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Contact Locations Investors News Events Privacy Careers. Working at IQVIA Life at IQVIA See all jobs. Insights The IQVIA Institute Reports Advancing Biosimilar Sustainability in Europe. About the Report. A growing number of biologic medicines have been developed and approved over the past decade, improving the lives of patients worldwide. However, patient access to biologics has been limited, partly due to their relatively high cost.

Biosimilars are increasingly available across Europe, bringing with them the opportunity to generate competition for biologic therapies and thereby lower medicine costs and increase patient access. This report puts forth a framework for the evaluation of sustainability in the biosimilars market and identifies its key policy elements.

Based on these criteria, current policies and market dynamics are assessed to identify where risks to sustainability exist and the best practices that can support the long-term positive contribution of biosimilars in Europe. Report Summary. Biosimilars are now an integral part of the market for biologics, which accounted for 277 billion in sales globally in 2017 and is projected to reach 452 billion by 2022.

Use of biosimilars in the EU5 countries alone stands to offer savings of more than 10 billion between 2016 and 2020. To sustain the market for biosimilars in the long-term, ongoing benefits for all stakeholders must be ensured. Sustainable policies therefore provide for patient access and physician prescription choice, provide a means to manage existing healthcare budgets for payers, and safeguard a healthy level of competition, supply, and product safety and quality. Current European policies and market dynamics were assessed to identify the risks and challenges to sustainability, with the aim to identify best practices that can be leveraged to support long-term sustainability of the biosimilars market in Europe.

Overall, biosimilars have increased patient access to biologic medicines, and this growth is supported by a regulatory environment and clinical guidelines that create a neutral or positive climate for biosimilars relative to originator biologics, and thus supports their sustainability. However, some elements of a sustainable system were found to potentially be at future risk due to payer driven-switch and specific purchasing systems.

Specifically, payer-driven switch was found to reduce physician prescription choice, potentially leading to loss of product options currently working for patients and reducing patient involvement in the treatment decision. Additionally, single-winner tenders were found to disrupt market forces and competition, thereby not supporting long-term sustainability. Several alternative policies currently in place in Europe can be leveraged to ensure and support the long-term sustainability of the biosimilars market while additionally fulfilling the needs of all stakeholders.

Key Findings. Sustainability in the biosimilars marketplace ensures benefits for all stakeholders. Biosimilars are a key means to alleviate nicola p iq option challenges faced by many stakeholders in the currently constrained European budgetary environment. Elements of biosimilar sustainability represent the needs of all stakeholders including patients, physicians, payers and manufacturers and support the healthy functioning of the marketplace for medicines.

Policies can influence the achievement of these elements variably, and it is therefore valuable to explore which current biosimilar policies in Europe best secure a sustainable environment supporting these. Launch of a biosimilar brings with it increased patient use of biologic medicines. In the years following biosimilar launch, significant growth is seen in the use of biologic molecules.

However, growth often slows to pre-launch levels within a few years, reflecting the declining competitiveness of the molecule itself within a market that includes innovative therapies. Uptake also varies by country; in Norway, where biosimilars are strongly promoted by health authorities, and national tenders are used, uptake is fast and use of biologic medicines grow.

In contrast, in countries like Italy, where health authorities have a more conservative perspective regarding biosimilars, the uptake has been slower. Faster and higher biosimilar penetration is seen when national tenders are run as single tenders with single winners, as in the case of Norway and Denmark, however this mechanism was found to jeopardise long-term sustainability.

The European regulatory environment and clinical guidelines are generally positive toward sustainability. Overall, the current European regulatory environment creates a neutral or positive environment for biosimilars relative to originator biologics and supports sustainability. However, two potential areas pose a risk to sustainability payer-driven switch and tender systems that award total molecule market volume to a single competitor.

Payer-driven switch was found to reduce physician prescription choice, potentially leading to loss of product options currently working for patients and to reduce patient involvement in the treatment decision. Although single-winner tenders were found to achieve greatest price reduction on biologic products when biosimilar competition exists, they were also found not to support long-term sustainability as they disrupt market forces and competition by excluding nonwinner manufacturers from the market for the duration of the tender contract.

Additional evidence suggests single-winner tenders do not always optimise savings, since physicians can still use non-preferred product at a higher price; whereas multi-winner tenders offer price reductions on all contracted products. Several policies currently in place in Europe can be leveraged to support the long-term sustainability of the biosimilars market.

Based on sustainable policies currently in place in Europe, a set of best practices can be leveraged to ensure long-term sustainability of the biosimilars market, while additionally fulfilling the needs of all stakeholders. These include creating positive incentives to promote biosimilar uptake, taking steps to ensure that physicians retain prescription freedom to offer the best product selection for a specific patient and designing tenders and contracts to have multiple winners and include criteria other than price.

Report Charts. Chart 1 Availability of Biosimilars in Europe. Chart 2 The EMA s Definitions of Interchangeability, Switch and Substitution. K Example of a National Framework for Biosimilar Commissioners. Chart 4 A Multi-Stakeholder Definition of Sustainability for the Biosimilar Marketplace. Chart 5 Biosimilar Sustainability Assessment Framework Key Areas.

Chart 6 Biosimilar Sustainability Assessment Framework Qualitative and Quantitative Metrics Examined. Chart 7 Countries and Molecules Assessed. Chart 8 Growth in Molecule Utilisation Across Countries with Successfully Adopted Biosimilars, as a Percentage of 2012 Values. Chart 9 Growth in Utilisation by Country of all Molecules Exposed to Biosimilar Competition Where Biosimilars Were Successfully Adopted, as a Percentage of 2012 Values.

