Last week, I wrote about Janssen’s withdrawal of the lung cancer drug Rybrevant (amivantamab) from the German market.
Just a week later, Janssen now announced that they won’t launch another cancer drug, Tecvali (teclistamab), onto the German market. Janssen said this decision was driven by the upcoming changes to the AMNOG assessments and to the price setting, which prevents innovation.
The hemato-oncology drug Tecvali received conditional EMA approval for the treatment of multiple myeloma on 24 August 2022. This was based on an accelerated assessment using data from a Phase 1/2 study.
While Germany generally is one of the first markets where a product is launched, Janssen wants to “critically assess launching in Germany and the possible timeframe”.
Given the conditional approval based on a small trial including only a few patients, Janssen would expect a negative HTA outcome from G-BA’s benefit assessment. The additional benefit, that Tecvali can offer, would not be shown by the currently available evidence.
Patients in Germany can receive treatment with Tecvali only through an already existing “named patient programme”.
Further reading related to benefit assessments and withdrawals in Germany
- Market-withdrawals
- Which endpoints are important to the G-BA and IQWiG?
- How does the G-BA pick the appropriate comparator?
- When can an off-label drug be the appropriate comparator therapy?
- Regular and abbreviated early benefit assessments – Is this the end of orphan drug privileges?
- HTA guide
- EUnetHTA21 starts preparation for joint HTA from 2024
- G-BA assessment of orphan drug gene therapies, Zolgensma and Libmeldy
- IQWiG methods version 6.0, English