Type One Nation: Phoenix
Type One Nation: Phoenix
I want to thank the Phoenix Arizona chapter of the JDRF for inviting me to speak at their Type One Nation event. I met so many people who all just want their lives to be less about managing and a lot more about living. I didn’t want to waste a moment while I was there so I did a Bold With Insulin breakout session, sat in on a Q&A and talked more about the ideas from the Juicebox Podcast on the main stage during lunch. I wished that I could have stayed longer but I needed to make a flight so I could be at my son’s first college baseball game in the morning.
I am already receiving emails and pictures from people who where ready to be bold and immediately began making changes to how they think about using insulin after they went home. It was a (too short) but terrific trip and I would love to go back in the future when I have more time to spend with the D-community in Arizona.
HUGE thanks to Vickie for recommending me for the gig and to the chapter leadership for being bold in how they bring good information to their members.
If you were there and have any pictures that I don’t please send them so that I can share.
Insulin Assistance Programs - Programas de Asistencia con Insulina
We are grateful to be insured and to have access to affordable insulin.
If you are uninsured, underinsured or struggling to pay for insulin... there are programs that can help.
Desplácese hacia abajo para la traducción al español
from Eli Lilly - If you have no insurance, are underuninsured or affected by the Government shutdown and would like more facts about Lilly’s patient assistance programs.
There are live representatives at the Lilly Diabetes Solution Center to help people find cost saving solutions for their Lilly insulins based on individual circumstances – including government employees. Call the Solution Center at 833-808-1234 Monday through Friday from 8 a.m. to 9 p.m. EST. or visit their website.
from Novo Nordisk - The Novo Nordisk Patient Assistance Program (PAP) is our continued commitment to people living with diabetes and the Novo Nordisk Triple Bottom Line. The Diabetes PAP provides free medicine to those who qualify. If approved, a free 120-day supply of medicine will be sent to the prescribing health care providers’ office to be picked up at the patient's convenience. Novo Nordisk will automatically contact the health care provider prior to your next refill to approve the medication reorder. More info on their website.
from Sanofi - Our passion is to improve access to medicines and healthcare. Patients are our number one priority, and to meet their needs more efficiently, Sanofi US offers an integrated patient support program titled Sanofi Patient Connection (SPC). More info on their website.
If you have more or different links please contact me and I will add them to this list. Thank you!
"Because of your podcast (Juicebox), I have significantly reduced the amount of spikes that I get."
Estamos agradecidos de estar asegurados y de tener acceso a una insulina asequible.
Si no tiene seguro, tiene un seguro insuficiente o tiene dificultades para pagar la insulina ... existen programas que pueden ayudarlo.
de Eli Lilly: Si no tiene seguro, no tiene seguro o está afectado por el cierre del gobierno y le gustaría obtener más información sobre los programas de asistencia al paciente de Lilly.
Hay representantes en vivo en el Centro de Soluciones para la Diabetes de Lilly para ayudar a las personas a encontrar soluciones económicas para sus insulinas de Lilly según las circunstancias individuales, incluidos los empleados del gobierno. Llame al Centro de soluciones al 833-808-1234 de lunes a viernes de 8 a.m. a 9 p.m. EST. o visite su sitio web.
de Novo Nordisk: El Programa de Asistencia al Paciente (PAP) de Novo Nordisk es nuestro compromiso continuo con las personas que viven con diabetes y la Línea de Triple Beneficio de Novo Nordisk. El Diabetes PAP proporciona medicamentos gratuitos a quienes califican. Si se aprueba, se enviará un suministro gratuito de 120 días de medicamentos al consultorio de los proveedores de atención médica que prescriben para que lo recojan a la conveniencia del paciente. Novo Nordisk se comunicará automáticamente con el proveedor de atención médica antes de su próxima renovación para aprobar el nuevo pedido de medicamentos. Más información en su página web.
de Sanofi: Nuestra pasión es mejorar el acceso a los medicamentos y la atención médica. Los pacientes son nuestra prioridad número uno, y para satisfacer sus necesidades de manera más eficiente, Sanofi US ofrece un programa integrado de asistencia al paciente titulado Sanofi Patient Connection (SPC). Más información en su página web.
