Transcript The Value of New Medicines WIPO Arab Regional Meeting IP as a Power Tool for Economic Growth Susan Kling Finston Associate Vice President PhRMA Amman, June 1, 2004

The Value of
New Medicines
WIPO Arab Regional Meeting
IP as a Power Tool
for Economic Growth
Susan Kling Finston
Associate Vice President
PhRMA
Amman, June 1, 2004
Value of New Medicines
• To Individual Patients and Families
• For the Benefit of the Larger Societies,
including the Levant
• Specific Benefits to the Jordanian
Economy (2000 – 2004)
New Medicines. New Hope.
The value to Patients:
I.
Improving quality of life by reducing
hospitalizations and helping patients
avoid surgery.
II. Reducing side effects.
III. Decreasing mortality and morbidity.
New Medicines. New Hope.
I. New Drugs Improving Quality of Life
• Reducing hospitalizations and
emergency room visits
• Avoiding surgery
• Helping patients remain more active
and independent
New Medicines. New Hope.
New Drugs Reduce Visits to Hospital and ER
Asthma Management Program Improves Outcomes for
Children with Asthma
90%
85%
Percent of Patients
80%
Before Program
After Program
70%
55%
60%
50%
40%
35%
30%
30%
20%
10%
0%
ER Visits
Hospitalizations
Source: P.J. Munzenberger and R.Z. Vinuya, “Impact of an Asthma Program on the Quality of Life of Children in an Urban
Setting,” Pharmacotherapy, 22 (2002): 8, 1055-1062.
New Medicines. New Hope.
Medicines Help Prevent Invasive
Surgeries
“[F]or ulcers, a few pills have
replaced major surgery.”
Former FDA Commissioner Dr. Mark McClellan, Speech
before Drug Information Association, Ottawa, Canada
November 18, 2003
New Medicines. New Hope.
Medicines Allow Patients to Remain Independent
Longer
New Alzheimer’s Medicine Delays Need for Costly
Nursing Home Care
Average Number of Months Until
Nursing Home Placement
73 Months
80
70
60
43 Months
50
40
30
20
10
0
Less Drug Use (<5mg/Day, <8 Weeks
Treatment)
More Drug Use (>5mg/Day, >36 Weeks
Treatment)
Source: G. Provenzano, et al., “Delays in Nursing Home Placement for Patients with Alzheimer’s Disease
Associated with Treatment with Donepezil May Have Health Care Cost-saving Implications,” Value in
Health, 4 (2001): 2,158.
New Medicines. New Hope.
II. New Medicines Reduce Side Effects
• New medicines have been found to reduce side effects,
often leading to improved compliance and better health
outcomes.
• Approximately 20% to 30% of patients who take
conventional NSAIDs develop persistent side effects, and
more than 10% are estimated to discontinue treatment as a
result. (Source: “Anti-Inflammatory and Upper Gastrointestinal Effects of Celecoxib in Rheumatoid Arthritis,”
The Journal of the American Medical Association, Vol. 282, No. 20, November 24, 1999.)
• A new family of NSAIDs known as Cox-2 inhibitors have
been proven to cause less stomach irritation and carry a
lower risk of complications than conventional NSAIDs.
New Medicines. New Hope.
New Medicines Often Have Fewer Side Effects
and Less Complicated Dosing Regimens
• In the United States, the number of patients treated for
depression has grown from 1.7 million to 6.3 million
over the last decade.
• One of the primary reasons for the increase was the
steady broadening of prescription drug options
available to treat depression, including a new class of
antidepressant medications, which have fewer side
effects and require less complicated dosing regimens.
Source: Olfson, Mark et al., “National Trends in the Outpatient Treatment of
Depression,” The Journal of the American Medical Association, 2002; 287:
203-209.
New Medicines. New Hope.
III. Pharmaceuticals Reduce Mortality
and Morbidity
• Pharmaceuticals have eliminated or brought under control
many diseases that once had high mortality rates (e.g.,
influenza, polio, pneumonia, diphtheria).
• Medicines have helped dramatically reduce mortality rates
for other diseases and conditions (e.g., AIDS, asthma, heart
attacks, strokes, ulcers).
• Medicines are alleviating symptoms for a wide range of
diseases.
New Medicines. New Hope.
