Colorado PROFILES, The Colorado Clinical and Translational Sciences Institute (CCTSI)
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Michael Joseph Anthony DiStefano

TitleAssistant Professor
InstitutionUniversity of Colorado Denver - Anschutz Medical Campus
DepartmentSOP-DOCP General Operations

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    R03HS029960     (DISTEFANO, MICHAEL J)Sep 1, 2024 - Aug 31, 2025
    NIH
    Measuring the Impact of Price Ceiling Controls: A Case Study of Insulin Out-of-Pocket Caps
    Role: Principal Investigator

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    Collapse selected publications
    Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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    1. Nikitin D, Rind DM, McQueen B, Raymond F, Sanchez S, DiStefano MJ, Zemplenyi A, Lee W, Ollendorf D. The effectiveness and value of suzetrigine for moderate to severe acute pain: A summary from the Institute for Clinical and Economic Review's Midwest Comparative Effectiveness Public Advisory Council. J Manag Care Spec Pharm. 2025 Jul; 31(7):729-734. PMID: 40577034.
      View in: PubMed
    2. Zemplenyi AT, Chen NC, Anderson KE, Adamson B, DiStefano MJ, Nair KV, McQueen RB. Key Considerations for Assessing Real-World Comparative Effectiveness in the Context of the Drug Price Negotiation Program: A Case Study of Pembrolizumab. Pharmacoeconomics. 2025 Sep; 43(9):1147-1160. PMID: 40549122.
      View in: PubMed
    3. Socal MP, Kandula NR, Bareamichael PI, Ballreich J, Odouard I, Kang SY, Acha JO, Anderson KE, DiStefano M, Gerchman F, Levy JF. Improving Affordability of Pharmaceutical Treatments for Diabetes: A Call for Action. Diabetes Care. 2025 Jun 21. PMID: 40542615.
      View in: PubMed
    4. Zemplenyi A, Leonard J, Wright GC, DiStefano MJ, Nair K, Anderson KE, McQueen RB. Innovative Payment Models for Sickle-Cell Disease Gene Therapies in Medicaid: Leveraging Real-World Data and Insights from CMMI's Gene Therapy Access Model. Pharmacoeconomics. 2025 May; 43(5):583-594. PMID: 39982606.
      View in: PubMed
    5. DiStefano MJ, Dardouri M, Moore GD, Saseen JJ, Nair KV. Compounded glucagon-like peptide-1 receptor agonists for weight loss: the direct-to-consumer market in Colorado. J Pharm Policy Pract. 2025; 18(1):2441220. PMID: 39776466.
      View in: PubMed
    6. Charlton V, DiStefano MJ. The ethical canary: narrow reflective equilibrium as a source of moral justification in healthcare priority-setting. J Med Ethics. 2024 Dec 23; 50(12):835-840. PMID: 38373831.
      View in: PubMed
    7. DiStefano MJ, McQueen RB, Gao V, Klein MP, Snell-Bergeon JK, Polsky S. The Cost of Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Type 1 Diabetes Pregnancies in the United States: A Cost-Consequences Analysis Using Real-World Evidence. Diabetes Technol Ther. 2025 Apr; 27(4):329-333. PMID: 39699652.
      View in: PubMed
    8. Anderson KE, Sahu M, DiStefano MJ, Asche CV, Mattingly TJ. Pharmacy Closures and Anticonvulsant Medication Prescription Fills. JAMA. 2024 Dec 03; 332(21):1847-1849. PMID: 39495537.
      View in: PubMed
    9. Nikitin D, Mustafa RA, McQueen B, Zemplenyi A, DiStefano MJ, Nhan E, Kayali Y, Richardson M, Rind DM, Pearson SD, Agboola F. The effectiveness and value of midomafetamine-assisted psychotherapy for posttraumatic stress disorder. J Manag Care Spec Pharm. 2024 Oct; 30(10):1191-1195. PMID: 39321122.
