ASH Annual Meeting and Exposition
ASH Annual Meeting and Exposition
December 20, 2019
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Despite lower price of generic imatinib, overall costs for chronic myeloid leukemia remain high

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Gary H. Lyman, MD, MPH, FRCP, FASCO
Gary H. Lyman

ORLANDO — The price of generic imatinib has decreased substantially in the United States over the past 2 years, according to a speaker at ASH Annual Meeting and Exposition.

The decline comes after steep increases in the price of the branded drug, which transformed treatment of chronic myeloid leukemia, and several years of expensive generic options.

“What we found is that, in 2018 and the first part of 2019, the uptake of generic imatinib continued to increase and the drop in price has been quite substantial,” Gary H. Lyman, MD, MPH, FRCP, FASCO, senior lead for health care quality and policy of Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center and professor of medicine and medical oncology at University of Washington, told Healio. “The decrease is probably approaching 70% to 80%. It’s good news for patients with CML and the health care system, but it’s puzzling why drug prices in general — including the brand names — are still exorbitant in the U.S. while much cheaper in other countries. The difference is dramatic.”

However, the introduction of second- and third-generation tyrosine kinase inhibitors that could complement and sometimes replace brand-name imatinib (Gleevec, Novartis) has complicated the price issue because generic versions of these drugs are not available.

Lyman spoke with Healio about the decrease in the price of generic imatinib, the persistent high prices of second- and third-generation TKIs for patients with CML, and the future of cancer drug prices in the United States.

Question: What prompted you to conduct this analysis?

Answer: The generic version of imatinib has been out for about 3 years. The brand name, Gleevec, has been around for 20 years and has revolutionized treatment and survival of patients with CML. The patent expired in 2013 and the opportunity arose for generics to come on the market, but the price of generic imatinib was initially very high along with the introduction of second- and third-generation TKIs. Advocates for these TKIs said they should be used in addition to or instead of Gleevec in some situations. The problem is that they do not have generic versions.

Normally, generic drugs are developed to provide lower-priced competition and to rein in the ever-increasing cost of cancer care. Here, we have a more nuanced issue as the second- and third-generation drugs have their own patents and are being used instead of imatinib.

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The introduction of generics for Gleevec did not initially bring down the price of the drug. In fact, the price of Gleevec continued to go up. The year Gleevec launched, the price was $40,000 per year for the standard dosing schedule. When the patent expired in 2013, it was $80,000 per year.

By the time the generics came out, the price of Gleevec was close to $140,000 per year for a typical patient. It was even more disconcerting when these second- and third-generation drugs came in with their own patents.

What’s worse is that the generic versions of imatinib came in almost as expensive as Gleevec. Some publications a year or 2 into the generic experience did not show much of a decrease in price.

Q: What were the implications for patients with CML?

A: Drug adherence is the biggest indicator of how the patient will do in the future. If the patient stops taking the drug or interrupts the therapy because they can’t afford it, the chance of the disease returning increases proportionally.

More patients with CML are living longer, so the number of patients with this disease has grown every year. Prior to the introduction of imatinib, it was 20,000 people. It is estimated that there will be 180,000 people living with CML by 2050. A large proportion of these patients will remain on these drugs for many years or their entire lifespan.

We are in a vicious cycle in America where patients stop drugs or go into financial ruin just to keep taking their medicine. One of the arguments for these second- or third-generation drugs is that there is a chance the patients may be able to stop therapy after 5 or 6 years. Evidence has shown that the second- and third-generation drugs may do better at eradicating residual disease.

However, to date, the randomized trials have not shown a difference in PFS or OS between imatinib or the second- or third-generation drugs. So now there is debate about whether to start patients with these new drugs instead of waiting until they progress on imatinib. It would be simple, but these new drugs are expensive and have considerably more side effects than imatinib. Current guidelines state that you can go either way as long as you are closely monitoring the patient. The biggest issue is the cost. It’s an enormous problem even for patients even with insurance. The cost that employers or insurers have passed on to patients has gotten out of control.

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Q: Has the price of imatinib begun to go down?

A: Data over the last couple of years have shown the reduction of the price of generics has really begun to take hold. By my count, there are 11 companies producing generic imatinib that are approved by the FDA. Gleevec is still out there, but the generics have made major inroads as first-line therapy for CML. They were first approved in 2015, and the early experience was that they were just as expensive as Gleevec.

At the same time, the price in Canada for the patented drug was one-third or one-quarter of the price of the drug in the United States. The price of the generic was even lower. Finally, the price in the United States for the generic finally seems to be coming down and is more in line with the rest of the world.

Q: Is there anything else you would like to add?

A: This is a problem unique to the United States. Although expenditures for health care in the U.S. now surpass $11,000 per individual, life expectancy in the United States is far below that in most developed countries and, unlike all developed countries, has actually decreased over the last 3 consecutive years. At the same time, the average cost of a new cancer drug approved by the FDA is over $10,000 per month. Many of them are even more complicated than imatinib. In other countries, even the originator has a much lower price, and the generics are substantially less expensive than that. Clearly, allowing market forces to control cancer drug prices in the U.S. does not work for many reasons.

CMS is prohibited from negotiating drug prices with industry. That’s by congressional mandate, even though it’s done in other countries. Here, we have the “Wild West” in drug pricing, and companies see this as a cash cow.

We see similar trends with biosimilars. The initial results with biosimilar prices have not been as dramatic in terms of competitive pricing as we’ve seen in other countries. However, early indications are that these are beginning to fall, albeit with some delay.

I haven’t given up hope. Greater and greater competition should force prices down. Our data show that this is finally taking hold with imatinib and hopefully will continue as patents eventually expire on the next-generation agents as well. Although the exorbitant price of these agents in the U.S. is a challenge, access to these lifesaving drugs in the developing world also is an enormous challenge. We clearly need both national and global efforts to solve these critical issues for patients with cancer. – by John DeRosier

Reference:

Lyman GH. The US experience with generic imatinib in CML: Did cost predictions meet reality? Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2019; Orlando.

Disclosures: Lyman reports advisory/consultant roles with Agendia, Amgen, Genomic Health, Halozyme, Mylan, Partners Healthcare, Pfizer, Samsung Bioepis and Spectrum.

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