About This Report
1. Figure is according to Janssen internal financial accounting. Our R&D investment figures are global because R&D investment cannot be segmented by region. The R&D activities we undertake around the world collectively contribute to product development for the benefit of all consumers, regardless of market.
2. The financial figures in this section have not been audited and should not be read in conjunction with our filings with the Securities and Exchange Commission.
3. The YODA Project. “Summary of Data Inquiries and Requests.” http://yoda.yale.edu/summary-data-inquiries-and-requests; http://yoda.yale.edu/table-3-data-requests-approved.
4. Represents the year-over-year change in the average list price, or wholesale acquisition cost (WAC).
5. Represents the year-over-year change in the average net price, which is WAC less rebates, discounts, and returns.
6. Data is an approximate number provided by the external program administrator.
7. PhRMA. 2016 Biopharmaceutical Research Industry Profile. Report. April 2016. http://phrma-docs.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-profile.pdf.
8. U.S. Food and Drug Administration. "The Drug Development Process – Step 2: Preclinical Research." April 26, 2017. https://www.fda.gov/forpatients/approvals/drugs/ucm405658.htm.
9. Analysis Group. The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development. Report. July 2017. http://phrma-docs.phrma.org/files/dmfile/Biopharmaceutical-Pipeline-Full-Report.pdf.
10. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "Development & Approval Process (Drugs)." October 6, 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm.
11. National Institute of General Medical Sciences. "Why Do Basic Research?" April 22, 2011. https://publications.nigms.nih.gov/basicresearch/#basic.
12. Li, Danielle, Pierre Azoulay, and Bhaven N. Sampat. "The Applied Value of Public Investments in Biomedical Research." Science 356, no. 6333 (2017): 78-81. doi:10.1126/science.aal0010.
13. PhRMA. PhRMA Chart Packs: Biopharmaceuticals in Perspective. Report. 2017. https://chartpack.phrma.org/biopharmaceuticals-in-perspective-2017/research-and-development/biopharmaceutical-industry-does-the-vast-majority-of-research-to-translate-basic-science-into-new-medicines
14. PhRMA. 2016 Biopharmaceutical Research Industry Profile. Report. April 2016. http://phrma-docs.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-profile.pdf.
15. PhRMA. PhRMA Chart Packs: Biopharmaceuticals in Perspective. Report. 2017. https://chartpack.phrma.org/biopharmaceuticals-in-perspective-2017/research-and-development/biopharmaceutical-industry-does-the-vast-majority-of-research-to-translate-basic-science-into-new-medicines
16. Figure is according to Janssen internal financial accounting. Our R&D investment figures are global because R&D investment cannot be segmented by region. The R&D activities we undertake around the world collectively contribute to product development for the benefit of all consumers, regardless of market.
17. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "NDA and BLA Approval Reports – New Molecular Entity (NME) Drug and New Biologic Approvals." https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htm.
18. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "CDER Breakthrough Therapy Designation Approvals." https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM481542.pdf.
19. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "Breakthrough Therapy." U.S. Food and Drug Administration. January 4, 2018. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm.
20. Figure(s) according to internal analysis of publicly available financial disclosures. As noted in the “About This Report” section, the R&D investment figures in this report do not incorporate information from Actelion Ltd. As a result, these figures differ from the Johnson & Johnson Form 10-K filing, which discloses Johnson & Johnson R&D investment of approximately $10.6 billion (an approximate increase of $1.5 billion from 2016) and Janssen R&D investment of approximately $8.4 billion (an approximate $1.4 billion increase from 2016).
21. CMR International. CMR’s 2017 Global R&D Performance Metrics Programme. 2017. CMR International is a Clarivate Analytics business.
23. Strimbu, Kyle, and Jorge A. Tavel. "What Are Biomarkers?" Current Opinion in HIV and AIDS 5, no. 6 (2010): 463-66. doi:10.1097/coh.0b013e32833ed177.
24. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry: Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention. Report. February 2008. https://www.fda.gov/downloads/Drugs/.../Guidances/ucm071624.pdf.
25. Figure is according to Janssen internal financial accounting. Our R&D investment figures are global because R&D investment cannot be segmented by region. The R&D activities we undertake around the world collectively contribute to product development for the benefit of all consumers, regardless of market.
26. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "NDA and BLA Approval Reports – New Molecular Entity (NME) Drug and New Biologic Approvals." https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htm.
27. U.S. Food and Drug Administration Center for Drug Evaluation and Research. "CDER Breakthrough Therapy Designation Approvals." https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM481542.pdf.
28. Mathias, Susan D., Steven R. Feldman, Ross D. Crosby, Hilary H. Colwell, Kelly McQuarrie, and Chenglong Han. "Measurement properties of a patient-reported outcome measure assessing psoriasis severity: The psoriasis symptoms and signs diary." Journal of Dermatological Treatment 27, no. 4 (December 04, 2015): 322-27. doi:10.3109/09546634.2015.1114567.
29. The YODA Project. “Summary of Data Inquiries and Requests.” http://yoda.yale.edu/summary-data-inquiries-and-requests; http://yoda.yale.edu/table-3-data-requests-approved.
31. Bioethics International. "Bioethics International Releases the "Good Pharma Scorecard" in BMJ Open, Ranking the Top 20 Largest Pharmaceutical Companies on Clinical Trial Transparency." News release, December 5, 2017. https://www.prnewswire.com/newsreleases/bioethics-international-releases-the-good-pharmascorecard-in-bmj-open-ranking-the-top-20-largest-pharmaceuticalcompanies-on-clinical-trial-transparency-300566497.html.
33. The financial figures in this section have not been audited and should not be read in conjunction with our filings with the Securities and Exchange Commission.
36. Johnson & Johnson has voluntarily posted the 2016 aggregated data for our companies covered by Open Payments, as submitted to CMS on March 31, 2017. Due to the CMS data review process, there may be differences between the aggregated totals for data posted here and aggregated totals derived from currently available data on the CMS website.
37. Perfetto, Eleanor M., Elisabeth M. Oehrlein, Marc Boutin, Sarah Reid, and Eric Gascho. "Value to Whom? The Patient Voice in the Value Discussion." Value in Health 20, no. 2 (February 2017): 286-91. doi:10.1016/j.jval.2016.11.014.
38. Neumann, Peter J., Theodore G. Ganiats, Louise B. Russell, Gillian D. Sanders, and Joanna E. Siegel. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 2016.
39. Alphs, Larry, Carmela Benson, Kimberly Cheshire-Kinney, Jean-Pierre Lindenmayer, Lian Mao, Stephen C. Rodriguez, and H. Lynn Starr. "Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia: A Randomized, Open-Label, Review Board-Blinded 15-Month Study." The Journal of Clinical Psychiatry 76, no. 5 (May 2015): 554-561.
40. Lichtenberg, Frank. Pharmaceutical Innovation and Longevity Growth in 30 Developing and High-income Countries, 2000-2009. Working paper. The National Bureau of Economic Research. July 2012. doi:10.3386/w18235.
41. Siegel, Rebecca L., Kimberly D. Miller, and Ahmedin Jemal. "Cancer Statistics, 2017." CA: A Cancer Journal for Clinicians 67, no. 1 (2017): 7-30. doi:10.3322/caac.21387.
42. Gotto, Antonio M., Stephen J. Boccuzzi, John R. Cook, Charles M. Alexander, James B. Roehm, Gregg S. Meyer, Michael Clearfield, Stephen Weis, and Edwin Whitney. "Effect of Lovastatin on Cardiovascular Resource Utilization and Costs in The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)." The American Journal of Cardiology 86, no. 11 (2000): 1176-181. doi:10.1016/s0002-9149(00)01198-x.
43. Bozzette, Samuel A., Geoffrey Joyce, Daniel F. McCaffrey, Arleen A. Leibowitz, Sally C. Morton, Sandra H. Berry, Afshin Rastegar, David Timberlake, Martin F. Shapiro, and Dana P. Goldman. "Expenditures for the Care of HIV-Infected Patients in the Era of Highly Active Antiretroviral Therapy." New England Journal of Medicine 344, no. 11 (2001): 817-23. doi:10.1056/nejm200103153441107.