      View in: PubMed
    10. Markell J, Odouard I, Anderson GF, DiStefano MJ. Consumer Perceptions of Safety Information in Direct-to-Consumer Print Advertisements for Alzheimer Drugs. JAMA Netw Open. 2024 08 01; 7(8):e2431110. PMID: 39212994.
      View in: PubMed
    11. DiStefano MJ, Pearson SD, Rind DM, Zemplenyi A. How Do the Institute for Clinical and Economic Review's Assessments of Comparative Effectiveness Compare With the German Federal Joint Committee's Assessments of Added Benefit? A Qualitative Study. Value Health. 2024 08; 27(8):1066-1072. PMID: 38679288.
      View in: PubMed
    12. Charlton V, DiStefano M. An empirical ethics study of the coherence of NICE technology appraisal policy and its implications for moral justification. BMC Med Ethics. 2024 03 06; 25(1):28. PMID: 38448909.
      View in: PubMed
    13. DiStefano MJ, Zemplenyi A, Anderson KE, Mendola ND, Nair KV, McQueen RB. Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program. Expert Rev Pharmacoecon Outcomes Res. 2024 Feb; 24(2):171-180. PMID: 37961908.
      View in: PubMed
    14. DiStefano MJ, Zemplenyi A, McQueen RB. Assessing clinical benefit in the Medicare Drug Price Negotiation Program: A 2-step approach for improving transparency, consistency, and meaningful patient engagement. J Manag Care Spec Pharm. 2024 Mar 01; 30(3):252-258. PMID: 38241282.
      View in: PubMed
    15. Zemplenyi A, Leonard J, DiStefano MJ, Anderson KE, Wright GC, Mendola ND, Nair K, McQueen RB. Using Real-World Data to Inform Value-Based Contracts for Cell and Gene Therapies in Medicaid. Pharmacoeconomics. 2024 Mar; 42(3):319-328. PMID: 37989969.
      View in: PubMed
    16. Charlton V, DiStefano M, Mitchell P, Morrell L, Rand L, Badano G, Baker R, Calnan M, Chalkidou K, Culyer A, Howdon D, Hughes D, Lomas J, Max C, McCabe C, O'Mahony JF, Paulden M, Pemberton-Whiteley Z, Rid A, Scuffham P, Sculpher M, Shah K, Weale A, Wester G. We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment. Health Econ Policy Law. 2024 04; 19(2):153-173. PMID: 37752732.
      View in: PubMed
    17. DiStefano MJ, Levy JF, Odouard IC, Anderson GF. Estimated Savings From Using Added Therapeutic Benefit and Therapeutic Reference Pricing in United States Medicare Drug Price Negotiations. Value Health. 2023 11; 26(11):1618-1624. PMID: 37689264.
      View in: PubMed
    18. Anderson KE, DiStefano MJ, Liu A, Mattingly TJ, Socal MP, Anderson GF. Incorporating Added Therapeutic Benefit and Domestic Reference Pricing Into Medicare Payment for Expensive Part B Drugs. Value Health. 2023 09; 26(9):1381-1388. PMID: 37285915.
      View in: PubMed
    19. DiStefano MJ, Karim SA, Krubiner CB, Hofman KJ. Integrating Health Technology Assessment and the Right to Health in South Africa: A Qualitative Content Analysis of Substantive Values in Landmark Judicial Decisions. J Law Med Ethics. 2023; 51(1):131-149. PMID: 37226744.
      View in: PubMed
    20. DiStefano MJ, Kang SY, Parasrampuria S, Anderson GF. Comparison of Out-of-Pocket Spending on Ultra-Expensive Drugs in Medicare Part D vs Commercial Insurance. JAMA Health Forum. 2023 05 05; 4(5):e231090. PMID: 37234016.
      View in: PubMed
    21. DiStefano MJ, Markell JM, Doherty CC, Alexander GC, Anderson GF. Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising. JAMA. 2023 02 07; 329(5):386-392. PMID: 36749334.
      View in: PubMed
    22. DiStefano MJ. Moral and Social Values in Evidence-Informed Deliberative Processes for Health Benefit Package Design Comment on "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide". Int J Health Policy Manag. 2023; 12:7480. PMID: 37579447.
