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False Hope: ABMT for Breast Cancer Health Plan Perspective

False Hope: ABMT for Breast Cancer Health Plan Perspective. Academy Health: Annual Research Meeting San Diego, California, June 2004 Wade M. Aubry, M.D. Former Chief Medical Officer, Blue Shield of California Former National Medical Consultant, BCBS Association.

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False Hope: ABMT for Breast Cancer Health Plan Perspective

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  1. False Hope: ABMT for Breast CancerHealth Plan Perspective Academy Health: Annual Research Meeting San Diego, California, June 2004 Wade M. Aubry, M.D. Former Chief Medical Officer, Blue Shield of California Former National Medical Consultant, BCBS Association RAND Health

  2. Role of Plan Medical Director • Oversee process of developing coverage policies through health plan medical policy committee • Ongoing review and evaluation of new evidence on emerging medical technologies to stay current • Oversee UR based on policies; review cases for medical necessity (as defined) and apply Experi-mental & Investigational exclusion if appropriate • Preauthorize high cost procedures, such as bone marrow transplants for various applications • Be consistent to minimize liability risk RAND Health

  3. HDC/ABMT for Breast Cancer:Early Experience • Emergent procedure – 1985-88 • Early requests for insurance coverage during this period • Medical Directors felt that procedure was experimental • Phase 2 studies – Single site, non-randomized, small numbers, extensive patient evaluation, historical or no controls • Phase 2 studies – Preliminary to what? • Phase 3 RCTs to test hypothesis? Not planned initially • Wider diffusion to clinical practice? RAND Health

  4. The HDC/ABMT Natural Experiment Emergence 1985-89 Adjuvant therapy Comb. therapy Hi-dose chemothx Bone marrow tx Growth factors Phase 2 studies Court trials 1991-99 Mandates 1994 ff Clinical utilization pathway ~20,000 Entrepreneurial oncology, 1991-99 For-profit; not-for-profit Legitimation AMA; Dream Team; Standard of care Telling the story: print, TV; medicine; NCI Evaluation Insurers, clinicians, NCI Recognition 1988-89 No FDA Med. profession H Insurers Patients ~1,000 Clinical evaluation pathway ASCO 1999 Stadtmauer, Peters, Bergh, French, Bezwoda Technology assessments, 1988-96 OHTA; BSC; BCBSA; AMA; Aetna; ECRI; Kaiser; ICSI Clinical trials, 1990-2003:E/PBT-01; CALGB 9082; INT-0121; SWOG 9623 Audits RAND Health

  5. Pathway II: Phase 2 to Widespread Clinical Use • Evaluation depends on medical profession: • Commitment to “gold standard” is qualified • You can’t fight something with nothing: • Weakness of “standard therapy” • “Bias” toward the experimental • Outcomes: response rate (CR, PR); survival • Academic oncology legitimates wider use: • Many centers engaged in Phase 2 studies • “Dream Team” document widely circulated RAND Health

  6. Pathway II (cont.) • Oncology engages health insurers: • Billing and coding of non-standardized requests • Issue is coverage of experimental procedures • Administrative denials of coverage • Search for effectiveness – BUT • Insurers’ lack legitimacy to insist on effectiveness • Desperate patients & plaintiffs’ lawyers turn to the courts; Oncology support for “best available” Rx RAND Health

  7. Primary Legal Issues • Contract interpretation: • exp/invest exclusion; medical necessity clause; chemotherapy coverage; BMT coverage; specific HDC/ABMT exclusion • Standard of care • Informed consent • Bad faith denial of claims • Expert witnesses & clinical trial evidence • Sympathy & emotion RAND Health

  8. Litigation Trends (Maddeningly Unpredictable) • Fox v. HealthNet, 1993: $89 M verdict • No pre-Fox vs. post-Fox differences re wins • 1988-1993: insurers, 17; patients, 16 • 1994-2002: insurers, 26; patients, 28 • Litigation peaks in 1993-94 • Settlements strongly favor patients after Fox • Four jury verdicts are mixed RAND Health

  9. Utilization in the 1990s • ~20,000 women receive HDC/ABMT for breast cancer; est. 600 premature deaths • 1,000 women on protocol • Median age, 1993-2000, 44-47 • Median length of stay,19-24 • Median charges, $103,924-$71,760; est. total cost over 10 years, $2 billion • Payers: PPO/FFS, 53.9%; HMO, 23.4% RAND Health

  10. Factors Driving Utilization • Phase 2 studies • Court decisions • State legislative mandates: e.g., Minnesota • Federal agency decisions: e.g., OPM • Entrepreneurial activity: RT/RO; NFP • Physician advocacy • Patient demand RAND Health

  11. Technology Assessments • NCHSR/OHTA: 1988 • BCBSA: 1988, 1990 • David Eddy, J Clinical Oncology, 1992 • Demonstration project • “Dream Team” document, 1990 • Aetna: MCOP & independent medical review • ECRI: late entrant; patient information • BCBSA: 1995 – 96: “HDC not worse than” • Treatment-related mortality down • South African Phase 3 trial RAND Health

  12. Pathway I: Hypothesis Testing by Phase 3 RCTs • Physician-scientists ask for trial coverage • NCI asks for clinical research financing: • Crisis in clinical research. • Insurers ask for data (TA, clinical trials): • US HealthCare finances the Philadelphia trial • BCBSA TEC evaluates data, creates support mechanism • Parties agree to NCI high-priority trials RAND Health

  13. Randomized Controlled Trials • What is being studied? • Stage IV: metastatic breast cancer • Stage II: early stage, high-risk breast cancer • Standard versus new; BMT; regimen; dosage? • Trials • PBT-01 => ECOG • INT-0163/CALGB 9082 • ECOG 2190/INT-0121 • SWOG 9623 RAND Health

  14. Standard coverage Part of reimbursement Paid for by plans Post-pay for procedure Existing contracts govern Paid from premiums Demonstration Not part of reimbursement Paid by BCBSA Pre-pay for procedure New contracts Paid from other sources BCBSA TEC Clinical Trial Demonstration Project RAND Health

  15. ASCO Meeting, May 1999 • NCI Director’s meeting, February 1999: • How do we announce the results of trials? • Posting information about trials on web in April • ECOG/PBT-01: Stadtmauer: metastatic • CALGB: Peters; DSMB • Sweden: J Bergh • S Africa (Bezwoda 2) : beneficial • France (PEGASE) RAND Health

  16. Lessons • Developing evidence (collaboration of centers) • Evaluating evidence (transparent process for TA) • Health plans’ coverage decision making process (open, objective, timely, consistent) • Flexible coverage of high priority clinical trials • Voluntary and mandatory independent medical review • Physician roles (informed consent, COI issues) • Patients (access to objective information on treatment options and clinical trials) • The print & electronic media (balanced reporting) RAND Health

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