Thursday, May 05, 2016

Why I'm Not (Yet) Supporting #MyPumpChoice

This week, there was a bit of a brew-ha-ha over the joint announcement [see HERE for the news] from United Healthcare (the largest for-profit healthcare insurer in the U.S.) and Medtronic over insulin pump coverage, specifically that United Healthcare had chosen Medtronic to be the company's "preferred" insulin pump supplier, hence other pump and pump supply brands like Roche, Tandem or Animas would generally not be covered.  Yes, they buried it on page 7 and kind of did it on the down low which was sleazy, kind of like banks do with changes in terms to credit cards or new fees being added on your checking account.  That wasn't the best way to share the news.

Being a former Animas (now Johnson & Johnson) pump user, I guess could have been a little upset over the matter, but my reaction was much more of "so what?" instead.


Well, my perspective has been shaped by my 40 years of living with Type 1 diabetes (yes, the summer of 2016 will be my 40th diabetes anniversary, but I haven't claimed any medals that I'm probably entitled to from either Joslin or Lilly, and I'm not sure I even want to, but that's a separate discussion).  When I was diagnosed as a 7-year old child in 1976, things were a little different, but frankly, in spite of the many claims about how much different things are today, treatment today is really not different by all that much.

Relevant History

For one thing, when I was diagnosed, there were exactly 2 brands of insulin sold in the U.S., made by Eli Lilly & Company and E.R. Squibb & Sons, Inc. (better known as Squibb, now part of Bristol Myers Squibb).  Our Canadian neighbors had their own insulin manufacturer since they actually discovered insulin, and Connaught Laboratories (part of the University of Toronto until 1972), later became a crown corporation of Canada which was ultimately sold off in a privatization effort as were many other crown corporations, mainly under the leadership of then-Prime Minister Brian Mulroney.  Today, the Canadian birthplace of insulin is part of Sanofi, which has the distinction of now being home to both the Canadian and German companies originally granted licenses to make insulin from University of Toronto back in the 1920's.

As a practical matter, however, Squibb's insulin was really more of an afterthought at the time.  In the U.S. market, which was estimated to be 40-50% of the world market, Lilly held an estimated 83% share in those days.  But since the early eighties, the insulin industry has steadily consolidated, although a few companies have entered the world market, only to later be acquired by one of the three giants.  Anyway, in 1981, five companies (Novo, Nordisk, Eli Lilly, the German chemical and pharmaceutical company Hoechst [which later became Aventis, now known as Sanofi] and of course, Squibb, which would sell its insulin business and exit that market) accounted for more than 90% of the world insulin market.  I should also note that at that time, Novo Nordisk was two separate companies (both based in Denmark).  In 1989, the CEO of Nordisk Gentofte approached rival Novo Industri A/S with a proposal to merge their companies, hence they became known as Novo Nordisk in 1989.

Realize that in the late 1970's, Squibb's fortunes in insulin were somewhat plagued by various manufacturing problems, and purity was an issue.  Ultimately, they partnered with Novo (or was it Nordisk?) to solve those problems.  Novo Nordisk only entered the U.S. market in the mid-1980s with a 50/50 joint venture then known as Squibb-Novo, which Novo Nordisk later bought outright from Squibb.  Insulin pumps only emerged a few years after that, but just one company existed at the time: Minimed, a then-startup based near Los Angeles, which years later would be acquired by medical device giant Medtronic in 2001.  The reality is that Medtronic-Minimed as it was known for some time has a great deal of expertise in the insulin pump market, perhaps moreso than many of the startups in the space.

Back to Coverage Issues

Anyway, when the "preferred" announcement that United Healthcare would cover Medtronic pumps, largely because both companies had negotiated preferential pricing agreements, social media was alive with comments, mostly complaints.  As I understand it, Insulet products are excluded from this decision, hence tubeless pumps will still be covered.  My response to all of the bellyaches online was that was really no different from preferred brands of insulin or blood glucose testing supplies.  Do you have much choice in those things?  Not really.  I ask why insulin pumps are any different?

For insulin, you can still get coverage of other brands, but you'll pay a lot more for the non-preferred brands.  However, medications like insulin, including the relevant preservatives used in those products can have some very serious adverse effects, so most plans will cover them, but you'll pay a lot more, and they'll likely make it quite difficult to get coverage for those non-formulary brands, but it CAN be done.

