The potential contribution of increased new drug use to Russian

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Transcript The potential contribution of increased new drug use to Russian

The potential contribution of
increased new drug use to
Russian longevity and health
Frank R. Lichtenberg
[email protected]
Columbia University
and
National Bureau of Economic Research
Introduction
• Life expectancy at birth in Russia is currently 9 years lower than it is
in the U.S. (70 vs. 79 years).
• The Russian government seeks to increase Russian life expectancy
by 4 years by 2018.
• The primary policies that the government has implemented to
increase Russian life expectancy are policies aimed at reducing
smoking and alcohol consumption.
• Even if these policies are extremely effective, they are likely to
increase life expectancy by only a small fraction of the amount
sought by the government.
• To achieve substantial gains in Russian life expectancy by 2018,
significant additional changes will be required.
• The adoption and diffusion of new drugs can make a substantial
contribution to Russian longevity growth.
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Hypothesis: longevity and health are
directly related to Rx quality
Rx quality 
Longevity
and health ↑
Rx quality is not directly observable, but…
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Hypothesis: Rx quality is directly
related to Rx vintage
Rx vintage 
Rx quality 
Longevity
and health ↑
Rx vintage is defined as the original FDA approval year of the drug’s active ingredient(s)
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Correlation across countries between 2000-2009 change in
life expectancy at birth and change in drug vintage,
controlling for changes in income, unemployment rate, education, urbanization,
health expenditure, immunization rate, HIV prevalence and tuberculosis incidence
Change in life expectancy at birth
2
1
0
-1
Note: size of bubble is proportional to country population.
-2
-0.06
-0.05
-0.04
-0.03
-0.02
-0.01
0.00
0.01
0.02
0.03
0.04
0.05
0.06
Change in POST1990%
Lichtenberg FR (2012). “Pharmaceutical Innovation and Longevity Growth in 30 Developing and High-income Countries, 2000-2009,” Health Policy and Technology
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3(1): 36-58, March 2014.
How does access to new drugs in Russia
compare with access in other countries?
Number of drugs whose world launch year was
between 2000 and 2010 launched by end of 2011
250
222
200
150
114
100
50
0
USA
Russia
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Mean launch year of drugs consumed in 2009, by country
Portugal
Netherlands
Italy
Japan
Spain
Greece
Belgium
Finland
Turkey
Austria
United States of America
Germany
Poland
France
Sweden
United Kingdom
Singapore
Canada
Morocco
Republic of Korea
South Africa
Australia
Argentina
Egypt
Malaysia
Russia
Thailand
Mexico
Philippines
Colombia
Indonesia
1920
1967.5
1965.6
1965.3
1964.8
1964.2
1964.0
1963.4
1961.4
1960.4
1959.3
1959.1
1959.1
1958.9
1956.1
1955.8
1955.2
1953.7
1952.8
1952.0
1951.7
1951.5
1951.3
1951.3
1949.8
1948.8
1943.5
1942.3
1941.8
1940.2
1938.8
1928.3
1925
1930
1935
1940
1945
1950
1955
1960
1965
1970
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Relationship across countries between
GDP per capita and mean launch year of drugs consumed, 2009
1970.0
1965.0
1960.0
1955.0
1950.0
1945.0
Russia
1940.0
1935.0
1930.0
1925.0
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
GDP per capita (constant 2000 US$)
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Post-1990 drugs as % of all drugs consumed, 2009
Netherlands
Greece
Italy
Portugal
Spain
Japan
Finland
United States of America
Turkey
Belgium
Austria
Canada
France
Republic of Korea
Australia
United Kingdom
Germany
South Africa
Argentina
Sweden
Poland
Singapore
Malaysia
Mexico
Philippines
Morocco
Egypt
Colombia
Thailand
Russia
Indonesia
17%
16%
16%
15%
15%
15%
14%
14%
13%
13%
11%
11%
11%
9%
9%
9%
9%
8%
8%
8%
7%
6%
4%
4%
4%
3%
3%
3%
2%
1%
1%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
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Relationship across countries between
GDP per capita and post-1990 drugs as % of all drugs consumed, 2009
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
Russia
0%
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
GDP per capita (constant 2000 US$) NY.GDP.PCAP.KD
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Effect of expanded access to
new drugs on life expectancy
• If the fraction of “new” (post-1990) drugs increased
from its actual value in Russia (1%) to the mean value
of all 31 countries (9%), life expectancy at birth in
Russia would increase by about 2.1 years.
• As discussed above, this estimate controlled for the
effects on life expectancy of real per capita income, the
unemployment rate, mean years of schooling, the
urbanization rate, real per capita health expenditure
(public and private), the DPT immunization rate among
children ages 12-23 months, and some risk factors (HIV
prevalence and tuberculosis incidence).
