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1、1Hepatitis C Market ReportIssue 1 February 2020Hepatitis CMarket Report Issue 1 May 2020This report was made possible through the generous support of the UK Department For International Development(DFID)Department for International DevelopmentDisclaimer:The data sources primarily used for analysis i

2、n the report include the India Import Export data,CHAI country teams,Ministry of Health counterparts,stakeholder(WHO,UNPD,and NGO and civil society partners,such as FIND,World Hepatitis Alliance,etc.)conversations,and regulatory information provided by drug suppliers.CHAI has taken precautions to ve

3、rify the information shared on the report.However,the analysis in the report is not exhaustive,and the responsibility for the interpretation and use of the material lies with the reader.The mention of specific companies or supplier products does not imply that CHAI is endorsing or recommending them.

4、Design&Layout: Clinton Health Access Initiative Inc.(CHAI)2020This is the first version of the Clinton Health Access Initiative Inc.s(CHAI)Hepatitis C Virus(HCV)market report.The shipment data obtained from the India Import Export Database,and the in-country commodity pricing data collected from our

5、 global partners and through the support of our Ministry of Health(MoH)counterparts are the foundation of the reports analyses.The data allows CHAI to address information gaps and construct a more comprehensive view of the hepatitis C market.We would like to thank our colleagues from Treatment Actio

6、n Group(TAG);Coalition PLUS;World Hepatitis Alliance(WHA)and its members across countries;Treat ASIA/amfAR;World Health Organization(WHO);Mdecins du Monde;Mdecins Sans Frontires-France;The Global Fund to Fight AIDS,Tuberculosis and Malaria(GFATM);Pan American Health Organization(PAHO);United Nations

7、 Development Program(UNDP);Medicines Patent Pool(MPP);The Foundation for Innovative New Diagnostics(FIND);and the Aga Khan University(AKU)for supporting us in collecting and aggregating data and for their invaluable feedback during the development and refinement of the report.We are also grateful to

8、 Hetero,Mylan and Cipla,pharmaceutical companies providing WHO PQd SOF and DCV both for HCV treatment,for sharing their registration status across high-burden countries.Acknowledgements4Hepatitis C Market ReportARVAntiretroviralARTAntiretroviral TherapyBEBioequivalenceCHAIClinton Health Access Initi

9、ative Inc.COCountry OfficeCPTCarriage Paid ToCRPCollaborative Registration ProcedureCT/NGChlamydia trachomatis/Neisseria gonorrheaCYCalendar YearDAADirect-Acting AntiviralsDAPDelivery At PlaceDCVDaclatasvirEIDEarly Infant DiagnosisERPExpert Review PanelFDCFixed Dose CombinationFDFFinished Dosage For

10、mFOBFreight On BoardFPPFinished Pharmaceutical ProductGFATMThe Global Fund to Fight AIDS,Tuberculosis and MalariaGHSSGlobal Health Sector StrategyG/PGlecaprevir/Pibrentasvir(Fixed Dose Combination)HBVHepatitis B VirusHCVHepatitis C VirusHIVHuman Immunodeficiency VirusIAImmunoassayLDVLedipasvirLMIC L

11、ow-and Middle-Income CountryMoHMinistry of HealthMPPMedicines Patent PoolMTBMycobacterium TuberculosisNATNucleic Acid TestPAHOPan American Health OrganizationPCRPolymerase Chain ReactionPPMPooled Procurement MechanismQAQuality AssuredRBVRibavirinRDTRapid Diagnostic TestRNARibonucleic AcidSOFSofosbuv

12、irSOF/DCVSofosbuvir/Daclatasvir(Fixed Dose Combination)SOF+DCVIndividual Sofosbuvir and Daclatasvir CombinedSOF/LDVSofosbuvir/Ledipasvir(Fixed Dose Combination)SOF/VELSofosbuvir/Velpatasvir(Fixed Dose Combination)SRAStringent Regulatory AuthoritySVR12Sustained Virologic Response at week 12VELVelpata

13、svirVLViral LoadWHO PQdWorld Health Organization Prequalified Acronyms5Hepatitis C Market ReportAcknowledgements 3Key Takeaways6Key Statistics8Introduction10World Health Organization Recommended HCV Testing and Treatment Algorithm12HCV Diagnostics16Supplier Landscape17Pricing Trends20HCV Treatment27

14、Supplier Landscape28Volume Trends30Pricing Trends32Volume Based Pricing41Looking Forward43Glossary45Appendix46Contents6Hepatitis C Market ReportKey TakeawaysDIAGNOSTICSThe World Health Organization(WHO)now recommends a simplified diagnostics algorithm for HCV.The current algorithm includes HCV antib

15、ody screening,confirmation of viremia by Viral Load(VL),and confirmation of cure by VL at week 12 post-treatment(SVR12).The previous guidance for genotyping and week four monitoring has been removed.1The use of quality assured(QA)diagnostic products,which are Stringent Regulatory Authority(SRA)appro

16、ved or WHO Prequalified(PQd),is important to maintain a high standard of care.Procurement agents are encouraged to assure the quality of products under consideration.2Inclusive pricing offers a set price and aggregates specific cost components for more streamlined procurement.Diagnostic pricing ofte

17、n contains complex individual cost components,which may be challenging to ascertain.Price visibility is essential to identify opportunities for cost reductions and to assure the cost-effective growth of public programs.34Current diagnostic pricing within public programs varies broadly with some coun

18、tries achieving low prices(illustrated in Exhibits 7 and 8)which can serve as a benchmark for other programs.57Hepatitis C Market ReportTREATMENTSeveral other countries are expanding their HCV treatment programs,but the overall progress toward achieving WHO elimination goals by 2030 is slow.Low-and

19、Middle-Income Countries(LMICs)can now aim to achieve a price of under US$100 per patient course for 12 weeks of treatment with WHO PQd Sofosbuvir(SOF)and Daclatasvir(DCV).LMICs with a procurement plan,large procurement volumes and strong public commitment by government to HCV elimination over a defi

20、ned period of time can further aim for US$60 per patient course for 12 weeks of treatment with WHO PQd SOF and DCV,as observed in Rwanda.Countries can seek opportunities to accelerate registration/time limited import approval of WHO prequalified/ERP reviewed products to ensure product availability,s

21、upply security,and access to affordable prices by fostering competition.Limited data on in-country DAA procurement and procurement budgets has restricted capability to predict future market trends for DAAs.Transparency on in-country procurement plans can help identify future demand for DAAs.The glob

22、al benchmark prices for drugs have declined significantly(illustrated in Exhibit 12);however,several countries continue to pay substantially higher prices.Countries can explore global procurement mechanisms such as the United Nations Development Program(UNDP)health procurement mechanism,the Global F

23、und Pooled Procurement Mechanism(PPM),and the Pan American Health Organizations(PAHO)Strategic Fund to procure HCV treatment at more affordable prices.Global procurement mechanism benchmark prices may also be used by countries as reference prices for local tenders,or for negotiating in-country price

24、s with suppliers.Countries can explore alternative pricing mechanisms such as public-private partnerships and insurance schemes in order to reduce the financial burden on patients paying out-of-pocket.Countries observing high price mark-ups can reduce prices by identifying different contributing fac

25、tors and limiting them where possible.Countries can benefit from lower pricing by planning procurement and ordering DAAs in optimal quantities and/or publicly committing to HCV program scale-up toward elimination.India,Egypt,Pakistan,Rwanda are examples of countries that have committed to scaling up

26、 their HCV programs.To accelerate progress towards HCV elimination,countries will need to intensify case finding efforts.Countries that prioritized patients who were previously diagnosed and awaiting care for HCV treatment will need to focus on active case finding.123689745Key StatisticsGlobal HCV B

27、urden and Progress20202020203010%30%90%2016399Kdeaths from HCV 2015living with chronic HCV globally 71million peoplereceived treatment for HCV infection million people57%2017know their HCV status million people13.119%2017HCV Elimination Goalsreduction in number of hepatitis-related bybyreduction of

28、new hepatitis-related reduction by WHO Global Health Sector Strategy(GHSS)on viral hepatitis calls for the elimination of HCV as a public health threat by 2030203065%reduction by THe GOal iS TO aCHieVedeathsinfections8Hepatitis C Market ReportPricing for quality assured products is lowest in Rwanda

29、among high-burden lMiCsLowest available market prices for WHO PQd diagnostics and drugsThe Global Fund Pooled Procurement Mechanism Price Benchmarks for Drugs*$60/patient course For 12 weeks of treatment with SOF and DCV$79.47/patient cure+=RDT$0.75 Vl test$9.36 Treatment price$60*SVR12 test$9.36$79

30、/patient course for 12 weeks with SOF/DCV FDC$94/patient course for 12 weeks with individual SOF+DCVPricing breakdown in Rwanda:9Hepatitis C Market Report10Hepatitis C Market ReportIntroductionApproximately 71 million people worldwide(as of 2015)are chronically infected with HCV,one of the worlds mo

31、st prevalent infectious diseases.1 More than 80 percent of the burden is in LMICs.2 The HCV epidemic continues to grow both in size,with 1.75 million new infections annually,and in severity,causing more than 400,000 deaths per year from advanced liver disease,including cancer.3 Despite its high prev

32、alence,morbidity and mortality,only 19 percent(13.1 million)of people living with HCV knew their status in 20174,and only 7 percent(5 million)received treatment worldwide as of 2017.5 Many factors contribute to this major gap in access,including limited awareness due to the asymptomatic nature of HC

