BERLIN, Feb 16 (APM) - Germany's added benefit assessment is taking a dangerous path towards excluding an increasing number of new drug, an industry leader told a conference on Thursday.
Han Steutel, head of Bristol Myers Squibb Germany and chair of the association of research-based pharmaceutical companies in Germany vfa, said: "20% of the drugs assessed for added benefit in Germany since 2011 have been withdrawn from the market. I am very concerned that this percentage will rise in the next few years."
"Companies were forced to withdraw these drugs because of unacceptable pricing conditions," said Steutel, who was speaking at the Handelsblatt Pharma 2017 conference in Berlin.
He said it is a consequence of how the higher health technology assessment (HTA) body G-BA rates new drugs, with 40% of the 214 drugs assessed since 2011 having a no added benefit.
The pharma industry had warned German authorities and politicians against this risk during the discussion of the AMNOG law before 2011, Steutel reminded.
"We were told that pharma companies can't renounce the German market. But we have now reached a 20% rate," he said.
He added the gap is growing between the way Germany assesses cancer drugs and the approach in the U.S.
"When the U.S. assesses cancer drugs with overall response rate, we, in Germany, only evaluate the overall survival. This gap will become wider in the next few years."
Recently, three G-BA assessments came under sharp criticism from the industry: on Bayer's cancer drug Stivarga (regorafenib), AstraZeneca's lung cancer drug Tagrisso (osimertinib) and Bristol-Myers Squibb's immuno-oncology combination Opdivo (nivolumab)+Yervoy (ipilimumab) (APMMA 50981).
Bayer and AstraZeneca withdrew their products after the G-BA ruling and initial pricing negotiations (APMMA 47463, APMMA 50253).
"This problem doesn't get the attention it deserves" from German decision makers, Steutel said.
"Patients will not miss products that are not available on the German market because they will simply not know what they are missing," he said.
Steutel named it the "Airbag paradox"; drivers did not miss airbags when they were not on the market but airbags would have saved many lives.
A tougher pricing policy on new drugs is not necessary in Germany, given the past evolution. The cost explosion feared in the last years did not happen, said Steutel.
Drug spend for the health instance increased by 2.6% on average from 2009 to 2015, less than the increase of total health insurance spend in the same period. Patent-protected drugs represent only 6% of all health insurance costs.
The cost of the new hepatitis C drugs, introduced from 2014, was highly criticised but it has halved since then, because treated patients are now healed, Steutel said.
The introduction of a volume pricing threshold in Germany and other restrictive measures in the drugs care reinforcement bill (AM-VSG), currently in discussion in Parliament, come at thew wrong time in the international situation, Steutel said.
The new German context could be interpreted as negative signal to innovation. "The threshold along with the continuation of the price moratorium are really not tools that stimulate drug innovation".
It collides with the orientation taken by U.S. president Donald Trump on U.S. drug pricing policy and the priority given to innovation, Steutel suggested.
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