Postmarket policy considerations for biosimilar oncology drugs

Renwick, Matthew J; Smolina, Kate; Gladstone, Emilie J.; Weymann, Deirdre; Morgan, Steven G.

doi:10.1016/s1470-2045(15)00381-2

Cited by 59 publications

(64 citation statements)

References 38 publications

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“…For instance, prices of biosimilars are linked to originator prices, the required difference between the biosimilar and the originator price is lower compared to generics (e.g., 30% for generics and 15% for biosimilars in Croatia; and 50% for generics and 30% for biosimilars in Lithuania) [117]. While generic substitution has been widely implemented in European countries, this is not the case for biosimilar substitution at pharmacy level [118,119]. Though European countries seem to be advanced related to biosimlar medicines compared to the rest of the world, overall governments in European countries appear to be still struggeling to develop the best policy option mix for best benefitting from biosimilar medicines.…”

Section: Biosimilar Medicines' Policiesmentioning

confidence: 99%

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Vogler

Paris

Ferrario

et al. 2017

Appl Health Econ Health Policy

151

118

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Key points for Decision Makers: European countries apply different pharmaceutical pricing and reimbursement policies. These policies are frequently assessed against their financial consequences and their ability to contain costs but less so in terms of access to medicines. Policies should be accompanied by regular evaluations, facilitated by the use of the appropriate methodology and access to the relevant data. There appears to be a need for additional changes beyond traditional pharmaceutical pricing and reimbursement policies. Collaborative approaches (e.g. between countries or between regulatory authorities, pricing and reimbursement agencies) and more transparency in terms of real medicine prices, R+D costs and medicines in the pipeline are considered as possible pathways for the future. AbstractThe paper discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation, however implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the 2 hospital and offpatent outpatient sectors has proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing, and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.3

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Section: Biosimilar Medicines' Policiesmentioning

confidence: 99%

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Vogler

Paris

Ferrario

et al. 2017

Appl Health Econ Health Policy

151

118

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“…In most other regions with a known policy, pharmacy-level substitution is either not permitted or permitted only in certain circumstances, such as for treatment-naïve patients. 153 As a result, switches from an originator product to a biosimilar are typically authorized by the prescribing healthcare professional, subject to patient consent. In Latin America, medical societies have expressed concern about pharmacy-level substitution of biosimilars, 145,146 given its potential implications for pharmacovigilance and safety.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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“…Price linkage [22][23][24]26,36] All selected countries except for Greece, where price setting is based on ERP as described above, link the biosimilar price to the price of the reference medicine, with price reduction being mandatory in three countries (Hungary, Italy, and Poland). In Hungary, the first biosimilar is priced 30% below the reference medicine price, and each subsequent medicine is discounted by another 10%.…”

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%

“…Policies directed at pharmacists [19,23,26,36,91] In the majority of investigated EU MSs, substitution of biologics by pharmacists is generally either not allowed or not recommended. France is the first EU country to explicitly authorize by law the automatic substitution of biosimilars under specified conditions (for medicines belonging to the same group, called the 'similar biologic group', at treatment initiation or to continue a treatment already initiated with the same biosimilar, when substitution is not prohibited by the physician, with information about substitution provided to the prescriber and the biosimilar name written on the prescription).…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

See 1 more Smart Citation

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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Postmarket policy considerations for biosimilar oncology drugs

Cited by 59 publications

References 38 publications

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

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

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