33、V infection,lack of funding and infrastructure for public screening and treatment programs,and the historically high costs of previous treatments(interferon-based)that had high toxicities and low success rates.WHO and its member states committed in 2016 to eliminate viral hepatitis by 2030.The avail

34、ability and pricing of pan-genotypic DAAs with cure rates over 95 percent and minimal side effects,coupled with a simple diagnostic algorithm,make the goal of achieving HCV elimination by 2030 feasible.Although uptake has been uneven across LMICs and scale up has been concentrated in few countries,d

35、eclining costs for diagnosis and treatment have resulted in increases in the number of patients initiated on treatment.In turn,increasingly affordable and effective diagnostic tools and medications are enabling the simplification and decentralization of HCV diagnosis and treatment services,supportin

36、g further scale-up of services.HCV screening and diagnosis using existing technologies is feasible and the cost of testing continues to decline.A number of inexpensive and robust Quality Assured(QA)tests are available for screening and confirmation of viremia including rapid antibody tests and labor

37、atory-based and near point-of-care VL diagnostics.The introduction of DAAs in the market in 2014 has been a game changer for HCV treatment.DAAs are significantly superior to interferon-based treatment in several aspects.Depending on the regimen used,DAAs are pan-genotypic,have high cure rates(over 9

38、5 percent)with minimal side effects,and are orally administered over eight to 12 weeks.Since 2014,the cost of treating HCV in LMICs has come down significantly from over US$3,000 per patient course with interferon-based treatment(before the introduction of DAAs)to as low as US$60 per patient course

39、in 2019 with WHO PQd individual SOF and DCV(SOF+DCV)in Rwanda.While the number of people who initiated DAA-based treatment for HCV rose between 2015 and 1 Polaris Observatory HCV Collaborators.Global prevalence and genotype distribution of hepatitis C virus infection in 2015:a modelling study.Lancet

40、 Gastroenterol Hepatol 2017.2 Polaris Observatory HCV Collaborators.Global prevalence and genotype distribution of hepatitis C virus infection in 2015:a modelling study.Lancet Gastroenterol Hepatol 2017.3 WHO global health estimates for 2015 published in 2016(Global Health Estimates 2015:deaths by c

41、ause,age,sex,by country and by region,20002015.);2016.4 WHO Progress report on HIV,viral hepatitis and sexually transmitted infections;2019.5 Web Annex 1.Key data at a glance.In:Progress report on HIV,viral hepatitis and sexually transmitted infections 2019.Accountability for the global health secto

42、r strategies,20162021.Geneva:World Health Organization;2019.11Hepatitis C Market Report2016 from approximately one million to one and a half million,only a few countries such as India,Egypt and Pakistan were responsible for the bulk of that increase.Patients in Egypt and Pakistan accounted for about

43、 half the patients who started DAA treatment in 2016.6 Uptake of DAAs has been limited across several high-burden LMICs and challenges to access continue to exist.Some of these market challenges include lack of awareness among stakeholders on global benchmark pricing,availability of WHO PQd product

44、options in-country,slow or limited in-country product registration,and limited domestic and donor financing.As a result,volumes of patients put on treatment have not increased in proportion to the decline in price of DAAs.Similar challenges also exist for diagnostics.Global targets for viral hepatit

45、is elimination are predicated on achieving widespread diagnosis of the majority of persons living with chronic viral hepatitis.Implementing reliable and affordable testing in LMICs is essential to enable the successful use of DAAs in treatment.However,despite substantial global price reductions,the

46、cost of diagnostics remains high in many countries,with drivers ranging from fragmented demand,limited in-country registrations,high mark-ups and non-coordinated procurement.Furthermore,there are significant gaps in publicly available information for the global diagnostics market in the areas of pri

47、cing,test volumes and in-country registrations.Taking into account market challenges on the treatment and diagnostics front,there is a risk that countries may not reach the WHO endorsed Global Health Sector Strategy(GHSS)HCV elimination goal by 2030.Better market transparency for key stakeholders,in

48、cluding governments,suppliers,and donors,could be a step toward mitigating these market challenges.The aim of this HCV market report is to provide an overview of supplier landscape for WHO PQd/ERP reviewed HCV treatment drugs and diagnostics,outline historical volumes and pricing trends,highlight gl

49、obal benchmark prices,and suggest potential ways in which countries can access diagnostics and drugs at more affordable prices.The report focuses on LMICs with a high HCV burden,and WHO PQd/ERP reviewed products as they meet quality assurance standards and have been declared bioequivalent to the inn

50、ovator products.While the report does not advocate the use of locally approved products,pricing information on the report accounts for locally approved products(which do not meet global quality standards but meet local quality standards),in addition to WHO PQd/ERP reviewed products,as these products

51、 are available and being used in several LMICs.A concise report on historical pricing and volume trends will help the broader HCV community to understand the market landscape,identify existing gaps,and work toward solving demand and supply related problems in the market.Addressing the market related

52、 problems can help expedite progress in achieving HCV elimination by 2030.Impact of COVID-19 Pandemic on Hepatitis C EliminationAs significant public health resources are redirected to address the COVID-19 pandemic,the strain on systems being pushed beyond limits to support pandemic preparedness and

53、 response is having critical implications on global health programs.Policies in place on physical distancing and redirected efforts of Ministries of Health and healthcare workers is affecting HCV diagnosis,treatment and harm reduction programs to varying degrees across countries.For the most part,co

54、untries are suspending routine screening,screening campaigns and clinic visits,which is disrupting HCV case finding efforts.There is a risk of incidence of HCV increasing with closure of harm reduction centers,without having policies in place to ensure that people who inject drugs that are at high r

55、isk of HCV infection have alternative access to critical harm reductions services,such as needle and syringe programs and opioid substitution therapy.Furthermore,the temporary closure of healthcare facilities and limits to non-emergency visits to reduce risk of SARS-CoV-2 virus transmission is affec

56、ting HCV treatment uptake.The world is facing an unprecedented pandemic crisis in COVID-19.The responses to the pandemic must also ensure that momentum in the scale-up of HCV elimination programs and other health priorities is not lost.Global and country action towards controlling COVID-19 can reinf

57、orce the fight against other epidemics;COVID-19 investments,for example,in the expansion of diagnostic capacity,supply chain systems,and upskilling of healthcare workers can lay the foundation for an acceleration of efforts to strengthen health systems overall.These opportunities cannot be overshado

58、wed by the overwhelming challenges the world is facing.6 WHO Progress Report on Access to Hepatitis C Treatment;Mar 2018.12Hepatitis C Market ReportWorld Health Organization Recommended HCV Testing and Treatment AlgorithmDiagnostics algorithmThe WHO recommends a simplified,two-step algorithm to diag

59、nose HCV.The algorithm includes an antibody screening test followed by a VL test for confirmation of viremia.7 All those who test positive for VL should be referred for treatment regardless of disease stage,though the duration of treatment may differ depending on the presence of cirrhosis.Twelve wee

60、ks after completing treatment,a VL test for confirmation of cure is recommended(SVR12).A health worker prepares samples for HCV testing at a lab in Rwanda Christine McNab13Hepatitis C Market ReportAssessment of hepatic fibrosis by APRI or FIB-4.Assessment of co-morbidities,pregnancy,and potential dr

61、ug-drug interactions.Genotyping for adolescents(12-17 years)to determine the appropriate treatment regimen.Recommended prior to treatment:Genotyping for adults when pan-genotypic DAAs are used in treatment.HCV viral load at week four due to a lack of clinical evidence in predicting cure.No longer ne

62、cessary:exhibit 1:Who Recommended Hcv Diagnostics Cascade for Adults7RDTLab-Based IAConfirmation of ViremiaViral Load TestViral Load Test Week 12(SVR12)Pan-genotypicTreatmentConfirmationof CureScreening7 Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infect

63、ion,World Health Organization(WHO);July 2018.14Hepatitis C Market ReportTreatment algorithmTreatment for Adults(18 years or older)For adults,WHO recommends pan-genotypic regimens including SOF with DCV SOF+DCV or SOF/DCV Fixed Dose Combination(FDC),Sofosbuvir/Velpatasvir(SOF/VEL)or Glecapravir/Pibre

64、ntasvir(G/P)as potential options for treatment.As per WHO guidelines,genotyping is not required for adults prior to treatment initiation,but continues to be recommended for adolescents(aged 1217 Defer Treatmentexhibit 2:WHO Recommended HCV Treatment Cascade,2018Genotyping testTesting for Liver Fibro

65、sisTesting for Liver Fibrosisyears)when a non-pan-genotypic regimen is used.In the near future it is anticipated that pan-genotypic regimens will be approved for younger age bands,abrogating the need for genotype testing in these groups.Further,factors such as the level of liver fibrosis(identified

66、through aspartate-to-platelet ratio index),comorbidities,pregnancy,and potential drug interactions should be considered while identifying the desired treatment regimen and length of treatment(refer to Exhibit 2 for details).*Persons with HCV genotype 3 infection who have received interferon and/or r

67、ibavirin in the past should be treated for 16 weeks;US guidelines now recommend 8-week treatment for cirrhotic and non-cirrhotic patients.*May be considered in countries where genotype distribution is known and genotype 3 prevalence is 5%.Details on treatment recommendation and algorithm for adolesc

68、ents and children available in Appendix 1.Source:WHO Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection,2018.Genotype 1,4,5,6:SOF/LDV:12 weeksGenotype 2:SOF+RBV:12 weeksGenotype 3:SOF+RBV:24 weeksOther considerations(comrbidities,pregnancy,potential d

