J.P. 摩根-美股-制药行业-全球制药业：2019年美国买家调查要点-2019.3-48页.pdf

1See the end pages of this presentation for analyst certification and important disclosures,including non-US analyst disclosures.J.P.Morgan does and seeks to do business with companies covered in its research reports.As a result,investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report.Investors should consider this report as only a single factor in making their investment decision.Global Equity ResearchMarch 2019Global BioPharma 2019 US Payer Survey TakeawaysAnupam Rama AC212-622-J.P.Morgan Securities LLCUS BiotechnologyCory Kasimov AC212-622-Carmen Augustine212-622-US SMID Biotechnology Jessica Fye AC212-622-Eric Joseph,PhD AC212-622-Yuko Oku212-622-US Major&Specialty PharmaEkaterina V.Knyazkova212-622-9576 Christopher Schott,CFA AC212-622-Christopher Neyor212-622-0334 Matthew T.Holt,PhD212-622-Tessa T.Romero212-622-EU Pharma&BiotechRichard Vosser AC(44-20)7742-James D Gordon(44-20)7742-James P Quigley(44-20)7742-Matthew Bannon212-622-Daniel Wolle212-622-Xiling Chen212-622-J.P.Morgan Securities PLCSarita Kapila(MD)(44-20)7134-Laerke L Engkilde(44-20)7742-2917 2Key TakeawaysMacro industry perspectiveOverall,our 2019 survey,similar to the past two editions,suggests incremental pressure from payers and this is consistent with our prevailing view on industry dynamicsPayers remain focused on managing cost with formulary access and to a lesser extent with copaysConsistent with last years feedback,our 2019 survey suggests payers foresee a modest increase in out-of-pocket expense for patients Payers see self-policing(e.g.,limiting price increases to a low single-digit percent after rebates)by drug providers as helpful or neutral,but unlikely to fully alleviate pushbackMost payers see substantial change to the current drug rebate system in the next 3-5 yearsOver time,biosimilars should play an increasing role in cost managementPayers increasingly looking at biosimilars on a product by product basisMarket size appears to be an increasingly relevant factor in payer interest in biosimilars,which is not surprising in our view given the effort needed to move share with these productsSimilar to prior years,ease of switching and relative cost are also important considerations for payers3Key TakeawaysSpecific therapeutic areasFor diabetes,the survey results suggest that payers see room for both greater pricing concessions and formulary exclusions,which is anticipated by us and investorsThis is generally consistent with our diabetes pricing assumptions and market expectations for flat to declining price in this category Interestingly,while GLP-1s clearly remain in focus for payers,this years survey suggested a lower likelihood of cost/access pressures Oncology drugs continue to be in focus;however,compared to our 2018 survey it does appear that concerns about combination regimens&cell therapy have slightly moderatedIn dermatology,roughly half(48%)of payers expect tightening of biologic formulary access over the next 2-3 years as new agents come to marketFor REGNs Dupixent,most payers continue to have moderate or tight restrictions in atopic dermatitis(AD),similar to our 2018 survey(although an increasing fraction now have no restrictions);in the new asthma indication,restrictions are similar(mostly moderate/tight)On the heels of significant price decreases for the PCSK9 class,payers do expect a trend toward loosening restrictions in 2019while we have not seen this dynamic play out in a significant way to-date,this could bode well for script/sales trends as we get further into the yearIn the HIV class,survey findings once again suggest generics could have an increasing role in disease management,but we do not expect this to be a significant near-term headwind4Key TakeawaysSpecific therapeutic areasFor rare diseases,less than 30%of respondents expect to see increased formulary management/drug pricing pressure this year(vs.50%in last years survey)For one-time/curative therapies(e.g.,gene therapy),the preference was unsurprisingly for outcomes-based rebate arrangements;however,there was an interesting shift in interest toward buy&bill and single payment models(which appear to be easier to process within the existing infrastructure),relative to last yearIn hemophilia,payers continue to be focused on total treatment cost when evaluating a new therapeutic option;while convenience is once again the least important factor to payers,there was a slight shift in importance vs.2018Little has changed from last year on the CGRP front,similar to last year payers expect to a)limit the number of therapies on formulary(most expect to include 2)and b)in general see increasing rebates/discounts over timeThis is consistent with our expectation for steep gross/nets in the classIn familial amyloid polyneuropathy,the remaining 60%of Onpattro/Tegsedi reviews should be completed by the end of 2019,and we believe both agents will be covered by the vast majority of payersATTR market prescribing