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
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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?
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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:
About UsBiosimilar 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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