the value of new medicines wipo arab regional meeting ip as a power tool for economic growth susan...

The Value of The Value of New MedicinesNew Medicines

WIPO Arab Regional MeetingIP as a Power Tool

for Economic Growth

Susan Kling FinstonAssociate Vice President

PhRMA

Amman, June 1, 2004

New Medicines. New Hope. New Medicines. New Hope. New Medicines. New Hope.

Value of New MedicinesValue 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)


The value to Patients: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.


I. New Drugs Improving Quality of LifeI. New Drugs Improving Quality of Life

• Reducing hospitalizations and emergency room visits

• Avoiding surgery

• Helping patients remain more active and independent


New Drugs Reduce Visits to Hospital and ERNew Drugs Reduce Visits to Hospital and ER

85%

55%

35%30%

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70%

80%

90%

ER Visits Hospitalizations

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Asthma Management Program Improves Outcomes for

Children with Asthma

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.

After ProgramBefore Program


Medicines Help Prevent Invasive Medicines Help Prevent Invasive SurgeriesSurgeries

“[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


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Less Drug Use (<5mg/Day, <8 WeeksTreatment)

More Drug Use (>5mg/Day, >36 WeeksTreatment)

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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.

Medicines Allow Patients to Remain Independent Medicines Allow Patients to Remain Independent LongerLonger

New Alzheimer’s Medicine Delays Need for Costly Nursing Home Care

43 Months

73 Months


II. New Medicines Reduce Side EffectsII. 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 Often Have Fewer Side Effects New Medicines Often Have Fewer Side Effects and Less Complicated Dosing Regimensand 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.


III. Pharmaceuticals Reduce Mortality III. Pharmaceuticals Reduce Mortality and Morbidityand 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.


Drug Discoveries Have Helped Control Death Drug Discoveries Have Helped Control Death Rates for Chronic and Acute ConditionsRates 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 Drugs Decrease Mortality for New Drugs Decrease Mortality for Deadly DiseasesDeadly 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 HIV-1 Seroconversion After the Introduction of HAART,” The Lancet, 362 (2003): 1267-1274.


Study Finds Direct Correlation Between Study Finds Direct Correlation Between Reductions in Mortality and Number of New Reductions in Mortality and Number of New Drugs for DiseaseDrugs 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.


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)Medicines Ease SymptomsMedicines Ease Symptoms

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.

New Drug to Treat Overactive Bladder Improves Symptoms; Reduces Patient Care Needs

Patients Not Treated With New Drug Patients Treated With New Drug

Improved Symptoms Reduced Office Visits


Value to SocietyValue to Society

I. Curbing overall health care spending.

II. Increasing worker productivity.

III. Preventing disease and/or mitigating the complications of disease.


I. New Drugs Reduce Total Medical SpendingI. New Drugs Reduce Total Medical Spending

• The use of newer drugs tends to lower all types of non-drug 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


Research Shows Using New Medicines Research Shows Using New Medicines Reduces Health Care SpendingReduces 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).


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Drugs Help Control Hospital and Drugs Help Control Hospital and Ambulance CostsAmbulance CostsMood Stabilizers Result in Savings for Patients with Bipolar Disorder

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


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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.

Unimproved Group Improved Group

$2,914 in Savings

$4,093 in Savings

Diabetes Costs Reduced Through Improved Glycemic Control

New Medicines Reduce Costs by Averting New Medicines Reduce Costs by Averting Complications and ReducingComplications and Reducing SymptomsSymptoms


II. New Drugs Increasing Worker II. New Drugs Increasing Worker ProductivityProductivity

• 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


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Medicines Can Greatly Improve Medicines Can Greatly Improve Productivity and Save Employers Money Productivity and Save Employers Money New Migraine Medicine Produces Productivity Savings that Far Outweigh Drug Costs

Source: R.F. Legg, et al., “Cost Benefit of Sumatriptan to an Employer,” Journal of Occupational and Environmental Medicine, 39 (1997): 7, 652-657.