Drug Discoveries Have Helped Control Death
Rates for Chronic and Acute Conditions
Examples:
• Antibiotics have helped cut death rates from
rheumatic fever and rheumatic heart disease by 83%
from 1965 to 1996.
• Medicines such as ACE Inhibitors, beta-blockers, and
nitrates have helped cut death rates from
atherosclerosis (hardening of the arteries) by 74%.
• H2 blockers and proton pump inhibitors helped cut
death rates from ulcer of the stomach and duodenum
by 72%.
New Medicines. New Hope.
New Drugs Decrease Mortality for
Deadly Diseases
• “From Killer to Chronic Disease: Drugs
Redefine Cancer for Many”
Headline to Washington Post story, January 29, 2003,
which noted that thanks to advances in care, cancer has
evolved into a “chronic disease, much like asthma,
diabetes, and, more recently, AIDS.”
• AIDS death rate fell 80% in the last decade
with introduction of HAART drug therapy.
Source: CASCADE Collaboration, “Determinants of Survival Following HIV1 Seroconversion After the Introduction of HAART,” The Lancet, 362 (2003):
New Medicines. New Hope.
1267-1274.
Study Finds Direct Correlation Between
Reductions in Mortality and Number of New
Drugs for Disease
• Over 45% of the variation in mortality across diseases
1970-1991 is explained by the amount new drugs are
used to treat the disease – New drugs the most
important factor in mortality reductions.
• Each of the 436 new drugs introduced 1970-1991,
annually adds 11,200 aggregate years of life to the
U.S. population.
Source: Lichtenberg, Frank, “Pharmaceutical Innovation, Morality Reduction,
and Economic Growth,” Presented at the Conference on the Economic Value
of Medical Research, December 1999.
New Medicines. New Hope.
Medicines Ease Symptoms
New Drug to Treat Overactive Bladder Improves
Symptoms; Reduces Patient Care Needs
80%
74%
70%
60%
50%
40%
40%
30%
20%
10%
0%
Patients Not Treated With New Drug
Reduced Office Visits
Average Number of Office Visits per
Patient (in First 3 Months of Study)
Percent of Patients with Improved
Symptoms (in First 3 Months of Study)
Improved Symptoms
0.6
0.5
0.5
0.4
0.3
0.26
0.2
0.1
0.0
Patients Treated With New Drug
New Medicines. New Hope.
Source: T.B. Boone, et al., “Treatment Patterns and Associated Symptom Improvement During Six Months of Care for Overactive
Bladder: A Prospective, Observational Study,” Clinical Therapeutics, 24 (March 2002): 3, 397-408.
Value to Society
I. Curbing overall health care spending.
II. Increasing worker productivity.
III. Preventing disease and/or mitigating
the complications of disease.
New Medicines. New Hope.
I. New Drugs Reduce Total Medical Spending
• The use of newer drugs tends to lower all types of nondrug medical spending, reducing the total cost of treating a
condition.
• Hospitalization rates fall
• Length-of-stay in the hospital goes down
• Visits to family doctors and specialists are reduced
• Prevent costs associated with complications and symptoms
• Help avert costly surgeries
New Medicines. New Hope.
Research Shows Using New Medicines
Reduces Health Care Spending
• Use of newer medicines increased drug costs by $18, but
reduced hospital and other non-drug costs by $129.
→ So for each additional $1 spent on newer
pharmaceuticals, $6.17 is saved in total health care
spending
→ Of that amount, $4.44 comes from savings in hospital
spending.
Frank R. Lichtenberg, “Benefits and Costs of Newer Drugs: An Update,”
(Cambridge, MA: National Bureau of Economic Research, June 2002).
New Medicines. New Hope.
Drugs Help Control Hospital and
Ambulance Costs
Change in Annual Costs per Patient
Mood Stabilizers Result in Savings for Patients with
Bipolar Disorder
$1,000
$430
$522
$0
-$52
-$1,000
-$2,000
-$3,000
-$2,329
-$4,000
-$3,614
-$5,000
-$5,044
-$6,000
Ambulatory
Savings
Hospital
Savings
Drug Costs
Nursing
Home Care
Costs
Other
Savings
Source: J. Li, et al, “Cost of Treating Bipolar Disorder in the California Medicaid (Medi-Cal) Program”, Journal of Affective
Disorders, 71 (2002): 1-3, 131-139
Total Health
Care
Savings
New Medicines. New Hope.
