High Drug Costs Mean Patients With CML Delay Therapy

Kristin Jenkins

October 06, 2016

For some patients diagnosed with chronic myelogenous leukemia (CML), the costs associated with filling a prescription for a highly effective but expensive oral anticancer drug can delay treatment for months, say researchers.

About 30% of Medicare beneficiaries with CML did not initiate therapy with a tyrosine kinase inhibitor (TKI) within 6 months of diagnosis, study of Surveillance, Epidemiology, and End Results (SEER)–Medicare data shows.

Patients with a Medicare subsidy for prescriptions were 35% more likely to start TKI therapy promptly compared with beneficiaries who didn't have drug coverage, according to Stacie B. Dusetzina, PhD, assistant professor in the Eshelman School of Pharmacy and the Gillings School of Global Public Health at the University of North Carolina (UNC) at Chapel Hill, and colleagues.

The report was published October 3 in the Journal of Clinical Oncology.

"Our findings highlight important gaps in TKI use among Medicare beneficiaries with CML and suggest that high cost sharing may result in delays in initiation of these life-saving medications," the researchers say.

The median time to initiation of treatment after CML diagnosis was 58 days among patients who had a Medicare cost-sharing subsidy compared with 108 days for beneficiaries who didn't have the subsidy (P = .04), the study showed.

"This is very concerning as these delays may be an indicator that the patient is trying to find funds to pay for their first treatment," said Aaron N. Winn, the study's lead author and a PhD candidate at the Gillings School at UNC.

Current guidelines recommend that TKI therapy be initiated immediately after diagnosis of CML, which accounts for 20% of all leukemias seen in adults. The average age at diagnosis of this myeloproliferative disorder is 64 years.

TKIs, such as imatinib (Gleevec, Novartis), dasatinib (Sprycel, Bristol-Myers Squibb), and nilotinib (Tasigna, Novartis), have dramatically reduced mortality rates for patients with CML and contributed to life expectancy approaching that of the general population, the authors note. Results from a recent Swedish study show that thanks to TKI therapy, patients of all ages diagnosed in 2013 will lose less than 3 life-years (perfect health) as a result of CML.

On the other hand, low adherence can decrease response to treatment, the authors point out. Some patients may require stem cell transplantation, experience poor clinical outcomes, or have a shortened life expectancy.

Ask Patients About Financial Challenges

Physicians need to be aware of this treatment barrier and ask patients about any challenges they might face with filling a prescription or taking a medication as prescribed, Dr Dusetzina told Medscape Medical News. Often, she added, physicians don't know how much a patient has to pay for drug therapy.

"In some cases, physicians may be able to point patients to financial resources, such as foundations, assistance programs, or financial counselors, to help them navigate the insurance system or to prepare for potential high costs," she said.

In the United States, most adults 65 years of age and older qualify for the national health insurance program, which provides hospital coverage at no charge. Outpatient medical services and prescription drug benefits are not covered by Medicare Part D and must be purchased separately.

Medicare Part D beneficiaries without additional coverage are required to pay out-of-pocket expenses up to a 2016 catastrophic spending threshold of $4850. After this, a coinsurance fee of 5% of the monthly cost of the drug is charged for each prescription refill. Because a TKI costs approximately $11,000 per month, the copay is about $550.

In the first month of TKI therapy, out-of-pocket costs for Medicare beneficiaries without a subsidy can total nearly $3000, the researchers said. It is estimated that 40% of patients enrolled in Medicare qualify for a low-income subsidy because they have an annual income of less than $17,820 and assets below $13,640.

Study Details

For the study, the researchers looked at SEER-Medicare data from 2007 through 2011 for 393 patients aged 66 years or older with a diagnosis of Philadelphia chromosome–positive CML. All were continuously enrolled in Medicare inpatient and outpatient medical coverage for 1 year before diagnosis.

Mean age at diagnosis was 77 years, and more than 40% of the population was older than 80 years. About 40% received cost-sharing subsidies and 85% were white.

Patients who were younger, had lower comorbidity, or had a later year of diagnosis were more likely to fill their prescriptions promptly. Of those who did start treatment, 61% stuck with it at least 80% of the time during the first 6 months.

Patients 80 years or older were less likely to start therapy or adhere to it compared with patients aged 66 to 69 years. Previous studies have shown that about 50% of the elderly population in the United States has $13,800 or less in liquid assets and that this amount decreases with age, the researchers pointed out.

When data analysis was restricted to patients who lived for at least 180 days after diagnosis, the statistically significant difference disappeared between the two groups in terms of the probability of starting a TKI or sticking with therapy. This could indicate that with time, patients without subsidies find the financial resources to cover initial costs, Dr Dusetzina said.

Unadjusted data showed that 90 days after diagnosis, 48% of Medicare recipients without subsidies had started treatment compared with 63% of those with subsidies. At 6 months, the gap had closed almost completely: 64% of patients without subsidies had started TKI therapy compared with 65% of those with subsidies.

Because drug therapy costs are highest during the catastrophic phase of the health plan benefit, it has been proposed that Medicare Part D remove the 5% catastrophic phase coinsurance, Dr Dusetzina told Medscape Medical News in an interview. Alternatively, out-of-pocket spending on a single prescription could be limited to a fixed amount that is no higher than $250.

"We should work to make effective drugs more accessible to patients that need them," she said.

Generic imatinib may help reduce the financial burden for patients, but this shouldn't detract from concerns highlighted by the study results, the researchers said.

"Even in light of imatinib losing patent protection, we believe our general finding that high cost sharing may result in delays in initiation of these life-saving medications remains valid for this and other cancers for which orally administered drugs are recommended."

In fact, generic imatinib products in the United States are not much cheaper than the branded product (Gleevec), as recently reported by Medscape Medical News. The first-generic imatinib in the United States (from Sun Pharma) cost almost the same as the branded product (Gleevec), noted Hagop Kantarjian, MD, chairman of the leukemia department at The University of Texas MD Anderson Cancer Center in Houston.

"The current Red Book price of Gleevec is $146,000, and the Red Book price for Sun's generic is $140,000, so there really isn't much difference in price," he said. "So this is how pharma does things — Sun said the price would be 50% to 70% of Gleevec, but it turned out to be 90%."

Dr Kantarjian pointed out that many generic versions of this drug are already available — more than 18 worldwide, including 3 in Canada.

Generic imatinib costs $8000 per year in Canada and about $400 per year in India. "Unfortunately, the drug companies have the Americans 'squeezed' because they can and they are charging what they can," he emphasized.

The study authors have disclosed no outside sources of funding or relevant financial relationships. Dr Kantarjian has disclosed no relevant financial relationships.

J Clin Oncol. Published online October 3, 2016. Abstract

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