A market failure case study:
African snake antivenoms
Julien Potet
Dr Jen Cohn
MSF Access Campaign
Meeting at Fondation Mérieux, January 2015
Estimates of burden of snakebite in sub-Saharan
Africa
• Chippaux (2008):
– Envenomings: 500,000
– Deaths: 25,000
• Kasturiratne (2008):
– Envenomings: 90,622 – 419,639
– Deaths: 3,529 – 32,117
• Chippaux (2011):
– 314,078 envenomings ‘registered’ in modern health care system
• Highest incidence found in African savannah, where Echis spp. (eg
carpet vipers) are found
– Often >100 bites per 100,000 population per year
– Mortality rate (without effective antivenom) around 10-12%
One market, or several sub-regional markets in SSA?
• Three types of products:
– ‘PanAfrican’ polyspecific (i.e. Sanofi’s Fav-Afrique)
– ‘Sub-regional’ polyspecific (i.e. SAVP polyvalent)
– Monospecific
Overview of African snake antivenom products
Company
Country of
production
Clinical data?
Fav-Afrique
Sanofi-Pasteur
France
Limited, good results
ASNA-C
Bharat Serums and Vaccines India
Limited, negative results
ASNA-D
Bharat Serums and Vaccines India
No data
Snake Venom Antiserum (Pan-African)
VINS Bioproducts
India
No data
Antivipmyn-Africa
Instituto Bioclon / Silanes
Mexico
Limited, mixed results
Inoserp PanAfrica
Inosan
Spain
No data
EchiTabPlus
ICP
Costa Rica
RCT, good results
SAIMR Polyvalent
SAVP
South Africa
Limited
Snake venom antiserum Echis ocellatus
VINS Bioproducts
India
No data
EchiTabG
MicroPharm
UK
RCT, good results
Monospecific Echis ocellatus/Echis pyramidum
SAVP
South Africa
Limited
Monospecific Dispholidus typus (boomslang)
SAVP
South Africa
Limited
Product
PanAfrican polyspecific
Sub-Regional polyspecific
Monospecific
The African antivenom crisis
in the medical journals
The African antivenom crisis
• Late 1990s:
– ~100,000 vials available in SSA
• Late 2000s:
– ~300,000 vials available (~83,000 ‘treatments’)
– 90% of sales for two low-cost products of dubious efficacy
• ASNA-C: Limited data, negative results
• VINS PanAfrican: no data
• 2014: Sanofi ceases production of Fav-Afrique
– 20,000 vials sold out in just 6 months
– Vials to expire in June 2016
• The African antivenom access crisis is both a supply crisis
and a demand crisis
Market failure: five
underlying causes
1. Neglect of
snakebite victims
2. Poor
understanding of
cost-effectiveness
3. Unstable demand
4. No quality
requirements
5. Equine polyclonal
serums
considered as
outdated
1. Invisible victims, invisible disease
• Rural impoverished populations with little political voice
(farmers)
• Not transmissible, not controllable, considered a fatality
• Burden vastly ‘hidden’
– MSF experience in South Sudan and CAR
• Take Home message:
– There may be no ‘market’, but there are ‘unmet needs’ for sure
– Demand for modern medicine can be stimulated if quality
interventions are provided
2. An unkown fact: antivenom is one of the most
cost-effective interventions
• Habib (2015): antivenom therapy (EchiTabG/EchiTabPlus)
found highly cost-effective in Nigeria:
– Cost per DALY averted: US$100
– Cost per death averted: US$2,330
– Cost-effectiveness ratio: better than ART and rotavirus
vaccination, equivalent to HPV vaccination
• Need for similar studies with other products in other settings
– Requires good baseline/intervention clinical data
– Also for MoHs to understand that low-cost ineffective products
are NOT cost-effective
• Take home message:
– Quality antivenoms are highly cost-effective products
3. Unstable demand
• User-fees & cost-recovery stifle both demand and supply:
– Demand: Victims often incapable to rapidly mobilise $100 or so
– Supply: By fear that antivenom may expire before being sold,
small rural hospitals may prefer not to stock antivenoms
• No donor support: antivenoms are not listed as priority by
any funding agency
• Take home message:
– Vicious circle: victims can’t pay, no donor support, MoHs don’t
take financial risk to purchase products (or they opt for low-cost
ineffective products)
4. No independent quality control
• Most African antivenoms are produced and used in countries
with regulatory authorities with limited capacity
• WHO has established clear norms to evaluate quality of
antivenom products. However, no quality control in practice.
– WHO-PQP has no resources to evaluate antivenoms and other Ig
serums (i.e. no bank of reference venoms, no GMP audits)
– Purchasers (MoHs) do not ask for compliance with quality
standards
• Take home message:
– There is no framework to push producers to comply with quality
norms
5. Misconception: there is no future for
hyperimmune equine serums
• mAbs are promising but not mature yet to replace
equine polyclonal immune serums in short term
• Most big pharmaceutical companies (except Sanofi)
have already disengaged from hyperimmune equine
serum.
– Limited global capacity to produce and purify equine
plasma (shortage of rabies Ig)
• Take home message:
– At global level, the capacity to produce equine serums is
not sufficient to meet needs.
Eight measures to address market failure and
improve access
• Short term
1.
2.
3.
4.
Produce another batch of Fav-Afrique to address shortage
Finalise technology transfer for continued production of Fav-Afrique
Open a new WHO position on access to antivenoms and snakebite
management
Conduct pre-clinical and clinical studies to compare existing African
antivenoms
• Medium term
5.
6.
7.
8.
Conduct more cost-effectiveness studies to guide policy-making
Support suppliers of hyperimmune equine serums to increase global
production capacity
Finance WHO-PQP for quality control of antivenoms
Support purchase and procurement to meet needs in African
countries, with obligation to buy only WHO-PQed products
http://www.msfaccess.org/