Maureen O'Sullivan (Dublin Central, Independent)
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429. To ask the Minister for Health if his attention has been drawn to the frustration of patients such as persons with MS regarding approval of new medicines; if he will report on efforts to work in conjunction with other countries to expedite the process; and if he will make a statement on the matter. [50855/18]

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.

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.

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 NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.

Currently, there are three indications for the treatment of multiple sclerosis going through the reimbursement process. All had applications made in 2018.

The NCPE completed a health technology assessment on 29 August 2018 for Ocrelizumab (Ocrevus) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). They recommended that Ocrelizumab (Ocrevus) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

On 4 October 2018 the NCPE completed their assessment for Ocrelizumab (Ocrevus) indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS). They did not recommend that Ocrelizumab (Ocrevus) be reimbursed for this indication.

The HSE is the statutory decision-making body for medicine reimbursement. It will make the final decision on whether Ocrelizumab (Ocrevus) will be reimbursed for each of these indications, taking into consideration the statutory criteria in the 2013 Act.

The HSE has also commissioned a HTA of Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex) which is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. A full pharmacoeconomic assessment is currently underway by the NCPE.

The challenge of securing affordable access to innovate medicines is not unique to Ireland. Over the past two years, I and officials have been engaging with a number of voluntary EU forums including the Roundtable meetings with EU Health Ministers and the pharmaceutical industry, High Level Pharmaceutical Policy Meetings and the Valletta Technical Committee in an effort to identifying solutions to issues of medicine pricing, sustainability and supply.

On the 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way.

The Beneluxa Initiative on Pharmaceutical Policy will have an important role to play in securing faster access to innovative medicines and provide important platforms in which to strengthen the policy mix and deliver on the shared objective of securing access to high cost, innovative treatments at affordable prices. The patient is at the centre of this collaborative international approach.