Gaxilose (1) – LacTest®

• As the necessary evidence has not been provided, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).

Adults and elderly patients with clinical symptoms of lactose intolerance

• No dossier was submitted by the pharmaceutical manufacturer by the relevant deadline.
• Pursuant to Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V), this means that no assessment has been carried out as to whether the active ingredient gaxilose has any additional benefit, no additional benefit or a less benefit compared with the appropriate comparator therapy, and the additional benefit of Gaxilose in relation to the appropriate comparator therapy is deemed not proven.
• In summary, the additional benefit of Gaxilose is assessed as follows: as the required proof has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of SGB V).
• Appropriate comparator therapy
  • The appropriate comparator therapy for the diagnosis of hypolactasia in adults and elderly patients with clinical symptoms of lactose intolerance is: the H₂ breath test.
• Overall assessment
  • Overall, there is hardly any directly comparable evidence available for the diagnostic procedures mentioned in section 2.
  • The body of evidence is more extensive for the H₂ breath test than for the lactose tolerance test.
  • The H₂ breath test is by far the most commonly used method in everyday clinical practice.
  • A biopsy is an invasive procedure which, in itself, carries a higher risk for the patient than the H₂ breath test.

Courtesy translation only, please refer to the German original.