Antimicrobial drugs market returns analysis : : final report / Aylin Sertkaya [and three others].

Format:

Book

Author/Creator:

Sertkaya, Aylin, author.

Language:

English

Subjects (All):

Drug development.

Physical Description:

1 online resource

Other Title:

Antimicrobial drugs market returns analysis

Place of Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the Assistant Secretary of Planning and Evaluation, 2022.

Summary:

This study examines how recently approved antimicrobial drugs are performing relative to their added clinical benefit and the contributing factors to this performance compared to other types of drugs. Using public and proprietary data sources coupled with expert interviews, we estimate the development cost and comparative added clinical benefit of a total of 32 drugs (Table E - 1) of which 12 are antimicrobials (AM cohort), 14 are oncology drugs (oncology cohort), and the remaining 6 are other types of drugs that are similar to antimicrobials with respect to certain characteristics such as treatment duration and DRG-style1 reimbursement (non-AM comparator cohort). We then compare the comparative added clinical benefit of each drug to its market performance within each drug cohort. We find that the drugs in the AM cohort have average to high development and approval costs when compared to the non-AM comparator and oncology cohort drugs. However, once cost of failures and opportunity cost of capital are accounted for, drugs in the AM cohort have the lowest expected capitalized development and approval costs of 1,508 million on average, which is less than that estimated for drugs in the non-AM comparator (3,198 million) and oncology (6,293 million) cohorts. In other words, compared to those drugs in the non-AM comparator and oncology cohorts, AM cohort drugs are the least costly to develop and obtain regulatory approval for. Our analysis indicates that there is a direct relationship between market performance defined as nine quarters of cumulative global sales since market launch and comparative added clinical benefit within each cohort. In other words, drugs with higher overall comparative added clinical benefit scores tend to have higher early market sales compared to other drugs in the same cohort on average, although there are a few exceptions. While this relationship holds across all three drug cohorts examined here, the magnitude of sales is exponentially higher for the oncology cohort drugs than those in the AM and non-AM comparator cohorts. The average cumulative 9 quarter sales for the highest-ranking AM and non-AM comparator drugs are 42 million and

Contents:

ACKNOWLEDGMENTS

DISCLAIMER

LIST OF ACRONYMS

EXECUTIVE SUMMARY

1. INTRODUCTION

2. STUDY OBJECTIVES

3. DRUGS SELECTED FOR ANALYSIS

3.1. AM Drug Cohort

3.2. Non-AM Comparator Drug Cohort

3.3. Oncology Drug Cohort

4. DEVELOPMENT AND APPROVAL COST ANALYSIS

4.1. Data Sources

4.2. Model Parameters and Assumptions

4.3. Results

4.4. Limitations

5. EVALUATION OF COMPARATIVE ADDED CLINICAL BENEFIT

5.1. Methodology and Data Sources

5.2. Results

5.3. Limitations

6. MARKET PERFORMANCE ANALYSIS

6.1. Methodology and Data Sources

6.2. Results

6.3. Limitations

6.4. Sensitivity Analysis

7. DISCUSSION AND CONCLUSION

8. REFERENCES

APPENDIX A. INFORMATION COMPILED ON DRUGS SELECTED FOR ANALYSIS

APPENDIX B. SENSITIVITY ANALYSIS OF THE RELATIONSHIP BETWEEN OVERALL COMPARATIVE ADDED CLINICAL BENEFIT SCORE AND FIRST 9-QUARTER SALES.

Notes:

Description based on publisher supplied metadata and other sources.