MonthlyCosts

MonthlySavings

Monthly Drug Costs per Employee Treated

Monthly Employer Savings per Employee Treated

10 : 1 Benefits : Costs


Medicines Can Reduce Days Missed Medicines Can Reduce Days Missed From WorkFrom Work

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Antidepressants Reduce Absenteeism

Source: A.J. Claxton, et al., “Absenteeism Among Employees Treated for Depression,” Journal of Occupational and Environmental Medicine, 41 (1999):7, 605-611.

SSRI Drug Treatment BeginsMonth


III. New Drugs Can Prevent or Mitigate the III. New Drugs Can Prevent or Mitigate the Complications of DiseaseComplications 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


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One Drug Combination of Drugs

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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.

Medicines Help Prevent DisabilityMedicines Help Prevent DisabilityRheumatoid Arthritis Drug Treatment Reduces Chance of Disability


Medicines Prevent Serious Disease Events:Medicines Prevent Serious Disease Events:Cholesterol Fighting Drugs Reduce Risk of Heart Attack or Cholesterol Fighting Drugs Reduce Risk of Heart Attack or StrokeStroke

• 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,” The New York Times, November 14, 2001.


• 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/yearCost 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.

Medicines Reduce the Risk of Complications:Medicines Reduce the Risk of Complications:Strides in Ulcer Treatment Exemplify Ability of Strides in Ulcer Treatment Exemplify Ability of Pharmaceutical Innovation to Prevent or Mitigate Pharmaceutical Innovation to Prevent or Mitigate Complications of DiseaseComplications of Disease


Hepatitis C Virus (HCV) and its Hepatitis C Virus (HCV) and its Epidemiology in Levant AreaEpidemiology 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.


Prevalence of HCV in Our Countries Prevalence of HCV in Our Countries

Iraq, 0.5

Jordan, 2.1

Libya, 7.9

East Medit., 4.6

0 2 4 6 8 10

Prevalence of HCV

%


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Cost per life years gained

(Euro)

PegIntron(1.5)+ Rebetol

Stool Guaiac

Pneum Vacc Anti-hypertensives

CABG Mammogram

Combination Therapy is Excellent Value Compared with Combination Therapy is Excellent Value Compared with Other Well Accepted InterventionsOther Well Accepted Interventions


Value to JordanValue to Jordan

I. Growth in Pharmaceutical Industry Economic Activities

II. Development of New Related Sectors

III. Overall Benefits to the Jordanian Economy


Growth in Pharmaceutical Industry Growth in Pharmaceutical Industry Economic Activities (2000 - 2004) 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


Growth of PartnershipsGrowth 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.


Development of New SectorsDevelopment of New Sectorsin Jordan - - Clinical Reseachin Jordan - - Clinical Reseach

• PhRMA members: Aventis, BMS, Eli Lilly, Janssen Cilag, MSD, Novartis, Organon, Pfizer and Schering AG

• Key areas:– Cancer - Cardiovascular– Renal Failure - Anti-infectives– Schizophrenia - Diabetes– Epilepsy - Osteoporosis– Antibiotics - Painkillers


Growth of Clinical Trial Activity in Jordan

Data: Internal PhRMA Survey, Spring 2004

Clinical trials

Pfizer Eli Lilly Novartis MSD Aventis Schering AG

Pre-2000

1 Almost none None None None None

2004 4 2 4 3 6 1

Subject AntifungalCardiovascular

OsteoporosisSepsisCancer

ThalassaemiaCancer

OsteoporosisOsteoarthritisCardiovascular

OncologyOsteoporosisCardiovascularDiabetesAnti-infectives

Computer tomographyCardio angiography investigations


Development of New SectorsDevelopment of New Sectorsin Jordan - - Medical Tourismin Jordan - - Medical Tourism

• Jordan has four major sites

• Each with several medical/holistic health centers:

– Dead Sea

– Ma’een Falls

– Jordanian Hummah

– Afra Falls


Overall Benefits to the Jordanian EconomyOverall 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.


PhRMA International Points of ContactPhRMA International Points of Contact

Washington DC:

[email protected] Susan Finston

Amman, Jordan:

[email protected] Samir Mansour

the value of new medicines wipo arab regional meeting ip as a power tool for economic growth susan...

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