On 4 February, Germany's Federal Joint Committee (G-BA) published its final decisions on chemotherapy-induced nausea and vomiting treatment Akynzeo, type 2 diabetes drug Xultophy, and COPD treatment Spiolto Respimat, finding an additional benefit, for one patient group, only in the last.
IHS Life Sciences perspective | |
Implications | The G-BA's decisions on these medicines are unsurprising, as they are the same as those from IQWiG. |
Outlook | Having already withdrawn Tresiba from the German market, Novo Nordisk may consider doing the same with Xultophy, which has received a second knockback from the G-BA. The G-BA's verdict on Spiolto Respimat is relatively positive for Boehringer, and the company is expected to submit a new dossier with data from ongoing trials within half a year that could help to upgrade the verdict further. |
Akynzeo assessed to show no additional benefit
On 4 February, Germany's Federal Joint Committee (G-BA) published its final resolution on the early benefit assessment of the Helsinn Birex (Switzerland) drug Akynzeo (netupitant + palonosetron) in the prevention of acute and delayed nausea and vomiting associated with moderately or highly emetogenic chemotherapy.
In the case of moderately emetogenic chemotherapy, the appropriate comparator set by the G-BA was the combination of a serotonin antagonist and dexamethasone. The producer submitted data from a study in which Akynzeo in combination with dexamethasone was compared with palonosetron in combination with dexamethasone. According to the G-BA, there is currently no agreement in current guidelines that the chemotherapy treatment received by the patients included in the study (cyclophosphamide and an anthracycline) constitutes a 'moderately' emetogenic chemotherapy regimen. Therefore, it decided that the study data could not be used to assess the drug's added benefit, meaning that no additional benefit was shown in this treatment situation.
In the case of highly emetogenic chemotherapy, the appropriate comparator was set as the triple combination of a serotonin antagonist, a neurokinin-1 receptor antagonist, and dexamethasone. In this treatment situation, the G-BA concluded either that Akynzeo showed no added benefit or that the data submitted did not allow an added benefit to be derived. An additional benefit was seen with regards to diarrhoea, among the side effects of treatment. However, in concordance with the Institute for Quality and Efficiency in Healthcare (IQWiG), the G-BA concluded that this was insufficient to change the overall assessment, concluding that the drug showed no added benefit in this treatment situation (see Germany: 19 November 2015: Germany's IQWiG finds no added benefit for Akynzeo in chemotherapy-induced nausea and vomiting). The full documentation on Akynzeo's early benefit assessment can be accessed here, in German.
Xultophy shows no added benefit, according to G-BA
Also on 4 February, the G-BA published its final resolution on the early benefit assessment of the Novo Nordisk (Denmark) fixed combination therapy Xultophy (insulin degludec + liraglutide) in the treatment of type 2 diabetes in adults, in combination with oral antidiabetic drugs, in order to improve blood-sugar control, when oral antidiabetics do not sufficiently regulate blood sugar, alone or in combination with a GLP-1 receptor agonist or basal insulin.
The appropriate comparator therapy defined by the G-BA was metformin plus human insulin, or human insulin alone if metformin was not a therapy option. The G-BA decided that Xultophy showed no additional benefit, stating that the producer did not submit data from a relevant clinical study in which Xultophy was directly compared with the chosen appropriate comparator. In this case, the G-BA reached the same conclusion as IQWiG. The full documentation on Xultophy's early benefit assessment in this indication can be accessed here, in German.
Spiolto Respimat shows added benefit in one patient group
The G-BA also published on 4 February its final decision on the early benefit assessment of the Boehringer Ingelheim (Germany) treatment Spiolto Respimat (tiotropium + olodaterol), indicated as a bronchodilator for maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD).
Two treatment situations were identified in the case of Spiolto Respimat: patients with moderate COPD and patients with more severe COPD, with two or more exacerbations per year. In the first group, the appropriate comparator therapy set was a long-acting beta2-adrenergic agonist (LABA) or a long-acting anticholinergic (tiotropium), or the combination of these two. In this group, the G-BA decided that Spiolto Respimat showed a hint of a minor additional benefit compared with tiotropium. It stated that in particular, the results in the submitted studies regarding cessation of treatment due to unwanted effects gave the treatment an advantage. It also stated that according to particular COPD measurements, there appeared to be a distinct advantage for women treated with Spiolto Respimat. However, it concluded that because the basis of this apparent additional advantage for women remained unclear, it would not have any impact on its overall assessment in this treatment situation.
In patients with more severe COPD and two or more exacerbations per year, the G-BA set the comparator therapy as an LABA plus an anticholinergic and additional inhaled corticosteroids. For this treatment situation, the G-BA concluded that there was an indication of a lesser benefit for Spiolto Respimat, with a statistically significant number of exacerbations greater in the case of the assessed drug than with the appropriate comparator.
The G-BA restricted the duration of the validity of its decision on the extent of Spiolto Respimat's additional benefit to six months, since the producer is due to complete clinical trials that will allow for the assessment of the treatment in comparison with both tiotropium and olodaterol as single treatments.
The full documentation relating to Spiolto Respimat's early benefit assessment can be accessed here.
Outlook and implications
Akynzeo was approved for marketing in the European Union in May 2015. So far, it has been approved for reimbursement in Sweden, and recommended with restrictions by the Scottish Medicines Consortium. A negative verdict by the German organization is a blow in terms of its prospects in markets that defer to German health technology assessment decisions.
Novo Nordisk has already withdrawn its single-ingredient, ultra-long-acting insulin Tresiba (insulin degludec) from the German market, and another negative verdict on Xultophy (it was already assessed to show no additional benefit in a wider type 2 diabetes indication) may lead the company to remove the combination treatment as well. Xultophy has been approved for marketing in the EU since September 2014.
For Spiolto Respimat, the verdict of the G-BA is quite positive. The patient population with moderate COPD is considerably higher than that with a severe form of the disease – estimated in Germany as up to 2.55 million people. New data submitted may also help to upgrade the G-BA's assessment.