乌鸦传媒

Multiple sclerosis (MS) drug costs nearly tripled over 7 years, despite the introduction of a generic version of a common MS drug, an analysis of Medicaid data showed.

Medicaid spending on 15 MS disease-modifying therapies jumped from $453 million in 2011 to $1.32 billion in 2017, reported Daniel Hartung, PharmD, MPH, of Oregon State University in Portland, and co-authors, in .

"Increased spending was primarily driven by increases in prescription costs, which doubled during this time period," Hartung said in a statement. "Most of these drugs cost more than $70,000 per year on average and costs for these drugs are among the highest drug cost areas for private insurers, as well as Medicare and Medicaid."

The introduction of a generic version of an important MS drug, glatiramer acetate (Copaxone), in 2015 "had a minimal effect on prices overall," he added.

The analysis comes on the heels of a released this week that illustrated patients' deep concerns about drug prices. That study showed that 40% of people with MS were changing how they were taking their disease-modifying therapies (DMTs) for financial reasons.

"We know that early and ongoing, continuous treatment is so important to people staying as healthy as possible and trying to stave off relapses," said Bari Talente, the society's executive vice president of advocacy.

"Seeing that people are delaying filling their prescriptions or spacing out doses and treatments is heartbreaking," Talente told 乌鸦传媒. "People are being put in a position where they're putting their health at risk because of affordability."

Stopping or skipping treatments may not carry immediate consequences and that may influence patients' decisions, she added. "They may have relapses right away, or they may not. It can be difficult to quantify what the negative impact really is."

Previous research has shown that among patients with private health insurance, out-of-pocket costs for MS drugs rose 20-fold from 2004 to 2016. And over 11 years, list prices of self-administered MS drugs more than quadrupled, a review of Medicare data reported.

In their analysis, Hartung and co-authors used Medicaid State Drug Utilization Data from 2011 to 2017 to look at:

• Interferon-β-1a IM (Avonex)

• Interferon-β-1b (Betaseron; Extavia)

• Interferon-β-1a SC (Rebif)

• Peginterferon-β-1a (Plegridy)

• Fingolimod (Gilenya)

• Teriflunomide (Aubagio)

• Dimethyl fumarate (Tecfidera)

• Natalizumab (Tysabri)

• Alemtuzumab (Lemtrada)

• Ocrelizumab (Ocrevus)

• Glatiramer acetate 20 and 40 mg (Copaxone)

• Generic glatiramer acetate 20 mg (Glatopa), approved in April 2015

• Mylan Pharmaceuticals' generic glatiramer acetate (20 and 40 mg), approved in October 2017

The jump in gross annual MS DMT expenditures from $453 million to $1.32 billion from 2011 to 2017 was driven primarily by increases in per-prescription costs, which doubled during the study period, the researchers reported. Total utilization levels were stable, but use shifted from older self-injectable interferon and glatiramer acetate-based therapies to oral DMTs like dimethyl fumarate, teriflunomide, and fingolimod.

Net spending, after adjusting for potential rebates paid to Medicaid, also rose from $278 million to $600 million per year. Some of this increase was due to Medicaid expansion through the Affordable Care Act, but even on a per-enrollee basis, spending more than doubled, Hartung said.

In 2015, generic glatiramer acetate 20 mg (Glatopa) was approved, but this appeared to have little effect on the overall trajectory of costs, the researchers noted. In the 18 months before Glatopa was launched, many name brand (Copaxone) users moved to the 40 mg version of the glatiramer acetate. Just after Glatopa was introduced, Copaxone costs increased by $441 per prescription.

"Before the introduction of the generic drug, the maker of the brand name drug worked to push its market share from the 20 mg dose to the 40 mg dose, which was not interchangeable with the new generic," Hartung said. "The low market share for the generic drug was also because the generic drug was only 15% less expensive than the brand name drug at 20 mg at approximately the same cost as the 40 mg dose when it launched," he added.

Mylan introduced 20 mg and 40 mg generic versions of glatiramer acetate in October 2017, near the end date of the study. By the fourth quarter of 2017, more than 26% of total DMT utilization was a glatiramer acetate product, but just over a third of all glatiramer acetate use was for a generic.

In July 2018 -- after the study's end date -- , making it the lowest-cost DMT on the market, the researchers noted, but how this will affect future DMT use and prices remains to be seen.

The analysis has several limitations, the team added. The analysis was limited to Medicaid spending, and considered only direct costs associated with reimbursement of each drug. Total spending may reflect both changes in Medicaid reimbursement formulas and DMT invoice prices for pharmacies, depending on the state. Cost-per-prescription analyses were restricted to self-administered drugs because infused medications are reimbursed differently.

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