Prescribing Practices Based on Recommendations of the Veterans Health Administration’s National Precision Oncology Program

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Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

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Correspondence: Jenna Armstrong (jenna.armstrong@va.gov)

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Correspondence: Jenna Armstrong (jenna.armstrong@va.gov)

Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

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Abstract Presented at the 2019 Association of VA Hematology/Oncology Annual Meeting
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The Current State of VHA’s National Precision Oncology Program

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Abstract: 2018 AVAHO Meeting

Purpose: To inform VA stakeholders of the availability of Precision Oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, lowtoxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A system-wide National PO Program (NPOP) including patients in rural areas launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from NPOP records and cancer characteristics were extracted from NPOP and medical records. Drug use data was obtained from the VA Corporate Data Warehouse. NGS testing results and annotations were extracted from NPOP records.

Results: In all, 3,981 samples have been sent for NGS sequencing via NPOP. 3,036 samples were sequenced successfully and 597 failed (83.57% successful). Of the successful samples, 99 are liquid biopsies and 2,880 have Watson for Genomics treatment recommendations. Utilization of NPOP services has increased across VHA since the national rollout, from 4 participating facilities in NPOP’s first quarter (Q4 2016) to 51 facilities last quarter (Q3 2018). Average samples sent per month in 2018 is 182, up from 105 in 2017. Despite these increases, NGS testing is not yet systematically utilized at all participating facilities and 79 facilities did not participate last quarter. NPOP is servicing a large rural population (34% rural), which is similar to that of all VHA patients (33%) and more than twice the national rate (14%). The top diagnoses were lung (1,333: 917 adeno, 283 squamous, 133 non-small cell), colorectal (307), prostate (297), skin (154) and head and neck (75). 158 patients have been prescribed 225 of the recommended treatments before (130) and after (95) the NGS results date.

Conclusions: Utilization of NGS testing in the VHA population has grown significantly over the past year throughout most of the country. The higher volume has been facilitated through improvements in NPOP’s data infrastructure. Additional VHA patients can benefit from NGS gene panel testing to guide therapeutic decisionmaking.

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Abstract: 2018 AVAHO Meeting
Abstract: 2018 AVAHO Meeting

Purpose: To inform VA stakeholders of the availability of Precision Oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, lowtoxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A system-wide National PO Program (NPOP) including patients in rural areas launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from NPOP records and cancer characteristics were extracted from NPOP and medical records. Drug use data was obtained from the VA Corporate Data Warehouse. NGS testing results and annotations were extracted from NPOP records.

Results: In all, 3,981 samples have been sent for NGS sequencing via NPOP. 3,036 samples were sequenced successfully and 597 failed (83.57% successful). Of the successful samples, 99 are liquid biopsies and 2,880 have Watson for Genomics treatment recommendations. Utilization of NPOP services has increased across VHA since the national rollout, from 4 participating facilities in NPOP’s first quarter (Q4 2016) to 51 facilities last quarter (Q3 2018). Average samples sent per month in 2018 is 182, up from 105 in 2017. Despite these increases, NGS testing is not yet systematically utilized at all participating facilities and 79 facilities did not participate last quarter. NPOP is servicing a large rural population (34% rural), which is similar to that of all VHA patients (33%) and more than twice the national rate (14%). The top diagnoses were lung (1,333: 917 adeno, 283 squamous, 133 non-small cell), colorectal (307), prostate (297), skin (154) and head and neck (75). 158 patients have been prescribed 225 of the recommended treatments before (130) and after (95) the NGS results date.

Conclusions: Utilization of NGS testing in the VHA population has grown significantly over the past year throughout most of the country. The higher volume has been facilitated through improvements in NPOP’s data infrastructure. Additional VHA patients can benefit from NGS gene panel testing to guide therapeutic decisionmaking.

Purpose: To inform VA stakeholders of the availability of Precision Oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, lowtoxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A system-wide National PO Program (NPOP) including patients in rural areas launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from NPOP records and cancer characteristics were extracted from NPOP and medical records. Drug use data was obtained from the VA Corporate Data Warehouse. NGS testing results and annotations were extracted from NPOP records.

Results: In all, 3,981 samples have been sent for NGS sequencing via NPOP. 3,036 samples were sequenced successfully and 597 failed (83.57% successful). Of the successful samples, 99 are liquid biopsies and 2,880 have Watson for Genomics treatment recommendations. Utilization of NPOP services has increased across VHA since the national rollout, from 4 participating facilities in NPOP’s first quarter (Q4 2016) to 51 facilities last quarter (Q3 2018). Average samples sent per month in 2018 is 182, up from 105 in 2017. Despite these increases, NGS testing is not yet systematically utilized at all participating facilities and 79 facilities did not participate last quarter. NPOP is servicing a large rural population (34% rural), which is similar to that of all VHA patients (33%) and more than twice the national rate (14%). The top diagnoses were lung (1,333: 917 adeno, 283 squamous, 133 non-small cell), colorectal (307), prostate (297), skin (154) and head and neck (75). 158 patients have been prescribed 225 of the recommended treatments before (130) and after (95) the NGS results date.

Conclusions: Utilization of NGS testing in the VHA population has grown significantly over the past year throughout most of the country. The higher volume has been facilitated through improvements in NPOP’s data infrastructure. Additional VHA patients can benefit from NGS gene panel testing to guide therapeutic decisionmaking.

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Evaluation of Implementation of Tumor Next-Generation Sequencing Within the Veterans Health Administration (VHA)

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Abstract: 2018 AVAHO Meeting

Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.

Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.

Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.

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Abstract: 2018 AVAHO Meeting
Abstract: 2018 AVAHO Meeting

Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.

Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.

Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.

Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.

Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.

Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.

