Ama­zon sub­sidiary Pill­Pack reach­es a set­tle­ment with US gov­ern­ment and will have to shell out over $5.6M

Ama­zon’s on­line phar­ma­cy has set­tled a law­suit in New York af­ter al­le­ga­tions of over­billing for the life­sav­ing drug in­sulin.

The set­tle­ment re­solves al­le­ga­tions that the phar­ma­cy, known as Pill­Pack, im­prop­er­ly billed gov­ern­ment health­care pro­grams like Medicare and Med­ic­aid for more in­sulin pens than pa­tients need­ed ac­cord­ing to their pre­scrip­tions, and for false­ly un­der-re­port­ing the days in­sulin sup­plies were dis­pensed.

Un­der the set­tle­ment, Pill­Pack has agreed to pay ap­prox­i­mate­ly $5.6 mil­lion to the US gov­ern­ment and over $175,000 to oth­er states that were fraud­u­lent­ly over­billed for in­sulin. As a part of the set­tle­ment, Pill­Pack has al­so ad­mit­ted and ac­cept­ed re­spon­si­bil­i­ty for cer­tain con­duct, in­clud­ing that it dis­pensed in­sulin pens that ex­ceed­ed im­posed days-of-sup­ply lim­its.

Dami­an Williams

“Phar­ma­cies are trust­ed to pro­vide ac­cu­rate in­for­ma­tion to Gov­ern­ment health­care pro­grams and to pre­vent waste when dis­pens­ing med­ica­tions to pa­tients. Pill­Pack abused this trust by dis­pens­ing in­sulin re­fills long be­fore pa­tients need­ed them and by false­ly re­port­ing the days of sup­ply of in­sulin ac­tu­al­ly dis­pensed to pre­vent its claims for re­im­burse­ment from be­ing de­nied,” US at­tor­ney Dami­an Williams said in a state­ment.

Ac­cord­ing to the gov­ern­ment, Pill­Pack sought re­im­burse­ment for in­sulin pens, but it was re­quired to re­port the quan­ti­ty dis­pensed and the days of sup­ply.

In­stead of ac­cu­rate­ly re­port­ing the days of sup­ply and con­tact­ing the Cen­ters for Medicare and Med­ic­aid Ser­vices, the gov­ern­ment al­leged that Pill­Pack would dis­pense and bill for the full car­ton and re­duce the days of sup­ply re­port­ed to the gov­ern­ment pro­gram to con­form to the lim­it. As a re­sult, for those claims, Pill­Pack re­port­ed days-of-sup­ply da­ta to GH­Ps that were dif­fer­ent from, and low­er than, the days-of-sup­ply that should have been re­port­ed.

From April 2014 through Nov. 2019, Pill­Pack’s gen­er­al prac­tice was to dis­pense in­sulin pens to pa­tients us­ing full car­tons. Pill­Pack would dis­pense and bill for the full car­ton and false­ly un­der­re­port the days of sup­ply to make it ap­pear that the dis­pens­ing did not vi­o­late the pro­gram’s days-of-sup­ply lim­it.

This prac­tice of un­der-re­port­ing al­so led Pill­Pack to dis­pense pre­ma­ture re­fills to pro­gram ben­e­fi­cia­ries, which led to fre­quent­ly dis­pensed in­sulin pen re­fills days or weeks be­fore pa­tients need­ed them ac­cord­ing to their pre­scrip­tions.

Pill­Pack, which was ac­quired by Ama­zon in 2018, was brought un­der Jeff Be­zos’ fold dur­ing a time when he, Berk­shire Hath­away and JP Mor­gan were try­ing to think up ways to dis­rupt the US health­care sys­tem. While Pill­Pack was not a part of that ven­ture, Ama­zon in­her­it­ed Pill­Pack’s phar­ma­cy li­cens­es in all 50 states, be­com­ing a play­er in the phar­ma­cy de­liv­ery ser­vice.

How­ev­er, Pill­Pack’s set­tle­ment al­so comes at a time when the av­er­age re­tail price for in­sulin has risen dra­mat­i­cal­ly over the years, over 54% from 2014 to 2019, ac­cord­ing to GoodRx.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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