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Arden's Day Blog

Arden's Day is a type I diabetes care giver blog written by author Scott Benner. Scott has been a stay-at-home dad since 2000, he is the author of the award winning parenting memoir, 'Life Is Short, Laundry Is Eternal'. Arden's Day is an honest and transparent look at life with diabetes - since 2007.

type I diabetes, parent of type I child, diabetes Blog, OmniPod, DexCom, insulin pump, CGM, continuous glucose monitor, Arden, Arden's Day, Scott Benner, JDRF, diabetes, juvenile diabetes, daddy blog, blog, stay at home parent, DOC, twitter, Facebook, @ardensday, 504 plan, Life Is Short, Laundry Is Eternal, Dexcom SHARE, 生命是短暂的,洗衣是永恒的, Shēngmìng shì duǎnzàn de, xǐyī shì yǒnghéng de

Filtering by Tag: Insulin Pricing

Sanofi Insulin Pricing Program

Scott Benner

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








Statement from FDA Commissioner on Insulin Pricing

Scott Benner

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.