EUSA Pharma is pursuing registration and funding for Qarziba in Australia with the help of local firms Emerge Health and KMC Healthcare

This medicine, also known as Dinutuximab-beta, an anti-GD2 monoclonal antibody for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.

The full notes regarding Qarziba can be found on the registration application on the TGA website under Emerge Health Pty Ltd

Registration - Therapeutic Goods Administration (TGA)

Determination is a formal process that allows the Australian Government's Therapeutic Goods Administration (TGA) to make a decision regarding whether a medicine is eligible for registration. 

The sponsor of the medicine must submit an application for determination to allow the TGA to make a decision on whether the medicine meets the eligibility criteria. These eligibility criteria are designed to ensure that only products providing the most benefit to patients are eligible.

Eligibility criteria are published through the TGA website.

Funding - Pharmaceutical Benefits Advisory Committee (PBAC) 

The PBAC is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists and consumer representatives.

Its primary role is to recommend new medicines for listing on the Pharmaceutical Benefits Scheme (PBS). No new medicine can be listed unless the committee makes a positive recommendation. 

The PBAC meets three times a year, usually in March, July and November.

If the registration with the TGA is successful, Qarziba would go to the PBAC meeting in March 2020. 

When recommending a medicine for listing, the PBAC takes into account the medical conditions for which the medicine was registered for use in Australia, its clinical effectiveness, safety and cost-effectiveness (‘value for money’) compared with other treatments.

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