69、rug-drug intractions)Other considerations(comrbidities,pregnancy,potential drug-drug intractions)Non-cirrhotic patients:SOF+DCV or SOF/DCV:12 weeksSOF/VEL:12 weeksG/P:8 weeks*Cirrhotic patients:SOF+DCV or SOF/DCV:24 weeks or 12 weeks*SOF/VEL:12 weeksG/P:12 weeks*12-17 years18+years50 bottles in the

70、India Import Export data included in analysis;Each bottle has 28 pills.Source:India Import Export Data;CHAI Analysis.regimen options or formulations for procurement.Decline in exports of SOF/LDV(non-pan-genotypic regimen),increase in exports for SOF/VEL(pan-genotypic regimen),and uptake of SOF/DCV F

71、DC and SOF+DCV(pan-genotypic regimen)indicate,not surprisingly,a preference for pan-genotypic regimens over non-pan-genotypic regimens.India,Egypt,Pakistan,Rwanda are examples of countries that have committed to scaling up their HCV programs.To accelerate progress towards HCV elimination,countries w

72、ill need to intensify case finding efforts.Countries that prioritized patients who were previously diagnosed and awaiting care for HCV treatment will need to focus on active case finding.Several other LMICs are expanding their HCV treatment programs but slow treatment uptake is a risk to achieving W

73、HO elimination goals by 2030.Limited data on in-country DAA procurement and procurement budgets has restricted capability to predict future market trends for DAAs.Increased procurement planning and transparency on in-country procurement plans can help suppliers identify future demand for DAAs and pl

74、an production accordingly,potentially making products available with a shorter lead-time.200K180K160K140K120K100K80K60K40K20K02017 2018 20192017 2018 20192017 2018 20192017 2018 20192017 2018 2019#of patient courses for 12 weeks of treatment114K177K131K101K1K1K9K38K36K24K17K11K16K47KSOF DCV SOF/DCV

75、SOF/LDV SOF/VELKeY TaKeaWaY32Hepatitis C Market ReportThe price of HCV treatment has fallen significantly over the past five years with the introduction of more effective treatment and expansion of the generic landscape for DAAs.Exhibit 12 illustrates that before 2014,there were no DAAs in the marke

76、t and price for interferon-based therapy was over US$3,000 per patient course.In 2014,with the introduction of DAAs,the price per patient course offered by the innovators was over US$750.More recently,the price for WHO PQd generic SOF and DCV has come down to US$60 per patient course for 12 weeks in

77、 Rwanda,making this price the new global benchmark price for WHO PQd HCV treatment.While some countries such as India,Pakistan,and Egypt are paying lower than US$60 per patient course,they are procuring locally approved products,which can be manufactured at a lower cost than WHO PQd products.Exhibit

78、 13 summarizes the weighted average price for a 12-week DAA treatment course in LMICs.Prices are shown in Freight On Board(FOB)terms.These are prices at which generic suppliers export drugs from India.They do not include shipping,customs,storage,and distributor-associated costs.Usually there are in-

79、country costs added to the FOB price,resulting in a higher final price to the buyer(price mark-ups addressed in detail in subsection on In-country Price Mark-ups).The trend in Exhibit 13 indicates that FOB prices for DAAs exported from India have reduced significantly The Rwanda HCV Elimination Prog

80、ram was launched in December 2018.As part of the program,the Rwanda Ministry of Health committed to eliminate HCV by treating 112,000 patients over a period of five years(2019-2024).The strong political will to scale-up the public program and eliminate HCV helped Rwanda obtain a price of$60 per 12-w

81、eek patient course with WHO PQ SOF+DCV.This price was obtained without a volume guarantee.Rwanda now plans to accelerate the timeline for HCV elimination to 2021.Pricing Trends33Hepatitis C Market Reportexhibit 12:Price Evolution of HCV Drugs(USD)exhibit 13:Weighted Average FOB Price*(USD)for 12 Wee

82、ks of Treatment with DAAs in LMICsNote:*SOF+DCV refers to a combination of SOF and DCV singles;SOF/DCV refers to FDC.Source:CHAI Analysis;The Global Fund Pool Procurement Reference Pricing as of Jan 2020;UNDP procurement support team as of Apr 2020.Note:SOF and DCV refer to singles,whereas SOF/DCV,S

83、OF/VEL and SOF/LDV refer to FDCs;*Pricing reflects Freight on Board price,which does not include shipping,customs and distributor-associated costs.Usually there are in-country costs added to the FOB price which result in a higher final price to the buyer;The price is weighted average of volumes of a

84、ll orders 50 bottles and their respective prices per bottle;Only orders above 50 bottles considered;Each bottle has 28 pills;Prices are for both WHO PQd/ERP reviewed and locally approved products.Source:India Import Export Data.from 2016 to 2020.This trend can be attributed to an increase in the num

85、ber of generic drug suppliers manufacturing DAAs and an increase in volumes as some countries scale-up.As of 2019,SOF/DCV FDC was exported at the lowest weighted average FOB price(US$86 per patient course for 12 weeks),followed by a combination of individual SOF and DCV(US$89 per patient course for

86、12 weeks).FOB price for SOF/VEL declined in 2019 as volumes demanded by LMICs increased.Countries including India,Myanmar,and Pakistan procured SOF/VEL in large quantities from Indian suppliers in 2019.FOB price for 12 weeks of treatment with DAAs$401$354$264$192$104$195$159$109$86$66$60$62$49$63$26

87、$150$22520019SOF DCV SOF/DCV SOF/VEL SOF/LDV$3,500$3,000$2,500$2,000$1,500$1,000$500$0Price of HCV drugs(USD)$3000$750$94$79$79$60Pre-DAAInterferon Based Treatment Price(Before 2014)Innovator Access Price for SOF+DCV(2014)The Global Fund PPM Reference Price for SOF+DCV(Q1 2020)The Global

88、Fund PPM Reference Price for SOF/DCV(Q1 2020)Rwanda Elimination Program Price(Q1 2020)UNDP Procurement Price for SOF+DCV(Q1 2020)Pricing for 12 weeks of treatment with SOF+DCV or SOF/DCV*$500$400$300$200$100$034Hepatitis C Market Reportexhibit 14:In-country Price for 12 Weeks of Treatment with SOF a

89、nd DCV*Note:*SOF and DCV refer to singles,SOF+DCV refers to a combination of SOF and DCV singles,SOF/DCV refers to FDC;The prices mentioned are public sector prices paid by govt.in country if available,or lowest identified private sector prices if public sector price not available;Prices shown can b

90、e for originator or generic product;Amongst generic products,prices can be for WHO PQd/ERP reviewed or locally quality assured products;Price data for DCV not available for Ethiopia and Thailand;Price breakdown between SOF and DCV not available for Cameroon,Myanmar,Rwanda and Pakistan;DCV price for

91、Vietnam as of Q1 2019 as DCV was unavailable in-country from Q2 2019-Q1 2020;Prices as of 2018 for Nepal,and as of 2019 for all other countries.Source:CHAI analysis for India,Nigeria,Indonesia,Vietnam,Rwanda,Cambodia,Myanmar,Ethiopia;Coalition PLUS for Malaysia;Treat ASIA/amfAR Aug 2018 and Sep 2019

92、 updates for Ukraine,Thailand and Nepal;World Hepatitis Alliance and members for Egypt,Philippines and Cameroon;Aga Khan University for Pakistan.SOF/LDV and SOF/VEL are comparatively expensive regimens based on FOB prices,however,the in-country price trend may differ from one country to another.For

93、example,the in-country price of both SOF/VEL and SOF/LDV is cheaper than the price of SOF+DCV in Vietnam.This is due to the limited number of DCV products available in-country,combined with a large number of locally approved SOF/LDV suppliers ensuring a competitive market for this product.Three DCV

94、products have been registered in Vietnam since Q4 2019,which may lead to a decline in DCV price in the future.In the case of SOF/VEL,Gilead registered its product in Vietnam in 2019 and offered the product at a lower price than that of SOF+DCV.While the global benchmarks for DAA prices have declined

95、,there is significant variability in prices across high-burden countries.Exhibits 14,15,and 16 show that while some countries are accessing DAAs at less than US$40 per patient course for 12 weeks,some are paying more than US$700 per patient course for 12 weeks.There is no standardized global price t

96、hat countries are accessing yet.In-country procurement mostly occurs by either the private sector,or the public sector through tenders or country specific negotiations with suppliers.Egypt,India,and Pakistan have secured very low prices for DAAs across regimens as they are scaling-up public programs

97、 rapidly and moving towards HCV elimination.However,these countries are using locally approved products(that are not WHO PQd/ERP reviewed),which tend to be less expensive.While the prices of non-WHO PQd products are lower,they could indicate lower limits for pricing possible on commoditized WHO PQd

98、products(i.e.products which have been manufactured at a large scale for more than three years).Price per 12 weeks of treatment(USD)$1,600$1,200$800$400$0CameroonThailandRwandaEgyptVietnamIndonesiaPhilippinesNepalMalaysiaCambodiaNigeriaEthiopiaMyanmarUkraineIndiaPakistan$1,347$750$734$640$505$290$273

99、$231$207$117$93$92$78$60$45$39$28SOF DCV SOF+DCV SOF/DCVExample high burden HCV countries(non exhaustive)35Hepatitis C Market Reportexhibit 15:In-country Price for 12 Weeks of Treatment with SOF/LDV*exhibit 16:In-country Price for 12 Weeks of Treatment with SOF/VEL*Note:*SOF/LDV refers to FDC;SOF/LD

