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Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Index

A

Abbott Laboratories, 190n.1

Abbreviated new drug application (ANDA), 6, 40–41

Abdominal aortic aneurysm repair, 116

Access

to health care, 22, 86, 144

to new drugs, 53–67

ACE inhibitors, 37, 50n.10

Adrenal medulla tissue transplantation, 100

Adriamycin, 60

AIDS (acquired immune deficiency syndrome), 5, 55, 83, 144

drug therapies, 145, 172, 174–175, 178

Alcon Laboratories, Inc., 81

Allergan Medical Optics, 81

Allergy treatment, 89

Alzheimer's disease, 190

American Home Products Corporation, 190n.1

American Medical Association, 7, 107–108

Drug Evaluations, 7, 61

Ancillary services, 24

Anesthesia, 76, 94

Angina pectoris, 4, 99

Angioplasty equipment, 77

Animal research, 5, 99, 128, 170–171

Annual update factor, 28

Antibacterials, 160

Antibiotics, 37

Antihistamines, 89

Antihypertensive drugs, 25–26

Antitrust legislation, 2

Appendectomies, 97

Applied research, 188

Arterial switch surgery, 98

Arthroscopy, 96, 107, 108

Artificial heart, 85, 92

Artificial Heart Program (NIH), 74, 75

Assessment of technology, 31, 84, 100, 111, 141, 144–145

“Assignment,” 117, 120n.6

Association of Community Cancer Centers (ACCC), 55, 58

Austenal Dental, Inc., 73

Austria, 129

Autologous bone marrow transplantation, 56

Axid, 50n.10

Azidothymidine (AZT), 175

B

Baby boom, 22

Banyu Pharmaceutical Company, Ltd., 164

Baxter Healthcare Corporation, 149

Beckman, Arnold, 91

Beckman Instruments, Inc., 91

Beecham Group P.L.C., 160, 183

Belgium, 138n.3, 147

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

medical device industry, 81

pharmaceutical industry, 126–127, 130, 133, 134

Beta blockers, 4, 25

Biliary lithotripsy, 79–80, 98

“Bioequivalence,” 17n.4

Biologics Evaluation and Research Center

(FDA), 179–180n.1

Biotechnology, 8

drug regulation, 129, 173, 175, 177

drug research, 36, 49–50n.8

Japanese industry, 161, 165

Blood cardioplegia, 98

Blue Cross and Blue Shield Association, 61–62, 105

Medical Advisory Panel, 106

Blue Shield of California, 108, 113, 116, 117, 120n.5

Breast cancer, 56

Breast reconstruction, 116

Bristol-Myers Squibb, 158, 183, 190n.1

C

Calcium channel blockers, 37

California, 29–30

Medicaid coverage, 47–48, 107, 113

Office of Statewide Health Planning and Development, 112

Canada, 28, 29

Cancer

chemotherapy innovations, 53–56, 64

chemotherapy reimbursement, 7, 56–65

drugs, 5, 17n.5, 40, 55, 59–62, 64, 83, 172, 174, 175, 178

patients, 56, 61, 66

screening, 144, 171

Capitated plans, 11–12, 29

Capoten, 50n.10

Carcinogenicity bioassay, 171

Cardiac arrhythmias, 4

Cardiac catheterization, 28, 116

Cardiac Pacemaker Registry, 85

Cardiac pacemakers, 76, 85, 91

Cardiac surgery, 28, 96–97, 98, 112, 113, 116

Cardiac transplantation, 99, 112, 113–114, 120n.5, 151

Cardiovascular disease

drug therapies, 37, 40, 174, 175

mortality, 37

Carte Sanitaire, 151

Case management, 13

Case studies, 23, 24, 73

Cataracts, 80, 81

Catastrophic Care Act (1988), 61, 62

Catheter ablation of abnormal cardiac conduction foci, 116

Cefazolin, 160

“Centers of excellence,” 115

Cephalosporins, 25

Certificate-of-need regulations, 1, 113

Chemonucleolysis, 108

Chemotherapy

innovations, 53–56, 64

reimbursement policies, 7, 56–65, 66

Chest radiographs, 30

Chiron Corporation, 81

Chiron Ophthalmics, Inc., 81

Cholecystectomy, 14, 97, 108

Cholesterol-reducing drugs, 26, 37, 162

Chronic disease drugs, 40

Ciba-Geigy Corporation, 158, 161

Cimetidine, 25

Class action suits, 136

Class I devices, 17n.8, 76

Class II devices, 17n.8, 76

Class III devices, 17n.8, 76, 79, 80–81

Clinical practice, 37, 55, 141

Clinical trials

cancer therapies, 54, 55, 61, 62, 63, 64, 65, 66, 67

pharmaceutical, 7, 40, 128, 136, 158–159, 171–174, 178–179, 180n.2

Phases of, 5, 170–176, 180nn.2, 4, 5, and 7

surgical procedures, 13, 99, 102, 103

Cochlear implants, 11, 28, 109–110

Coding

medical devices, 94–95

surgical procedures, 13, 97, 102, 105, 107–111, 118

Compassionate use, 7, 17n.5, 173, 178–179

Computerized tomography, 24, 29–30, 103, 146, 148–149, 151

Concurrent review, 13

Consensus NCEs, 37, 38

Consumer groups, 130

Contact lenses, 18n.12

Contingency fees, 136

Contraception, 10, 76

Coopervision G.m.b.H., 81

Copyrights, 182, 189

Coronary artery bypass grafting (CABG), 24, 26, 98, 99, 112–113

reimbursement policy, 108, 111

selective contracting, 14, 115, 116

Coronary artery disease, 26

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Cost containment, 1–2, 6–7, 31, 77

