The US Food and Drug Administration (FDA) has announced it is changing the way it approves copycat versions of branded insulin products for use in diabetes. Announcing the changes on December 11, which will take effect in 2020, FDA Commissioner Scott Gottlieb, MD, said: “Diabetes affects nearly 30 million Americans. Access to affordable insulin is literally a matter of life and death.”
The move cannot come too soon. As widely documented by Medscape Medical News, the cost of many branded insulins in the United States has soared in recent years, prohibiting access for many patients with diabetes. Most recently, a newly published study showed that 25% of patients have skimped on insulin because of cost.
“We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive,” Gottlieb added. “These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”
Biosimilar versions of insulin (see box for explanation) are expected to be somewhat cheaper than the branded products, although the price differential will vary between markets and depending on healthcare systems. Cost savings with biosimilar insulins in the European Union (EU), for example, are estimated to be between 11-40% of branded origin products.
Biologics and biosimilar drugs are now routinely used in many specialties, such as rheumatology and dermatology, but thus far, the use of biosimilar insulins for the treatment of diabetes has been much slower to gain acceptance.
Why is that? What specific concerns could be holding back physicians from prescribing these agents? Speakers at the Diabetes Professional Care (DPC) meeting held in London, UK, last month explored some of the issues at play, and Medscape Medical News was there to listen to their arguments.
The reasons for the reluctance are numerous. Firstly, physicians and patients don’t like change and they are not always sure that biosimilars will be as effective as the originator products. And switching between different insulin products isn’t as simple as just changing from a branded chemical drug to a generic version. Staff costs are involved in moving patients to a new insulin, and in the case of patients with type 1 diabetes, they may be using technology such as insulin pumps, which makes swapping products even more complicated.
And although biosimilar insulins are cheaper than branded insulins, they are not that much cheaper. Indeed, not cheap enough, some would argue, to justify the change. And depending on the design of the healthcare system and specific country, the people putting the effort in to make the swaps do not always reap the rewards — they don’t stand to gain from the cost savings.
And yet there is a feeling that costs will eventually come down more, both of biosimilar insulins and the branded products they are competing with. They simply have to if diabetes is to be tackled worldwide, as insulin represents the biggest spend of all in terms of diabetes medicines.
This potential for further cost-savings with biosimilar insulins means they could also be a treatment option in the future for patients with diabetes in many lower- and middle-income countries that currently cannot fund branded insulin analog treatment.
A recent modeling study published in Lancet Diabetes & Endocrinology — as reported by Medscape Medical News — predicts that global insulin needs are set to rise 20% by 2030 because of the global epidemic of type 2 diabetes.
Without major improvements in access, however, half of the 79 million adults with type 2 diabetes who will need insulin by then will go without unless something changes to make insulin more affordable.
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