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Why is there less access to new drugs in
Russia than in other countries?
Possible reasons for the fact that access to new drugs is lower in
Russia than it is in other countries with similar incomes
• Public per capita pharmaceutical expenditure
in Russia ($16) was less than half of the
average expenditure in all high-middle income
countries ($34)
• Factors may inhibit or delay licensing of new
medicines
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Pharmaceutical private spending per capita, $US at exchange rate
high-middle income countries, 2004-2006
Lithuania
Poland
Mexico
Brazil
Uruguay
Venezuela, Bolivarian Republic of
Bulgaria
Chile
Croatia
Dominica
Costa Rica
Russian Federation
Latvia
Gabon
Jamaica
Kazakhstan
Romania
Argentina
Serbia
Turkey
Saint Lucia
Panama
Belarus
Suriname
Belize
Saint Kitts and Nevis
Grenada
Cuba
Cook Islands
Fiji
Saint Vincent and the Grenadines
$119
$119
$102
$100
$96
$92
$82
$78
$68
$66
$61
$60
$58
$58
$52
$48
$47
$45
$44
$44
$36
$35
$34
$34
$32
$31
$28
$28
Mean = $56
Source: Annex: The World Medicines Situation 2011 - Medicine Expenditures.
http://apps.who.int/medicinedocs/en/m/abstract/Js20052en/
$18
$13
$6
0
20
40
60
80
100
120
140
15
Pharmaceutical public spending per capita, $US at exchange rate
high-middle income countries, 2004-2006
Croatia
Saint Kitts and Nevis
Poland
Lithuania
Turkey
Latvia
Serbia
Cuba
Brazil
Romania
Cook Islands
Mexico
Saint Vincent and the Grenadines
Costa Rica
Belarus
Panama
Bulgaria
Argentina
Uruguay
Grenada
Dominica
Suriname
Saint Lucia
Russian Federation
Chile
Kazakhstan
Belize
Malaysia
Fiji
Gabon
Venezuela, Bolivarian Republic of
Jamaica
$126
$82
$75
$64
$64
$54
$50
$43
$43
$42
$41
$35
$34
$34
$32
$31
$28
$23
$23
$21
$21
$20
$18
$16
$13
$13
$12
$12
$11
$9
Mean = $34
Source: Annex: The World Medicines Situation 2011 - Medicine Expenditures.
http://apps.who.int/medicinedocs/en/m/abstract/Js20052en/
$4
$4
0
20
40
60
80
100
120
140
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Factors that may inhibit or delay
licensing of new medicines
• Lack of transparency in the registration system
• Unclear deadlines for registration, lack of clarity concerning necessary
steps in the process
• Unlike other regulatory jurisdictions, the absence of a legal procedure for
pre-submission meetings with experts on Clinical Trials (CT)
protocol/design for innovative drugs
• The absence/rare opportunity to meet with experts during the submission
process
• The lack of strong legal protection from disclosure of commercially
valuable data submitted to the Ministry of Health
• The law didn’t specify clear labeling requirements concerning
indications/instructions for use
• The Russian Pharmacopeia was not harmonized with any of the leading
reference pharmacopeias, leading to out-of-date quality requirements
• No specialized requirements for the authorization/licensure of biosimilars
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Summary
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The adoption and diffusion of new drugs can make a substantial contribution to Russian
longevity growth.
Almost half of the 222 drugs launched in the U.S. during the period 2000-2010 had not been
launched in Russia by the end of 2011.
The drugs used in Russia are about 15 years older than those used in the U.S., and over 20
years older than the drugs used in the top five countries. The mean launch year of drugs
used in Russia is low, even relative to other countries with similar income levels.
Only 1% of the drugs consumed in Russia in 2009 were less than 20 years old. In 30 other
developing and high-income countries, the mean fraction of drugs consumed in 2009 that
were less than 20 years old was 9%.
My estimates indicate that if the fraction of drugs consumed that were less than 20 years old
increased from its actual value in Russia (1%) to the mean value of all 31 countries (9%), life
expectancy at birth in Russia would increase by about 2.1 years.
Expanded use of new drugs will also increase the ability of the population to work, attend
school, and perform activities of daily living, and it will reduce the utilization of nonpharmaceutical medical services, such as hospitals, nursing homes, and physician office visits.
Although private per capita pharmaceutical expenditure in Russia was slightly higher than
average in all high-middle income countries during 2004-2006, public per capita
pharmaceutical expenditure in Russia was less than half of the average in all high-middle
income countries.
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