Minnesota is fighting back against rising insulin costs

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Alec Smith’s Insulin Affordability Act provides citizens with a long-term solution to diabetes spending.

The average person with diabetes spends about $16,752 per year on medical expenses, according to the American Diabetes Association, with diabetes accounting for $9,601.1

This is estimated to be 2.3 times what a person without diabetes spends on health care costs each year. The rising cost of insulin is usually a major concern related to these expenses, causing many diabetics to ration supplies or refuse to purchase needed medications. To counteract this, Minnesota passed the Alec Smith Insulin Affordability Act to give its citizens hope and a long-term solution.

Alec Smith was 26 when he died after rationing his insulin.
He couldn’t afford the medication after aging out of his parents’ health insurance. Smith’s average monthly expenses, including insulin and testing supplies, totaled $1,300. Unfortunately, for many people with diabetes, this is not uncommon. After that tragedy, the Minnesota legislature began examining insulin costs and found that out-of-pocket expenses had tripled in the previous decade.2 The law passed by a staggering 111 votes to 22 and Gov. Tim Walz signed it into law in April 2020.

The Alec Smith Insulin Affordability Act regulates insulin costs in two parts: ongoing and urgent need. The Urgent Needs portion allows eligible individuals who have an urgent need for insulin to receive a one-time 30-day supply of insulin from their pharmacy for a co-payment of $35.3 Typically this is once per 12 month period. However, some patients may qualify for an additional 30-day supply. The continuing requirement portion applies to manufacturers and states that the manufacturer must make insulin available to eligible patients for one year and provide the option to renew annually. A 90-day supply is provided to the patient for a maximum co-payment of $50. Insured patients may opt into a manufacturer’s co-pay program if it offers better value for money. If a manufacturer refuses to participate, it can be fined
up to $3.6 million per year of non-compliance, and that can double
in the second year.2

To qualify for the Urgent Need portion, the patient must demonstrate an Urgent Need for Insulin, which means the patient has less than 7 days of insulin supply and is likely to experience significant health consequences when that supply is depleted. The patient must reside in Minnesota, not be enrolled in Medical Assistance or MinnesotaCare, pay more than $75 per month for insulin, and present ID proving Minnesota residency.3 If the patient is under the age of 18, the legal guardian or parent is responsible for proof of residency. A second 30-day coverage will be provided if the patient is awaiting the start of medical care or coverage from MinnesotaCare, or if the patient’s application for continued need has been denied and the patient is awaiting a response to an appeal from the Minnesota Board of Pharmacy .

To receive continuing needs, the patient must be a Minnesota resident, have a family income that is equal to or less than 400% of federal poverty guideline income, not be eligible to receive health care through most federally funded programs, not be eligible for benefits for Received prescription drugs through the US Department of Veterans Affairs and are not enrolled in Medical Assistance or MinnesotaCare. Insurance does not exclude a patient from continuing to be in need. However, if the deductible is less than $75 for a 30-day supply, the patient is not eligible.

Each insulin manufacturer offers ongoing needs programs, part of the law, and provides additional support to patients. For example, Eli Lilly and Company’s Lilly Diabetes Solution Center helps patients develop solutions to insulin-related financial difficulties. Direct support is provided through rebate programs, unbranded insulin and savings cards.4 Eli Lilly also encourages product donations directed to patients who meet eligibility requirements. Novo Nordisk and Sanofi offer similar programs.

As cheap and valuable as the deed may be, there was resistance
by Pharmaceutical Research and Manufacturers of America (PhRMA). The day before the law went into effect, PhRMA filed a lawsuit alleging the law violates the US Constitution. “Minnesota is forcing insulin manufacturers to give their product to state residents for free with no compensation for Minnesota,” PhRMA said in the lawsuit.5

A US District Court judge dismissed the case on March 15, 2021. “I’m pleased that the court saw through Big Pharma’s baseless lawsuit against the law,” Minnesota Attorney General Keith Ellison said in a statement.6

Conclusion

The Alec Smith Insulin Affordability Act gives hope to patients with diabetes who can’t afford the rising cost of insulin. To accommodate a diverse patient population, the law includes relief for both long-term and urgent situations provided by manufacturers and pharmacies. It is evident that the law has been adjusted to provide maximum benefit for improving health care outcomes, but not everyone shares this belief. Although PhRMA has resisted, affordable health care is seen as essential thanks to advocates who did not see Alec Smith’s death as an acceptable victim of the insulin crisis.

Katelyn m. skeeters is a PharmD candidate at the College of Pharmacy at the University of Kentucky at Lexington.

Joseph L. finch III, JD, DSC (HON), BS Pharma, FAPhAis Professor of Pharmacy Law and Policy and Professor of Governance for the Kentucky Pharmacists Association at the College of Pharmacy, University of Kentucky at Lexington.

references

1. American Diabetes Association. Economic cost of diabetes in the US in 2017. diabetes treatment. 2018;41(5):917-928. doi:10.2337/dci18-0007

2. Minnesota House passes Alec Smith Insulin Affordability Act. Minnesota House of Representatives. April 14, 2020. Accessed January 12, 2022. https://www.house.leg.state.mn.us/Caucus/View/DFL/29389

3. Insulin Safety Net Program in Minnesota. Minnesota Pharmacy Board. Accessed January 12, 2021. https://mn.gov/boards/pharmacy/insulinsafetynetprogram/

4. Lilly Minnesota Insulin Safety Net Program. Eli Lilly and Co. Accessed January 12, 2021. www.lilly.com/resources/minnesota-insulin-safety-net-program

5. Edwards K, Haavik E. ‘This fight isn’t over’: Insulin affordability law goes into effect as pharmaceutical industry sues. KARE11. July 1, 2020. Accessed January 12, 2021. www.kare11.com/article/news/local/kare11-sunrise/alec-smith-insulin-affordability-act-in-effect-last-minute-lawsuit-filed/ 89 -7e8d4bec-a6ee-4b77-8ff1-5971cf8a07ce

6. Big Pharma’s lawsuit challenging the Minnesota Affordable Insulin Act is dismissed. bring me the news March 16, 2021. Accessed January 12, 2022. bringmethenews.com/minnesota-news/big-pharmas-challenge-to-minnesotas-affordable-insulin-law-is-dismissed

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