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Update on the Global Use of Bedaquiline and Delamanid for Programmatic Management of Drug- Resistant Tuberculosis DR-TB Scale-Up Treatment Action Team (DR-TB STAT) October 2017
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Mar 15, 2018

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Page 1: Update on the Global Use of Bedaquiline and Delamanid for ...drtb-stat.org/wp-content/uploads/2017/10/DR-TB-STAT-slidedeck... · Update on the Global Use of Bedaquiline and Delamanid

UpdateontheGlobalUseofBedaquilineandDelamanid

forProgrammaticManagementofDrug-ResistantTuberculosis

DR-TBScale-UpTreatmentActionTeam(DR-TBSTAT)

October2017

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Content

• WhatisDR-TBSTAT?• Newerdrugsfordrugresistanttuberculosis(DR-TB)treatment• Registration,pricing,andimpactonaccesstonewerdrugs• Timelineofnewerdrugintroduction• Globalprogressonintroductionofnewerdrugs:graphs,

maps,treatmentcascade• UptakeofBDQandDLMinthePAHOregion• References

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DR-TBSTATTaskForce• FormedinApril2015inresponsetoa“CalltoAction”to

accelerateaccesstonewerdrugsforDR-TB*• OfficiallyadoptedasaGlobalDR-TBInitiative(GDI)TaskForcein

July2015• Multiagencyparticipation• CollectsinformationfromNationalTBProgramsandpartners

eachmonthonthenumberofindividualswhohavereceivedeitherBDQorDLMunderprogramconditions

• Monthlyteleconferencesandquarterlyglobaldatareports• Providestechnicalassistanceandsupportforcountriesto

overcomebarrierstonewerdrugintroduction• Datacurrentto1July2017• Seemoreatwww.drtb-stat.org*http://www.msfaccess.org/content/call-action-accelerate-access-dr-tb-drugs

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NewerdrugsforDR-TBtreatment

• Bedaquiline• Delamanid

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Bedaquiline(BDQ) Delamanid(DLM)Rxlength, pills 6months, 188pills(100mgtablet) 6months,672pills(50mgtablet)

Indication MDR-TB (WHOEssentialMedicinesList) MDR-TB (WHOEssentialMedicinesList)

WHOEML Yes Yes

Registration Restrictedusepre-XDR/XDRConditionalapprovalRegisteredin18countries;underassessmentin16(11/30highDR-TBburdencountrieswithoutsubmissionyet)

BroaderrecommendationforMDR-TBConditional approvalRegisteredin6countries;underassessmentin4(25/30highDR-TBburdencountrieswithoutsubmissionyet)

PatentStatus Intellectual propertybarriers(compoundandmultiplesecondarypatents)until2029

Intellectual propertybarriers(compoundandmultiplesecondarypatents)until2031

Voluntarylicensing?

Not clearifengagementinbilateralorMedicinesPatentPool(MPP)-ledvoluntarylicensenegotiations

Noadvanceonpotentialvoluntarylicenses

Businesspartners

Pharmstandard inCommonwealthofIndependentStates(CIS)countries

R-PharminCIScountries;MylaninIndia,SouthAfricaandothercountrieswhereOtsukadoesnotoperate

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Bedaquiline(BDQ) Delamanid(DLM)Competition No No

Stringent regulatoryauthorityapprovedsuppliers

1(Janssen) 1(Otsuka)

GDFprice $0throughGDF6-monthsupply:$900lower incomecountries;$3000middle incomecountries; $30,000upperincomecountries

$1,700for6-monthsupply

Targetprice range(USD)

$8.80 - $16.40/month $3.50- $8.60/month

‘Accesspolicies’ DonationApril 2015:30,000coursesover4yearsforGlobalFund-eligiblecountries;quotaforCIScountries;compassionateuseprogramphasedoutin2015

Donation announcedApril2015:20%ofMDR-TBpatientsby2020;noinformationavailable

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Timeline:introductionofbedaquiline anddelamanid

