6. 08 Aflibercept 4 mg 1 mL injection, 1 X 1 mL vial, 4 mg 1 mL injection, 1 X 09 mL syringe; Eylea

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Public Summary Document – March 2015 PBAC Meeting


4 mg/0.1 mL injection, 1 x 0.1 mL vial, 4 mg/0.1 mL injection, 1 x 0.09 mL syringe;

Eylea®; Bayer Australia Ltd

  1. Purpose of Application

    1. The minor submission requested PBAC advise the Minister that aflibercept pre-filled syringe and vial presentations be ‘a’ flagged for the treatment of wet age-related macular degeneration (AMD), central retinal vein occlusion (CRVO), and diabetic macular oedema (DME).

  1. Requested listing

    1. The submission proposed to maintain the current existing General Schedule listing of aflibercept injection for the vial and, when listed, the pre-filled syringe presentations with an added ‘a’ flag between the two formulations to enable pharmacists to substitute presentations without reference to the prescriber.

  1. Background

    1. At the March 2012 meeting, the PBAC recommended listing aflibercept vial and pre-filled syringe on the PBS as an Authority Required benefit for treatment of subfoveal choroidal neovascularisation (CNV) due to age related macular degeneration (AMD). At the time of listing, ''''''' '''''''''''''''''' ''''''''' '''''''''''''''' ''''' '''''''''''''''''''''' '''''''''''''' '''' ''''''''' '''''''''''''''''' ''''''''''''''''''' ''''''''' '''''''''''''''''''' only the vial was listed.

    1. At the November 2014 PBAC meeting, aflibercept vial and pre-filled syringe were recommended under Section 85 to extend the listing to include patients with DME and CRVO. The PBAC considered that authority applications through the PBS and Specialised Drugs Branch of the Department of Human Services would be appropriate for aflibercept, similar to administrative arrangements for ranibizumab and aflibercept in AMD.

  1. Current situation

    1. Vial

Aflibercept vial contains 100µL of extractable volume to ensure a single 50µL injectable dose containing 2mg of aflibercept is delivered.

    1. Pre-filled syringe (PFS)

Aflibercept PFS is supplied in a glass 1mL syringe. The target fill volume for each syringe is 90µL of extractable volume. The PFS can deliver a single 50µL injectable dose containing 2mg of aflibercept.

    1. While the extractable volume for the vial differs slightly for the PFS, both the vial and PFS provides a usable amount to deliver a single dose of 50µL. It must only be administered by an ophthalmologist experienced in administering intravitreal injections.

    1. The Sponsor proposed that ‘a’ flagging of the two presentations will provide greater flexibility in supply of aflibercept upon launching of the pre-filled syringe in order to ensure continuity of treatment in the event that demand for either vial or pre-filled syringe exceeds the forecast volume.

    1. The Sponsor requested that the same Special Pricing Arrangements apply for both forms of aflibercept.

    1. Consistent with existing practices, the prescriber can choose to mark the prescription with “Substitution not permitted” if they have a strict preference for either the vial or pre-filled syringe.

  1. Consideration of evidence

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