[Ip-health] Drugmakers warn Germany over "punitive" price moves

Tahir Amin tahir at i-mak.org
Wed Jun 13 13:27:23 PDT 2012


http://www.pharmatimes.com/Article/12-06-11/Drugmakers_warn_Germany_over_punitive_price_moves.aspx

Drugmakers warn Germany over "punitive" price moves

"Punitive" drug pricing measures introduced in Germany in recent years are
jeopardising German patients' access to innovative therapies that are
available to citizens throughout Europe and the rest of the world, the
government has been warned.


These measures include the 16% mandatory rebate introduced in August 2010,
plus "an international reference pricing system that links the price of
medicines in Germany to those in countries like Greece and a medicines
assessment system that links the price of new medicines to generics,"
according to Richard Bergstrom, director general of the European Federation
of Pharmaceutical Industries and Associations (EFPIA), speaking in Berlin
on June 8.


"Germany has traditionally led the rest of Europe in providing quick access
to new medicines for its citizens and recognising the value of new
medicines and vaccines  - this position is now under threat," he warned.

It was "absolutely appropriate that Germany manages its healthcare budget
carefully and assesses medicines to ensure that they are priced at a level
that reflects the value they deliver," he emphasised, but added that early
experience with the Act for Restucturing the Pharmaceutical Market in
Statutory Health Insurance (AMNOG) - which took effect on January 1, 2011 -
has been "very disappointing."


"The problems lie with a law that is flawed in parts, inflexible
interpretation and an unwillingness to consider creative solutions," he
said.


EFPIA points out that its member companies have found the choice of
comparator often differs from that chosen for the development programme
after consultation with the European Medicines Agency (EMA), and that this
is being used to force German pricing for innovative new medicines to match
that of much older generic products, which is undermining incentives for
R&D.

"German patients would benefit from a more thoughtful and interactive
choice of comparators, based on medical and patient reality. Price
comparisons should be made with patented products, not generics, and there
should be more meaningful consultation and discussion," it says.

The industry has found "the set-up very rigid," added Mr Bergstrom.
"Unfortunately, many of my member companies have been forced to announce
that several new medicines will not be made available in Germany, because
the model seeks to base the price for new medicines on what is paid for
much older, generic medicines. This is not good for German patients and not
good for the country as it strives to retain companies and attract new
investments." he said.


AMNOG is now "in a learning phase - the original intent was good, but some
things were lost in translation to the practical model," he added.


Another concern is the choice of reference countries as a basis for price
negotiations, Mr Bergstrom went on. "The decision by the arbitration panel
to include Greece in the basket of countries is hard to understand," he
said.

"The pharmaceutical industry accepts short-term sacrifices in Greece to
support the country at a crisis moment. When trying to benefit from lower
prices in Greece, German policymakers fail to acknowledge hat some
countries have to pay more to sustain innovation - and Germany has
benefited more than most countries from investments by the pharmaceutical
industry," he added.

Birgit Fischer, director general of the German research-based industry
association VFA, emphasised that Europe is in crisis, that growth will only
come from sectors which innovate, and that a key way forward is to invest
in R&D.

Germany has the ability to strengthen Europe, but it also has the most to
lose if Europe "appears resistant to innovation," she warned.


- Also last week, Germany's Federal Joint Committee (G-BA) asked, for the
first time, for a benefit assessment of drugs launched before 2011. AMNOG
allows for such a request if the products compete for other medicines for
which there is an early benefit assessment or if they are considered to be
therapeutically important.

The G-BA is seeking benefit assessments for a range of diabetes treatments
- Merck & Co's Januvia (sitagliptin) and Janumet (metformin plus
sitagliptin), Novartis' Galvus (vildagliptin) and Eucreas (metformin plus
vildagliptin) and AstraZeneca/Bristol-Myers Squibb's Onglyza (saxagliptin)
- because they are direct competitors to Boehringer Ingelheim's Trajenta
(linagliptin), for which the committee issued a negative opinion at the end
of march.

The manufacturers have until December 31 to submit the benefit data to the
B-GA, which is due to commence an evaluation of gliptin drugs next January.


See also EFPIA press release at:
http://www.efpia.eu/content/default.asp?PageID=559&DocID=13034

-- 
Tahir Amin
Co-Founder and Director of IP
Initiative for Medicines, Access & Knowledge (I-MAK)
Email: tahir at i-mak.org
www.i-mak.org



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