We Need Get Insulin Added to the National "Preventive Medication Coverage" List

For 2018 World Diabetes Day (which is on November 14 of each year, the date of discoverer Frederick Banting's birth), I avoided much "celebration" or even acknowledgement. Its not that I don't care -- indeed, I can remember my involvement of working to get Congressional recognition of the day and helping to persuade the then-UN representative with written letters to that the United States' citizens actually supported the day's (and month's) creation way back in the early 1990's. Prior to that, diabetes wasn't even acknowledged outside of the medical profession.

That said, in many ways, I hate these honorary "days" or "months" because they really marginalize all of the other days and months that we must go on without so much as an acknowledgement, and frankly, there are some huge problems with diabetes treatment in the United States, perhaps more so than elsewhere in the world.

One of the most disgusting developments in recent years has been the runaway prices for insulin, which if I'm being frank, are simply greed-driven price hikes for decades-old drugs whose development costs were recuperated years ago. Years ago, I addressed biosimilars and the bogus reasons they hadn't emerged (see my coverage at http://blog.sstrumello.com/2007/01/business-of-diabetes-real-story-behind.html) but today, the distribution and payment hierarchy have added vastly to the prices people with diabetes pay for insulin.

Without getting too wonky, the main issue that gets insufficient attention is the runaway prices for all of what's needed to treat this chronic disease that have skyrocketed and have shown no signs of deflation. In particular, insulin prices have increased about 1200% (that's one thousand two hundred per cent) over the past decade. The pharmaceutical industry has convinced itself that list prices for drugs are irrelevant, which is a falsehood. Artificially-high list prices for insulin, combined with nearly as high rebates paid to third-party drug wholesalers, Pharmacy Benefits Managers (PBM's), healthcare insurance companies and retail drugstores all add to the not-at-all transparent pricing structure that masquerades a hugely inefficient pharmaceutical distribution system where every party benefits from higher prices EXCEPT patients. Needless to say, because of that, the drug industry and and related parties including the healthcare insurance industry have worked tirelessly to preserve the expensive status quo.

Congressional caucuses are largely irrelevant, officially they are a group of members of the U.S. Congress from both the Democratic and Republican parties that meet to pursue common legislative objectives. Formally, caucuses are formed as Congressional Member Organizations (CMO's) through the U.S. House of Representatives and governed under the rules of that particular chamber. Typically, its just another title lawmakers give themselves because they seldom accomplish much and frequently, the caucus members own voting records work against the very objectives they claim to support. That said, occasionally, they do something, and their research has potential to yield meaningful results if the caucus acts on their findings. Quite recently, the Congressional Diabetes Caucus actually released a relevant report about insulin pricing which meets the definition of "runaway" price increases.

In June 2017, Representatives Diana DeGette (D-CO) and Congressman Tom Reed (R-NY) who are the co-chairs of the caucus, sent letters requesting meetings from 3 key stakeholders: the Pharmaceutical Research and Manufacturers of America (PhRMA), the Pharmaceutical Care Management Association and America's Health Insurance Plans. These are the major trade groups for the pharmaceutical industry, the pharmacy benefit managers and the health insurance industry, respectively. After meeting with officials from these three organizations, the members released key findings summarizing what was discussed in these meetings and a separate, additional meeting with the American Diabetes Association. The caucus reports that average insulin prices have doubled since 2012, and many patients are also facing high prices due to high deductibles (prevalence of deductible insurance plans have increased steadily and now represent more than half of all plans), coinsurance and formulary exclusions.

More details on the caucus' research can be found on chairwoman DeGette's web page at https://diabetescaucus-degette.house.gov/insulin-pricing/ with the actual report found at https://diabetescaucus-degette.house.gov/sites/diabetescaucus.house.gov/files/Congressional%20Diabetes%20Caucus%20Insulin%20Inquiry%20Whitepaper%20FINAL%20VERSION.pdf.

DiabetesMine first addressed my idea at https://www.healthline.com/diabetesmine/insulin-pricing-meeting-2016 and its worth re-visiting.  The Diabetes Patient Advocacy Coalition (DPAC) has coverage of the report at http://diabetespac.org/report-on-insulin/ while T1D Exchange (the folks who run Glu https://myglu.org/) have also chimed in on the topic https://myglu.org/articles/how-all-payer-healthcare-might-bring-down-the-price-of-insulin although they have addressed thoughts on pricing more generally not the diabetes caucus reporting, and of course, so have the ADA and JDRF among the big diabetes nonprofit organizations that take credit, in reality, its the complaints and voices of people with diabetes that brought the latter two organizations to even acknowledge the problem.

Revealed in that report were an acknowledgement of the physical path that moves the insulin from manufacturers to pharmacies (and, in-turn, patients), and the subsequent flow of insulin payments. Because so many parties are involved in both, efforts to address upward price pressures, the report suggests doing more to encourage more insulin biosimilars (so far, ALL biosimilars are coming from Big 3 insulin suppliers although the partnership of Mylan/Biocon have a Lantus biosimilar to be branded as Semglee pending FDA re-review as well as legal settlement with Sanofi), hence discounts have been modest at best -- reportedly only 15% off, compared to discounts of 75% to 80% for most small molecule drugs, to which big pharma responds that insulin is so much more complicated than small molecule drugs therefore the discounts are smaller, which is an outright falsehood). The report also recommends formulary changes that standardize the process for requesting exemptions or filing appeals from formulary changes, and that Congress could convene working groups composed of patients, providers, PBM's, and health insurers to develop a patient-centric appeals system. In addition, it recommends standardizing drug formulary disclosure of patient cost-sharing information, and potentially introducing legislation directing CMS to develop a series of standard formulary designs that provide cost-sharing information in an accessible manner, plus limiting the number of changes an insurer is permitted to make to a formulary each year, and finally capping out-of-pocket expenses for prescription drugs that are needed for chronic conditions.

First, note that most of these recommendations impact Medicare (and to a lesser extent, Medicaid), so they will not have material impact on private healthcare insurance which impacts most people.

A Practical Step Big 3 Insulin Makers Can and Should Be Doing Now, But They Aren't Doing

The elephant in the room is something Congress COULD do it if they were so inclined, specifically to make sure that all insulin varieties are added to the CDC's and CMS/Medicare list to the national "Preventive Medication Coverage" list https://www.healthcare.gov/coverage/preventive-care-benefits/ which is a list of so-called preventive medicines and services without charging you a copayment or coinsurance, which is true even if you haven't met your yearly deductible. Virtually all private healthcare insurances cover these items already, except for short-term insurance plans which are considered junky insurance plans that Obamacare did away with anyway. It would be a fairly straightforward matter to get insulin added to this list, yet Congress never bothered to do so because they never saw insulin as preventative. In fact, several of the medicines on that list (such as statins) have never been proven to prevent cardiovascular events such as heart attacks or strokes, so they are no more "preventative" than insulin.

Now, if the Big 3 insulin makers were truly so concerned, they would have lobbied long ago to get insulin added to this list, but guess what? They didn't bother. I think its very clear what needs to be done: to get all forms of insulin (not just the old ones like regular and NPH) added to the national "Preventive Medication Coverage" list, making it either lower-cost or even one of the $0 co-pays on the insurance plan and doing so would be a fairly straightforward matter to do, but it needs to be uniformly supported by but most parties, and so far, big pharma as fought it at every step of the way. One has to ask why they are fighting this, but their answers for fighting it are more as a matter of principle, rather than having a very good reason for doing so.

The short-term solution, I propose, is to make sure that insulin is added to the national "Preventive Medication Coverage" list. That would likely impact everyone on Medicare (and Medicaid), as well as many private healthcare insurance plans quite quickly.

Now, can we get everyone on the same page, please?!

