Drugmakers urged to tackle increasing cost of new cancer therapies

Speaking at the ASCO annual meeting, Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, questioned the cost of new cancer therapies, highlighting studies showing that recent price rises haven't corresponded to increases in the drugs' effectiveness. "These drugs cost too much," Saltz remarked, adding "the unsustainably high prices of cancer drugs is a big problem, and it's our problem."

Saltz focused on the cost of a regimen comprised of Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) and the CTLA-4 inhibitor Yervoy (ipilimumab), with data presented at ASCO showing that patients with advanced melanoma who received the combination lived for a median of 11.5 months without their disease getting worse, versus 6.9 months and 2.9 months, respectively, for the two drugs alone. Saltz noted that the benefit of the drug combination was "truly, truly remarkable for a disease that five years ago we thought was virtually untreatable." However, he said that combining the drugs would cost around $295 000 per patient over nearly one year, adding that at this price it would cost $174 billion to treat all suitable patients in the US for just one year.

According to Saltz, the cost of new cancer drugs in the US rose from $4716 in the period from 2000 through 2004 to around $9900 from 2010 through 2014, when measured using inflation-adjusted dollars. "Cancer-drug prices are not related to the value of the drug," Saltz commented, adding "prices are based on what has come before and what the seller believes the market will bear." Saltz called on industry, physicians and insurers to work together with the government to address the issue.

Opdivo and Yervoy are authorised individually to treat melanoma in the US, with the FDA set to make a decision on approval of the combination by September 30. In response to Saltz's comments, a spokeswoman for Bristol-Myers Squibb said the company couldn't comment on a potential price for the combination. She noted that Yervoy has a cost of $131 213 per patient for a full course of treatment, while Opdivo costs about $150 000 annually per patient.

Other companies developing similar combination treatments have said that they may explore alternative pricing models, with AstraZeneca CEO Pascal Soriot suggesting that the drugmaker will discount the cost of its regimens if they come to market. Meanwhile, companies are also looking at ways to identify patients that will respond to the treatments, avoiding using them in subjects that won't respond.

"Payers around the world and in the US – they're very interested in making sure they're only going to treat patients who have the potential to benefit," commented Daniel O'Day, chief operating officer for Roche's pharmaceutical unit. Roche and AstraZeneca are collaborating with Ventana Medical Systems to develop tests that identify patients with high levels of the protein PD-L1, which predicts the best response to Opdivo and similar drugs, while Bristol-Myers Squibb and Merck & Co. are collaborating with Agilent Technologies' Dako unit on assays.

Bloomberg Intelligence analyst Asthika Goonewardene said that while PD-L1 has flaws as a measure of drugs' effectiveness, "it's the only real one out there right now." Goonewardene noted that the tests are a useful tool for companies seeking to show doctors why they should use one treatment over another. "Roche and Merck will be cramming this down doctors' throats using it as a tool to differentiate their drugs" from Opdivo, Goonewardene added.

Briggs Morrison, chief medical officer at AstraZeneca, said "it's clear [the company's test is] going to be able to identify people who have huge benefits, and people who have small benefits." However, he said drugmakers "are definitely not there yet" in developing a standard test that all patients can use. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, noted that the lack of a standard test "is one of the big problems" in the immuno-oncology field. Pazdur said that the agency is trying to persuade companies to work together on tests, although it has no authority to force them to.

For related analysis, see ViewPoints: Express Scripts wants to extend pay-for-performance model to cancer drugs in the US – but devil may be in details.

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