44. Roebuck, M. C., J. N. Liberman, M. Gemmill-Toyama, and T. A. Brennan. "Medication Adherence Leads To Lower Health Care Use And Costs Despite Increased Drug Spending." Health Affairs 30, no. 1 (2011): 91-99. doi:10.1377/hlthaff.2009.1087.
45. Altarum Institute. A 10-Year Projection of the Prescription Drug Share of National Health Expenditures, Including Nonretail. Report. August 2015. http://altarum.org/sites/default/files/uploaded-publication-files/Non-Retail%20Rx%20Forecast%20Data%20Brief%2010-14-14.pdf.
46. PhRMA. 2017 Biopharmaceutical Research Industry Profile. Report. 2017. http://phrma-docs.phrma.org/industryprofile/pdfs/2017IndustryProfile_Brochure.pdf.
47. Kim, David D., Colby L. Wilkinson, Elle F. Pope, James D. Chambers, Joshua T. Cohen, and Peter J. Neumann. "The Influence of Time Horizon on Results of Cost-Effectiveness Analyses." Expert Review of Pharmacoeconomics & Outcomes Research 17, no. 6 (May 23, 2017): 615-23.
48. Frieden, Thomas R. "Evidence for Health Decision Making – Beyond Randomized, Controlled Trials." New England Journal of Medicine 377, no. 5 (August 03, 2017): 465-75. doi:10.1056/nejmra1614394.
49. U.S. Food and Drug Administration Center for Drug Evaluation and Research. “Real World Evidence.” September 18, 2017. https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm.
50. Westrich, Kimberly, MA. Current Landscape: Value Assessment Frameworks. Report. June 2016. http://www.npcnow.org/publication/current-landscape-value-assessment-frameworks.
51. Dubois, Robert, and Kimberly Westrich. "Value Assessment Frameworks: How Can They Meet The Challenge?" Health Affairs Blog, March 2, 2017. doi:10.1377/hblog20170302.058979.
52. Westrich, 12.
Pricing & Patient Access
53. Cubanski, Juliette, Anthony Damico, Jack Hoadley, Kendal Orgera, and Tricia Neuman. Medicare Part D: A First Look at Prescription Drug Plans in 2018. Report. October 13, 2017. https://www.kff.org/medicare/issue-brief/medicare-part-d-a-first-look-at-prescription-drug-plans-in-2018/.
54. The Henry J. Kaiser Family Foundation. “The Medicare Part D Prescription Drug Benefit.” September 26, 2016. http://kff.org/medicare/factsheet/the-medicare-prescription-drug-benefit-fact-sheet/.
55. Manufacturers must provide a rebate of 23.1 percent of the Average Manufacturer Price (AMP) per unit or the difference between the AMP and the best price per unit, plus an adjustment of Consumer Price Index-Urban (CPI-U) based on the launch date and current quarter AMP, whichever is greater. Centers for Medicare & Medicaid Services. "Medicaid Drug Rebate Program." November 24, 2017. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html.
56. United States Government Accountability Office. Report to the Ranking Member, Committee on Homeland Security and Governmental Affairs, U.S. Senate – PRESCRIPTION DRUGS Comparison of DOD and VA Direct Purchase Prices. Report. April 19, 2013. https://www.gao.gov/assets/660/654019.pdf.
57. Represents the year-over-year change in the average list price, or wholesale acquisition cost (WAC).
58. Represents the year-over-year change in the average net price, which is WAC less rebates, discounts, and returns.
59. U.S. Product Portfolio includes pharmaceutical products sold by the company. Products are primarily in the areas of Oncology, Immunology, Cardiovascular and Metabolic Disease, Neuroscience, and Infectious Diseases.
60. Annual percent change vs. prior year calculated at product level and weighted across company’s U.S. Product Portfolio.
61. Represents the year-over-year change in the average list price, or wholesale acquisition cost (WAC).
62. Represents the year-over-year change in the average net price, which is WAC less rebates, discounts, and returns.
63. Grabowski, Henry, Margaret Kyle, Richard Mortimer, Genia Long, and Noam Kirson. Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act. Report. November 2011. https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2010.0270.
