Identifying newly approved medications in Medicare claims data: a case study using tocilizumab
ABSTRACT Background After U.S. licensure, parenterally administered medications are identified using non‐specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not...
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| Published in | Pharmacoepidemiology and drug safety Vol. 22; no. 11; pp. 1214 - 1221 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Chichester
Blackwell Publishing Ltd
01.11.2013
Wiley Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1053-8569 1099-1557 1099-1557 |
| DOI | 10.1002/pds.3475 |
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| Abstract | ABSTRACT
Background
After U.S. licensure, parenterally administered medications are identified using non‐specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described.
Objectives
To describe a generalized approach using non‐specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010.
Methods
We used 2008–2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non‐specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity.
Results
Of 472 803 claims with non‐specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80–99), specificity 100% (99–100) and PPV 97% (84–100).
Conclusion
Claims‐based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. Copyright © 2013 John Wiley & Sons, Ltd. |
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| AbstractList | After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described.
To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010.
We used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity.
Of 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100).
Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. ABSTRACT Background After U.S. licensure, parenterally administered medications are identified using non‐specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described. Objectives To describe a generalized approach using non‐specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010. Methods We used 2008–2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non‐specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity. Results Of 472 803 claims with non‐specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80–99), specificity 100% (99–100) and PPV 97% (84–100). Conclusion Claims‐based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. Copyright © 2013 John Wiley & Sons, Ltd. Background After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described. Objectives To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010. Methods We used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity. Results Of 472803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100). Conclusion Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. Copyright © 2013 John Wiley & Sons, Ltd. [PUBLICATION ABSTRACT] After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described.BACKGROUNDAfter U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described.To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010.OBJECTIVESTo describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010.We used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity.METHODSWe used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity.Of 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100).RESULTSOf 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100).Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes.CONCLUSIONClaims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. |
| Author | Yun, Huifeng Curtis, Jeffrey R. Xie, Fenglong Chen, Lang Lewis, James D. Wright, Nicole C. Kilgore, Meredith L Zhang, Jie Chen, Rui Delzell, Elizabeth |
| AuthorAffiliation | 1 University of Alabama at Birmingham; Birmingham AL 2 Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania |
| AuthorAffiliation_xml | – name: 2 Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania – name: 1 University of Alabama at Birmingham; Birmingham AL |
| Author_xml | – sequence: 1 givenname: Jeffrey R. surname: Curtis fullname: Curtis, Jeffrey R. email: jcurtis@uab.edu organization: University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, AL, USA, Birmingham – sequence: 2 givenname: Fenglong surname: Xie fullname: Xie, Fenglong organization: University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, AL, USA, Birmingham – sequence: 3 givenname: Rui surname: Chen fullname: Chen, Rui organization: Epidemiology, University of Alabama at Birmingham, AL, USA, Birmingham – sequence: 4 givenname: Lang surname: Chen fullname: Chen, Lang organization: University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, AL, USA, Birmingham – sequence: 5 givenname: Meredith L surname: Kilgore fullname: Kilgore, Meredith L organization: Department of Health Care, Organization and Policy, School of Public Health, University of Alabama at Birmingham, AL, USA, Birmingham – sequence: 6 givenname: James D. surname: Lewis fullname: Lewis, James D. organization: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, PA, USA, Philadelphia – sequence: 7 givenname: Huifeng surname: Yun fullname: Yun, Huifeng organization: University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL, USA – sequence: 8 givenname: Jie surname: Zhang fullname: Zhang, Jie organization: Epidemiology, University of Alabama at Birmingham, AL, USA, Birmingham – sequence: 9 givenname: Nicole C. surname: Wright fullname: Wright, Nicole C. organization: Epidemiology, University of Alabama at Birmingham, AL, USA, Birmingham – sequence: 10 givenname: Elizabeth surname: Delzell fullname: Delzell, Elizabeth organization: Epidemiology, University of Alabama at Birmingham, AL, USA, Birmingham |
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| Cites_doi | 10.1002/acr.21638 10.1002/art.23417 10.1016/j.semarthrit.2010.03.003 10.1016/j.autrev.2005.07.006 |
