Aindrias Moynihan (Cork North West, Fianna Fail)
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440. To ask the Minister for Health the length of time it takes to approve new MS drugs here; the MS drugs in the approval process; the length of time they have been undergoing approval; and the steps he is taking to reduce that time and improve access for persons with MS [47086/18]

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. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. 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.

There are currently three indications going through the reimbursement system. All had applications made in 2018.

The NCPE competed 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.