12:00 AM
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Mar 18, 2013
 |  BioCentury  |  Regulation

Disarmamentarium in Germany

G-BA blockade on new diabetes drugs leaving Germans with few treatment options

The lack of a clear scientific rationale combined with apparently contradictory reasoning underlying the benefit assessments of two diabetes drugs in Germany could leave patients with few choices: make do with metformin or sulfonylureas, go on insulin, or cross the border to buy newer drugs out of pocket.

On Feb. 21, the German Federal Joint Committee (G-BA) released a final assessment of Trajenta linagliptin that waved aside clear benefits on weight and hypoglycemia - and signals of cardiovascular benefit - to conclude the dipeptidyl peptidase-4 (DPP-4) inhibitor was no better than sulfonylureas.

G-BA said the reason the hypoglycemia benefit was not compelling was that the Trajenta arm used a fixed-dose regimen while the comparator glimepiride arm used a titrated regimen - which was in keeping with the sulfonylurea's label.

As a result for the pricing body's conclusion, Trajenta would be paid for in line with generic sulfonylureas. But Boehringer Ingelheim GmbH has decided not to launch it in Germany.

Last week, Germany's Institute for Quality and Efficiency in Health Care (IQWiG) gave essentially the opposite reason for finding no additional benefit for supplementing insulin therapy with Forxiga dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor from partners AstraZeneca plc and Bristol-Myers Squibb Co.

The health technology assessment agency, which provides preliminary benefit assessments of drugs to G-BA, said a benefit could not be determined for Forxiga plus insulin because both arms used a fixed-dose regimen instead of optimizing insulin therapy for individual patients.

G-BA also is seeking to review the three DPP-4 inhibitors that were already on the market before Germany's AMNOG pricing law took effect in 2011: Januvia sitagliptin from Merck & Co. Inc., Galvus vildagliptin from Novartis AG and Onglyza saxagliptin from AstraZeneca and Bristol-Myers (see BioCentury, Feb. 18).

Two German diabetologists contacted by BioCentury said the assessments show G-BA is taking whatever tack necessary to reduce drug prices, at the expense of patient welfare.

They are concerned the committee will use the same tactics to reach similar conclusions for other new classes of diabetes drugs, such as glucagon-like peptide-1 (GLP-1) analogs.

The end result could see other companies pulling their drugs from Germany, leaving diabetics with few therapeutic options in that nation.

Benefits ignored

While sulfonylureas typically provide a slightly greater reduction in HbA1c than DPP-4 inhibitors, drugs in the newer class are weight neutral, cause little hypoglycemia and have no known adverse cardiovascular (CV) effects.

In contrast, sulfonylureas including glimepiride commonly cause weight gain and hypoglycemia. Glimepiride's U.S. label also contains a special warning of an increased risk of CV mortality.

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