Logistic Toxicity: Obstacles to the Efficient Delivery of Cancer Care
The Merriam-Webster dictionary defines “logistics” as the things that must be done to plan and organize a complicated activity that involves many people. The modern delivery of cancer care precisely parallels this definition.
“Bilateral mastectomy?” I repeat incredulously. “Yes. My surgeon told me radiation would be best for me, but I can’t do that.” She is a vigorous woman aged 68 years who recently had a 1.6-cm receptor-positive breast cancer excised, but the tumor was anatomically unsuitable for the short-course radiation (MammoSite) we had planned to give her. Standard radiation would involve 6 weeks of Monday through Friday visits to the outpatient radiation department. She continues, “We live in Cayuga, Texas, and it is an hour and a half each way to either Dallas or Waco. My husband has had a stroke, and I just can’t leave him alone for 3 or 4 hours a day. The surgeon says my breasts are so large that removing 1 would leave me lopsided, so we are going to remove them both.”
Although her rural stoicism is endearing, the need to amputate both her breasts because of a small cancer is a frustrating example of what I call “logistic toxicity.” In 2014, diagnosing and treating cancer is unavoidably complicated, involving innumerable people, but with all the technology and healthcare delivery sophistication, why does it seem that it continues to get harder, not easier, to deliver routine cancer care? Why do the logistics of payment assistance programs, drug shortages, and clinical trial execution make it almost impossible to practice medicine as one would wish?
The exploding revolution in the development of new oral oncolytics may soon free many patients with cancer from frequent visits to outpatient cancer centers for prolonged infusions, allowing patients and their caregivers more freedom to go to work or stay at home, although those same oral medications, with their $10,000 monthly price tag, bring their own challenges (see my “financial toxicity” article in the September issue).
To potentially overcome the daunting coinsurance burdens these costly new oral cancer medications bear, most pharmaceutical and biotechnology companies have financial assistance programs to help patients with the large cost burdens that their medical insurance plans do not cover. Many of these programs are surprisingly generous, but every company has its own forms, requiring different financial metrics and demographic details that elderly, ill, and not so well-educated patients often need help with how to fill them out properly. Our financial counselors frequently provide this needed assistance, but even they find the variation and complexity of the forms daunting and are often unsuccessful in obtaining the requested funding. Several follow-up phone calls and significant delays are usual before patients can be enrolled in these programs, and many companies candidly acknowledge that less than 25% of eligible patients ever receive the financial aid to which they are entitled. In other words, logistic toxicity frustrates everyone in this circle.
Shortages of generic oncology drugs are caused by a special brand of logistic toxicity—governmental price controls. The Medicare Modernization Act of 2003 was intended to reduce excess profitability of the “buy-and-bill” model of Medicare Part B oncology drug delivery by applying the well-known Medicare average sales price (ASP) + 6% formula to them. Although drug spending has indeed been moderated by this legislation, as market competition has ground the price of generic oncology drugs down to a few dollars per dose, the 6% margin can no longer absorb any substantial price increases to adapt to inevitable changes in supply and demand. Whether it is the availability of beef in the former Soviet Union or the availability of life-saving generic oncology drugs in the United States, the cause of the shortages is always the same—government price controls.
Anyone who enrolls patients in clinical trials in 2014 can certainly understand the term “logistic toxicity” in reference to our current regulatory burden. In their elegant editorial on this topic recently published in the Journal of Clinical Oncology, Steensma and Kantarjian describe the cancer-like growth of 25 years of bureaucratically generated regulations that have been implemented without any testing or proof that safety is enhanced.1
For-profit commercial contract research organizations now harry researchers through a process riddled with ridiculous queries and clinically insignificant detail. Trials that could be written up, approved by an Institutional Review Board in a few months, and executed at a cost of less than $5000 per patient in the early 1990s now take more than 2 years to begin enrolling patients and cost more than $100,000 per patient to complete. No data that safety is enhanced by this increase in logistic toxicity have ever been provided or sought, but there is no doubt that drug development has been made much more costly and patient access to potentially lifesaving new drugs has been delayed or prevented (ie, they die before having access to a game-changing drug such as ibrutinib in chronic lymphocytic leukemia).
Everyone could probably conjure a different example of logistic toxicity in oncology; for example, why isn’t one aspect of “meaningful use” to ensure that electronic health record (EHR) systems are able to communicate with one another? Unlike de Tocqueville,2 I do not believe that we are inevitably destined to have our innovations and energies compressed by a web of complexity and regulation. I think we need to forcefully advocate for solutions to these problems for ourselves and for our patients. Possible solutions include:
- My patient with the small breast cancer could have been managed with intraoperative radiation. The technology is available and has been shown to have acceptable comparability to standard approaches. Although it is possible there is a modest increased chance of local recurrence with the novel approach, subsequent mastectomy will still be curable in the vast majority of such patients. Why does better have to be the enemy of good?
- Financial aid for expensive oral oncolytics could be simplified by all pharmaceutical and biotechnology companies using the same standard form, as is done for college admissions, requesting the minimal required data. Just as some colleges ask for an additional essay, companies could still ask for 1 or 2 unique items as an addendum to the basic form. Financial counselors would become facile with this uniform approach, and more patients would get the financial assistance they need to pay for these critical medications
- We could pay for generic drugs by one of the several successful formulas used in European countries or we could pay ASP + 50% for mature generic oncology drugs. This latter approach would provide a strong economic incentive for companies to continue manufacturing the drugs and would provide a similar incentive for oncologists to prescribe these lower-cost drugs in lieu of more costly branded agents
- Clinical trials should be standardized, streamlined, and automated with the help of experienced clinical researchers and modern computer technology to staunch the avalanche of paper and irrelevant minutiae that are smothering clinical trial execution (and hopefully rid us of the parasitic contract research organizations at the same time). Only things that are needed to ensure patient safety and identify meaningful efficacy and toxicity would be included in the protocols
- One last thing…EHR systems should talk to each other.
- Steensma DP, Kantarjian HM. Impact of cancer research bureaucracy on innovation, costs, and patient care. J Clin Oncol. 2014;32:376-378.
- de Tocqueville A. “Soft Despotism.” In: Democracy in America. Vol II. Book 4;1840.