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| Keywords | Tocilizumab Diseases of the osteoarticular system Autoimmune disease Inflammatory joint disease Monoclonal antibody linkage Epidemiology Drug Immunopathology Health insurance registry Medicare biologics Treatment efficiency Part D certolizumab Pharmacovigilance Denosumab Parenteral administration pharmacoepidemiology Case study Immunomodulator Chronic Treatment Register Rheumatoid arthritis Immunosuppressive agent tocilizumab rheumatoid arthritis denosumab |
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| References | Curtis JR, Jain A, Askling J, Bridges SL, Jr., Carmona L, Dixon W, et al.A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries. Semin Arthritis Rheum 2010; 40(1): 2-14 e1. Kremer JM. The CORRONA database. Autoimmun Rev 2006; 5(1): 46-54. DiMartino LD, Curtis LH, Williams RL, et al. Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities. Food Drug Law J 2008; 63(4): 891-900. Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, et al. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum 2008;58(5):1299-1309. Curtis JR, Yun H, Matthews R, Saag KG, Delzell E. Adherence with intravenous zoledronate and intravenous ibandronate in the United States Medicare population. Arthritis Care Res (Hoboken) 2012; 64(7): 1054-1060. 2008; 58 2006; 5 2010; 40 2012; 64 2008; 63 e_1_2_7_6_1 e_1_2_7_5_1 e_1_2_7_4_1 e_1_2_7_3_1 e_1_2_7_9_1 e_1_2_7_8_1 e_1_2_7_7_1 DiMartino LD (e_1_2_7_2_1) 2008; 63 18438830 - Arthritis Rheum. 2008 May;58(5):1299-309 22328117 - Arthritis Care Res (Hoboken). 2012 Jul;64(7):1054-60 16338211 - Autoimmun Rev. 2006 Jan;5(1):46-54 20674669 - Semin Arthritis Rheum. 2010 Aug;40(1):2-14.e1 19601387 - Food Drug Law J. 2008;63(4):891-900 |
| References_xml | – reference: Curtis JR, Jain A, Askling J, Bridges SL, Jr., Carmona L, Dixon W, et al.A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries. Semin Arthritis Rheum 2010; 40(1): 2-14 e1. – reference: Kremer JM. The CORRONA database. Autoimmun Rev 2006; 5(1): 46-54. – reference: Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, et al. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum 2008;58(5):1299-1309. – reference: DiMartino LD, Curtis LH, Williams RL, et al. Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities. Food Drug Law J 2008; 63(4): 891-900. – reference: Curtis JR, Yun H, Matthews R, Saag KG, Delzell E. Adherence with intravenous zoledronate and intravenous ibandronate in the United States Medicare population. Arthritis Care Res (Hoboken) 2012; 64(7): 1054-1060. – volume: 58 start-page: 1299 issue: 5 year: 2008 end-page: 1309 article-title: Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve‐month, multicenter, randomized, double‐blind, placebo‐controlled, phase II clinical trial publication-title: Arthritis Rheum – volume: 63 start-page: 891 issue: 4 year: 2008 end-page: 900 article-title: Using medicare administrative data to conduct postmarketing surveillance of follow‐on biologics: issues and opportunities publication-title: Food Drug Law J – volume: 64 start-page: 1054 issue: 7 year: 2012 end-page: 1060 article-title: Adherence with intravenous zoledronate and intravenous ibandronate in the United States Medicare population publication-title: Arthritis Care Res (Hoboken) – volume: 5 start-page: 46 issue: 1 year: 2006 end-page: 54 article-title: The CORRONA database publication-title: Autoimmun Rev – volume: 40 start-page: 2 issue: 1 year: 2010 end-page: 14 article-title: A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries publication-title: Semin Arthritis Rheum – ident: e_1_2_7_8_1 – ident: e_1_2_7_5_1 – ident: e_1_2_7_9_1 doi: 10.1002/acr.21638 – ident: e_1_2_7_3_1 doi: 10.1002/art.23417 – ident: e_1_2_7_4_1 – ident: e_1_2_7_6_1 doi: 10.1016/j.semarthrit.2010.03.003 – ident: e_1_2_7_7_1 doi: 10.1016/j.autrev.2005.07.006 – volume: 63 start-page: 891 issue: 4 year: 2008 ident: e_1_2_7_2_1 article-title: Using medicare administrative data to conduct postmarketing surveillance of follow‐on biologics: issues and opportunities publication-title: Food Drug Law J – reference: 18438830 - Arthritis Rheum. 2008 May;58(5):1299-309 – reference: 16338211 - Autoimmun Rev. 2006 Jan;5(1):46-54 – reference: 22328117 - Arthritis Care Res (Hoboken). 2012 Jul;64(7):1054-60 – reference: 20674669 - Semin Arthritis Rheum. 2010 Aug;40(1):2-14.e1 – reference: 19601387 - Food Drug Law J. 2008;63(4):891-900 |
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Background
After U.S. licensure, parenterally administered medications are identified using non‐specific drug codes. Accurately identifying these... After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical... Background After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications... |
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| SubjectTerms | Algorithms Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - therapeutic use Arthritis, Rheumatoid - drug therapy Biological and medical sciences biologics certolizumab Clinical Coding Clinical trial. Drug monitoring Cohort Studies Databases, Factual denosumab Diseases of the osteoarticular system Drug Approval Drug therapy General pharmacology Humans Inflammatory joint diseases Injections Insurance, Health, Reimbursement - statistics & numerical data linkage Medical coding Medical sciences Medicare Part D pharmacoepidemiology Pharmacoepidemiology - methods Pharmacology. Drug treatments Registries registry rheumatoid arthritis Sensitivity and Specificity tocilizumab United States |
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| Title | Identifying newly approved medications in Medicare claims data: a case study using tocilizumab |
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