Germany’s IQWiG denies Astellas’ incontinence drug

Astellas yesterday became the latest pharma company to have a drug knocked back for use in Germany by the country's health guidance body IQWiG.

IQWiG, which assesses the cost-effectiveness of treatments for reimbursement in Germany, published an evaluation of Astellas' Betmiga (mirabegron) that does not recommend its use in the treatment of overactive bladder (OAB).

This review will be taken into consideration by the Federal Joint Committee (GBA), which will then recommend on whether the drug should be reimbursed on Germany's healthcare system.

Betmiga was approved in the EU in 2013 to treat OAB and, as per the AMNOG drug reimbursement process in Germany, was assessed by IQWiG against the current standard therapy - in this case tolterodine.

IQWiG determined that Betmiga had a superior side effect profile to tolterodine as there were fewer incidences of dry mouth. However, the health watchdog said that when it came to patient mortality, morbidity and quality of life, no added value could be ascertained as the Astellas had not provided enough data.

“[A] final assessment of positive and negative effects for added value is not possible,” said IQWiG in a statement.

The decision is in contrast to the positive guidance from the UK's National Institute for Health and Care Excellence (NICE), which recommended Betmiga for OAB in 2013.

It is also the latest in a series of negative recommendations from IQWIG following the introduction of the AMNOG pricing scheme in 2010. Companies such as Eisai and Germany's Boehringer Ingelheim have been vocal in their criticism of the system after having new treatments knocked back.

Olysio recommended in Germany

There was also positive news from IQWiG, however, with a recommendation for Janssen's hepatitis C treatment Olysio (simeprevir).

The drug is one of several new medicines revolutionising the treatment of hepatitis C and it is emerging as one of Janssen's key products, with sales for its first full year on the market on course to top $2bn.

A positive decision from the GBA would be a huge boost to this growth, although IQWiG's evaluation does not cover all patients with hepatitis C.

According to IQWiG, Olysio does have additional benefits compared to current treatment options in patients who have the genotype 1 strain of hepatitis C and have received no prior treatment, have relapsed after therapy or have not responded to previous treatment.

However, the organisation could not establish the benefits of Olysio in patients with the genotype 4 strain of infection as it said Janssen did not provide adequate data.