update on the global use of bedaquiline and delamanid for...
TRANSCRIPT
UpdateontheGlobalUseofBedaquilineandDelamanid
forProgrammaticManagementofDrug-ResistantTuberculosis
DR-TBScale-UpTreatmentActionTeam(DR-TBSTAT)
October2017
Content
• WhatisDR-TBSTAT?• Newerdrugsfordrugresistanttuberculosis(DR-TB)treatment• Registration,pricing,andimpactonaccesstonewerdrugs• Timelineofnewerdrugintroduction• Globalprogressonintroductionofnewerdrugs:graphs,
maps,treatmentcascade• UptakeofBDQandDLMinthePAHOregion• References
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
NewerdrugsforDR-TBtreatment
• Bedaquiline• Delamanid
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
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
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
ProgressofglobalBDQintroduction• 10,164 patientshavereceivedBDQasof1July2017(67%inSouth
Africa,15%inRussia)• 13,825ordersfromtheGlobalDrugFacility
0
2000
4000
6000
8000
10000
12000
Jul-1
5
Sep-15
Nov-15
Jan-16
Mar-16
May-16
Jul-1
6
Sep-16
Nov-16
Jan-17
Mar-17
May-17
Jul-1
7
BDQ
GlobalBDQimplementation*
*Asof1July2017
ProgressofglobalDLMintroduction• 688 patientshavereceivedDLMasof1July2017,mostlyinMSF,IRD
andPIHsites(endTB project)• 3,238 ordersfromtheGlobalDrugFacility
0100200300400500600700800
Jul-1
5
Sep-15
Nov-15
Jan-16
Mar-16
May-16
Jul-1
6
Sep-16
Nov-16
Jan-17
Mar-17
May-17
Jul-1
7
DLM
*adjustedtoexcludecompassionateuseofDLMinNovember2016
GlobalDLMimplementation*
*Asof1July2017
GlobalProgress:BDQandDLM
0
2000
4000
6000
8000
10000
12000Jul-1
5
Sep-15
Nov-15
Jan-16
Mar-16
May-16
Jul-1
6
Sep-16
Nov-16
Jan-17
Mar-17
May-17
Jul-1
7
BDQ
DLM
*adjustedtoexcludecompassionateuseofDLMinNovember2016
Globalprogress:BDQandDLMversusminimum estimatedglobalneed
0
10000
20000
30000
40000
50000
60000
70000
80000
Jul-1
5
Sep-15
Nov-15
Jan-16
Mar-16
May-16
Jul-1
6
Sep-16
Nov-16
Jan-17
Mar-17
May-17
Jul-1
7
BDQ
DLM
Goal
*calculationofglobalestimatedneedfornewdrugsadjustedtoreflectcumulativenumberofpatientsstartedontreatmentforRR-TBin2015and2016
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)
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