Antiretroviral purchasing and prescription practices in Mexico

Report
Antiretroviral purchasing and prescription
practices in Mexico: constraints, challenges and
opportunities
8th International AIDS Economics Network
Pre-Conference Meeting
July 19, 2014 - Melbourne, Australia
Claire Chaumont (1), Sergio Bautista Arredondo (1), Juan José Calva (2) , Roberto
Bahena González (1), Gerda Hitz (1), Arturo González de Araujo (3), Mauricio
Hernández-Ávila (1)
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
(1) National Institute of Public Health, Mexico, (2) National Institute of Medical
Sciences and Nutrition Salvador Zubirán, Mexico, (3) COFAPI, Mexico
Outline of the presentation
• Background & Objectives
• Methodology
• Results
• Discussion
• Take-away messages
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
HIV Treatment and Care in Mexico
• Concentrated epidemic
– HIV Prevalence: 0.24%, mostly among IDU, MSM, SW (1)
– Number of PLHIV: 179,478 in 2011 (1)
• Universal access to ART guaranteed through main public
institutions
– High level of coverage: 85% in 2011 (1)
– 60% provided through the Ministry of Health-Popular Health Insurance (PHI
or Seguro Popular) & 30% through the main social security institution (IMSS),
with independent procurement and distribution processes
• Emerging challenges
– New WHO guidelines soon to be adopted by the country
– Expected increase in number of patients due to early treatment and better
detection practices
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Challenges related to ARV expenditures
• ARV drugs account for roughly 75% of the care and treatment
budget for the average LAC country (2)
• Evidence suggests that ARV prices paid by Mexico are on average 8
times higher than similar upper-middle income countries (3)
• In 2008, creation of the Coordinating Commission for Negotiating
the Price of Medicines and other Health Inputs (CCPNM) (4)
– Substantial reductions in ARV prices obtained in early years but further
reductions have been less effective
• Financial pressure on the MoH’s budget might ultimately threaten
universal access to ART
– In 2011, spending related to HIV-AIDS accounted for 32.4% of the Fund for
Protection against Catastrophic Expenditures of the PHI (5)
Urgent need to understand the characteristics of ARV purchases
and prescriptions in Mexico
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Study Objective
• To understand the characteristics of ARV purchases and
prescriptions in Mexico, both in terms of procured
prices, volumes and type of purchased and prescribed
drugs, as well as in terms of current and futures trends.
– Analysis of ARV prescriptions for the MoH/PHI
– Analysis of prices and volumes of generic and patented drugs procured
by the Mexican National Agency for Prevention and Control of
HIV/AIDS (CENSIDA) for the MoH/PHI for the period 2007-2012 and
tendencies scenarios based on current spending by CENSIDA
– Comparison between ARV annual costs paid by Mexico and by
countries with similar income
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Methodology
• Analysis of the types and volumes of ARV combinations
prescribed to patients between 2008 and 2013
– Based on SALVAR, a database used by the Ministry of Health to
monitor ARV prescriptions for patients covered by the Popular
Health Insurance
• Retrospective analysis of procurement prices, volumes
and type of ARVs procured by the MoH/PHI between
2007 and 2012
• Comparison between annual ART costs for the 7 most
important patented drugs in Mexico and procurement
data from the WHO’s Global Price Reporting Mechanism
(GPRM) database
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Main results: Prescription practices
• There is a tendency towards a simplification of the
prescription:
– Out of 53,357 MoH patients under ARV treatment in 2013,
90% took any of 22 most commonly prescribed drug
combinations
– Out of these 22 combinations, 95% are in accordance with
ARV therapy official national guidelines
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Main results: Procurement prices and volumes of ARV
drugs
• Between 2010 and 2012, CENSIDA spent a total of USD 400.39
