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Rules put in place to reduce patients' out-of-pocket costs and close the coverage gap for drugs in Medicare Part D were outpaced by the rising prices of branded anticancer medications, according to new research.

Expected out-of-pocket costs for a patient requiring a 12-month prescription rose from $8,794 in 2010 to $10,470 by 2019, reported Stacie Dusetzina, PhD, of Vanderbilt University School of Medicine in Nashville, Tennessee, and colleagues.

During this stretch, the Affordable Care Act attempted to reduced patients' coinsurance -- the so-called donut hole -- from 100% to 25% for oral drugs covered under Medicare Part D, but this was counterbalanced by the average price of filling a prescription increasing by 40.4%, as described in .

"The number of orally administered anticancer medications covered under Part D has increased since 2010, with mean monthly point-of-sale prices for anticancer drugs reaching nearly $14,000 in 2018," the authors wrote. "Anticancer drug prices have increased beyond inflation between 2010 and 2018, resulting in higher out-of-pocket spending for patients despite the Part D coverage gap closing."

At the start of the study, 13 branded oncologic drugs were covered by Medicare Part D -- this rose to 54 drugs by 2018. The average point-of-sale prices for filling a prescription increased from $7,438 in 2010 to $13,992 in 2018, by which point nearly all drugs (48 of 54) had monthly prices that exceeded $10,000 (21 had monthly prices over $15,000). On average, drug prices increased 5.8% per year.

The largest increase in average 1-month prescription cost was for gefitinib (Iressa) -- an EGFR inhibitor used to treat lung cancer -- which rose from $1,960 to $7,960 from 2010 to 2018 (306% increase).

Only drugs available at the start of the study period doubled in price:

• Sorafenib (Nexavar), 125% increase
• Everolimus (Afinitor), 107% increase
• Imatinib (Gleevec), 106% increase

The largest reduction was seen with generic imatinib, which dropped from $8,570 following its introduction in 2016 to $4,822 in 2018 (44% decrease). But for branded drugs, only two had price decreases during the study period -- a 3% reduction for vemurafenib (Zelboraf) and 1% reduction for ponatinib (Iclusig).

Dusetzina's group explained that efforts to close the coverage gap are unlikely to help cancer patients needing oral therapies.

"Because beneficiaries pay a percentage of the drug's price and have no out-of-pocket spending limits on Part D, even large price decreases may not provide sufficient financial relief to patients requiring long-term anticancer drug use," they concluded. "Efforts to reduce drug prices and limit beneficiary out-of-pocket spending are needed to improve access to high-cost drugs."

To come up with point-of-sale drug prices, the researchers examined Medicare formulary and pricing files from 2010 to 2018. For all the drugs studied, nearly all Part D plans required coinsurance (98%). Prices were adjusted for inflation using the Consumer Price Index.

Limitations noted by the authors included the fact that rebates and discounts were not factored into drug prices, though they said that cancer medications covered under Part D are less likely to have rebates due to a lack of head-to-head rivals. They also said that findings may not be generalizable, as drugs for cancer are considered a protected class under Medicare Part D.