Erlotinib for Advanced NSCLC is "Marginally" Cost Effective

Fran Lowry

February 25, 2010

February 25, 2010 — Adding the tyrosine kinase inhibitor erlotinib to the treatment of patients with advanced nonsmall-cell lung cancer (NSCLC) costs roughly CDN$95,000 for each year of life gained, according to an economic analysis by Canadian researchers.

At that price, erlotinib is "marginally" cost effective, they report in a new study published online February 16 in the Journal of the National Cancer Institute.

"The cost of erlotinib is within the reasonable range," said lead author Natasha B. Leighl, MD, from the National Cancer Institute of Canada (NCIC) Clinical Trials Group Working Group on Economic Analysis and a medical oncologist at the Princess Margaret Hospital in Toronto, Ontario. "In this era of new targeted drugs for cancer, it's not extremely expensive. In fact, it's probably less expensive than most, but it's also not highly cost-effective, so it's not cheap either."

Erlotinib has been the standard treatment for patients with advanced NSCLC in the United States and Canada ever since the results of the NCIC Clinical Trials Group BR.21 trial showed a modest improvement in overall survival (2 months) and a better quality of life when the drug was added to regular supportive care in patients who had failed all of their previous chemotherapy options.

Unlike in the United States, the Canadian government determines the cost-effectiveness of their therapies, she told Medscape Oncology.

We hope that our attempt to quantify the cost/benefit of erlotinib will be translated to other healthcare systems.

"When we look at a potential new treatment, we always review its cost and the potential impact on our public healthcare system. Most important are the results. Does this drug help patients? Does it improve survival, quality of life? The cost data are not meant to detract from this at all, but we need to know what it really costs to treat people," said Dr. Leighl.

Dr. Leighl said she hopes that the information generated by this economic analysis will provide additional data to guide review of the drug in other countries.

"We hope that our attempt to quantify the cost/benefit of erlotinib will be translated to other healthcare systems," she explained.

Better Value in Never Smokers and in Patients With High EGFR Counts

The BR.21 trial randomized 488 patients to erlotinib and 243 patients to placebo, or regular supportive care.

Dr. Leighl and her team analyzed the data from all 731 patients in the BR.21 trial, which included information about hospitalization, treatment, testing, blood transfusions, and all of the other events patients experienced as part of that randomized clinical trial. All patients were followed until they died.

The investigators determined that the specific cost of erlotinib treatment was $94,638 (in 2007 Canadian dollars) per life-year gained (95% confidence interval [CI], $59,359 to $429,148).

They also found that erlotinib was more cost-effective in never smokers, costing $39,487 per life-year gained (95% CI, $29,963 to $68,081), and in patients who had a high epidermal growth-factor receptor (EGFR) gene copy number, costing $33,353 per life-year gained (95% CI, $91,232 to $384,569).

The Sky's the Limit

Scott D. Ramsey, MD, professor in public health sciences at the Fred Hutchinson Cancer Research Center in Seattle, Washington, thinks it is high time that the United States took a page out of Canada's book and started to do cost-effectiveness studies.

In an editorial accompanying the cost-effectiveness study, Dr. Ramsey writes that "the unwillingness of public and private health systems and providers in the United States to consider costs in decisions about access to these products presents a clear signal to drug manufacturers."

Erlotinib is used widely in the United States; sales of the drug totaled $457 million in 2008, Dr. Ramsey noted. However, decisions to use the drug are not made explicitly on the basis of cost-effectiveness.

"We don't really have a method for using cost-effectiveness in this country, because we don't really have a system for making choices based on value," he told Medscape Oncology.

The United States is already starting to ration care on the basis of the price of the drugs, he continued.

"There are fourth and fifth tiers for coverage of cancer therapies that are based strictly on the price of the drug. Those tiers make patients pay very high out-of-pocket costs, sometimes 20%, 30%, 40% of the cost of the drug, which for some of these drugs can run into tens of thousands of dollars. If we are willing to move away from looking strictly at price and look instead at value, then we would want to make choices about access based on what gives us the most health benefit for expenditure."

Cost-effectiveness is a science that has been in existence for 50 years and has been adopted by almost every other country. The United States has been reluctant to look at cost in regard to decisions about treatment and is paying the price for that now, Dr. Ramsey said.

"We don't have price regulation in this country, and the prices are going to reflect what the manufacturers think providers and patients are willing to pay. Everyone is using the same strategy, but this is an untenable strategy in the long run," he said.

Spiraling costs for oncology drugs will affect everyone, not just the uninsured, Dr. Ramsey warned.

"The prices of oncology products are by far the fastest growth in any insurance plan. Even people who are not affected today are going to be affected as insurance companies try to figure out ways to control their costs. There are literally hundreds of drugs in the [US Food and Drug Administration] pipeline right now for cancer, and those drugs are going to come at price tags ranging from $5,000 to $20,000 per month."

The unsustainable high cost of cancer drugs was the subject of a 2009 feature story by Medscape Oncology.

This is the tool that the world has adopted, with the exception of the United States.

Cost-effectiveness studies represent one way to try to control these burgeoning costs. "Do we want people to have equal access to a $100,000 drug that adds 1 month of life, or to a $100,000 drug that adds 2 years to a person's life? Right now, we don't make any distinctions based on that criterion," Dr. Ramsey said. "We can ignore it, but insurance companies are going to have to deal with it somehow, and I think that making decisions purely on price is problematic in itself."

The Federal government has begun to realize that if they are going to have any control over what they spend, they will have to give people the most health benefits for the amount of money they can afford, suggests Dr. Ramsey.

"In other words, do cost-effectiveness studies," Dr. Ramsey said. "This is the tool that the world has adopted, with the exception of the United States. It's time we did, too."

Dr. Leighl and Dr. Ramsey have reported no relevant financial interests.

J Natl Cancer Inst. Published online February 16, 2010. Abstract

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