July 2015, Special ASCO Edition

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Treating with Checkpoint Inhibitors—Figure $1 Million per Patient

Value-Based Cancer Care

Leonard Saltz, MD, Chief of Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center (MSKCC), New York City, wants the new checkpoint inhibitors to be available to his patients, but he questions how society will pay for them.

Offering his perspective on value during the plenary session presentation, Saltz estimated that widespread use of immunotherapy agents could cost this country $174 billion a year.

The CheckMate 067, which evaluated the programmed death-1 (PD-1) inhibitor nivolumab plus the cytotoxic T-lymphocyte antigen-4 inhibitor ipi­limumab in patients with advanced melanoma, was a testament to the benefit of checkpoint inhibitors. The immunotherapy doublet combination yielded a median progression-free survival of 11.5 months, compared with 6.9 months for nivolumab alone and 2.9 months for ipilimumab alone.

“A median progression-free survival of 11.5 months for combination immunotherapy is truly remarkable for a disease that 5 years ago was thought virtually untreatable,” Saltz remarked. “As a clinician, I want these drugs and others like them to be available for my patients. As one who worries about how we will make them available and minimize disparities, I have a major problem, and that is that these drugs cost too much.”

How much? “Approximately 4000 times the cost of gold,” according to Saltz. First-quarter 2015 prices show the average per-mg wholesale price to be $28.78 for nivolumab, $51.79 for pembrolizumab (the other anti–PD-1 agent), and $157.46 for ipilimumab.

He calculated that the treatment cost for a typical patient receiving the CheckMate 067 combination would be $295,566. The use of nivolumab alone would cost $103,220, while ipilimumab alone—which yielded a median duration of remission of less than 3 months—would cost $158,252.

Rounding this up to about $300,000 for an individual patient with a 20% copay, he also determined that the patient’s out-of-pocket cost would total $60,000.

Applying the total figure to the 589,430 patients dying of metastatic cancer each year, the treatment would cost society $173,881,850,000, Saltz projected.

“That’s $174 billion for drugs treating patients with metastatic disease—no adjuvant therapy—for 1 year only,” he emphasized.

Dosing and Scheduling Are Cost Drivers

Joining Saltz in commenting on the cost of the checkpoint inhibitors was Peter Bach, MD, also of MSKCC, who suggested, in a separate presentation, that lower doses of these agents may be as effective as higher doses and considerably less expensive.

He referred to the pivotal study of pembrolizumab versus ipilimumab in advanced melanoma (N Engl J Med. 2015;372:2521-2532), which employed pembrolizumab at 10 mg/kg every 2 or 3 weeks. The study’s authors indicated a “lack of a dose-response relationship, congruent with results” of the KEYNOTE-001 and KEYNOTE-002 trials of the drug, showing “administration of pembrolizumab at doses ranging from 2 mg/kg every 3 weeks to 10 mg/kg every 2 weeks did not affect outcomes.”

“The authors noted that a lower dose is equally effective….That sounds like equivalence,” Bach suggested.

But what is clearly not equivalent, he continued, is the cost of using these different schedules of pembrolizumab. He figured the monthly costs this way for an average-sized patient: $9000 for 2 mg/kg every 3 weeks, $46,000 for 10 mg/kg every 3 weeks, and $69,000 for 10 mg/kg every 2 weeks. Saltz’s calculation for the highest dose was actually higher at $83,500.

At this cost, for the highest, most frequently administered dose, a 75-kg melanoma patient receiving 26 courses of pembrolizumab would generate a treatment cost of $1,009,944.

“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,” Saltz said.

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