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Wednesday, April 24, 2013

Worldwide Risk Sharing and Other Forms of Managed Entry Agreements for Medicines - New Market Study Published



Managed entry agreements apply to an increasing number of new, innovative drugs in a growing number of markets. They are designed to share the risk between the manufacturer and the payer, consequent on uncertainties - usually at launch - about the product’s value (clinical- and cost-effectiveness), budget impact and/or utilisation to optimise performance, whilst at the same time allowing patient access. For many products considered costly they are almost essential to achieve reimbursement where health technology assessment is applied.

To Read the Complete Report with TOC Visit: http://www.marketresearchreports.biz/analysis/166814


Risk Sharing and Other Forms of Managed Entry Agreements for Medicines, Worldwide covers all the main types of agreements (finance-based, outcome- or performance-based, and compliance-based) and their many variants in all countries that employ them. The confusing taxonomy associated with the topic (e.g. price/volume deals, budget impact schemes, cost capping, cost sharing, coverage with evidence development, money back guarantees, conditional reimbursement, listing agreements, payment for performance, payment by results) is clearly explained. 

Find out from a manufacturer’s perspective:
  • Which party should first propose an agreement and at what stage?
  • What types of agreements are possible and where?
  • Which therapeutic classes are most affected?
  • Can an agreement accepted in one country be rolled out to another?
  • Is standardisation of design likely?
  • How is monitoring conducted?
  • What types of outcome are measurable in performance-based schemes?
  • How much confidentiality surrounds finance-based deals?
  • What are the benefits of risk sharing, what are the concerns?
  • How much do schemes burden the health service?
  • Have past agreements delivered on expectations?
  • Is more of the same the way forward?


Focussing on markets with the most experience of risk sharing – Australia, Belgium, Canada, France, Italy, Portugal, Sweden and the UK – the report in total covers 24 countries across Europe, North America and Asia-Pacific. Deals where the payer is an insurer/health system at the national or local level, or an individual patient are included. Numerous brand name examples are cited by country/agreement type with 12 case studies in more detail.


Latest Report:

Biosimilars: Current Situation & Future Prospects, Worldwide: http://www.marketresearchreports.biz/analysis/98752


The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with the vast majority of leading originator brands in the global biologics market expected to lose some degree of protection by 2019. All major countries now make provision for an abbreviated biosimilar development and regulatory pathway. Funds are flowing into the sector and many new partnership agreements signed. Everything in the biosimilar garden might look rosy, but what is the reality?

Biosimilar sales of $16+ billion were forecast in the EU and US alone for 2011.This estimate turned out to be 50-times too high. Does publication of the long-awaited guidance on the US Biologics Price Competition and Innovation Act mean a new dawn for biosimilars, or another false one? Written with the understandable detail and objectivity you need, Biosimilars:
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