List prices of self-administered multiple sclerosis (MS) drugs more than quadrupled in 11 years, and Medicare spending for Medicare Part D beneficiaries soared more than 10-fold during the same period, an analysis of claims data showed.
Self-administered MS disease-modifying therapy (DMT) prices rose from a mean of $18,660 to $75,847 a year from 2006 to 2016, reported Alvaro San-Juan-Rodriguez, PharmD, of the University of Pittsburgh, and co-authors in JAMA Neurology. Medicare spending on these drugs went from $7,794 to $79,411 per 1,000 Medicare beneficiaries during the same period.
"This study is the first to evaluate the impact of rising prices of multiple sclerosis drugs on Medicare Part D drug spending and patients' out-of-pocket spending," San-Juan-Rodriguez told MedPage Today. "Multiple sclerosis drugs have been well-known for presenting high price increases over the last years. Yet the impact of these high and rising drug prices on Medicare Part D spending and patients' out-of-pocket spending was unclear," he said.
"This study is an important contribution because it demonstrates to taxpayers and policymakers that rising prices of multiple sclerosis drugs have resulted in large increases in Medicare spending and patient out-of-pocket costs," he added.
Before 2009, only four self-administered DMTs were approved to treat MS: glatiramer acetate 20 mg (Copaxone), interferon beta-1a 30 µg (Avonex), interferon beta-1a 8.8/22/44 µg (Rebif), and interferon beta-1b (Betaseron). Since then, seven new branded agents have entered the market: interferon beta-1b (Extavia), fingolimod (Gilenya), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), glatiramer acetate 40 mg (Copaxone) and peginterferon beta-1a (Plegridy), and generic glatiramer acetate 20 mg (Glatopa).
In this study, San-Juan-Rodriguez and colleagues looked at prices, market share, and spending on these self-administered DMTs, using a 5% random sample of Medicare Part D claims data.
From 2006 to 2016, the annual cost to the Medicare Part D program for DMTs rose from an estimated $396.6 million to $4.4 billion. Drug prices jumped from an average of $18,660 to $75,847, or 12.8% annually. Fingolimod and brand-name glatiramer 20 mg were at the higher end of the range of annual costs of treatment, and interferon beta-1b (Extavia) and generic glatiramer 20 mg were at the lower end.
While brand-name glatiramers accounted for most of the market, platform drugs (beta-interferons and glatiramer) experienced a market share drop over time in favor of newer therapies.
Out-of-pocket costs for Medicare Part D beneficiaries using self-administered DMTs also rose markedly: from $372 to $2,673 per 1,000 Medicare beneficiaries of all kinds during the 2006-2016 period. (San-Juan-Rodriguez and colleagues didn't report out-of-pocket costs per patient using the drug.)
Overall, DMT costs increased in parallel and "the entry of new products seems to only propel costs higher," observed Daniel Hartung, PharmD, MPH, and Dennis Bourdette, MD, both of the Oregon Health & Science University in Portland, in an accompanying editorial.
"The pharmaceutical and biotechnology industries claim that the high prices reflect the expense of research and development and need to incentivize continued innovation," they wrote. But "these claims do not explain the continuous rise in the three drugs originally approved for MS, interferon beta-1b (Betaseron), interferon beta-1a (Avonex), and glatiramer acetate (Copaxone)," they noted. "These drugs have long since recouped any cost of drug development, yet their prices have continued to rise."
These three drugs had modest increases in price until 2002, when another interferon beta-1a (Rebif) was introduced at a price approximately 30% higher, initiating "the ever-increasing prices of DMTs for MS," they pointed out.
San-Juan-Rodriguez and colleagues also noted that the proliferation of MS drug approvals "did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs." This pattern serves as a counterexample to arguments that competition leads to lower prices.
Neurologists should "look carefully at their relationships with pharmaceutical and biotechnology companies and call them to task for unreasonable increases in prices," Hartung and Bourdette wrote. "Remaining silent should not be an option."
"The development of DMT for MS has been one of the great achievements of neurology in the past 25 years," they continued. "Neurologists should not allow the unfettered increases in price for these drugs hurt the health care system or patients."
The analysis had several limitations, the researchers noted. It included only self-administered DMTs for MS and not those administered in physician offices, which are reimbursed under Medicare Part B. The results apply only to the Medicare Part D population, they added.
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