Industry Perspective re: QIBA

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Marshall Cameron
5 years ago
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1 QIBA Annual Meeting May 18, 2014 Crystal City, VA 2014 May 21 Industry Perspective re: QIBA Richard A. Frank, MD, PhD Chief Medical Officer Siemens Healthcare USA Chair, MITA Coverage & Research Committee Speaking on behalf of the Medical Imaging & Technology Alliance (MITA) For Gail Rodriguez, Executive Director Disclosures Richard A. Frank, MD, PhD is employed by Siemens Healthcare USA as the Chief Medical Officer. The Medical Imaging & Technology Alliance (MITA) represents medical imaging, radiation therapy, and radiopharmaceutical manufacturers. Dr Frank chairs MITA s Coverage and Research Committee. 1

2 Kudos to QIBA Profiling Clinically relevant content Validation of profile Implementation via stakeholders Accreditation of sites Revision to catalyze enhanced product performance Education, Metrics Sustainability What will drive use of the profiles? Is there a role for industry beyond innovation and design to performance? Industry Roles - primary Innovation in technology for detection and characterization of pathology to inform patient management Improve efficacy, enhance safety, and expand accessibility Innovation in therapeutic options and IT infrastructure eg EHRs Regulatory approval for innovative technology (safety and efficacy) Installation, validation, and training in use of technology Address quality issues which may be attributed to product design Examples of innovations CAD Iterative Reconstruction Detector efficiency and configuration Minimally invasive surgery Examples of incremental improvements Reporting tools EHRs, DICOM Quantitation You asked for reduced radiation exposure with the same or better quality, and we delivered 2

3 2010: CT dose mentioned 2100 times in English language media (Source: Google News) Industry Roles - primary Radiation Dose Mitigation Standards NEMA XR 25 (2010): Computed Tomography Dose Check NEMA XR 26 (2012): Access Controls for Computed Tomography: Identification, Interlocks, and Logs NEMA XR 27 (2012): X-ray Equipment for Interventional Procedures User Quality Control Mode NEMA XR 28 (2013): Supplemental Requirements for User Information and System Function Related to Dose in CT NEMA XR 29 (2013): Standard Attributes on Computed Tomography (CT) Equipment Related to Dose Optimization and Management 3

4 Industry Roles - primary Dose Reduction Innovations Automatic Exposure Control Wider coverage detectors Shutter modes Advanced electronics First and second generation CT iterative reconstruction DICOM Radiation Dose Structured Report XR 25 Dose Check Standard Typical CTC Radiation Dose (per exam) Dose in msv Annual background from naturally occurring radiation 2008 * ACRIN NCTCT 2013 ** Typical Today Horizon *** * 2008 ACRIN NCTCT- Berrington de González A, Kim KP, Knudsen AB, et al. Radiation-related cancer risks from CT colonography screening: a risk-benefit analysis. AJR 2011; 196: **2013 Yee J, Keysor KJ, Kim DH. The time has arrived for national reimbursement of screening CT colonography. AJR Am J Roentgenol Jul;201(1):73-9. ***2013 Chang KJ, Yee J. Dose reduction methods for CT colonography. Abdom Imaging Apr; 38(2):

Industry Roles - primary Typical Radiation Dose (per exam) Annual background from naturally occurring radiation * Smith-Bindman R, Lipson J, Marcus R, et al.

5 Industry Roles - primary Typical Radiation Dose (per exam) Annual background from naturally occurring radiation * Smith-Bindman R, Lipson J, Marcus R, et al. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med 2009;169: **Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011; 365: *** Data on file at I-ELCAP. International Early Lung Cancer Investigators. Survival of Patients with Stage I Lung Cancer Detected on CT Screening. The New England Journal of Medicine. 2006; 355: Industry roles - secondary Support the clinical community in gaining coverage for procedures Enable quality metrics in support of professional societies (eg, dose) Examples of support for coverage and quality Establish quality standards for product design (a primary role for MITA) Standardize product design for quality metrics in professional use Standardize product design for reporting Advocate appropriate use and clinical practice guidelines Comment on research plans and HTAs by AHRQ/USPSTF, EBPs, Payers (public & private) Participate in design and build of research infrastructure Participate in development and implementation of pragmatic, relevant quality metrics 5

6 Industry roles - NOT Practice of medicine Clinical practice guidelines/appropriate Use Criteria Promotion [off-label] Accrediting radiology sites Tracking performance of sites (quality of reads, doses administered Conduct of CER Industry Roles - secondary Healthcare Technology Assessments New technology is MORE expensive and LESS effective than existing one Rational decision to go against new technology New technology is MORE expensive and MORE effective than existing one Decision makers must decide if the increased costs are worth the increase in effectiveness New technology is LESS expensive and LESS effective than existing one Decision makers must decide if the reduced costs are worth the reduction in effectiveness New technology is LESS expensive and MORE effective than existing one Rational decision to go in favor of new technology 6

7 Industry Roles - secondary Pursuing Coverage and Payment for New Applications Low Dose CT for Lung Cancer Screening Amyloid PET Imaging in Dementia CT Colonography for Colo-rectal Cancer CMS NCA USPSTF B FDA Approval Amyloid Agents CMS NCA USPSTF Research Plan CMS CED MITA-QIBA Shared Objectives How do we measure and report progress, and what s next? 1 st Profile FDG PET/CT Profile Validation Implementation 2 nd -n th Profile Profiles for U/S, MR, CT Validation Implementation Site Accred n Expanded and enhanced profiles for PET/CT, eg Amyloid 1 st Profile up-spec d Validation Implementation Site Accred n Site upgrades Accreditation, Certification 7

8 MITA-QIBA Discussion How best to work toward our common objective of raising the performance and value of quantitation? Heard in the hallways; Help us validate profile X, and then, Release support for profile X in products. Work backward from; Who should aspire to the profiles and why? What will be the value to them and what then is the commensurate resource they would allocate? What must be done to raise awareness and enable the aspirations of these users? 8

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