How Big Insurance, PBMs, the FDA, Congress and AstraZeneca made me pay so much for my inhaler.

The piece I wrote last week about the high cost of breathing for many Americans, including me, prompted calls and emails and turned out to be more timely than I expected. 

As I noted, my Medicare Part D pharmacy plan required me to pay $606.00 for a three-month supply of Symbicort, one of the leading inhaler brands. What I have learned is that the cost of inhalers for people in the U.S. with asthma (25 million), COPD (16 million) and other respiratory issues has been increasing rapidly, in large part because of the unavailability of approved generics. And insurers and their PBMs, largely useless when it comes to health care price increases, punish people who need inhalers by making them pay more and more every year out of our own pockets. 

Well, a new study just published in Health Affairs helps explain why those costs keep going up: The vast majority of all inhaler products approved by the FDA since the mid ‘80s have been brand-name products with years of patent protection. 

As the Regulatory Affairs Professionals Society wrote about the study, brand-name inhaler manufacturers “have successfully used patent hops, cross-listed patents, and other nonpatent regulatory exclusivities to keep generic manufacturers out of the U.S. inhaler market over the last 35 years.” 

According to the study’s authors, “85 percent of the products approved by the FDA since 1986 were brand-name products, with a median of sixteen years of protection from generic competition.” Another key finding: 

“Manufacturers often shifted ingredients from one delivery device to another, obtaining new patents and thereby extending their market exclusivity. Among products where such “device hops” occurred, the median time from approval of an originator product to the last-to-expire patent of follow-ons was twenty-eight years.”

Oy.

But I did come across a bit of encouraging news: the FDA has finally approved a generic version of AstraZeneca’s Symbicort. Mylan Pharmaceuticals got the green light a couple of months ago to market what will be called Breyna, although, as GoodRx noted, the company hasn’t said exactly when it will be available, although hopefully sometime this year. 

That doesn’t mean, however, that insurers and their PBMs will cover Breyna and pass the savings on to those of us who like to breathe. That’s because insurers/PBMs often cut deals with brand-name drug makers and refuse to provide any coverage for cheaper generics. That’s your middlemen at work, folks. It’s how they make the big bucks. 

But if you can’t wait for Breyna to be available–and for your insurer/PBM middleman to do the right thing (do not hold your breath)–you might want to order your next inhaler from countries like Canada and New Zealand that have discovered it is possible to get by without those middlemen. 

I checked with a couple of sources–PharmacyChecker.com and DrugStoreUnlimited.com–(I know the founders of both) and found out that I could save a bundle by having my future inhalers mailed to me from lovely places like Vancouver and Christchurch. DrugStoreUnlimited told me I could get a three-month supply of my Symbicort inhaler from New Zealand for $286.03 ($319.97 less than what my WellCare Part D plan would make me pay). I could also get a three-month supply of a generic version from Turkey for $174.04. That’s right. There are generic versions of Symbicort, just not here (yet) in the U.S.A. Other countries’ drug approval people moved faster than ours to approve a generic version. 

One of my subscribers, Dan Kass of the HealthCare Shopping Network, wrote to say he had saved hundreds of dollars by ordering his Lipitor from Canada. He told me he could get a three-month supply of Symbicort for $220, depending on the dose. Gabe Levitt of PharmacyChecker showed me I could get my Symbicort from Canada or New Zealand for as low as 29 cents a dose, compared to the $1.68 a dose CVS and WellCare would have me fork over. 

Bottom line: you can get a better deal on many if not most medications by ordering them from our allies abroad, even if you have health insurance (unless you’ve already spent so much out-of-pocket you’ve met your deductible for the year). And know that many of the drugs we Americans take every day are made outside of the U.S.

(Note: the FDA has occasionally intercepted medications being shipped to Americans from abroad, as Tarbell reported in 2018, but I’m told the interceptions are rare. The folks at HealthCare Shopping Network told me the feds haven’t bothered them since they poked around their Canadian MedStore locations in Florida in October 2017.)

What happens (or doesn’t happen) on the House floor

Another reader–a former Republican congressman and friend of mine–took exception to some of the details in my inhaler story last week, specifically about the “shenanigans” another former Republican congressman said happened in the wee hours of the night back in 2003 when Congress was debating the bill that established the Medicare Part D program. 

He said he did not see lobbyists on the House floor twisting arms to get the bill passed or that Congressional leaders “froze” the C-SPAN cameras while the alleged arm-twisting was taking place. I first wrote that both reportedly happened in Nation On The Take, How Big Money Corrupts Our Democracy And What We Can Do About It. I quoted former Republican Rep. Dan Burton of Indiana as saying, “A lot of shenanigans were going on that night that they (House leaders) didn’t want on national television.”

(As I wrote in Nation on the Take, “Lobbyists who previously served in Congress had floor privileges until the enactment of the Honest Leadership and Open Government Act of 2007, which was passed in the aftermath of the Jack Abramoff lobbying scandal.)

I wasn’t on the House floor that night or even in the visitors’ gallery, so I can’t speak from personal knowledge. My main source for the alleged shenanigans was a 2007 60 Minutes segment entitled, Under the Influence. 

My former Republican congressman friend reminded me that, despite the shortcomings of the Medicare Modernization Act of 2003, it did make prescription drugs more affordable for millions of American seniors. Prior to the passage of that bill, most seniors had to pay the full retail price for their medications. 

Even he acknowledges, though, that many Medicare beneficiaries have to pay far too much out of their own pockets for often life-saving medications. He supports efforts to reduce and cap out of pockets for most prescription medications, as does the Lower Out-of-Pockets NOW Coalition, which (full disclosure) I lead.