But for testing supplies, which are a medical device, I think you're $#!t out of luck getting any coverage for non-preferred brands, folks.  The insurance company is under almost zero obligation to even cover those things, although some states impose more restrictions on insurance carriers than others (rates in those states tend to be higher than in less regulated states, including much of the South).  For coverage of continuous glucose monitoring devices, the policy is somewhat less clear.  Right now, Medtronic doesn't even make a standalone CGM, hence it appears that Dexcom is still covered, especially if patients use pen devices rather than a pump.  But all that could change in the future if Medtronic gets its act together and starts selling a standalone CGM device and sensors.  The company has hinted it could move in that direction in the future, but right now they simply aren't ready, and my sense is that won't be ready in the near future, either.

Shame on you? Really, that's the best you can do?  Come on.  They're both public companies with a fiduciary responsibility to shareholders, so you need more substance than that.

The main issue from my perspective is that while such preferred relationships are routine in today's healthcare market, many patients are getting pissed off because choices are being taken away from them.  Pumps can contain a variety of different features, and in the past, there were some very legitimate differences.  For example, when I pumped insulin a number of years ago, at that time, Minimed pumps could only deliver insulin in complete 1-unit increments, so I went with an Animas pump because it enabled 1/10th of a unit increments, which was a very big deal for me.  While this particular difference no longer exists, it did back in the early 2000's, and we might see potential new innovations, such as smarter bolusing technology, etc. so the differences aren't always cosmetic as some are implying.

Also, some prefer Omnipods over pumps with tubing (a legitimate issue for some people, think of athletes who might find it the only viable technology for them), which is why Insulet pumps are exempted from this decision.  In the end, much of the bellyaching is just complaints from people who seemingly readily switch from say Abbott test strips to J&J One Touch strips without much complaining.  But occasionally there are some significant differences in areas like accuracy at different blood sugar levels, but you basically have to read the fine-print disclosure in mice-type to see that, and accuracy details are limited in many disclosures.  But the old J&J One Touch Ultra test strips, for example, showed statistically less accuracy at hypoglycemic levels than did Roche's Accu-Check strips did at that time, yet I don't recall there being a campaign to protest that.  Why not?  I have hypoglycemia issues, so that is a big deal for people like me.

I realize that an insulin pump is with you 24/7/365 so it's very personal for many, but how is not having a choice of pump any different from not having a choice of test strips when certain brands aren't as accurate?  So far, the campaign about #mypumpchoice rings pretty hollow to me, but I'm open to a truly persuasive argument.  The only thing is that so far, I haven't heard any arguments that are very persuasive.

I'm covered by United Healthcare, and I don't feel as if I've been screwed out of anything.  It might limit my choice on pumps, and that might not sit well, but I also really don't like limits on my choice of testing supplies or insulin, and yet that's done all the time and people seem willing to accept that.  As I said, I can be convinced, but so far, the diabetes patient community hasn't even convinced me, and I'm one of you!

Author P.S.:  I'm not interested in a campaign that's about pumps exclusively.  We need to address the issues that also include insulin brands, strips and medical care more generally.  This is a broader effort, but one that needs to be addressed.  Don't ask for my help in something more narrowly focused.


Mike Ratrie said...

Call it the straw that broke the camel's back. First, insurance/PBMs forced us to change our test strips (I was able to appeal this one b/c I use the Accu-Chek Combo System), then they forced us to change our way expensive insulin, NOW they are forcing us into one non-waterproof pump brand with an inferior integrated CGM?

So, as a community, the DOC needs to push back on all of these b/c each forced change takes choice away. It drives a wedge between the relationship of the patient and their HCP.

Granted, the concept of cost containment is a noble goal, but to insist that the only way to achieve the goal is by having all us us drive black Model Ts isn't the way.

Unknown said...

Here's an argument that's pretty persuasive on the difference between meds and devices:

Also, do you not see how, if we let this go unchecked, it could easily lap over into CGM where so many of us are getting great results on a clearly superior product(Dexcom), but we could lose access to that if we allow Medtronic to do its wheeling & dealing?

Scott E said...

Your thought is certainly one that crossed my mind. If, in the end, the differences are largely superficial, does it matter what pump we get to use? Are we that shallow?

But I do look at this for what it means in the bigger picture, and as a continuing trend of insurers, not doctors, dictating treatment. That's a big concern of mine.

I also look at what it means for the industry in general, and if the decrease in choices will stifle further adoption or further advancement in pump tech. But that is a relatively weak argument, which I really can't quantify.

And yes, I am just a little bit vain.

But your points are very valid and I respect you for posting then. Also-- thanks for the history lesson.

Sarah Howard said...

I agree with the point that it should not be only about this one company restricting pumps. But I agree with the comments that the effort as part of a broader trend to try to stop the insurance companies from limiting choices in all aspects of diabetes care (could be broadened to other diseases as well!), including meters, insulins, etc. Meds and tech both should be decided by doctors and patients, not insurance companies. This simply reduces competition, which will not reduce costs in the long run. (Costs for UHC may be lower in the short run, but higher in the long run, if innovation is stifled ... innovations that can lead to better diabetes control).

Mike Hoskins said...

Like those above pointed out. I see this as different because we're talking high-cost pumps versus medications or even strips and meters.

Strips aren't personal. Sure, accuracy used to be a bigger difference. But a strip's a strip. And no one cares about the meters because they often don't cost anything in comparison. Really, insulin is along the same lines... yes, they may be different to some extent. But in reality, the nuts and bolts are the same and it's not a "personal choice of which I want to use more." If Novo works as well a Lilly as well as Apridra and you don't care, then it doesn't matter. And with insulin, you can fight to get the differences if need be.

As to pumps: Personally, if I don't like the device I need to use all the time, I'm less likely to use it as effectively as I would otherwise. Sure, I'll take insulin with it and do enough to survive. But I won't take full advantage of the benefits. If I can't see the screen well enough, or it's not waterproof, or whatever else matters to me. If I'm forced to use Animas but detest the 1980s-looking screen display, I may be less inclined to stare at it as much and dose accordingly or play with settings.

And then... what about CGM? Sure, suddenly this carries over and those of us using a Dexcom will be forced to go through more hoops to get our CGM (beyond what we already must with sensors, pre-approvals, etc). Eventually, our doctors determine it's just too much paperwork and time away from patients, and they start just going with the Preferred Brand and not even advocating for other devices that might work better.

Know how you feel about closed loop, so I get that this is a tougher sell. But imagine the same logic applied from above. And then, these smaller companies (pumps, CGM, APs, etc) who are losing market share even more as a result of these widespread preferred partnerships, simply stop manufacturing. And then we are truly left with less option and competition, which also means the Preferred Brand won't be as inclined to do better because the competition has evaporated.

Anyhow, I appreciate your response and think it adds to the discussion on this. Very important to hear all POVs. Thanks for writing this, Scott.

/End Rant

Sarah Howard said...

In response to Mike: with all due respect, I care about the meters! My insurance company limits us to Bayer meters (thankfully my endo protested and got an exception for all her patients). If I had to only use Bayer meters, I wouldn't test in the dark (no night light), in the cold (freestyle works when I'm skiing), in wet weather camping (only freestyle works), etc. My meter makes a *huge* difference for me. Add up the cost of strips over the years and it is expensive! Insulin also -- I didn't have luck with humalog in the pump and so use novolog now. I think all of these items should be available to people independent of insurance company, pumps included. And agree that cgms are a big one, I'm sure that UHC will start limiting dex receivers, why should they pay for those when the minimed receiver is built into the pump? I use a minimed pump and just switched from enlite to dexcom due to inaccurate enlite sensor. lucky!

Mike Hoskins said...

Agreed, SarahH. I more meant: upfront cost. Pumos cost a lot up front, whereas meters, strips, even insulin don't in comparison. Doesn't mean that stuff isn't important and costly to us (especially over time), but not in the context of money the insurer has to pay at the start of just getting us on a new insulin pump.

Bernard said...

Thanks Scott for laying this all out. I'm glad you're happy with UHC.

I don't like this because pumps are more personal. While Medtronic is the big player in this area, Tandem, Insulet and others have been innovating much more in recent years. And Dexcom also in the CGM space. I'm concerned that these smaller players will lose customers and end up failing.

Re treatment being not much different from the '70s, the overall approach is the same but having a CGM versus using urine tests and being able to deliver micro doses of insulin are big changes in efficacy and accuracy and do count for a lot. The next big step, which I can't wait for, is the arrival of an Artificial/Bionic pancreas on the market. And that may actually happen within the next 5 years. Oh, and then the cure which will be five years after that. ;-)

Christopher Wilson said...