A Decade+ Later, Biosimilar Insulin Is Here

More than a decade ago (the article I published on my blog was originally posted on January 8, 2007 although I began research into the subject the preceding summer, see the article at http://blog.sstrumello.com/2007/01/business-of-diabetes-real-story-behind.html for more background), I asked a number of very legitimate questions (some of which were later answered, others were not), with the most notable one being about why so many other diabetes medicines had "generics" but insulin did not (in spite of the fact that its patents had expired years ago).  Unfortunately, in my research, I discovered the some of the sordid inner-dysfunction of the U.S. pharmaceutical market, and now, 11 years later, the pharmaceutical industry still behaves as if it was business as usual, making few (if any) fundamental changes, and some downright sleazy operating practices to try and turn a century-old product into a cash cow (although truth be told, the NET margins for insulin have barely increased over time, but list prices have risen by over 1,000% over the past decade alone).  Catch my recent post on the recent price hikes at http://blog.sstrumello.com/2016/11/changes-in-price-of-insulin-in-graphics.html for a visual -- its simultaneously stunning and sickening.

Patents for recombinant DNA (rDNA) biosynthetic human insulin expired years ago, yet no money-savings generic insulin varieties EVER came to market -- and that's still true even today.  Initially, the drug industry tried to blame others for runaway prices (that has become a recurring pattern with the pharmaceutical industry; it's never big pharma's fault, and the industry ALWAYS blames others for the industry's own failures), claiming that Federal lawmakers failed to pass legislation governing generic biopharmaceuticals (also known as biosimilars and follow-on biopharmaceuticals).

The problems were that:

a) because insulin made via recombinant DNA technology was the very first-ever biotechnology medicine, insulin is grandfathered -- and governed as -- a "small-molecule" drug like aspirin, even while it was made using biotechnology, so that was just an unfounded excuse NOT to bring cheaper versions to market and
b) once Congress finally DID pass legislation to regulate copies of biopharmaceuticals as a provision of the Affordable Care Act (also known as the ACA or Obamacare) in 2010, the drug industry then worked overtime to prevent all generic (biosimilar) competition from ever coming to market with a barrage of frivolous lawsuits over patents, processes, weights and measures, packages, delivery devices, trademarks, etc.

In the end, most of the lawsuits failed, but the industry succeeded in delaying (but not preventing) biosimilar competition from coming to market.  This is a standard industry practice, and the costs are already factored into business plans.  Every delay means millions in pharma profits, so its an established industry practice and most every company in the pharmaceutical industry knows how the game is played very well.

Without getting into the lengthy history of insulin over the last 50 years, lets just say that after more than a decade, biosimilar insulin varieties have FINALLY hit the U.S. market.  This could (not assuredly) bring some relief to people with diabetes in the United States, although the rebate wall that keeps prices artificially high remains firmly in place.  On the latter issue, there have been recent promises from UnitedHealthcare to share some of the rebates with patients (see https://nyti.ms/2H89R0L for the news) and Aetna will do the same (see https://bit.ly/2HgX7tj for more), yet still other big insurers including Anthem and Cigna have not yet moved in the same direction.  However, Cigna is in the process of acquiring pharmacy benefits manager (PBM) Express Scripts (see https://nyti.ms/2FrhLSe for the news on that), whereas Anthem is in the process of starting its own PBM which will start operations next year (see https://bit.ly/2oZjPe7 for the announcement).  Anthem's move prompted the sale of Express Scripts given that its business prospects were shrinking.  Its possible when the dust has settled and the PBM business as we know it has disappeared by being folded into big insurance, we could see some meaningful change on that front, although its far from certain.

Basaglar, First Insulin Biosimilar (of Sanofi's Lantus) Made by Lilly and Boehringer Ingelheim

But the bestselling insulin on the market known as Lantus (U-100 insulin glargine rDNA origin) made by Sanofi would lose its patent exclusivity in 2015, so rival Eli Lilly & Company, Inc. and its partner Boehringer Ingelheim announced they would start selling a biosimilar branded as Basaglar (which is just another version of U-100 insulin glargine rDNA origin).  Note that I use these terms biosimilar and follow-on biologic interchangeably in this post.  News of Lilly's (and Boehringer Ingelheim's) plans to introduce a Lantus biosimilar emerged in 2014 (it was not a secret, the filings for FDA approval made them known to the industry via its infamous Orange Book, and the FDA tentatively approved Basaglar in August 2014).

Predictably, Sanofi filed a lawsuit (see http://reut.rs/1nbk2nP for the news) accusing Lilly of infringing on seven patents related to insulin and devices used to deliver it.  Just over a year later, on September 28, 2015, there was news that Sanofi had settled its lawsuit against Lilly pertaining to Basaglar (see https://prn.to/2HfAMw8 for the press release).  In my opinion, the lawsuit against was settled pretty quickly because Sanofi was suing a company that knew the insulin business better than almost anyone.  In the end, a settlement of the terms Sanofi wanted and Lilly was willing to pay was the most cost-effective manner to avoid a costly trial in which a judge and/or jury would decide the outcome.

Lusduna Nexvue and Semglee are Other Lantus Biosimilars Pending Introduction Soon

Lilly/Boehringer Ingelheim are not alone in pursuit of Lantus biosimilars.  Two other companies are also seeking to introduce Lantus biosimilars, including one from Merck & Co., Inc. and co-development partner South Korea-based Samsung Bioepis which received tentative FDA approval for another copy of U-100 insulin glargine on July 20, 2017 (see the press release at  https://www.businesswire.com/news/home/20170720005270/en/Merck-Announces-U.S.-FDA-Grants-Tentative-Approval for more) which will be branded Lusduna Nexvue.

Not surpisingly, on October 24, 2017, Sanofi also sued Merck (and Samsung) over Lusdana Nexvue.  The lawsuit isn't identical to the one levied against Basaglar, Sanofi filed a patent infringement suit against Merck/Samsung in the U.S. District Court for the District of New Jersey alleging infringement on 18 patents in its suit related to Lantus (insulin glargine) and the SoloStar pens, so while Sanofi claims that more patents are being infringed upon in this case (mainly for the insulin pens; Lilly has KwikPens that are exempt from Sanofi's patent claims on SoloStar since Lilly's KwikPens are already on the market).

A third Lantus copy from Mylan Pharmaceuticals and co-development partner India-based Biocon to be branded Semglee is also pending introduction after a settlement or court ruling on similar lawsuits filed by Sanofi.  On June 17, 2017, the two co-development partners presented data on their U-100 insulin glargine product from the INSTRIDE studies at the American Diabetes Association's 77th Scientific Sessions in San Diego.  It's worth noting that the Sanofi lawsuits trigger an automatic 30-month stay under the Hatch-Waxman Act which governs insulin, and the litigation could still go to court, although it's unclear whether either will go that far.

Impressive Sales Growth of Basaglar Thus Far

So far, we already saw pretty impressive sales growth last year for Lilly's Basaglar, and that was while it was still new and not sold in all markets.  Sales of Basaglar quintupled in 2017 to $423 million (admittedly, from a low base of $86 million in 2016).  In Q4 2017, revenue more than tripled year-over-year to $154 million, from a very low base of $40 million in Q4 2016. Sequential growth was not quite as positive, with sales rising just 6% from $146 million in Q3 2017, but its still fairly early in the introduction cycle.  The transcript of that call can be viewed at https://seekingalpha.com/article/4141906-eli-lillys-lly-ceo-david-ricks-q4-2017-results-earnings-call-transcript for complete details.

That said, Basaglar already has pretty strong formulary coverage in the U.S. (Lilly has been aggressive in trying to reclaim formulary coverage it lost to Novo Nordisk over the years under Mr. Conterno's leadership), Basaglar is now preferred over Sanofi's Lantus on the CVS Caremark and UnitedHealthcare OptumRx formularies), although Basaglar will face pricing pressure on its insulin franchise in the U.S., particularly as more competing options become available for payers.  It's also worth noting that Lilly is also aggressively pursuing Medicare Part D sales to help offset high rebating in the commercial healthcare insurance channel.  Mr. Conterno cited "increased utilization in Medicare Part D starting January 1" adding, "by the way, we've seen excellent [Basaglar] uptake."

