The IO Central Chemoembolization Discussion Group this week raised the issue of getting insurance approval for atypical tumors. Not surprisingly, the insurer in this case turned out to be Blue Cross, one of the worst carriers for Interventional Oncology procedures. My local carrier administrator hews closely to the FDA labeling and strict wording of CPT codes. Any deviation is called “experimental” therapy, which is the specious justification for not agreeing to pay for the procedure. Hence patients with metastatic colon cancer can get Y-90, but not chemoembolization. Only HCC and NET’s get approved for chemoembolization.
Lack of Level 1 data is often cited as the justification for calling something “experimental”, even when there is ample supportive literature and the procedure has been widely used in practice for many years, or when the tumor is so uncommon that substantial trials will never be performed. This rationalization is a cover for what they are really doing, which is rationing care.
While this is maddening for the physician and traumatic for the patient, it is also a consequence of the patient’s (or their employer’s) choice of insurance. Other insurance carriers pay for these procedures. Unfortunately, since most health insurance in the U.S. is employer-driven, patients often have few options.
Rationing of IO therapy exists under many false pretenses. There are major centers in the U.S. that do not offer chemoembolization to Childs B patients, arguing that benefit has never been shown in this population. Another specious argument, since virtually all clinical trials are limited to Childs A, to avoid confounding deaths from liver failure as opposed to tumor progression among patients with more advanced cirrhosis. Absence of evidence is not evidence of absence. A treatment that kills HCC will do it as well in a Childs B patient as in a Childs A patient; the B patients will not live as long on average either way, but they live longer of you threat their HCC than if you don’t.
A more pervasive form of rationing is the abuse of the BCLC Staging system. While quite effective in segregating patients into balanced prognostic groups, it is often misused in triaging patients to therapy. The Barcelona group’s recommendation is to offer chemoembolization for BCLC-B, and sorafenib for BCLC-C. There is no rational argument for this. As with Childs class, chemoembolization works equally well to kill HCC whether you are a BCLC-B or BCLC-C; the C’s don’t live as long either way, but median survival doubles if they get chemoembolization, and chemoembolization provides longer survival at less cost than sorafenib. Most HCC patients treated with chemoembolization at major US centers are in fact BCLC-C.
Rationing treatment of advanced HCC is a societal contract based on averages. For a group of patients with a poor average prognosis, some entity (an insurer, a government) decides not to spend collective societal resources (premiums, taxes) for a small average improvement in survival. As I tell my patients, no one is average; everyone is either better or worse. The big unknown in determining prognosis is response to therapy. I have plenty of patients who presented with macrovascular invasion and and AFP >10,000 who had complete or near-complete responses to chemoembolization and went on to live for years (see Goodbye to Hy, 8/28/12).
How can rationing be addressed systematically? Doing randomized controlled trials for every nuance of interventional therapy is impractical. An alternative approach is cost & comparative effectiveness studies. Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care (quoted from the AHRQ website). In this way the value of IO in the context of complete cancer care can be quantified and incorporated into treatment algorithms. The new WCIO Comparative Effectiveness Task Force will be exploring this approach.