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 nationwide continue to come from biopharmaceutical firms with a significant presence in New Jersey. New Jersey’s life sciences community includes approximately 430,000 direct, indirect, and induced employees in the State — and is a central contributor to the State’s economy, bringing new cures and therapeutics to the Patients who need them.
Focus: Protect Patient Access to Health Care Innovation
BioNJ is devoted to ensuring that Patients have access to the treatments they need when they need them — Because Patients Can’t Wait®. Beginning in 2022 and progressing into 2023, BioNJ is working to support more equitable access to clinical trials among communities who continue to be underrepresented among the newest innovations in biomedical science. The inception of BioNJ’s Health Equity in Clinical Trials initiative represents a manifestation of this priority.
The Health Equity in Clinical Trials Initiative is devoted to three primary goals:
- NJ Baseline: Understanding the current status of participant demographic representation across clinical trials conducted throughout the State and considering strategies to improve on collection and representation by underrepresented groups
- Collecting & Connecting the Dots: Inventorying what innovator companies are doing to improve and expand representation by underrepresented communities in clinical trials, sharing those efforts and best practices across the ecosystem to encourage learning and collaboration across clinical trial sponsors
- MBA Business Plan Competition: Fostering innovative new approaches to improving demographic representation in clinical trials from teams of MBA and graduate students via MBA Business Plan competitions
BioNJ held the inaugural MBA Business Plan competition on December 3rd at Rutgers University, hosting 8 teams from across the country, providing a venue for innovation towards developing more effective strategies to achieve greater demographic representation in clinical trials conducted throughout the State. We look forward to preparing for subsequent competitions to continue enabling future leaders of the life sciences to collaborate and connect with current experts to pursue greater health equity in clinical trials.
The goal of our initiative is to produce tangible improvements in equitable access in clinical trials throughout New Jersey that will also be applicable nationwide and internationally. Following the completion of this initiative in 2023, BioNJ will produce practicable insights that can be operationalized by every entity interested in achieving greater equity in clinical trial participation so that every Patient has access to the newest and most effective treatments when they need them.
Protecting New Jersey’s Status as “Medicine Chest of the World”
New Jersey has earned the reputation of being the nucleus of biopharmaceutical research, development, and manufacturing nationwide following decades of leadership in life sciences innovation. As the “Medicine Chest of the World”, entities throughout New Jersey responded early and effectively to confront the COVID-19 pandemic — creating and advancing new diagnostics, therapeutics, and vaccines with unprecedented efficiency. Nearly 40% of FDA drug approvals in 2020-2021 were produced by companies with a footprint in New Jersey. The biopharmaceutical and medical technology industries create over 300,000 direct and indirect jobs throughout the State, with New Jersey being the only state in the union where a high degree of life science specialization spans 4 of the 5 major industry subsectors.
While many of the provisions in the Inflation Reduction Act of 2022 were laudable, several specifically target the life sciences — an industry that is central to the economic activity of New Jersey. In 2023, BioNJ will continue to work to ensure that the ramifications of these policies are diminished for life sciences entities in New Jersey.
Additionally, legislation at the State level that targets the healthcare system arose in early 2022. Once again, many of the provisions in this legislative package are likely to improve Patient access to the medications they need. However, several provisions within the package will inevitably inhibit the delivery of therapeutics as rapidly as possible. BioNJ will continue to engage both the Governor and Legislature to ensure that the ultimate legislation truly achieves a goal that we all share: Patients having access to new and more effective lifesaving therapeutics as rapidly as possible. BioNJ remains committed to working closely with policymakers and regulators throughout our State to promote policies that support Patient access to medicines as rapidly as possible. The Garden State has always been the home of biomedical innovation nationwide, and BioNJ is devoted to advocating for policies that accelerate innovation, avoiding policies that inhibit biomedical progress, and ensuring that Patients have access to a growing and more effective armamentarium of medicines — Because Patients Can’t Wait®.
Regulating Prior Authorization & 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 and the implementation of capricious and onerous prior authorization policies interferes with the decisions that Patients make with their physicians.
Step therapy — also known as “fail first” — is a utilization management tool and type of prior authorization that requires Patients to try and fail with one or more treatments before gaining access to the treatment initially prescribed by the Patient’s clinician. Interfering with the treatment decisions of a clinician and Patient can result in dire and unnecessary consequences that would have been avoided had third parties never intervened.
Further, prior authorization policies more broadly can result in sudden changes in covered medications, disrupting the lives and well-being of Patients who have relied on medications for years to sustain healthy lives. Additionally, physicians regularly confront overly burdensome administrative work to navigate these policies and advocate on behalf of Patients. Enacting reasonable guidelines on prior authorization practices is critical to ensure that Patients and their physicians are not shocked or burdened with the decisions of third parties that ultimately determine which medications are available.
BioNJ believes that, in many instances, step therapy results in delaying Patient access to necessary and lifesaving therapies. Studies show that over 50 percent of Patients are required to try two or more treatments before receiving authorization to get the treatment originally prescribed by their physician. Other states around the country have developed statutory guardrails for the appropriate use of step therapy. These guardrails are motivated by clinical evidence and developed by independent experts who have relevant biomedical expertise, rather than maximizing insurer profitability.
Fortunately, legislation has been introduced and made progress in both the New Jersey Senate and General Assembly to establish clinically appropriate guidelines for prior authorization practices. A1255 (Stanley/Conaway/Benson) and S1794 (Gopal/Singer) would help improve Patient access to the therapies that they and their physicians decide are best for them when they need them most. We look forward to working with the sponsors and our coalition partners to have this important legislation signed into law in 2023.
Finally, BioNJ intends to guide educational efforts to support increased public healthcare literacy — particularly helping to illuminate the role that Pharmacy Benefit Managers (PBMs) play in driving healthcare costs. There is no reason that Patients should have to worry about whether they understand the nation’s complicated healthcare landscape when they are navigating the choices that they make in partnership with their clinicians. We look forward to working with coalition partners among Patient advocates, physicians, and pharmacists to produce a resource on which every Patient can rely in these critical moments.
Operationalize the 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.
Following the advocacy of a coalition of groups, including BioNJ, we were pleased to see Governor Murphy sign S2682 (Gopal/Kean/Dancer/Benson/Verrelli) in June of 2021, establishing the New Jersey Rare Disease Advisory Council (RDAC). Given the unique challenges that Patients diagnosed with rare diseases confront, we look forward to continuing to provide assistance in having the RDAC become fully appointed and operational in 2023 to enable the Council to pursue its critical mission.
To learn more, contact:
Ian McLaughlin, Ph.D.
Vice President, Government Affairs