Chart 10 Time to First Sales for Biosimilars versus Branded Products by Country. Chart 11 Infliximab Biosimilar Prescribing Targets Set by KVs and KVB in Germany. Chart 12 Biosimilar Penetration in Norway Over Time. Chart 13 Biosimilar Penetration in Denmark and France. Chart 14 Infliximab Per DDD Product Costs by Swedish Country in Relation to Use of Single- Versus Multiple-Winner Tenders, Q1 2018. Chart 15 Competition in Germany. Chart 16 Percent Difference Between Biosimilar and Originator Price at Biosimilar Launch by Country.

Chart 17 List and Net Prices in Germany, as Percent of Originator List Price. Chart 18 Biosimilar Sustainability Metrics Across Countries Based on Existing Policies. Chart 19 Payer-driven Switch Scenarios Impact on Sustainability in the Biosimilar Marketplace. Chart 20 Tendering Scenarios Impact on Sustainability in the Biosimilars Marketplace. Chart 21 Best Practices to Achieve Sustainability for All Stakeholders in the Biosimilars Market.

Chart 22 Metrics to Evaluate. Chart 23 Multi-Stakeholder Assessment. IQVIA Institute Inquiries. We are ready to help you better understand and benefit from the work of the IQVIA Institute for Human Data Science. Please get in touch today to learn more. So that you can get your new wheels quicker, we have most of our alloy wheels in stock.

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Results showed the AcrySof IQ PanOptix group had superior visual outcomes at six months in uncorrected intermediate visual acuity at 60 cm p 1. To raise patient awareness on cataract treatment options, Alcon has developed the More to See campaign, including a survey conducted in 12 countries across Europe, Middle East and Africa in 2017 to understand the knowledge on cataract disease and treatment of consumers aged 60 and over.

Results showed that few people 39 are aware that some surgical options for cataract treatment can also provide vision correction. When asked, the majority 82 would be willing to have an advanced surgical option that could treat their cataract and improve their vision. These results shows the need for further patient information at time of cataract surgery 2. More details are available on www. AT LISA is a registered trademark owned by or licensed to ZEISS.

About Cataracts. Cataracts are one of the most common age-related eye conditions and one of the leading causes of vision loss 7. The World Health Organization WHO estimates that nearly 18 million people are bilaterally blind from cataracts in the world, making the condition responsible for almost half of all global cases of blindness 8.

A cataract is a cloudy area in the naturally clear lens of the eye that affects vision. The vast majority of cataracts happen because of normal aging, but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts 9. As a cataract develops, the eye s lens gradually becomes cloudy, allowing less light to pass through, which makes it more difficult to see 10. About the AcrySof portfolio. The AcrySof IQ portfolio comprises monofocal, toric and multifocal IOLs to address the individual needs of patients with cataract.

The AcrySof IQ IOL platform leverages a unique BioMaterial, high-performance BioMechanics and advanced BioOptics to help maximize cataract patient outcomes. Since its first launch in 1994, the AcrySof IOLs have been implanted more than 100 million times, improving the sight and lives of tens of millions of patients over the past 20 years. Important Information about AcrySof PanOptix IOLs. AcrySof IQ PanOptix was launched in 2015, it is currently available in more than 70 countries worldwide.

As with any surgical procedure, there are associated risks. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk benefit ratio before implanting a lens of this type. This is particularly so in a patient with any of the conditions described in the AcrySof IQ PanOptix physician labeling. Some patients may experience visual disturbances and or difficulty seeing due to the multifocal lens design, especially under dim light conditions.

As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explanation of an AcrySof IQ PanOptix IOL. Posterior capsule opacification PCO may significantly affect the vision of patients with multifocal IOLs sooner in its progression than in patients with monofocal IOLs. This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.

Forward-looking statements can generally be identified by words such as potential, can, will, plan, expect, anticipate, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements.

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements.

There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future.

Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG s current Form 20-F on file with the US Securities and Exchange Commission.

Lapid-Gortzak R, Duch F, Elies D, Guarro M, Martinez A. Multicenter Visual Outcomes Comparison of Two Trifocal Presbyopia Correcting IOLs 6 Months Post-op Results. World Ophthalmology Congress. Barcelona 2018. More to See campaign survey EMEA. Alcon data on file. January 2017 Lee BS, Chang DF. Comparison of the Rotational Stability of Two Toric Intraocular Lenses in 1273 Consecutive Eyes.

Ophthalmology 2018 Gundersen GK, et al. Trifocal intraocular lenses a comparison of the visual performance and quality of vision provided by two different lens designs. Clinical Ophthalmology 2017 11 1081 1087. Estimation of Light Energy Distribution for PanOptix IOL. Alcon data on file, 2015. García-Pérez et al. Short term visual outcomes of a new trifocal intraocular lens. BMC Ophthalmology 2017 17 72.

Prevent Blindness. Vision Problems in the U. Accessed April 2017. The International Agency for the Prevention of Blindness. Accessed April 2018. American Optometric Association AOA. Causes of Cataract. Accessed May 2017. Cleveland Clinic. Accessed August 2015. About Novartis. Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care.

Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49. 1 billion, while R D throughout the Group amounted to approximately USD 9. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. Novartis is on Twitter.

For Novartis multimedia content, please visit www. For questions about the site or required registration, please contact email protected. About Alcon. Alcon is the global leader in eye care. As a division of Novartis, we offer the broadest portfolio of products to enhance sight and improve people s lives. Our purpose is reimagining eye care, and we do this through innovative products, partnerships with eye care professionals and programs that enhance access to quality eye care.

Learn more at www. Alcon is on Facebook. Novartis Media Relations. Central media line 41 61 324 2200. Our products touch the lives of more than 260 million people each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors, and there are millions more who are waiting for solutions to meet their eye care needs. Eric Althoff Novartis Global Media Relations 41 61 324 7999 direct 41 79 593 4202 mobile email protected.



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