Rafael Fonseca, M.D.
Visiting Fellow in Healthcare Policy at the Goldwater Institute
Naomi Lopez
Director of Healthcare Policy at the Goldwater Institute
Disclosures
Dr. Fonseca has disclosed consulting with Amgen, BMS, Celgene, Takeda, Bayer, Janssen, Novartis, Pharmacyclics, Sanofi, Merck, Juno, Kite, Aduro, OncoTracker, Oncopeptides, GSK, and AbbVie. He is a member of the scientific advisory boards for Adaptive Biotechnologies and OncoTracker.
Introduction
End Notes
[1] Eric Saganowsky, “Biden Looks to Germany for Answers on How to Tackle High U.S. Drug Prices: Analyst,” Fierce Pharma, October 20, 2020, https://www.fiercepharma.com/pharma/biden-looks-to-germany-for-answers-how-to-tackle-high-u-s-drug-prices-analyst, and Biden-Harris Health Care, https://joebiden.com/healthcare/#.
[2] Centers for Medicare & Medicaid Services, International Pricing Index (IPI) Model, October 2018, https://innovation.cms.gov/innovation-models/ipi-model.
[3] Institute for Clinical and Economic Review, https://icer-review.org/about/.
[4] National Council on Disability, “Quality-Adjusted Life Years and the Devaluation of Life with Disability: Part of the Bioethics and Disability Series,” November 6, 2019, https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf.
[5] Jennifer Hinkel, “Having Cancer Doesn’t Make Me Worth Less,” medium.com, April 21, 2016, https://medium.com/@jenniferhinkel/having-cancer-doesn-t-make-me-worth-less-2dab642928d9.
[6] National Council on Disability.
[7] ICER, “ICER Presents Alternative Pricing Models for Remdesivir as a Treatment for COVID-19,” news release, May 1, 2020, https://icer-review.org/announcements/alternative_pricing_models_for_remdesivir/.
[8] The Patient Protection and Affordable Care Act of 2010, Section 1182(e), https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.
[9] State of Oklahoma HB 2587, http://webserver1.lsb.state.ok.us/cf_pdf/2019-20%20COMMITTEE%20AMENDMENTS/House/HB2587%20FULLPCS1%20SEAN%20ROBERTS-SH.PDF.
[10] Rebecca L. Siegel, Kimberly D. Miller, and Ahmedin Jemal, “Cancer Statistics, 2020,” CA: A Cancer Journal for Clinician 70, no. 1 (January/February 2020): 7-30, https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21590.
[11] American Cancer Society, “Managing Cancer as a Chronic Illness,” https://www.cancer.org/treatment/survivorship-during-and-after-treatment/when-cancer-doesnt-go-away.html.
[12] Gokaraju K. Raju, Sean Khozin, Karthik Gurumurthi, Reuben Domike, and Janet Woodcock, “Patient-Centered Approach to Benefit-Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non-Small-Cell Lung Cancer,” JCO Clinical Cancer Informatics 4 (August 27, 2020): 769-783, https://ascopubs.org/doi/pdf/10.1200/CCI.19.00103.
[13] Rafael Fonseca, et al., Cost vs. Value and the Price of Innovation in Cancer Care: Oral Anticancer Drugs in Multiple Myeloma, as a Case Study, Goldwater Institute, March 28, 2018, https://www.goldwaterinstitute.org/wp-content/uploads/2018/03/fonseca-healthcare-paper-final.pdf.
[14] National Council on Disability.
[15] Naomi Lopez, Timothy Sandefur, Jeffrey Singer, and Rafael Fonseca, public comment re: “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency, File Code CMS-4187-P,” December 17, 2018, https://www.goldwaterinstitute.org/wp-content/uploads/2019/10/Comment-on-Regulation-to-Require-Drug-Pricing-Transparency181217.pdf.
[16] U.S. Food and Drug Administration, “Generic Drugs: Questions & Answers,” June 1, 2018, https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers.
[17] IQVIA Institute, “Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023,” May 2019, https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023.
[18] The Mount Sinai Hospital/Mount Sinai School of Medicine, “Novel Drug Cocktails Strengthen Targeted Cancer Therapies While Lessening Side Effects,” news release, August 1, 2018, https://www.mountsinai.org/about/newsroom/2018/novel-drug-cocktails-strengthen-targeted-cancer-therapies-while-lessening-side-effects.
[19] FDA, “Highlights of Prescribing Information” for Keytruda (pembrolizumab), https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s040lbl.pdf.
[20] National Council on Disability, 48.
[21] Eleanor MacKillop and Sally Sheard, “Quantifying life: Understanding the History of Quality-Adjusted Life-Years (QALYs),” Social Science and Medicine 211 (July 2018): 359-366, https://reader.elsevier.com/reader/sd/pii/S0277953618303605?token=54FE319C7C7F96AE3B988E3CB8BDCD240D3F364493A01B34D99F45CDA788EC71F5EFC3293F42C788D1A4645ACA770289.
[22] Melina Arnold, et al., “Progress in Cancer Survival, Mortality, and Incidence in Seven High-Income Countries 1995-2014 (ICBP SURVMARK-2): A Population-Based Study,” The Lancet 20 (November 2019): 1493-1505.
[23] “UK’s NICE Backs Tagrisso for First-, Second-Line EGFR-Positive Lung Cancer,” Precision Oncology News, September 11, 2020, https://www.precisiononcologynews.com/cancer/uks-nice-backs-tagrisso-first-second-line-egfr-positive-lung-cancer#.X32FeGhKjIU.
[24] Breast Cancer Now and Prostate Cancer UK, “International Comparisons of Health Technology Assessment,” 2016, https://breastcancernow.org/sites/default/files/report_final_12_august.compressed_1.pdf.
[25] Shaun Lintern, “Coronavirus: U-Turn on Critical Care Advice for NHS Amid Fears Disabled People Will Be Denied Treatment,” The Independent, March 25, 2020, https://www.independent.co.uk/news/health/coronavirus-nhs-treatment-disabled-autism-nice-covid-19-a9423441.html.
[26] William S. Smith, “Quality Adjusted Life Years (QALY): The Threat to Older Americans,” Pioneer Health Policy Brief, March 2020, https://pioneerinstitute.org/wp-content/uploads/dlm_uploads/QALYcovid-PB.pdf.
[27] For a detailed comparison between NICE and ICER, see Praveen Thokala, Josh J. Carlson, and Mike Drummond, “HTA’d in the USA: A Comparison of ICER in the United States with NICE in England and Wales,” Journal of Managed Care and Specialty Pharmacy 26, no. 9 (September 2020): 1162-1170.
[28] Rafael Fonseca and Jennifer Hinkel, “Value and Cost of Myeloma Therapy—We Can Afford It,” American Society of Clinical Oncology Educational Book 38 (May 23, 2018): 647-655, https://ascopubs.org/doi/pdf/10.1200/EDBK_200869.
[29] See Pioneer Institute, “ICER: Key Questions for Policy Makers to Consider about Health Care Treatment Value,” https://pioneerinstitute.org/wp-content/uploads/KeyQuestionsHandout.pdf, for a detailed list of questions that should be discussed and considered.
[30] The Patient Protection and Affordable Care Act of 2010, Section 1182(e), https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.
[31] State of Oklahoma.
[32] State of Oklahoma.