Europe, 130–131, 133

and medical device innovation, 10–12, 77–79, 82, 83, 86

private insurers, 57

and surgical procedure innovation, 13–14, 96, 108, 111, 113, 116, 118, 119

Cost-effectiveness, 119

cardiac transplantation, 113–114

of drug formularies, 50n.20

HMOs and, 11–12, 29, 30

lithotripsy, 149–150

and medical device innovation, 10–12, 91, 142, 146, 152

model of diffusion and, 22, 24–26, 27, 30–31

MRI utilization, 29

pharmaceutical studies, 8, 25–26, 190

public policy and, 144, 145, 190

Costs

of disease, 190

health care, 1, 4, 15–16, 21–22, 25, 26– 27, 50n.20, 77, 85, 151, 181, 186, 187, 190

hospital, 7, 75, 77, 111, 147–148

induced costs, 23, 24, 31

lithotripsy, 78

medical device innovation, 10, 18n.12, 91–92

pharmaceutical research and development, 6, 37–40, 41, 42–43, 44, 45, 46, 100, 127, 182–183, 187

physicians and, 27

surgery, 14, 79, 81, 97, 98, 99–100, 105, 110–111, 112, 114, 115, 116, 118, 119

of technology, vii, 63, 145–146 See also

Prices, pharmaceutical

Coverage, 1, 13, 16n.1, 25

interim, 12, 14 See also

Reimbursement

Crippled Children's Services, 113

Crout, Richard, 175

Current Procedural Terminology (CPT), 13, 57, 107–108, 119n.1

Cyclosporine, 96

Cytoxan, 60

D

Demand

for health services, 142

for medical devices, 75

for pharmaceuticals, 139n.8, 157

for technology, 1, 3, 4–5, 22

Denial of payment, 56, 58, 61, 63, 65

Denmark

health care system, 147, 148, 150, 151

pharmaceutical industry, 126–127, 131– 132, 134

Development of technology. See

Research and development

“Device lag,” 10, 83

Devices. See

Medical devices

Devices and Radiological Health Center (FDA), 179–180n.1

Diagnosis-related groups (DRG), 1–2

hospitals and, 13, 27, 28, 56–57, 63, 77, 109, 110, 117, 119n.2

medical devices, 10, 11, 77

pharmaceutical therapies, 56–57, 179

surgical procedures, 11, 109–110, 117

Diagnostic technologies, 26, 75, 144

Dialysis machines, 151

Diasonics, Inc., 79

Diffusion of technology, 16, 27, 29, 66

control of, 1, 2, 10, 21, 56, 73

and health care costs, 21–22, 24–26, 30–31

medical devices, 10, 70, 71, 72, 73, 85, 91, 141, 144, 146, 149–150

payment policies and, 14, 28, 53, 77, 109, 119, 144, 150–151

surgical procedures, 13, 96, 97, 101–102, 112–113, 114, 119

DiMasi, Joe, 39

Diuretics, 37, 50n.10

Dornier Medical Systems, 9, 79, 149–150

Dow Chemical Company, 183

Doxazosin, 156

Drug Amendments (1962, Food, Drug, and Cosmetic Act), 169

Drug Evaluation and Research Center (FDA), 179–180n.1

Drug Evaluations (American MedicalAssociation), 7, 61

Drug Information (U.S. Pharmacopeia), 7, 61

Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act, 1984), 6, 40–41, 42, 129–130, 135, 139n.9, 177

Drugs. See

Pharmaceuticals

Duke University, 42

Dutch Organization for Applied Scientific Research, 149

E

Education, 182, 188

Effectiveness evaluation, 21

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

pharmaceuticals, 174, 175, 179–180n.1, 180n.4

Efficacy evaluation

medical devices, 4, 12, 15, 18n.10

pharmaceuticals, 4, 5, 63

surgical procedures, 99, 101–102

Elderly, 80, 81, 85

Electrocardiograms, 30

Electronic fetal monitoring, 24

Electron microscopy, 36

Electrophysiologic mapping (EPS), 116

EMI Medical, Inc., 148–149

Endoscopic papillotomies, 103

End-stage renal disease, 25, 26, 98

Europe, 2, 139n.10, 189

health care systems, 14, 123, 124, 147– 148, 152

medical device innovation, 15, 141–146, 148–153

patent laws, 14, 15, 17n.2, 123, 129–130, 133, 137, 138n.5, 139n.9

pharmaceutical innovation, 14–15, 37, 123–138, 157–158, 163, 165

European Commission, 124, 128, 129, 134, 135, 137, 152

European Court of Justice, 134, 138n.1, 139n.12

European Economic Community (EEC), 137, 163, 164

medical device policies, 141–146, 149–153

pharmaceutical regulation, 15, 128, 130, 131, 132, 133, 135, 136, 138n.1, 139n.11, 161

