Fidaxomicin: Data subsequently submitted by manufacturer prove added benefit

July 24, 2013, Institute for Quality and Efficiency in Health Care

In the commenting procedure on early benefit assessment pursuant to the German Act on the Reform of the Market for Medicinal Products (AMNOG), under certain circumstances drug manufacturers may submit to the Federal Joint Committee (G-BA) additional documents for dossiers. The Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed such additional information for two studies comparing the antibiotic fidaxomicin, which is used for diarrhoea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults with caused by Clostridium difficile. IQWiG already presented an assessment pursuant to AMNOG in April 2013.

On the basis of the dossier submitted by the manufacturer, an advantage of fidaxomicin for the outcome "global cure" could be inferred for severe cases and recurrences. However, the magnitude of this advantage could not be inferred from the data presented. In addition, it could not be excluded that more severe side effects occurred precisely in these cases, thus outweighing advantages with regard to global cure. An overall conclusion on added benefit was therefore not possible.

Greater harm not proven in patients with severe disease

In the commenting procedure the manufacturer subsequently provided study results in a form that allows the weighing of positive and negative effects. Whereas no statistically significant difference between fidaxomicin and was shown for all-cause mortality, the data provide proof of an added benefit for the outcome "global cure" in patients with severe or recurrent disease. In addition, in these subpopulations there is no suggestion of greater harm from fidaxomicin than from vancomycin.

An overall conclusion is thus possible: an added benefit of fidaxomicin versus the appropriate comparator therapy (vancomycin) is now proven for the treatment of patients with severe or recurrent Clostridium difficile infections. IQWiG classifies the extent of added benefit as minor.

An added benefit in patients with mild disease was not claimed by the manufacturer.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the G-BA conducted a commenting procedure in which the manufacturer submitted additional information. The G-BA subsequently commissioned IQWiG on 28 May 2013 to undertake a new assessment including the additional data.

If, in the course of the discussions on a commission of the G-BA, a need for further revision arises, IQWiG presents its report in the form of an addendum. The Institute sent this addendum to the contracting agency (the G-BA) on 12 June 2013. The G-BA then decides on the extent of the added benefit in each case, thus completing the early benefit assessment.

Explore further: Fidaxomicin in Clostridium difficile infection: Added benefit not proven

Related Stories

Fidaxomicin in Clostridium difficile infection: Added benefit not proven

July 2, 2013
The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults who have diarrhoea caused by Clostridium difficile. In an early benefit assessment pursuant to ...

Aflibercept in AMD: No proof of added benefit

June 5, 2013
It is not proven that patients with wet age-related macular degeneration benefit from the new drug aflibercept, as the drug manufacturer did not present any suitable data for a comparison with the current standard therapy ...

Aflibercept in colorectal cancer: Indication of minor added benefit

July 11, 2013
The drug aflibercept (trade name: Zaltrap) has been approved in Germany since February 2013 in combination with a certain chemotherapy for adults with metastatic colorectal cancer in whom chemotherapy with oxaliplatin could ...

Added benefit of ingenol mebutate is not proven

June 6, 2013
The drug ingenol mebutate (trade name: Picato) has been approved in Germany since November 2012 as a gel for the treatment of certain forms of actinic keratosis in adults. In an early benefit assessment pursuant to the Act ...

Added benefit of saxagliptin/metformin combination is not proven

April 29, 2013
The fixed combination of the drugs saxagliptin and metformin (Komboglyze) has been approved in Germany since November 2011 for the treatment of type 2 diabetes mellitus. In an early benefit assessment pursuant to the "Act ...

Added benefit of dapagliflozin is not proven

June 6, 2013
Dapagliflozin (trade name: Forxiga) has been approved in Germany since November 2012 for the treatment of type 2 diabetes mellitus. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal ...

Recommended for you

Leprosy's drug resistance and origin revealed by genome analysis

January 24, 2018
Leprosy is an infectious disease with gruesome symptoms. It damages the skin, peripheral nerves, the upper respiratory tract, and the eyes. Despite being curable with multidrug therapy, leprosy still persists in many developing ...

Nanoparticle vaccine offers universal protection against influenza A viruses, study finds

January 24, 2018
Researchers have developed a universal vaccine to combat influenza A viruses that produces long-lasting immunity in mice and protects them against the limitations of seasonal flu vaccines, according to a study led by Georgia ...

A new theory on reducing cardiovascular disease risk in binge drinkers

January 23, 2018
A new study shows that binge drinkers have increased levels of a biomarker molecule—microRNA-21—that may contribute to poor vascular function.

Flu infection study increases understanding of natural immunity

January 23, 2018
People with higher levels of antibodies against the stem portion of the influenza virus hemagglutinin (HA) protein have less viral shedding when they get the flu, but do not have fewer or less severe signs of illness, according ...

New long-acting approach for malaria therapy developed

January 22, 2018
A new study, published in Nature Communications, conducted by the University of Liverpool and the Johns Hopkins University School of Medicine highlights a new 'long acting' medicine for the prevention of malaria.

Virus shown to be likely cause of mystery polio-like illness

January 22, 2018
A major review by UNSW researchers has identified strong evidence that a virus called Enterovirus D68 is the cause of a mystery polio-like illness that has paralysed children in the US, Canada and Europe.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.