Developing a Oncology Treatment Resource for Claims-Based Research: Innovation with Medications

Transcription

1 Developing a Oncology Treatment Resource for Claims-Based Research: Innovation with Medications Donna R. Rivera, PharmD., MSc. Scientific Project Officer and Pharmacist Surveillance Informatics Branch Surveillance Research Program National Cancer Institute June 20th, 2017

2 Project Background 2

3 Treatment Research using Claims Data Claims data are an increasingly useful component of cancer research Cancer registries can use claims data for: registry operations- case finding supplementing treatment data research There is currently wide variability in the selection of appropriate codes (HCPCS, NDC, CPT, ICD-9, ICD-10) could influence research and registry operations 3

4 Overview of the Observational Research in Oncology Toolbox Need: A comprehensive resource is needed to standardize mapping of relevant codes for use in automated systems, for manual abstraction, or for research analyses Purpose: To develop an interactive database tool for the extramural community to use as a reference to improve reproducibility and as a resource to facilitate cancer surveillance, cancer epidemiology, and pharmacoepidemiology research. 4

5 Observational Research Toolbox 5

6 Phase I Phase II 6

7 Methods Medication dispensing and administration use two main classifications for billing purposes: Healthcare Common Procedure Coding System (HCPCS) HCPCS Level II codes Five digit codes (comprised of one letter and four numbers) typically used to bill for Medicare Part B ( or other federally sponsored insurers) National Drug Codes (NDCs) NDC The universal drug identifier, comprised of 9 or 11 digits divided into three sections which identify the drug manufacturer, individual chemical entity, and package size Parenteral Medications administered by a healthcare professional in an inpatient or outpatient setting Oral Medications All drugs have an NDC, however billing most common for community pharmacy claims These two systems serve as an integral part of the medication use process at the dispensing phase and well as a surrogate marker for the administration phase of the use process in research 7

8 CanMED Cancer Medications Enquiry Database Cancer Medications Enquiry Database (CanMED) is an interactive database tool developed as an effort within the Division of Cancer Control and Population Sciences at NCI to provide standardized resources for cancer treatment related studies. The HCPCS database primary inclusion criteria: SEER*Rx database or the CMS 2016 HCPCS Index FDA Approval Independent Review in Commercially Available drug database (example: Lexicomp) Drug Classification matched with SEER*Rx Additional drug characteristics added for research 8

9 Categories of Cancer Treatment Matched to SEER*Rx Categories Chemotherapy Hormonal Immunotherapy Ancillary General systemic treatment which targets various phases of the cell cycle to destroy cancer cells Alkylating Agents Antimitoitic Agents Antimetabolites Antitumor Antibiotics Enzyme Inhibitors (BCL-2, mtor) Hedgehog Pathway MAP/MEK Inhibitors Plant Alkaloids Proteasome inhibitors Recombinant Fusion Drugs Topoisomerase Inhibitors Tyrosine Kinase Inhibitors Available for the treatment of hormonally linked cancers, including primarily breast and prostate cancer Androgen Antiandrogenic Antiprogestin Aromatase Inhibitors Glucocorticoids Retinoic Acid Derivatives Ergot Derivatives Estrogens SERMs GnRH Agonists Somatostatin Analogues Primarily target immune response and mediate tumor growth through immune modification Biological response Modifiers Monoclonal antibodies, Cancer vaccines Antibody-drug conjugates Checkpoint inhibitors Cytokines Immunomodulators Immune Serums Radioimmunotherapy Thalidomide Analogs Medications required for, or directly associated with the administration of a chemotherapy agent Protective Agents Antiemetics Hematopoietic Agents Antidotes Metabolic Agents Bisphosphonates 9

10 CanMED HCPCS- Oncology Database

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12 CanMED NDC- Oncology Database

13 Drug Classes and SEER*Rx

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16 New Drug Update

17 80 Trends in Oral versus Intravenous Chemotherapeutics ( ) Number of Drugs Oral IV Year of Approval

18 New Oral Oncolytic Drugs Tyrosine Kinase Inhibitors Mechanism: Inhibition of selective protein kinases abnormalities (targets) in pathways responsible for signal transduction and subsequent processes of carcinogenesis Medication Cancer Site Approval Cabometyx (cabozantinib) adv RCC, medullary thyroid 4/2016 Votrient (pazopanib) VEGFR, PDGFR, FGFR Alunbrig (Brigatinib) EML4-ALK ROS1, IGF-1R, FLT3, EGFR Rydapt (Midostaurin) FLT3 mutation IDT, VEGFR Kisquali (ribociclib) CDK4 and CDK6 for HER2-, HR+ adv RCC, adv soft tissue sarcoma 7/2016 mnsclc 4/2017 AML, mast cell leukemias adv breast cancer 4/2017 3/2017 and 5/2017 with letrozole 18

19 Oral Chemotherapeutics Potential Side Effects which may require treatment: Hypersensitivity Rash (TKI associated) Mucositis Hypertension (VEGF) Provider Administered Left Ventricular Dysfunction Elevated Liver Enzymes Renal Toxicity Pneumonitis Hematological Toxicities (anemia, thrombocytopenia) Edema CINV Patient Administered Adherence and Persistence Patient Management Symptoms and ADE 19

20 New Oral Oncolytic Drugs BCL-2 Inhibitors Selectively inhibit the anti-apoptic BCL-2 protein, which when overexpressed can cause proliferation or resistance Venclexta (Venetoclax) approved 4/2016 for treatment of CLL with 17p deletion PARP Inhibitors Zejula (niraparib) approved 3/2017 for ovarian cancer Rubraca (rucaparib) 12/2016 for advanced ovarian cancer 20

21 New Intravenous Immunotherapy Agents Monoclonal antibodies alter regulation of immune cell function Brand Name Generic Name Mechanism Cancer Site Approval Date TECENTRIQ LARTRUVO atezolizumab olaratumab Monoclonal antibody, PD-L1 checkpoint inhibitor Urothelial carcinoma, mnsclc 5/2016 Recombinant human IgG1 antibody, PDGFR-a blocker Soft tissue carcinoma 10/2016 BAVENCIO IMFINZI avelumab durvalumab Monoclonal antibody, PD-L1 checkpoint inhibitor Monoclonal antibody, PD-L1 checkpoint inhibitor Urothelial carcinoma, Merkel cell carcinoma 3/2017 Urothelial carcinoma 5/

22 Thank you! Questions? Acknowledgements: Bradley Ohm Sean Brennan Valentina Petkov Clara Lam Lynne Penberthy Angela Mariotto Joan Warren Lindsey Enewold Annie Noone Dolly Penn 22

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