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Update on the VA Precision Oncology Program

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Abstract 31: 2017 AVAHO Meeting

Purpose: To inform VA stakeholders of the availability of precision oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, low-toxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A systemwide PO program (POP), including patients in rural areas, launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from POP records and cancer characteristics were extracted from POP and medical records. Drug use data were obtained from the VA Corporate Data Warehouse. NGS testing results, and annotations were extracted from POP records.

Results: 1,442 tumor samples were sent for NGS testing as of 5/21/17 from 61 facilities. Rural patient testing (35%) was similar to VHA rurality (33%) and more than twice the US rate (14%). Most common diagnoses: lung (688: adeno 482, squamous 134), unknown (114), colorectal (103), skin (96), prostate (76), and H&N (66). Sample test requests increased rapidly after national implementation in July 2016 (23 samples/month prior to implementation to mean 126 samples/month 3 months later) as did the number of participating facilities (10/quarter to 39/month). Sequencing success rate increased from 68% to 71% over the same interval, while mean turn around time remained similar at 19.7 and 19.1 days, respectively. To date, 26 patients received a recommended drug outside a clinical trial, some more than 9 months after NGS. 5 additional patients had received an NGS-recommended drug prior to testing. NGS results are available for a cohort of 344 patients including: lung 200 (adeno 138, squamous 51), skin 28, LN 20, liver 19, GI 16. 979 variants were found most commonly in TP53, KRAS, STK11, APC, PIK3CA, and CDKN2A. 228 patients (66%) had actionable results (on-label drug 24, off-label drug 165, clinical trial 213). A PO consultation service (available by IFC) and a liquid biopsy are now available nationally.

Conclusions: Implementation of tumor NGS testing in VHA has been successful. Further program expansion, addition of hematological malignancies, deployment of informatics tools and efforts to expand access to appropriate drugs are ongoing.

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Abstract 31: 2017 AVAHO Meeting
Abstract 31: 2017 AVAHO Meeting

Purpose: To inform VA stakeholders of the availability of precision oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, low-toxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A systemwide PO program (POP), including patients in rural areas, launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from POP records and cancer characteristics were extracted from POP and medical records. Drug use data were obtained from the VA Corporate Data Warehouse. NGS testing results, and annotations were extracted from POP records.

Results: 1,442 tumor samples were sent for NGS testing as of 5/21/17 from 61 facilities. Rural patient testing (35%) was similar to VHA rurality (33%) and more than twice the US rate (14%). Most common diagnoses: lung (688: adeno 482, squamous 134), unknown (114), colorectal (103), skin (96), prostate (76), and H&N (66). Sample test requests increased rapidly after national implementation in July 2016 (23 samples/month prior to implementation to mean 126 samples/month 3 months later) as did the number of participating facilities (10/quarter to 39/month). Sequencing success rate increased from 68% to 71% over the same interval, while mean turn around time remained similar at 19.7 and 19.1 days, respectively. To date, 26 patients received a recommended drug outside a clinical trial, some more than 9 months after NGS. 5 additional patients had received an NGS-recommended drug prior to testing. NGS results are available for a cohort of 344 patients including: lung 200 (adeno 138, squamous 51), skin 28, LN 20, liver 19, GI 16. 979 variants were found most commonly in TP53, KRAS, STK11, APC, PIK3CA, and CDKN2A. 228 patients (66%) had actionable results (on-label drug 24, off-label drug 165, clinical trial 213). A PO consultation service (available by IFC) and a liquid biopsy are now available nationally.

Conclusions: Implementation of tumor NGS testing in VHA has been successful. Further program expansion, addition of hematological malignancies, deployment of informatics tools and efforts to expand access to appropriate drugs are ongoing.

Purpose: To inform VA stakeholders of the availability of precision oncology (PO) services for Veterans with advanced cancer.

Background: PO offers the promise of effective, low-toxicity targeted therapies tailored to individual tumor genomics but is unequally available within VHA. A systemwide PO program (POP), including patients in rural areas, launched in July 2016.

Methods: Patients tested with multigene next generation sequencing (NGS) tumor testing through 2 contracted vendors were identified from POP records and cancer characteristics were extracted from POP and medical records. Drug use data were obtained from the VA Corporate Data Warehouse. NGS testing results, and annotations were extracted from POP records.

Results: 1,442 tumor samples were sent for NGS testing as of 5/21/17 from 61 facilities. Rural patient testing (35%) was similar to VHA rurality (33%) and more than twice the US rate (14%). Most common diagnoses: lung (688: adeno 482, squamous 134), unknown (114), colorectal (103), skin (96), prostate (76), and H&N (66). Sample test requests increased rapidly after national implementation in July 2016 (23 samples/month prior to implementation to mean 126 samples/month 3 months later) as did the number of participating facilities (10/quarter to 39/month). Sequencing success rate increased from 68% to 71% over the same interval, while mean turn around time remained similar at 19.7 and 19.1 days, respectively. To date, 26 patients received a recommended drug outside a clinical trial, some more than 9 months after NGS. 5 additional patients had received an NGS-recommended drug prior to testing. NGS results are available for a cohort of 344 patients including: lung 200 (adeno 138, squamous 51), skin 28, LN 20, liver 19, GI 16. 979 variants were found most commonly in TP53, KRAS, STK11, APC, PIK3CA, and CDKN2A. 228 patients (66%) had actionable results (on-label drug 24, off-label drug 165, clinical trial 213). A PO consultation service (available by IFC) and a liquid biopsy are now available nationally.

Conclusions: Implementation of tumor NGS testing in VHA has been successful. Further program expansion, addition of hematological malignancies, deployment of informatics tools and efforts to expand access to appropriate drugs are ongoing.

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