Barriers to the Uptake of Biosimilars and Possible Solutions: A Belgian Case Study

Dylst, Pieter; Vulto, Arnold G.; Simoens, Steven

doi:10.1007/s40273-014-0163-9

Cited by 70 publications

(72 citation statements)

References 18 publications

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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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Section: Resultsmentioning

confidence: 99%

key Drivers for Market Penetration of Biosimilars in Europe

et al. 2016

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“…Biosimilars should be distinguished from generics, especially in terms of higher development costs, owing to the complexity and high cost of the manufacturing process, and different development requirements [48,119]. Despite significant differences between biosimilar and generic markets, similar trends have been observed with regard to the factors potentially influencing generic and biosimilar uptake.…”

Section: Discussionmentioning

confidence: 99%

“…Tendering [19,23,26,[44][45][46][47][48] Tendering processes for biologics are in place in all surveyed countries, except for Greece where biosimilars are excluded from tenders, according to a specific circular [49]. Tenders are generally organized at hospital level in all countries of interest, except for Germany, where tendering operates mainly in the outpatient setting (managed by statutory sickness insurance funds).…”

Section: Supply-side Policies For Biosimilarsmentioning

confidence: 99%

“…Policies directed at physicians [6,19,23,26,36,48,55,56] Pharmaceutical prescription budgets or prescription quotas, potentially impacting biosimilar prescription, are in place in eight countries (Belgium, Germany, Greece, Hungary, Italy, Spain, Sweden, and the UK); in half of these countries, there are policies specifically targeting biosimilars (Germany, Hungary, Italy, and Sweden). In Germany, considered one of the most successful EU MSs in creating a positive attitude towards biosimilars [6], prescription budgets and quotas for biosimilars are set in ambulatory care.…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

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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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“…52 There is often uncertainty about the interchangeability of biosimilar and reference medicines, which is fuelled by variation in definitions and guidance between the EMA and FDA. 53 Furthermore, questions have been raised about who will ultimately benefit from associated cost savings.…”

Section: Potential Barriers To the Uptake Of Biosimilar Medicines Andmentioning

confidence: 99%

Potential Solutions for Sustaining the Costs of Cancer Drugs

Lopes¹,

Vulto²,

Wilking³

et al. 2017

European Oncology &Amp; Haematology

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The growing burden of cancer urgently requires sustainable solutions to ensure continued access to effective and safe treatments for all patients within Europe. The aim of this article, the third in a series of perspectives, is to discuss potential approaches to sustain cancer care and increase patient access to treatments. Much work remains to ensure the sustainability ceiling (where costs of care exceed the benefits) is not reached. Immediate steps must be taken to avoid this, including patient education to encourage earlier diagnosis, use of treatment-response biomarkers, improving efficiency of healthcare systems, use of managed-entry agreements, introduction of value-based medicines with measurable outcomes and use of less expensive medicines. Here we discuss these potential solutions with a focus on reducing the cost of cancer drugs, using biosimilar medicines as an example. Biosimilar and generic medicines offer a cost-effective treatment option that may help combat the substantially increasing costs of cancer drugs. Competition from biosimilar medicines is expected to drive a decrease in the cost of medicines, resulting in increased affordability and access to therapy, and therefore a greater number of patients could be treated. However, various barriers must be overcome to increase the uptake of biosimilar medicines and education is needed to allay misperceptions and encourage greater use.

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Barriers to the Uptake of Biosimilars and Possible Solutions: A Belgian Case Study

Cited by 70 publications

References 18 publications

key Drivers for Market Penetration of Biosimilars in Europe

key Drivers for Market Penetration of Biosimilars in Europe

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

Potential Solutions for Sustaining the Costs of Cancer Drugs

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