64. IMS Institute for Healthcare informatics. Price Declines after Branded Medicines Lose Exclusivity in the U.S. Report. January 2016. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/price-declines-after-branded-medicines-lose-exclusivity-in-the-us.pdf?la=en&hash=642B9A40F3F176CE93E8E9F791EE2BE4975C8580.
65. Danzon, P. M. "Prices and Availability of Pharmaceuticals: Evidence from Nine Countries." Health Affairs (July 2003). doi:10.1377/hlthaff.w3.521.
66. PhRMA. Cancer Medicines: Value in Context. Report. 2017. https://www.phrma.org/report/chart-pack-cancer-medicines-value-in-context
67. Bujar, Magdalena, MSc, Neil McAuslane, PhD, and Lawrence Liberti, MSc, RPh, RAC. R&D Briefing 62: New Drug Approvals in ICH Countries 2007 - 2016. Report. April 6, 2017. http://www.cirsci.org/wp-content/uploads/2017/04/ICH-Approval-times-CIRS-Briefing-62-FINAL-18042017.pdf.
68. Zhang, Yuting, Hana Chantel Hueser, and Inmaculada Hernandez. "Comparing the Approval and Coverage Decisions of New Oncology Drugs in the United States and Other Selected Countries." Journal of Managed Care & Specialty Pharmacy 23, no. 2 (2017): 247-54. doi:10.18553/jmcp.2017.23.2.247.
69. Represents the year-over-year change in the average net price, which is WAC less rebates, discounts, and returns.
70. U.S. Department of Labor. Bureau of Labor Statistics. "CONSUMER PRICE INDEX – DECEMBER 2017." News release, January 12, 2018. https://www.bls.gov/news.release/archives/cpi_01122018.pdf.
72. U.S. Centers for Medicare and Medicaid Services. "NHE Fact Sheet." December 06, 2017. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html.
73. Fein, Adam, Ph.D. "New Data Show the Gross-to-Net Rebate Bubble Growing Even Bigger." Drug Channels. June 14, 2017. http://www.drugchannels.net/2017/06/new-data-show-gross-to-net-rebate.html.
74. IQVIA INSTITUTE for Human Data Science. Medicines Use and Spending in the U.S.: A Review of 2016 and Outlook to 2021. Report. May 2017. https://www.iqvia.com/institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2016
76. Cohen, Robin A., Michael E. Martinez, and Emily P. Zammitti. "Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January – March 2017." August 2017. https://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201708.pdf.
77. Claxton, Gary, Larry Levitt, and Michelle Long. "Payments for Cost Sharing Increasing Rapidly Over Time." Peterson-Kaiser Health System Tracker. April 12, 2016. https://www.healthsystemtracker.org/brief/payments-for-cost-sharing-increasing-rapidly-over-time/#item-start.
78. Avalere Health. "Majority of Drugs Now Subject to Coinsurance in Medicare Part D Plans." News release, March 10, 2016. http://avalere.com/expertise/managed-care/insights/majority-of-drugs-now-subject-to-coinsurance-in-medicare-part-d-plans
79. Fein, “New Data Show the Gross-to-Net Rebate Bubble Growing Even Bigger.”
80. PhRMA. Prescription Medicines: Costs in Context. Report. 2015. http://phrma-docs.phrma.org/sites/default/files/pdf/prescription-medicines-costs-in-context.pdf
81. PhRMA. Commercially-Insured Patients Pay Undiscounted List Prices for One in Five Brand Prescriptions, Accounting for Half of Out-of-Pocket Spending on Brand Medicines. Report. March 29, 2017. https://www.phrma.org/report/commercially-insured-patients-pay-undiscounted-list-prices-for-one-in-five-brand-prescriptions-accounting-for-half-of-out-of-pocket-spending-brand-medicines
82. Udall, Margarita, Anthony Louder, Brandon T. Suehs, Joseph C. Cappelleri, Ashish V. Joshi, and Nick C. Patel. "Impact of a Step-Therapy Protocol for Pregabalin on Healthcare Utilization and Expenditures in a Commercial Population." Journal of Medical Economics 16, no. 6 (April 8, 2013): 784-92. doi:10.3111/13696998.2013.793692.
