We Must Incorporate Value into Our Decision-Making Process

John L. Marshall, MD

November 2012, Vol 3, No 8 - VBCC Perspectives

?We should all read with great interest the New York Times opinion piece by Peter B. Bach, MD, and colleagues from Memorial Sloan-Kettering Cancer Center on their rationale for not including ziv-aflibercept (Zaltrap) in its formulary for patients with metastatic or advanced colorectal cancer.

Their argument is simple, they said: This new drug provides no additional benefit over existing medicines for the same type of cancer, yet it is significantly more expensive and has a higher toxicity profile. As the au­thors note, anyone reviewing these facts would come to the conclusion that this medicine does not carry the necessary value to support the higher cost.

This development was inevitable. Just as the tide rises, we have seen several new therapies that yield modest improvements in outcome but that also come with an ever-increasing price tag. Examples include sipuleucel-T (Provenge), a nearly $100,000 per year prostate cancer immunotherapy that adds 4 months of survival, and, now ziv-aflibercept, an anti–vascular endothelial growth factor therapy that offers a benefit similar to the existing therapy bevacizumab (Avastin), but with higher toxicity and a significantly higher price tag.

As we recognize that we can no longer simply expand the amount of money we are spending on healthcare, we increasingly have to make value-based clinical decisions.

Although we are throwing stones at recent therapy pricing decisions, it is important to remember Susan Desmond-Hellman, MD, MPH, former president of product development at Genentech, defending the price of bevacizumab, by stating that it was “what the market would bear.”

As long as there are third-party payers and providers, and as long as patients do not directly feel the impact of the cost of their therapies, we will continue to see ever-escalating drug costs. It may be that at this point, with the multiple external pressures being applied to the healthcare system, that the market will no longer bear high-priced medicines that bring little additional value to our patients and to patient care.

Our group at Georgetown’s Otto J. Ruesch Center for the Cure of Gastro­intestinal Cancers has been working in collaboration with other centers to develop a value metric for drug approvals for this very circumstance. One could envision that drugs such as ziv-aflibercept would be useful in the treatment of certain patients with metastatic colorectal cancer, but not at double the price of its competitor.

If we were to apply a value metric for drug approval that links payers and the approval process, as is suggested by Bach and colleagues, this drug would not have gained US Food and Drug Administration approval, especially not at that price. However, the manufacturers could have made a decision to lower the price and enter the market as a less-expensive option, which would, in my opinion, have been a more appropriate strategy, and one that may be forced on Zaltrap and its makers in the future.

We clearly need a collaboration of payers, patients, employers, and pro­viders to ensure transparency in healthcare. I am reminded of the book The Cost of Hope by Amanda Bennett, which is an outstanding review of a single patient’s course through cancer therapy. Ms Bennett reviews her husband’s treatments and emotional well-being through his battle with cancer, as well as the consumption of healthcare through the process. In one of the more striking examples, her husband underwent 76 separate computed tomography scans in the course of his care.

As we “pick on” our drugs as a high-cost item, we must also remember that we consume a great deal of resources as cancer care providers. As such, we need to look at our entire process, and assess it for the value it brings—not only to judge new ap­proaches but also to evaluate our existing approaches, removing the ones that are not helping our patients’ outcomes or quality of life.

In a way, we owe something to Zaltrap and its high price. I believe that this will be a turning point in cancer drug development, and that the pendulum will begin to swing back toward value. My concern is that the pharmaceutical industry will decide that the return on investment is not sufficient to support cancer drug development, particularly as we in­creasingly personalize our approach to therapy, which shrinks the overall drug market.

We are at a critical time; we must incorporate value into our decision-making. We must alter our drug approval process to enable rapid, efficient drug development in the era of personalized medicine. We must connect our payers, patients, employers, and providers so that the medicines of tomorrow will be measured by value and will be incorporated into daily practice based on safety and efficacy, as well as on their impact and magnitude of benefit for individual patients.