100、V is not a pan-genotypic DAA regimen and is not recommended by WHO for use in adults.However,it remains the only WHO-recommended all-DAA regimen for adolescents(12-17 years).The prices are public sector prices paid by govt.if available,or lowest identified private sector prices if public sector in-c

101、ountry price not available;Prices shown can be for originator or generic product;Amongst generic products,prices can be for WHO PQd/ERP reviewed or locally quality assured products;Prices as of 2019.Source:CHAI analysis for Nigeria,Indonesia,Vietnam,Myanmar,Ethiopia;Coalition PLUS for Brazil;Treat A

102、SIA/amfAR Aug 2019 updates for Ukraine and Thailand;mapCrowd for Egypt(mapCrowd accessed on 29th April 2020);World Hepatitis Alliance member for Cameroon.Note:*SOF/VEL refers to FDC;The prices are public sector prices paid by govt.to the supplier if available,or lowest identified private sector pric

103、es if public sector in-country prices not available;Prices shown can be for originator or generic product;Amongst generic products,prices can be for WHO PQd/ERP reviewed or locally quality assured products;Prices as of 2019.Source:CHAI Analysis for India,Nigeria,Indonesia,Vietnam,Myanmar;Coalition P

104、LUS for Colombia and Brazil;World Health Alliance member for Philippines;mapCrowd for Egypt(mapCrowd accessed on 29th April 2020);Aga Khan University for Pakistan.Price per 12 weeks of treatment(USD)$1,000$1,500$4,600$500$0PhilippinesIndonesiaNigeriaVietnamMyanmarEgyptColombiaBrazil$4,500$1,470$1,27

105、5$1,140$900$576$190India$105$1,041Price per 12 weeks of treatment(USD)Indonesia$855Nigeria$750Ethiopia$465Cameroon$252Egypt$95Ukraine$90$888Vietnam$171Myanmar$327ThailandBrazil$1,148$1,500$1,000$500$0Pakistan$8436Hepatitis C Market ReportIn Vietnam,regimens are available in public hospitals where pa

106、tients can pay out-of-pocket for treatment.The Vietnam government formally announced in 2018 that as of 1st January 2019,50 percent of HCV drug costs will be covered by the public health insurance scheme in National and Provincial health facilities a significant step toward sustainable financing.Thi

107、s effort aims to reduce the financial burden to patients,who were facing high out-of-pocket expenses for drugs and diagnostics.Myanmar has initiated a public-private partnership model in three public healthcare facilities across Yangon and Mandalay so that patients diagnosed in both the public and p

108、rivate sectors that are ineligible for free care through the public program,but willing and able to pay out of pocket,have access to WHO PQd/ERP reviewed drugs and lab services at reduced costs.Some other high-burden countries are working toward expanding their HCV programs to increase access to tre

109、atment.For example:Indonesia expanded its national hepatitis program to seven new provinces in 2018 and one new province in 2019.This led to hepatitis treatment being available in 15 out of 34 provinces in Indonesia.In Morocco,the public sector has not yet begun treatment of HCV with DAAs,but is wor

110、king toward it.A significant step forward has been made in Nigeria,building off CHAIs efforts in Nasarawa.In February 2020,the Governor of Nasarawa State announced the governments commitment to scale-up HCV elimination efforts,with the goal to treat 124,000 HCV patients and eliminate HCV by 2024.Thi

111、s Patients accessing treatment through the public sector program in India can access SOF+DCV and SOF/VEL free of charge.Similarly,patients in Rwanda,Myanmar,and Indonesia can access SOF+DCV free of charge through the public sector program.Before Indias launch of its National Program in July 2018 in

112、India,SOF/LDV was available free of charge to patients in Punjab and Haryana.The National Program now recommends the use of SOF with DCV,and SOF/VEL,which are available free of charge to public sector patients.As the national program no longer recommends the use of SOF/LDV,patients would now have to

113、 pay out-of-pocket to access this drug.Similarly,patients pay out-of-pocket for SOF/LDV and SOF/VEL in Myanmar,and Indonesia.In Nigeria,while the drugs are procured through the MoH to facilitate pooled procurements and volume-based pricing benefits,patients pay out-of-pocket for drugs at public sect

114、or hospitals with a minimal price mark-up above the MoH procurement price to cover basic operational costs.In Cambodia,patients co-infected with HIV and HCV on Antiretroviral Therapy(ART)could access SOF and DCV free of charge in the public sector,but paid out-of-pocket for other regimens.However,ac

115、ross countries where drugs are procured by the public program and provided free of charge to patients,procurement is limited by available budget.Hence,there are limited volumes of drugs available free of charge for treatment of public sector patients,which might lead to public sector patients having

116、 to wait to be able to obtain treatment for free.Given the lack of funding for HCV treatment,some high-burden countries have identified alternative ways to reduce price of treatment to patients.For example:Patients receive treatment for HCV in Vietnam37Hepatitis C Market Reportcreates a platform for

117、 possible collaborations and opportunities for market-shaping discussions that can further accelerate the uptake of HCV diagnostics and curative treatments.High-burden middle-income countries such as Brazil and Colombia are still paying high prices for originator DAAs as they are not included in BMS

118、,Gilead,and AbbVies licensing agreements for DAAs.Brazil is procuring SOF/LDV and SOF/VEL from Gilead,and the products are available in the public sector.Colombia has two main insurance schemes:the contributory plan and the subsidized plan.The contributory regime is administered federally and applie

119、s primarily to a cadre of public employees and self-employed workers with contributory capacity.The subsidized(non-contributory)scheme is for informal workers and low-income self-employed workers.Procurement via the PAHO Strategic Fund for Epclusa(originator SOF/VEL at US$4,000 for 12 weeks)has been

120、 limited to procurement by the contributory plan.However,negotiations are in process to allow the subsidized scheme to be linked with the procurement of DAAs via orders to the PAHO Strategic Fund.Georgia is on track to achieve elimination by 2025 and it is estimated that 50 percent of Georgias popul

121、ation of 4 million people has been screened and 44,500 have been cured,as of Mar 2020.Georgias progress so far has been helped by a drug donation from Gilead,strong political backing and information systems,availability of HCV commodities,engagement with civil society,and advocacy.Global benchmark p

122、rices for drugs have declined significantly.However,many countries continue to pay exorbitant prices.LMICs can aim to achieve a price of less than US$100 per patient course for 12 weeks of treatment with WHO PQd SOF and DCV.Countries can also aim for$60 per patient course for 12 weeks of treatment w

123、ith WHO PQd SOF and DCV if there is strong public commitment by government to HCV elimination over a defined period of time and procurement volumes are large,as observed in Rwanda.KeY TaKeaWaYState Governors HCV elimination dialogue,Nasarawa,Nigeria Nasarawa State Government38Hepatitis C Market Repo

124、rtin-country Price Mark-upsPrices remain high for HCV medications in some countries despite a decline in FOB prices offered by generic suppliers.This trend can be attributed to in-country price mark-ups.In-country mark-ups may include shipping and insurance,import duties and in-country taxes,storage

125、,facility maintenance and transportation costs,pharmacists salaries,distributor margins,etc.,as illustrated in Exhibit 17.exhibit 17:In-country Fixed and Variable Costs Included in DAA Pricing(Illustrative;Non-exhaustive List of Sources of Price Mark-up)Note:Freight on Board(FOB)is the price at whic

126、h the supplier exports the drug from the country.This price does not include price mark-ups.Price for SOF for 12 weeks of treatment and price mark-upsFreight on Board(FOB)PriceShipping&insuranceImport Duties,Taxes,In-Country Transport,etc.Storage cost/Pharmacists Salary,Facility Maintenance CostDist

127、ributor-MarginsFinal Price$147$30815%10%20%38%Price per patient for 12 weeks of SOF(USD)$0$100$200$300$400$500exhibit 18:In-country Price Mark-ups on SOF(Indicative)Note:*Freight on Board(FOB)prices are prices at which the supplier exports the drug from the country.These prices do not include shippi

128、ng,customs,storage and distributor-associated costs;The SOF FOB price is the weighted average of volumes of orders 50 bottles and their respective price per bottle;In-country price mark-ups are indicative and only directional as weighted average FOB price of multiple suppliers is compared with in-co

129、untry price offered by a single supplier.Source:India Import Export Data for FOB price;CHAI analysis for Indonesia,Cambodia and Vietnam in-country prices;World Hepatitis Alliance member for Philippines in-country price;CHAI analysis for mark-up percentages.Price per patient for 12 weeks of SOF(USD)$

130、600$200$300$500$700$800$400$100$0Price mark-up(%)SOF wt.avg.FOB Price*SOF In-country PriceVietnam234%$225$750Cambodia59%$132$83Philippines370%$120$566Evaluating what the breakdown of the various price mark-ups are(such as supply chain related costs and profit margins)is important.This could provide

131、countries with the opportunity to work toward optimizing price-to-patient.Exhibits 18 and 19 demonstrate an indicative range of price mark-ups across countries,with some countries paying small mark-ups while others paying large mark-ups.39Hepatitis C Market Reportexhibit 19:In-country Price Mark-ups

132、 on DCV(Indicative)Note:*Freight on Board(FOB)prices,which are the prices at which the supplier exports the drug from the country.These prices do not include shipping,customs,storage and distributor-associated costs;The DCV FOB price is the weighted average of volumes of all orders 50 bottles and th