millions for the purchase of close to 3 million packs of
antiretroviral medicines
• Out of 35 generic and patented drugs, only 8 patented drugs
represented 78% of total expenditures
• The combination Efavirenz+Emtricitabina+Tenofovir, either
taken as one or two pills represented 45% of total expenditures
• Reductions in procurement prices obtained by the CCPNM in
the first years and at the 2008 IAS Conference were substantial
but further reductions were much smaller
• Simple projections show that the current decrease in ARV prices
will not be sufficient to compensate future increase of new
patients
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Main results: Procurement prices and volumes of ARV
drugs
Drug name
Emtricitabine+Tenofovir
Lopinavir+Ritonavir
Atazanavir
Efavirenz+Emtricitabine+Tenofovir
Efavirenz
Ritonavir
Raltegravir
Tenofovir
Others - Patented drugs
Others - Generic drugs
Total
2010
$
41.37
$
21.75
$
12.63
$
$
$
$
$
$
$
$
$
6.91
4.70
2.72
2.92
4.59
26.90
$
$
$
$
$
$
$
124.50
$
Expenditures (in million - 2010 USD)
2011
2012
Total
21.54 $
64.51 $ 127.42
5.34 $
32.66 $ 59.74
4.74 $
22.93 $ 40.30
$
36.20 $ 36.20
9.14 $
1.56 $ 17.61
5.14 $
3.82 $ 13.66
3.23 $
3.45 $
9.39
1.08 $
5.57 $
9.58
3.68 $
8.34 $ 16.60
14.97 $
28.00 $ 69.88
68.85
$
207.05
$
Volume (number of packages - in thousands)
2010
2011
2012
Total
242.1
115.5
431.4
789.0
88.8
23.7
175.8
288.3
56.3
20.4
112.6
189.3
0.0
0.0
194.0
194.0
193.3
239.9
49.3
482.5
28.4
31.7
26.9
87.0
5.3
6.1
7.8
19.1
18.8
6.8
39.5
65.0
30.6
30.3
46.2
107.1
235.8
177.5
309.6
722.8
%
32%
15%
10%
9%
4%
3%
2%
2%
4%
17%
400.39
$
899.28
$ 651.78
$ 1,393.08
%
27%
10%
6%
7%
16%
3%
1%
2%
4%
25%
$ 2,944.14
Variation
Drug name
2007
Atazanavir
Efavirenz
Efavirenz+Emtricitabine+Tenofovir
Emtricitabine+Tenofovir
Lopinavir+Ritonavir
Raltegravir
Ritonavir
Tenofovir
Instituto Nacional
de Salud Pública
2008
2009
2010
2011
$
$
4,282
924
$
$
3,257
519
$
$
2,586
412
$
$
2,731
435
$
$
2,822
464
$
$
3,565
5,571
$
$
1,015
2,376
$
$
$
$
$
2,613
4,773
7,445
957
2,263
$
$
$
$
$
2,075
3,368
5,911
714
1,796
$
$
$
$
$
2,081
3,173
6,305
719
1,898
$
$
$
$
$
2,271
2,927
6,451
704
1,939
Centro de
Investigaciones en
Sistemas de Salud
2012
$
$
$
$
$
$
$
$
2,481
386
2,272
1,820
2,447
5,412
618
1,719
2013
$
$
$
$
$
$
$
$
2,629
402
2,345
2,014
2,520
5,368
648
1,785
Variation
(since 2008 or
Variation
(2007-2008) most recent year) (Total period)
-24%
-44%
-27%
-14%
-6%
-5%
-19%
-23%
-3%
-23%
-47%
-28%
-32%
-21%
-39%
-57%
-3%
-44%
-55%
-28%
-36%
-25%
Main results: Comparison with international
procurement prices
• Annual costs of treatment in Mexico are higher than
costs supported by similar countries for the majority
of the drugs studied
– Costs are also similar or higher than costs reported by
high-income countries in the database (when the
information is available)
– Costs often remain higher even when considering only
originator drugs bought directly to the pharmaceutical
company owning the patent
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Comparison for selected drugs
COSTO PROMEDIO POR AÑO DE TRATAMIENTO ATAZANAVIR
PESOS DEL AÑO 2010
CENSIDA-México y Grupos de Países Seleccionados
COSTO PROMEDIO POR AÑO DE TRATAMIENTO EFAVIRENZ+EMITRICITABINE+TENOFOVIR
PESOS DEL AÑO 2010
CENSIDA-México y Grupos de Países Seleccionados
Atazanavir
CENSIDA-Mexico
Países de ingresos altos
Países de ingresos medio-altos
Efavirenz+Emtricitabine+Tenofovir
CENSIDA-Mexico
Países de ingresos medio-bajos
Países de ingresos altos
Países de ingresos medio-altos
Países de ingresos medio-bajos
30000
90,000
80,000
25000
70,000
20000
60,000
50,000
15000
40,000
10000
30,000
20,000
5000
10,000
0
0
2007
2008
2009
2010
2011
2012
2013
2007
2008
2009
Patente
2010
2011
2012
2007
2013
Emtricitabine+Tenofovir
Países de ingresos altos
Países de ingresos medio-altos
2009
2010
2011
2012
2013
2007
2008
2009
2010
2011
2012
2013
Genérico
COSTO PROMEDIO POR AÑO DE TRATAMIENTO LOPINAVIR+RITONAVIR
PESOS DEL AÑO 2010
CENSIDA-México y Grupos de Países Seleccionados
COSTO PROMEDIO POR AÑO DE TRATAMIENTO EMITRICITABINE+TENOFOVIR
PESOS DEL AÑO 2010
CENSIDA-México y Grupos de Países Seleccionados
