ASCO Connection

July 2017

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strategy is useful for drugs that have similar clinical response rates, because a payer can obtain competitive bids and then give preference to the lowest-cost regimen. There have been so many drug discoveries in the past decade that many cancer types now have mul- tiple effective agents. Step therapy allows patients to obtain treatment at a lower cost. Prohibition of step therapy eliminates competition, raises costs, and hurts everyone except the pharma- ceutical manufacturer. A free market determines prices on the basis of merit, and mandates prevent free market actions. Removal of man- dates presents a win-win proposition for patients and payers. DR. SALTZ Oncologist Perspective KNOW THE PRICE Any one change that doctors could make would only be a first step toward the ultimate goal of provision of lower- cost, higher-value medicines for our patients. To me, that first step would be physician acceptance, practice, and promotion of transparency in price. In simple terms, that means knowing the prices of the drugs prescribed, considering those prices as one of the many factors in decision making, and discussing the prices of the prescribed drugs as openly as we discuss other risks, toxicities, and benefits. I make a sharp distinction here between the words price and value. A true, constructive consideration of the value of a particular medicine cannot realistically occur unless we know the amount of money that we are being asked to pay for it. That is the defini- tion of price, or cost, that I refer to for this discussion: the amount of money that will be paid for the drug. I am not, for this exercise, getting into who is paying for it, what other costs are or are not involved, what alternatives are available, or any other of a number of important, arguably relevant consid- erations, and I am not making a judg- ment about whether the price is too high, too low, or just right. I am simply saying that we must stop putting our heads in the sand and pretending that we do not need to know, think about, or talk freely about the price. Consider for a moment the inherent ambiguity in the word value. Value can be used as a noun or a verb. The way to define it in a constructive discussion aimed at definitions of high- and low- value care is as a noun; in that respect, the value of a drug would be defined by a ratio of objective positives and nega- tives of that drug, with price as one of the negatives. Note that price and value move in opposite directions. For any drug with a fixed degree of ben- efits and adverse effects, the higher the price, the lower the value, and the lower the price, the higher the value. So, we cannot begin to meaningfully determine the value until we know the price, just as we could not meaningfully determine value without knowing the other positive and negative aspects of the drug. Price is not the defining fac- tor in value, but it is one of the compo- nents without which the value cannot be defined. Too often, our consideration of price can be distracted by the shift of the discussion to value and its defini- tion as a verb; we value a response, a defined amount of extended life, or relief from a symptom. The verb defini- tion of value necessarily takes us into subjective, as opposed to objective, criteria, and the very nature of these resist correlation with a price. In fact, such a focus prevents delineation of value and distracts us from a meaning- ful and constructive discussion of what is high-value care and, just as impor- tant, what is not. The lung cancer therapy necitumumab is an excellent example of why man- dates force prices beyond reason. 7 This drug was added to cisplatin and gemcitabine and compared with cispla- tin and gemcitabine alone in patients with stage IV squamous cell lung cancer. Three percent of the patients who received necitumumab suffered a cardiac arrest. The difference in median progression-free survival was 0.2 months (5.7 vs. 5.5 months), but the overall survival favored the neci- tumumab group by 1.6 months (11.5 vs. 9.9 months). These results are so mea- ger that the National Comprehensive Cancer Network assigned a category-3 recommendation to the drug —an endorsement that most insurers, including Medicare, do not cover. How- ever, the mandates require coverage at any price, because the drug has an FDA approval. The manufacturer priced this drug at $11,430 per month. The competing regimen, cisplatin and gemcitabine, costs less than $1,000 per month. It is difficult to believe that anyone except the manufacturer would consider this to be a value, but it does not matter. The law mandates cover- age; therefore, price is not negotiable. Necitumumab is not an isolated exam- ple. Salas-Vega et al 8 reviewed 62 new cancer molecules approved between 2003 and 2013 in the United States and Europe. The review showed no evi- dence to suggest that 16 of those drugs (30%) increased overall survival com- pared with best alternative treatments. If manufacturers knew that these prod- ucts would not be reimbursed in the market, they would focus their atten- tion on different molecules that offer better results. Other mandates are emerging. Sev- eral states are now considering laws to prohibit step therapy for cancer. Step therapy requires treatment with a preferred regimen before the patient is eligible for a second therapy. This FEATURES l Current Controversies in Oncology 24 I 07.2017

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