G-BA Proposes RWE Scheme for Zolgensma Use in Germany

Date: February 8, 2021 | Country: GERMANY | Region: EUROPE | Type: Pricing & Reimbursement | Keywords: #g-ba #hta #monitoring #novartis #pricing #rwd #rwe #sma #zolgensma

PRICENTRIC BRIEF:

  • Germany’s Federal Joint Committee (G-BA) has asked Novartis to collect data on Zolgensma (onasemnogene abeparvovec) when used in routine clinical practice, in order to evaluate it for an additional benefit assessment
  • This is because there is no direct comparison available for Zolgensma, due to the nature and the novelty of the treatment, and as such the G-BA says that its comparison to treatment alternatives cannot yet be conclusively assessed
  • In order to mitigate these gaps in data, the G-BA wants Novartis to plan and implement a corresponding registry study in order to close the evidence gaps

 

THE DETAILS

BERLIN, Germany – Germany’s Federal Joint Committee (G-BA) has asked Novartis to collect data on Zolgensma (onasemnogene abeparvovec) when used in routine clinical practice, in order to evaluate it for an additional benefit assessment.

This is because there is no direct comparison available for Zolgensma in the treatment of spinal muscular atrophy (SMA), due to the nature and the novelty of the treatment, and as such the G-BA says that its comparison to treatment alternatives cannot yet be conclusively assessed.

In order to mitigate these gaps in data, the G-BA wants Novartis to plan and implement a corresponding registry study in order to close the evidence gaps.

As such, to help the group form the basis for a new additional benefit assessment, all doctors who want to use Zolgensma are obliged to take part in the data collection.

“We are getting approved drugs with increasingly weaker evidence in the supply. We have to try – especially with drugs for orphan diseases – to keep the balance between the need for urgently needed treatment alternatives and good evidence on the long-term additional benefit of a drug,” explained Professor Josef Hecken, impartial chairman of the G-BA.

He continued, “Since a change in the law in 2019, we can now combine the use of the drug with a question we have specified for data collection from supply practice. With the data on the long-term additional benefit obtained from the patients’ everyday treatment, the G-BA will be advising again on Zolgensma from summer 2027 at the latest.”

The change officially came into effect on February 4, 2021.

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