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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

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

Role of plan medical director
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

Hdc abmt for breast cancer early experience
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

The hdc abmt natural experiment
The HDC/ABMT Natural Experiment



Adjuvant therapy

Comb. therapy

Hi-dose chemothx

Bone marrow tx

Growth factors

Phase 2 studies

Court trials



1994 ff

Clinical utilization pathway ~20,000

Entrepreneurial oncology, 1991-99

For-profit; not-for-profit


AMA; Dream Team;

Standard of care

Telling the story: print, TV; medicine; NCI


Insurers, clinicians,





Med. profession

H Insurers



Clinical evaluation pathway

ASCO 1999

Stadtmauer, Peters,

Bergh, French,


Technology assessments, 1988-96


Clinical trials, 1990-2003:E/PBT-01;

CALGB 9082; INT-0121; SWOG 9623


RAND Health

Pathway ii phase 2 to widespread clinical use
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

Pathway ii cont
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

Primary legal issues
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

Litigation trends maddeningly unpredictable
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

Utilization in the 1990s
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

Factors driving utilization
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

Technology assessments
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

Pathway i hypothesis testing by phase 3 rcts
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

Randomized controlled trials
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

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


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

Asco meeting may 1999
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


  • 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