BERLIN, Sep 1 (APM) - Germany's higher health technology assessment (HTA) body G-BA has found a hint of considerable added benefit for Lilly/Boehringer Ingelheim's diabetes drug Jardiance (empagliflozin) in diabetic patients with manifest cardiovascular disease in its reassessment published on Thursday.
But G-BA was not positive about the two pharmas' combination of Jardiance and metformin, Synjardy, concluding that there was no added benefit in any sub-groups in a separate assessment.
These two assessments had been eagerly awaited in Germany since the results of the EMPA-REG OUTCOME study were released in September 2015, showing that empagliflozin is associated with a 38% drop in cardiovascular mortality for high-risk patients (APMMA 44107), and with benefit in heart failure mortality (APMMA 44903).
Boehringer started a reassessment procedure for Jardiance in March, hoping to get a better rating than the first "no added benefit" obtained in February (APMMA 41386), and coupled it with the first assessment of the newly launched Synjardy.
The positive reassessment for Jardiance opens the door to a price increase, which will now be negotiated with umbrella payer group GKV-Spitzenverband and is planned to conclude at the end of February 2017.
Jardiance had undergone a 40% price cut in January following the initial assessment (APMMA 45823).
G-BA did not follow the recommendation given in June by lower HTA body IQWiG, which found no added benefit for either drug (APMMA 48113). One reason for this is that G-BA divided the patient population in a different way from IQWiG and distinguished patients with "manifest cardiovascular disease" from those without.
Five combination therapies were chosen, consisting of glibenclamide or glimepiride, alone or with metformin or metformin plus human insulin, or with another hypoglycaemic drug.
Of the 10 subgroups formed, G-BA found a hint of considerable added benefit in four, all consisting of patients with "manifest cardiovascular disease", and a hint of minor added benefit in one subgroup of patient without manifest cardiovascular disease (taking Jardiance with another hypoglycaemic drug other than insulin, if cholesterol is not adequately controlled with diet and exercise).
G-BA justified this division by the fact that the EMPA-REG OUTCOME study deals exclusively with patients with diabetes and "manifest cardiovascular disease" according to defined criteria, and is relevant only for these patients in an HTA procedure.
Only one subgroup with patients with "manifest cardiovascular disease" taking Jardiance with another drug used to treat cardiovascular risk factors failed to receive a positive rating; there was a lack of data for this group.
G-BA said that the results from the EMPA-REG-OUTCOME study could not be used to assess Synjardy.
It said Boehringer had based its evaluation of Synjardy on the total population and not on the relevant subpopulation, which had received a daily dose of at least 1700 mg of metformin. The company had not shown that the results of the total population could be transferred to the relevant subpopulation.
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