thedisclaimer5Jul2023藥醫(yī)保降幅長期趨緩，企業(yè)談判具有靈活性LongtermPriceCutforInnovativeDruginNRDLtoSlowDownMoreFlexibilityforCompanyinNegotiationseccomuanhtiseccom熱點(diǎn)速評FlashAnalysis(PleaseseeAPPENDIX1forEnglishsummary)國家醫(yī)療保障局(NHSA)發(fā)布《談判藥品續(xù)約規(guī)則(2023年版征求意見稿)，整體延續(xù)2022版的框架，亦有部分調(diào)整。主要調(diào)整包括：1)納入常規(guī)目錄管理的條件新增“談判進(jìn)入目錄且連續(xù)納入目錄‘協(xié)議期內(nèi)談判藥品部分’超過8年的藥品”。2)簡易續(xù)約規(guī)則區(qū)分連續(xù)納入目錄“協(xié)議內(nèi)談判藥品部分”4年及以內(nèi)、超過4年兩類。4年及以內(nèi)品種計(jì)算規(guī)則與2022年規(guī)則相同；超過4年的品種，支付標(biāo)準(zhǔn)在計(jì)算值基礎(chǔ)上減半。3)醫(yī)?；鹬С鲱A(yù)算從2025年續(xù)約開始不再按照銷售金額65%計(jì)算，而是以納入醫(yī)保支付范圍的藥品費(fèi)用計(jì)算。考慮到參照標(biāo)準(zhǔn)的變化，醫(yī)保支付節(jié)點(diǎn)金額也相應(yīng)調(diào)增。從2025年起，談判藥品簡易續(xù)約的醫(yī)保支付節(jié)點(diǎn)金額從2/10/20/40億元相應(yīng)調(diào)增為3/15/30/60億元。4)按照現(xiàn)行藥品注冊管理辦法及注冊分類標(biāo)準(zhǔn)認(rèn)定的1類化學(xué)藥品、1類治療用生物制品、1類和3類中藥，續(xù)約時(shí)如比值A(chǔ)>110%，企業(yè)可申請通過重新談判確定降幅，重新談判的降幅可不一定高于按簡易續(xù)約規(guī)則確定的降幅。如談判失敗，調(diào)出目錄。老產(chǎn)品降價(jià)規(guī)則明確、預(yù)期長期降幅趨緩。征求意見稿中提到，連續(xù)納入目錄內(nèi)8年的藥品可進(jìn)入常規(guī)目錄管理、連續(xù)納入目錄超過4年的藥品，簡易續(xù)約時(shí)支付標(biāo)準(zhǔn)在計(jì)算值基礎(chǔ)上減半。我們認(rèn)為，按2018年為醫(yī)保目錄執(zhí)行首年開始計(jì)算，目錄內(nèi)8年以上藥品可能在2025年開始正式進(jìn)入常規(guī)目錄，在專利期內(nèi)價(jià)格企穩(wěn)。對于連續(xù)納入目錄超過4年的藥品，我們理解為按規(guī)則降價(jià)幅度減半，故藥品的銷售峰值有邊際提升可能。醫(yī)?；鹬С鲱A(yù)算口徑將變更，數(shù)據(jù)精確度可能提高。根據(jù)征求意見稿，醫(yī)?；鹬С鲱A(yù)算自2025年續(xù)約開始，口徑由“銷售金額的65%”更改為“納入醫(yī)保支付范圍的藥品費(fèi)用”。我們認(rèn)為，藥品費(fèi)用口徑費(fèi)用在信息化提高的前提下，數(shù)據(jù)精確度可能更高，較銷售額65%的估算值更有利于醫(yī)?；鹬С龊皖A(yù)算的長期管理。此外，我們認(rèn)為2025年起對醫(yī)保支付節(jié)點(diǎn)金額調(diào)增至3/15/30/60億元主要系口徑變更，按占用醫(yī)保資金規(guī)模分級的邏輯和臨界值沒有變醫(yī)保談判給予企業(yè)一定的靈活性。征求意見稿提出，對于1類化學(xué)藥、1類治療用生物制品等，若建議續(xù)約時(shí)如比值A(chǔ)>110%，企業(yè)可申請重新談判，降幅不一定高于簡易續(xù)約規(guī)定的降幅。我們認(rèn)為，本條規(guī)定，尤其是在醫(yī)保支出或比值在規(guī)則的臨界值時(shí)，給予企業(yè)在醫(yī)保談判中一定的靈活度，對創(chuàng)新藥亦是一定程度上的政策支持。行業(yè)監(jiān)管政策風(fēng)險(xiǎn)。25Jul20232Fig1.《談判藥品續(xù)約規(guī)則(2023年征求意見稿)》中，醫(yī)保協(xié)議期內(nèi)時(shí)間較長藥品的降價(jià)幅度放緩、藥品支付節(jié)點(diǎn)金額提高rceNHSAHTI35Jul20233APPENDIX1SummaryEvent.TheNationalHealthSecurityAdministration(NHSA)issuedtheRulesforNegotiatingDrugRenewals(DraftforComments2023),whichcontinuestheframeworkofthe2022versionasawhole,withsomeadjustments.Keyadjustmentsinclude:1)Theconditionsforinclusionintheregularcataloguemanagementareadded:"drugsthathavebeenincludedinthe'negotiateddrugpart'ofthecatalogueformorethan8consecutiveyears.”2)Thesimplifiedrenewalrulesdistinguishbetweentwocategories:thosethathavebeenincludedinthecataloguefor≤4consecutiveyearsand>4years.Therulesfordrugsincludedfor≤4yearsarethesameasthosefor2022version.Forthoseincluded>4years,thepaymentstandardishalvedonthebasisofthecalculatedvalue.3)Themedicalinsurancefundexpenditurebudgetwillbecalculatedbasedonthecostofdrugscoveredbymedicalinsuranceinsteadof65%ofthesalesfromtherenewalofthecontractin2025.Takingintoaccountthechangeinthereferencestandard,theamountofmedicalinsurancepaymentnodeshasalsobeenincreasedfrom0.2/1/2/4bnRMBto0.3/1.5/3/6bnRMBfrom2025.4)ForClass1chemicals,Class1therapeuticbiologicalproducts,Class1andClass3traditionalChinesemedicines,ifratioA>110%atthetimeofrenewal,thecompanycanapplyforrenegotiation,andthepricecutinrenegotiationmaynotnecessarilybehigherthanthepricecutdeterminedaccordingtothesimplifiedrenewalrules.Ifrenegotiationsfail,thedrugwillberemovedfromthecatalogue.Comments.Theprice-cutrulesformatureproductsareclear,andthelong-termdeclineisexpectedtoslowdown.AsmentionedintheDraftforComments,drugsthathavebeenincludedinthecataloguefor8consecutiveyearscanentertheregularcataloguemanagement,anddrugsthathavebeenincludedinthecatalogueformorethan4consecutiveyearswillbehalvedonthebasisofthecalculatedvalueatthetimeofsimplifiedrenewal.Webelievethatbasedonthecalculationof2018asthefirstyearofimplementationofthemedicalinsurancecatalogue,drugsmorethan8yearsinthecataloguemayofficiallyentertheregularcataloguein2025,andthepricewillstabilizewithinthepatentprotectionwindow.Fordrugsthathavebeenincludedinthecatalogueformorethan4consecutiveyears,weunderstandthatthepricereductionishalvedaccordingtotherules,sothepeaksalesofdrugsmaybemarginallyincreased.Thecalibreforbudgetformedicalinsurancefundspendingwillchange,andtheaccuracyofthedatamaybeimproved.Accordingtotheconsultationdraft,themedicalinsurancefundexpenditurebudgetwillbechangedfrom"65%ofthesalesamount"to"drugexpensesincludedinthescopeofmedicalinsurancepayment"startingfromtherenewalofthecontractin2025.Webelievethatunderthepremiseofimprovinginformatization,theaccuracyofdatamaybehigher,whichismoreconducivetothelong-termmanagementofmedicalinsurancefundexpenditureandbudgetthantheestimateof65%ofsales.Inaddition,webelievethattheincreaseintheamountofmedicalinsurancepaymentnodesto0.3/1.5/3/6billionRMBfrom2025ismainlyduetothechangeincalibre,andthelogicandcut-offvalueofgradingaccordingtothescaleofmedicalinsurancefundsoccupiedhavenotchanged.Companiesaregivensomeflexibilityinhealthinsurancenegotiations.TheDraftproposesthatforClass1chemicaldrugsandClass1therapeuticbiologicalproducts,iftheratioisproposedtobeA>110%atthetimeofrenewal,theenterprisecanapplyforrenegotiation,andthereductionisnotnecessarilyhigherthanthereductionstipulatedinthesimplifiedrenewal.Webelievethatthisprovision,especiallywhenthemedicalinsuranceexpenditureorratioisatthethresholdoftherules,givescompaniesacertaindegreeofflexibilityinmedicalinsurancenegotiations,andisalsoacertaindegreeofpolicysupportforinnovativedrugs.Risks.Risksofindustryregulatorypolicy.4下下m56 78