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Nearly 1.5 million Americans have type 1 diabetes (T1D) and require lifelong insulin. Many now have a tough time affording insulin. The average annual insulin expense per patient with T1D was $2,864 in 2012. The cost had roughly doubled by 2016, to $5,705 per patient. There has not been a significant increase in the use of insulin analogs (eg, glargine, detemir, degludec, glulisine, lispro, aspart); daily insulin requirements increased by only 3% from 2012 to 2016. Insulin analogs have more than 90% of the insulin market share and are not available as generics.

The American Diabetes Association has testified before Congress about insulin price increases. Legislation targeting manufacturers (including 3 top insulin manufacturers) has been introduced to lower prescription medicine costs. At least 2 lawsuits have been filed in federal courts against insulin manufacturers for price gouging. Lastly, the FDA is stepping in to reclassify insulins from drugs to biologics (effective in March 2020). This will let biosimilar insulins enter the market, increasing competition and decreasing costs. In the meantime, help patients get manufacturer rebates and coupons to lower their insulin costs.

• Fuglesten Biniek J. Health Care Cost Institute 2019; published online January 2019.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

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