CMS fi­nal­ized guid­ance this week that could de­lay Medicare ne­go­ti­a­tions for block­buster drugs such as Mer­ck’s Keytru­da.

The guid­ance de­scribes how CMS will im­ple­ment the third cy­cle of Medicare drug price ne­go­ti­a­tions, in­clud­ing how it will ex­pand pro­tec­tions for cer­tain or­phan drugs in ac­cor­dance with Pres­i­dent Don­ald Trump’s re­cent­ly en­act­ed tax and spend­ing pack­age. The move is a win for the phar­ma­ceu­ti­cal in­dus­try, which has lob­bied for those ex­tra pro­tec­tions.

But An­na Kaltenboeck, who co-au­thored the In­fla­tion Re­duc­tion Act’s drug ne­go­ti­a­tion sec­tion, told End­points News it could re­sult in missed sav­ings on ex­pen­sive, wide­ly-used drugs.

“For some of these prod­ucts, be­cause the ne­go­ti­a­tion just kicks in many years lat­er, it sim­ply de­lays ac­cess to sav­ings,” she said.

Am­gen’s cho­les­terol-cut­ting drug Repatha can re­duce the risk of events like heart at­tack and stroke in high-risk pa­tients who have not had one of these is­sues be­fore, ac­cord­ing to new da­ta from a large tri­al.

Repatha is al­ready ap­proved for use in these pa­tients, but the clin­i­cal proof of its ef­fec­tive­ness could dri­ve in­creased sales for the com­pa­ny.

Repatha is now the on­ly mem­ber of its class, known as PC­SK9 in­hibitors, proven to sig­nif­i­cant­ly cut the num­ber of car­dio­vas­cu­lar events when used for both pri­ma­ry and sec­ondary pre­ven­tion.

Pri­ma­ry pre­ven­tion de­scribes the use of a drug to pre­vent CV events in pa­tients who have nev­er had one be­fore, while sec­ondary pre­ven­tion refers to a drug's use in pa­tients who pre­vi­ous­ly ex­pe­ri­enced a heart is­sue. Repatha’s la­bel was ex­pand­ed in Au­gust to in­clude both us­es. Around three-quar­ters of heart at­tacks or strokes in the US are first-time events, Am­gen said Thurs­day.

Jeanne Mar­raz­zo, the for­mer di­rec­tor of the NI­H's Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID), claimed that HHS Sec­re­tary Robert F. Kennedy Jr. fired her be­cause she filed a whistle­blow­er com­plaint over his politi­cized stance on vac­cines, among oth­er is­sues.

Pri­or to her dis­missal in March, Mar­raz­zo was told she would be trans­ferred to the In­di­an Health Ser­vice, which nev­er oc­curred, ac­cord­ing to her whistle­blow­er fil­ing. She was then let go about three weeks af­ter fil­ing a whistle­blow­er com­plaint, along with Kath­leen Neuzil, the for­mer di­rec­tor of NI­H's Fog­a­r­ty In­ter­na­tion­al Cen­ter, which sup­ports NI­H's in­ter­na­tion­al col­lab­o­ra­tions on re­search.

Mar­raz­zo's lawyer De­bra Katz said in a state­ment Wednes­day that "there is no doubt she was re­moved from her po­si­tion as Di­rec­tor of NI­AID in re­tal­i­a­tion for her pro­tect­ed whistle­blow­er ac­tiv­i­ty."

Three ad­vo­ca­cy groups have writ­ten to the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty (CMA) de­mand­ing an in­ves­ti­ga­tion in­to whether phar­ma com­pa­nies co­or­di­nat­ed with the US gov­ern­ment and UK trade groups to ex­ert pres­sure and raise drug prices in the coun­try.

The CMA re­ceived the let­ter on Sept. 26 from UK-based pa­tient ad­vo­ca­cy groups Bal­anced Econ­o­my Project, Just Treat­ment and Glob­al Jus­tice Now, which al­leged that com­pa­nies are work­ing with the US ad­min­is­tra­tion and a UK phar­ma trade group, the As­so­ci­a­tion of the British Phar­ma­ceu­ti­cal In­dus­try, to pres­sure the UK gov­ern­ment.

Rough­ly a month ago, UK Health Sec­re­tary Wes Street­ing failed to strike a deal on drug pric­ing with phar­ma com­pa­nies, mean­ing the UK’s drug re­bate tax stayed at near­ly 23%. This is very high com­pared to oth­er coun­tries, such as France’s 5.7% tax. Many top drug­mak­ers have since then crit­i­cized the British gov­ern­ment, say­ing it is cre­at­ing a bad busi­ness en­vi­ron­ment.