133、eir respective price per bottle;In-country price mark-ups are indicative and only directional as weighted average FOB price of multiple suppliers is compared with in-country price offered by a single supplier.Source:India Import Export Data for FOB price;CHAI analysis for Cambodia,Indonesia and Viet

134、nam in-country price;Treat ASIA/amfAR Aug 2018 for Nepal in-country price;World Hepatitis Alliance member for Philippines in-country price;CHAI analysis for mark-up percentages.Price per patient for 12 weeks of DCV(USD)$200$300$500$600$700$800$400$100$0Price mark-up(%)DCV wt.avg.FOB Price*DCV In-cou

135、ntry PriceCambodia38%$72$99Nepal74%$95$166Philippines283%$44$168Vietnam528%$95$597Countries observing high price mark-ups can reduce prices by identifying different contributing factors and limiting them where possible.KeY TaKeaWaY40Hepatitis C Market Reportinternational Procurement MechanismsIntern

136、ational and regional organizations such as GFATM,UNDP,and PAHO have implemented central mechanisms through which they pool procurement and negotiate lower prices with suppliers.Countries can consider these mechanisms for product procurement.Countries can also use the prices offered by these mechanis

137、ms as benchmarks for local tenders,or for negotiating price deals with suppliers.The Global Fund Pooled Procurement Mechanism(PPM):GFATM leverages its position as one of the largest buyers of antiretroviral(ARV)drugs and other related HIV health products in the global health market to establish fram

138、ework agreements and negotiate reference prices for several key,yet often low-volume,essential medicines recommended by WHO.GFATM leverages the PPM to aggregate order volumes on behalf of participating grant implementers to negotiate prices and delivery conditions with suppliers.The current prices n

139、egotiated by GFATM for 12 weeks of HCV treatment are US$94 for individual SOF+DCV,US$79 for SOF/DCV FDC,and US$165 for SOF/LDV.GFATM procures DAAs from WHO PQd/ERP reviewed suppliers only.Learn more about The Global Fund Pooled Procurement Mechanism here.Learn more about The Global Funds terms for H

140、CV drugs being open to other buyers to PPM here.The UNDP Health Procurement Mechanism:The UNDP Health Procurement Mechanism supports Ministries of Health with procurement services for DAAs.UNDP also provides advice on intellectual property,regulatory aspects,and national supply chain strengthening.A

141、 hundred and five countries(refer to Appendix 3.3 for names of countries)can access the UNDP procurement mechanism by signing a Financing Agreement with UNDP Country Office(CO)and transferring funds to the CO.UNDP prioritizes quality-assured health products.The current prices negotiated by UNDP for

142、12 weeks of HCV treatment are US$79 for SOF+DCV,US$90 for SOF/LDV,and US$270 for SOF/VEL.UNDP procures SOF+DCV and SOF/LDV from WHO PQ/ERP reviewed suppliers only.When UNDP negotiated prices,there were no QA suppliers for SOF/VEL;hence,UNDP conducted in-house assessment of manufacturing sites and pr

143、oduct dossiers before procuring SOF/VEL from supplier(s).In 2018-2019,UNDP procured DAAs for 20,000 patients in Kazakhstan(all patients on SOF and DCV)and 3,600 patients in Ukraine(2,690 patients on SOF/LDV,950 on SOF and DCV).In 2019,UNDP procured SOF and DCV for 400 patients in Azerbaijan.For 2020

144、-2021,Turkmenistan plans to outsource procurement for 500 patients on SOF/VEL,and 500 patients on SOF and DCV.PAHO Strategic Fund:PAHOs Strategic Fund offers technical support in procurement planning and supply management of DAAs.It negotiates with different international suppliers to obtain lower p

145、roduct prices in the Americas.The Member States(list available in Appendix 5)can purchase DAAs through the Strategic Fund.The most recent prices negotiated by the PAHO Strategic Fund for 12 weeks of HCV treatment are US$129 for SOF and DCV,and US$4,050 for SOF/VEL or SOF/LDV.All products offered thr

146、ough the Fund meet PAHO/WHO quality standards.However,several member countries are unable to access the Strategic Fund negotiated prices because they have not been included in BMS/Gileads licenses.As a result,these countries may end up paying more than the price negotiated by the Strategic Fund.Lear

147、n more about the PAHO Strategic Fund here.Countries can explore global procurement mechanisms to procure HCV treatment at a more affordable price.Countries can also use the prices offered by these mechanisms as benchmarks for local tenders,or for negotiating price deals with suppliers.KeY TaKeaWaY41

148、Hepatitis C Market ReportPrograms that have aggressively scaled-up treatment volumes have usually benefited from significant price breaks,as shown in Exhibit 20.For orders in the range of over 3,000 patient courses12 of SOF and DCV,Egypt and Pakistan have been able to receive very competitive FOB pr

149、ices,of up to 125%reduction over orders in the range of 1,000-3,000 patient courses12.Rwanda too has procured over 3,000 patient courses12 and has obtained a Volume Based Pricingcompetitive price for DCV.However,DCV exported to Rwanda is more expensive than DCV exported to Pakistan despite higher or

150、der volumes in Rwanda.This could be driven by the fact that Rwanda is procuring WHO PQd products while Pakistan might be procuring locally approved products without WHO PQ.Non WHO PQd products can be cheaper than WHO PQd productsexhibit 20:2019 Volume Based Pricing for DAAs(USD)Note:Only orders goin

151、g to LMICs and above 50 bottles considered;Each bottle has 28 pills;Two orders of SOF going to Indonesia in the range of 1K-3K patient courses each excluded as they were outliers Source:India Import Export DataRange for#of patient courses for 12 weeks of treatmentPrice per 12 weeks of treatment(USD)

152、$300$250$200$150$100$50$0SOF DCV$94$55$1491K$80$28$1081K-3K3K+$43$64$21SOF/LDV$1551K$1461K+SOF/VEL$2643K Patient CoursesSource:India Import Export DataCountries without the resources to procure high volumes can still optimize order sizes through quantification and procurement planning exercises to e

153、nsure they receive the lowest volume-based pricing.Country programs can benefit from lower pricing by planning procurement and ordering DAAs in optimal quantities.SOFDCV#patient coursesFOB price for 12 weeks of treatment(USD)#patient coursesFOB price for 12 weeks of treatment(USD)Egypt39.7KUS$39Paki

154、stan8.7KUS$3217.1KUS$10KeY TaKeaWaY43Hepatitis C Market ReportWhile several countries including India,Pakistan,Egypt,and Rwanda have scaled-up their programs and are consequently on the path to elimination,global progress toward WHO 2030 HCV elimination goals is slow.The increasing availability of c

155、ost effective,QA diagnostics and treatment options,in parallel with the simplified WHO guidance on testing,has lowered some barriers to feasible and effective diagnosis and care.Diagnostic and drug pricing is now a far less significant barrier to scale-up of HCV programs in LMICs than previously.Som

156、e LMICs,with limited public and donor funding available,have effectively utilized public-private partnerships or insurance schemes as a means to augment public programs and kick start testing and treatment.Despite recent achievements,a wide range of prices exists across LMICs for testing and treatme

157、nt with some countries paying high prices for commodities.Even within countries,the lack of mature public programs,multiple procurement channels,and the absence of coordinated activities across disease areas may lead to disparate and high prices.Diagnostic pricing often contains complex and difficul

158、t to discern components such that the ultimate cost to the program may be unknown.The lack of publicly available data on diagnostic prices and volumes and limited in-country information regarding DAA procurement budgets continues to hamper accurate forecasting.While these and other challenges persis

159、t in many countries,there are ways in which countries can seek opportunities to scale-up programs.options,in parallel with the simplified WHO guidance on testing,has lowered some barriers to feasible and effective diagnosis and care.Increased domestic and international financing for HCV elimination

160、is urgently needed to reach the 2030 target of HCV elimination globally.Looking Forwardcost effective,QA diagnostics and treatmentThe increasing availability of44Hepatitis C Market ReportGoing forward,countries can increase accessibility and affordability of diagnostics and drugs by accelerating in-

161、country registration of WHO PQd diagnostics and treatment products.This will facilitate competition in the market and the availability of QA commodities to maintain a high quality of care.Countries can target a 12 week treatment course using WHO PQd SOF and DCV for less than US$100 per patient cours

162、e,or even as low as US$60 per patient course if there is strong public commitment by government to HCV elimination over a defined period of time and procurement volumes are large as observed in Rwanda.Countries can also aim to optimize procurement volumes in order to maximize available procurement b

163、udgets.Identifying and reducing price mark-ups on products can help optimize supply-chain costs.A number of global pricing agreements by diagnostics suppliers and global procurement mechanisms for DAAs now exist,which can be leveraged to streamline procurement and lower prices respectively.Recent ex

164、perience has shown that,with strong political will and a public commitment to work towards HCV elimination within a reasonable timeframe,countries can secure diagnostic and treatment commodities to cure HCV for less than US$100 per patient,and in some cases lower than that.Nascent programs that are

165、beginning to implement HCV treatment programs should consider the benefits of rapid scale up,in order to secure affordable pricing of diagnostics and drugs and decrease the need for ongoing costs by eliminating the disease in their countries.In 2016 alone,as per WHO estimates,399,000 patients died d

166、ue to HCV infection.If the world is able to achieve elimination(as defined by WHO)by 2030,we would have reduced mortality from HCV infection to less than 140,000 deaths(65%reduction).Increased domestic and international financing for HCV elimination is urgently needed to reach the 2030 target of HCV

