ADA Ruminations - Does Insulin "Innovation" Actually Help Patients?

I saw a number of new insulin options being introduced on the exhibit floor of the ADA Scientific Sessions and while they do seem like they will be useful to patients I am more concerned that they are somewhat false innovations that have been designed solely to make money.  And during a symposia session on the costs of medications for diabetes an alarming picture of the insulin industry emerged.   In this post I'll be exploring the landscape of insulin costs from the patient perspective and it isn't a pretty sight.

First I'd like to summarize some of that I head from Dr. Irl Hirsch who has had T1 himself since the age of six and he really appreciates the patient perspective.  Dr. Hirsch's talk was entitled "Changing Costs of Insulin Therapy."  The US insulin market in 2005 was valued at $7.3B but by 2013 the market had grown to over $20B and has a 15% growth rate.  There has been and continues to be major growth and presumably profitability in the insulin market.  And unfortunately there is not a lot of transparency to costs.  Often the prices are based on what is called Average Wholesale Prices (AWP) which is the benchmark used for reimbursement but Hirsch describes that cost as "fraudulent."  It is an elevated price and is rarely what is paid.  He gave an example of a 49 year old patient who needed 3 boxes of aspart pens and was given the AWP of $1481 but in fact paid $75.

3 of the 15 Drugs That Had
Greater Than 15% Rise Are Insulin

And most alarming insulin prices have been rising at a rate that simply makes my hair catch on fire (well, whatever hair I have left).  Hirsch noted that of the 30 drugs that doubled in price in the last 5 years 3, of them were insulin.  And most recently of the 15 drugs that saw a greater than 20% price increase in the last year, 3 of them were insulin.  Market analysts rate the insulin companies as a "value growth" opportunity because the market accepts price increases.  As patients if we don't have price competitive options we have no other choice than to accept price increases.  And this is the real issue, the insulin market is not operating with fair, open and transparent competition.  And Hirsch is not to keen on biosimilar's changing the market, at least Sanofi and Eli Lilly will be in the biosimilar market and it is unlikely they will destroy their own markets.

Is There Collusion in the Insulin Market?

The most alarming thing is that these price rises don't seem in line with other medical costs.  There doesn't seem to be anything about insulin production that suggests that costs are rising.  And Hirsch showed a chart that showed that showed that overall medical costs actually went up slowly while insulin costs skyrocketed.  And it is very difficult to understand the costs by looking at prices in other countries since the prices seem all over the map.  And most alarming is a chart that Hirsch showed that Lantus from Sanofi and Levemir from Novo Nordisk both increased their prices in lock step 16 times.  The chart at left shows the recent price increases.  In a competitive market you would not expect prices to move in such a coordinate manner.  That raises the suspicion that companies are cooperating in raising prices and essentially acting as a monopoly.  In fact Hirsch in very strong terms suggested that the government should look into this behavior and consider prosecuting the companies.  He noted reports of three patients reducing carb intake in order to reduce their need for insulin and that these price increase have a dire impact on patients.

What Has Happened to U-500?

And the other aspect of this whole market is what has happened with human insulin.  Human insulin is still available on the market but has been dropping in market share from 2011 to 2014, Hirsch attributes this to "promotional detailing."  A New England study looked even looked at the option of using NPH as a first insulin rather than an analog simply as many patients were not moving to insulin because of cost.  There are serious questions about whether the mild reduction in hypos offered by modern analog insulins actually justify this significantly greater cost.  After all the cost of insulin manufacturing is cheap.  And then there is the strange case of U-500 from Lilly which has risen in an alarming way as shown at right.  Historically U-500 was priced at a modest increment above U-100 but now is at many multiples.  Obviously the laws of supply and demand don't seem to be working.

And some of what has happened with U-500 may have been intentional manipulation of the market in order to pave the way for new insulin products.  Toujeo from Sanofi is a U-300 version of the popular Lantus U-100 with three times as much insulin in each mL.   Eli Lilly has also introduced a U-200 version of their Humalog which has twice the concentration of insulin.  Unfortunately as I walked the exhibit floor and asked the companies about their pricing each of these products are expected to have the same price per unit as previous products.  It seems crazy, the vast majority of pharmaceutical products have very modest price increases for higher dose/concentration products.  After all the actual cost of the drug production is a very small part of the cost.  None of these products will save costs.  In fact they will likely increase patient costs.

Hirsch had only some weak recommendations on how to dig ourselves out of this situation.  He recommended that medical residents and fellows be taught how to prescribe human insulin.  He thinks patient grassroots advocacy is vitally important by it is really unclear about the role of the ADA and JDRF given their ties to industry.  Technically it should be the mission of pharma companies to help patients and cure disease but unfortunately we don't always see them fulfill that mission.  There are some organizations that look at how well pharma companies do in supporting access to medicine. One initiative called Access to Medicine rates companies on different factors in providing access.

But in the end, the insulin landscape looks pretty bleak.  There is some innovation but it isn't likely to lead to any important improvements in insulin performance and it only likely increase costs.  And the continued rise in insulin costs is hugely alarming.  While many patients will likely continue to get coverage from insurance and other reimbursements, those costs in the end are passed on to patients and society.   I came away from the ADA Sessions feeling like we need to stand up as patients and advocate against unethical and immoral behavior in the marketing of insulin.  If we don't do anything who will?