Medical research has had a tremendous impact and gives people battling cancer every reason to be hopeful as well as engaged. It is not only doctors and researchers who are responsible for medical breakthroughs. Patients, people, and companies raising money and awareness for cancer research – often armed with the passion and determination that comes from being impacted by cancer – deserve substantial credit for progress. Patients participating in clinical trials and advocates figure prominently in medical advances as well. Drug companies invest millions to bring drugs and therapies to market driven by the wonderful engine of capitalism and profit.
In the rare instance where the drug or treatment appears to be effective, government regulatory hurdles must be satisfied. Designed to protect patients and the public, regulations often serve their intended purpose. But sometimes government agencies charged with protecting the public actually harms it. Regulation interposes tremendous costs and delays during which time patients suffer and die. When one government agency limits access to a life-saving treatment that was approved by another agency and increases the costs of healthcare on Americans with the same proposed rule, we have a story that should outrage the public. Government reimbursement of radioimmunotherapy presents such a story.
A Concise History Of Cancer Treatment: Historically, there have been three main treatments for cancer: removing the tumors with a scalpel or saw (surgery); killing the cancer cells by injecting the patient with toxic chemicals (chemotherapy); or destroying the cancer cells with high beam radiation (radiation therapy). Refinements in all techniques (e.g., microscopic and robotic surgery, better and more chemotherapy agents and regiments, and 3D radiation) have benefited patients enormously. To be sure, each of these treatments has saved and extended untold lives over the years. But all treatments have direct costs, indirect costs (e.g., lost productivity), side-effects, and risks. Often patients suffer extensively or are even killed by the side-effects of treatment, rather than by the cancer itself.
This is an exciting time for cancer research. The investment in research coupled with our better understanding of the microbiology of cancer has brought us into the dawn of the personalized age of cancer treatment.
A Better Way: What if we had a treatment that would target the cancer, attach onto the cancer cells and leave the healthy cells alone (through a monoclonal antibody for example), and stimulate the immune system to attack the cancer cells? What if we added a radioactive element that goes directly to the cancer cells to finish them off?
Such a therapy actually has been developed and has been named appropriately radioimmunotherapy or RIT. It took a long time, a large monetary investment as well as scientific genius to develop RIT. Work in the 1980s, led to clinical trials in the 1990s, and resulted in U.S. Food and Drug Administration (FDA) approval of RIT a few years ago. There are two versions: I-labeled tositumomab (Bexxar) and Y-labeled ibritumomab (Zevlin).
RIT Has Proven Effective For Some Follicular Lymphomas: As regular readers of this column know, this examiner is a survivor of non-Hodgkin lymphoma so, in that sense, I have a special interest in this subject. But I did not have follicular lymphoma and did not receive RIT. No one is suggesting that RIT is a panacea or that it will work for most cancers – it will not. But RIT is a cure (at least a decades-long remission provider) for many people with follicular lymphomas – a category of slow growing or indolent blood cancers that, until recently, was widely thought to be treatable, but incurable. There is more than a 15-year track record of success.
RIT is a therapy that many believe should be given to some patients with follicular lymphoma as a front-line treatment, in addition to patients who have failed other treatments. In many cases, RIT may improve the outcome, reduce the side-effects, and be much more cost effective. Could RIT work for aggressive lymphomas or other cancers? It might, but we may never know of all the effective uses for RIT or derive its full benefits. RIT remains grossly under-prescribed even for patients with follicular lymphomas where its use is plainly indicated. There are several reasons why this effective treatment is underused that have nothing to do with patient well-being.
CMS Reimbursement Rule: Topping the list of patient barriers to access to RIT is our government. Centers for Medicare and Medicaid Services (CMS) – through its wrong-headed reimbursement policy – nearly forced the treatment off the market in 2007/2008. Many of us engaged with CMS and later Congress to keep the treatment alive. Some headway was made, but CMS reimbursement still limits patient access and threatens the viability of this treatment at least with respect to one of the two formulations of RIT.
