An articlesupported by nearly 120 leukemia specialists published today in Blood, the most cited peer-reviewed publication in the field of hematology published by the American Society of Hematology, increases in costs of treatments for chronic myeloid leukemia (CML) in the United States has reached unsustainably high levels and may be leaving many patients under- or untreated because they cannot afford care.

The articlepresents a well documented controversial opinions an provides a sounding board for what is important to the science and practice of hematology toady. Chronic myeloid leukemia was selected as the focus of this article because it is considered a highly curable disease due to the emergence of powerful, targeted CML therapies known as tyrosine kinase inhibitors (TKIs) that allow patients to manage their disease with few symptoms by taking well-tolerated oral drugs.

Declining mortality rates
Since the introduction of TKI therapy more than a decade ago, the annual mortality of patients with this disease has declined from 10% to 20% in the early 2000s to just 2% today and the estimated 10-year survival of CML patients has increased from 20% to more than 80%.

While in past decades patients with CML could only expect a grim prognosis after initial diagnosis,now they are enjoying close to normal life spans as long as they receive and adhere to prescribed treatments. The management of CML has become similar to that of chronic disorders such as diabetes and hypertension. However, the key in this success remains the availability of extremely expensive CML drugs.

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?Patients with CML have a much better outlook today than ever before, thanks to advances that have greatly improved survival rates. But these patients now face dire financial struggles as they try to maintain their treatment regimen with the drastically inflating cost of care. And this issue likely extends to patients with other types of cancer who require ongoing treatment to maintain therapeutic benefit,? said corresponding author Hagop Kantarjian, MD, chairman of the leukemia department at The University of Texas MD Anderson Cancer Center.

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The Cost of Cancer
In the article in Blood, Kantarjian and colleagues note that newly approved CML treatments in the U.S. are priced substantially higher than older options. They also note that this trend is consistent among other cancer types. For example, of the 12 drugs approved by the U.S. Food and Drug Administration (FDA) for various cancer indications in 2012, 11 were priced above $100,000 per year.[1] Monthly cancer drug prices today (more than $10,000 per month on average) have almost doubled from just a decade ago, when they averaged $5,000 per month.

The overall cost burden on families is significant, as out-of-pocket cancer care-related costs comprise approximately 25-30% of an average annual household budget. Cancer care-related costs contribute heavily to the unprecedented cost of health care in the U.S., now estimated at 18% of the U.S. Gross Domestic Product, compared with just 6-9% in much of Europe. [2] ?A major question we need to answer is how to determine the ?right? price for these drugs. In many cases, it makes sense to let the market govern the price; however, when a product is directly related to a patient?s survival over a period of years, it is critical to set a price that allows companies to profit and ensures that patients can afford their treatment,? Kantarjian said. ?Since CML treatments must be taken on an ongoing basis, we are concerned that the surging prices are potentially harming patients.?

Non-adherence
Research suggests that up to 10% of patients in the U.S. fail to take prescribed drugs, largely because of cost concerns.[3] And while U.S. CML survival rates have improved in the last decade, the estimated survival remains at roughly 60%, suggesting that a portion of the population is not receiving adequate treatment, which may be related in part to the high cost of these therapies. By comparison, in Sweden, where costs are managed and compliance rates are high, CML survival rates are at least 80%.[4]

However, commenting on the costs of cancer therapies in general and based on an earlier studies, Ramon Luengo-Fernandez, MSc, from the University of Oxford, UK, said that ?Cancer poses a considerable economic burden not only to healthcare systems but to other areas of the economy, including productivity losses through early mortality and time-off-work, and relatives who have to forego work/leisure to care for cancer patients.?[5]

Lowering prices?
?We believe that lowering the prices of CML drugs might improve accessibility to treatment and increase treatment adherence, effectively expanding the population of patients who live longer by continuing their TKI therapy,? Kantarjian noted.

A joint approach
Advancing a long-term solution for the high price of these cancer drugs requires the participation of and collaboration among many invested parties, including treating physicians, patients, advocacy groups, and pharmaceutical companies, as well as government entities, insurance companies, and pharmacies. Such collaborations also requires agreement from a cooperative group on how best to manage the research process to control treatment costs, how the community can balance those investments, and how newly approved products are priced in the market; similar to established processes in other countries around the world. ?Identifying better ways to manage the cost of cancer care will require an evolution in thinking about current pricing-related policies and regulations, including those that limit price negotiation for Medicare coverage of treatments, as well as patent-related laws that limit the introduction of more affordable generic drugs,? explained Kantarjian.

References:
[1] New Drug Approvals Hit 16-Year High In 2012. Chemical and Engineering News. 91 (5): 15-17. 2013. Last accessed May 2, 2013
[2 ]National Health Expenditure Projections 2011-2020. Last accessed October 20, 2012.
[3] The costly war on cancer-New cancer drugs are technically impressive. But must they cost so much?? The Economist: May 26 2011.
[4] Bjorkholm M, Ohm L, Eloranta S, et al. Success story of targeted therapy in chronic myeloid leukemia: a population-based study of patients diagnosed in Sweden from 1973-2008. J Clin Oncol: 29: 2514-2520. 2011. Last accessed May 2, 2013
[5] First Ever Estimate Reveals the Direct and Indirect Economic Burden of Cancer in Europe; Onco’Zine, 29 September 2012.Last accessed May 2, 2013.

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