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Germany Issues Benefit Assessment For InterMune’s Esbriet, Despite Orphan Drug Status

 
• By Faraz Kermani

Germany’s senior health technology assessment body, the G-BA, has said that InterMune’s Esbriet is beneficial, but says it is unsure to what extent. However, such added value assessments for orphan drugs could be illegal.

The German Joint Federal Committee’s (G-BA’s) decision on March 15 to give the go-ahead for price negotiations to begin for InterMune Inc.’s idiopathic pulmonary fibrosis product Esbriet (pirfenidone) comes as no surprise. However, its assessment, mirroring an earlier judgment from the Institute for Quality and Efficiency in Health Care (IQWiG), that Esbriet offers an “unquantifiable benefit” to patients has rattled the some in the pharmaceutical industry.

The confirmation is a worrying development in the sense that IQWiG’s initial decision to assess the added benefit of an...

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More from Europe

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 
• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

More from Geography

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.