Emerging Technology in Cancer Treatment: Radiotherapy Modalities

Dr. Hevezi has outlined some exciting new developments in the field of radiation oncology in his thorough review. Since its inception, radiation oncology has been geographically based, ie, related to the radiation exposure of tumor vs normal tissue. It is therefore a logical extension of new radiographic technology that allows for more precise placement of radiation fields than ever before. Further, as outlined by Dr. Hevezi, the development of treatment planning computers coupled to verification computers on the liner accelerator is associated with precise radiation delivery that exploits the relative radiation dose between the tumor and normal tissue, allowing higher doses to be used without increased toxicity. Stereotatic Body Radiation Therapy
One additional example is the concept of stereotaxis for the treatment of tumors within the body utilizing either a single fraction or a small number of fractions with a high degree of precision. This technology, called stereotatic body radiation therapy (SBRT), requires high targeting accuracy and rapid dose falloff gradients encompassing tumors.[1] SBRT can be applied to localized malignant conditions in the body using minimally invasive stereotactic tumor localization and radiation delivery techniques but requires a high degree of precision when directing the ionizing radiation. Maneuvers to limit the movement of the target volume during treatment planning and delivery are often required to achieve the necessary precision. Reimbursement Issues
For radiation oncologists, advances in technology represent a "revolutionary" shift in the paradigm for the treatment of cancer patients. As noted by Dr. Hevezi, we are fortunate that intensity-modulated radiation therapy (IMRT) has been recognized for reimbursement, making it more widely available. Conversely, the socioeconomics of health-care reimbursement remains a complicated and highly regulated process.[2] On the one hand, we have the Medicare system imposed by the Centers for Medicare and Medicaid Services (CMS) and the CPT and relative value process of new medical procedures supervised by the American Medical Association; on the other hand, we have the decision-making processes of the private healthcare networks. The process of establishing reimbursement for new technology is confusing, but one of the main principles of its introduction into clinical use is the approval by the Food and Drug Administration. Unlike pharmaceuticals, medical technology is approved based on safety, not efficacy. Once such technology is approved, manufacturers are empowered to encourage its use, and those pioneering its introduction into clinical practice are free to use it. Obtaining reimbursement, however, is quite another story. One example of this process was the introduction of IMRT, for which CPT codes had been assigned to identify the work and expense associated with both treatment planning and delivery. Interestingly, while going through the relative value update committee to set the reimbursement for IMRT, it was determined that IMRT would be used in 5% of cases, with 95% of cases using the older, threedimensional conformal radiation techniques (3D-CRT). Through 2002, it appears that use of IMRT actually comprised 15% of all radiation treatments, and that number is likely to rise substantially as more centers come online in 2003. One dilemma is a reluctance among third-party payers to reimburse for these services without substantial data supporting an enhanced efficacy. Furthermore, as the Medicare system remains "budget neutral," the use of new technology such as IMRT requires shifts in money from other codes and, in turn, runs the risk of reduced valuations as utilization increases. That said, it may be better that new technology services and procedures be introduced with category III codes (temporary codes used to collect data for emerging technology, services, and procedures) until outcomes confirm their efficacy. Outcomes Data
As physicians, we remain perplexed; we are anxious to offer the latest technology that we believe gives our patients the best chance of successful treatment, and we are encouraged to do so by industry and our colleagues. Yet, we remain reluctant to initiate clinical trials to assess the efficacy of this technology. Nonetheless, without data to substantially support the use of any new technology, we run the risk of not being able to support its reimbursement. Too few randomized trials have clearly identified the advantages of IMRT, and as such, many private payers severely limit its use. The uncertainty of whether this technology is actually better is weighed against the factors that concern us should it not be offered-the failure to offer new technology from both medicolegal and business aspects.[ 3] Again, these concerns are best answered by mature, prospective data outlining the advantages of the new technique. Just being able to provide it is no longer enough. Ultimately, if outcome data sup- port the additional resources required for implementing a new technology, it will have to be accepted. However, if the data are retrospective and only related to the technique's implementation, then that may not warrant its widespread introduction into the community. With the emergence of "evidence-based" outcomes as a measure for reimbursement, we face a catch-22 in which advisory committees for CMS or private payers rule against such technology based on a lack of data.[4] Data are not only important in assessing efficacy, but also in demonstrating when new technology is only marginally or not at all effective, and this can have a significant impact on decreasing its (over)utilization and the cost of care. As such, there is tremendous value in publishing studies with a negative outcome. It is entirely possible that the steep dose gradients produced by IMRT or SBRT may miss subclinical disease and may be inappropriate for some types of cancer. Without outcome data, this consideration remains circumspect. Conclusions
In conclusion, the review by Dr. Hevezi outlines the exciting advances in the field of radiation oncology. Nevertheless, we should be reminded that enrolling patients into studies to determine the appropriate use of this technology is of primary importance, not only to document better outcomes, but to better defend-from a socioeconomic point of view-its implementation, and ultimately enable appropriate patient access.