Scott, this sentence: "They're both public companies with a fiduciary responsibility to shareholders, so you need more substance than that." really misses an improtant point. UHC is actually abdicating its long-term fiduciary responsibility to its shareholders with this deal. How so? Let me lay it out for you.

UHC is letting themselves be used by Medtronic to drive Medtronic's competition out of business. I'll give you three guesses as to what happens to insulin pump prices when Medtronic becomes the only player in the game, but you should only need one. Pump prices will skyrocket. In the long-term, eliminating competition will drive costs to payers like UHC up, not down. Pump therapy is proven, and the accepted standard of care of T1Ds with insulin needs that vary, so payers will still be required to cover the pumps.

This deal is actually UHC shooting themselves in the foot in the long-term. They're so focused on the year-end p/e ratios for THIS YEAR, that they're sacrificing the benefits of having suppliers that need to compete and keep their costs down over the long haul. Becoming reliant on a monopoly is bad for business. Helping to create that monopoly is doubly bad. The people in UHC's C-level suites ought to be under fire from the stockholders and the board of directors that answers to those stockholders for a strategic screwup of this magnitude.

Scott S said...

Thanks to everyone for their comments. Christopher, I disagree with you mainly because you are making a huge and unsubstantiated presumption that the healthcare insurance business has any concern for long-term goals, when the fact is that short-term p/e ratios is really what drives ALL of their decisions, and the best proof for that is all the hoops that patients with any chronic illness must go through in order to get care they even when such coverage is guaranteed by Federal and/or state laws. Appeals and denials are not anomalies, they are routine and no one can deny this. The reason is because no patient will be with a particular insurer for the long-term, they routinely switch by changing employers and therefore they are guaranteed to change insurance companies routinely, and the insurance companies' actuaries have the actual data to prove it.

In terms of pump companies, the reality is that big companies like Medtronic, J&J (Animas), and Roche (Disetronic, now Accu-Chek) all actively compete, but startups struggle to offer comparable pricing, although most venture capitalists are well aware of the issue and factor that into their investment plans. But the reality of this decision driving startups out of the space has not been proven by facts, as companies continue to enter this lucrative space because there's still plenty of money to be made.

Again, so far all I've seen is threats but little substantive data to back why this deal does not work for the for-profit companies (United Healthcare and Medtronic) or the pump suppliers involved. Startups may have a tougher entry, but it can and has been done.

Unknown said...

My biggest concern is the waterproof issue. The Animas Vibe is waterproof for 12 feet up to 24 hours, while the Omnipod is waterproof up to 25 feet for 60 minutes - but ONLY the pod portion. The Medtronic is not waterproof at all. I do water aerobics at least 3x a week, and sometimes swim for 30 minutes after class, so if I were on a pump (I am not at this time) and were forced onto a Medtronic pump, I would have to be without insulin for an hour or more a day, several days a week, plus also for showering afterwards.

I tried the Omnipod, and it just didn't work for me and I gave up on using an insulin pump at all because, at the time, I wasn’t aware of any other pump that I could use in water without having to disconnect. I just learned of the Animas Vibe. I had too many pods fail, or rip off, in a short trial period to have any faith in it. Also due to my extreme insulin resistance and insulin requirements, it was necessary to switch to a U-500 insulin so as to make the pods affordable in the first place.

There are some pretty big differences between the Vibe and the Medtronic MiniMed 530G, and the Omnipod. The Vibe doses a 5U bolus (remember, I’m T2, that’s only part of a bolus for me!) in 8.3 seconds. The other two take 183 seconds - over 2 minutes! If I’m having to bolus 15, 20, or more units that REALLY ads up. A 20U bolus would take 12.2 minutes instead of 33.2 seconds. Surely that will impact glucose control after eating, or affect how early you need to start bolusing before meals, and make bolusing before restaurant meals particularly difficult, if not impossible.

The Vibe has a max bolus of 35U. The MiniMed has a max bolus of 25U - again, extremely insulin-resistant T2 here. While my insulin needs might drop when going onto a pump, I quite often bolus 30U of insulin at meals, so would have to bolus twice with the Medtronic pump.

The Vibe’s battery life is about 3-4 weeks. The PDM of my OmniPod went through a set of AAA batteries within a week. That's a lot of waste going into landfills - not that UHC cares, but it's important to me.