MarketResearchReports.Biz presents this most up-to-date research on "Orphan Drugs in Europe: Pricing, Reimbursement, Funding and Market Access Issues"

Albany, NY -- (SBWire) -- 09/26/2013 --The cost of treating rare disease in an age when austerity measures are hitting total healthcare funding across Europe is a highly controversial, even emotive subject. There is a clear and pressing clinical need, a strong patient voice and the treatments themselves sometimes offer the only hope. But is this enough to assure premium prices and special status in an era of budget limitations, and growing demands for evidence of clinical and cost effectiveness?

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Payers are becoming increasingly strict. Four of the first seven orphan drugs to enter Germany’s AMNOG procedure were considered to bring only minor additional benefit and for two others the benefit was deemed non-quantifiable. Discounts were required for all. Re-evaluation by the Transparency Commission in France has seen both SMR and ASMR scores downgraded with resultant price cuts. Half of all orphan drugs evaluated have been rejected by one or more HTA bodies in the UK.

Manufacturers of treatments for Fabry and Pompe diseases are currently negotiating discounts in the Netherlands to prevent delisting after results from a four-year conditional reimbursement PMS period disappointed. On a more positive note, September 2013 saw the start of the first pilot pan-EU assessment under the Mechanism of Co-ordinated Access to Orphan Medicinal Products (MoCA-OMP) initiative.

Orphan Drugs in Europe: Pricing, Reimbursement, Funding & Market Access, 2013 Edition is a fully revised and greatly enlarged version of Justpharmareports best-selling 2008 and 2011 reports, and the author’s sixth major title on the subject.

Updated to autumn 2013, it includes:

- Availability, price and reimbursement status for all 64 EU-designated orphan drugs as of June 2013 with centralised marketing authorisations granted prior to end-2012.
- How orphan drug policies differ across Europe. Expanded sections on each EU-5 country, Belgium, Netherlands and Sweden. 25 countries covered in total.
- Both hospital and out-of-hospital market segments.
- How reimbursement systems treat orphan drugs. ‘High cost’ funding systems explained.
- Impact of health technology assessment.
- How managed entry agreements and patient registries can help bridge the data gap.
- Key role of patient advocacy groups.
- 15 case studies.
- The potential for European collaboration to accelerate market access.

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Risk Sharing And Other Forms Of Managed Entry Agreements For Medicines, Worldwide: http://www.marketresearchreports.biz/analysis/166814

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.

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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?

Pharmaceutical Pricing & Distribution In Japan, 2012 Update: http://www.marketresearchreports.biz/analysis/132982

No serious pharmaceutical company can afford to ignore Japan, a $120 billion market, the second-largest in the world. It remains a tough and highly competitive market to crack, however, with the environment for developing and marketing medicines dominated by price.

No new brand can be introduced without a yakka (reimbursement price) set by the
government. Innovative drugs receive price premiums while others are capped at the price of older entrants. Discounting to the trade is inescapable, but is punished by downward price revisions on a scale and frequency unseen elsewhere. Big selling brands are repriced.

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Distribution is inherently linked to the pricing process and is particularly opaque to outsiders This latest, fully-updated and enlarged version of the critically-acclaimed best-seller includes

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