Once people try biomiliars, they are likely to use them again (assuming the price is lower, almost no one is going to pay any more for them), which is a good omen for the U.S. biosimilar industry.  Also, once there are several different manufacturers of the same type of insulin, prices are likely to come down a bit further, although the industry has a problem because it pays enormous rebates to insurance companies through their pharmacy benefits managers (PBM's), so big rebates are expected to get drugs on insurance company formularies; failure to do so means the product is less likely to sell.  The drug industry has convinced itself that incremental improvements are sufficient to drive sales growth going forward, and perhaps if its the correct incremental improvement, they'll be right.

But ... marginal improvements won't guarantee that payers will be willing to buy it for a higher price.  I think those days are over.  Payers are in control, and they aren't falling for bogus tricks pharma used in the past.  Look at Humalog sales as proof.  They are declining in the face of growing price pressure (as have prices for rival products, such as Novolog from Novo Nordisk and Apidra from Sanofi).  With a biosimilar version of Humalog recently launched in the U.S. (more on that in the next few paragraphs), we may not see huge improvements from a margin perspective.  The big insulin makers are hoping that slightly-faster versions including Novo's Fiasp which is a faster version of Novolog has already been introduced, and Lilly promises a newer, faster version of Humalog is right around the corner.  But most of the growth is coming from outside the U.S.

Why Lilly Likely Pursued Basaglar

For Lilly, the biosimilar basal insulin Basaglar filled an enormous void in its insulin portfolio because for nearly 10 years, Lilly sold no basal insulin analogue at all, only a century-old variety that many doctors and patients disliked (OK, the latter hated) using because it could be very unpredictable.  That also resulted in the company not being listed on some insurance formularies, which did not help the company's long-standing insulin business.  Several years ago, Lilly hired an executive named Enrique A. Conterno to run the company diabetes business.  Under his leadership, Lilly is no longer being dropped from formularies in favor of Novo Nordisk insulin varieties, and has even gained share, although a lack of a basal analogue meant payers had to secure those from another company.

Sanofi immediately sued Lilly over Basaglar, but because it was coming from insulin giant Lilly, Sanofi knew what it could and could not get away with.  Whether Merck or Mylan can do the same thing for their Lantus biosimilars remains to be seen.  But I stand with the idea that more competition never hurt consumers (or in this case, patients!).  We know, for example, that Mylan's Semglee is already approved in Australia (see the press release https://www.prnewswire.com/news-releases/mylan-and-biocon-receive-approvals-from-the-european-commission-and-tga-australia-for-semglee-biosimilar-insulin-glargine-300620737.html for details), so it seems as if its only a matter of time before its available at U.S. pharmacies, and the lawsuit is the main impediment right now.  While Mylan is new to the U.S. insulin market, it's no stranger to the legal environment that pharmaceutical sales in the U.S. must contend with.  Ditto for Merck.

Sanofi was probably not happy that a rival insulin-manufacturer Lilly was the first to copy its bestselling Lantus, which had been one of Sanofi's most profitable products for nearly two decades.  But it wasn't competing with a tiny startup, but one of the oldest insulin-manufacturers still in existence, so Lilly was pretty tough to bully in court.  The two eventually settled for an undisclosed amount, and I'm guessing Sanofi will expect future settlements to be comparable in size for the Merck and Mylan versions of Lantus (Lusdana Nexvue and Semglee, respectively), although as more competition emerges, the value of the Lantus product will continue to decline, hence settlements will likely decline, too.  The fact that Medicare cannot negotiate prices is a major problem that pharma wants to continue and may continue under the current Congress and Donald Trump, but at some point, the largess of taxpayer dollars being paid to big pharma will likely be challenged by lawmakers, and then the dynamic could change dramatically.

Next Category of Insulin Biosimilar: Humalog Copy from Sanofi Called Admelog

Sanofi decided it would return the favor and sell a Humalog copy (U-100 insulin lispro rDNA origin) which it secured FDA regulatory approval for on December 11, 2017.  It's slightly less clear to me what the business objective for Sanofi to introduce a Humalog biosimilar, even if its already now on the U.S. market.  However, there's definitely some tit-for-tat going on, and it may what be the industry needs in the absence of innovation.

Plus, Admelog COULD lead to cannibalization of Sanofi's own rapid-acting insulin analogue (which still enjoys patent protection, though its less likely able to command a premium given that both Humalog, and very soon Novolog will no longer have U.S. patent protection) known as Apidra (U-100 insulin glulisine rDNA origin), but it might help the company secure coverage on a few insurance company formularies.

Unlike Lilly and Novo, it does not sell all insulin varieties that it could be selling ... the company refuses to sell its old biosynthetic 'human' insulin regular and isophane sold under the brand name Insuman (I referred to that insulin brand in 2015, catch that post at http://blog.sstrumello.com/2015/01/2014-observations-in-type-1-diabetes.html for more) and I stand with my original thoughts on that.  For Sanofi, the formulary game is one the company has utterly failed at doing for anything other than Lantus.  Its more recent, higher-concentration (U-300 varieties) and combo insulin-GLP products simply aren't sufficient anymore.  Right now, it continues to offer HUGE rebates to pharmacy benefits managers (PBM's) and insurance companies to keep Lantus on many formularies.  Right now the company is selling it with discount cards, and while the price is somewhat lower than Humalog itself, its only marginally less expensive IMHO.  But when the primary means of selling it is via discount cards, then the longer-term business strategy is unclear to me.  Maybe it's just to compete with Lilly since Lilly has also lost patent protection for its only analogue?

As I noted already, it's somewhat less clear to me what the business objective for Sanofi is by introducing a Humalog biosimilar.  After all, offering Admelog COULD cannibalize Sanofi's own rapid-acting insulin analogue (which still enjoys U.S. patent protection, for the time being, anyway) known as Apidra (U-100 insulin glulisine rDNA origin), but it might help the company secure coverage on some insurance company formularies ... although the company still does not sell its old biosynthetic 'human' insulin regular and isophane sold under the brand name Insuman (noted above), which may be an impediment to getting on insurance company formularies.

As for the prospects of additional biosimilars, that is unclear right now.  I suspect that as patents expire for Novo Nordisk's Novolog (U-100 insulin aspart rDNA origin) which will be the next patent to expire, we could see biosimilar versions of that from both Lilly and Sanofi.  Merck and Mylan could decide to pursue copies as well.  We could potentially see biosimilars come from Novartis' Sandoz business unit, and while Israel's Teva is also a possibility, that company has some bigger management issues to resolve in the short-term.

But, as I wanted to see in 2006 (when I first started researching the issue), the era biosimilars is finally here.  The market dynamics are very different today from 10 years ago.  I would remind my readers that biosimilars are actually very different from non-medical switching (such as an insurance company forcing a patient who uses Novolog to switch to Humalog, which is NOT the same insulin).  In fact, so far, the incidence of complaints about biosimilars have been more about poor communications and patient confusion with patients asking if they have to switch from Lantus to Basaglar, for example, when they are really the same insulin.

Biosimilars are not generics and some patients may have issues with them.  For example, they use different vectors in culturing them, such as how Novo Nordisk uses yeast whereas Lilly uses bacteria in making insulin.  Also, each manufacturer may use different preservatives in their insulin formulations which can cause allergies in some patients, and they use different ampoule/vial shapes and/or stoppers), and the packaging colors may be different.  But the products are likely more similar than different insulin varieties are.