      View in: PubMed
    23. Krubiner CB, Tugendhaft A, DiStefano MJ, Barsdorf NW, Merritt MW, Goldstein SJ, Mosam A, Potgieter S, Hofman KJ, Faden RR. The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa. Value Health Reg Issues. 2023 Mar; 34:23-30. PMID: 36455448.
      View in: PubMed
    24. DiStefano MJ, Abdool Karim S, Krubiner CB. Integrating health technology assessment and the right to health: a qualitative content analysis of procedural values in South African judicial decisions. Health Policy Plan. 2022 May 12; 37(5):644-654. PMID: 34792599.
      View in: PubMed
    25. DiStefano MJ, Alexander GC, Anderson GF. Reply to: The informed majority could help make research into Alzheimer's disease fairer and more efficient. J Am Geriatr Soc. 2022 06; 70(6):1883-1885. PMID: 35343584.
      View in: PubMed
    26. Krubiner CB, Barsdorf NW, Goldstein SJ, Mosam A, Potgieter S, DiStefano MJ, Tugendhaft A, Merritt MW, Li R, Chalkidou K, Faden RR, Hofman KJ. Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach. Int J Technol Assess Health Care. 2022 Mar 08; 38(1):e26. PMID: 35256036.
      View in: PubMed
    27. DiStefano MJ, Alexander GC, Polsky D, Anderson GF. Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey. J Am Geriatr Soc. 2022 06; 70(6):1685-1694. PMID: 35129210.
      View in: PubMed
    28. Kang SY, DiStefano MJ, Yehia F, Koszalka MV, Padula WV. Critical Care Beds With Continuous Lateral Rotation Therapy to Prevent Ventilator-Associated Pneumonia and Hospital-Acquired Pressure Injury: A Cost-effectiveness Analysis. J Patient Saf. 2021 03 01; 17(2):149-155. PMID: 30896557.
      View in: PubMed
    29. DiStefano MJ, Kang SY, Yehia F, Morales C, Anderson GF. Assessing the Added Therapeutic Benefit of Ultra-Expensive Drugs. Value Health. 2021 03; 24(3):397-403. PMID: 33641774.
      View in: PubMed
    30. DiStefano MJ, Krubiner CB. Beyond the numbers: a critique of quantitative multi-criteria decision analysis. Int J Technol Assess Health Care. 2020 Jul 01; 1-5. PMID: 32605684.
      View in: PubMed
    31. Kang SY, Bai G, DiStefano MJ, Socal MP, Yehia F, Anderson GF. Comparative Approaches to Drug Pricing. Annu Rev Public Health. 2020 04 02; 41:499-512. PMID: 31874070.
      View in: PubMed
    32. DiStefano MJ, Rivera YM, Thrul J, Ali J. Promoting Justice in Locating and Tracking Research Participants Through Social Media. Am J Bioeth. 2019 06; 19(6):71-73. PMID: 31135312.
      View in: PubMed
    33. Kang SY, DiStefano MJ, Socal MP, Anderson GF. Using External Reference Pricing In Medicare Part D To Reduce Drug Price Differentials With Other Countries. Health Aff (Millwood). 2019 05; 38(5):804-811. PMID: 31059372.
      View in: PubMed
    34. Ali J, DiStefano MJ, Coates McCall I, Gibson DG, Al Kibria GM, Pariyo GW, Labrique AB, Hyder AA. Ethics of mobile phone surveys to monitor non-communicable disease risk factors in low- and middle-income countries: A global stakeholder survey. Glob Public Health. 2019 08; 14(8):1167-1181. PMID: 30628548.
      View in: PubMed
    35. DiStefano MJ. Characterizing "Civil Unrest" as a Public Health Determinant. Am J Public Health. 2018 07; 108(7):e20. PMID: 29874496.
      View in: PubMed
    36. DiStefano MJ. Wearable Biometric Technologies and Public Health. Am J Bioeth. 2017 01; 17(1):79-81. PMID: 27996903.
      View in: PubMed
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