- Insulin drugmakers face new criticism for their pricing and use of patents on diabetes treatments, as two reports released Thursday by the largest bipartisan Congressional caucus and a pharma-focused consumer group shined a light on the pharma companies' business practices.
- In a report on the insulin market, Congressional Diabetes Caucus co-chairs attacked the current system as "unfairly putting insulin out of reach, placing millions of lives at risk." Their report makes 11 policy recommendations for Congress, ranging from encouraging value-based contracts to requiring more disclosure on rebates and list prices to addressing patent extensions.
- The Initiative for Medicine, Access and Knowledge, meanwhile, unveiled an analysis of the patents protecting Sanofi's top-selling diabetes treatment Lantus, finding nearly all of patent applications for the drug were filed by the French pharma after it was approved.
These reports hint at what could be a coming battle for U.S. lawmakers in regulating drugmakers and combating rising drug pricing, particularly as political experts and polls suggest the U.S. House of Representatives could flip to Democratic control and leadership following the Nov. 6 midterm elections.
Democrats have made healthcare a focal point going into next week's elections, and going after the pharmaceutical industry has a level of bi-partisan support that other healthcare issues, particularly insurance reform, lack.
And now, the Congressional Diabetes Caucus, with more than 290 congressional members from both parties, is stepping up criticism on insulin drugmakers in particular, advocating reforms on pricing and formularies among other policies.
Eli Lilly, Novo Nordisk and Sanofi control much of the market for insulin, which remains a lucrative market despite growing pricing pressures from payers in the U.S.
The report from I-MAK highlights how aggressive patenting, at least for Sanofi's Lantus (insulin glargine), may be playing a role in keeping insulin prices high.
Lantus was among the world's best-selling drugs last year, posting more than $5 billion in worldwide sales. Through the first nine months of 2018, the diabetes drug notched roughly $3.1 billion in sales.
Sanofi filed its first Lantus patent in 1994, and the Food and Drug Administration approved the drug in 2000. I-MAK found 69 of its 74 U.S. patent applications, or about 93%, were filed after the drug was approved and launched. The original patent expired in 2015.
These have extended Lantus' patent protection to 2031, the report stated, protecting it from generic or biosimilar competition in the meantime. (Sanofi said in its 2017 annual report that its Lantus patents expire in March 2028).
While multiple Lantus biosimilars are available in Europe and Japan, only one copycat rival has launched in the U.S.: Eli Lilly's Basaglar (insulin glargine), which was approved in December 2016 as a follow-on biologic.
"The U.S. cannot fix the drug pricing crisis until it solves the drug patent problem," the report stated.
On pricing, I-MAK found that from 2012 to 2016, Lantus had the highest annual price increases for Medicaid, at more than 18% per year, and the second highest for Medicare among the drugs it has reviewed.
In those four years, average annual per-person Medicare spending rose nearly 90%, from $1,284 to $2,431. Taxpayer spending on Lantus through those two government programs totaled $22 billion from 2012 to 2016, increasing over time from $2.5 billion in 2012 to $5.8 billion in 2016.
I-MAK's report concluded by urging for more public dialogue on patenting practices and their impact on drug prices. The congressional report suggests that may happen sooner rather than later on insulin, especially if Democrats take control of the House.