Zosia Chustecka

June 01, 2015

CHICAGO — One of the new immunotherapies would cost more than $1 million per patient per year at the higher dose currently being studied in many different cancer types, an expert has warned.

"This is unsustainable.... We must acknowledge that there must be some upper limit to how much we can, as a society, afford to pay to treat each patient with cancer," said Leonard Saltz, MD, from Memorial Sloan Kettering Cancer Center, New York City.

Dr Saltz was speaking at an extra session entitled Perspective on Value conducted at the end of the plenary session here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. He has been vocal in the past about the high cost of cancer therapies, and he even managed to get one company to lower its price when his center's team refused to use it.

In his talk, Dr Saltz focused on a plenary presentation that showed dramatic results for the combination of two immuotherapies together, ipilimumab (Yervoy, Bristol-Myers Squibb Company) and nivolumab (Opdivo, Bristol-Myers Squibb Company) in metastatic melanoma. The results "are truly, truly remarkable for a disease that 5 years ago we thought that was basically untreatable," he said.

"As a researcher, I am deeply gratified to see how basic research has been elegantly translated to useful drugs that are benefiting patients today, and as a clinician, I want to have these drugs and others like them available for my patients," he said. "But as someone who worries about making cancer care available to everyone and minimizing disparities, I have a major problem with this ― these drugs cost too much."

 
These drugs cost too much. Dr Leonard Saltz
 

Dr Saltz discussed the difference between value and benefit and that in assessing the value of any therapy, downsides such as toxicity have to be taken into account, as does the cost of the drug.

Nivolumab costs $28.78 per mg of drug, whereas ipilimumab costs $157.46 per mg.

"To put that into perspective, that's approximately 4000 times the cost of gold," he commented.

Cost of Immunotherapy Combo

Next, Dr Saltz calculated the cost of the combination of these two melanoma drugs for an average-size American patient; and here he digressed to note that with the current obesity epidemic, the average-size American now weighs 80 kg.

In the latest trial, the cost of using ipilimumab alone was $158,282 (for a median progress-free survival [PFS] of 2.9 months), the cost of nivolumab alone was $103,220 (for a PFS of 6.9 months), and the cost of the combination was $295,566 (PFS of 11.4 months, nearly four times that seen with ipilimumab alone, which is currently the standard of care). These results are predicted to lead to a sea change in the treatment of melanoma.

But how will patients afford these new therapies?

Patients on Medicare have a 20% co-pay, so for this combination of immunotherapies costing nearly $300,000, they would have pay $60,000 out of their own pocket for this treatment.

Expanding to Other Cancer Types

So far, the new immunotherapies are approved for use only in melanoma and lung cancer, but they are showing promise in many other cancer types, and experts believe that they will soon form the backbone of all cancer therapy.

Dr Saltz led the audience through a "thought experiment" that looked at a possible future scenario that could result from this research.

In the United States, there are 589,430 cancer deaths each year, and cancer deaths are ultimately due to metastatic disease, Dr Saltz commented. If all of these patients were to receive the immunotherapy combination (589,430 x $295,566), that would work out to more $174 billion per year, just for drugs to treat metastatic cancers for the first year only.

Dr Saltz discussed briefly the skyrocketing costs of new cancer drugs, which have already been reported extensively on Medscape Medical News, and he concluded, as have others, that "cancer drug prices are not related to the value of the drug" but that "rather, prices are based on what the market has come to bear and what the seller believes that the market will bear."

He then gave the alarming example of a drug that would cost more than $1 million.

The latest immunotherapy, pembrolizumab (Keytruda, Merck Sharp & Dohme Corp), was approved at the end of 2014 for use at a dose of 2 mg/kg for the treatment of melanoma. For this, it costs around $14,500 per month.

But a much higher dose of 10 mg/kg, pembrolizumab is now being used in clinical trials (featured in five abstracts presented at the ASCO meeting), and this higher dose works out to be $83,000 per month.

In calculating what the expense would be for a year, Dr Saltz dropped the weight of the hypothetical patient to 75 kg; for such a patient, pembrolizumab at the higher dose of 10 mg/kg (26 doses per year at $51.79 per mg) would cost $1,009,944 per patient per year.

"That is over $1 million per patient per year," he emphasized.

"This is unsustainable," he declared, and added the dictionary definition of the word: "not able to be maintained or supported in the future, especially without causing damage or depletion of resource."

Patients cannot afford these therapies. They cannot afford the co-pays, and, increasingly, they are not able to afford medical insurance.

"This year, the premium for a family insurance plan plus out-of-pocket healthcare costs will equal approximately half the average US household income," he noted.

"If we carry this to its illogical extreme, by 2028, 100% of household income would be needed to cover insurance premiums plus out-of-pocket costs."

Urgent discussion is needed on all this, he said, and "we must encourage (rather than suppress) discussion of value and cost in cancer care."

American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. Presented May 31, 2015.

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