Vertex’s Kalydeco May Face Added Cost Assessments In Germany
This article was originally published in The Pink Sheet Daily
Vertex Pharmaceutical’s orphan drug for cystic fibrosis may face an additional reimbursement evaluation in Germany after IQWiG says it may breach the €50 million per year cost threshold.
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Vertex's cystic fibrosis product Kalydeco is one of five new molecular entities given a positive opinion by Europe's Committee for Medicinal Products for Human Use on May 25, which also included Almirall's novel COPD therapy aclidinium and Novo Nordisk's recombinant Factor XIII.
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.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.