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June 7, 2004RAND Health1 False Hope: ABMT for Breast Cancer Health Plan Perspective Academy Health: Annual Research Meeting San Diego, California, June.

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Presentation on theme: "June 7, 2004RAND Health1 False Hope: ABMT for Breast Cancer Health Plan Perspective Academy Health: Annual Research Meeting San Diego, California, June."— Presentation transcript:

1 June 7, 2004RAND Health1 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

2 June 7, 2004RAND Health2 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

3 June 7, 2004RAND Health3 HDC/ABMT for Breast Cancer: Early Experience Emergent procedure – –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?

4 June 7, 2004RAND Health4 The HDC/ABMT Natural Experiment Court trials Entrepreneurial oncology, For-profit; not-for-profit Mandates 1994 ff Emergence Adjuvant therapy Comb. therapy Hi-dose chemothx Bone marrow tx Growth factors Phase 2 studies Recognition No FDA Med. profession H Insurers Patients Technology assessments, OHTA; BSC; BCBSA; AMA; Aetna; ECRI; Kaiser; ICSI Clinical evaluation pathway ~1,000 Clinical utilization pathway ~20,000 Clinical trials, : E/PBT-01; CALGB 9082; INT-0121; SWOG 9623 ASCO 1999 Stadtmauer, Peters, Bergh, French, Bezwoda Audits Legitimation AMA; Dream Team; Standard of care Evaluation Insurers, clinicians, NCI Telling the story : print, TV; medicine; NCI

5 June 7, 2004RAND Health5 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

6 June 7, 2004RAND Health6 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

7 June 7, 2004RAND Health7 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

8 June 7, 2004RAND Health8 Litigation Trends (Maddeningly Unpredictable) Fox v. HealthNet, 1993: $89 M verdict No pre-Fox vs. post-Fox differences re wins – : insurers, 17; patients, 16 – : insurers, 26; patients, 28 Litigation peaks in Settlements strongly favor patients after Fox Four jury verdicts are mixed

9 June 7, 2004RAND Health9 Utilization in the 1990s ~20,000 women receive HDC/ABMT for breast cancer; est. 600 premature deaths 1,000 women on protocol Median age, , 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%

10 June 7, 2004RAND Health10 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

11 June 7, 2004RAND Health11 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

12 June 7, 2004RAND Health12 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

13 June 7, 2004RAND Health13 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

14 June 7, 2004RAND Health14 BCBSA TEC Clinical Trial Demonstration Project 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

15 June 7, 2004RAND Health15 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)

16 June 7, 2004RAND Health16 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)


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