Therapeutic Interferon Interchange in Relapsing Multiple Sclerosis Lowers Health Care and Pharmacy Expenditures with Comparable Safety

Hahn, Nicole; Palmer, Kelsey E; Klocke, Shilpa; Delate, Thomas

doi:10.7812/tpp/18-046

Cited by 3 publications

(5 citation statements)

References 19 publications

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“…This strategy had been successfully implemented in another Kaiser region. 11 Despite these agreed upon recommendations, use of the preferred interferon‐beta product remained low at 20.9% in 2010 and 20.1% in 2011 among all prescribed DMTs. For pwMS starting their first DMT, use of the preferred interferon‐beta product rose from 25% ( n = 68) in 2010 to 39% ( n = 103) in 2011.…”

Section: Resultsmentioning

confidence: 99%

“…It was recommended that pwMS on higher priced interferon‐beta products be converted to the preferred interferon‐beta, with the exception of those who were previously unable to tolerate the preferred interferon‐beta. This strategy had been successfully implemented in another Kaiser region 11 . Despite these agreed upon recommendations, use of the preferred interferon‐beta product remained low at 20.9% in 2010 and 20.1% in 2011 among all prescribed DMTs.…”

Section: Resultsmentioning

confidence: 99%

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The Multiple Sclerosis Treatment Optimization Program

Langer‐Gould

Cheng²,

Li³

et al. 2021

Ann Clin Transl Neurol

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Objective To design and implement a health system level intervention to reduce escalating multiple sclerosis (MS) disease modifying treatment (DMT) expenditures and improve outcomes. Methods We conducted stakeholder meetings, reviewed pharmacy utilization data, and abstracted information in subsets of persons with MS (pwMS) from the electronic health record to identify gaps in, and barriers to improving, quality, and affordability of MS care in Kaiser Permanente Southern California. These results informed the development and implementation of the MS Treatment Optimization Program (MSTOP). Results The two main gaps identified were under‐prescribing of highly effective DMTs (HET, 4.9%) and the preferred formulary DMT (20.9%) among DMT‐treated pwMS. The main barriers identified were prescribers’ fear of rare but serious HET side effects, lack of MS‐specific and health systems science knowledge, Pharma influence, evidence gaps, formulary decisions‐based solely on costs, and multidirectional mistrust between neurologists, practice leaders, and health plan pharmacists. To overcome these barriers MSTOP developed four strategies: (1) risk‐stratified treatment algorithm to increase use of HETs; (2) an expert‐led ethical, cost‐sensitive, risk‐stratified, preferred formulary; (3) proactive counter‐launch campaigns to minimize uptake of new, low‐value DMTs; and (4) discontinuation of ineffective DMTs in progressive, non‐relapsing MS. The multicomponent MSTOP was implemented through education, training, and expanding access to MS‐trained providers, audit and feedback, and continual evidence reviews. Interpretation The causes of wasteful spending on MS DMTs are complex and require multiple strategies to resolve. We provide herein granular details of how we designed and implemented our health system intervention to facilitate its adaption to other settings and conditions.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The Multiple Sclerosis Treatment Optimization Program

Langer‐Gould

Cheng²,

Li³

et al. 2021

Ann Clin Transl Neurol

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“…When KP had negotiated a 3 or more‐year contract with a significantly lower price on an interferon‐beta product, neurologists were encouraged to discuss switching to the lowest priced option with the patient with a low threshold for switching back should the patient be unable to tolerate the less expensive version. This strategy, when supported by pharmacists in KP Colorado, showed no evidence of return of disease activity, tolerability was generally high, with few pwMS switching back to the nonpreferred interferon‐beta, and the cost savings were significant 6 . As is standard practice in KP, patients on brand name glatiramer acetate were switched to generic when it became available unless their prescribing neurologist specifically requested a brand name.…”

Section: Methodsmentioning

confidence: 99%

“…This strategy, when supported by pharmacists in KP Colorado, showed no evidence of return of disease activity, tolerability was generally high, with few pwMS switching back to the nonpreferred interferon-beta, and the cost savings were significant. 6 As is standard practice in KP, patients on brand name glatiramer acetate were switched to generic when it became available unless their prescribing neurologist specifically requested a brand name.…”