New Medicines Reduce Costs by Averting
Complications and Reducing Symptoms
Diabetes Costs Reduced Through Improved Glycemic
Control
Unimproved Group
Improved Group
$14,000
$12,000
$10,213
$2,914 in
Savings
$11,562
$4,093 in
Savings
Costs
$10,000
$8,000
$7,469
$7,299
$6,000
$4,000
$2,000
$0
Three Years After Study
Four Years After Study
Source: E.H. Wagner, et al., “Effect of Improved Glycemic Control on Health Care Costs and Utilization,” Journal of the
American Medical Association, 285 (2001): 2, 182-189.
New Medicines. New Hope.
II. New Drugs Increasing Worker
Productivity
• Pharmaceuticals make it possible for
patients to perform better on the job; worker
productivity improves
• With effective medicines absenteeism falls
• Employers save money that would have
been lost to physical and mental illness
New Medicines. New Hope.
Medicines Can Greatly Improve
Productivity and Save Employers Money
New Migraine Medicine Produces Productivity Savings
that Far Outweigh Drug Costs
100
Monthly
Costs
$43.78
Monthly Employer Savings
per Employee Treated
0
-100
Monthly Drug Costs per
Employee Treated
Monthly
Savings
-200
-300
10 : 1
Benefits : Costs
-400
-$435.00
-500
New Medicines. New Hope.
Source: R.F. Legg, et al., “Cost Benefit of Sumatriptan to an Employer,” Journal of Occupational and Environmental Medicine,
39 (1997): 7, 652-657.
Medicines Can Reduce Days Missed
From Work
Antidepressants Reduce Absenteeism
Days Absent per Month
5
4
3
2
1
0
-6
-5
Month
-4
-3
-2
-1
1
2
3
4
5
6
SSRI Drug Month
Treatment Begins
Source: A.J. Claxton, et al., “Absenteeism Among Employees Treated for Depression,” Journal of Occupational and
Environmental Medicine, 41 (1999):7, 605-611.
New Medicines. New Hope.
III. New Drugs Can Prevent or Mitigate the
Complications of Disease
• Drug treatments reduce disability resulting
from a disease
• They minimize the chance of serious
disease complications
• Medicines lower risk of serious disease
events, such as heart attack
• New medicines can slow disease
progression
New Medicines. New Hope.
Medicines Help Prevent Disability
Percent Having Advanced Disability
After 54 Weeks of Treatment
Rheumatoid Arthritis Drug Treatment Reduces
Chance of Disability
25%
23%
20%
15%
11%
10%
5%
0%
One Drug
Combination of Drugs
Source: J.B. Wong, et al., “Estimating the Cost-effectiveness of 54 Weeks of Infliximab for Rheumatoid Arthritis,” American
Journal of Medicine, 113 (2002): 400-408.
New Medicines. New Hope.
Medicines Prevent Serious Disease Events:
Cholesterol Fighting Drugs Reduce Risk of Heart Attack or
Stroke
• Cholesterol-lowering drugs, known as statins, safely
reduced the risk of a heart attack or stroke by one-third in
the world’s largest study of people at high risk for these
conditions.
• About 25 million people worldwide take statins today. The
new findings suggest that about 200 million people
worldwide would benefit from the drugs.
• According to the study’s lead investigator, if 10 million
high-risk patients started taking statins, 50,000 deaths
would be prevented each year.
Source: Lawrence K. Altman, “Cholesterol Fighters Lower Heart Attack Risk, Study Finds,”
New Medicines. New Hope.
The New York Times, November 14, 2001.
Medicines Reduce the Risk of Complications:
Strides in Ulcer Treatment Exemplify Ability of
Pharmaceutical Innovation to Prevent or Mitigate
Complications of Disease
• Before 1977, the year in which stomach-acid blocking H2
antagonist drugs were introduced 97,000 ulcer surgeries
were performed each year. By 1987, that number dropped
to fewer than 19,000.
• In the 1990s cost of drug therapy for ulcers:
$900/person/year
Cost of surgery: $28,000
• The new treatment saves at least $224 million a year in
health care costs.
Source: “The Contribution of Pharmaceutical Companies: What’s at Stake for
America,” The Boston Consulting Group, September 1993.
