Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study.

This study aimed to compare drug costs and healthcare costs of a 1 year adjuvant course with intravenous biosimilar trastuzumab vs. subcutaneous reference trastuzumab in HER2-positive breast cancer from the Belgian hospital perspective. Our simulation is based on the methodology used by Tjalma and colleagues, and considered costs of drugs, healthcare professional time and consumables. We calculated intravenous drug costs for different body weights, and computed drug costs and healthcare costs to treat 100 patients with either trastuzumab formulation, assuming a binomial body weight distribution in this sample. Scenarios were run to account for drug discounts and intravenous vial sharing. Drug costs amounted to €1,431,282 with intravenous biosimilar trastuzumab and €1,522,809 with subcutaneous reference trastuzumab for a sample of 100 patients in the base case analysis. When healthcare professional time and consumables were also considered, healthcare costs with intravenous biosimilar trastuzumab were similar to those with subcutaneous reference trastuzumab. Differences in healthcare costs between intravenous biosimilar trastuzumab and subcutaneous reference trastuzumab depended on the level of discounts on these formulations and on intravenous vial sharing. Our case study demonstrates that comparing costs of intravenous vs. subcutaneous formulations is complex and multifactorial, and entails more than a simple cost comparison of products.

Policies for biosimilar uptake in Europe: An overview.

BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. RESULTS: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. CONCLUSIONS: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Societal value of generic medicines beyond cost-saving through reduced prices.

OBJECTIVE: This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. METHODS: A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. RESULTS: Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. CONCLUSION: Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.

BACKGROUND: Biosimilars are medicinal products that are similar to a biopharmaceutical that has already been authorised. As biopharmaceuticals are expected to dominate the best-selling pharmaceuticals worldwide by 2016, the emergence of biosimilars imposes an important challenge for governments. At this moment, the uptake of biosimilars in Belgium is limited, with market shares close to 0%. OBJECTIVE: This study aimed to identify the barriers that impede the uptake of biosimilars in Belgium. METHODS: Semi-structured interviews were conducted to investigate in depth the barriers to the uptake of biosimilars in Belgium. Respondents were selected through selective sampling so that all different stakeholders were represented (authorities, physicians, pharmacists, patients, academics and industry). Respondents were contacted by e-mail and letter with a request for participation. A thematic framework was used to analyze the data. RESULTS: Three main barriers to the uptake of biosimilars in the Belgian market were identified: a lack of confidence towards biosimilars by some stakeholders; uncertainty about the interchangeability and substitution of biosimilars; and a hospital financing system that discourages the use of them. Providing all stakeholders with objective information on the concept of biosimilars, reforming the financing of hospitals, developing and implementing prescription quota in hospitals, setting up patient registries for biosimilars and speeding up the pricing and reimbursement process of biosimilars are suggested solutions to increase the uptake of biosimilars in Belgium. CONCLUSIONS: To fully capture the potential savings of biosimilars, governments should take measures to increase their uptake. The Belgian government, and also the manufacturers of biosimilars, should take measures to reduce the uncertainties related to biosimilars and raise confidence among prescribers. In addition, the financing of hospitals should be reformed and incentives should be developed to stimulate physicians to prescribe biosimilars.

Does increased use of generic medicines by elders in Belgium help to contain escalating health care budgets?

This study explored the use of generic medicines among elders in Belgium. The generic market share by volume for elders in 2010 was 23.1%, while this was 23.7% for the total Belgian population in 2009. Pharmaceutical expenditure in Belgium was €649.74 per capita for elders in 2010. Calculations of possible savings through an increased use of generic medicines showed that these savings were rather limited (4.48% when the generic market share by volume increased to 95%). The full potential of generic medicines in the elder population has not yet been realized in Belgium, due to the limited use of generic medicines and their relatively high prices. The Belgian government should implement additional incentives for physicians, pharmacists, and patients to increase the use of generics and combine these with policies to lower prices of generic medicines and policies to decrease the volume of medicines used by elders and rationalize the prescribing of medicines for elders.

Analysis of Spanish generic medicines retail market: recommendations to enhance long-term sustainability.

The use of generic medicines in Spain is traditionally low compared to other European countries, despite efforts of the Spanish government in the past. This paper provides a perspective on the Spanish generic medicines retail market and how the current policy environment may affect the long-term sustainability. The Spanish government's focus on prices of generic medicines (e.g., mandatory price cuts, reference price set at the lowest level) have made them amongst the lowest in Europe. In our opinion, this combination of continuous pressure on prices and limited diffusion of generic medicines may undermine the long-term sustainability of the Spanish generic medicines retail market. The unique experience in Spain shows the impact of demand-side policies on the use of generic medicines. Because a sustainable generic medicines retail market is important to maintain future competition in the off-patent medicines market, this perspective paper rounds off with recommendations to increase its sustainability.

Generic medicines: solutions for a sustainable drug market?

Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

Demand-side policies to encourage the use of generic medicines: an overview.

Demand-side policies to encourage the use of generic medicines are important to increase their use. A plethora of different demand-side policies has already been initiated by European governments, thereby targeting physicians, pharmacists and patients. This review aims to give an overview of the different demand-side policies which governments have at their disposal and to evaluate their impact on the use of generic medicines. Positive knowledge and perceptions of physicians, pharmacists and patients of generic medicines are necessary prerequisites to increase the use of generic medicines and governments should initiate policies to achieve this. These policies should be combined with policies to increase their financial responsibility to the healthcare system and policies to facilitate the prescribing of generic medicines.

How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing? / ¿Cómo pueden contribuir los sistemas de remuneración farmacéutica a la dispensación de medicamentos genéricos?

Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demand-side. Pharmacists’ remuneration is one factor influencing the dispensing of generic medicines. Objective: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing. Methods: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices. Results: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price. Conclusion: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-for-performance remuneration system provides a stimulus for generic medicines dispensing as pharmacists are not penalized for dispensing them but also needs to account for the loss of income to pharmacists from prohibiting discounting practices (AU)

Los medicamentos genéricos pueden producir mayores ahorros a los presupuestos sanitarios cuando se apoyan con incentivos tanto a la oferta como a la demanda. La remuneración de los farmacéuticos es un factor que influye en la dispensación de medicamentos genéricos. Objetivos: El objetivo de este artículo es proporcionar una revisión de diferentes sistemas remunerativos de medicamentos genéricos en Europa, con idea de explorar con la remuneración de los farmacéuticos puede contribuir a la dispensación de genéricos. Métodos: Se obtuvieron datos de una revisión de la literatura, de una tesis de Master en Atención Farmacéutica en la Universidad Católica de Lovaina, y de un correo enviado a todos los miembros del Grupo Farmacéutico de la Unión Europea solicitando información sobre los sistemas locales de remuneración de farmacéuticos comunitarios y la posible existencia de informes sobre las prácticas de descuentos. Resultados: La remuneración de los farmacéuticos en la mayoría de los países europeos consiste en la combinación de una tasa fija por artículo y un cierto porcentaje del precio de compra o del precio de venta del medicamento. Este componente porcentual puede ser fijo, regresivo o con topes para los medicamentos de muy alto coste, y actúa como un desincentivo para dispensar medicamentos genéricos. Los descuentos para medicamentos genéricos son practica común en varios países Europeos, pero la información sobre esta práctica tiende s ser confidencial. Sin embargo, los datos de Bélgica, Francia, Holanda y Reino Unido indican que los porcentajes de descuento varían del 10% al 70% del precio del mayorista. Conclusión: Los farmacéuticos pueden jugar un papel importante en el desarrollo del mercado de genéricos. No se debería penalizar financieramente a los farmacéuticos por dispensar genéricos. Por tanto, su remuneración debería moverse hacia una tasa-por-acto en lugar de un rembolso precio-dependiente, que es lo que ocurre en la mayoría de los países Europeos. Este sistema de remuneración en tasa-por-acto produce estímulos para la dispensación de genéricos, ya que los farmacéuticos no son penalizados por dispensarlos, pero también necesita tener en cuenta las pérdidas de ingresos al prohibir las prácticas de descuentos (AU)

How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?

UNLABELLED: Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demand-side. Pharmacists''remuneration is one factor influencing the dispensing of generic medicines. OBJECTIVE: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing. METHODS: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices. RESULTS: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price. CONCLUSIONS: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-for-performance remuneration system provides a stimulus for generic medicines dispensing as pharmacists are not penalized for dispensing them but also needs to account for the loss of income to pharmacists from prohibiting discounting practices.

The impact of reference-pricing systems in Europe: a literature review and case studies.

As healthcare budgets are continuously rising in Europe, governments implement a wide variety of policies to control them. Reference pricing is a popular tool for governments to contain pharmaceutical expenditures, as 22 European countries have implemented this system. This article evaluates the impact of reference-pricing systems on drug use, drug prices, drug expenditure and health outcomes. In addition, two case studies, one for statins and one for proton-pump inhibitors, were carried out. Reference pricing drives down prices of drugs subject to the system and the use of these drugs has increased. Reference pricing creates short-term savings but the long-term growth of drug expenditure has not been reduced by reference pricing. Health outcomes of patients were not negatively affected by the system.

Does the market share of generic medicines influence the price level?: a European analysis.

BACKGROUND: After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. OBJECTIVE: This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. METHODS: Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. RESULTS: Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. CONCLUSIONS: The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?

OBJECTIVES: To explore the current status (2010) of tendering programs for outpatient pharmaceuticals in the European countries and how these programs operate. METHODS: A survey was designed to assess the features of tendering programs in European countries. All 27 countries of the European Union plus Norway were included in the study. The survey was sent to national representatives of authorities and organizations and to academic researchers with expertise in the domain. RESULTS: Nineteen of the 28 countries have responded to the questionnaire (68%). Seven countries have adopted tendering programs for pharmaceuticals in ambulatory care. Tendering was more popular in countries with a mature generic medicines market (54%) than in countries with a developing generic medicines market (12.5%). A legal basis, criteria to grant the tender, the number of winners and the duration of the tender were amongst the features for the program to work. CONCLUSIONS: Tendering programs can achieve savings in the short term. There are however some problems allied with the policy and the effects in the long term are still unclear. It can be concluded that the policy can work, but the features of the programs have to be well-thought-out.

Generic Medicine Pricing Policies in Europe: Current Status and Impact.

Generic medicine pricing is an area of national responsibility of European Union countries. This article aims to present the current status and impact of generic medicine pricing policies in ambulatory care in Europe. The study conducts a literature review of policies relating to free-pricing systems, price-regulated systems, price differentiation, price competition and discounts, and tendering procedures; and a survey of European generic medicine pricing policies. Competition from Indian generic medicine manufacturers, European variation in generic medicine prices and competition between generic medicine manufacturers by discount suggest that the potential savings to health care payers and patients from generic medicines are not fully realized in Europe. One way of attaining these savings may be to move away from competition by discount to competition by price. Free-pricing systems may drive medicine prices downwards under specific conditions. In price-regulated systems, regulation may lower prices of originator and generic medicines, but may also remove incentives for additional price reductions beyond those imposed by regulation. To date, little is known about the current status and impact of tendering procedures for medicines in ambulatory care. In conclusion, the European experience suggests that there is not a single approach towards developing generic medicine pricing policies in Europe.