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Impact of Generic Competition on Prices of Branded Self-administered Disease-Modifying Therapies for Multiple Sclerosis

San-Juan-Rodriguez, Alvaro (2021) Impact of Generic Competition on Prices of Branded Self-administered Disease-Modifying Therapies for Multiple Sclerosis. Master's Thesis, University of Pittsburgh. (Unpublished)

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Prices of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in the US increased drastically over the last decade, continuing to grow even after the introduction of generic competition. Prior research on DMT prices mostly employed measures of list prices, which do not account for discounts. Thus, the extent to which discounts offset list price increases of individual agents and the impact of generic competition on net prices of DMTs remains unclear.
In this retrospective descriptive study, we used 2010-2019 pricing data for branded self-administered DMTs from SSR Health, which provides estimates of net prices and discounts for most branded prescription drugs. For each drug and year, we estimated annual costs of treatment based on list and net prices, and discounts for Medicaid and other payers. We constructed interrupted time series analysis models to test whether the introduction of generic competition was associated with a change in price trajectories of incumbent agents.
List prices of DMTs experienced a drastic growth in 2010-2019, increasing at an annual rate of 10.4%. Discounts varied widely within the category, and for most agents, only offset list price increases partially. After accounting for discounts, net prices still increased substantially at an annual rate of 8.9%. After the introduction of the first generic glatiramer in 2015, net price growth of original glatiramer, subcutaneous interferon beta-1a and fingolimod slowed down significantly. The second wave of generic entries in 2017 was associated with a significant change in net price trajectories of original glatiramer, leading to a considerable decrease in net price.
Public health significance: MS affects almost one million individuals in the US, and treatment with DMTs is crucial for reducing clinical exacerbations’ frequency and severity. However, high and rising prices of DMTs can limit affordability, reducing patient access and adherence. Understanding pricing patterns, the role of manufacturer discounts, and the impact of generic competition in the DMT category will be paramount to inform policymakers in developing policies aiming to facilitate the entry of generics and biosimilars into the US prescription drug market. Such policies will likely reduce affordability barriers, improving patients’ quality of life, and clinical outcomes.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
San-Juan-Rodriguez, Alvaroalvarosjrodriguez@gmail.comals4400000-0003-4555-3154
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairRoberts, Eric T.eric.roberts@pitt.edueric.roberts
Committee MemberDonohue, Julie M.jdonohue@pitt.edujdonohue
Committee MemberHernandez, Inmaculadainh3@pitt.eduinh3
Date: 21 January 2021
Date Type: Publication
Defense Date: 24 November 2020
Approval Date: 21 January 2021
Submission Date: 11 November 2020
Access Restriction: 2 year -- Restrict access to University of Pittsburgh for a period of 2 years.
Number of Pages: 54
Institution: University of Pittsburgh
Schools and Programs: School of Public Health > Health Policy & Management
Degree: MS - Master of Science
Thesis Type: Master's Thesis
Refereed: Yes
Uncontrolled Keywords: Generic competition, drug pricing, disease-modifying therapies, multiple sclerosis
Date Deposited: 21 Jan 2021 16:42
Last Modified: 21 Jan 2023 06:15


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