So far, I have NOT heard of as many reports of patient problems switching to/from biosimilars as I have with non-medical switching from one insulin variety to another.  Unfortunately, price cuts are also not as big as we've seen with traditional, generic small-molecule drugs.  But non-medical switching may be a tinderbox waiting to explode (see more at http://diabetespac.org/dpac-statement-non-medical-switching/ and http://www.keepmyrx.org/issues/non-medical-switching/ for detail) will be an ongoing debate and challenge, but I suspect (and sincerely hope) there will be fewer issues with the emerging market for insulin biosimilars.

Author P.S., October 12, 2018: There was news today based on securities filings in South Korea that Merck and co-development partner Samsung Bioepis will terminate its plan to introduce a (see more HERE for details) to introduce a Lantus (U-100 insulin glargine rDNA origin) biosimilar that was to be branded as Lusdana Nexvue) in the U.S.. For its part, Merck said absolutely nothing about it, but Samsung Bioepis was the one to disclose to shareholders that Merck had terminated its agreement on the product saying that Merck had canceled the development and commercialization partnership for the Lantus biosimilar, dubbed Lusduna Nexvue in the U.S. As a result, Merck paid Samsung Bioepis $155 million to cover the investment Samsung had made so far in the product, plus interest, a spokeswoman for the company confirmed.

A (Belated) Tribute to David Mendosa

I still have some trouble coming to grips with the fact that on May 8, 2017, the Diabetes Community (D-OC) lost one of the Diabetes Online Community's true pioneers and I'd say founders: David Mendosa (http://www.mendosa.com/ -- for the time being, anyway).  David passed away following a diagnosis of angiosarcoma in the liver -- which is evidently a type of cancer.  I think the fact that he passed away from something other than diabetes or its complications is a true testament to David's belief of living life to the fullest in spite of diabetes, which need not impede anyone, in spite of being dealt a pretty lousy hand in the proverbial card game of life.  He would have been proud that if something led to his death, it definitely was not diabetes.

David was out there online long before there even was a D-OC, and his wisdom and courage arguably paved the way for what has become a thriving virtual community of people with diabetes online, which is not limited to the U.S., but now has communities worldwide.  In the very early days of his ventures online, some of us knew him as "Rick" Mendosa, which was a name he used professionally when he first started writing about the formerly-taboo topic of diabetes, which was expected to be kept in the proverbial closet and not mentioned in public.  David changed all that, and he also legally changed his name to David in 2005.  I was fortunate enough to have met David several times over the years, and it was really an honor just to meet the man who paved the way for the D-OC before it even existed.  When he began, he was still living in California and he acknowledged that while he loved the climate in California, he later relocated to Boulder, Colorado in 2004, which he was quite fond of in part, because it was a college town with very open-minded people.

David had Type 2 diabetes, but he was a true reporter and dealt with only the facts, not the misinformation, rumors and innuendo about diabetes that was so prevalent online before him.  His accuracy and focus on diabetes of all varieties is something I really appreciated.  He also chronicled his experience with the very first FDA-approved GLP-1 inhibitor (Byetta) which he acknowledged did help him to lose a few pounds (but he was the first to acknowledge that it was not attributed solely to that, he and his efforts were a much bigger part of that, only that it helped out) whereas other Type 2 treatments actually inhibited weight management, and too many still do.

David was also a fan of low-carb solutions, which he felt made his life with diabetes (and many others) vastly easier, as he was fond of acknowledging that big insulin dosages can also lead to really big screw-ups, not to mention unwanted weight gain.  He was also quite candid about aging and the challenges that brought, but also the joys that brought, too.  Oh, and he was a fan of photography, too.

But there was far more to David than all of that, and above all else, he made a point of noting that no one solution is appropriate for everyone who lives with diabetes.  Finally, he was, like me, a fan of the science and facts, which I tried to build my own blog upon, and along with it, a formal acknowledgement that diabetes is an industry like others, which must be acknowledged for its plusses and minuses.  That also led me to the conclusion that regulators have a very big part to play in what treatment options are available, and that patients deserve a very big role in how that plays out.  But today, thanks to David's contribution, there's an acknowledgement that diabetes is first and foremost, a business, and diabetes has a well-deserved reputation as a growth industry. David was also the first to acknowledge that hucksters are targeting people with diabetes more and more with their scams and schemes, but I think because of him, there's now a perception that like all businesses, there are those which are ethical, and those which are not.  Sometimes it's a grey area, so caveat emptor.

I owe a great deal to David, and I like to think that I have kept my part of the bargain that David instilled in me, and hopefully added to the the role that we play in not only our personal health, but also that we can play an important role with regulators, too, even if they would prefer not to deal with us because it makes their jobs tougher to do!

That's not our problem, it's our obligation.  Please do not forget it!  David, thank you for your role in creation of the diabetes online community we know as of 2017.  You helped lay the cornerstone for this community, and you will be missed but not forgotten!

How Patient Advocacy Helped Persuade Medicare to Cover Dexcom

This week, there was some very good news from the Centers for Medicare & Medicaid Services (CMS) and the JDRF, notably for people with Type 1 diabetes who rely on Dexcom CGM devices.  Essentially, CMS has accepted FDA labeling for the system and will no longer prohibit coverage.

JDRF did a press release which can be seen at http://www.prnewswire.com/news-releases/jdrf-encouraged-by-medicare-decision-to-take-first-step-toward-coverage-of-continuous-glucose-monitors-for-people-with-type-1-diabetes-300390684.html.

Dexcom had its own release which can be seen at http://www.businesswire.com/news/home/20170112006146/en/Centers-Medicare-Medicaid-Services-CMS-Classify-Therapeutic.

This really began last year when Dexcom submitted a supplemental application to its existing FDA premarket approval to add a new indication for use of the Dexcom G5 Continuous Glucose Monitoring System, asking that it be officially approved for making insulin dosage decisions.

Previously, the Dexcom G5 was only approved to measure glucose in interstitial fluid as an adjunctive device meant to complement, but not replace, the information obtained from more traditional fingerstick blood glucose monitoring devices.  According to an FDA briefing document (see https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/UCM511810.pdf for more detail), the level of accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system is "close to, but not as good as, typical self-monitoring blood glucose meters in the U.S. market."

I agree with the FDA briefing document and won't use my Dexcom for dosing decisions, but some do and they find the trending info. CGM's provide to help in their decision-making.  But the Dexcom application request raised some questions as to whether the FDA would even agree to re-label the device.  At a hearing held on on Friday, July 22 2016, the FDA's clinical chemistry and clinical toxicology advisory panel voted 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits (see http://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-non-adjunctive-label-for-dexcom-g5-mobile-cgm-system-300302609.html for more detail) of the proposed new label indication would outweigh the risks.  Although the FDA is not bound by its advisory panels' votes, it often heeds their advice in making its decisions.

There was some patient activism involved in helping to persuade the FDA to re-label the device.  For example, in early July 2016, the diaTribe Foundation (see https://diatribe.org/sign-diatribes-letter-fda-supporting-use-cgm-insulin-dosing for the recommended letter text) began seeking signers for a letter it had drafted in support of the new indication Dexcom was seeking, and it aimed to get at least 1,000 signers to the letter (apparently, their letter was signed by over 10,000 people with diabetes and their families, see http://ow.ly/M69L3085eZb for more).  There were also advocacy efforts by the Diabetes Hands Foundation, Diabetes Daily, Diabetes Patient Advocacy Coalition (DPAC), the JDRF and others (Insulin Pumpers, for example).  Personally, I liked the diaTribe Foundation's letter, and I used that as the basis for my own comments on why I felt the new label indication was appropriate when I submitted my own comments to what was then an open-docket at FDA.  But, I think what was unique (and encouraging) about all of the efforts was the degree of spontaneous organization and collaboration amongst all the parties involved.  Instead of contradictions and bickering, most of the initiatives built upon the efforts of one another.