European Parliament, 130

European Patent Convention, 129, 138n.5

Evaluation

medical device, 76, 93

pharmaceutical, 4, 5, 61, 63, 174, 175, 179–180n.1, 180nn.2 and 4, 185

surgical procedures, 12–13, 99, 101–102, 104–105, 111

Exercise tolerance testing, 26

Experimental therapies, 7, 17n.5, 64, 99, 102

Extracorporeal shock wave lithotripsy (ESWL), 78–80

Extracranial/intracranial arterial bypass surgery, 99

Eye diseases, 80, 81

F

“Fast-follower” drugs, 184–185

Federalism, 85

Fee-for-service systems, 1, 26, 30, 108

Fiberoptic endoscopes, 96

Fluorouracil, 60

Food, Drug, and Cosmetic Act (1938), 5, 169

Drug Amendments (1962), 169 510 (k)

provision, 9–10, 11, 18n.10, 93

Medical Device Amendments (1976), 9, 10, 76

Food and Drug Administration (FDA)

cancer drug approval and labeling, 55, 58, 59–61, 64, 65, 66–67, 83, 175

Cardiac Pacemaker Registry, 85

evaluation centers, 179– 180n.1 510(k)

applications, 9–10, 11, 18n.10, 93

generic drug regulations, 6, 139n.9, 170

medical device regulation, 4, 9–10, 11, 12, 18nn.10 and 11, 28, 76, 79–81, 82, 83, 85, 93, 100, 108

pharmaceutical regulation, 4, 5–6, 7, 8, 17n.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100, 101, 102, 108, 128, 136, 169–176, 177, 179, 180nn.7 and 8, 188

Food Safety and Applied Nutrition Center

(FDA), 179–180n.1

Formularies, 7–8, 17n.7, 30, 47–48, 50n.20, 61, 102

Fox, Renee, 4

France

health care system, 138nn.3 and 6, 147– 148, 151

medical device industry, 81, 149, 150

pharmaceutical industry, 126, 127, 130, 134, 137–138

pharmaceutical regulation, 128, 132, 133

Fujisawa Pharmaceutical Company, Ltd., 160, 162

G

Gallstone lithotripsy, 79–80, 98

Gastric balloon placement, 99

General Accounting Office (GAO), 10, 18n.11, 76

General Electric Company, 73

Generic drugs, 7, 43, 46, 47, 61, 65

in Europe, 15, 123–124, 131, 133

HMOs and, 30

regulation of, 6, 17n.4, 40–41, 42, 139n.9, 170, 177, 185

Generic substitution laws, 7

Genetic engineering, 145

Germany, 138n.3, 147, 148

medical device industry, 81, 149–150

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

medical device regulation, 151

pharmaceutical industry, 126, 127, 133, 138, 162, 163, 166, 186–187

pharmaceutical regulation, 128, 130, 132, 134

Gibbon, John H., Jr., 96–97

Glaxo Holdings P.L.C., 161, 190n.1

Global budgeting, 28–29, 31

Good Licensing Practices, 161

Good Manufacturing Practices, 150, 161

Greece, 127, 138n.6, 147

Gross National Product price deflator, 43, 50n.14

Group C drugs, 5, 17n.5, 55, 62, 63, 178 See also

Cancer: drugs

H

Hairy cell leukemia, 64

Hansen, Ron, 39, 44

Hatch, Orrin G., 85

Health care, 56

access to, 22, 86, 144

costs, 1, 4, 15–16, 21–22, 25, 26–27, 50n.20, 75, 77, 85, 151, 181, 186, 187, 190

Europe, 14, 123, 124, 147–148, 152

Japan, 163

liability, 94

technology and, 22–24, 53, 82, 142

Health Care Financing Administration (HCFA), 8, 24

Bureau of Eligibility, Reimbursement and Coverage (BERC), 106

Cardiac Pacemaker Registry, 85

Common Procedure Coding System, 119n.1

experimental therapy coverage, 62–63, 67, 179

medical device coverage, 10–11, 12, 80, 81–82, 85

Office of Coverage Policy, 10–11

pharmaceutical coverage, 17n.5, 178

surgical procedures coverage, 105, 106, 109–110, 113, 114, 115

Health care market, 3–4

Health insurance, 4, 22, 26, 138n.7, 148, 178

Health Insurance Association of America, 7, 62

Health maintenance organizations (HMO), 57

cost containment, 1–2, 11–12, 58, 187

drug formularies, 17n.7

selective contracting, 105, 115

technology utilization, 29–30, 31

Health outcomes

surgical, 14, 99, 100, 112–113, 114, 115, 116

technology and, 21, 22, 24–26, 28

Heart valves, 76

Hemodialysis, 25, 98

Herniorrhaphy, 14, 104, 106

Hewlett-Packard Company, 73, 149

High Technology Directive (1987), 130

Hip fracture patients, 116

Hoechst-Roussel Pharmaceuticals, Inc., 158

Hoffman-LaRoche, Inc., 90, 161

Home health care, 12

Honeywell, Inc., 115

Hospital Provisions Act (Netherlands), 151

Hospitals, 144

cancer care, 54–55, 66

clinical research, 63, 66, 128, 179

coding practices, 13, 105, 109–110, 118, 119n.2

competition for patients and surgeons, 29, 55, 104, 112–113, 114

cost shifting, 57

costs of technology utilization, 24, 26

drug formularies, 17n.7, 61

Europe, 147–148, 150, 151

liability, 94

payment systems and cost containment, 1, 7, 26, 75, 77, 79, 91, 105, 111, 118, 119

