How much excess US spending was associated with the delay in generic competition because of the transition from a daily to a 3-times-weekly version of glatiramer acetate?
In this economic evaluation, prices and spending on glatiramer remained high until generic competition for daily and 3-times-weekly versions began in 2017. The 2.5-year delay in full generic competition from 2015 to 2017 may have been associated with excess spending of $4.3 billion to $6.5 billion.
The findings suggest that policy makers should consider policies that prevent manufacturers from delaying generic competition by introducing a new version of an existing drug and provide incentives to develop incremental innovations to existing drugs that are commensurate to the level of investment and risk involved.
Market exclusivity for daily injections of glatiramer acetate, a disease-modifying therapy for multiple sclerosis, expired in 2015. In 2014, the manufacturer launched an alternate 3-times-weekly version that was widely adopted, sustaining market dominance of brand-name glatiramer until late 2017.
To estimate excess US spending associated with the transition from daily to 3-times-weekly glatiramer.
Design, Setting, and Participants
This economic evaluation estimated total US glatiramer spending from January 1, 2011, to June 30, 2019, using a national cohort from 3 data sources that collectively represent approximately 40% of the US glatiramer market: Medicare Part D, Medicaid, and a claims database of commercially insured and Medicare Advantage patients.
Main Outcomes and Measures
Outcomes were quarterly US glatiramer spending, estimated as price × use. Manufacturer list prices for generic products and estimates of net (postrebate) prices for brand-name products were used. Linear regression and interrupted time series models were used to compare spending trends in 3 periods: before generic competition (2011-2015), during generic competition for daily glatiramer (2015-2017), and during generic competition for daily and 3-times-weekly glatiramer (2017-2019).
From 2011 to 2015, US glatiramer spending increased to $962 million per quarter and did not decrease with generic competition of only daily glatiramer (2015-2017). After generic competition began for 3-times-weekly glatiramer in 2017, prices decreased by 47% to 64%, and spending decreased to $508 million per quarter in 2019 (P < .001 for slope). The delay in decreased spending from 2015 to 2017 was associated with excess spending of $4.3 billion to $6.5 billion.
Conclusions and Relevance
These findings suggest that 2.5 years of delayed generic competition related to introduction of a new version of branded glatiramer acetate was associated with $4.3 billion to $6.5 billion in excess spending. Extended market exclusivity from introducing a new version of an existing brand-name drug can yield manufacturer returns out of proportion to the level of investment or risk involved; more limited incentives could encourage incremental innovations to existing drugs at a lower societal cost.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Rome BN, Tessema FA, Kesselheim AS. US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate. JAMA Intern Med. Published online July 20, 2020. doi:10.1001/jamainternmed.2020.2771
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: