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DPP-4 inhibitors for type-2 diabetes: The first retroactive benefit assessment completed – winners and losers
On 1 October, the G-BA announced the completion of the first retroactive benefit assessment of a class of medicines under AMNOG. The class involved is the DPP-4 inhibitor class of oral type-2 diabetes medicines, three examples of which were launched on to the market well before AMNOG came into effect. The first of these Januvia, which came on the market in 2006, and it was followed by Galvus and then Onglyza. Products combining these three DPP-4 inhibitors with established standard oral type-2 diabetes drug metformin have also been launched, although only those of Merck & Co. (Janumet) and Novartis (Eucreas) were launched before the coming into force of AMNOG.
A long drawn-out process
The benefit assessment process for this drug class was delayed significantly as a result of a legal technicality in which Novartis challenged the benefit assessment process. They brought the case to court in late 2012 after the G-BA had requested that the producers involved submit value dossiers back in June of that year. Cutting a long story short, in March 2013, Novartis' appeal was overturned and the courts tightened the law to stop similar legal action in the future. Nevertheless, the German Pharmaceutical Industry Association (BPI) remained steadfastly critical of the retroactive assessment process, arguing that older drugs would experience price erosion anyway, and that there would be little to be gained from putting them all through the AMNOG grinder.
The retrospective assessment process went ahead and the DPP-4 inhibitors were the first on its conveyor belt. From the perspective of Germany's SHI funds, this class was a natural choice to be assessed first. Sales of oral type-2 diabetes drugs grew by 11.2% year-on-year in 2012, with DPP-4 inhibitors driving this growth, taking their share of the value of the oral type-2 diabetes drug market from 54.2% in 2011 to 62.6% in 2012.
It could have been worse...
It could have been worse for the producers. When IQWiG released its benefit assessment report in July 2012, it concluded that only one of the class - Januvia - showed a hint of a minor additional benefit in one of four treatment situations. Neither of the other two products was considered to have additional benefits in any treatment settings. However, on 1 October - the same day as the G-BA published its resolutions - IQWiG published a release stating that manufacturer submissions resulted in a change in its recommendation for Januvia, and Janumet, recommendations which mirror the G-BA's final resolution.
In its final resolution, the G-BA decided that Januvia demonstrated an indication of a minor additional benefit as monotherapy and in combination with metformin, and it also decided that metformin combination therapy Janumet demonstrated an indication of a minor additional benefit. The G-BA diverged from IQWiG's across-the-board negative recommendations on Onglyza, deciding that it demonstrated an indication of a minor additional benefit in combination with metformin. However, Novartis' Galvus and Eucreas received no additional benefit status.
Diabetes care under fire in Germany
It would be an understatement to say that the temperature in the field of diabetes care in Germany has been elevated during the past year. First came IQWiG and the G-BA's decisions not to accord an additional benefit status to domestic pharma major Boehringer Ingelheim's DPP-4 inhibitor Trajenta. even though the drug had two early benefit assessments (the drug was launched post-AMNOG, and therefore went through the process as normal). Then came the G-BA's decision to create three new reference groups for insulins - although this was subsequently reversed.
Losers and winners
The G-BA's resolution on the DPP-4 inhibitor class has losers and winners. Merck & Co. certainly come out the biggest winner, while AstraZeneca and BMS may be contented that they were not left out of the price negotiation process. Novartis is the clear loser together with Boehringer (and its partner Lilly) - who opted not to launch Trajenta in Germany to avoid entering the reference-pricing system - if post-AMNOG assessments are also included. Novartis estimates that around 300,000 patients in Germany are being treated with Galvus. German medical newspaper Ärtzte Zeitung reported that the company described the G-BA's decision as "incomprehensible", and accused the G-BA of not taking relevant findings in its study data and findings from daily practice into account. For his part, the chairman of the G-BA, Josef Hecken, shrugged off the criticisms of the benefit assessment, describing Novartis' study data as "too incomplete", in contrast with their competitors.
Now, Merck & Co. and AstraZeneca - BMS will progress to price negotiations with the National Association of Statutory Health Insurance Funds, while Novartis still has the option to undergo benefit assessment again.
We will be talking more about potential impact of AMNOG and IRP on DPP-4 inhibitors at ISPOR in Dublin the first week of November. Stop by our presentation or our booth (#117) to learn more.
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