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Italy Reimburses Zolgensma Through “Payment at Result” Model, Priced at EUR 2.155 M

Date: March 18, 2021 | Country: ITALY | Region: EUROPE | Type: Pricing & Reimbursement | Keywords: #aifa #alternativepaymentmodel #avexis #cellandgenetherapy 
#novartis #paymentatresult #pediatric #ssn

PRICENTRIC BRIEF:

  • Novartis’ Zolgensma (onasemnogene abeparvovec) is priced at EUR 2,155,124.65 (ex-factory, excluding VAT), with a retail price (VAT included) of EUR 3,556,817.72, according to Italy’s Official Gazette and the Italian Medicines Agency (AIFA)
  • The reimbursement deal for Zolgensma, which includes obligatory discounts on the ex-factory price of the gene therapy, is a “payment at result” contract with checkpoints at 12, 24, 36, and 48 months, and is valid for 24 months, without the option for renewal
  • Zolgensma is reimbursed in Italy through the SSN for the treatment of all children with SMA Type 1 weighing below 13.5 kg—in November, AIFA initially announced that Zolgensma would be available through the SSN for use within the first six months of life in SMA patients with genetic diagnosis biallelic mutation in the SMN1 gene and up to two copies of the SMN2 gene or Type 1 SMA

 

THE DETAILS

ROME, Italy – Novartis’ Zolgensma (onasemnogene abeparvovec) is priced at EUR 2,155,124.65 (ex-factory, excluding VAT), with a retail price (VAT included) of EUR 3,556,817.72, according to Italy’s Official Gazette and the Italian Medicines Agency (AIFA).

The reimbursement deal for Zolgensma is a “payment at result” contract with checkpoints at 12, 24, 36, and 48 months, and is valid for 24 months, without the option renewal. As part of the deal, an obligatory discount on the ex-factory price will be applied at public health facilities, including those accredited by Italy’s national health service (SSN).

In Italy, Zolgensma is reimbursed through the SSN for the treatment of all children with SMA Type 1 weighing below 13.5 kg. AIFA initially announced in November 2020 that Zolgensma would be available through the SSN for use within the first six months of life in SMA patients with genetic diagnosis biallelic mutation in the SMN1 gene and up to two copies of the SMN2 gene or Type 1 SMA.

AIFA’s Scientific-Technical Committee (CTS) determined Zolgensma to be an innovative therapy and reimbursement was allowed for patients up to six months of age. According to AIFA, at the same time the agency’s Price and Reimbursement Committee (CPR) negotiated with Novartis to achieve a sustainable SSN price for Zolgensma.

Under the agreement, Novartis committed to making the drug available free of charge in clinical trials for children weighing between 13.5 and 21 kg, in order to acquire additional efficacy and safety data on such patients in a controlled setting.

Although not yet authorized in Italy, Zolgensma was made available under Law 648 of December 23, 1996, which stipulates that drugs can be reimbursed by the SSN for an unauthorized indication when there is no valid therapeutic alternative or the alternative medicine is costlier. Specifically, the drug must be authorized in another country, or Phase 2 clinical trials investigating the drug must be ongoing in Italy or have wrapped.

Last May, the European Commission granted conditional approval for Zolgensma for the treatment of patients with 5q spinal muscular atrophy (SMA) with a biallelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a biallelic mutation in the SMN1 gene and up to three copies of the SMN2 gene.

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