Will more biosimilar agents help lower the high cost of insulin?
The availability of more biosimilars insulins are, in the long run, going to make a difference in the price of insulin, but it will take time and require regulatory changes.
Basaglar (Lilly), a follow-on to insulin glargine (Lantus, Sanofi), and Admelog (Sanofi), a follow-on to insulin lispro (Humalog, Lilly), have each been available for a few years. Unfortunately, neither has resulted in any significant drop in insulin prices. If you look at the list prices (per 1,000 units) for Basaglar ($261) vs. Lantus ($302) vs. Toujeo (insulin glargine injection, Sanofi; $338), it’s hard to see the benefits of competition. This is not surprising. When the first generic for Lipitor (atorvastatin) came out, the price, similarly, was not much lower than the brand name medication.
Most experts in drug pricing believe it requires three or four versions of the same drug before you see real downward price pressure. If there were, say, four versions of insulin glargine on the market, from four different manufacturers, that would be more likely to exert significant price pressure.
That said, there are challenges specific to manufacturing biosimilar insulins and bringing them to market. Making a generic version of a nonbiologic agent is relatively easy. Biologic agents are different. Also, there are not a lot of companies out there making follow-on insulins. Who makes Basaglar? Lilly. Who makes Admelog? Sanofi. This is a market with significant barriers to entry.
The FDA recently convened a hearing to solicit ideas to help increase access and facilitate the efficient development of biosimilar and interchangeable insulin products. This is a good start. The fewer regulatory hurdles impeding the development of biosimilars, the more companies will want to enter the marketplace. There are several biologic drugs that earn billions of dollars a year in revenue. As the regulatory environment becomes friendlier to biosimilars, we will see not only more insulin biosimilars, but biosimilars in other therapeutic areas. As the FDA takes steps to make it easier for companies to make biosimilars, we are going to see much more competition in the market. This will not solve the problem of high insulin prices, but it will certainly be a step in the right direction.
Robert Lash, MD, is chief professional and clinical affairs officer at the Endocrine Society. Disclosure: Lash reports he provides consulting services to Express Scripts.
I wouldn’t expect that throwing in a couple more competitive biosimilars is going to do much to really move the needle on insulin pricing.
The insulin market is different from the other markets where biosimilars might come in and disrupt things, because there is already a decent degree of competition.
When we looked at the potential savings from the introduction of biosimilars in our RAND report, we noted that established insulins will likely have one-half the biosimilar uptake and price discounts. In retrospect, that may have been overly generous.
There are already several available long-acting insulins out there.
It does not take a whole lot of competition to get to the point where pharmacy benefit managers (PBMs) and insurance companies are able to leverage the fact that there is a competitor to get much deeper discounts in the form of rebates. It just takes two to get the leverage in place to get to these huge discounts off manufacturer list prices. With insulin, that competition has already resulted in net prices that were pretty low. Researchers can’t see those net prices, so we can’t see exactly how low they are. My sense is that, as list prices for insulins have increased, the discounts negotiated by PBMs increased as well.
One possible scenario is that the list price increased at the same pace or at a greater pace, whereas the net price for those with insurance coverage hasn’t increased much at all. The reason net prices would stay flat is because of that degree of competition that is already in the market.
That doesn’t mean the introduction of more biosimilar insulin products couldn’t make things more competitive and lower prices further, but when you compare insulin to some of the other biologics where there are no other close substitutes, you are looking at two very different scenarios.
There are several real concerns in this market. The first is that list prices for insulin are going through the roof, and so for those who do not have insurance or have poor coverage, this is a huge problem. That’s an important, more general policy point that has to do more with coverage than with biosimilars, but it’s an important point worth making.
The other important point is even as new competitors enter the market, at least from a couple different manufacturers, the fact that that has happened through the traditional regulatory pathway tells you about the size of the market. In some ways, insulin is unique among biologics in that there is enough on the table to attract multiple competitors in a way you don’t see vs. other biologics. So, there is something that is working with insulin. From a policy perspective, without net price information, it is tough to tell how the competition is working right now.
Andrew Mulcahy, PhD, MPP, is senior health policy researcher at the RAND Corporation, a nonprofit, nonpartisan research organization. Disclosure: Mulcahy reports no relevant financial disclosures.