boston-based research group that uses a controversial method to determine the value of drugs. ICER uses the “Quality Adjusted Life Years” methodology to determine treatment value, which is based on an arbitrary evaluation of the value of one year of perfect health. ICER ignores individual Patient preferences in its reviews. And the ICER approach to drug value assessment may be discriminatory, as it places a lower value on the lives of the disabled, the elderly and Patients with a rare disease.

What does the Growing Threat of ICER Mean?

CVS Health, the New York Medicaid program and the U.S. Department of Veterans Affairs (VA) have all used ICER drug value assessments to decide if Patients can access certain drugs. In 2018, in an attempt to deny patients access to a life-changing treatment, New York Medicaid announced that the cystic fibrosis drug Orkambi was not worth the cost.

Now, New Jersey has formed an Office of Medicaid Innovation, which may have its sights set on adopting a similar review process for new treatments. The Office of Medicaid Innovation will lead New Jersey Medicaid’s work on value-based payment and explore how to get “the best value for health care dollars.” While the Office of Medicaid Innovation has not explicitly stated its intent to implement ICER reviews, this language implies that it may explore this option.

ICER 2020 Value Assessment Framework

In 2020, ICER launched a new value assessment framework that it claims incorporates feedback from numerous stakeholders across the biopharmaceutical industry and Patient advocacy community. In October 2019, the Biotechnology Innovation Organization (BIO) submitted comments to ICER on its draft 2020 framework which emphasized the need for “substantive changes to ICER’s methodology.”

While ICER has touted that its new, more “Patient-centric” framework takes a wholistic view of the value a therapy provides, the fact remains that as long as the ICER framework uses the QALY methodology to measure treatment value, it remains deeply flawed and poses a serious threat to Patients in New Jersey and around the country.

What ICER Means for Patients

If ICER reviews are adopted more widely, it could deny Patients access to new and life-savings drugs. It would allow ICER – rather than physicians – to make treatment decisions for patients. One estimate found that, if Medicare used an ICER-style model, 59 to 93 percent of prescriptions to treat complex conditions may not be covered. When Patients can’t access the treatments they need, it can lead to complications, increased doctor visits, trips to the ER, and even death.

What incentive would life sciences companies have to innovate if the drugs they produce can’t reach the Patients who need them? ICER could bring innovation to a halt.

How You Can Take Action

Because Patients Can’t Wait®, any solution to control health care costs in New Jersey must promote innovation, incorporate the unique needs of Patients, and ensure access to care. Join us in our efforts to protect medical innovation and access to life-changing treatments for New Jerseyans and all Americans. Sign up and we’ll send you email opportunities to take action online and in your community.

Help us spread the word and lend your voice on the importance of protecting medical innovation coming from New Jersey’s life sciences industry on behalf of Patients. We have shared sample social media posts below that can be customized to fit your unique voice and perspective.

  • New Jersey’s innovation life sciences ecosystem creates life-saving treatments and cures that give Patients hope, but it’s under threat. Help preserve access to life-saving care by taking action at
  • How do we define drug value for Patients? Regulators in New Jersey could be asking themselves this very question to determine access to innovative, life-changing treatments. Help us protect innovation and the Patient voice in drug value assessment:
  • FACT: Between 2014-2018, not one of ICER’s reviews of rare disease drugs resulted in a “high-value” rating. ICER is dangerous for those with a rare disease – and all Patients. Join us and in our efforts to protect Patients and innovation. Learn more:
  • ICER’s controversial methodology threatens Patients everywhere, especially those with a disability. In fact, use of the QALY in state Medicaid may violate the Americans with Disabilities Act. Learn more and help us protect Patient here:
  • If policymakers adopt ICER reviews, it will allow ICER – rather than physicians – to make treatment decisions for Patients. When Patients can’t access the treatments they need, it can lead to complications. Learn how we can protect Patients and innovation:

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