Prospective Payment System and, 11, 14, 27–29, 56, 63, 77, 117, 118, 119

Howmedica, Inc., 73

Humana Hospital Audubon, 104

Human immunodeficiency virus (HIV), 5

Hydroxyzine, 156

Hypertension, 30

I

Imaging devices, 23, 26, 75, 91

Immunostimulants, 162

Immunosuppressive drugs, 96

Income tax law, 90, 183

Induced costs, 23, 24, 31

Inflation, 43, 50n.14, 184, 187

Innovation, 1–2

dynamic model of, 2–5

medical devices, 4, 8–12, 89–95, 97

medical devices, Europe, 15, 141–153

medical devices, public policy and, 69– 86, 89, 92, 95

pharmaceutical, 4, 5–8, 66, 166, 184, 186, 188, 189, 190

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

pharmaceutical, Europe, 14–15, 37, 123–138, 157–158, 163, 165

pharmaceutical, public policy and, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190

pharmaceutical, regulation and, 169–177, 181–182, 186–187

pharmaceutical, reimbursement and, 63–65, 178–179

public policy and, 2, 16, 56

surgical procedures, 4, 12–14, 96–119

Inpatient treatment, 57

Institutional Review Boards (IRB), 13, 99, 171, 173, 180n.3

Insurance

claims systems, 6–7, 13

Europe, 147

health, 4, 22, 26, 138n.7, 148, 178

Japan, 157

liability, 10

Insurers, 178

denial of payment, 56, 58, 64

and drug labeling, 59, 61, 62, 64, 65–66

and surgical procedures, 14, 105, 106, 115, 120n.4

Intensive care units, 24, 75

Interferon, 64–65

Interim coverage, 12, 14

Internal Revenue Service, 90

International Classification of Diseases, 109

Intraocular lenses, 18n.12, 73, 80–82, 111, 117

Intrauterine devices, 76

Investigational device exemption (IDE), 81, 82

Investigational drugs, 17n.5, 62–63, 173, 178–179

Investigational New Drug (IND), 37–38, 55, 170, 171–174

treatment IND, 5–6, 55, 62, 178

IOLAB Corporation, 81

IOPTEX Research, Inc., 73, 81

Ireland, 129, 133–134, 138nn.3 and 5, 147

Israel, 81

Italy, 130

health care system, 138n.3, 147, 149

pharmaceutical industry and regulation, 130, 133, 134, 137–138, 162

J

Japan, 81, 188

National Health Insurance, 157, 159, 161, 163–164

pharmaceutical industry and regulation, 2, 14, 15–16, 126, 127, 129–130, 139n.11, 155–166, 187

Johnson & Johnson Products, Inc., 81, 190n.1

Journal of the American Medical Association, 104

K

Kaiser Permanente, 29–30

Kentucky, 47–48

Kidney stone lithotripsy, 78, 79, 80, 149– 150

Kyowa Chemical Industry Company, Ltd., 157

L

Laparoscopic gynecological surgery, 14

Lasagna, Louis, 39, 173

Lasagna Committee. See

National Committee

to Review Current Procedures for

Approval of New Drugs for Cancer and

AIDS

Laser atherectomies, 96

Lasers, 18n.12, 75, 77

Lawyers, 137

Lederle Laboratories, 158

Liability law

and diffusion of technology, 2, 10, 71, 72, 75–76, 84, 94

Europe, 15, 136

Lilly, Eli, & Company, 160, 164, 190n.1

Linear accelerators, 151

Lithotripsy, 9, 28, 73, 78–80, 98, 149–150, 151

Liver transplantation, 98, 112, 151

Louisville, Ky., 104

Lung cancer, 56

M

Magnetic resonance imaging, 26, 29, 146, 149, 151

Managed care plans, 13, 29–30, 48, 57, 58

Marion Laboratories, Inc., 183

Marketing, 185

Massachusetts General Hospital, 112

Mastectomy, 116

Medicaid, 1

and medical devices, 75, 77

pharmaceutical reimbursement, 8, 17n.7, 47–48, 50n.19, 178

surgical procedures coverage, 106–107

Medical care. See

Health care

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Medical compendia, 7, 17n.6, 61, 67

Medical Device Amendments (1976, Food,

Drug, and Cosmetic Act), 9, 10, 76

Medical devices

Classes of regulation, 17n.8, 76, 79, 80–81

diffusion of, 10, 70, 71, 72, 73, 85, 91, 102, 141, 144, 146, 149–150

and health care costs, 22, 23

patent protection, 9, 70–71, 89–90, 100– 101

regulation of, 4, 9–10, 11, 12, 17nn.8 and 9, 18n.10 and 11, 28, 76, 79–81, 82, 83, 84, 85–86, 97, 100, 108, 173

and surgical innovation, 96, 108

Medical devices industry, 8–9, 12, 95, 152

patents and, 9, 89–90

regulation and, 9–10, 69–73, 74, 76, 79, 86, 86n.1

research spending, 18n.12, 75, 90, 91–92, 145–146

Medical devices innovation, 4, 8–12, 89–95, 97

Europe, 15, 141–153

public policy and, 69–86, 89, 92, 95, 141– 142, 144–145

Medical oncology, 54

Medical practice. See Clinical practice

Medicare, 77

and demand for technology, 1, 75

medical device reimbursement, 12, 25, 28, 79, 80, 81, 82, 85

pharmaceutical reimbursement, 6, 57, 62– 63, 178

surgical procedure reimbursement, 105, 106, 107, 109, 113, 114, 115, 116–117, 120n.6 See also