Just before Christmas 2016, we got a decision.  FDA agreed to expand the approved use of Dexcom's G5 Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment (insulin dosage) decisions in people 2 years of age and older with diabetes (see the press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm for details).  This was definitely something many patients with diabetes wanted to see happen, although maybe not for the reason of avoiding a fingerstick as some writers erroneously presume.  Rather, it's the implication the decision might have on securing Medicare coverage of the Dexcom G5 system.  Of course, an FDA label is one thing, but getting Medicare to cover these devices was an entirely different matter.  Medicare is huge, but is frequently difficult to work with and is sometimes unpredictable.

This week, the Centers for Medicare & Medicaid Services (CMS) re-classified therapeutic Continuous Glucose Monitors (CGM) as "Durable Medical Equipment" under Medicare Part B, which means that for some patients with diabetes who are on Medicare, they actually might be able to get coverage now.  It's not a blanket decision, but the direction seems clear.  Also, many insurance companies base coverage decisions based upon what Medicare does, so this might help some gain coverage with private insurance, too.

Here's the CMS link to the coverage details:  https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682R.html.

A downloadable document link to the full CMS Ruling No. CMS-1682-R can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf.

Changes in the Price of Insulin, In Graphics!

In September 2016, the media was flooded with stories about the rediculously expensive price of EpiPens, which is basically epinephrine used to treat severe allergies (such as when some people get stung by bees or encounter peanuts), as the pens cost more than $600 for a package of two.  The news was that the price of EpiPens had skyrocketed, which is a generic drug with an innovative delivery device that enables even people unfamiliar with doing so to give an epinephrine injection in order to rapidly address allergic reactions.  Prices for the devices had increased by 600% over the past decade.  Suddenly, everyone was remarkably empathetic to the persons who need to pay more than $300 for an EpiPen.  But as I already noted in my preceding post (see https://goo.gl/cWvNRz for my post), that incident was remarkably familiar to people who have to buy insulin, glucagon and supplies needed to manage diabetes.

I pointed to a Bloomberg article (see http://www.bloomberg.com/news/articles/2015-05-06/diabetes-drugs-compete-with-prices-that-rise-in-lockstep for that) which showed a sickeningly similar trend of dramatic price increases for insulin (especially) and other diabetes-care items.  The Washington Post finally addressed this issue with an article of their own (see https://www.washingtonpost.com/news/wonk/wp/2016/10/31/why-insulin-prices-have-kept-rising-for-95-years/ for the article), so did the Wall Street Journal (see http://www.wsj.com/articles/insulin-prices-soar-while-drugmakers-share-stays-flat-1475876764 for the article), and NBC News did so today (see http://www.nbcnews.com/business/consumer/insulin-new-epipen-families-facing-sticker-shock-over-400-percent-n667536 for the article).  [Finally, Business Insider covered the story on May 15, 2017, see their article at http://www.businessinsider.com/insulin-prices-increased-in-2017-2017-5 for more detail.]  One of the articles noted that one version of insulin carried a list price of $17 a vial in 1997 is now priced at $138 today. Another that launched two decades ago with a sticker price of $21 a vial has been increased to $255.

Since I've seen some stunning charts and graphs in these articles, I thought it might be worth sharing the story ... graphically.  The images below are courtesy of Bloomberg and The Washington Post, the WSJ and NBC News, but paint a graphic picture of what's become of the insulin market in recent years.  The trends are even more stunning with these graphics!  Note that if you click on many of the charts, that will take you to the original articles.

On April 8, 2016, NPR's Science Friday covered the rising prices of insulin in a segment entitled "Diabetes Drug Prices Tripled in a Decade" (listen below, or by visiting http://bit.ly/2mlI95Z for the story).


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Obviously, the trend from biosynthetic "human" insulin to patent-protected insulin analogs was part of story, but those patents are all expiring.  The biggest-selling basal insulin known as Lantus (U-100 insulin glargine rDNA origin) will see the first knock-offs being launched by the end of 2016, and CVS has already pulled Sanofi's costly basal insulin from next year's formularies.  Although I hadn't anticipated biosimilars coming from other big pharma players, the fact is that pharmacy benefits managers including CVS, Express Scripts and United Healthcare's own OptumRx unit (which bought Catamaran in March 2015, see the news at http://www.wsj.com/articles/unitedhealth-to-buy-catamaran-for-12-8-billion-in-cash-1427709601 for more) are now pushing for lower prices, and getting them.  This has hurt players like Novo Nordisk very badly.  The only problem is that the lower prices they're getting come from rebates, so the discounts are invisible, meaning they're done without any changes to list prices for insulin.

That's good for big payers, but not so good for the rest of the market.

American Public Media's Marketplace had a great radio segment dedicated to this topic.  See below, or visit http://www.marketplace.org/2017/01/31/world/drug-makers-insulin-accused-price-fixing:

At least one law firm is seeking to have its case against the big 3 insulin makers classified as a class action, and if that happens any insulin user can be a part of the class, so stay tuned for more. For more detail, visit the following website: https://www.hbsslaw.com/cases/insulin-overpricing.

Novo's Ills Are Indicative of Something Other Than A Free Market for Insulin

As I've already addressed, a few weeks ago (see my post at http://blog.sstrumello.com/2016/08/the-business-of-diabetes-cvs-caremarks_5.html for more), Novo Nordisk's CEO Lars Rebien Sorensen rather unceremoniously announced he was retiring early (see http://fortune.com/2016/09/01/novo-nordisk-ceo-retire-insulin/ for more) which was kind of an acknowledgement that the era of easy price increases for its products in the U.S. is over.  Already, CVS Caremark and United Health announced that they are dropping Sanofi's Lantus in favor of biosimilar versions from Lilly/Boehringer or Merck/Samsung, and there's reason to presume that biosimilars will pressure Novo's products even more.  This week, Novo also announced it was taking the very rare step of laying off approximately 1,000 employees, something the Danish company has almost never done, including about 500 people in its R&D department.

When a reporter asked him if that meant the company was cutting into the bone of the company, rather than the fat, the response he gave was rather interesting:

"The next line of products have to have an even greater height of innovation, which means those that do not have that height of innovation will have to be culled," Soerensen said. "Otherwise, it's going to be difficult for us to get reimbursement for our drugs. Me-too or me-better drugs will not be good enough in the future and hence we need to prioritize."

That kind of sounds like an acknowledgement (to me, anyway) that some of its newer products, most notably Tresiba (U-100 insulin degludec rDNA origin) is acknowledged even by the current leadership to be a "me-better" product, rather than anything really truly innovative.

Indeed, Jeremy Greene, an associate professor at the Johns Hopkins University School of Medicine said "If any drug should be available generically, it should be insulin." adding the new insulins are "not so much better that it justifies the presence of people who can't afford any drug."

In August, the $#!t hit the fan over EpiPen price increases.  In effect, the price of the EpiPen, which treats emergency allergic reactions and things like bee stings, but is not really a drug that must be taken daily, had climbed sixfold over the last several years. At drug price-comparison website GoodRx, the cheapest price at the time was $614 for a package containing two, or more than $300 per EpiPen, up from about $100 for two EpiPens not too long ago.

The story was an all-too-familiar one: a company buys an old drug that no one else makes anymore, raises prices and impedes patient access to life-saving treatment in the process.  We saw a similar situation when "Pharma Bro" Martin Shkreli made news a few weeks earlier.  As the then-CEO of Turing Pharmaceuticals, he acquired an old anti-parasite medication called Daraprim and immediately increased the price from roughly $13.50 to $750.  He seemed to relish in giving his middle finger to people impacted by the decision.

In the case of the EpiPen, the target of that tired narrative was a medical device with an unusual amount of brand name recognition, no real alternatives and a growing patient population — Mylan Inc.'s EpiPen.  Epinephrine is a generic medicine, and is widely available but the delivery device (in this case, a pen) was unique and made it easy for people who aren't medical professionals to administer.

