Emerging Technology in Cancer Treatment: Radiotherapy Modalities

October 1, 2003

Dr. Hevezi has outlined someexciting new developments inthe field of radiation oncologyin his thorough review. Since its inception,radiation oncology has beengeographically based, ie, related to theradiation exposure of tumor vs normaltissue. It is therefore a logical extensionof new radiographic technologythat allows for more preciseplacement of radiation fields than everbefore. Further, as outlined by Dr.Hevezi, the development of treatmentplanning computers coupled to verificationcomputers on the liner acceleratoris associated with precise radiationdelivery that exploits the relativeradiation dose between the tumorand normal tissue, allowing higherdoses to be used without increasedtoxicity.

Dr. Hevezi has outlined someexciting new developments inthe field of radiation oncologyin his thorough review. Since its inception,radiation oncology has beengeographically based, ie, related to theradiation exposure of tumor vs normaltissue. It is therefore a logical extensionof new radiographic technologythat allows for more preciseplacement of radiation fields than everbefore. Further, as outlined by Dr.Hevezi, the development of treatmentplanning computers coupled to verificationcomputers on the liner acceleratoris associated with precise radiationdelivery that exploits the relativeradiation dose between the tumorand normal tissue, allowing higherdoses to be used without increasedtoxicity.Stereotatic BodyRadiation Therapy
One additional example is the conceptof stereotaxis for the treatmentof tumors within the body utilizingeither a single fraction or a small numberof fractions with a high degree ofprecision. This technology, calledstereotatic body radiation therapy(SBRT), requires high targeting accuracyand rapid dose falloff gradientsencompassing tumors.[1] SBRTcan be applied to localized malignantconditions in the body using minimallyinvasive stereotactic tumor localizationand radiation deliverytechniques but requires a high degreeof precision when directing the ionizingradiation. Maneuvers to limitthe movement of the target volumeduring treatment planning and deliveryare often required to achieve thenecessary precision.Reimbursement Issues
For radiation oncologists, advancesin technology represent a "revolutionary"shift in the paradigm for thetreatment of cancer patients. As notedby Dr. Hevezi, we are fortunate thatintensity-modulated radiation therapy(IMRT) has been recognized forreimbursement, making it more widelyavailable. Conversely, the socioeconomicsof health-care reimbursementremains a complicated and highlyregulated process.[2] On the onehand, we have the Medicare systemimposed by the Centers for Medicareand Medicaid Services (CMS) and theCPT and relative value process of newmedical procedures supervised by theAmerican Medical Association; on theother hand, we have the decision-makingprocesses of the private healthcarenetworks.The process of establishing reimbursementfor new technology is confusing,but one of the main principlesof its introduction into clinical use isthe approval by the Food and DrugAdministration. Unlike pharmaceuticals,medical technology is approvedbased on safety, not efficacy. Oncesuch technology is approved, manufacturersare empowered to encourageits use, and those pioneering itsintroduction into clinical practice arefree to use it. Obtaining reimbursement,however, is quite another story.One example of this process wasthe introduction of IMRT, for whichCPT codes had been assigned to identifythe work and expense associatedwith both treatment planning and delivery.Interestingly, while goingthrough the relative value update committeeto set the reimbursement forIMRT, it was determined that IMRTwould be used in 5% of cases, with95% of cases using the older, threedimensionalconformal radiation techniques(3D-CRT). Through 2002, itappears that use of IMRT actuallycomprised 15% of all radiation treatments,and that number is likely torise substantially as more centers comeonline in 2003.One dilemma is a reluctance amongthird-party payers to reimburse forthese services without substantial datasupporting an enhanced efficacy. Furthermore,as the Medicare system remains"budget neutral," the use ofnew technology such as IMRT requiresshifts in money from othercodes and, in turn, runs the risk ofreduced valuations as utilization increases.That said, it may be better thatnew technology services and proceduresbe introduced with category IIIcodes (temporary codes used to collectdata for emerging technology,services, and procedures) until outcomesconfirm their efficacy.Outcomes Data
As physicians, we remain perplexed;we are anxious to offer thelatest technology that we believe givesour patients the best chance of successfultreatment, and we are encouragedto do so by industry and ourcolleagues. Yet, we remain reluctantto initiate clinical trials to assess theefficacy of this technology. Nonetheless,without data to substantially supportthe use of any new technology,we run the risk of not being able tosupport its reimbursement. Too fewrandomized trials have clearly identifiedthe advantages of IMRT, and assuch, many private payers severelylimit its use. The uncertainty of whetherthis technology is actually better isweighed against the factors that concernus should it not be offered-thefailure to offer new technology fromboth medicolegal and business aspects.[3] Again, these concerns arebest answered by mature, prospectivedata outlining the advantages of thenew technique. Just being able to provideit is no longer enough.Ultimately, if outcome data sup-port the additional resources requiredfor implementing a new technology,it will have to be accepted. However,if the data are retrospective and onlyrelated to the technique's implementation,then that may not warrantits widespread introduction into thecommunity. With the emergence of"evidence-based" outcomes as a measurefor reimbursement, we face acatch-22 in which advisory committeesfor CMS or private payers ruleagainst such technology based on alack of data.[4]Data are not only important in assessingefficacy, but also in demonstratingwhen new technology is onlymarginally or not at all effective, andthis can have a significant impact ondecreasing its (over)utilization and thecost of care. As such, there is tremendousvalue in publishing studies witha negative outcome. It is entirely possiblethat the steep dose gradients producedby IMRT or SBRT may misssubclinical disease and may be inappropriatefor some types of cancer.Without outcome data, this considerationremains circumspect.Conclusions
In conclusion, the review by Dr.Hevezi outlines the exciting advancesin the field of radiation oncology.Nevertheless, we should be remindedthat enrolling patients into studies todetermine the appropriate use of thistechnology is of primary importance,not only to document better outcomes,but to better defend-from a socioeconomicpoint of view-its implementation,and ultimately enable appropriatepatient access.

Disclosures:

The author(s) have no significant financial interest or other relationship with the manufacturers of any products or providers of any service mentioned in this article.

References:

1.

Timmerman R, Papiez L, SuntharalingamM: Extracranial stereotactic radiation delivery:Expansion of technology beyond thebrain. Technol Cancer Res Treat 2:153-160,2003.

2.

Potters L, Steinberg M, Wallner P, et al:How one defines intensity modulated radiationtherapy. Int J Radiat Oncol Biol Phys 56:609-610, 2003.

3.

McNeil B: Shattuck lecture: Hidden barriersto improvement in the quality of care.N Engl J Med 345:1612-1620, 2001.

4.

Garber AM: Evidence-based coveragepolicy. Health Aff (Millwood) 20:62-82,2001.