Prospective Payment System

Medstone International, 79

Medtronic, Inc., 91

Meiji Seika Pharmaceutical International,

Ltd., 157

Merck & Company, Inc., 158, 161, 164, 182, 183–184, 188, 190, 190n.1

Mergers, 183

Meta-analysis, 101

Methotrexate, 60

Methylmethacrylate, 96

Metropolitan Life Insurance Company, 115

Microprocessors, 93

Modifiable selective reimbursement, 14

Monitoring technologies, 94

Morbid obesity, 99

Mortality and morbidity, 14, 37, 99, 100, 111, 115

Mutamycin, 60

Myocardial infarction, 25

N

National Aeronautics and Space Administration, 74–75

National Cancer Act (1971), 54

National Cancer Institute (NCI), 55, 62, 64, 172, 179

National Center for Health Statistics, 109

National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS (Lasagna Committee), 62, 172, 173

National Health Insurance (Japan), 157, 159, 161, 163–164

National Health Service (United Kingdom), 132, 150, 153n.2

National Hospital Formulary, 61

National Institutes of Health (NIH), 63

and AIDS drugs, 174

Artificial Heart Program, 74, 85

cancer therapy media campaign, 55

research spending, 49, 54, 67, 72, 74, 75, 85, 102, 103, 182–183, 188

Small Business Innovation Research grants, 92

National Science Foundation, 188

Netherlands, 126–127, 130, 131–132, 134, 138n.3, 147–148, 151

New chemical entities (NCE), 37, 126, 129, 186–187, 188, 191n.2

consensus, 37, 38

discoveries, Japan, 159, 160, 162, 164– 165

regulation of, 159, 174

reimbursement policy, 178

research costs, 39, 49n.5

New Drug Application (NDA), 170

abbreviated, 6, 40–41

approval time, 37–38, 42, 172, 173, 174–176

available to generic competition, 139n.9

data requirements, 6, 50n.9, 171

supplemental, 7, 61, 64, 176–177, 179

New York (state), 113

Nixon, Richard M., 54

Non-steroidal anti-inflammatory drugs

(NSAID), 37

Northgate Research Corporation, 79

Nursing home care, 11–12, 29, 116

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

O

Office of Health Technology Assessment (OHTA), 10–11, 28

Off-label use, 7, 58–62, 64–65, 179, 180n.8

Omnibus Budget Reconciliation Act (1980), 117

Oncology, 54, 55, 57, 66

Oncovin, 60, 61

Open-heart surgery, 28, 98, 112, 113, 116

Ophthalmology, 80

Opportunity costs, 7, 49n.6, 50n.16

Oral H2 blockers, 103

Oregon, 107

Organ transplants, 28, 96, 107, 114

bone marrow, 56

cardiac, 99, 112, 113–114, 120n.5, 151

liver, 98, 112, 151

renal, 98, 107

Orphan disease drugs, 174

Outcomes. See

Health outcomes

Outpatient services, 11, 12, 27, 57, 77, 116– 117

P

Parallel importing, 132

“Parallel track system,” 6

Parkinsonism, 100

Patent protection, 100–101, 182, 189

effective patent life, 6, 14, 15, 17nn.2 and 3, 41–43, 47, 53, 64–65, 123

Europe, 14, 15, 17n.2, 123, 129–130, 133, 137, 138n.5, 139n.9

Japan, 15, 16, 156, 160, 163, 165

medical devices, 9, 70–71, 89–90, 100– 101

pharmaceuticals, 5, 6, 40, 41–43, 46, 47, 50n.11, 64–65, 66, 139n.9, 163, 165, 177, 185, 186