People with diabetes kind of looked at all the news and thought to ourselves "So what? Welcome to the club, EpiPen folks ... have you seen the insane prices of insulin lately?"  Of course, we didn't have much data to back it up, and since most people really have no clue what the real prices are for medicines we rely on, its a pretty tough claim to substantiate.

But earlier this year, Bloomberg had an interesting article entitled "Hot Drugs Show Sharp Price Hikes in Shadow Market" [http://www.bloomberg.com/news/articles/2015-05-06/diabetes-drugs-compete-with-prices-that-rise-in-lockstep] which interestingly enough, looked at insulin prices.

On May 30, 2015, the price for a vial of the blockbuster diabetes medication Lantus (U-100 insulin glargine rDNA origin) went up by 16.1%. On the very next day, Lantus's only direct competitor, Levemir (U-100 insulin detemir rDNA origin), also registered a price increase -- of precisely 16.1%.

The pattern repeated itself six months later when Lantus, from French drugmaker Sanofi, was marked up 11.9% percent, and Levemir, made by Novo Nordisk A/S, matched the price increase again exactly.

Clearly, this is not how competitive, free markets are supposed to work.

I should acknowledge that insulin was definitely not the only type of medicine to exhibit this type of price inflation.  But it is indicative of a market that is definitely not a competitive one, not exactly a free market.

Some of this comes directly from Bloomberg, but its worth sharing with the diabetes community.

Is this price-matching a coincidence?  I think not.

Bloomberg's analysis revealed that in 13 instances since 2009, prices of Lantus and Levemir -- which dominate the global market for basal insulin with approximately $11 billion in combined sales -- had gone up in tandem in the U.S., according to SSR.

The article also discusses the shady world of "shadow pricing", and rebates given to big payers and how prices outside the United States, which arguably subsidizes the rest of the world with the prices paid.  Ironically, the drug and biotech industry lobbied very hard to prevent one of the biggest payers in existence, Medicare, from negotiating drug prices under the Medicare drug benefit signed into law by President George W. Bush.  Most other countries have price controls, or at least are able to negotiate based on how much they are buying.

For example, in Germany, almost every German belongs to one of some 160 nonprofit "sickness funds," or nonprofit insurance collectives. The sickness funds cover both medical visits and prescription drugs. Drug prices there are already lower than in the U.S. because sickness funds negotiate with both physician groups and drug manufacturers to set costs of all treatments across the board. But in the U.S., Medicare isn't even allowed to negotiate lower drug prices.

As for prices, Sanofi and Novo "are taking the same price increase down to the decimal point within a few days of each other," said Richard Evans, an analyst with SSR. "That is pretty much a clear signal that your competitor doesn't intend to price-compete with you."

A pattern of insulin makers matching each others price increases “certainly indicates a market that isn’t competitively healthy,” said David Balto, an antitrust lawyer and former Federal Trade Commission policy director. However, if two companies act independently to follow each other’s price increases, it’s not an antitrust violation, he said.

But Lilly, which once dominated the U.S. insulin market with an estimated market share of 85% for insulin sold in the U.S. back in 1985, basically ignored the diabetes business as it pursued neuroscience with drugs like Prozac and Zyprexa.  Lilly had to partner with the German drug company Boehringer Ingelheim for most of its newer diabetes medicines, but since bringing in Enrique A. Conterno to run the diabetes business a few years ago, has suddenly started appearing on more drug formularies than it has in years.  But Lilly's willingness to compete on price, at least with some big payers like United Healthcare and Kaiser Permanente, doesn't mean retail prices are likely to show any decreases.

For their part, drug manufacturers like to keep prices as secret as possible.

"How much a patient pays is based on a negotiation between the payer and the pharmacy," said Ken Inchausti, a Novo Nordisk spokesman. He said the company couldn't comment fully without knowing details of a patient's health plan.

Have a look at this video (see below, or by visting http://bloom.bg/1IjpdgL for the link).



Author P.S., October 8, 2016:  The Wall Street Journal acknowledged big price increases for insulin but seems to lay responsibility for the increases on drug wholesalers like McKesson and AmerisourceBergen for the price increases, not the manufacturers who offer PBMs big "rebates" which reduces the end prices paid for by insurance companies.  For details, refer to the article at: "Insulin Prices Soar While Drugmakers' Share Stays Flat" http://on.wsj.com/2dl1znP

A Tribute to Kathy Putzier

It seems like these days, half of my posts are tributes (actually, its true, though I have a few others mixed in), and today, unfortunately, will be another one.  This one is for Kathy Putzier.  Her sister Joan Meece shared the news on Facebook on Wednesday, August 17, 2016, so I presume the actual date was sometime around that, although details are still trickling in right now.

One irony, which I think perhaps Kathy would have appreciated, is the fact that another person also named Kathy Putzier who was also from the Twin Cities area passed away around the same time, although the other Kathy was 82 years old, so it definitely wasn't the same woman that the diabetes community knew and loved, as the Kathy Putzier we knew was just 63 years old.

Early d-bloggers knew Kathy first as "Minnesota Nice" (not a bad term based on my knowing her!) and her blog was known as "Purple Haze" (see http://kathy4762.blogspot.com/ for her archived posts).  In 2012, Kathy decided to devote her time to other pursuits, so she decided to stop blogging, although I believe she remained pretty active on TuDiabetes, which was the place she decided to continue her online diabetes work.

Like me, Kathy was one of the earlier members of the d-blogging community as a person with Type 1 diabetes, and many in the Minneapolis area including Scott K. Johnson and others had met up her quite a few times.  No doubt, their sense of loss is bigger than mine.  But a few years ago, I went to Minneapolis for a long weekend (I think it was Memorial Day weekend), and Kathy and I were going to try and get together that weekend (I did get to reconnect that weekend with Allison Nimlos during that visit, which was great, but others like Scott Johnson were out-of-town that weekend).  As things sometimes happen, when Kathy and I spoke on the phone, the timing just did not enable us to meet in person during that visit, as she had some family activities going on that weekend, too.

As a result, my memories of Kathy were mainly of her personality expressed online, which I think were a genuine representation of her as a person ("Minnesota Nice" was a good name, based on my phone conversations with her!).  Kathy was also dealing with some kidney problems, although I don't know for certain if that was the cause of death for her, but as someone who was also diagnosed in the so-called "dark ages" of diabetes care a few years before me (she was diagnosed in 1973, I was diagnosed in 1976), so also she saw the evolution -- and in some cases, the de-volution, of diabetes care, just as I have over the years.  We would sometimes reminisce about those days, which as I've blogged in the past, are not quite as terrible as many newcomers to the world of Type 1 diabetes have been taught to believe (catch my post at http://goo.gl/UQRIfK for more details).

Kathy with World Diabetes Day postcard (I think!)

Kathy and some Minneapolis D-friends.

Kathy (second in on the left side) and the Minneapolis D crowd.

Kathy circa 1975. She looked pretty much the same in 2016!

Anyway, this was an event from this week, although I haven't yet found an obituary for Kathy, as details become available, they can be found on TuDiabetes.  Kathy's Facebook page was at https://www.facebook.com/kathy.putzier though if you weren't already Facebook friends with her, I think it might be too late.  Also, a tribute page was created for her on TuDiabetes at http://www.tudiabetes.org/forum/t/share-memories-of-kathy-putzier/55526 which you can check out.

I'm sorry to hear about Kathy's passing, but just as I noted in my post a few weeks ago about Kitty, I know that today, Kathy is now in perfect health and can look down at her vast network of friends here on earth and smile at how many are missing her now.  Kathy, I'm glad to have known you, even if it was mainly online!