Bexxar is a singular therapeutic regimen that consists of four specific components. Indeed, that is precisely how it has been approved by the FDA and that is how it has been administered in clinical practice. Yet, CMS – in its proposed 2012 CMS-1525-P Rule – classifies only one of the four components of Bexxar as “therapeutic,” while classifying two of the components as “diagnostic” and the other as “supply.” The significance is that the classification of three of the four components as being non-therapeutic results in a decrease in the amount of reimbursement to the point that hospitals lose a significant amount of money on each treatment they administer.
There are several problems with the CMS proposed reimbursement rule. Fundamentally, the proposed rule denies patients with access to a life-saving treatment. Even with the large federal debt and the raging spending debate, a life-saving cancer treatment should take priority over other items on which the government fritters away money. The proposed rule directly limits access to patients on Medicare and Medicaid. The impact is much broader, however, because insurers often base their determinations upon Medicare and Medicaid reimbursement. Also, anti-discrimination rules limit hospitals from providing access to private patients that are not available to Medicare patients. Simply stated, the proposed rule fails the humanity test.
Additionally, the proposed rule is inconsistent with the manner in which the treatment was approved by another agency of the government (the FDA) and inconsistent with the reality that the treatment is singularly a therapy. RIT diagnosis nothing and it supplies nothing. Only through the blurry vision of regulators can the components of RIT be seen as diagnostic or supply. The CMS proposed rule is a fiction that fails the reality test.
This leaves containment of health care costs as the only potential justification for the proposed rule. However, RIT has proven to be a cost-effective treatment. Moreover, it is administered in two doses a week apart and targets the cancer cells. Thus, the side-effects and collateral damage to the patient often is much less than chemotherapies and other treatments which are harsher and more prolonged. When one considers the savings of costs during remission, the reduction of costs associated with more extended treatments, and the reduction of costs associated with treating the side-effects of other treatments, it becomes clear that increased reimbursement and access to RIT for patients in which the therapy is indicated actually saves taxpayers considerable money. http://www.lymphomation.org/cms-rep.pdf; http://bloodjournal.hematologylibrary.org/content/117/1/45.full.pdf+htmlhttp://bloodjournal.hematologylibrary.org/content/117/1/45.full; http://theoncologist.alphamedpress.org/content/13/6/655.full.
If CMS did the math properly, it would understand that its proposed rule increases health care costs at the same time it harms patients. Giving the American health care consumer less benefit for a higher cost is unacceptable at any time, much less in a time of budget scrutiny. The proposed rule fails the cost test.
Fortunately, the fix is simple: properly classify the treatment for reimbursement purposes. Of course, such an easy fix will not be made unless the CMS is inundated with a flurry of missives and comments from concerned citizens.
Under-Prescribed By Doctors: Although the main barrier to access to RIT is CMS reimbursement, there are other limitations. Believe it or not, some doctors are not prescribing RIT in many instances in which it is indicated. Sometimes, it is lack of knowledge about the treatment. But in other instances, it is about money. Because of the radioactive element, many facilities are not trained or licensed to administer the treatment. Rather than losing a patient (and dollars) to a major medical institution, some misguided doctors do not recommend the treatment or even discourage patients from receiving the treatment at least until the doctor is on the verge of losing the patient to death.
Education of physicians and pressure from advocates and patients would go along way in overcoming this barrier. Lack of awareness and accurate information on the part of patients must be overcome with public awareness, education, and accurate information so that patents make informed decisions about their treatment options. For example, many patients are told that using RIT will limit future options such as a stem cell transplant down the road, but that usually is not the case.
What Can You Do? Lymphoma patient advocates have been left largely on their own to fight the battle. A petition is being circulated and will be sent to CMS Director Dr. Donald Berwick and others demanding the changes necessary to reimburse RIT and to remove the CMS barrier to patient access. You can have meaningful input with just a minute or two or your time by signing the petition. You also can contact CMS directly or submit public comments. The comment period ends on August 30, 2011. Take a couple of few minutes and help keep this important treatment option accessible to patients.
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