1 Management Sciences for Health

Stronger health systems. Greater health impact.

Overcoming Barriers to Access to Medicines and Health Technologies for Cancer

Douglas Keene, Vice-President Center for Pharmaceutical Management Management Sciences for Health UICC Montreal, Canada August 27-30, 2012

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Outline

!  Barriers to access to cancer medicines and technologies

!  Pharmaceutical systems approach !  Affordable access

•  Price reduction strategies •  Procurement options •  Quality, safety, and regulation •  Non-price barriers to palliation and pain control

!  Engaging the private sector •  Access to existing medicines, vaccines, and technologies

•  Product innovation

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Cancer treatment is unaffordable in most low and many middle income countries

Philippines: cervical cancer treatment x2 annual income Pakistan: chemotherapy for leukemia = $20,000, x7 annual income Rwanda: treatment of some cancers, if available, x50+ annual income

•  In most low income countries 50-90% of medicines out of pocket; includes those for chronic conditions

•  17/24 WHO essential cancer medicines unavailable or unaffordable in developing countries

•  Cancer medicines remain unaffordable in sub-Saharan Africa,, India, Latin America, and middle-income countries such as Egypt and Morocco.

Domingo'EJ,'Dy'Echo'AV.Epidemiology,'preven7on'and'treatment'of'cervical'cancer'in'the'Philippines.'J'Gynecol'Oncol.'2009'Mar;20(1):11H6.'

Aziz'Z.'Across'genera7ons:'cancer'treatment'in'developing'countries.'J'Clin'Oncol.'2008;26(30):4990H1'

Quick'JD.'Essen7al'medicines'twentyHfive'years'on:'closing'the'access'gap.'Health'Policy'Plan.'2003'Mar;18(1):1H3.'

World'Health'Report'(2010).'Op7ons'for'financing'and'op7mizing'medicines'in'resourceHpoor'countries.''

Boyle'P,'Levin'B:'World'Cancer'Report'2008.'WHO:'WHO'press;'2008.'

Orem'J,'Wabinga'H.'The'roles'of'na7onal'cancer'research'ins7tu7ons'in'evolving'a'comprehensive'cancer'control'program'in'a'developing'country:'experience'from'Uganda.'Oncology.'

2009;77(5):272H80.'

'Meremikwu'MM,'et'al'(2005).'Socioeconomic'constraints'to'effec7ve'management'of'Burkib's'lymphoma'in'southHeastern'Nigeria.'Trop'Med'Int'Health.'10(1):92H8'

Cancer'Pa7ents'Aid'Associa7on,'India.'Cancer'drugsHPricing'and'Patents,'September'2010.'Department'of'Industrial'Policy'and'Promo7on,'Ministry'of'Commerce'and'Industry,'Government'of'India.'hbp://dipp.nic.in/iprHfeedback/Feedback_01_CL_10September2010.pdf;accessed'Dec'8,'2010'

Howard'SC,'Marinoni'M,'Cas7llo'L,'et'al.'Improving'outcomes'for'children'with'cancer'in'lowHincome'countries'in'La7n'America:'a'report'on'the'recent'mee7ngs'of'the'Monza'Interna7onal'

School'of'Pediatric'Hematology/Oncology'(MISPHO)HPart'I.'Pediatr'Blood'Cancer.'2007;48:364–369.'

ElHZawahry'HM'et'al.'Cost'and'outcome'of'treatment'of'adults'with'acute'myeloid'leukemia'at'the'Na7onal'Cancer'Ins7tuteHEgypt.'J'Egypt'Natl'Canc'Inst.'2007;19(2):106H13'

Boutayeb'S'et'al'(2010).'Es7ma7on'of'the'cost'of'treatment'by'chemotherapy'for'early'breast'cancer'in'Morocco.'Cost'Eff'Resour'Alloc.'2010;8:16'

'

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For many treatable cancers, chemotherapy costs are a major share of total treatment costs

Nigeria:(Direct(costs(of(trea/ng(a(child(with(Burki8’s(Lymphoma(

'Cost(per(child(treated((US($)(( %(

Laboratory'tests'H'First'diagnosis'' '''''''' '18.90'' 12%'

Cytotoxic(drugs( ( (103.80(( 63%(

Laboratory'tests'H'FollowHup' '9.60' 6%'

Hospital'and'other'costs' '31.50'' 19%'

Total'direct'cost' '163.80'' 100%'

Meremikwu'MM,'et'al.Socioeconomic'constraints'to'effec7ve'management'of'Burkib's'lymphoma'in'southHeastern'Nigeria.'Trop%Med%Int%Health'2005.'10:'92H98'

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Pharmaceutical systems approach to access

Essential package for cancer care and control

Guidelines for prevention, detection, treatment , and palliative care & essential medicines list for cancer

