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Italy Reimburses Novartis’ Luxturna for Hereditary Retinal Disease

Date: January 22, 2021 | Country: ITALY | Region: EUROPE | Type: Pricing & Reimbursement | Keywords: #aifa #cellandgenetherapy #earlyaccess #innovativedrug #novartis #payback 
#pediatrics #specialfund #spendingceiling #ssn

PRICENTRIC BRIEF:

  • The Italian Medicines Agency (AIFA) has given the go-ahead to reimburse Novartis’ ophthalmic gene therapy Luxturna (voretigene abeparvovec) for treating hereditary dystrophy in pediatric and adult patients with vision loss due to confirmed biallelic mutation of the RPE56 gene who have sufficient, viable retinal cells
  • As an innovative medicine, Luxturna will be paid for through Italy’s special fund for non-oncology medicines whose reserve consists of €500 million
  • A spending cap of €21.6 million over 24 months has been put in place, which includes any previous spending on the gene therapy, even costs incurred via early access schemes, and if this threshold is crossed within this timeframe, net of any discounts achieved through negotiation, the excess will be refunded through payback

THE DETAILS

ROME, Italy – The Italian Medicines Agency (AIFA) has given the go-ahead to reimburse Novartis’ ophthalmic gene therapy Luxturna (voretigene abeparvovec) for treating hereditary dystrophy in pediatric and adult patients with vision loss due to confirmed biallelic mutation of the RPE56 gene who have sufficient, viable retinal cells.

The decision to reimburse Luxturna under the national health service (SSN) took effect January 10, 2021.

The ex-factory price (excluding VAT) of Luxturna is €360,000. A spending cap of €21.6 million over 24 months has been put in place, which includes any previous spending on the gene therapy, even costs incurred via early access schemes. If this threshold is crossed within this timeframe, net of any discounts achieved through negotiation, the excess will be refunded through payback.

Novartis was the recipient of the Prix Galien Italia 2019 prize for “Medicines for Advanced Therapy” for Luxturna due to its innovativeness. As an innovative medicine, it will be paid for through Italy’s special fund for non-oncology medicines whose reserve consists of €500 million.

As reported by About Pharma, two children have so far been treated with Luxturna at the Ophthalmology Clinic of the University of Campania Luigi Vanvitelli. Now that the treatment is being reimbursed, ophthalmologists are eager to administer it to more patients.

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