dynamics are likely to be driven by the preference of physicians/patients vs.payers5SURVEY RESULTS:GENERAL QUESTIONNAIRE6Survey was launched on March 7,2019 Enrollment criteria:US payers who play a role in determining what agents gain formulary listings at their institutionsRespondent characteristics:Each respondent had a mean/median of 6M/4M lives covered by their institutionSample size:N=25Which of the following best describes where you are currently employed?Survey BackgroundSource:JP Morgan Research60%16%12%12%0%0%10%20%30%40%50%60%70%MCO/health planFormulary group for network ofhospitalsFormulary group for singlehospitalPBMOther%of respondentsn=257In your professional opinion,how important are each of the following factors in terms of making it more likely for you to manage/restrict access via formulary?Scale of 1 to 7.Cost of therapy,size of potential patient population,and number of available therapies in the class were the three most important factors cited by respondents that would make them more likely to manage/restrict access via formularyJPM View:It is not surprising that cost of therapy is the#1 factor,similar to our 2018 survey.However,we continue to see payers utilizing a multi-faceted approach in formulary management(highlighted by the incremental step down between the 2nd-5thmost important factors).Potential for off-label use and the availability of generics appear to be significantly less important to payers Cost of therapy seen as the most important factor driving management of formulary accessDrivers of Formulary AccessSource:JP Morgan ResearchOther important factors:if product is contracted,safety concerns,total cost of care,unmet needMore importantLess important60%52%48%48%32%32%28%0%10%20%30%40%50%60%70%80%90%100%Cost oftherapyMagnitude ofclinicalbenefitSize ofpotentialpatientpopulationNumber ofavailabletherapies inclassPotential foroff-labelusagePaid frommedical vsdrug benefitAvailability ofgenerics inthe category%of respondents ranking therapeutic area as 1st,2nd,or 3rdmost likelyn=253.73.53.53.02.82.42.20.01.02.03.04.05.06.07.0Cost oftherapySize ofpotentialpatientpopulationNumber ofavailabletherapies inclassAvailability ofgenerics inthe categoryMagnitude ofclinicalbenefitPotential foroff-labelusagePaid frommedical vsdrug benefitn=258Please rate the following ways in which you are likely to manage benefits going forward.Scale of 1 to 5.Narrowing formularies and prior authorization programs were ranked as the most important tools for managing benefits going forward,followed by step therapy programsPushing cost burden on to patients(e.g.,by increasing co-pays or moving to co-insurance)was the least popular route of managing benefitsJPM View:These results are not surprising and consistent with company commentaryNarrow formularies and prior authorization programs expected to be the most important ways to manage benefits going forwardMethods of Managing BenefitsSource:JP Morgan ResearchMore likelyLess likely2.42.02.11.91.60.01.02.03.04.05.0NarrowingformulariesPrior authorizationprogramsStep therapyprogramsMoving to co-insuranceIncrease co-paydifferentialsn=2572%68%60%56%44%0%10%20%30%40%50%60%70%80%90%100%NarrowingformulariesPrior authorizationprogramsStep therapyprogramsMoving to co-insuranceIncrease co-paydifferentials%of respondents ranking therapeutic area as 1st,2nd,or 3rdmost likelyn=259In your professional opinion,how,if at all,will patient out-of-pocket cost change over the next 2-3 years?Similar to our 2018 survey,a majority of payers(72%)expect modest increases in out-of-pocket costs over the next 2-3 years while 24%are expecting significant increases(an increase from 12%in 2018)Notably,no payers expect any sort of decrease in out-of-pocket costsJPM View:Patient out-of-pocket costs have been and continue to be a controversial topic for both payers and the biopharma industrythey are a key driver in making drug pricing such a populist issue.Compared to our 2018 survey,this years results appear fairly consistent and point to a modest increase in out-of-pocket costsPatient out-of-pocket costs expected to increase modestly over the next 2-3 yearsExpectations for Patient Out-of-Pocket CostsSource:JP Morgan Research24%72%4%0%0%0%10%20%30%40%50%60%70%80%90%100%Significant increaseModest increaseNo changeModest decreaseSignificant decrease%of respondents n=2510If the safe harbor provisions for rebates are removed for Medicare Part D,what impact do you expect on total pharma drug spending,out-of-pocket costs,and insurance premiums?While not necessarily a focus of our survey group,we asked payers about the potential impact from the removal of the safe harbor from Part D plansInsurance premiums were expected to increase.However,payers did not expect out-of-pocket spend to decrease and saw net prices of drugs increasing JPM View:We are a bit surprised by this view most manufacturers see potential changes to Part D resulting in lower out-of-pocket drug spend for patients(although premiums