Despite increased competition from an expanded number of approved multiple sclerosis (MS) medications and the introduction of a generic agent, drug prices have nearly doubled, and spending on these agents has nearly tripled over the past 7 years.
Investigators found that spending on 15 disease-modifying therapies (DMTs) within the Medicaid program increased from $453 million in the first quarter of 2011 to $1.32 billion in the fourth quarter of 2017.
The average cost per prescription increased from $3080 to $6420 during that period.
"We pursued this research because some attribute the escalating prices in the MS space to a lack of generic competition," lead author Daniel M. Hartung, PharmD, MPH, of the Oregon Health and Science University College of Pharmacy in Portland, told Medscape Medical News.
The US Food and Drug Administration (FDA) approved the first generic DMT for MS in the United States, glatiramer (Glatopa, Sandoz), in April 2015. However, this failed to curb the trend of rising MS drug prices.
"It was unfortunate, but perhaps not surprising, that the entrance of a new generic for one of the most commonly prescribed MS medications, Copaxone (glatiramer acetate injection, Teva), had little effect on the continued cost escalation for drugs within the same class," said Hartung.
The study was published online January 15 in Neurology.
The new findings build on previous research showing that prices for MS DMTs increased four- to fivefold between 2000 and 2013.
Glatiramer is one of the most frequently prescribed medications in this patient population. In 2013, Medicare spending on glatiramer totalled $820 million, just a shade off the $939 million the agency paid neurologists for all clinical services in that year.
In the current study, investigators examined total Medicare spending and use for 15 DMTs. Their analysis was based on CMS drug utilization data.
The researchers also examined the impact on MS drug pricing and utilization of the FDA's approval of generic glatiramer. The investigators restricted the analysis to the nine self-administered DMTs, because these agents "are most likely to compete against each other." They also excluded peginterferon-β-1a because it was only available a short time before the generic agent was approved.
Across all agents, the median annual cost increase was 12%. Among DMTs available during this time, the cost of interferon-β-1a SC increased the most, from $2760 to $6507 per prescription. Interferon-β-1b (Extavia, Novartis) increased the least, from $2629 to $4018 per prescription.
Notably, newer oral agents accounted for an increasing proportion of overall spending in recent years. For example, by the fourth quarter of 2017, 45% of Medicaid spending was on oral DMTs.
In terms of market share, in 2017, the most common MS medication was dimethyl fumarate, at 23%, followed by fingolimod, at 13%, and glatiramer acetate 40 mg (Teva), at 10%.
Teva received FDA approval for a new 40-mg formulation of glatiramer acetate in January 2014, a little more than 1 year before the 20-mg generic entered the market. By the second quarter of 2015, 48% of use of glatiramer acetate from Teva had shifted from the original 20-mg formulation to the new 40-mg version.
The extent to which Teva shifted market share to its 40-mg, noninterchangeable version prior to launch was surprising, Hartung said.
"The strategy of moving sales of a product that is nearing the end of its period of market exclusivity to a slightly altered, but non-interchangeable, version is a common industry tactic that likely blunted the impact of this new generic," the researchers note.
The "generic paradox" phenomenon, in which the price of a branded drug increases shortly after its generic counterpart becomes available, has been reported with other agents, including Nitrostat vs nitroglycerin, Intuiv vs guanfacine ER, and Abilify vs aripiprazole.
In the current study, the researchers note that the Sandoz generic of glatiramer acetate was only 15% less expensive than the branded 20-mg Sandoz version.
In addition, the generic agent cost almost the same as the 40-mg Sandoz formulation. Both factors could have contributed to lower uptake of the generic, they note.
"The continued use of branded glatiramer acetate may also reflect reticence for conversion to a generic by patients and clinicians for clinical reasons," the investigators write.
There is "an urgent need for robust generic competition within the DMT class," they add.
A second generic formulation of glatiramer acetate (Mylan) was approved near the end of the current study. The prices for both generics "dropped substantially" in mid- to late-2018, Hartung said. "It will be important to examine how these changes have affected the market."
Barrier to MS Treatment
Commenting on the findings for Medscape Medical News, Alvaro San-Juan-Rodriguez, PharmD, said the findings are concerning and noted that rising drug prices limit MS patients' access to treatment.
However, Medicaid rebates for MS DMTs are likely greater than the average Medicaid rebate, he added. "Therefore, the actual increase in net spending on MS DMTs may have been lower than the one described by the authors," said San-Juan-Rodriguez, a research fellow in pharmacy and therapeutics at the University of Pittsburgh Graduate School of Public Health.
"Nevertheless, I commend the authors for this timely contribution to the literature," said San-Juan-Rodriguez, who was also lead author of a study that evaluated Medicare Part D trends in spending, prices, and market share for self-administered DMTs in MS.
The National Multiple Sclerosis Society supported the study. Hartung is a consultant for MedSavvy and receives research support from AbbVie. San-Juan-Rodriguez has disclosed no relevant financial relationships.
Neurology. Published online January 15, 2020. Abstract
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Cite this: MS Drug Prices Continue to Skyrocket - Medscape - Jan 23, 2020.