Si tiene más o diferentes enlaces, por favor contácteme y los agregaré a esta lista. ¡Gracias!
Juicebox Podcast in Diabetes Forecast Magazine!
Diabetes podcasts in the spotlight!
A huge thanks to Diabetes Forecast Magazine for spending some ink on the podcasts dedicated to people living with type 1 diabetes. You can listen to my show below or follow the link to Diabetes Forecast to see the others highlighted.
Apple Podcasts - http://bit.ly/JBPAPod
Android - http://bit.ly/jbpandroid
Spotify - http://bit.ly/JBPspot
Google Play - http://bit.ly/JBPGoogplay
or JuiceboxPodcast.com
Check out the latest edition of Diabetes Forecast Magazine… on your newsstand now.
Statement from FDA Commissioner on Insulin Pricing
The FDA has issued a statement intended to spur competition and lower prices. I’ve pulled out and included a few passages that are about insulin. You can read the entire statement as written here.
from FDA.gov
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework.
“There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.”
We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible.
We’re also releasing today two critical guidance documents that describe how the agency plans to implement Congress’ direction that we transition certain biological products currently approved as drugs under the FD&C Act to be licensed as biologics under the PHSA.
Transitioning these drugs to the PHSA will let them to be treated as biologics under that law. And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic.
Starting in March 2020, the approved marketing applications for the small subset of “biological products” such as insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA. Sponsors have known about this transition for a decade. They’ve had time to prepare.
“As a result, we’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive. These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”
Today, we’re laying out our policy on how these products will transition from the drug pathway to the biologics pathway, and in so doing, how we intend to use this new framework to promote competition. The two guidance documents we’re releasing today, one final and one draft, describe how the FDA intends to accomplish the transition of these products under the “Deemed to be a License” provision of the BPCI Act. The final guidance deals with “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009,” finalizes the FDA’s draft guidance from 2016.
We’ve shaped these policies to implement the intent of Congress, and to make sure a few things happen. First, that the anti-evergreening provisions under the biosimilars legislation – meant to prevent sponsors from being able to game the exclusivity provisions to forestall biosimilar entry – will apply to these newly deemed products, including insulin.
Omnipod DASH Security
from Business Wire
Insulet’s Omnipod DASH™ Insulin Management System Receives ISO 27001 Certification for Information Security
The Only Insulin Pump to Receive Both ISO 27001 and DTSec Certifications
Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced it has received ISO (International Standards Organization) 27001 certification of its Omnipod DASH™ System. ISO 27001 certification is the international standard for best practice in an information security management system globally. Insulet also recently announced that the Company received the DTSec (Diabetes Technology Society’s) Cybersecurity Standard for Connected Diabetes Device Security certification for the Omnipod DASH System. Insulet is the only insulin pump company to receive both certifications.
ISO 27001 is an internationally recognized standard for information security best practice that adheres to the highest international data security standards. DTSec leverages ISO/IEC 15408 to provide a framework for risk-based, multi-stakeholder definition of security requirements. The Omnipod DASH System, Insulet’s next-generation platform, was designed to be the foundation for the Company’s future innovation. With the ISO 27001 and DTSec certifications, the Omnipod DASH System is now globally recognized for incorporating the highest standards for information and cyber security and safety, including secure data transfer between the Pod and the personal diabetes manager (PDM), as well as secure cloud storage.
“This is part of a large-scale organizational commitment to ensure the highest-level of cyber security of our Omnipod DASH System and to provide information security our Podders can trust,” said Dr. Aiman Abdel-Malek, Executive Vice President and Chief Technology Officer. “We are committed to remaining at the forefront of best-in-class standards to secure patients’ safety and privacy. Our compliance with these internationally recognized standards sets us apart from others in the global insulin pump market and provides our users with further peace of mind that they can rely on a highly safe and secure product to manage their diabetes.”
Insulet’s Omnipod DASH System received FDA clearance in June 2018 and is currently in limited market commercial release. The Company expects to fully launch the product commercially in early 2019.
Try a free no obligation demo of the Omnipod today!