Germany's Federal Joint Committee (G-BA) has decided that the Gilead Sciences (US) drug Zydelig shows an additional benefit in some chronic lymphocytic leukaemia (CLL) patients, and that GlaxoSmithKline (GSK, UK)'s Eperzan provides additional benefits in one of four treatment situations.
IHS Life Sciences perspective | |
Significance | The G-BA has given additional benefit status to new medicines in recent decisions: the Gilead Sciences treatment Zydelig was judged to demonstrate additional benefits for some CLL patients, while the GSK type 2 diabetes drug Eperzan was judged to have additional benefits in one out of four treatment situations. |
Implications | In the case of Zydelig, the G-BA's decided that the drug demonstrates an improvement, in comparison with IQWiG's across-the-board 'no additional benefit' verdict. In the case of Eperzan, the G-BA agreed with IQWiG's decision. |
Outlook | Particularly in the case of Zydelig, it seems that an additional benefit status was awarded in the context of the severity of the disease, irrespective of the shortcomings of the dossier submitted. This is a positive development for patients as well as the manufacturer. |
Germany's Federal Joint Committee (Gemeinsamer Bundesauschuss: G-BA) has published its final decision document on the early benefit assessment of the Gilead Science (US) drug Zydelig (idelalisib), in the treatment of patients with chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The G-BA has differed from the verdicts of Germany's Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen: IQWiG) in the case of two of the patient groups for whom treatment with the drug has been under review.
G-BA finds indication of 'unquantifiable' additional benefit for Zydelig in two patient groups
IQWiG had decided that no additional benefit could be demonstrated in any of the patient groups, taking issue with the combining in the study data of patients with refractory and relapsed CLL, as well as the use of one-arm studies in the data for follicular lymphoma and two CLL treatment situations (see Germany: 6 January 2015: Germany's IQWiG decides Gilead's Zydelig shows no additional benefit). However, the G-BA, while noting the inadequacies of the data, diverged from the institute in awarding an 'unquantifiable' additional benefit in two patient groups. The details of these can be found below, and the full set of documents relating to the drug's early benefit assessment can be accessed here, in German.
G-BA final decision on early benefit assessment of Zydelig, all indications/population subgroups | |||
Indication/population subgroup | Appropriate comparator therapy | G-BA verdict on extent of additional benefit | Justification |
Patients with CLL who have been pre-treated with at least one therapy, of which: | - | - | - |
-patients with relapsed CLL, for whom chemotherapy is indicated | Chemotherapy in combination with rituximab | None | The required evidence has not been submitted. |
-patients with relapsed CLL, for whom chemotherapy is not indicated | Best supportive care | Indication of an unquantifiable additional benefit | Additional benefit can be perceived in a qualitative, not quantitative, sense. |
-patients with refractory CLL, for whom chemotherapy or treatment with Arzerra* is indicated | Patient-specific, optimtised therapy | None | The required evidence has not been submitted. |
-patients which refractory CLL for whom chemotherapy or treatment with Arzerra is not indicated | Best supportive care | None | The required evidence has not been submitted. |
First-line treatment of patients with 17p deletion or TP53 mutation in patients unsuitable for chemoimmunotherapy | Best supportive care | Indication of an unquantifiable additional benefit | "Significant treatment effects" perceived; severity of the disease taken into consideration. |
Follicular lymphoma refractory to at least two previous therapy lines | Best supportive care | None | The required evidence has not been submitted. |
Source: G-BA *Arzerra (ofatumumab; GlaxoSmithKline, UK) | |||
Eperzan judged to show hint of minor additional benefit in one treatment setting
The G-BA has also recently published its final decision on the GlaxoSmithKline (GSK, UK) type 2 diabetes drug Eperzan (albiglutide). In this case, its conclusion matched that of IQWiG (see Germany: 5 January 2015: Germany's IQWiG finds GSK's Eperzan shows indication of minor additional benefit in type-2 diabetes treatment). It found a hint for a minor additional benefit of the drug in the case of one of the four treatment situations for which it was assessed – in combination with another blood-sugar-lowering drug (other than insulin) or in triple combination with metformin (the G-BA states that if metformin is contra-indicated in this treatment setting, then human insulin should be used). In this case, the appropriate comparator therapy was metformin and a sulphonylurea (glibenclamide or glimepiride). The G-BA balanced what it described as the advantage of the lower damage due to a reduction in confirmed symptomatic hypoglycaemia compared with the appropriate comparator, with the disadvantage of negative reactions at the site of injection in the case of Eperzan. The full documentation of Eperzan's early benefit assessment can be accessed here, in German.
Outlook and implications
Zydelig was approved for marketing in the European Union in September 2014, and Germany is likely to be one of the first major EU markets to complete a full health technology assessment of the drug. Significantly, the G-BA decided to award an additional benefit status to Zydelig in the treatment of CLL patients with 17p deletion or TP53 mutation even though, in the data submitted, the appropriate comparator therapy set by the G-BA – best supportive care – was not implemented in the study on which the data in the dossier was based. In this case, the G-BA chose to take the severity of the disease into account and awarded the drug additional benefit status, albeit unquantifiable (reflecting its concerns about the data submitted). This underlines the fact that some degree of flexibility on formalistic concerns exists in the German system in the case of the most severe diseases.
In the case of Eperzan, a glucagon-like peptide 1 (GLP-1) receptor agonist, the first example of which appeared in the market in the middle of the previous decade, it is also perhaps a positive sign that the G-BA has seen fit to award additional benefit status to this drug, considering the harsh line it has taken on newer types of type 2 diabetes treatments in the last few years. Nevertheless, it will be up against strong competition in this market space in Germany, including from another GLP-1 receptor agonist, the Novo Nordisk (Denmark) bestseller Victoza (liraglutide).