New approach to administrative medical decision-making: evidence-based medicine using high dose chemotherapy/bone marrow transplant for breast cancer.
BACKGROUND
Payment for experimental treatments using medical necessity criteria has been controversial. The process of obtaining a decision on coverage of an experimental treatment can be distressful for the treating physician, the patient, and family members.


METHODS
The techniques of evidence-based medicine were used to assist with treatment/coverage decisions concerning high dose chemotherapy with autologous bone marrow transplants (HDC/ABMT) for invasive breast cancer.


RESULTS
We reviewed the literature, finding minimal evidence for effectiveness of HDC/ABMT for invasive breast cancer; therefore, it is our opinion that it remains an experimental therapy. Its cost utility is likely to be low (approximately $100,000 per additional quality year gained). Numerous patients have been treated with HDC/ABMT outside of clinical trials, impeding scientific analysis of the treatment's effectiveness.


CONCLUSIONS
Data-based policies and procedures for funding experimental medical treatments need to be developed to eventually replace the medical necessity criteria.
Lucey
C
C
21st Century Health Concepts, Baton Rouge, La 70809, USA.
Westphal
J R
JR
D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000191:economics; D016026:Bone Marrow Transplantation / Q000191:economics; D001943:Breast Neoplasms / Q000191:economics / Q000628:therapy*; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D019458:Insurance Coverage; D007349:Insurance, Health, Reimbursement; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D000970:Antineoplastic Agents