BioNJ Background
BioNJ is New Jersey’s life sciences trade association, representing nearly 400 research-based life sciences companies, academic institutions, Patient advocacy organizations and other stakeholder members. New Jersey’s life sciences ecosystem has consistently been a global leader in innovation in biopharmaceutical research, development and manufacturing. The State’s life sciences sector is comprised of nearly 3,300 life sciences establishments with more than 1,000 drugs in development. A substantial percentage of all FDA new drug proposals continue to come from biopharmaceutical firms with a significant New Jersey presence. New Jersey’s life sciences community has nearly 430,000 direct, indirect and induced employees in the State and is a critical cog to the State’s economy as well as to bringing new therapies and cures to the Patients who need them.
Focus: Protect Patient Access to Health Care Innovation
BioNJ strongly supports measures that enhance Patient access to innovations in health care.
We believe that Patients should have access to the right treatments at the right time – Because Patients Can’t Wait®. As groundbreaking and lifesaving cures are developed, timely Patient access to these treatments is critically important.
Step Therapy
Health plans continue to utilize tools that can result in slowed Patient access to treatments when they’re needed most. The use of step therapy is an alarming trend in health coverage. Step therapy – also known as “fail first” – is a utilization management tool that requires Patients to try and fail with one or more treatments before gaining access to the treatment prescribed by the Patient’s health practitioner.
BioNJ believes, in many instances, step therapy results in delaying Patient access to necessary and lifesaving therapies. In fact, studies show that more than 50 percent of Patients are required to try two or more treatments before receiving authorization to get the treatment originally prescribed by their physician. While step therapy may be appropriate for certain Patients, Patients with cancer, HIV, mental illness, arthritis, epilepsy and many other disease states simply cannot wait for the right therapy. Other states around the country have developed guidelines for the appropriate use of step therapy. These guidelines are clinical and developed by independent experts.
Thankfully, legislation has been introduced in both the Senate and General Assembly to establish clinically appropriate guidelines for step therapy usage. A-4815 (Conaway/Benson) and S-3051 (Vitale/Addiego) would help improve Patient access to the therapies they need when they need them most. We look forward to working with the sponsors to pass this important legislation in 2022.
Rare Disease Advisory Council
For far too many Patients diagnosed with a rare disease, a treatment remains out of reach. Defined by Congress as a condition with 200,000 or fewer Patients, an estimated 95 percent of the over 7,000 identified rare diseases do not have a dedicated cure. Up to 30 million Americans have been diagnosed with a rare disease, including thousands here in New Jersey.
Fortunately, legislation has been introduced to help improve research, treatment and care for rare disease Patients in New Jersey. A-4016 (Dancer/Benson/Verrelli)/S-2682 (Gopal/Kean) would create the New Jersey Rare Disease Advisory Council (RDAC). The RDAC will ensure New Jersey rare disease Patients have a voice in our state while raising awareness of the rare disease community. We will work to make the RDAC become a reality in 2022.
Maintaining New Jersey’s “State of Innovation” Status
Our state has long been a hotbed of innovation in biopharmaceutical research, development and manufacturing. Groundbreaking discoveries in medical research have happened right here in New Jersey. This is a tradition that continues today as innovative companies discover cures for a wide array of therapeutic areas. The biopharmaceutical sector has also stepped up to the plate during the COVID-19 pandemic, leading the way in bringing COVID-19 treatments, vaccines, diagnostics and testing to Patients around the world. Many of these COVID-19 advances were discovered by companies with a significant New Jersey footprint.
Governor Murphy, Senate President Sweeney, and Speaker Coughlin worked collaboratively in 2020 to bring the next stage of targeted business incentives to New Jersey. In addition to a number of new and improved programs, the New Jersey Innovation Evergreen Fund will bring critical early investment to high potential companies while programs such as Emerge, Inspire, and Ignite will foster job retention and economic development along with rent assistance to start-up and emerging companies.
But we must be cautious moving forward so as not to disrupt this long tradition of innovation in our state. We believe the Patients we serve should have access to the treatments they need at the time they are needed. We believe in the value of medical innovation in lowering health care costs by reducing expensive institutional care while improving quality of life for the Patients we serve. We must keep the value of these innovations at the forefront. BioNJ remains concerned with the proliferation of policy proposals that could have the practical impact of limiting the ability of our Patients to access desperately needed treatments. Proposals such as “value” assessments that rely on cost consideration – rather than the overall value to the Patient and health care system – to assess coverage of a particular treatment or restricted Medicaid formularies should be rejected. We should instead pursue policies that protect the medical innovation that is helping people lead longer, healthier lives.
BioNJ is committed to working closely with our State elected officials in support of access to medicines. We must protect Patient access to new and lifesaving therapies here in the Garden State.
Because Patients Can’t Wait®
Debbie Hart
President and CEO
DHart@bionj.org
