Why Pharma and Oncologists Should Kiss and Make Up

Financial Toxicity: No Easy Answer

Entering the exam room during a recent consultation, I encountered a patient who was tearful, angry, and anxious. Although it's commonplace for a medical oncologist to encounter this combination of emotions during patient encounters, the circumstances of her distress were atypical. This patient was well, cancer-wise. The previous year, she had been diagnosed with a low-stage, node-negative, anal squamous cell carcinoma. She was treated for this highly curable cancer with a standard combination of radiation and chemotherapy. She completed all treatment without issue and had a complete resolution of her treatment-related toxicities.

She is, by all of our assessments, cured of her cancer. She realizes that, in all likelihood, she will remain disease-free. But the ongoing financial debt of her treatment has overwhelmed her. Upon entering the room, her disposition was that of someone with an advanced malignancy rapidly approaching a terminal outcome.

Admittedly, I was caught off guard. In fact, in a clinic day full of palliative chemotherapy discussions and scan reviews, this was supposed to have been an "easy one." Once I understood the problem, I found myself ill equipped to help her. She had already availed herself to the case management team, which frankly was the only resource I knew to be at my disposal. She also had arranged a payment plan so that she can meet her debt over time without incurring any credit penalties. Yet, in order to maintain this payment status, she will need to delay her retirement by several years.

She is, by all of our assessments, cured of her cancer... But the ongoing financial debt of her treatment has overwhelmedher.

Even in spite of these burdens, my patient is relatively fortunate, financially speaking. All of her treatments consist of standard, off-patent interventions, and as they are complete, her bills, relatively expensive though they may be for her, will not amass further. Considering that this is the potential financial impact of one of the most straightforward, inexpensive treatment courses available to a cancer patient, one shudders to imagine how the significantly higher costs of newer therapies or therapies administered in an ongoing manner affect other cancer patients. Cost becoming the limiting factor to patients receiving cancer treatment is all too real a threat.

But a Cure at Any Cost?

At this year's American Society of Clinical Oncology (ASCO) meeting, the cost of care received an unusual and important spotlight when, during the plenary session, Dr Leonard Saltz was able to devote a podium presentation to the value of cancer care, calling attention to the high and rising cost of treatments.^[1]

At that same plenary, Dr Jedd Wolchok presented exciting phase 3 data on the value of combination ipilimumab and nivolumab in the management of advanced melanoma.^[2] Immunotherapy has become perhaps the most talked about and important recent therapeutic development in cancer medicine, and the encouraging survival data in what was only recently a disease with a dismal prognosis certainly met this expectation.

When Dr Saltz addressed the cost issue, he addressed the ipilimumab/nivolumab data specifically, stating that if similar costs were necessary to treat every American cancer patient for 1 year, the bill would reach a stunning $174 billion annually.

The big results presented at the annual meeting do typically generate press coverage, and this year has been no exception. Some coverage has been offered to Dr Saltz's dissertation on costs.^[3] Much more coverage has addressed the immunotherapy results. For example, the British news magazine The Economist, which reports news in terms of world finance, devoted a two-page story to the immunotherapy prospects, with only a short mention of any consideration of cost tacked on as an afterthought in the last paragraph.^[4] If there is any doubt about what aspects from this year's meeting have generated buzz, one need only come to the oncology clinics. I am certain that I am not alone when I report that most of my patients have come to clinic with newspaper clippings or video clips about the immunotherapy advances, inquiring where this may fit in their care. Not one has brought up the cost issue. When I raise it, it is rapidly dismissed out of hand as an unnecessary consideration in this cancer fight.

Can Pharma and Oncologists Make the Marriage Work?

When issues of cost arise, it is easy to point the finger at Big Pharma. The argument is made that if pharmaceutical companies set the costs of drugs, they can also lower them. Obviously it is not so simple. If you view Dr Saltz's ASCO presentation, you will note that the page is sponsored by Celgene and Takeda. With this dependence, some might say that the pharmaceutical industry has become a necessary evil; I would assert that it is not an evil at all. The industry has succeeded in research where the government/grant system has clearly fallen short.

In an era when public funding for research is being reduced, there is certainly no way that we would have the advancements in such treatments as immunotherapy without the intelligence and the efficiency that the pharmaceutical industry brings to the table. It is not just that we need Pharma; we should welcome Pharma because Pharma gets the job done.

What is necessary, then, is a commitment from both sides to make the marriage work in the context of rising financial costs. As Dr Saltz illustrated, the long-term finances are not tenable. If the problem is not addressed from within, we only open ourselves to oversight from the outside, in the form of government regulation as well as scrutiny and disdain from the lay public.

Imagine if therapy cost became a routine outcome reported with the data.

Perhaps the first step is a greater transparency of costs. Honestly, I have a poor understanding of how much my patients are actually billed for the treatments that I prescribe. I know which treatments are generic and which remain on patent, but beyond that, my ability to describe costs rapidly becomes murky.

Imagine if therapy cost became a routine outcome reported with the data. In published studies, in addition to overall survival and response rate, the cost per dose could be routinely reported. Suddenly we have a new endpoint to discuss, immediately convertible into a ratio of survival time per dollar amount. Before starting any therapy, patients could be advised on the cost-per-month of their survival.

The implications of such reporting, I realize, will have limited value in the direct clinical setting. After all, no patient faced with impending death from cancer should be forced to decide whether the cost of his or her treatment is worth it. Without an intervention, however, such a decision will certainly become more commonplace and one that a greater transparency of costs could almost certainly avoid. This transparency would better inform practitioners in their treatment recommendations. Moreover, a transparency of costs would inform the lay public, who are not (or not yet) affected personally by cancer, in decisions about their personal health finances and their advocacy for the use of public funding.

This public identification of cancer costs can serve as a call to arms, but only if the dialogue continues. Clinicians need to have the costs of the treatments we are prescribing neatly handed to us, in ways that we can readily interpret and disseminate. The pharmaceutical industry, in turn, needs to be welcomed into this transparency as an invited partner, recognized for taking the great risk of exposure and acknowledged for their contributions to the developments made to care rather than as a scapegoat for the corresponding high costs of care. This is an almost insurmountable task, and it can only move forward with a uniform agreement by all involved.

ASCO leaders and pharmaceutical CEOs can certainly lead the way. Dr Julie Vose, the newly installed ASCO president, has already announced the launch of a framework to evaluate these values in a recent statement presented in the Journal of Clinical Oncology.^[5,6] But change will only occur if the public moves in a similar direction. Community practitioners and the liaison officers manning the pharmaceutical booths at the meetings need to be able to recognize and discuss without accusation the costs that come along with therapies. We owe it to our profession and to our patients to make this happen so that hope for a cure is not derailed by fiscal unsustainability.

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