Section: Interventionmentioning

confidence: 99%

Decreasing Multiple Sclerosis Treatment Expenditures and Improving Quality at the Health System Level

Langer‐Gould

Cheng²,

Li³

et al. 2022

Annals of Neurology

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for the Kaiser Permanente Southern California Multiple Sclerosis specialist group Objective: This study was undertaken to evaluate a multicomponent health system intervention designed to reduce escalating disease-modifying treatment (DMT) expenditures and improve multiple sclerosis (MS) outcomes by increasing use of preferred formulary and highly effective DMTs (HETs). Methods: We conducted a trend study of treatment utilization and expenditure outcomes prior to (2009)(2010)(2011) and during (2012-2018) MS Treatment Optimization Program (MSTOP) implementation in Kaiser Permanente Southern California (KPSC) compared to a Kaiser Permanente region of similar size. Annual relapse rates (ARRs) were obtained from KPSC's electronic health records.

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“…В литературе встречаются сведения о клинических исследованиях, позволяющих сделать вывод о возможности замены препаратов рчИФН бета-1а на рчИФН бета-1b, однако такую воз-можность не следует рассматривать как полную взаимозаменяемость данных подтипов интерферонов. Выбор гликозилированной или негликозилированной формы в каждом конкретном случае зависит от множества факторов, в том числе от индивидуальных особенностей пациента [4][5][6][7].…”

Section: Introductionunclassified

Development and certification of a pharmacopoeial reference standard for primary structure identification of purified recombinant interferon beta-1b by peptide mapping

Goloshchapova¹,

Rounova²,

Minero³

et al. 2022

Biological Products. Prevention, Diagnosis, Treatment

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Medicines based on recombinant human interferons (rhIFNs) beta-1a and beta-1b are used as first-line treatment of multiple sclerosis. Meanwhile, rhIFN beta-1a and beta-1b have structural differences associated with the eukaryotic or prokaryotic expression systems, respectively. Pharmacopoeias require identification of the primary structure of recombinant proteins by peptide mapping, which involves the use of reference material. Currently, there is no international reference standard available for rhIFN beta-1b structural identification.The aim of the study was development and certification of a pharmacopoeial reference standard for identification of the amino acid sequence of purified rhIFN beta-1b by peptide mapping.Materials and methods: rhIFN beta-1b produced by GENERIUM and endoproteinase Glu-C from Staphylococcus aureus V8 were used in the study. The peptide mapping was performed using reverse-phase high-performance liquid chromatography (RP HPLC) and high-resolution mass spectrometry. Statistical evaluation of the results included calculation of the arithmetic mean, standard deviation, and coefficient of variation.Results: the authors developed and certified a Russian Pharmacopoeia reference standard for structural identification of rhIFN beta-1b (PhRS 3.2.00447). The certified characteristic is the range of retention times of characteristic peaks: the absolute retention time was 42.0–43.2 for the third (reference) peak, the relative retention time was 0.61–0.66 for the first peak, 0.68–0.73 for the second peak, 1.04–1.06 for the fourth peak, 1.14–1.15 for the fifth peak, 1.22–1.24 for the sixth peak, and 1.29–1.30 for the seventh peak. Conclusions: the authors developed requirements for the rhIFN beta-1b pharmacopoeial reference standard. The material chosen as the candidate reference standard was an intermediate rhIFN beta-1b product sampled before addition of human serum albumin. The quality control was carried out in accordance with the developed specification. The authors analysed the amino acid sequence of the molecule, confirmed the presence of the disulfi e bond, and obtained the certifi d characteristic of the reference standard. Comparative analysis of the peptide maps of the certified rhIFN beta-1b pharmacopoeial reference standard and the rhIFN beta-1a reference standard revealed differences between the maps, and, therefore, confirmed the relevance of the developed reference standard.

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Therapeutic Interferon Interchange in Relapsing Multiple Sclerosis Lowers Health Care and Pharmacy Expenditures with Comparable Safety

Cited by 3 publications

References 19 publications

The Multiple Sclerosis Treatment Optimization Program

The Multiple Sclerosis Treatment Optimization Program

Decreasing Multiple Sclerosis Treatment Expenditures and Improving Quality at the Health System Level

Development and certification of a pharmacopoeial reference standard for primary structure identification of purified recombinant interferon beta-1b by peptide mapping

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