167、 elimination globally.Healthy children,that define the countrys future,play basketball in Rwanda Christine McNab45Hepatitis C Market ReportExpert Review Panel(ERP)ERP is a risk based review by WHO PQ Team.It provides advice to allow for interim procurement,time limited for a maximum of one year,duri

168、ng which time the product should progress towards prequalification by WHO or approval by a Stringent Regulatory Authority(SRA).Finished Dosage Form(FDF)A final drug product,for example,tablet,capsule,solution,etc.Freight on Board(FOB)Export price which does not include shipping,customs and distribut

169、or associated costs.Usually there are in-country costs added to the FOB price which result in a higher final price to the buyer.Medicines Patent Pool(MPP)The Medicines Patent Pool(MPP)is a United Nations-backed public health organization that negotiates with patent holders for licenses on lifesaving

170、 medicines for LMICs.These licenses permit multiple suppliers to produce and distribute generic versions of patented medicines in developing countries.Competition between quality-assured generic pharmaceutical companies helps bring prices down and accelerates access to new treatments in developing c

171、ountries.Stringent Regulatory Authorities(SRA)The national drug regulatory authorities which are members or observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH)are considered as Stringent Regulatory

172、Authority as per the GFATM Quality Assurance Policy for Pharmaceutical Products.Members include European Union member States,Japan,and the United StatesWHO Prequalification ProgramWHO Prequalification Program aims to ensure that diagnostics,medicines,vaccines and immunization-related equipment and d

173、evices for high burden diseases meet global standards of quality,safety and efficacy.This information is used by UN and other procurement agencies to make purchasing decisions.Glossary46Hepatitis C Market ReportAppendixappendix 1:World Health Organization Recommended HCV Testing and Treatment Algori

174、thmDiagnostics algorithmThe WHO recommends a simplified,two-step algorithm to diagnose HCV.First,a blood test to screen for HCV antibodies,using either a RDT or lab-based Immunoassay(IA)is performed.A positive antibody result indicates that the individual has been exposed to the pathogen.Although so

175、meone may have been exposed to a virus,and thereby possess antibodies against the pathogen,their immune system may have successfully cleared the virus from their body.A subsequent RNA nucleic acid VL test is therefore performed for individuals who screen positive for HCV antibodies to confirm active

176、 viremia prior to initiating treatment.All those who test positive for VL should be referred for treatment regardless of disease stage,though the duration of treatment may differ depending on the presence of cirrhosis.When RNA testing is not available,quantification of HCV core Antigen(HCV cAg)by th

177、e lab-based Abbott ARCHITECT platform may serve as confirmation of viremia.Twelve weeks after completing a full treatment course,a VL test is recommended to provide a confirmation of HCV cure.Due to the sensitivity required for SVR12 however,HCV cAg testing is not recommended for confirmation of cur

178、e.The need to maintain VL testing for SVR12 is therefore essential and cannot be replaced solely through the use of quantification of cAg in the diagnostics cascade.In targeting elimination as set by the WHO,testing needs to be cost-effective and streamlined.Screening using rapid antibody tests and

179、confirmation of viremia and cure by VL is therefore the method most often employed in elimination programs.Previous diagnostic guidelines recommended the use of viral load monitoring at week 4 and required the determination of the viral genotype to enable appropriate treatment.The current diagnostic

180、s cascade,recommended by WHO in 2018,is simplified from the previous guidance.Assessing viral load at week 4 has been eliminated due to the lack of evidence correlating viral load at week 4 with those who achieve cure.In addition,when pan-genotypic DAAs are utilized in treatment,genotyping is not re

181、quired,thereby significantly reducing the cost and complexity of testing.47Hepatitis C Market Reportappendix 2:DAA Originators and Licensing AgreementsGilead,BMS,and AbbVie,the originators of key HCV drugs(DAAs),have agreements that allow them to license/sublicense their drugs to generic suppliers,i

182、n order to make drugs available at affordable prices in a large number of LMICs.List of eligible countries covered under the licensing agreements in Appendix 3.Gilead:Gilead has directly licensed SOF,SOF/LDV,SOF/VEL and sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX)to generic suppliers.Fourteen ge

183、neric suppliers have a license for Gileads drugs.Indian generic suppliers listed in Exhibit 22 are permitted to sell Gilead licensed drugs across 105 countries,whereas Pakistani and Egyptian generic suppliers including Ferozsons(Pakistan),Magic Pharma(Egypt)and Pharmed(Egypt)are only permitted to ma

184、nufacture and sell in their local markets.BMS:In 2015,BMS signed a licensing agreement with Medicines Patent Pool(MPP)for sublicensing its originator daclatasvir(Daklinza)to generic Treatment algorithmTreatment for Adults(18 years or older)For adults(18 years or older),WHO recommends pan-genotypic r

185、egimens including SOF and DCV(individual SOF+DCV or SOF/DCV FDC),SOF/VEL or G/P as potential options for treatment.Genotyping is not required.Liver fibrosis(identified through aspartate-to-platelet ratio index),comorbidities,pregnancy,and potential drug drug interactions should be considered while i

186、dentifying desired treatment regimen and length of treatment.Treatment for children(under 12 years of age)and adolescents(12-17 years of age)WHO recommends that in children under 12 years,treatment be deferred until they either reach 12 years or until DAA regimens are approved for those less than 12

187、 years.For adolescents(12-17 years),2018 WHO HCV Treatment Guidelines recommend the use of genotype-specific regimens including SOF/LDV or sofosbuvir with ribavirin(SOF+RBV).Genotyping is required prior to determination of appropriate treatment regimen.Urgent efforts are underway by WHO and partners

188、 to review pharmacokinetic and clinical data on SOF/DCV,the pan-genotypic regimen most widely used among adults,to determine whether it could be recommended for use among adolescents(1217 years).The ability to treat all adolescents 12 years and older with the most widely used and least expensive DAA

189、 regimen is highly desirable.More recent FDA approvals have expanded treatment availability beyond these guidelines:In August 2019 SOF/LDV and SOF+RBV received FDA approval for use down to age of 3 years or older,and in April 2019 G/P was approved for use in ages 1217 years.The FDA approved in March

190、 2020 the use of SOF/VEL,in combination with ribavirin,in children down to the age of six years.suppliers.A hundred and twelve countries were included in this agreement and eight generic suppliers currently have a sublicense for the product.In 2019,BMS ceased distribution of Daklinza in US and Europ

191、ean markets for commercial reasons.In Mar 2020,BMS announced that the marketing authorizations for Daklinza will be withdrawn or will be allowed to lapse in countries where the product no longer is routinely prescribed or where there are other therapeutic options available.This will affect some addi

192、tional countries outside the licensed territory to the Medicines Patent Pool(MPP).Following the withdrawal/lapse of the marketing authorization in each country,the patents in that country will be allowed to lapse.In the interim period between the withdrawal/lapse of a marketing authorization and the

193、 patent expiry,BMS will not enforce its patents for Daklinza in that country.Patients diagnosed with HCV in additional countries will soon have access to generic versions of daclatasvir.This list,with or without existing patents,includes Albania,Armenia,Belarus,Bosnia,Bulgaria,Chile,Colombia,Egypt,J

194、ordan,Kazakhstan,Kosovo,Kyrgyz Republic,Lebanon,Macedonia,Malaysia,Mexico,Moldova,Montenegro,Peru,Romania,Serbia,Thailand,Tajikistan,Ukraine,Uruguay,and Venezuela.48Hepatitis C Market ReportMylans daclatasvir will replace BMS Daklinza as the reference product for future WHO PQ/ERP reviews of generic

195、 daclatasvir.AbbVie:AbbVie signed a licensing agreement with MPP for G/P in November 2018,and Mylan was the first supplier to obtain the sublicense in Dec 2019 to manufacture G/P.It could take over two years for a generic supplier to develop and commercialize G/P after obtaining a sublicense to manu

196、facture it,given that manufacturing the product and obtaining quality assurance can be a time-consuming process.BMS signed the licensing agreement with MPP for DCV in November 2015 and the first DCV WHO PQ exhibit 22:Generic Licensees for SOF,DCV,SOF/LDV,SOF/VEL,SOF/VEL/VOx,G/Pfiling was in Q2 2017.