December2012 FDAgrantsacceleratedapprovalforbedaquiline

June2013 WHOreleasesinterimguidelinesforuseofbedaquilinetotreatDR-TB

March2014 EMAconditionallyapprovesbedaquiline

April2014 EMAconditionallyapprovesdelamanid

October2014 WHOreleasesinterimguidelinesforuseofdelamanidtotreatDR-TB

May2015 WHOaddsbedaquilineanddelamanidtoEssential MedicinesList

April2015 Janssen/USAIDlaunchbedaquilinedonationprogram

April2015 OtsukaannouncesFighTBack Initiativedelamaniddonationprogram

October2015 Georgiabecomesfirstcountrytoreceivedonatedbedaquiline

October2016 WHOguideline updateontheuseofshorterMDR-TBregimen

October 2016 WHO releasesguidanceondelamaniduseforDR-TBinchildren

March2017 WHOreleasesGDGmeetingreport ontheuseofbedaquilineforDR-TB

September2017 WHOreleasesstatementonoff-labeluseofbedaquilineanddelamanid

December2017 Fiveyearsafterbedaquiline approval

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ProgressofglobalBDQintroduction• 10,164 patientshavereceivedBDQasof1July2017(67%inSouth

Africa,15%inRussia)• 13,825ordersfromtheGlobalDrugFacility

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BDQ

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GlobalBDQimplementation*

*Asof1July2017

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ProgressofglobalDLMintroduction• 688 patientshavereceivedDLMasof1July2017,mostlyinMSF,IRD

andPIHsites(endTB project)• 3,238 ordersfromtheGlobalDrugFacility

0100200300400500600700800

Jul-1

5

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DLM

*adjustedtoexcludecompassionateuseofDLMinNovember2016

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GlobalDLMimplementation*

*Asof1July2017

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GlobalProgress:BDQandDLM

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DLM

*adjustedtoexcludecompassionateuseofDLMinNovember2016

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Globalprogress:BDQandDLMversusminimum estimatedglobalneed

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BDQ

DLM

Goal

*calculationofglobalestimatedneedfornewdrugsadjustedtoreflectcumulativenumberofpatientsstartedontreatmentforRR-TBin2015and2016

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UptakeofBDQandDLM:PAHOregion

• Brazilisahigh-burdenTBcountryandPeruisahigh-burdenMDR-TBcountry

• Overallitisestimatedthattherearemorethan7,000personsinthePAHOregionwhoneedednewdrugsoverthetwoyearperiodbetween2015and2017

• Fewerthan150peopleinthePAHOregionhavereceivednewerdrugsunderprogramconditions,justover2%ofthosewhoneededthem

• PAHOcountriesthathaveintroducednewerdrugsunderprogramconditions:Peru,HaitiandtheDominicanRepublic

• Brazil:compassionateuseaccessfornewerdrugs• Delamanid ordersviaGDFonlyforDominicanRepublic(4treatments)• Bedaquiline ordersviaGDFonlyforDominicanRepublic(34treatments),

Peru(211treatments),Haiti(20treatments),Bolivia(3treatments)

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References1. Médecins SansFrontières OutofTime:AccesstoTreatmentforDR-TB.MSFBriefing

Document,December2015.2. GothamDetal. Targetgenericpricesfornoveltreatmentsfordrug-resistant

tuberculosis.15th EuropeanAIDSConference,Barcelona,abstractPS2/42015.3. Médecins SansFrontières DR-TBDrugsUndertheMicroscope,2016.4. Brigden G,Hewison C,Varaine H.Newdevelopmentsinthetreatmentofdrug-

resistanttuberculosis:Clinicalutilityofbedaquilineanddelamanid.InfectionandDrugResistance8:367-378,2015.

5. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm6. http://www.who.int/tb/publications/WHO_BDQimplementationplan.pdf7. https://www.jnj.com/news/all/SIRTURO-bedaquiline-Receives-Conditional-Approval-

in-the-European-Union-for-the-Treatment-of-Multi-Drug-Resistant-Tuberculosis8. http://www.businesswire.com/news/home/20140429006457/en/Otsuka-Wins-

European-Marketing-Authorization-Deltyba%E2%84%A2-delamanid#.U2EqM1VdXKM9. http://www.who.int/tb/publications/delamanid-in-mdr-tb-treatment/en/10. http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-

list/en/11. http://siapsprogram.org/2016/01/13/8006/12. http://www.who.int/tb/features_archive/otsuka_2015/en/13. http://siapsprogram.org/2015/10/13/drug-safety-and-monitoring-are-key-as-

bedaquiline-donation-program-launches-in-georgia/14. http://www.who.int/tb/publications/delamanid-in-mdr-tb-treatment/en/15. https://www.jnj.com/news/all/SIRTURO-bedaquiline-Receives-Conditional-Approval-

in-the-European-Union-for-the-Treatment-of-Multi-Drug-Resistant-Tuberculosis