On 25 August 2022, Janssen has announced that they have withdrawn the lung cancer drug Rybrevant (amivantamab) from the German market with immediate effect.
Rybrevant as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.
The G-BA concluded the benefit assessment for Rybrevant on 7 July 2022 and found “no additional benefit” in both subgroups. The G-BA did not consider the ITC based on registry data as suitable. Both, the German Society for Hematology and Medical Oncology (DGHO) and the German Society for Pneumology and Respiratory Medicine (DGP) recommended to award an additional benefit.
This negative HTA outcome would likely lead to a lower negotiated reimbursement price. This negotiated reimbursement price in Germany is publicly available and can be used by other markets as a price reference.
Therefore, Janssen has decided to completely withdraw the product before the price negotiations are complete, thereby avoiding a low public reference price.
German patients of the Rybrevant target population will now suffer the consequences of missing out on an important treatment option due to the formal problems of the benefit assessment regulations. The G-BA had estimated there are only 9-26 patients in Germany, nonetheless especially these patients have a particularly poor prognosis where other drugs or chemotherapy are not very efficacious.
For patients who had already started therapy on Rybrevant, the product will now be imported.
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
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If drugs become available immediately in Germany, how do they decide on pricing? What stops manufacturers from raising the price in the knowledge that it would be reimbursed?
When the product is launched in Germany, the manufacturer can set the price freely. This price is then applicable for the first 12 months (this will be reduced to 6 months from 2023). We see very high launch prices in Germany, and there is no mechanism that would stop manufacturers from very high prices. But for hospital products for example, the drug prices have to be absorbed within the DRG flat rate. If the prices are too high, then hospitals might decide to use a different product instead. Hospitals can also apply for extra funding (NUB funding, ZE funding) to cover high drug costs that exceed their DRGs, but this takes a bit of time. So while manufacturers can freely set the launch price, they should consider this. Pricing it too high might mean the product is just not prescribed in the end.