The Business of Diabetes: CVS Caremark's Salvo in Biosimilar Insulin for 2017

Its already mid-2016, and for nearly the past decade, I've been pushing for so-called "biosimilars" or "follow-on biologics" like insulin to be legalized and then introduced in the U.S. (I first investigated this issue back in 2006, and published an article on it in January 2007). The reality is that without any form of generic competition, prices continue to rise with absolutely nothing to stop them.  In recent years, there have been some hyper-aggressive price-increases from the insulin oligopoly, especially within the last 3 years or so.  The reason: they all KNOW that their insulin analog patents are about to expire soon, so they've made a shameless money-grab with huge price increases before that happens.  The retail cost of a vial of insulin is now over $125 a vial, and that's for old varieties like Regular or NPH which have been on the market for like 95 years.  I haven't even bothered to price insulin analogs!

The Affordable Care Act (a.k.a. "Obamacare") finally legalized biosimilar medicines in the U.S. Before that, there was a lot of complaining and bellyaching from pharmaceutical and biotechnology companies that there was no regulatory pathway, which was only true for some newer biotech medicines.  Because insulin was the very first biotech medicine ever approved by the FDA, its grandfathered under the law as a "small-molecule" drug (along with human growth hormone, another very early-generation biologic medicine), so there was no legal impediment for biosimilars.  Consider the case of a very early biosimilar version of human growth hormone known as Omnitrope, which was approved on June 1, 2006, several YEARS before the Affordable Care Act was passed into law on on March 23, 2010 and later implemented in 2011.

The industry bellyaching was more excuses than anything else as far as insulin was concerned.  Frankly, there just wasn't very much incentive from pharma to pursue biosimilar insulin products like Regular and NPH because most American patients were already being switched to more expensive, patent-protected insulin analogs.  But its now fair to presume that this particular money tree has just dropped its last leaf for the likes of Lilly, Sanofi and Novo Nordisk.  The real question is how patients with diabetes will be impacted?

On Monday (August 2, 2016), Express Scripts notified (see HERE for the news) its PBM customers that starting in 2017, 85 medicines would be excluded from its national formulary, and, as a result, that company anticipates about $1.8 billion in savings, up from $1.3 billion in 2016.

Then, the very next day [on August 3, 2016], competitor CVS, which is a large retail pharmacy with an equally large pharmacy benefits manager (PBM) business named Caremark (which competes directly with Express Scripts) levied the first salvo in this battle, announcing that it would recommend to its PBM clients that they drop Sanofi's Lantus (U-100 insulin glargine rDNA origin) from their formularies.  (See the news HERE).  Realize that PBM corporate clients are under zero legal or in many cases even contractual obligation to do so, and they can certainly choose to continue covering Sanofi's U-100 Lantus if they wish.  But as a practical reality, given the big cost-savings expected from following the recommended PBM formularies, most companies will likely follow Express Scripts' and CVS Caremark's recommendations.

CVS Caremark wrote to its PBM clients "CVS Health is taking a stand against egregious drug price increases that unnecessarily add costs for clients and their members.  On a quarterly basis, products with egregious cost inflation that have readily available, clinically appropriate, and more cost-effective alternatives may be evaluated and potentially removed from the formulary."

There was some murmur from people with diabetes about another choice being taken away from them, especially since formularies have become ever more aggressive in pursuit of lower prices for "therapeutically equivalent" medicines in recent years.  For example, over the last 7 years, my employer's insurance company PBMs have switched from Lilly Humalog (U-100 insulin lispro rDNA origin) to Novo Nordisk Novolog (which known as Novorapid in many other markets, but is U-100 insulin aspart rDNA origin) back to Lilly, back to Novo Nordisk, and back to Lilly over a few years.  I just got tired of routine switching to similar, but not identical, insulins that require new ratios and testing to make the switch to a new brand of insulin happen (insurance fights to give me any more test strips as it is).  True, one of the brand switches involved a switch to new insurance carrier, but the point was that I was being treated like a ping pong ball, and I grew tired of routine annual switching to save the insurance company money while my co-pays go up, so I pushed my endo to challenge the switch to slow-mo-log (slow motion from Novo), and after a few appeals, I did manage to get my way.  But that should not have happened, what doctors prescribe is supposed to based on medicine, not necessarily costs unless patients have a need.

I made a number of comments to the FDA on labeling and the like when the docket opened for biosimilars a while back, and I think FDA has tried to incorporate patient concerns into its final guidance.  But the business environment is something FDA has very little control over.  The CVS Caremark move to drop Sanofi's Lantus from its 2017 formulary is an acknowledgement that big pharma has gotten a little too greedy with the price increases.  I would add that market share leader Novo Nordisk has started paying a price for it.

When Novo Nordisk announced its earnings today (on August 5, 2016), the company's shares fell by 8% after Novo cut its forecast for 2017 full-year profit growth, and said it expected tough competition in the U.S. to pressure prices next year.  As a point of reference, Novo Nordisk gets around half its revenue from the U.S.

Diabetic Investor David Kliff has been warning of this for several years, arguing in 2013 that:

"The insulin market, both short and long acting, is transforming itself into a commodity market where price trumps performance. The GLP-1 is also undergoing this transition albeit at a slower rate."  He was also quite critical of Novo Nordisk management for naïvely believing that it could maintain very aggressive prices/price increases for its products faced with the genuine possibility of "generic" (biosimilar) competition for the first time.


Today, Novo Nordisk chief executive Lars Rebien Sorensen told investors "In the USA, the market environment is becoming increasingly challenging and contract negotiations for 2017 have reflected an intensifying price competition."


"Because of competition and biosimilar entries, we've had to increase our rebates to retain that level of access in the marketplace," Soerensen said by phone on August 5, 2016 (see HERE). "In reality, the only way you can insulate yourself from pricing pressures are by, long-term, introducing new and better products."

Meanwhile, rival Lilly, much as David Kliff told investors in 2013, anticipated that the insulin market was transforming into a commodity business, and in recent years, Lilly has aggressively competed on price to win a spot on various insurance company formularies ranging from Kaiser Permanente to United Healthcare.  Previously, Lilly hadn't paid very much attention to insulin, and that lack of attention allowed rival Novo Nordisk to usurp Lilly insulin from so many insurance company formularies.  But in December 2016, Lilly and its German partner Boehringer Ingelheim will introduce their own Lantus biosimilar (U-100 insulin glargine rDNA origin) branded as Basaglar.

Lilly isn't alone, either.  Rival Merck (along with its South Korean partner Samsung Bioepis) will also introduce a Lantus biosimilar, too.  Although they haven't yet come up with a brand name or logo yet, its Lantus biosimilar is now called MK-1293, which received the same FDA pre-approval as Basaglar did a a while ago (see the news HERE and HERE) and both Lilly and Merck's versions of Lantus are expected to compete aggressively with Sanofi's Lantus on price, hence CVS Health (Caremark) will have a few new choices for the best-selling insulin Lantus that it never enjoyed before.  The thing is, these are biosimilars, which are better than "therapeutically equivalent" switches that insurance has routinely put patients through recently.  But Lantus is merely the first and biggest insulin; products like Humalog, Novolog, Levemir and Aprida all face patent expirations soon.

Other potential competitors for biosimilar insulin include the Sandoz generics unit of Novartis, as well as Israeli drug giant Teva.  Although I did not anticipate competition coming from fellow big pharma giants like Merck and Lilly, the day of biosimilar insulin will indeed be here in early 2017.

For me, the main issue is not who makes the insulin, but the insurance companies routine switching that is starting to get on my nerves!

Update, September 1, 2016:  The news that Novo Nordisk's longstanding CEO, Lars Rebien Sorensen will retire early (at the end of 2016) was a direct result of pricing pressures mounting for the company (see HERE for more), as noted above.  Novo is much more reliant on fat profits from the U.S. even though it operates worldwide, profits outside the U.S. are much smaller.  The recent news is something of acknowledgement that the era of easy profits from the U.S. are going to be much harder in the future as large U.S. payers flex their muscles as described above.

