Abstract

ABSTRACTBackgroundPayment 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.MethodThe 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.ResultsWe 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.ConclusionData-based policies and procedures for funding experimental medical treatments need to be developed to eventually replace the medical necessity criteria.