Sanofi Insulin Pricing Program

from press release - 4/10/19

Starting in June, Sanofi will further expand its innovative Insulins Valyou Savings Program so people living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month. The expansion of this program helps to address the challenge too many patients face regarding unpredictable and unaffordable pricing for their insulin. 

“People living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month.”

People exposed to high out-of-pocket prices at the pharmacy counter can participate in the Insulins Valyou Savings Program regardless of income level. This includes those who are paying high retail prices for their insulin and those who don't qualify for other patient assistance programs. 

Under current government regulations, pharmaceutical companies cannot offer this type of program to patients insured under Medicare, Medicaid, or similar federal or state programs, though Sanofi supports changing rules to expand this access program to all those who might benefit.

For more information or to learn how to access this program, visit www.InsulinsValYOU.com.

Additional patient resources available for accessing Sanofi medicines

Sanofi continues to offer other resources to make insulins more accessible including co-pay cards which may limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of income level. In addition, Sanofi offers assistance programs that provide medications, including insulin, at no charge for qualified low-income, uninsured patients through the patient assistance component of the Sanofi Patient Connection program. Together, these programs demonstrate the company's dedication to finding support to help people living with diabetes gain access to the insulins they need.

Sanofi also encourages anyone who is prescribed a Sanofi medicine who may be having financial challenges or trouble navigating their insurance, to call Sanofi Patient Connection at (888) 847-4877 where eligible patients can be connected to the medicines and resources they need at no cost.

* The Insulins Valyou Savings Program does not include Sanofi's combination insulin product.

The entire press release is available here

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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!

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"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!

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.

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Contour Next One App

The Contour Diabetes app now integrates with Apple Health. Once you enabled the feature, data from the Contour app will be available in the Blood Glucose area of your iOS Health app.

Available in the iTunes app store here - Also available for Android

This is the meter that Omnipod users will be receiving when the DASH PDM is released sometime in the first quarter of 2019. Arden is using it now and we are finding the accuracy to be terrific!

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Omnipod + Fiasp is cleared in Europe

press release

Omnipod® Insulin Management System Now Available for Use in Europe with Fiasp® Fast-Acting Insulin

LONDON--(BUSINESS WIRE)--Oct. 2, 2018-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that Novo Nordisk’s Fiasp® (Fast-Acting Insulin Aspart) has been tested and found safe for use in Insulet’s Omnipod System in Europe. Fiasp® is a new-generation, ultra fast-acting insulin developed by Novo Nordisk that enters the bloodstream two times faster, compared to NovoRapid®, so it more closely matches a healthy body’s insulin response to a meal, thereby improving glycemic control. Insulet will showcase its Omnipod System during the European Association for the Study of Diabetes (EASD) annual meeting at the Messe Berlin Exhibition Halls in Berlin, Germany taking place 1st October to 5thOctober 2018.

This is the first European conference presence for Insulet since the Company assumed direct operations of its Omnipod System product line in Europe. At its booth (#3.P05), the Company will highlight the history of its innovation, from the current Omnipod System to its Omnipod Horizon™ Automated Glucose Control System currently in development. Insulet will also feature the Pod Challenge – an opportunity for attendees to wear a sample Pod to experience the freedom it allows patients.

“Our European team is thrilled for this opportunity to engage with leading regional healthcare practitioners and advocacy groups to showcase the unique benefits of our Omnipod System,” said DJ Cass, General Manager, Insulet Europe. “The addition of Fiasp for use with the Omnipod System provides another option for both patients and prescribers to support their diabetes management needs. EASD is an important venue for direct contact with the diabetes community across Europe so they can see firsthand how our innovative product will help make diabetes a smaller part of their patients’ lives.”

“It is encouraging to see that Fiasp keeps expanding its reach, potentially benefiting more people in need of it via the Insulet Omnipod System,” said Stephen Gough, Global Chief Medical Officer of Novo Nordisk. “With its ultra-fast acting profile, Fiasp has brought a new option for adults living with diabetes who require insulin to manage their post-meal spikes, and I am confident that they will find in Fiasp and the Omnipod System good allies to best manage their diabetes.”

Learn more about Omnipod today

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