Update, September 22, 2016:  In addition to PBM CVS Health (Caremark), there was news today that United Healthcare will be dropping Sanofi's Lantus (U-100 insulin glargine rDNA origin) from its formulary (see the news at HERE for more detail).  As the giants like CVS and United Healthcare drop costly insulin varieties, 2 possible responses could occur: either more follow suit, or Sanofi gets aggressive and lowers its prices.

Foracare TN'G Voice Meter: Great Option for PWD's With Visual Impairments (others, too!)

I pretty much limit my diabetes blogging these days, except when I think there's something REALLY important or unique to share, although much of what I began with now has several nonprofits and organizations to advance the issues.  Most of my diabetes-related stuff these days can be found on my Twitter feed, which is updated pretty much daily.  Still, when I need more space to share information, this blog is still where I turn.

As I last blogged a few weeks ago (see http://goo.gl/mi5nEm for my post), I was very sorry when my good friend Kitty Castellini passed away, not from diabetes or diabetes-related issues, but from a type of cancer.  Her passing is truly a loss for the broader diabetes community.  That's one reason I'm dedicating my post for today to her.  Kitty was unique for her concern about some under-served segments of out community, and I thank Kitty for that!  Incidentally, I did tell Kitty about this before she passed (or more specifically, I told her husband to share the news with her, but she was already pretty ill by that time, but I hope she was pleased to learn of it -- I think she would be).

Several years ago (in 2010), a bunch of us attended a diabetes social media conference which if I recall correctly was hosted by the pharma and medical device giant Roche (I think the one was held in Indianapolis).  One of the heated discussions that came up in that meeting was one that Kitty demanded to know more about: what the company was doing about blood glucose meters for the visually-impaired.

Mike Hoskins, yours truly, and Kitty at a  conference in 2010

Virtually all of the big manufacturers including Roche, Johnson & Johnson, Abbott, the former Bayer unit (now known as Ascensia Diabetes Care if I'm not mistaken) and others have basically abandoned that market, even though they all have a social obligation to do so in my opinion.  Kitty was the ONLY person at the event to raise that issue at that meeting, and Roche really had no good response.  Still, the visually-impaired market is a relevant and important segment, its just that the big manufacturers don't see a social obligation to serve that market I guess.  That, I think, was a good example of the kind of person Kitty was: concerned for others in the diabetes community.

Anyway, I seldom (if ever) review products because that's never been why I started blogging in the first place.  But a few weeks ago, I received an email from a company trying to compete in the blood glucose testing space, and what intrigued me about the product was not their mobile phone apps or even their meter's Bluetooth capabilities (even though those are interesting), but the meter's audio which indeed enables the visually-impaired (and others) to test their blood sugar levels by themselves and to know the results without assistance from someone with vision.

The company is called Foracare and they have U.S. headquarters in California, although they manufacture their products offshore (the product I tested was made in Taiwan, not mainland China, which is interesting itself).  Specifically, I tested the product called the Foracare TN'G (for Test N' Go) Voice blood glucose meter and test strips.

The basics of the product are pretty standard, although I compared the results to both meters by Roche and Johnson & Johnson, and guess what?  The results were pretty darn close, and that presumes that the Accu-Check or OneTouch meters are any more accurate to start with, which is actually a big presumption in the first place.

Suffice to say, I felt the accuracy of this meter and strips was quite good, and compared very closely to other major brands now on the market.  More importantly, however, is the fact that test results are read aloud to the user in audio, which I told the company I thought was a relevant fact that they were not marketing previously (now, they are!).  I also gave some feedback on apps which weren't specific to theirs, but apps generally, and my take is that an app isn't useful unless it either does something that cannot be done now, or saves on the laborious data-entry process that's expected of the diabetes population.  As I understand it, the Bluetooth capability also enables the results to be transmitted to a smartphone, though I did not test that as I wasn't really interested in that product feature.

All said, I would say that this product would definitely serve the needs of the visually-impaired diabetes market very well, and the accuracy is comparable with the big brands.  Also, the product is not only a viable competitor to big-name brands, but the company seems interested in what patients are asking for, at least from what I've seen.

I did struggle a bit with the audio defaults myself (then again, my hearing isn't the greatest, so not everyone will have difficulty with this), and it IS possible to increase the volume that readings are given to users, although its buried on page 14 of the manual http://www.foracare.com/testngo/FORA-TNG-Voice-manual.pdf) so just beware of that.  I would say that a CDE or doctor's office may be able to assist patients with a legitimate need, but once I figured that out, I was pleased.  At present, the audio options are available in English and Spanish (sorry for my Canadian friends seeking a Francophone option right now).  In fact, there's a button inside the battery compartment that enables you to adjust the volume and some other settings, just push that a few times and volume comes up there) Still, this is a hugely under-served market, and having a product available today serves an unmet need that was (and still is) all but ignored by the big manufacturers.

I did ask at the Roche Social Media summit a few years ago about Bluetooth capabilities, and they suggested that does seem to be the direction that meter manufacturers seem to be moving, which would to enable any Bluetooth-enabled meter to feature vocal applications, technically, anyway), although no company I am aware of has yet enabled this basic feature.  Frankly, that seems kind of like a lame excuse for a business decision to abandon the visually-impaired market.

However, in all, I am very comfortable recommending the Foracare TN'G Voice blood glucose meter and test strips to people with diabetes (PWD's) who are visually-impaired.  Its accuate, and the product offers something no big manufacturer does: the meter reads in audio the test results to the user.

That said, what about the meter and strips themselves?

Well, no calibration is necessary (thankfully that seems to be most all strips/meters these days, the fact that it was ever required was because manufacturers were lazy FYI), and the sample size required is tiny (0.5 microliters), plus it takes just 5 seconds or so to get a reading.  Again, most of that seems to be pretty standard these days, at least from big meter companies.  The Bluetooth app is an interesting, and potentially valuable, feature, but it does require the readings to be uploaded to the manufacturer-hosted site, and I have not investigated whether results can be downloaded into a spreadsheet or csv file, an area of ongoing frustration for PWD's.

As for insurance coverage, that seems to be an area the manufacturer is still working on.  But, I do believe that all insurance companies must offer coverage for a meter with audio if a person is visually-impaired regardless of the formulary brands under a plan (in other words, if a formulary brand doesn't have a meter the blind can use, they're obligated to cover one that blind patients can use).  How that is handled via appeals and the like, I'm not terribly familiar with, but as I understand it, its guaranteed under Federal law (imagine an insurance company that would not cover a wheelchair for someone who could not walk ... that's the equivalent in this case, of not covering a meter and strips that will read test results for someone who is blind), but for others, I think some work remains in terms of coverage for other insurance plans, so just beware of that, and I have not investigated Medicare issues, although aside from the mail order issue that DPAC http://diabetespac.org/ is already working on (search for the campaign to "Suspend Medicare's Competitive Bidding Program For Diabetes Testing Supplies"), gaining coverage via insurance is a more laborious process for the company.

I should also note while I'm on this subject that there is another meter/test strip brand that offers speaking meter that provides audible test results.  A press release came out  in 2013 about  (see the release at http://bit.ly/2b74UIN for more details).  Its called the Gmate® VOICE system from a company called Philosys, Inc. based in South Korea, and they have a webpage with details about their voice meter which can be found at http://www.gmate.com/voice.  I have personally never tried that meter, so I can't comment on it, and I also don't find their test strips in pharmacies anywhere although I believe they are actively selling it outside the U.S., but I can't really comment on how easy or difficult it may be to get their products, but readers may be interested in knowing it exists.

In short, I realize PWD's pretty much choose the formulary brands because there's a huge financial incentive to do so, but for people with visual-impairment today,  the Foracare TN'G Voice blood glucose meter and test strips is a great option.  In the future, once they get on Medicare's and various insurance company formularies, others may opt for these products, too.  They are quite accurate and good quality, too.