Budget impact analysis of teriflunomide (aubagio) proposed inclusion into the programme ‘7 high-cost nosologies’ on the budgets of RF federal and regional public authorities in the field of healthcare to ensure treatment of multiple sclerosis patients

Evdoshenko, Evgeniy; Solodun, I.Y.; Bashlakova, E; Holownia, M.; Polyakova, K. I.; Pokatilo, A; Хачанова, Н. В.; Davidovskaya, M.V.; Скоромец, А А

doi:10.30809/phe.2.2016.5

Cited by 3 publications

(1 citation statement)

References 16 publications

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“…Multiple sclerosis is a major medical and social problem in Russia with up to 150 000 people affected [1]. Administration of highly efficacious disease modifying drugs (DMDs), such as Natalizumab (NTZ) can significantly improve disease outcomes and patients’ quality of life [2].…”

Section: Introductionmentioning

confidence: 99%

Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

et al. 2019

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Background NTZ is approved in Russia for the treatment of highly active relapsing remitting multiple sclerosis and is reimbursed via federal budget program. However, no data about NTZ treatment in Russia and the effect of federal reimbursement have been performed so far. Objective To characterize the population of patients receiving natalizumab and assess the efficacy and risk-management plan (RMP) implementation of NTZ therapy in routine clinical practice in Russia. Methods We analyzed data for 334 patients, who received at least one infusion of NTZ. Relapse rate, MRI activity, NEDA-3 status after 2 years were assessed. Anti-JC virus antibodies status and RMP implementation were evaluated. Drop-out rate and reasons for therapy discontinuation were analyzed. Results Patients switched to natalizumab in Russia are mainly female (63%), with median EDSS score of 3.5 and high disease activity: 93% had at least 1 relapse and 58% had both T1Gd+ and new T2 lesion a year before therapy initiation. Introduction of federal reimbursement allowed patients with less relapses to start therapy with natalizumab. The only predictor of 6-month progression was EDSS score at the baseline of therapy (HR = 2.1375, 95%CI 1.0026–4.5570, p = 0.0492). 82% patients reached NEDA-3 at 24 month of therapy. 25% of patients discontinued NTZ for reasons: tolerability (14.5%), JCV antibody status (61%), and patient’s decision (17%). RMP was implemented in only 36% patients. Conclusion Natalizumab appeared to have high efficacy in Russian clinical practice. Federal reimbursement allowed less active patients to start natalizumab. More efforts should be done to improve RMP implementation.

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Section: Introductionmentioning

confidence: 99%

Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

et al. 2019

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Primary progressive multiple sclerosis: current issues of timely diagnosis

Popova

Boyko

Барабанова

et al. 2017

Z. nevrol. psikhiatr. im. S.S. Korsakova

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The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies

et al. 2022

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Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required.

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Budget impact analysis of teriflunomide (aubagio) proposed inclusion into the programme ‘7 high-cost nosologies’ on the budgets of RF federal and regional public authorities in the field of healthcare to ensure treatment of multiple sclerosis patients

Cited by 3 publications

References 16 publications

Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

Primary progressive multiple sclerosis: current issues of timely diagnosis

The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies

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