197、Developing generic G/P might take longer than developing generic DCV,as G/P is an FDC for which suppliers will have to develop two APIs and prove Bioequivalence(BE)for both.Developing DCV required development of only one API and proving its BE.India,although an HCV high burden LMIC that is included

198、in sublicense agreements for Gilead and BMS HCV drugs,has not been included in the licensing agreement for G/P.Note:Updated as of Jan 2020.Source:Gileads licensing agreement;BMS and MPP licensing agreement,AbbVie and MPP licensing agreement.DAA#of countries included in license/sublicense agreement%o

199、f countries included in the license/sublicense agreement that are LMICsGeneric sub-licenseesGileadSOF SOF/LDV SOF/VEL SOF/VEL/VOX105(Refer to Appendix 3.1 for list of countries)72%Aurobindo,Biocon,Cadila,Cipla,Ferozsons(Pakistan),Hetero,Laurus,Magic Pharma(Egypt),Mylan,Natco,Pharmed(Egypt),Sequent,S

200、trides,Sun PharmaBMSDCV112(Refer to Appendix 3.2 for list of countries)80%Aurobindo,Beximco,Cipla,Hetero,Laurus Labs,Mylan,Natco,Zydus CadilaAbbVieG/P96(Refer to Appendix 3.4 for list of countries)72%Mylan49Hepatitis C Market Reportappendix 3:Countries included in the licensing agreements for DAAsap

201、pendix 3.1COUNTRIES INCLUDED IN GILEADS LICENSING AGREEMENT FOR SOF,SOF/VEL,SOF/LDV,SOF/VEL/VOXAfghanistanCote dIvoireKenyaNauruSri LankaAlgeriaCubaKiribatiNepalSt.Vincent and the GrenadinesAngolaDjiboutiKyrgyz RepublicNicaraguaSudanAntigua and BarbudaDominicaLao PDRNigerSurinameBangladeshEgyptLesot

202、hoNigeriaSwazilandBelarusEl SalvadorLiberiaNorth KoreaTajikistanBeninEquatorial GuineaLibyaPakistanTanzaniaBhutanEritreaMadagascarPalauThailandBoliviaEthiopiaMalawiPapua New GuineaTimor-LesteBotswanaFijiMalaysiaParaguayTogoBurkina FasoGabonMaldivesPhilippinesTongaBurundiGambiaMaliRwandaTunisiaCambod

203、iaGhanaMarshall IslandsSamoaTurkmenistanCameroonGuatemalaMauritaniaSao Tome&Pr.TuvaluCape VerdeGuineaMauritiusSenegalUgandaCentral African RepublicGuinea-BissauMicronesiaSeychellesUkraineChadGuyanaMongoliaSierra LeoneUzbekistanComorosHaitiMoroccoSolomon IslandsVanuatuCongo,DRHondurasMozambiqueSomali

204、aVietnamCongo,Rep.IndiaMyanmarSouth AfricaZambiaCook IslandsIndonesiaNamibiaSouth SudanZimbabwe50Hepatitis C Market Reportappendix 3.2COUNTRIES INCLUDED IN BMS AND MPPS LICENSING AGREEMENT FOR DCVAfghanistanEl SalvadorMalawiSeychellesAlgeriaEquatorial GuineaMaldivesSierra LeoneAngolaEritreaMaliSolom

205、on IslandsAzerbaijanEthiopiaMarshall IslandsSomaliaBangladeshFijiMauritaniaSouth AfricaBelizeGabonMauritiusSouth SudanBeninGambia,TheMicronesiaSri LankaBhutanGeorgiaMongoliaSt LuciaBoliviaGhanaMoroccoSt Vincent and the GrenadinesBotswanaGrenadaMozambiqueSudanBurkina FasoGuatemalaMyanmarSurinameBurun

206、diGuineaNamibiaSwazilandCambodiaGuinea-BissauNauruSyriaCameroonGuyanaNepalTimor-LesteCape VerdeHaitiNicaraguaTogoCentral African RepublicHondurasNigerTongaChadIndiaNigeriaTunisiaComorosIndonesiaNiueTurkmenistanCongo,Democratic RepublicIraqPacific Islands(Palau)TuvaluCongo,RepublicJamaicaPakistanUgan

207、daCook IslandsKenyaPanamaUnited Republic of TanzaniaCosta RicaKiribatiPapua New GuineaUzbekistanCote dIvoireKorea,Dem.Rep.ParaguayVanuatuCubaLaosPhilippinesVietnamDjiboutiLesothoRwandaWest BankDominica LiberiaSamoaYemenDominican RepublicLibyaSao Tome and PrincipeZambiaEcuadorMadagascarSenegalZimbabw

208、e51Hepatitis C Market Reportappendix 3.3COUNTRIES INCLUDED IN UNDP HEALTH PROCUREMENT MECHANISM AfghanistanCubaKenyaNauruSudanAlgeriaDjiboutiKiribatiNepalSurinameAngolaDominicaKorea DPR ofNicaraguaTanzaniaArmeniaEgyptKyrgyz RepublicNigerThailandBangladeshEl SalvadorLao PDRNigeriaTimorLesteBeninEquat

209、orial GuineaLesothoPakistanTogoBelarusEritreaLiberiaPalauTongaBhutanEswatini(former Swaziland)LibyaPapu New GuineaTunisiaBoliviaEthiopiaMadagascarParaguayTurkmenistanBostwanaFijiMalawiPhilippinesTuvaluBurkina FasoGabonMaldivesRwandaUgandaBurundiGambiaMaliSaint Vincent and the GrenadinesUkraineCambod

210、iaGhanaMalaysiaSamoaUzbekistanCameroonGuatemalaMarshal IslandsSao Tome and PrincipeVanuatuCape VerdeGuineaMauritaniaSenegalVietnamCentral African RepublicGuinea BissauMauritiusSeychellesZimbabweChadGuyanaMicronesiaSolomon IslandsZambiaComorosHaitiMongoliaSierra LeoneCongoIndiaMoroccoSomaliaCook Isla

211、ndsIndonesiaMyanmarSouth AfricaCote dIvoireHondurasMozambiqueSouth SudanDemocratic Republic of the CongoKazakhstanNamibiaSri Lanka52Hepatitis C Market Reportappendix 3.4COUNTRIES INCLUDED IN ABBVIE AND MPPS LICENSING AGREEMENT FOR G/PAfghanistanEquatorial GuineaMaldivesSao Tome and PrincipeAngolaEri

212、treaMaliSenegalAntigua and BarbudaEswatiniMarshall IslandsSeychellesBangladeshEthiopiaMauritaniaSierra LeoneBelizeFijiMauritiusSolomon IslandsBeninGabonMicronesiaSomaliaBhutanGambiaMoroccoSouth AfricaBoliviaGeorgiaMozambiqueSouth SudanBotswanaGhanaMyanmarSri LankaBurkina FasoGrenadaNamibiaSudanBurun

213、diGuineaNauruSurinameCambodiaGuinea-BissauNepalTanzaniaCameroonGuyanaNigerTimor-LesteCape VerdeHaitiNigeriaTogoCentral African RepublicIndonesiaNiueTunisiaChadJordanPakistanTurkmenistanComorosKenyaPalauTuvaluCongoKiribatiPapua New GuineaUgandaCook IslandLaosPhilippinesVanuatuCote dIvoireLesothoRwand

214、aVietnamDemocratic Republic of CongoLiberiaSaint Kitts and NevisWest Bank&GazaDjiboutiLibyaSaint LuciaYemenDominicaMadagascarSaint Vincent&the GrenadinesZambiaEgyptMalawiSamoaZimbabwe53Hepatitis C Market Reportappendix 4:Generic Supplier In-country Registrations in Viral Hepatitis High Burden Countr

215、ies (non-exhaustive list as of Q4 2019-Q1 2020)SOF(400 mg)DCV(60 mg)SOF/DCV FDCSOF/LDVSOF/VELBrazilCambodiaHetero,Mylan,Natco,ACI,Beximco,Cambodia Pharmaceutical Enterprise,Dyson,Eskayef,Faas,Future Pharmaceutical Industries,Genome,Genix,Getz,Global Pharmaceuticals,Hilton,Incepta,Natco,PharmEvo,Sear

216、le,Strides,Swiss GarnierHetero,Mylan,Cambodia Pharmaceutical Enterprise,Genix,Getz,Hilton,Incepta,Natco,Searle Hetero,Mylan,Genix,Getz,Incepta,Natco,Swiss Garnier,Strides,Searle,TelphaHetero,Mylan,Beacon,Genome,Genix,Getz,SearleCameroonMylanMylanMylanMylanChinaColombiaCiplaEgyptHetero*EthiopiaHetero

217、,Cipla,Eva Pharma,Strides,MylanEva Pharma,MylanGileadGeorgiaIndiaAll LicenseesAll LicenseesAll LicenseesAll LicenseesAll LicenseesIndonesiaHetero,Mylan,Natco,StridesMylan,Natco,HeteroHeteroKyrgyzstanHeteroHeteroHetero,MylanHeteroMalaysiaHeteroHeteroMongoliaHetero,MylanMylanHetero,MylanMoroccoGalenci

218、a,Pharma 5Galencia,Pharma 5Mylan Mylan54Hepatitis C Market ReportSOF(400 mg)DCV(60 mg)SOF/DCV FDCSOF/LDVSOF/VELMyanmarHetero,Mylan,Natco,Unipharm,Intec,Genix,Top Prime,Zlfam,Getz,Pharmevo,InceptaHetero,Getz,JulpharMylan,Incepta,Top PrimeHetero,Mylan,Natco,Genix,GetzHetero,Mylan,Genix,GetzNepalHetero

219、Hetero(Temporary permit)Hetero(Temporary permit)NigeriaCipla,Hetero,MylanHetero,MylanMylanMylanMylanPakistanCipla,MylanMylanMylanMylanPeruHeteroPhilippinesMylan,HeteroMylanMylanRwandaHeteroNatcoSierra LeoneSouth AfricaTanzaniaCiplaHeteroHeteroMylanThailandHetero,MylanMylanMylanUgandaHetero,MylanMyla

220、nMylan,HeteroUkraineHeteroHeteroHeteroUzbekistanHeteroHetero,MylanHetero,MylanHeteroVietnamMylan,Natco,Strides,Atra,Ampharco U.S.A,Hera Biopharmaceutical,BV Pharma,Pymepharco,Cipla,Minh Hai,MedbolideHetero(SIQ),Mylan,BRV Healthcare,Hera BiopharmaceuticalMylan,Natco,Hera Biopharmaceutical,BV Pharma,P

