Written answers

Thursday, 3 December 2020

Department of Health

Medicinal Products

Photo of Noel GrealishNoel Grealish (Galway West, Independent)
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333. To ask the Minister for Health if xolair is available under the drugs payment scheme; if not, the cost of a 450mg injection dose; and if he will make a statement on the matter. [40839/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, including the Drug Payments Scheme (DPS), in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The HSE has advised that Omalizumab (Xolair®) is not available under the DPS, as it is not approved for use in the community under the statutory community drugs schemes.

However, maximum hospital pricing approval is in place for Omalizumab (Xolair®)for use in public hospitals. Under the current IPHA Framework Agreement on the Pricing and Supply of Medicines, hospitals can negotiate revised pricing arrangements with individual manufacturers.

In accordance with the IPHA agreement, the HSE reviews the pricing of non-patent-expired medicines annually. Hospital medicines subject to a price reduction are included in price realignment files which are published on the HSE website. The 2020 files include the reduced hospital pricing for Omalizumab(Xolair®):

- Xolair® 75mg Pre-Filled Syringe Solution for Injection x 1 : ex-factory price €164.48

- Xolair® 150mg Pre-Filled Syringe Solution for Injection x1 : ex-factory price €323.22

On 31 July 2020, the EMA extended marketing authorisation of Omalizumab (Xolair®) to include the following indication: as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.

The HSE has advised that, as of 1 December 2020, no pricing and reimbursement application has been received for the reimbursement of Omalizumab (Xolair®) for this indication.

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