by Hélène Mauduit
BERLIN, Jan 5 (APM) - German pharma lobbies have defended the benefit of new drugs launched on the German market and their value despite negative benefit assessment after umbrella payer group GKV-Spitzenverband (GKV-SV) made criticisms on Wednesday.
GKV-SV's deputy head Johan-Magnus von Stackelberg said in an interview with Funk Medien newspaper and in a statement that of the 129 drugs that underwent price negotiations under the new AMNOG procedure from 2011 to mid-December 2016, "only one third were able to prove added benefit, while one third showed no additional benefit and a third showed a mixed situation".
According to a graph GKV-SV sent to APM, 44 drugs proved full positive added benefit in all assessed patient-subgroups, 44 drugs obtained a mixed rating among various subgroups and 41 drugs were rated as having no added benefit in any subgroup.
GKV-SV also said that 29 drugs were still undergoing price negotiations, two drugs were being examined by an arbitration body called after price negotiations failed and 14 drugs had been withdrawn from the German market during the AMNOG procedure.
Without quoting Stackelberg, the newspaper wrote that the results of the assessment are considered by payers as a confirmation that "many new drugs are not needed at all".
The association of research-based pharmaceutical companies in Germany, vfa, responded to Stackelberg saying that the payers were waging an unfair campaign against drugs that were equivalent to standard therapies.
Drugs which are rated as having no added benefit by German HTA bodies IQWiG and G-BA are "often recommended in the guidelines of medical societies", said vfa general manager Birgit Fischer in a press release. The 'no added benefit' rating is "most of the time given for purely formal reasons".
vfa previously said that in many cases, a drug had failed to prove an added benefit because IQWiG or G-BA rejected the clinical results provided by the manufacturer on methodological criteria, even if these data had been sufficient to grant a marketing authorisation (APMMA 50862).
Drugs with no added benefit "are at least equivalent in comparison to existing therapies, otherwise they would not have received an authorisation. So they have benefit and, for some patients, they are a necessary treatment alternative".
"Medicine needs a wide range of equivalent drugs because no patient resembles another. A drug which helps one patient does not help others. What one is able to tolerate, others are not," Fischer said.
She added: "There must be no single therapy for all patients. We will continue to need a lot of equivalent drugs, for instance in HIV therapy or in neurological disorders.
The association of German small and middle-sized pharmaceutical companies, BPI, said that GKV-SV figures were "misleading" and aimed at "upsetting patients and doctors".
BPI gave its own calculation of the added benefit assessments, based on sub-groups evaluated until mid-September 2016. On the 259 sub-groups for which G-BA found no added benefit, the ruling was based on "purely formal reasons" in 180 cases, that is "more than 70%", BPI said in a statement.
According to BPI, reasons are 'formal' when G-BA judges that the evidence is incomplete or the data are inadequate or not sufficient for the assessment.
G-BA's ruling "does not state the therapeutic value of the drug for a single patient. Mr. von Stackelberg knows that", said BPI general manager Henning Fahrenkamp in a press statement.
The topic is particularly sensitive at the moment as the German Bundestag is discussing a reform of the AMNOG law with the aim of continuing to limit drug spending growth and to avoid "astronomical" drugs prices.
The two partners of the ruling coalition, Christian democrats from the CDU and CSU and social democrats from the SPD, are currently holding talks to find an agreement on the bill, called the drugs care reinforcement bill (AM-VSG). .
If an agreement is found in January, the bill could be passed in mid-February.
Stackelberg as well as other insurers criticised the bill for being too favourable to the pharmaceutical industry (APMMA 49989), and health expert Ulrich Schwabe even said it was 'dismantling' the AMNOG law and the procedure connecting pricing with added benefit assessment (APMMA 49751).
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).
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