will likely increase with this).On overall drug spend and net pricing,most manufacturers see this as a neutral event with slightly lower net pricing being offset by higher utilizationMedicare Part D ReformMost payers see premiums and,interestingly,total drug spending increasingSource:JP Morgan Research32%12%4%0%4%64%64%76%80%60%4%8%12%16%28%0%16%8%4%8%0%10%20%30%40%50%60%70%80%90%100%InsurancepremiumsOut of Pocket drugspendingTotal drug spendingNet drug pricesGross drug prices%of respondents selecting each categorySignificantdecreaseDecreaseNeutralIncreaseSignificantincreasen=2511What is the likelihood of a substantial change in the current commercial pharmaceutical rebate structure?The vast majority of respondents(70%indicating likely or highly likely)see a substantial change to the commercial rebate structure within the next 5 yearsHowever,few see major changes in the near term(only 16%indicate likely or highly likely in the next 2 years)JPM View:This is consistent with our view,although the timelines and the new pricing structure resulting from any changes remain a key unknown for the sector.In general,we see a move away from the current gross price/rebate structure as an incremental positive for the biopharma sector Rebate StructureMost payers see significant changes to the commercial rebate structure within the next 5 yearsSource:JP Morgan Research4%4%40%12%28%28%36%40%12%28%12%8%20%16%12%0%10%20%30%40%50%60%70%80%90%100%In 2 yearsIn 3 yearsIn 5 years%of respondents selecting each categoryHighly unlikely(80%)n=2512Which of the following factors would most influence your willingness to include biosimilars in your existing formularies?Scale of 1 to 7.Notably,”size of the end market”increased considerably versus our 2018 survey(only 32%of respondents)as a key factor for payers and now ranks among the most important Relative cost,strength of clinical data,&ease of switching/starting new patients on therapy remain the other three factors that most influence payers willingness to include biosimilars in formulariesJPM Take:We are not surprised by the increased importance payers placed on the size of market given the barriers and commercial challenges for biosimilar launches to date Market size,strength of data,&ease of starting patients are the factors most likely to influence biosimilar inclusion in formulariesOutlook for BiosimilarsSource:JP Morgan ResearchMore likelyLess likely64%64%64%60%36%28%16%0%10%20%30%40%50%60%70%80%90%100%Size of themarketStrength ofclinical dataEase ofswitching orstarting newpatientsRelative cost Completenessof biosimilarlabelindications vs.brandSeverity ofdiseaseDuration oftherapy%of respondents ranking therapeutic area as 1st,2nd,or 3rd most likelyn=253.93.73.73.72.82.41.80.01.02.03.04.05.06.07.0Relative costStrength ofclinical dataEase ofswitching orstarting newpatientsSize of themarketSeverity ofdiseaseCompletenessof biosimilarlabelindications vs.brandDuration oftherapyAverage scoren=2513Looking out 3-5 years,what best describes your view on the role that biosimilars will play in the market?Similar to our 2018 survey,most payers expect impact of biosimilars to vary by product(64%;vs.52%in 2018)while a still meaningful portion expect broader impact(28%;vs.40%in 2018)JPM View:We have long expected the impact of biosimilars to vary by market and product and this seems to be increasingly reflected in payer views.The fraction of payers who expect biosimilars to have a broad/significant impact regardless of category has come down in the last year(from 40%to 28%),likely as payers have had more experience with these products.As biosimilar launches increase in coming years(bNeulasta,bHerceptin,etc),we expect payers to form a more clear position on the role biosimilars could play in various markets Outlook for Biosimilars(cont.)Payers are more inclined to think biosimilar impact will vary by product vs.our 2018 surveySource:JP Morgan ResearchToo early to tell4%I am expecting significant/broad impact from biosimilars28%Impact will vary on a product by product basis64%I am expecting limited to no impact from biosimilars4%n=2514In the last 2-3 years,biosimilar adoption and product volumes have fallen short of commercial and market expectations.What are your expectations for biosimilar uptake over the next 2-5 years?Over the next 2-5 years,payers overwhelmingly expect biosimilar uptake to increase(68%,88%and 100%expect an increase in the next 2,3 and 5 years,respectively)JPM View:Between unrelenting media coverage of drug pricing,greater experience with biosimilars,and with an increasing number of biosimilar approvals/launches expected,we are not surprised that payers expect uptake of biosimilars to increase over the next few years Outlook for Biosimilars(cont.)Payers overwhelmingly expect adoption of biosimilars to tick up in the next 2-5 yearsSource:JP Morgan Research4%20%44%64%68%56%28%12%4%0%10%20%30%40%50%60%70%80%90%100%In 2 yearsIn 3 yearsIn 5 years%of respondents selecting each