Monday, November 19, 2018

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 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 with the actual report found at

DiabetesMine first addressed my idea at and its worth re-visiting.  The Diabetes Patient Advocacy Coalition (DPAC) has coverage of the report at while T1D Exchange (the folks who run Glu have also chimed in on the topic 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 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?!

No comments: