Use of biologics for psoriasis in Central and Eastern European countries

Rencz, Fanni; Kemény, Lajos; Gajdácsi, J.; Owczarek, Witold; Arenberger, Petr; Tiplica, G.S.; Stanimirović, Andrija; Niewada, Maciej; Petrova, Guenka; Marinov, Lyubomir; Péntek, Márta; Brodszky, Valentin; Gulàcsi, László

doi:10.1111/jdv.13222

Cited by 48 publications

(53 citation statements)

References 29 publications

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“…Product information for the use of all biologics for psoriasis [3][4][5]13] in the present study. PUVA, psoralen and ultraviolet A light.…”

Section: Resultsmentioning

confidence: 99%

“…Or who have a contraindication to Absolute contraindications were always considered as exclusion criteria [4][5][6][7][8][9][10][11][12][13][14]. Contraception was suggested for men and women with methotrexate and only for women with acitretin and biologics, and its refusal was considered an exclusion criterion for those therapies [10] Relative contraindications were carefully evaluated individually, and treatment was not begun if they were not removed or controlled with adequate interventions [10] Drug interactions were carefully evaluated in each individual case.…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, the same registries showed wide differences in the rates of patients treated with the biologics [3][4][5][6]. A possible explanation is that the European Medicines Agency (EMA) did not describe in detail the eligibility criteria for biologics and systemic conventional therapies [7][8][9][10], and therefore they left a margin of discretion in their interpretation.…”

Section: Introductionmentioning

confidence: 99%

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Prevalence of Phototherapy in the Age of Biologics

et al. 2018

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Background: The prevalence of narrow-band ultraviolet B (NB-UVB) use in Europe for moderate and severe psoriasis is unknown, because national registries for psoriasis do not monitor this treatment. Objectives: To quantify the use of phototherapy, biologics or conventional treatments in psoriasis, in a setting where European Medicines Agency (EMA) eligibility criteria for biologics were strictly applied, and phototherapy was included among first-line treatments. Methods: We followed a cohort of 1,090 patients who were referred to the only centre entitled to prescribe biologics and phototherapy during a 5-year period. Results: The cumulative number of treatment cycles was: 1,047 with NB-UVB phototherapy, 650 with systemic treatments and 239 with biologics; 754 patients received at least 1 course of NB-UVB phototherapy, 422 at least 1 course with a systemic treatment and 137 with a biologic; 595 patients were treated only with phototherapy. Conclusions: Regular use of NB-UVB as first-line treatment for moderate and severe psoriasis and adherence to the EMA eligibility criteria for biologics led to a relatively restricted use of biologics.

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“…Product information for the use of all biologics for psoriasis [3][4][5]13] in the present study. PUVA, psoralen and ultraviolet A light.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prevalence of Phototherapy in the Age of Biologics

et al. 2018

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“…Incentive policies applied to biosimilars are heterogeneous across countries. At the time of the review, pharmaceutical prescription budgets or prescription quotas were reported in place for half of the countries [14,19,[39][40][41][42][43] Financial incentives or penalties measures were found in countries applying pharmaceutical prescription budgets and/or prescription quotas, but were reported as not frequently enforced (Belgium, Germany) or enforcement was not documented in the literature (Greece, Italy, Sweden, the UK) [14,39,41,42,44] Except for Poland, where switching by the physician is generally encouraged [45][46][47], some countries (Belgium, France, and Italy) do not recommend switching even if they do not prohibit it [14,39], while some other countries might recommend it in some specific cases (e.g., products with same producer (Germany, Sweden) [14], sufficient elapse time between two treatments, or in case of treatment failure (Hungary) [46,47]. In Spain, patients who started biologic therapy usually continue to receive the same medicine, and all decisions should be taken by physicians [13].…”

Section: Resultsmentioning

confidence: 99%

key Drivers for Market Penetration of Biosimilars in Europe

et al. 2016

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Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition. Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake. Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.

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“…Hungarian guidelines permit switching between a suitable biosimilar and the original medicine in clinically justified cases (due to adverse events or a lack of efficacy), and at least 1 year after terminating the previous treatment [74,85]. In the UK, NICE left treatment choice to prescribers [30], but different -and often conflicting -recommendations are published by scientific associations; for instance, the British Society of Gastroenterology recommends switching those patients who are in a stable clinical response or remission on the reference medicine [86], while the National Rheumatoid Arthritis Society and the British Society for Rheumatology recommend that stable patients should not be switched [87].…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

Rémuzat

Kapuśniak²,

Caban³

et al. 2016

Value in Health

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Objective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician's responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs. Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake. ARTICLE HISTORY

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Use of biologics for psoriasis in Central and Eastern European countries

Cited by 48 publications

References 29 publications

Prevalence of Phototherapy in the Age of Biologics

Prevalence of Phototherapy in the Age of Biologics

key Drivers for Market Penetration of Biosimilars in Europe

Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

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