GLAD, SAD, BAD, and MAD Policies and Programs:
A Call to Evaluate Efficiency in Pharmaceutical Systems
Abstract
The pharmaceutical landscape is a complex mix of innovation, regulation, and market forces. As healthcare systems face rising costs and increasing demand for effective treatments, it is essential to evaluate the efficiency of policies and programs that determine access to and affordability of medications. This editorial introduces a framework of GLAD, SAD, BAD, and MAD policies and programs to categorize the efficiency and economic viability of pharmaceutical interventions. By critically assessing these categories, we aim to highlight the need for a systematic review of current practices and encourage a shift toward more sustainable healthcare solutions.
[1] NICE. Guide to the Methods of Technology Appraisal. NICE Process and Methods Guides. London2013.
[2] FDA. Generic Drug User Fee Amendments In: (FDA) FaDA, editor. Washington 2023.
[3] Starner CI, Gleason PP. Spinal Muscular Atrophy Therapies: ICER Grounds the Price to Value Conversation in Facts. J Manag Care Spec Pharm. 2019;25(12):1306-8.
[4] Majid Davari, Sadjad Bahman, Reza Hashempour, Azita Nabizadeh, Hashemi DA. Cost-effectiveness analysis and budget Impact analysis of Myozyme in the treatment of late-onset Pompe disease in Iran: Tehran University of Medical Sciences; 2021.
[5] Alexander GC, Emerson S, Kesselheim AS. Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility. JAMA. 2021;325(17):1717-8.
[6] EMA. Refusal of the marketing authorisation for Aduhelm (aducanumab) In: Agency EM, editor. 2022.
[7] FDA. OCREVUS® (ocrelizumab) injection, for intravenous use In: Administration FaD, editor. Washington 2017.
[8] Chisari CG, Bianco A, Brescia Morra V, Calabrese M, Capone F, Cavalla P, et al. Effectiveness of Ocrelizumab in Primary Progressive Multiple Sclerosis: a Multicenter, Retrospective, Real-world Study (OPPORTUNITY). Neurotherapeutics. 2023;20(6):1696-706.
[9] Montalban X, Belachew S, Wolinsky JS. Ocrelizumab in Primary Progressive and Relapsing Multiple Sclerosis. N Engl J Med. 2017;376(17):1694.
[10] Clark PA. Medical futility: legal and ethical analysis. Virtual Mentor. 2007;9(5):375-83.
[11] Kolodny A. How FDA Failures Contributed to the Opioid Crisis. AMA J Ethics. 2020;22(1):E743-50.
[12] Kolodny A, Courtwright DT, Hwang CS, Kreiner P, Eadie JL, Clark TW, et al. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annu Rev Public Health. 2015;36:559-74.
[13] Garrido MM, Balboni TA, Maciejewski PK, Bao Y, Prigerson HG. Quality of Life and Cost of Care at the End of Life: The Role of Advance Directives. J Pain Symptom Manage. 2015;49(5):828-35.
[14] Li D, Prigerson HG, Kang J, Maciejewski PK. Impact of Radiation Therapy on Aggressive Care and Quality of Life Near Death. J Pain Symptom Manage. 2017;53(1):25-32.
[15] Prigerson HG, Bao Y, Shah MA, Paulk ME, LeBlanc TW, Schneider BJ, et al. Chemotherapy Use, Performance Status, and Quality of Life at the End of Life. JAMA Oncol. 2015;1(6):778-84.
[16] Tucker-Seeley RD, Abel GA, Uno H, Prigerson H. Financial hardship and the intensity of medical care received near death. Psychooncology. 2015;24(5):572-8.
[2] FDA. Generic Drug User Fee Amendments In: (FDA) FaDA, editor. Washington 2023.
[3] Starner CI, Gleason PP. Spinal Muscular Atrophy Therapies: ICER Grounds the Price to Value Conversation in Facts. J Manag Care Spec Pharm. 2019;25(12):1306-8.
[4] Majid Davari, Sadjad Bahman, Reza Hashempour, Azita Nabizadeh, Hashemi DA. Cost-effectiveness analysis and budget Impact analysis of Myozyme in the treatment of late-onset Pompe disease in Iran: Tehran University of Medical Sciences; 2021.
[5] Alexander GC, Emerson S, Kesselheim AS. Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility. JAMA. 2021;325(17):1717-8.
[6] EMA. Refusal of the marketing authorisation for Aduhelm (aducanumab) In: Agency EM, editor. 2022.
[7] FDA. OCREVUS® (ocrelizumab) injection, for intravenous use In: Administration FaD, editor. Washington 2017.
[8] Chisari CG, Bianco A, Brescia Morra V, Calabrese M, Capone F, Cavalla P, et al. Effectiveness of Ocrelizumab in Primary Progressive Multiple Sclerosis: a Multicenter, Retrospective, Real-world Study (OPPORTUNITY). Neurotherapeutics. 2023;20(6):1696-706.
[9] Montalban X, Belachew S, Wolinsky JS. Ocrelizumab in Primary Progressive and Relapsing Multiple Sclerosis. N Engl J Med. 2017;376(17):1694.
[10] Clark PA. Medical futility: legal and ethical analysis. Virtual Mentor. 2007;9(5):375-83.
[11] Kolodny A. How FDA Failures Contributed to the Opioid Crisis. AMA J Ethics. 2020;22(1):E743-50.
[12] Kolodny A, Courtwright DT, Hwang CS, Kreiner P, Eadie JL, Clark TW, et al. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annu Rev Public Health. 2015;36:559-74.
[13] Garrido MM, Balboni TA, Maciejewski PK, Bao Y, Prigerson HG. Quality of Life and Cost of Care at the End of Life: The Role of Advance Directives. J Pain Symptom Manage. 2015;49(5):828-35.
[14] Li D, Prigerson HG, Kang J, Maciejewski PK. Impact of Radiation Therapy on Aggressive Care and Quality of Life Near Death. J Pain Symptom Manage. 2017;53(1):25-32.
[15] Prigerson HG, Bao Y, Shah MA, Paulk ME, LeBlanc TW, Schneider BJ, et al. Chemotherapy Use, Performance Status, and Quality of Life at the End of Life. JAMA Oncol. 2015;1(6):778-84.
[16] Tucker-Seeley RD, Abel GA, Uno H, Prigerson H. Financial hardship and the intensity of medical care received near death. Psychooncology. 2015;24(5):572-8.
Files | ||
Issue | Vol 11 No 01 (2025) | |
Section | Letter to Editor | |
Keywords | ||
Pharmaceutical System Efficiency Cost-Effectiveness Pharmaceutical policies pricing |
Rights and permissions | |
![]() |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Davari M. GLAD, SAD, BAD, and MAD Policies and Programs:. JPPM. 2025;11(01):1-4.