83. Bibeau, Wendy S., Haoda Fu, April D. Taylor, and Anita Y.M. Kwan. "Impact of Out-of-Pocket Pharmacy Costs on Branded Medication Adherence Among Patients with Type 2 Diabetes." Journal of Managed Care & Specialty Pharmacy 22, no. 11 (November 2016): 1338-347. doi:10.18553/jmcp.2016.22.11.1338.
84. Hopson, Sari, Kim Saverno, Larry Z. Liu, Ahmad Al-Sabbagh, John Orazem, Mary E. Costantino, and Margaret K. Pasquale. "Impact of Out-of-Pocket Costs on Prescription Fills Among New Initiators of Biologic Therapies for Rheumatoid Arthritis." Journal of Managed Care & Specialty Pharmacy 22, no. 2 (2016): 122-30. doi:10.18553/jmcp.2016.14261.
85. Mcguire, Maura J., and Aurel O. Iuga. "Adherence and health care costs." Risk Management and Healthcare Policy, 2014, 35-44. doi:10.2147/rmhp.s19801.
86. IMS Institute for Healthcare informatics. Avoidable Costs in U.S. Healthcare The $200 Billion Opportunity from Using Medicines More Responsibly. Report. June 2013. http://offers.premierinc.com/rs/381-NBB-525/images/Avoidable_Costs_in%20_US_Healthcare-IHII_AvoidableCosts_2013%5B1%5D.pdf.
87. Congressional Budget Office. Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services. Report. November 2012. https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/reports/MedicalOffsets_One-col.pdf
88. Sahni, Nikhil R., Anuraag Chigurupati, Bob Kocher, MD, and David M. Cutler. "How the U.S. Can Reduce Waste in Health Care Spending by $1 Trillion." Harvard Business Review. November 30, 2017. https://hbr.org/2015/10/how-the-u-s-can-reduce-waste-in-health-care-spending-by-1-trillion
89. Hackbarth, Andrew D., and Donald M. Berwick. "Eliminating Waste in US Health Care." JAMA 307, no. 14 (March 14, 2012): 1513-516. doi:10.1001/jama.2012.362.
90. IHI Triple Aim, a framework developed by the Institute for Healthcare Improvement, is a widely accepted metric that describes an approach to optimizing health system performance. More information is available at http://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx.
91. Greenwood, Kristina L., Joy LaMori, Besa Smith, Dilesh Doshi, and Cecile Davis. "Can Behavioral Health Data Improve the Accuracy of a Model to Predict Hospital Patient Readmissions? Poster #884." AcademyHealth Annual Research Meeting, June 25-27, 2017, New Orleans, LA.
92. Ruiz-Negron Natalia, Curtis Wander, Carrie McAdam-Marx, Jacquelina A. Pesa, Robert A. Bailey, Brandon K. Bellows. "Assessing the Impact of Treatment Intensification Versus Clinical Inertia on Follow-up A1C in a Managed Care Population: A Claims-based Analysis." Academy of Managed Care Pharmacy (AMCP) Nexus 2017 Meeting, October 16-19, 2017, Dallas, TX.
Resources for Patients
93. Van Nuys, Karen, Geoffrey Joyce, Rocio Ribero, and Dana P. Goldman. A Perspective on Prescription Drug Copayment Coupons. White paper. Leonard D. Schaeffer Center for Health Policy & Economics, University of Southern California. February 2018. http://healthpolicy.usc.edu/documents/2018.02_Prescription%20Copay%20Coupons%20White%20Paper_Final.pdf
94. Data is an approximate number provided by the external program administrator.
96. O'Reilly, Kevin B. "Survey Quantifies Time Burdens of Prior Authorization." AMA Wire. December 27, 2017. https://wire.ama-assn.org/practice-management/survey-quantifies-time-burdens-prior-authorization
97. Data is an approximate number provided by the external program administrator.
100. Based on product list price, or wholesale acquisition cost (WAC).
101. Data is an approximate number as reported by the Johnson & Johnson Patient Assistance Foundation, Inc.
102. According to internal financial accounting.
103. This estimate is based on assessment of donation amounts and publicly available data on approximate levels of patient assistance.
104. According to Janssen's Pre-Approval Access global tracking system.