After an initial approval of the diabetes management drug Linagliptin, known commercially as Trajenta®, the German Institute for Quality and Efficiency in Healthcare examined if the drug met the criteria for an “added benefit” to the comparable therapy already in place.
Since the manufacturer deviated from the testing protocol outlined by the Federal Joint Committee, the drug is now not considered to have an added benefit.
Protocol Not Met
According to the Institute for Quality and Efficiency in Healthcare, in order that a drug may be considered to have an added benefit, it must be tested in three different and specific treatment situations:
- The drug may be administered as a replacement for metformin. Some patients with certain medical conditions, such as impaired kidney function, should not take metformin and therefore the first testing criteria is when the drug tested is used as a substitute.
- The drug may be administered with metformin. This is called “Dual Therapy.” This type of therapy is used when the metformin does not work by itself to bring blood sugar levels under control. The results of the metformin and the new drug must be tested against another group that is taking metformin and another type of diabetes drug called a sulfonylurea.
- The drug may be administered with both metformin and a sulfonylurea. This is called “Triple Therapy.” This therapy is compared to a combination of metformin and insulin to see which is more effective.
The Institute for Quality and Efficiency in Healthcare (IQWiG) says that, according to the drug manufacturer’s study, the manufacturer did not follow the protocol (G-BA). The report on the IQWiG website says:
“…the manufacturer compared linagliptin with a different drug from the gliptin class (sitagliptin) in all three treatment situations and thereby deviated from the specifications of the G-BA. However, in IQWiG's opinion, the manufacturer insufficiently justified this deviation. For the dossier assessment IQWiG therefore uses the appropriate comparator therapy specified by the G-BA.”
This may change how doctors use the drug in diabetes treatment. There is no report of a repeat study using the G-BA protocol.