Róisín Shortall (Dublin North West, Social Democrats)
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745. To ask the Minister for Health the position regarding a new anti-calcitonin gene-related peptide, CGRP, medication for the preventative treatment of chronic migraine; if the National Centre for Pharmacoeconomics, NCPE, has completed its full health technology assessment; and if he will make a statement on the matter. [18900/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in this statutory process.

I am advised by the HSE that there are currently two products undergoing assessment by the National Centre for Pharmacoeconomics (NCPE) for the treatment of chronic migraine.

On 17 April 2019 the NCPE published a rapid review report on fremanezumab which is indicated for prophylaxis of migraine in adults who have at least four migraine days per month.

The rapid review offered the following recommendation to the HSE “a full health technology assessment is recommended to assess the clinical effectiveness and cost effectiveness of fremanezumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.”

The HSE is formally considering the NCPE recommendation.

The NCPE is in the process of carrying out a full health technology assessment on a second agent Erenumab (Aimovig) which is indicated for the treatment of migraine in adults who have at least 4 migraine days per month.

The applicant company submitted a dossier on 22 January 2019 and the NCPE has completed a preliminary review and is awaiting a response from the applicant company.

Robert Troy (Longford-Westmeath, Fianna Fail)
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746. To ask the Minister for Health if the same treatments will be put in place via the public service that are available to customers of a company (details supplied). [18908/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in this statutory process.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.

As outlined in the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

The HSE at all times ensures that the systems that it has in place are designed to ensure equitable access to all medicines across all therapeutic areas, cancer and non-cancer, from the resources provided to it.

In March 2019, the Vhi sent a circular to Oncologists advising them that it was extending cover to a number of new cancer medicines. The decision by the Vhi applies only to private care to private Vhi patients in private hospitals. It will have no impact on the availability and use of medicines in public hospitals, where there is no distinction between public and private patients.

The effect of the VHI decision will be that Vhi private patients in private hospitals may have access to a medicine that is not yet available in the public hospital system. However, a number of the medicines, or indications, which the VHI has now decided to cover, are at various stages of the HSE assessment and reimbursement process with a view to making them available in the public hospital system.