Sen­ate health com­mit­tee in­ves­ti­gates in­haler man­u­fac­tur­ers for high prices

Sen­ate De­moc­rats on the health com­mit­tee are press­ing in­haler man­u­fac­tur­ers over their high US prices and how they’ve used the patent sys­tem to main­tain ex­clu­siv­i­ty, ac­cord­ing to let­ters sent to As­traZeneca, Boehringer In­gel­heim, GSK and Te­va on Mon­day.

Sen­ate HELP com­mit­tee chair Bernie Sanders (I-VT), along­side top De­moc­rats Tam­my Bald­win (WI), Ben Ray Lu­ján (NM) and Ed Markey (MA), au­thored let­ters to As­traZeneca, Boehringer In­gel­heim, Te­va and GSK grilling the com­pa­nies on why they charge be­tween $200 and $600 for their in­halers. The sen­a­tors as­sert that the four com­pa­nies have ma­nip­u­lat­ed the reg­u­la­to­ry sys­tem to fend off gener­ic com­pe­ti­tion and rake in more rev­enue.

“There is no ra­tio­nal rea­son, oth­er than greed, as to why Glax­o­SmithK­line charges $319 for Ad­vair HFA in the Unit­ed States, but just $26 for the same in­haler in the Unit­ed King­dom,” Sanders said in a state­ment. “It is un­ac­cept­able that Te­va is charg­ing Amer­i­cans with asth­ma $286 for its QVAR Redi­Haler that costs just $9 in Ger­many. It is be­yond ab­surd that Boehringer In­gel­heim charges $489 for Com­bivent Respi­mat in the Unit­ed States, but just $7 in France.”

In the 13-page let­ters, the sen­a­tors note that 20 mil­lion adults and more than 4.5 mil­lion chil­dren in the US live with asth­ma, and 16 mil­lion adults have chron­ic ob­struc­tive pul­monary dis­ease.

In­haler man­u­fac­tur­ers for years have main­tained ex­clu­siv­i­ty by suc­ces­sive­ly re­leas­ing new in­haler prod­ucts that dif­fer slight­ly from pre­vi­ous ver­sions, dis­qual­i­fy­ing pre­vi­ous au­tho­rized gener­ics.

But GSK switched it up last year when it an­nounced plans to dis­con­tin­ue the brand-name ver­sion of its asth­ma med­ica­tion Flovent and fo­cus sole­ly on its au­tho­rized gener­ic, con­ve­nient­ly com­ing ahead of the Med­ic­aid re­bate cap lift­ing Jan. 1 of 2024.

The sen­a­tors give the com­pa­nies un­til Jan. 22 to re­spond to ques­tions about how they set their in­haler prices.

Specif­i­cal­ly, the sen­a­tors ask for de­tails on the vol­ume and cost of goods sold and the rev­enue gen­er­at­ed by pay­er type. They al­so ask for prices paid by each of the 10 largest com­mer­cial health plans and the five largest phar­ma­cy ben­e­fit man­agers.

De­tails on pa­tient as­sis­tance pro­grams and in­for­ma­tion on their patents list­ed in the Or­ange Book are al­so in­clud­ed in the re­quests.

And they press the phar­mas for more in­for­ma­tion re­lat­ed to their switch­ing to up­dat­ed ver­sions of their in­halers — from As­traZeneca’s Pul­mi­cort Tur­buhaler to its Pul­mi­cort Flex­haler, Te­va’s QVAR to its QVAR Redi­Haler, and GSK’s Flovent Diskus to Ar­nu­ity El­lip­ta.

“GSK has been a decades-long leader in bring­ing in­no­va­tion to res­pi­ra­to­ry med­i­cine un­der­pinned by a fair and ro­bust patent sys­tem,” a GSK spokesper­son wrote in an email to End­points News. “We con­tin­ue to be com­mit­ted to mak­ing our prod­ucts broad­ly ac­ces­si­ble to the pa­tients who need them and we will work with the HELP Com­mit­tee to ad­dress its con­cerns.”

A Boehringer In­gel­heim spokesper­son wrote in an email to End­points that there are many rea­sons why there are few man­u­fac­tur­ers of in­halers and oth­er drug-de­vice com­bi­na­tion pro­duc­tions, adding that they’re more cost­ly and com­plex to man­u­fac­ture than pills and oth­er small mol­e­cule drugs.

“Con­trary to what is pre­sent­ed in the Health, Ed­u­ca­tion, La­bor and Pen­sions (HELP) Com­mit­tee’s let­ter, on av­er­age, we pro­vide dis­counts and re­bates of 70 per­cent off the list price of our in­haler prod­ucts to in­sur­ers, phar­ma­cy ben­e­fits man­agers and oth­er par­ties,” they wrote. “Un­for­tu­nate­ly, these dis­counts rarely get passed along to the pa­tient. We al­so pro­vide prod­ucts free to el­i­gi­ble pa­tients through our pa­tient as­sis­tance pro­grams.”

Fur­ther, the spokesper­son said Boehringer In­gel­heim com­plies with all fed­er­al laws and guide­lines for patent list­ings.

As­traZeneca and Te­va did not im­me­di­ate­ly re­spond to End­points News’ re­quest for com­ment.

This sto­ry has been up­dat­ed to in­clude com­ment from Boehringer In­gel­heim.