CENSIDA-Mexico
2008
Patente
Genérico
Lopinavir+Ritonavir
CENSIDA-Mexico
Países de ingresos medio-bajos
50000
80000
45000
70000
Países de ingresos altos
Países de ingresos medio-altos
Países de ingresos medio-bajos
40000
60000
35000
50000
30000
40000
25000
20000
30000
15000
20000
10000
10000
5000
0
2007
2008
2009
2010
2011
2012
2013
Patente
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
50000
Sistemas de Salud
2007
2008
0
COSTO
PROMEDIO
POR AÑO
DE TRATAMIENTO
EMITRICITABINE+TENOFOVIR
2010
2011
2012
2013
2007
2008
2009
2010
2011
2012
2013
2007
2008
2009
2010
PESOS DEL AÑO
2010
Genérico
Patente
Genérico
CENSIDA-México y Grupos de Países Seleccionados
2009
CENSIDA-Mexico
Highde
income
countries
Países
ingresos
altos
Highde
milddle
income
countries
Países
ingresos
medio-altos
2011
2012
2013
Low de
milddle
income
countries
Países
ingresos
medio-bajos
Discussion: Legal and political options available to
bring prices down are limited
• Limitations due to international treaties
– Mexico is a signatory of the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS) agreement
– Mexico can’t make use of the TRIPS flexibilities (compulsory licenses)
due to its compliance with the North American Free Trade Agreement
• Limitations due to Mexico’s intellectual property and
procurement laws
– Mexico can’t import patented drugs
– Current regulations regarding clinical data availability limit new
entrants in the market after patent expiration (data protection)
• Limitation due to Mexico’s commercialization mechanisms
– The Federal Commission for the Protection against Sanitary Risks
(COFEPRIS) does not consider cost-effectiveness when awarding
approval for the commercialization of new medicines.
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Discussion: Only long-term safeguards can curb
expenditures
• Need to consider deeper structural changes in its drug
policies:
– Consolidate the role of the CCPNM in order to strengthen its
negotiation power with pharmaceutical companies
– Better take into account the economic impact of new drugs
when making them available to patients
– Improve procurement and distribution processes within the
MoH and better understand the costs associated with each
step of the process
– Consolidate public institutions negociation power and
technical capacity
– Review intellectual and property laws to facilitate the entry of
new actors in the market
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Take-away messages
• Mexico continues to pay relatively high prices for ARV
drugs
• Most of the expenditure is concentrated on a small
number of patented drugs, for which procurement
and purchasing are tightly regulated
• There is an extremely limited current set of legal and
structural options available to policy makers to bring
patented drugs prices down
• Policy-makers need to focus on long-term legal and
political safeguards to counter the high prices
imposed by pharmaceuticals
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Acknowledgments
We would like to thank the Mexican National Agency
for Prevention and Control of HIV/AIDS (CENSIDA) for
funding this study
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud
Selected references
1.
Centro Nacional para la Prevención y el Control de VIH/SIDA (2012). El
VIH/SIDA en México en 2012, Mexico.
2.
Pan American Health Organization (2013). Antiretroviral treatment in the
spotlight: a public health analysis in Latin America and the Caribbean.
Washington, D.C.
3.
Adesina A, Wirtz V & Dratler S (2012). Reforming antiretroviral price
negotiations and public procurement: the Mexican experience. Health
Policy and Planning 2012;1–10
4.
Gómez-Dantés O, Wirtz V, Reich M, Terrazasc P & Ortiz M (2012). A new
entity for the negotiation of public procurement prices for patented
medicines in Mexico, Bull World Health Organ 2012;90:788–792
5.
Comisión Nacional de Protección Social en Salud. Fideicomiso del
Sistema de Protección Social en Salud. Auditoría Financiera y de
Cumplimiento N° 11-0-12U00-02-0428 DS-056
Instituto Nacional
de Salud Pública
Centro de
Investigaciones en
Sistemas de Salud

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