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Sanofi discounts cancer drug by 50% after backlash

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Clear benefits must substantiate costs

In the past decade, advances in the treatment of metastatic colon cancer have improved survival. This advance has been slow and steady and has come as a result of innovative technology, unwavering researchers, brave patients, and funding from pharmaceutical companies and the National Cancer Institute. These advances do not come cheaply.

In 2004, the antiangiogenic agent bevacizumab (Avastin) was approved by the Food and Drug Administration for the treatment of metastatic colorectal cancer, with 5FU, leucovorin, and irinotecan as the first line of therapy. According to a commentary in the New England Journal of Medicine, the cost was estimated at $21,399 for an 8-week treatment course. Bevacizumab was responsible for more than 50% of that cost. The addition of bevacizumab to the standard chemotherapy improved the median overall survival from 15.6 months to 20.3 months.

Through a convoluted series of clinical trials – beyond the scope of this comment – the first line of therapy for the treatment of advanced colorectal cancer in the United States is 5FU, leucovorin, and oxaliplatin with bevacizumab. Second-line therapy is considered at the time of progression, signifying resistance to the first-line agents. What remained unclear is the role of further antiangiogenic therapy with the second-line chemotherapy agents.

Aflibercept (Zaltrap) was developed using a unique technology that "traps" multiple ligands of the vascular endothelial growth factor receptor, a possible improvement in bevacizumab. Rather than compare this agent directly with bevacizumab, a study was conducted in which 1,226 patients were randomized to standard second-line chemotherapy with or without aflibercept. The study showed that with the addition of aflibercept, the median overall survival from the start of second line therapy increased from 12.1 months to 13.5 months. Those patients that received bevacizumab with their first-line of therapy had a marginal benefit from 11.7 months to 12.5 months, while those that did not receive bevacizumab had a benefit from 12.4 months to 13.9 months with the addition of aflibercept.

In a similar study, 884 patients were randomized to receive standard second-line chemotherapy with or without continued bevacizumab. The median overall survival from the start of second-line therapy increased from 9.8 months to 11.2 months with the continuation of bevacizumab.



Dr. Mary Mulcahy

These studies show us that continuing antiangiogenic therapy with the second-line of chemotherapy may be beneficial. With two agents demonstrating comparable benefit with the second-line of chemotherapy, and with no evidence that one is better than another, cost is certainly an important consideration. With the time, money, and patients invested in new drug development, it is imperative that clear benefits are demonstrated at a cost that our overextended health care system can manage.

Mary F. Mulcahy, M.D., is an associate professor in the division of hematology/oncology at Northwestern University Feinberg School of Medicine, Chicago. She has no relevant disclosures.


 

The drugmaker Sanofi is cutting the price of its new colorectal cancer drug Zaltrap in half after physicians balked at the $11,000-a-month price tag.

Sanofi has not released official documentation detailing the specifics of the change, but in recent conversations with oncology experts, company officials laid out a plan to offer a 50% discount to anyone who purchases ziv-aflibercept (Zaltrap) from them on the wholesale market.

Dr. Leonard B. Saltz

The move follows a New York Times op-ed column in which Dr. Leonard B. Saltz, chief of the gastrointestinal oncology service at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, and two colleagues announced that they would not use Zaltrap because of its high price. He said in an interview that there are some lingering questions about the newly announced price reduction.

Discount vs. Price Reduction

For instance, he expressed concern that the 50% discount given to physicians and hospitals may not translate into a reduction in either Medicare reimbursement or copayments for patients, both of which are tied to the wholesale acquisition cost (WAC) of the drug.

Another problem with offering a discount without changing the official price of the drug is that this could inadvertently create a financial inducement for providers to choose that drug, Dr. Saltz said. If the providers are getting a 50% discount but are still being reimbursed at the full price, they would make a significant profit for using Zaltrap.

Dr. Saltz said he and his colleagues at Memorial Sloan-Kettering raised these issues with Sanofi officials but didn’t get an immediate response.

The Oncology Report contacted Sanofi about the Zaltrap price reduction, but company officials declined to comment.

‘A Good Thing for Patients’

Dr. Roy Beveridge, chief medical officer for the US Oncology Network, supported by McKesson Specialty Health, said in an interview that he’s confident that Sanofi made the price reduction in a way that will benefit patients and payers eventually. And he applauded the company’s unprecedented move to slash the price.

"It’s a good thing for patients," Dr. Beveridge said. "It’s a good thing for the system."

At the 1,000-plus physician US Oncology Network, oncologists consider efficacy, toxicity, and price when making determinations about which drugs are placed on its Level I Pathways. If something is more effective, it’s the first choice on the treatment pathway, Dr. Beveridge said. But if treatments are comparable in terms of efficacy and toxicity, then cost is a major consideration.

"We, as oncologists, recognize that increases of 15% per year are just not sustainable," he said.

With Sanofi’s decision to drop the price, Dr. Beveridge said he thinks more companies will be under pressure not to debut drugs with sky-high prices if they don’t offer significant new benefits.

"For those companies that have true innovative products and have something which is completely different and better, you’ll still see cost pressure going up," he said. "But for those that have results that are more comparable to other treatments, there’s going to be huge price pressure to be equal or lower than others."

Zaltrap Compared with Avastin

In October, Dr. Saltz, along with two other physicians at Memorial Sloan-Kettering, penned the op-ed in the New York Times saying that they had decided not to give Zaltrap to their patients because the drug did not provide greater efficacy than Genentech’s bevacizumab (Avastin), which sells for about $5,000 a month or less than half the cost of Zaltrap.

It was a relatively easy decision to make, said Dr. Saltz, who has been a paid consultant for Genentech and an unpaid consultant to Sanofi this year. They found no evidence that Zaltrap offered any benefit over Avastin, which they could get for about half the price. But Dr. Saltz said there needs to be more discussion in the United States about what to do in those more complicated cases where drugs offer fractionally more benefit at substantially increased prices.

There’s been a sense in the country that everything in health care is so important that it’s wrong to discuss costs, Dr. Saltz said, but that attitude has to change.

"We can’t afford that," he said. "It’s a fantasy and it’s untrue. We can’t just say that because we’re talking about health care, money is no object."

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