Revise guidelines as needed based on feedback/experience

Adapt guidelines for local settings; consider supply and maintenance for equipment

Information-sharing, networking, coordination of stakeholders for access to cancer care and control between WHO, IARC, GTF.CCC, IUCC, IAEA, INCTR, others

Selection

Pricing

Innovative service delivery

Manufacturer engagement for brand and generics

Contain distribution and dispensing mark-ups

Price information exchange for cancer products

All products: Elimination/ reduction of tariffs, taxes, fees

Generic/multi-source products: bulking purchasing, generic substitution

Brand/single-source products: price negotiation, donations, direct price controls

Demand & cost for cancer care & treatment

Demand forecast for cancer products

Procurement

Innovative financing: local and global

Develop global/regional procurement mechanism/s

Use local procurement mechanism/s as appropriate

Quality, Safety, Regulation

Quality assurance process linked to procurement mechanism

Expedited registration for products not available

Include quality experience in global price monitoring

Supply to national/local cancer programs

Global/Regional Level National/Local Level

Ensure supply and maintenance contracts for diagnostic, radiotherapy, other equipment

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Cost of cancer medicines – up to 10-fold variation in costs among generic sources

$0''

$500''

$1'000''

$1'500''

$2'000''

$2'500''

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1996 1997 1998 2000 2001 2004 2005 2008 2011

0

2000

4000

6000

8000

10000

12000

Year

US'$'per'person'pe

r'year

Differential3Pricing

Competitive3Pricing

Initial Prices$12,000

99% reduction of ARV prices through “leap frog” of competition and differential pricing

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Price reduction strategies for cancer medicines and vaccines

Generic/Mul/OSource(

'

• Compe77ve'purchasing'

• ''Pooled'procurement'

• ''Transfer'of'technology''

Brand/SingleOSource(

• Differen7al'pricing'• Dona7ons'• ‘Licensed'compe77on’'

• Compulsory'licensing'

'

'

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Global Procurement Mechanisms

Program( Focus(

Mul/lateral(/(DonorOSupported(

Stop'TB/Global'Drug'Facility'(GDF)' Tuberculosis'

Global'Fund'Voluntary'Pooled'Procurement'

Program'(VPP)'

AIDS,'TB,'Malaria'–'medicines,'

diagnos7cs,'bednets'

PEPFAR/USAID'Supply'Chain'Management'System'

(SCMS),Partnership'for'Supply'Chain'Management'

AIDS'medicines'and'diagnos7cs''

Asthma'Drug'Facility' Asthma'medicines''

UNICEF' Essen7al'medicines,'vaccines,'

health'commodi7es'for'children'

NonOprofit(procurement(agencies((illustra/ve)(

"'Ac7on'Medeor'"'ECHO'"'IDA'Founda7on''"'IMRES'"'Mission'Pharma'"'Orbipharma'"Trimed'

Essen7al'medicines'and'other'

health'commodi7es;'in'some'

cases'healthHrelated'equipment'

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Engaging the Private Sector – Examples of Current and Needed Actions

Access to existing medicines, vaccines, technologies •  South-south clinical trials using existing agents to treat other cancers – Cuba

with 20 LMC, 7 developed countries with nimotuzumab •  North-south transfer of production technology – Eli Lilly technology transfer

for off-patent MDR-TB to producers in China, India, S. Africa Product innovation •  Expansion of oral formulations for existing generic agents would reduce

burden on staff, patients, transport, and increase treatment completion •  Synthetic paclitaxel and synthetic derivatives (currently high cost because it’s

sourced from the bark of the Pacific yew tree) •  Among 19 global health challenges, cancer received 2nd highest number of

applications (26) to commercialize low cost health technologies (WHO) •  ‘Frugal innovation’ or ‘reverse innovation’ in/for India, Chinese, other large low-

income markets for radiotherapy, ultrasound, mammography

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Major Recommendations

1.  All products – WHO/inter’l clinical guidelines and essential medicines lists

2.  Generic meds & vaccs – sources & prices information, competitive pooled procurement from qualified suppliers

3.  Single-source meds & vaccs – negotiation, donation, ‘licensed competition’

4.  Technologies for detection, diagnosis, treatment – training, standardization, sources and prices info, support, telemedicine

5.  Procurement – add cancer medicines to existing global and regional mechanisms – no new cancer-specific procurement organizations

6.  Quality, safety, regulation, palliation, pain control – each are vital 7.  Private sector – active engagement to expand access to existing

products & encourage targeted ‘frugal’ innovation

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Stronger health systems. Greater health impact.

Saving lives and improving the health

of the world’s poorest and most vulnerable people

by closing the gap between knowledge and action in public health.