Newly passed New York Step Therapy Bill will bring better access to critical rare disease medicines

Mar 14, 2017
Newly passed New York Step Therapy Bill will bring better access to critical rare disease medicines

On Dec. 30, bill S.3419C/A.2834D – also known as the “New York Step Therapy Bill” – was signed into law by Governor Andrew Cuomo after unanimously passing both the Senate and Assembly chambers.

The bill is designed to improve access to vital medications by reforming the insurance industry directive known as step therapy or “fail first” which requires patients to try and fail one type of medication before being moved on to another, potentially more effective one.

“[The day] marks a tremendous victory for patients and physicians all across New York,” said Kathleen Arntsen, President and CEO of Lupus and Allied Diseases Association. “Finally, the medical decisions that are so critical and personal to each of us will be placed back in the hands of our treating physicians and we will be better protected from unjustifiable interference from insurers. Thank you, Governor Cuomo, for listening to us and understanding the importance of having timely access to proper treatment by putting patients first.”

With the new law, the process of prescribing medicines will become more transparent for doctors who will be able to seek exceptions to insurance company-imposed step therapy plans if they believe their patient needs a particular treatment.

The news of the bill’s passing is particularly personal to Arntsen, herself diagnosed with lupus in 1982 following years of undiagnosed illness as a child.

“For people struggling to manage complex, multisystem diseases or cancer, autoimmune conditions, mental health disorders or others, this bill will provide the process necessary for them to work with their healthcare provider to get the most appropriate treatment,” said Arntsen. “For autoimmune disorders like lupus for example, the disease’s heterogeneous nature means that no two cases are alike and treatment is highly individualized, making effective treatment for each patient a balancing act that requires thinking outside the box and immediate accessibility to the entire arsenal of available treatments.

“This new law means that complex, atypical patients with co-morbid conditions, who have a vast treatment regimen, allergies, a history of adverse reactions to drugs and do not meet the general patient population definition, now have a fair process to follow along with their treating physicians.”

The decision represents many years of hard work to better treatment and care for diseases of unmet need – lupus itself has only had one drug approved in 60 years.

“We fight for manufacturers to develop therapies, we struggle to get patients into clinical trials, we battle for treatments to get FDA-approval, and once approved we fight to get them covered. It took us over five decades to get a new drug approved for lupus but what good is it if physicians can’t get insurers to cover it and patients can’t get it.

“We are thrilled with the unanimous passage of the NY Step Therapy Reform Bill,” added Arntsen. “For over 6 long years a group of step therapy warriors, including nearly 80 patient advocacy and provider organizations, fought tenaciously to get this done. It is an amazing feat and wonderful example of successful stakeholder collaboration.”

Before the passing of the bill, insurance company implementation of step therapy protocols had been on the rise, with insurers employing it as a cost-saving measure.1

New York now joins other states in passing similar legislation in the past year, including Illinois, Indiana and Missouri. However, Arntsen believes the NY Step Therapy Bill is the strongest nationwide in its structure: “The bill represents a very fair and balanced model that can assist other states in developing legislation.

“We believe strongly that public policy must keep pace with innovation and protocols like step therapy stifle research and development. Lupus and Allied Diseases Association is proud to have been part of such a tremendous effort that will now allow our healthcare professionals who are educated and ethically bound to treat to the uniqueness of an individual.”


LADA (2016). New York patients gain better access to critical medications. Available at: (accessed March 2017).

Newly passed New York Step Therapy Bill will bring better access to critical rare disease medicines

Kathleen Arntsen is the President and CEO of the Lupus and Allied Diseases Association and has been a passionate, persuasive, and diplomatic leader, patient advocate and warrior for the lupus, rheumatology and autoimmune communities for 31 years. She has been appointed to a 2nd term as both the Lupus Patient Representative for the Office of Health & Constituent Affairs with the FDA, and as the Patient Advocacy Representative for the IUIS/WHO/AF/CDC Committee for the Standardization of Autoantibodies in Rheumatic & Related Diseases. Her professional background in insurance marketing, sales, classroom/field training, and healthcare provider medical billing/claims processing training combined with her personal 35-year journey in navigating our healthcare system and ongoing interaction with patients and loved ones has helped to shape her into one of the most powerful advocates in the nation.

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