1. Technology and Health Care HCA 701 November 10, 2005

2. Technology Assessment The process that examines the available evidence to form a conclusion as to the merits or role of a particular technology in relation to its possible use, purchase or reimbursement in current medical practice.  Examines the safety, effectiveness, efficiency and appropriateness  Includes medical devices, procedures and standards, and pharmaceuticals To maximize quality: the most effective health care service that science can provide Can we afford it?

3. Categories of Technology Devices - "the quiet heroes of health-care innovation"  Diagnostic devices (MRI, CAT, SPECT, etc.)  Treatment devices Medical and surgical procedures (examples):  Radial keratotomy used to improve vision.  Genetic testing  Treatment head injuries, cancers, joint replacements, etc. Pharmaceuticals  Efficient and appropriate uses for FDA approved drugs  Labeling – language used to delineate the clinical use of a drug (indications, dosage, adverse effects, etc.).  Understanding the long-term affects of uses of some drugs,  Understanding alternative uses for drugs (e.g., manoxodil)

4. Technology Life Cycle Investigation – laboratory and clinical studies to discover or create, refine and package a new diagnostic or treatment modality. Promotion – introducing the technology into the buying community. Acceptance and utilization – incorporating the technology into practice. Decline – as technology is supplanted by superior new technology. Obsolesce – when the new technology is obsolete and no longer appropriate.

5. Targeting Technologies for Assessment Improve individual patient outcome Positively affect a large population Reduce treatment costs Reduce unexplained treatment variation.

6. Three Components of Technology Assessment High Utilization  Rapidly increase uses of a technology may signal inappropriate or excessive utilization. (e.g., Cesarean births rates)  Uses of high technology for common conditions may be inappropriate  E.g., use of mammography for women under the age of 50 has sparked controversy on the practice of high technology. Potential for Harm  Requires different standards and assessment priorities for different risk factors in patients. High Cost – willingness of payers to pay form some technological procedures or diagnoses.

7. Performing Technology Assessment Scientific assessment: does it work? Clinical assessment: does it work better than something that already exists? Economic assessment: Cost (use of Cost benefit analysis). Social or societal issues:  will providers use it?  Will patients use it?  Are secondary benefits more detrimental than primary benefits?

8. Problems in Performing Technology Assessment Lack of Evidence (not enough literature or patients to study, or poorly conducted research) Lack of Agreement on How to Perform the Assessment (may lead to different results using different techniques) Inconsistent Evidence (may result from different or inconsistent research methods) Legal Interference (can be influenced from biased resources) Breadth of Topics (difficult to successfully study or assess all technologies) New Information (assessment process must be ongoing to adequately compare new uses)

9. The Impact of Pharmaceuticals on Health Care Prescription drugs account for more than 15% of health care spending ($162 billion) Faster growth than all other segments of health care Prescription drug coverage over the last 10 years has been a catalyst for growth Primarily a large multinational corporate enterprise  10 largest pharmaceutical companies accounted for 60% of all Rx sales in U.S. in 2004

10. Components of Pharmaceutical Development Manufacturing and Production Research and Development Selling and Promotion

11. Top 10 Pharmaceutical Companies, U.S. Sales 2004 Corp.U.S. Sales in (Billions) % Growth over previous year % Market Share Pfizer$30.7513.1 Glaxo Smith Kline18.818.0 J & J16.276.9 Merck & Co.15.086.4 Astra Zenneca11.3134.8 Novartis10.274.3 Sanofi-Aventis10.0134.3 Amgen9.5234.1 Bristol-Myers Squibb 9.2-43.9 Wyeth8.2113.5 Total Top 10139.159.3

12. Top 10 Products 2004 ProductManufacturerRx in MillionsMarket Share LipitorPfizer74.82.1 HYCD/APAPMallinckrodt49.51.4 SynthroidAbbot47.41.3 NorvascPfizer38.31.1 ToprolAstraZeneca35.01.0 ZoloftPfizer33.10.9 ZocorMerck29.60.8 HYCD/APAPWatson29.00.8 AlbuterolWarrick26.80.8 AmoxicillinTeva26.20.7

13. Where the promotional money goes (In Billions of Dollars)

14. Major Issues for Prescription Drug Policy Consumerism and the results of direct to consumer marketing Brand drugs vs. generic drugs  Benefits  Controlling patents Drug importation Government’s role in controlling prices  Can the market place take care of this?