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The Italian Medicines Agency adoptes the Note No. 98 which regulates anti-VEGF medicinal products in terms of prescription and intravitreal administration for AMD and DME - The Italian Medicines Agency adoptes the Note No. 98 which regulates anti-VEGF medicinal products in terms of prescription and intravitreal administration for AMD and DME
The Italian Medicines Agency adoptes the Note No. 98 which regulates anti-VEGF medicinal products in terms of prescription and intravitreal administration for AMD and DME
The Italian Medicines Agency has adopted the Note 98 which regulates anti-VEGF medicinal products in terms of prescription, intravitreal administration and use covered by the National Health Service (NHS) for the treatment of maculopathy (Decree No. 1379/2020, published on the Italian Official Gazette - General Series No. 323 of 31st December 2020).
Note No.98 refers to:
- medicinal products containing aflibercept and ranibizumab for the treatment of the Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME);
- medicinal products containing bevacizumab for the treatment of AMD and DME (for these indications the drug is covered by the NHS, according to the Law No. 648 of 23 rd December 1996);
- medicinal product containing brolucizumab for the treatment of AMD.
Following an in-depth review of the scientific evidence, the Technical-Scientific Committee of AIFA considered that all anti-VEGF medicinal products included into the Note No. 98 have similar effectiveness and safety:
- aflibercept, bevacizumab, brolucizumab and ranibizumab can be considered substantially comparable in the treatment of AMD;
- aflibercept, bevacizumab and ranibizumab can be considered comparable in the treatment of DME in patients with a visual acuity not worse than 20/40 (≥5/10).
For the common therapeutic indications, the medicines included in the Note No. 98 are considered to share comparable effectiveness and safety in most of the patients. Given the magnitude of the clinical need and with the aim to ensure the widest access to treatment within the NHS, ophthalmologists are recommended to prescribe the most cost-effective anti-VEGF drug according to the need of the individual patient.
Published on: 05 January 2021