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Basic report
An Analysis of Long-Term Care Reform Proposals

An Analysis of Long-Term Care Reform Proposals

U.S. Department of Health and Human Services An Analysis of Long-Term Care Reform Proposals Brian BurwellSysteMetrics Mary Harahan and John DrabekOffice of the Assistant Secretary for Planning and Evaluation, Office of Family, Community and Long-Term Care Policy David Kennell and Lisa AlecxihLewin-VHI February 1993 PDF Ver
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Basic report
Update on the Medical Litigation Crisis: Not the

Update on the Medical Litigation Crisis: Not the Result of the "Insurance Cycle"

U.S. Department of Health and Human Services
Basic report
Accessing Workers' Compensation Insurance

Accessing Workers' Compensation Insurance for Consumer-Employed Personal Assistance Service Workers: Issues, Challenges and Promising Practices

U.S. Department of Health and Human Services Accessing Workers' Compensation Insurance for Consumer-Employed Personal Assistance Service Workers: Issues, Challenges and Promising Practices Susan A. Flanagan, M.P.H. Westchester Consulting Group June 7, 2004 PDF Version (172 PDF pages)
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Summary of Long-Term Care Provisions Under the

Summary of Long-Term Care Provisions Under the Health Security Act

U.S. Department of Health and Human Services Short Long-Term Care Summary Under the Health Security Act March 1994 PDF Version (9 PDF pages)
The Planning and Operational Experience of the

The Planning and Operational Experience of the Channeling Projects

George Carcagno, Robert Applebaum, Jon Christianson, Barbara Phillips, Craig Thornton and Joanna Will Mathematica Policy Research, Inc. July 18, 1986
National Invitational Conference on Long-Term

National Invitational Conference on Long-Term Care Data Bases: Conference Package

Office of Social Services Policy
Post-Acute Care Issues for Medicare: Interviews

Post-Acute Care Issues for Medicare: Interviews with Provider and Consumer Groups, and Researchers and Policy Analysts

U.S. Department of Health and Human Services
Evaluation of the District of Columbia's

Evaluation of the District of Columbia's Demonstration Program,Managed Care System for Special Needs Children: Final Report

U.S. Department of Health and Human Services
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Appendix B - External Factors

HHS Strategic Goals and Objectives - FY 2001 . Appendix B - External Factors

In some cases, achieving our strategic goals and objectives may be impeded by factors that are beyond the control of the Department of Health and Human Services (HHS). For example, national or local economic conditions can influence whether we are successful in helping families on welfare become economically independent. In some cases, there may b
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Extended Market Exclusivity

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Extended Market Exclusivity

The prospect of splitting a small market with competitors may render a project financially infeasible. Provisions for market exclusivity via the existing Orphan Drug Act and the 1984 Drug Price and Competition and Patent Term Restoration Act, and/or similar means are necessary but not sufficient for lowering the barrier of a small and uncertain ma
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Venture Capital Evaluation of New Drug Investment

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Venture Capital Evaluation of New Drug Investment Opportunities

Venture capital firms (VCs) reported market potential (e.g., projected revenues) and probability of financial success as the main factors guiding investment decisions on new products. VC interviewees suggested that the evaluation of pharmacotherapies is no different from that of any other product or business plan. These companies are most interest
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Case Study 4: Nicorette

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 4: Nicorette

Introduction Drug Overview
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Case Study 3: Clozapine

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 3: Clozapine

Introduction Drug Overview
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NDA Phase

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. NDA Phase

A) Fast-track approval
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Discussion

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Discussion

As illustrated in the "Big Pharm Cold Start" scenario, the prospects of developing a new medication for cocaine abuse and taking it through a full product development cycle do not appear favorable given a moderate wholesale price comparable to LAAM ($2.50 per patient per day) and what amounts to an optimistic target market of 125,000 patients (i.e
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Scenario 5: Second Indication

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 5: Second Indication

Company S has a smoking cessation medication, Product S, that was recently introduced to the market. In its first two years, Product S has been highly successful, with projected PAR exceeding $500 million. Company researchers also have found strong early evidence that Product S may be very effective as a medication for cocaine addiction, and are e
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Scenario 4: Vaccine

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 4: Vaccine

In Scenario 4, the government has conducted preclinical R&D on a highly promising Product V that is designed to work as a vaccine with an annual booster.
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Scenario 3: Guaranteed Handoff

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 3: Guaranteed Handoff

In Scenario 3, a government research agency has taken a highly promising compound, Product G, into Phase III clinical trials. The government approaches a large pharmaceutical firm, Company G, that has a strong CNS product line. The government offers to turn over the rights to Product G in exchange for assistance in completing Phase III trials, sec
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Scenario 2: Biotech Gets Help

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 2: Biotech Gets Help

In this scenario, a small biotechnology firm, Company B, takes on the full product development cycle with a new class of compounds based on a recent scientific breakthrough that is highly specific to cocaine receptor neuropharmacology. The company anticipates that a new Product B from this class of compounds will have excellent compliance in the u
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Scenario 1: Big Pharm Cold Start

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 1: Big Pharm Cold Start

In this scenario, a large pharmaceutical company takes on the full product development cycle, i.e., a "cold start" with preclinical discovery and research. The new Product A will require about $150 million in uncapitalized expenditures to develop and will be ready for launch following FDA approval in 13 years. The company anticipates securing a pa

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