Patient outcomes. See

Health outcomes

Patients, 3, 185, 187

cancer, 5, 54, 55, 56, 61, 66

in clinical research, 50n.9, 62, 63

and payment policies, 56, 62, 63, 66, 120n.6, 131, 147

surgical, 99, 115, 116

Payers, 4

and health care costs, 27, 119

and medical devices, 94

and pharmaceuticals, 17n.5, 62, 102, 178, 180n.8, 187

Payment, 67, 96

denial of, 56, 58, 61, 63, 65

hospital, 75, 77, 105, 118

for investigational therapies, 62–63, 178– 179

Medicare, 62–63, 77, 81–82, 85, 116–117, 120n.6

physician, 1–2, 18n.13, 30, 105, 110, 118

public policy, 1–2, 5, 6–7, 12, 13–14, 15– 16, 16n.1, 75, 178–179

surgical procedure, 97, 104–117 See also

Coverage; Prospective Payment System; Reimbursement

Peer review, 13, 105, 111, 117

Penicillin, 156

Pepcid, 50n.10

Peptic ulcer disease, 25, 98, 99, 103

level="1"Percutaneous biopsy, 103

Percutaneous catheter ablation, 116

Percutaneous endoscopic techniques, 78

Percutaneous transluminal coronary angioplasty (PTCA), 11, 108, 112

Peter Principle, 26

Pfizer, Inc., 73, 156, 158, 163, 190n.1

Pfizer Laser Systems, 73

Pharmaceutical Affairs Law (Japan), 161

Pharmaceutical Manufacturers Association, 49n.5, 183, 191n.2

Pharmaceutical producer price index (PPPI), 43, 50nn.13 and 14

Pharmaceuticals, 22

AIDS drugs, 144, 145, 172, 174–175, 178

approval time, 17n.3, 37–38, 42, 172, 173, 174–176, 180nn.5 and 6

cancer drugs, 5, 17n.5, 40, 54, 55, 59–62, 64, 83, 172, 174, 175, 178

cardiovascular disease drugs, 37, 40, 174, 175

cholesterol-reducing drugs, 26, 37, 162

clinical trials, 7, 40, 128, 136, 158–159, 171–174, 178–179, 180n.2, 4, 5 and 7

cost-effectiveness analysis, 8, 25–26, 190

denial of payment, 58, 61, 65

diffusion of technology, 102

drug formularies, 7–8, 17n.7, 30, 47–48, 50n.20, 102

drug utilization, 15–16, 30, 125, 138n.3

labeling, 17n.6, 59, 64

new drugs, 8, 23, 36, 40, 45, 46–47, 48, 53–67

new indications, 58–62, 179

off-label use, 7, 58–62, 64–65, 179, 180n.8

patent protection, 5, 6, 40, 41–43, 46, 47, 50n.11, 64–65, 66, 89, 100–101, 139n.9, 163, 165, 177, 185, 186

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Phases of clinical trials, 5, 170–176, 180nn.2, 4, 5 and 7

polypharmacy, 69

product life cycle, 40–41, 43, 46, 47, 50n.18, 93, 184–185

regulation, Europe, 15, 123, 128–129, 131–132, 133, 135, 136, 137, 138n.1, 139n.11, 161

regulation, FDA, 4, 5–6, 7, 8, 17nn.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100, 101, 102, 108, 128, 136, 169– 176, 177, 179, 180nn.5, 6, 7 and 8, 188

regulation, Japan, 156, 158–159, 160–161, 164

research and development, 6, 35–49, 126– 127, 128–129, 135, 138n.4, 181–190

side effects, 6, 176, 180n.7

and surgical innovation, 96, 108

used in lithotripsy, 80 See also

Prices, pharmaceutical

Pharmaceuticals industry, 37, 65, 73, 89, 90, 95

and cancer drugs, 54, 55, 66

and clinical trials, 61, 64, 172, 176

Europe, 15, 126–127, 129, 132, 133–134, 135–136, 137, 138n.1, 139n.10

Japan, 15, 16, 155–166

patent protection and, 129–130, 177, 186

pricing behavior, 8, 43, 177, 187

research and development, 8, 35, 36, 38, 40, 46–47, 49, 127, 181–188, 190

return on investment, 8, 43–46, 47, 49n.6, 50n.16, 53, 64, 65, 123, 129, 177, 183, 185–186, 190

Pharmaceuticals innovation, 4, 5–8, 66, 166, 184, 186, 188, 189, 190

Europe, 14–15, 37, 123–138, 157–158, 163, 165

public policy and, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190

regulation and, 169–177, 181–182, 186– 187

reimbursement and, 63–65, 178–179

Phase I trials, 171, 173, 180n.2

Phase II trials, 5, 172, 175–176, 180n.5

Phase III trials, 173–174, 175–176, 180nn.4 and 5

Phase IV studies, 5, 176, 180n.7

Philips Medical Systems International, 149

pH meter, 91

Physician Payment Review Commission

(PPRC), 109

Physicians, 31, 117

and coding systems, 13, 107–109, 118

and health care costs, 27–28, 119

in Japan, 15, 157, 159

liability and, 94

payment systems, 1–2, 18n.13, 30, 105, 110, 118

prescription practices, 59, 64–65, 69, 176

reimbursement policies and, 1, 30, 53, 58, 85

and technological innovation, 4, 17n.6, 53, 65–66

Physician's Desk Reference, 59

Platelet activating factor antagonists, 162

Platinol, 60

Pneumonia, 25

“Polyintervention,” 69–70, 73–74, 78, 83–85, 86, 86n.1

Polypharmacy, 69

Portugal, 127, 129, 133, 138n.5, 147

Post-marketing surveillance

medical devices, 10, 76, 83, 101–102

pharmaceuticals, 5, 6, 136, 170, 176–177

Pre-certification, 13

Preclinical testing, 170–171

Preferred provider organizations (PPO), 1–2, 11

Pre-marketing application (PMA), 10, 79, 81, 82

Pre-marketing approval, 2, 15, 16, 136

medical devices, 9–10, 76, 79, 82, 83

pharmaceuticals, 5–6, 169

Prices, pharmaceutical, 8, 43, 44, 45, 50nn.13, 14, and 16, 139n.8, 186, 187

Europe, 123, 130–133, 134, 135, 136, 137, 138nn.6 and 7

generics and, 65, 133, 177

Japan, 157, 161, 166

Private foundations, 103

Private sector

European health care systems, 148

insurance industry, 178

public policy and, 78

research, 48–49, 70, 75, 149

Professional Review Organizations, 117

Prospective Payment Assessment Commission (ProPAC), 28, 110

Prospective Payment System (PPS)

and clinical research, 63

and diffusion of technology, 1–2, 27, 28, 31, 56–57

and medical devices, 10, 11, 77

and surgical procedures, 13, 28, 110, 116, 118, 119

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Prudential Insurance Company of America, 115

