|[September 27, 2013]
Research and Markets: European Payers Push Back on Orphan Drug Prices
DUBLIN --(Business Wire)--
Research and Markets (http://www.researchandmarkets.com/research/9kthmx/orphan_drugs_in)
has announced the addition of Just Pharma Reports's new report "Orphan
Drugs in Europe: Pricing, Reimbursement, Funding & Market Access Issues,
2013 Edition" to their offering.
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 economic value?
'Orphan Drugs in Europe: Pricing, Reimbursement,
Funding & Market Access Issues, 2013 Edition', a new publication from Justpharmareports,
finds that if there is discrimination by payers towards orphan drugs as
a group it is still in a positive way. The products are as diverse as
the diseases they treat and some are coming under greater scrutiny,
Four of the first seven orphan drugs to enter
Germany's AMNOG procedure were considered to bring only minor additional
benefit andfor two others the benefit was deemed non-quantifiable.
Discounts were required by GKV-Spitzenverband for all. Re-evaluation by
the French Transparency Commission has seen both SMR and ASMR scores
downgraded with resultant price cuts or delistings. 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 removal from
reimbursement after results from a 4-year risk-sharing PMS period
Other payer concerns include the numbers of marketed
and pipeline orphan drugs, the quality of clinical evidence, clustering
of treatments for the same rare disease, uncertainty on patient numbers
and dosage, the high prices being requested, diversion of funds away
from treating more common conditions, repurposed old medicines,
indication creep, displacement of cheaper alternatives, and a failure to
meet cost effectiveness thresholds.
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.
Updated to autumn 2013, the report 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.
For more information visit http://www.researchandmarkets.com/research/9kthmx/orphan_drugs_in
Source (News - Alert): Justpharmareports
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