10 Feb. 2019. We reported on Friday about an ingestible capsule that in tests with pigs safely injects insulin into their stomach walls with doses comparable to injections given to humans today. That device, designed by a team led by MIT biomedical engineer Robert Langer and gastroenterologist Giovanni Traverso at Brigham and Women’s Hospital in Boston, could offer an alternative to insulin injections given through the skin now needed by an estimated 425 million people worldwide with diabetes.
Before we start celebrating the end of injections, however, we need to deal with a more basic problem facing people with diabetes, namely the rapidly rising cost of insulin. A report in the Washington Post last month indicates a 10-milliliter vial of insulin with a list price of $21.00 in 1996, now sells for $275.00. Also, FDA Commissioner Scott Gottlieb, a speech given in December 2018, noted hearing of “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.”
Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. Type 1 diabetes is an autoimmune disorder where beta cells in the pancreas do not produce insulin. Type 1 diabetes is diagnosed primarily in children or young adults, where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders,
In June 2018, American Diabetes Association published a paper on insulin markets and prices showing a highly concentrated industry and complex supply chain. Today, only 3 insulin manufacturers serve the U.S. market: Eli Lilly & Co., Novo Nordisk, and Sanofi. While insulin distribution follows a traditional manufacturer-wholesaler-retailer supply chain, prices paid by consumers are significantly affected by negotiations with pharmacy benefit managers, or PBMs, and payers for health care services, including insurance companies, Medicare, and Medicaid. The report says PBMs exercise a strong influence on prices, since they administer drug benefits for some 266 million Americans, but just 3 of these companies — CVS Caremark, Express Scripts, and OptumRx — manage about 70 percent of all pharmacy claims.
The result is a confusing, shifting, and opaque target with little accountability. And from those conditions, patients face an inconsistent and confusing price structure for insulin, as the prices paid by consumers continue to rise. The American Diabetes Association paper cites 2 studies showing out-of-pocket costs of insulin for consumers, after all negotiated rebates and discounts, doubled from 2000 to 2013.
Let markets work
One way to break this syndrome of concentration and confusion is more market competition. The Biologics Price Competition and Innovation Act, part of the Affordable Care Act, reduces regulatory requirements for biosimilars, the name for biologic drugs that act like and are interchangeable with insulin and other biologic therapies. That law goes into effect next year, and Gottlieb noted in his December speech that FDA already issued guidance simplifying the regulatory process for reviewing biosimilars and, for insulin at least, reducing the market exclusivity period.
Another way of increasing competition is with natural remedies and behavioral changes not affected by the pharmaceutical supply chain. As we reported in July 2018, a clinical trial conducted by University of Miami is exploring the benefits of vitamin D and omega-3 fatty acids in children and adults as a treatment for type 1 diabetes. And another clinical trial that we reported last February shows a combination of low-carbohydrate diet, with close monitoring of health indicators and coaching via a mobile app are shown in a clinical trial to reverse type 2 diabetes, including reductions in medication and insulin therapy.
One more way to disrupt this market is with technology. Just last month, for example, we told about a clinical trial now underway testing the safety of implanted stem cells to generate working beta cells in the pancreas that produce insulin, in patients with type 1 diabetes. But pharma companies are also developing new technologies for treating diabetes. The capsule that delivers insulin injections to the stomach, described in our story on Friday, is being commercialized by Novo Nordisk, one of the 3 suppliers of insulin in the U.S. And as we reported last April, Eli Lilly & Co., another insulin maker, is licensing a a technology for implanting pancreatic beta cells in people with type 1 diabetes, from a company making implants of live cells to treat chronic diseases.
If health care consumers and taxpayers expect to gain the benefits of these technological advances, then government needs to make sure markets work like they should. If FDA, Federal Trade Commission, and Department of Justice cannot prevent today’s insulin makers from controlling tomorrow’s diabetes treatment technologies, then Congress needs to step in. Each congressional district, no doubt, has many people with diabetes that depend on it.
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