Public Health Service, 10–11

Public policy, 16, 25, 31, 56

Europe, 14–15, 123–138, 141–153

Japan, 15–16, 165

medical device innovation, 69–86, 89, 92, 95, 141–142, 144–145

payment, 1–2, 5, 6–7, 12, 13–14, 75, 178– 179

pharmaceutical innovation, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190

Pulse oximetry, 89–90

Q

Quality-adjusted life years, 25, 31n.1

Quality of life, 25–26, 142–143

Quinolones, 162

R

Regulation, 2, 13

approval time, 17n.3, 37–38, 42, 172, 173, 174–176, 180nn.5 and 6

certificate-of-need, 1, 113

Classes of medical devices, 17n.8, 76, 79, 80–81

generic drugs, 6, 17n.4, 40–41, 42, 139n.9, 170, 177, 185

medical devices, 4, 9–10, 11, 12, 17nn.8 and 9, 18nn.10 and 11, 28, 71, 72, 75–76, 78–81, 82, 83, 84, 85, 89, 92–93, 100, 108

medical devices, Europe, 15, 143–144, 150, 152

pharmaceuticals, 4, 5–6, 7, 8, 17nn.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100–102, 108, 169–177, 186–187

pharmaceuticals, Europe, 15, 123, 128– 129, 131–132, 136, 137, 138n.1, 139n.11, 161

pharmaceuticals, Japan, 156, 158–159, 160–161, 164

Phases of clinical trials, 5, 170–176, 180nn.2, 4, 5 and 7

“polyintervention,” 69–70, 73–74, 78, 83– 85, 86, 86n.1

surgical procedures, 97, 100, 113 See also

Food and Drug Administration

Reimbursement, 16n.1, 21, 96

and diffusion of technology, 26–30, 31, 53

Europe, 131, 144, 145–146, 147, 148, 150–151

HMOs and managed care plans, 13, 29– 30, 57, 58

hospital, 1, 27–29

Japan, 161, 164

Medicaid, 8, 17n.7, 47–48, 50n.19, 106– 107, 178

and medical devices, 71, 72, 77, 80, 83, 85, 94–95

Medicare, 6, 11, 12, 25, 27, 28, 31, 56–57, 62–63, 77, 79, 80, 81, 82, 85, 105, 106, 107, 109, 113, 114, 115, 116–117, 120n.6, 178

pharmaceutical, 6–8, 47–48, 56–65, 66, 177, 178–179, 180n.8

physician, 1, 30, 53, 58, 85

surgical procedures, 13, 96, 105, 106, 107, 109, 113, 114, 115, 116–117, 118, 120n.6 See also

Coverage; Payment

Reischauer, Edwin O., 155

Renal dialysis, 24, 151

Renal lithotripsy, 98, 110

Renal transplantation, 98, 107

Renin inhibitors, 162

Research, 16, 23–24, 74, 102, 103, 127, 142

animal studies, 5, 99, 128, 170–171

biomedical, 2–3, 48–49, 72, 75, 82, 138n.2, 182–183, 184, 188

cost-effectiveness, 8, 22, 24–26, 27

translation of, 70, 141

university, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188

Research Councils (United Kingdom), 149

Research and development

cancer and AIDS drugs, 40, 54–55, 64, 144, 145

contraceptives, 10

demand for technology and, 3, 4–5

medical devices, 9, 11, 12, 70, 74–75, 85, 89, 90–91, 92, 95

medical devices, Europe, 144, 145, 149– 150, 152

patent protection and, 6, 9, 41–43, 47, 64– 65, 185, 186

payment policies and, 11, 47–48, 64, 187

pharmaceutical, 6, 35–49, 64–65, 66, 181–190

pharmaceutical, costs of, 8, 37–40, 41, 42–43, 44, 45, 46–47, 49, 49nn.4, 5 and 6, 50n.17, 162, 182–183

pharmaceutical, Europe, 15, 123, 127, 131, 133–134, 135–136, 137, 186–187

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

pharmaceutical, Japan, 159–160, 162, 164, 165, 166, 186–187

pharmaceutical, return on investment, 8, 43–46, 47, 50n.16, 53, 64, 65, 123, 177, 183, 185–186, 190

