Non-medical switching is when stable patients are forced off their treatments because a change in the patient's coverage has occurred. These coverage changes are aimed at cutting costs for the plan, and because they have no medical justification, the practice has become known as “non-medical switching.” IFAA is currently working with other advocacy organizations to ensure legislative efforts that protect patients move forward.
IFAA participates in several advocacy Coalitions, including The National Coalition of Autoimmune Patient Groups (NCAPG) led by the American Autoimmune and Related Diseases Association (AARDA), the NIAMS Coalition, which serves as the arthritis division of the National Institutes of Health, and Patients for Biologic Safety and Access (PBSA) which consists of two dozen nonprofit groups who work together to ensure FDA standards are kept to ensure patient safety and that as biosimilars are being created, they are done so responsibly. See all Coalitions
IFAA has a unique perspective on issues surrounding biosimilars because we are patients who will be affected by their introduction to market. In addition to being patients, we are friends with other patients, and are active members of online communities where discussions about biosimilars are prominent. This enables us to be in the trenches among the dialogue, so we are in an ideal position to understand what is most concerning to patients in regards to biosimilars.
IFAA's role in biosimilar education and policy matters:
1. Leaders in patient education. We are patients and we are current and former teachers. Who better to provide answers about biosimilars to patients who need clarification? Visit our Biosimilars page to learn more about how IFAA is engaging in patient to patient education and to find additional resources on the topic.
2. Support existing initiatives that address concerns surrounding biosimilar entry to the marketplace. IFAA participates in existing coalitions and group efforts, alongside other major nonprofits, to support legislative efforts that ensure patient safety is considered as biosimilars enter the marketplace in the United States. We also have relationships with nonprofit leaders in Canada and Europe so we can stay updated on efforts internationally. Learn more about what is happening with biosimilars and public policy.
We are members of the Patients for Biologics Safety & Access (PBSA), a national coalition representing more than 20 patient advocacy organizations working to ensure that the voices and interests of patients are heard as the FDA considers approval of a new category of drugs known as biosimilars and will be working to build and continue relationships with other global agencies who are advocating about this topic. In August 2016, IFAA submitted supplemental comments to the FDA in response to its draft guidance on the labeling of biosimilars products, and will continue submitting testimony to ensure patient concerns are heard.
Left: "Step Therapy and You", Sacramento, CA. Tiffany Westrich-Robertson (Center) speaks about the ethics of step therapy, specifically how atypical patients are not included in the clinical research that insurance companies cite as 'proof of safety and efficacy'', thus justifying the least costly treatment recommendation.
Right: Kathleen Arntsen of LADA presents the patient perspective about biosimilars and ethical issues surrounding this at BIO International 2016, San Francisco panel "The Future of Biosimilars: How Will Policy and Market Dynamics Impact Patient Value and Access in the US?"
IFAA led a six month investigation into the ethics of step therapy, which is an insurance company policy whereby patients must try a less costly treatment first and fail it before the insurer will cover a more expensive treatment. In other words, the patient is stepped up to the costlier treatment after failing the cheaper one, thus the term step therapy.
IFAA was assisted by bioethicist consultants and Kathleen Arntsen, President & CEO of the Lupus & Allied Diseases Association, Inc. (LADA) as the public policy advisor.
IFAA has shown why step therapy is outdated and justified why it needs to be modernized in order to fairly treat patients and allow providers to act ethically, especially as biomedical innovation continues to advance. Personalized medicine is coming, but unless we become proactive and address it now, the healthcare system will be severely disrupted and patients will suffer unnecessarily.
Tiffany Westrich-Robertson, CEO of IFAA, and Ms. Arntsen of LADA have since begun presenting the findings and will continue using the results to press for the modernization of the step therapy protocol in order to place patient care back in the hands of the health care providers who are educated and ethically obligated to treat us. Learn more
Patients face issues in healthcare such as having access to treatments and ensuring there is adequate funding for disease research. IFAA is a major contributor to bringing the patient voice to the front lines.
While our primary focus is access to treatments and patient safety and education, we spend much of our advocacy efforts to present our findings from our investigation into the ethics of step therapy in the United States. We published the Ethics of Step Therapy position paper in 2015, with Kathleen Arntsen, CEO of Lupus and Allied Diseases Association (LADA), as the public policy expert. IFAA and LADA now working as a team, educating stakeholders about the ethical issues that directly affect our healthcare system and legislative efforts.
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