BERLIN, Oct 16 (APM) - Germany's highest health technology assessment (HTA) authority G-BA found no added benefit for Biogen Idec's multiple sclerosis drug Tecfidera (dimethyl fumarate) because of a lack of data showing additional efficacy and direct studies with comparator drugs.
In a Thursday statement, G-BA followed lower HTA body IQWiG's earlier decision (APMMA 39300), calling the indirect studies submitted by the pharma for added benefit assessment "incomplete" and "insufficient".
The G-BA chose interferon beta-1a or 1b or Teva's Copaxone (glatiramer) for comparison in the added benefit assessment, with Biogen opting to submit a network meta-analysis of 14 studies, comparing Tecfidera with Copaxone or placebo, and interferon 1a or 1b with Copaxone or placebo. Copaxone and placebos acted as "bridging comparators" for indirect comparison, under the U.S. group's approach.
According to the HTA body, Biogen's decision to submit data indirectly comparing Tecfidera to just one interferon beta-1a, Merck KGaA's Rebif, rather than also including its own Avonex, also an interferon beta-1a, was problematic.
The G-BA also said Biogen did not sufficiently evaluate whether the submitted studies met the requirements of similarity, homogeneity and consistency. Only studies with similar patient groups can be used in indirect comparisons, meaning "no valid conclusion" could be drawn with regard to the added benefit of Biogen's drug over comparator, said the G-BA.
Additionally, Biogen did not use an "appropriate" statistical model in the network analysis, which could result in insignificant treatment effects being read as significant, said the G-BA.
As a result, the HTA body found no-added benefit for Tecfidera, meaning the biotech will unlikely be able to fetch a higher price than similar drugs already available on the German market during negotiations with the payer.
jc/ns
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