221、ymepharco,Ampharco U.S.A,Minh HaiHetero(SIQ),MylanZimbabweHetero,Cipla,MylanMylanHetero*Hetero is manufacturing product locally in Egypt Source:Hetero(Apr 2020),Cipla(Jan 2020),Mylan(Apr 2020),CHAI,Coalition PLUS,World Hepatitis Alliance and its members.55Hepatitis C Market Reportappendix 5:Member s

222、tates of PAHOs Strategic Fund(June 2018)appendix 6:Guidance for procurement agents in obtaining visibility of diagnostic cost componentsMEMBER STATES OF THE STRATEGIC FUNDArgentinaEcuadorPanamaBahamasEl Salvador ParaguayBarbadosGuatemalaPeruBelizeGrenadaDominican RepublicBermudaGuyanaSaint Kitts and

223、 NevisBoliviaHaitiSaint LuciaBrazilHondurasSaint Vincent and the GrenadinesChileTurks and Caicos IslandsSurinameColombiaBritish Virgin IslandsTrinidad and TobagoCosta RicaJamaicaUruguay and VenezuelaCubaNicaraguaThe following questions and considerations may be valuable for developing an understandi

224、ng of the cost components which make up the final price to programs.Do the itemized costs which appear on the invoice match the expected prices based on the procurement agreement?Are you accessing the global ceiling prices for viral load tests through the procurement contract?If the specific inclusi

225、ons for each cost component on the invoice is not known,you are encouraged to enquire with the distributor to gain clarity of which incoterms are included for each component.It is valuable to understand which cost components are flexible.For example,are local taxes or import tariffs avoidable based

226、on the compassionate use of the products?Are the distributor mark-ups/margins reasonable?To understand what mark-up is reasonable,it may be helpful to benchmark off other programs such as HIV or TB.56Hepatitis C Market Reportappendix 7:Volumes and Pricing of DAAs exported from India to LMICs(2016-20

227、19)#of bottles exportedWeighted average price per bottle(USD)CountryDrug2000182019AFGHANISTANDCV11,000$21BANGLADESHSOF300$18DCV450$11BENINSOF/LDV50$59BOLIVIADCV120$15BURUNDISOF300$100SOF/VEL240770$101$102SOF/LDV600$104CAMBODIASOF3,6202,0942,5421,289$122$40$45$28DCV5001,5503,000

228、2,550$40$31$30$24SOF/DCV FDC90$40SOF/VEL7002,525$103$85CAMEROONSOF1,5963,050250$46$87$84SOF/VEL1,642$141SOF/LDV240$331COTE DIVOIRSOF144$178SOF/VEL30,000$134DEMOCRATIC REPUBLIC OF THE CONGOSOF/VEL144$14957Hepatitis C Market Report#of bottles exportedWeighted average price per bottle(USD)CountryDrug20

229、00182019EAST TIMORSOF120$18DCV180$11SOF/VEL480$86EGYPTSOF26,582140,093296,079119,020$70$15$12$13INDONESIASOF6,0009,70012,600$17$72$85DCV12,600298$30$30KENYASOF450$244SOF/LDV100503,600$188$34$58KYRGYZSTANSOF1,8687902,2513,329$112$50$51$37DCV3006,498$25$28SOF/VEL1,870$77SOF/LDV1,

230、0001,0021,755$125$74$50LAOSSOF150$40SOF/DCV FDC300$36SOF/VEL1,350$71MAURITANIASOF660$121DCV660$63MOLDOVASOF/VEL400$85MONGOLIASOF1,000300300$155$49$41DCV500300$20$17SOF/LDV19,66830,43132,5702,294$76$53$52$55MOROCCOSOF/LDV325$21258Hepatitis C Market Report#of bottles exportedWeighted average price per

231、 bottle(USD)CountryDrug2000182019MYANMARSOF18,15512,54544,06129,418$71$45$28$18DCV17,9004,5199,8063,755$24$27$25$23SOF/DCV FDC3,0001,726$36$27SOF/VEL3,3005,43668,161$117$164$80SOF/LDV7,0124,484$111$89NEPALSOF2,232$121DCV70200$45$32SOF/VEL800$84SOF/LDV576$120NIGERIASOF4,7205,040

232、1,000$103$49$18DCV3004001,000$59$27$12SOF/VEL30075$139$113PAKISTANSOF73,386100,002104,50443,080$35$16$11$22DCV9,60527,00025,06751,260$42$12$9$3SOF/VEL25,581$42PHILIPPINESSOF13,7653,442$40$40DCV4,135$15SOF/VEL1,000$90RWANDASOF2,996$16DCV117,898$7SRI LANKASOF100$101SYRIAN ARAB REPUBLICDCV100$25TAJIKIS

233、TANSOF5050$40$30SOF/VEL848$71SOF/LDV5156211,584864$100$59$49$5259Hepatitis C Market Report#of bottles exportedWeighted average price per bottle(USD)CountryDrug2000182019TUNISIASOF240$41UKRAINESOF84,698$20DCV21,234$10SOF/VEL7,475$90SOF/LDV9,648$30UZBEKISTANSOF1,1729,0071,55841,5

234、45$69$19$34$25DCV6,0373,23650,145$45$40$13SOF/VEL9,657$93SOF/LDV9,81518,5127,1625,101$78$55$49$54VIETNAMSOF46,3928,23912,5582,168$86$59$43$75DCV11,7508,5001,1882,162$43$36$36$36SOF/VEL23,8908,8008,141$118$115$90SOF/LDV13,9544,0128,720$95$59$65ZIMBABWESOF/LDV70$273Note:Only orders above 50 bottles co

235、nsidered;each bottle has 28 pills;Public and private sector orders both included;Wt.avg.price is weighted average of volumes of all orders 50 bottles and their respective price per bottle.Source:India Import-Export Database;Country categorization into LMICs based on the World Bank categorization Jun

236、e 2018.60Hepatitis C Market ReporteXHiBiT 23:SaMPle OF iNDia iMPORT eXPORT DaTaDATEIMPORTER EXPORTERPRODUCTDESTINATION QUANTITY UNITUNIT RATE(USD)FOB VALUE(USD)2019/1/18 AGP LIMITEDMYLANMYHEP ALL SOFOSBUVIR AND VELPATASVIR FILPAKISTAN8594PAC49.644266392019/3/14 OOO ASTOR ALLIANCE HETEROSOFGEN(55020

237、TABS)SOFOSBUVIR 400MG TABUZBEKISTAN1965PAC34.1367070.70The India import export data has been used across the report to calculate the uptake of key generic DAAs from India,the weighted average FOB price per bottle of key DAAs,and weighted average FOB price per bottle of key DAAs for different order s

238、izes.The data has also been used to compare the FOB price with the in-country price to get a sense of the in-country price mark-ups on DAAs.The analysis has excluded orders for less than 50 bottles as these orders are potentially placed by individuals or small pharmacies and have a high price per bo

239、ttle,tending to skew the analysis.While the data provides a directional understanding of treatment uptake across countries,it does have limitations.The data can be incomplete,and does not account for drugs that are manufactured in other countries such as Pakistan and Egypt.Hence,the analyses may not

240、 be complete or an accurate representation of the global DAA market.The quality of the product is not included(i.e.SRA approved/WHO PQd/ERP reviewed vs.locally approved product),hence,higher quality product typically sold at higher prices may skew prices upward or large number of locally approved pr

241、oducts may skew prices downward.CHAIS COUNTRY TEAMS,GLOBAL PARTNERS AND STAKEHOLDERSThe absence of public diagnostics databases containing information such as pricing and test volumes meant that CHAI was entirely dependent on global partners and CHAI country teams for testing information.CHAI is gra

242、teful to its global partners including Treatment Action Group,FIND,Coalition PLUS,World Hepatitis Alliance,Treat ASIA/amfAR for providing in-country information on prices and product registered in country for countries where CHAI does not have an HCV program.Our peers from these organizations shared

243、 the in-country data that they had available through primary research and their understanding of the market.In some cases,they connected us with their relevant individuals in their network who are based in-country and would have the relevant information available.appendix 8:Data SourcesCHAI has reli

244、ed upon three primary data sources for the analysis on the report.INDIA IMPORT EXPORT DATAThe India Import Export Data provides details on the volumes and prices of drugs exported from India to the rest of the world.As shown in Exhibit 23 below,the data has relevant details on date of export,importe

245、r name,exporter name,the product exported and the country to which it was exported,size of the export order,and the freight on board price.FOB prices are the prices at which the supplier exports the drug from the country.These prices do not include shipping,customs,storage and distributor-associated

246、 costs.Usually there are in-country costs added to the FOB price,resulting in a higher final price to the buyer.61Hepatitis C Market ReportData for CHAI program countries including India,Rwanda,Nigeria,Cambodia,Indonesia,Vietnam,Myanmar and Ethiopia was sourced from CHAI program country teams.The co

247、untry teams were supported by their MoH counterparts in obtaining the relevant information.The in-country prices have been used to compare prices across high-burden countries for key DAAs.These prices have also been used to compare the FOB price with the final in-country price in public/private sect

248、or.The approach has its limitations in understanding the DAA prices in countries that do not have a public program.This is due to the variability of prices in the private sector and lack of perfect knowledge on the range of prices offered across pharmacies in the private sector.GENERIC DRUG SUPPLIERSCHAI gathered information on in-country registration status of WHO PQd/ERP reviewed generic DAAs from suppliers including Hetero,Mylan,and Cipla.62Hepatitis C Market Report