Alvaro San-Juan-Rodriguez1, Chester B Good2,3, Rock A Heyman4,5, Natasha Parekh2,3, William H Shrank2,3, Inmaculada Hernandez1. 1. Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania. 2. Division of General Internal Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 3. Center for High-Value Health Care, Insurance Services Division, UPMC Health Plan, Pittsburgh, Pennsylvania. 4. Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 5. Multiple Sclerosis Center, UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania.
Abstract
IMPORTANCE: Before 2009, only 4 self-administered disease-modifying therapies (DMTs) were approved for the treatment of multiple sclerosis (MS). Since then, 7 new agents have entered the market. OBJECTIVE: To assess trends in prices, market share, and spending on self-administered DMTs for MS in Medicare Part D from 2006 through 2016. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used claims data from 2006 through 2016 from a 5% random sample of Medicare beneficiaries (a mean of 2.8 million Medicare beneficiaries per year). All prescription claims for self-administered DMTs for MS (glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod hydrochloride, teriflunomide, dimethyl fumarate, and peginterferon beta-1a) were extracted throughout the study period. MAIN OUTCOMES AND MEASURES: The main outcomes were the annual cost of treatment with each medication, based on Medicare Part D prescription claims gross costs and US Food and Drug Administration-approved recommended dosing; market share of each medication, defined as the proportion of pharmaceutical spending accounted by every drug; and pharmaceutical spending per 1000 Medicare beneficiaries for all drugs. The relative contributions of Medicare Part D Plans' payments, Medicare catastrophic coverage payments, low-income cost-sharing subsidies, patients' out-of-pocket costs, manufacturers' coverage gap discounts, and other payments toward pharmaceutical spending were further quantified. RESULTS: Annual costs of treatment with self-administered DMTs for MS more than quadrupled from 2006 to 2016, from a mean (SD) of $18 660 ($1177) to $75 847 ($16 956) and at a mean rate of 12.8% every year. Brand-name glatiramers accounted for the largest market share across the study period, ranging between $25 552 of $79 411 per 1000 Medicare beneficiaries (32.2%) and $10 342 of $21 365 per 1000 Medicare beneficiaries (48.4%). Platform therapies experienced a substantial drop from 2006 to 2016 in favor of newer therapies, with decreases in the market shares of brand-name glatiramers (per 1000 Medicare beneficiaries: $2861 of $7794 [36.7%] to $25 552 of $79 411 [32.2%]), interferon beta-1a (30 µg; per 1000 Medicare beneficiaries: $2521 of $7794 [32.3%] to $11 298 of $79 411 [14.2%]), interferon beta-1b (Betaseron; per 1000 Medicare beneficiaries: $1460 of $7794 [18.7%] to $3588 of $79 411 [4.5%]), and interferon beta-1a (8.8/22/44 µg; per 1000 Medicare beneficiaries: $951 of $7794 [12.2%] to $6588 of $79 411 [8.3%]) and increases in fingolimod (to $6311 of $79 411 per 1000 Medicare beneficiaries [7.9%]), teriflunomide (to $7177 of $79 411 per 1000 Medicare beneficiaries [9.0%]), and dimethyl fumarate (to $15 262 of $79 411 per 1000 Medicare beneficiaries [19.2%]). Throughout the study period, pharmaceutical spending per 1000 beneficiaries increased 10.2-fold (from $7794 to $79 411), and out-of-pocket patient spending per 1000 beneficiaries increased 7.2-fold (from $372 to $2673). The relative contribution of federal payments toward pharmaceutical spending increased from $5335 of $7794 (68.5%) to $58 620 to $79 411 (73.8%). CONCLUSIONS AND RELEVANCE: Per this analysis, prices of self-administered DMTs for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.
IMPORTANCE: Before 2009, only 4 self-administered disease-modifying therapies (DMTs) were approved for the treatment of multiple sclerosis (MS). Since then, 7 new agents have entered the market. OBJECTIVE: To assess trends in prices, market share, and spending on self-administered DMTs for MS in Medicare Part D from 2006 through 2016. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used claims data from 2006 through 2016 from a 5% random sample of Medicare beneficiaries (a mean of 2.8 million Medicare beneficiaries per year). All prescription claims for self-administered DMTs for MS (glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod hydrochloride, teriflunomide, dimethyl fumarate, and peginterferon beta-1a) were extracted throughout the study period. MAIN OUTCOMES AND MEASURES: The main outcomes were the annual cost of treatment with each medication, based on Medicare Part D prescription claims gross costs and US Food and Drug Administration-approved recommended dosing; market share of each medication, defined as the proportion of pharmaceutical spending accounted by every drug; and pharmaceutical spending per 1000 Medicare beneficiaries for all drugs. The relative contributions of Medicare Part D Plans' payments, Medicare catastrophic coverage payments, low-income cost-sharing subsidies, patients' out-of-pocket costs, manufacturers' coverage gap discounts, and other payments toward pharmaceutical spending were further quantified. RESULTS: Annual costs of treatment with self-administered DMTs for MS more than quadrupled from 2006 to 2016, from a mean (SD) of $18 660 ($1177) to $75 847 ($16 956) and at a mean rate of 12.8% every year. Brand-name glatiramers accounted for the largest market share across the study period, ranging between $25 552 of $79 411 per 1000 Medicare beneficiaries (32.2%) and $10 342 of $21 365 per 1000 Medicare beneficiaries (48.4%). Platform therapies experienced a substantial drop from 2006 to 2016 in favor of newer therapies, with decreases in the market shares of brand-name glatiramers (per 1000 Medicare beneficiaries: $2861 of $7794 [36.7%] to $25 552 of $79 411 [32.2%]), interferon beta-1a (30 µg; per 1000 Medicare beneficiaries: $2521 of $7794 [32.3%] to $11 298 of $79 411 [14.2%]), interferon beta-1b (Betaseron; per 1000 Medicare beneficiaries: $1460 of $7794 [18.7%] to $3588 of $79 411 [4.5%]), and interferon beta-1a (8.8/22/44 µg; per 1000 Medicare beneficiaries: $951 of $7794 [12.2%] to $6588 of $79 411 [8.3%]) and increases in fingolimod (to $6311 of $79 411 per 1000 Medicare beneficiaries [7.9%]), teriflunomide (to $7177 of $79 411 per 1000 Medicare beneficiaries [9.0%]), and dimethyl fumarate (to $15 262 of $79 411 per 1000 Medicare beneficiaries [19.2%]). Throughout the study period, pharmaceutical spending per 1000 beneficiaries increased 10.2-fold (from $7794 to $79 411), and out-of-pocket patient spending per 1000 beneficiaries increased 7.2-fold (from $372 to $2673). The relative contribution of federal payments toward pharmaceutical spending increased from $5335 of $7794 (68.5%) to $58 620 to $79 411 (73.8%). CONCLUSIONS AND RELEVANCE: Per this analysis, prices of self-administered DMTs for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.
Authors: Derek McFaul; Nektar N Hakopian; Jessica B Smith; Allen Scott Nielsen; Annette Langer-Gould Journal: Neurol Neuroimmunol Neuroinflamm Date: 2021-02-08
Authors: Marcello Moccia; Ilaria Loperto; Roberta Lanzillo; Antonio Capacchione; Antonio Carotenuto; Maria Triassi; Vincenzo Brescia Morra; Raffaele Palladino Journal: BMC Health Serv Res Date: 2020-08-26 Impact factor: 2.655