public policy and, 2, 47–48, 66–67, 85, 181–182, 183–184, 188

surgical procedures, 12, 103

Resource-based relative value scale(RBRVS), 1–2, 13, 18n.13, 30, 118– 119

Return on assets (ROA), 185–186, 190n.1

Rhône-Poulenc, Inc., 183

Risk-adjusted economic returns, 185

Rorer Group, Inc., 183

Roussel Uclaf, 158

S

Safety

medical devices, 12, 15, 18n.10, 79, 82, 83, 84, 85, 86

pharmaceuticals, 4, 5, 174, 175, 179–180n.1, 180n.2, 185

Sandoz, Inc., 158

Schering AG, 158

Schering-Plough Corporation, 190n.1

Science, 2–3, 70, 102

education, 182, 188

research spending, 74, 75, 103, 127, 135

Selective contracting, 13–14, 113–118, 119, 120n.4

Self-insured employers, 67, 115

Shionogi & Company, Ltd., 164

Shumway, Norman Edward, 99

Sick Funds Council (Netherlands), 151

Side effects, 6, 176, 180n.7

Siemens Corporation, 149

Small Business Innovation Research program, 92

Smallpox, 190

SmithKline Beecham P.L.C., 81, 183, 190n.1

Social security health care systems, 147–148

Spain

health care system, 138n.3, 147, 148

pharmaceuticals in, 127, 129, 132, 133, 134, 138nn.5 and 6

Squibb Corporation, 183

Stanford University, 99, 112, 113, 120n.5

States, 1, 8, 47–48, 50n.19, 76, 85, 187

“Substantial equivalence,” 17n.9

Supplemental NDA, 7, 61, 64, 176–177, 179

Supratentorial craniotomy, 107

Surgeons, 14, 115

Surgical procedures, 2, 22

cardiac, 28, 96–97, 98, 112, 113, 116

case loads, 112

cataract, 81

coding, 13, 97, 102, 105, 107–111, 118

innovation, 4, 12–14, 96–119

kidney stone, 78, 79

selective contracting, 13–14, 113–118, 119, 120n.4

Swan-Ganz catheter monitoring, 108

Sweden, 129, 136, 147, 150, 153n.2

Switzerland, 138n.3

pharmaceutical development, 126, 129, 132, 138, 166, 186–187, 191n.2

T

Tagamet, 50n. 10

Taito Corporation, 157

Taxation, 90, 183

Tax Equity and Fiscal Responsibility Act (1982), 56

Technology, 82, 104, 112, 188

assessment of, 31, 84, 100, 111, 141, 144–145

cost-effectiveness of, 12, 91, 152

demand for, 1, 3, 4–5, 22

dynamic model of innovation, 2–5

and health care costs, 1, 6, 21, 22–24, 114

policy incentives and, 1–2, 16, 53, 75, 77, 141, 142

translation of, vii, 70, 141

use of, reimbursement and, 26–30, 56–63 See also

Diffusion of technology;

Research and development

Technomed International, Inc., 79

Texas Heart Institute, 115

Thalidomide, 5, 158, 171

Thatcher, Margaret, 127

Tissue plasminogen activator, 110

Total hip joint replacement, 96

Toyo Jozo Company, Ltd., 157

Trade, 2, 148, 182, 189

import restrictions, 138n.1, 139nn.11 and 12, 156

parallel importing, 132

Trademarks, 182, 189

Translation of technology, 70, 141

Transparency Directive (1990), 134

Transurethral resection of the prostate (TURP), 109

Treatment IND, 5–6, 55, 62, 178

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
×

Treaty of Rome, 124, 131, 132, 134, 138n.1, 139nn.11 and 12

Tufts University, 39

U

Ulcer treatment, 103

Ultrasound, 75

“Unbundling,” 108, 120n.3

Uninsured persons, 22

United Kingdom

health care system, 138n.3, 147, 148

medical device industry, 146, 148–149

medical device regulation, 150, 151

National Health Service, 132, 150, 153n.2

pharmaceutical industry, 126, 127, 132, 134, 138, 138n.2 and 4, 139n.14, 166, 186–187

pharmaceutical regulation, 128, 130, 132– 133, 134, 136

United States, 2, 14, 15–16, 29, 31, 123

Defense Department, 75, 92

generic drug policy, 15, 40–41, 133

and medical device industry, 69–70, 73– 78, 85–86, 152

medical device market, 148, 150, 153

national debt, 189

Occupation Administration (Japan), 155, 156

patent law, 17n.2, 129–130, 165

pharmaceutical industry in, 36–40, 126, 127, 135–136, 157–158, 162, 163, 166, 183, 186–187, 188, 189, 191n.2

U.S. Congress, 25, 61, 62, 67

and cost containment, 8, 30, 77, 81, 85, 110

medical device regulation, 10, 76, 81, 83

pharmaceutical regulation, 170, 171, 177, 186, 189

U.S. Pharmacopeia, 7, 17n.6, 61

Universities, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188

University of California at San Francisco, 111

“Upcoding,” 108

Upjohn Company, 190n.1

Uruguay Round trade talks, 164, 165

Utilization review, 6–7, 29, 30, 62, 117

V

Vagotomy techniques, 98

VAMP Ltd., 139n.14

Vasotec, 50n.10

Vepesid, 60

Vernon, John, 40, 41, 43

Veterinary Medicine Center (FDA), 179– 180n.1

W

Warner Lambert Company, 190n.1

Washington (state), 47–48

Waxman-Hatch Act. See Drug Price

Competition and Patent Term

Restoration Act

West Germany. See Germany

World War II, 15, 139n.10, 155

X

X-ray crystallography, 36

Y

YAG laser, 18n.12

Yarbro, John W., 63

Z

Zantac, 50n.10

Suggested Citation:"Index." Institute of Medicine. 1991. The Changing Economics of Medical Technology. Washington, DC: The National Academies Press. doi: 10.17226/1810.
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The Changing Economics of Medical Technology Get This Book
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Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs.

This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care.

Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policies—as well as the involvement of numerous government agencies—affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures.

The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan.

This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

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