Costs for insulin products have historically been very high in the US [1]. A single vial of rapid-acting insulin has cost upwards of US$250 and data from 2016 showed that the average out-of-pocket monthly cost for a diabetic in the US was US$360, compared to US$65 in the UK and just US$19 in Italy.

This is set to change as the US Food and Drugs Administration (FDA) has recently transitioned to a new regulatory pathway allowing biosimilars of insulin products to be developed [2].

Now, the CMS (the federal agency that administers national health insurance in the US) has announced a new Medicare model to lower co-pays for insulin products.

The model will lower out-of-pocket co-pays to a maximum of US$35 for each 30-day supply of insulin. It is known as the Part D Senior Savings Model and aims to allow Medicare Part D prescription drug plans to offer a broad range of insulins at a significantly reduced co-pay.

CMS Administrator Seema Verma said: ‘The Part D Senior Savings Model provides an innovative market-driven approach that removes barriers to lower insulin costs. We call on health insurance plans and prescription drug manufacturers to take action and provide relief for America’s seniors who take insulin’.

Beneficiaries who enrol in a plan participating in the model could save an average of US$446 in out-of-pocket costs per year, says the CMS. It should also save the federal government over US$250 million over five years (as manufacturers will pay additional coverage gap discounts).

An additional statement from insulin maker Eli Lilly explains their participation in the programme, which they say occurs in response to the coronavirus pandemic. The ‘Lilly Insulin Value Program’ which will be open to anyone with commercial insurance, and those without any insurance, to fill their monthly prescription of Lilly’s insulin product for US$35. The programme is effective from 7 April 2020 and includes all Humalog (insulin lispro injection units/mL) formulations. It can be accessed by calling the Lilly Diabetes Solution Center and all active co-pay cards have been re-set to a US$35 amount.

A separate co-pay card for Humulin RU-500 (insulin human injection, 500 units/mL) can be obtained for US$25/month for those with commercial insurance. This can be accessed via www.humulin.com. Some insulin has also been donated by non-profits and will be available at no charge to those with minimal or no income.

‘Too many people in the U.S. have lost their jobs because of the COVID-19 crisis, and we want to make sure no one goes without their Lilly insulin," said Mike Mason, President, Lilly Diabetes.

‘It's critical that people with diabetes can reliably access insulin at a low, consistent out-of-pocket cost. Enabling a US$35 per month insulin co-pay regardless of employment status will help many Americans in this difficult time’, said CEOs Aaron Kowalski and Thom Scher on behalf of the JDRF-Beyond Type 1 Alliance. 

Related articles
Eli Lilly and Novo Nordisk launches lower-priced insulin options

Medicare Part D has no impact on generics prescribing in long-term care

WHO launches insulin prequalification programme

References
1. GaBI Online - Generics and Biosimilars Initiative. Reasons and solutions for the high cost of insulin in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/Research/Reasons-and-solutions-for-the-high-cost-of-insulin-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. FDA opens pathway to biosimilar insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Guidelines/FDA-opens-pathway-to-biosimilar-insulin-products

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