New Medicines. New Hope.
Hepatitis C Virus (HCV) and its
Epidemiology in Levant Area
• Discovered in 1989 as a small RNA blood-borne virus with
a large reservoir of chronic carriers worldwide
• Major cause of posttransfusion hepatitis prior to 1992
• Actual prevalence of HCV infection in Lebanon and Syria
is not known.
• Prevalence in Iraq 0.5%, Libya 7.9% and Jordan 2%*.
• Genotype 4 is the most prevalent type in the Middle East.
New Medicines. New Hope.
Prevalence of HCV in Our Countries
East Medit., 4.6
Libya, 7.9
Prevalence of HCV
Jordan, 2.1
Iraq, 0.5
% 0
2
4
6
8
10
New Medicines. New Hope.
Combination Therapy is Excellent Value Compared with
Other Well Accepted Interventions
Cost per life
years gained
(Euro)
50,000
40,000
30,000
20,000
10,000
0
PegIntron(1.5)
+ Rebetol
Stool
Guaiac
Pneum Vacc
CABG
Antihypertensives
Mammogram
New Medicines. New Hope.
Value to Jordan
I. Growth in Pharmaceutical Industry
Economic Activities
II. Development of New Related Sectors
III. Overall Benefits to the Jordanian
Economy
New Medicines. New Hope.
Growth in Pharmaceutical Industry
Economic Activities (2000 - 2004)
•
More New Product Launches:
– More than 32 new product launches
– Jordan joining “Global Launch” A-List
•
Growth in PhRMA Activities in Jordan:
– Ten Regional Offices
– 300% Growth in Direct Employment
New Medicines. New Hope.
Growth of Partnerships
•
Eli Lilly:
Agreed with Al Hikmeh to promote Cialis for erectile dysfunction in
the Jordanian market, as the first multi-national company to provide
exclusive promotion responsibility for an innovative drug.
•
Bristol-Myers Squibb:
Signed a 3-yr cooperative landmark agreement with King Hussein
Cancer Center (KHCC). This agreement extended cooperation to
Jordan already existing between B-MS and NCI (National Cancer
Institute) in US.
•
Novartis:
Levant Regional Office in Amman celebrates its fifth year in
operation serving several countries in the region; reached a
collaborative agreement with Dar Aldawa.
New Medicines. New Hope.
Development of New Sectors
in Jordan - - Clinical Reseach
•
•
PhRMA members:
Aventis, BMS, Eli Lilly, Janssen Cilag, MSD,
Novartis, Organon, Pfizer and Schering AG
Key areas:
– Cancer
– Renal Failure
– Schizophrenia
– Epilepsy
– Antibiotics
- Cardiovascular
- Anti-infectives
- Diabetes
- Osteoporosis
- Painkillers
New Medicines. New Hope.
Growth of Clinical Trial Activity in Jordan
Clinical
trials
Pfizer
Eli Lilly
Novartis
MSD
Aventis
Schering
AG
Pre2000
1
Almost none
None
None
None
None
2004
4
2
4
3
6
1
Subject
Antifungal
Cardiovascular
Osteoporosis
Sepsis
Cancer
Thalassaemia
Cancer
Osteoporosis
Osteoarthritis
Cardiovascular
Oncology
Osteoporosis
Cardiovascular
Diabetes
Anti-infectives
Computer
tomography
Cardio
angiography
investigations
Data: Internal PhRMA Survey, Spring 2004
New Medicines. New Hope.
Development of New Sectors
in Jordan - - Medical Tourism
• Jordan has four major sites
• Each with several medical/holistic health
centers:
– Dead Sea
– Ma’een Falls
– Jordanian Hummah
– Afra Falls
New Medicines. New Hope.
Overall Benefits to the Jordanian Economy
•
•
Benefits of Perception of strong Jordanian IP Regime
Growth in Jordanian Economy based on Knowledge
Economy
– Springboard for attracting PhRMA member activities
to Amman.
– Jordan’s pharmaceutical exports produced by
local firms increased by 30% overall to all
markets through 2003.
New Medicines. New Hope.
PhRMA International Points of Contact
Washington DC:
[email protected]
Susan Finston
Amman, Jordan:
[email protected]
Samir Mansour
New Medicines. New Hope.