Under European and Irish legislation, before a medicine can be placed on the market the manufacturer must seek a marketing authorisation from the Health Products Regulatory Authority (HPRA), or in the case of certain medicines, the European Medicines Agency. Medicines, containing a new active ingredient, indicated for use in, inter alia, a neurodegenerative disorder, such as Multiple Sclerosis, can only submit an application for a marketing authorisation to the European Medicines Agency (EMA) on behalf of the European Commission. European legislation, including Regulation (EC) No 726/2004 clearly sets out the defined timelines that must be met by the Agency in processing such applications.
Once a marketing authorisation has been granted by the European Commission this must be followed by an actual placing of the medicine on the Union market within 3 years else the marketing authorisation ceases to be valid. This means that the product must be marketed in at least one Member State. The decision to place a centrally authorised medicine on a particular Member State market is a commercial one for the marketing authorisation holder.
In Ireland, 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. As Minister for Health, I do not have any statutory power or function in relation to reimbursement of medicines.
Under the 2013 Act, if a company wishes to have a medicine reimbursed through the community drugs schemes; it must first submit an application to the HSE to have the 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 in order to appropriately determine the application), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine, or refuse to reimburse it.
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 (HTA) 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.
The HSE has advised that it has received 2 applications for pricing and reimbursement of Ocrelizumab in Multiple Sclerosis.
Application 1 is for use of Ocrelizumab for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Following a number of rounds of commercial negotiations, agreement has been reached in relation to the commercial terms which will apply to this indication when reimbursed. The HSE is currently working on putting in place the required administrative processes to support reimbursement of this specific indication.
Application 2 is for the use of Ocrelizumab for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. The HSE and the manufacturer have had a number of rounds of commercial negotiations in relation to this indication (use). Commercial discussions have concluded, the medicine has been reviewed by the HSE Drugs Group and the HSE Senior Leadership Team have received the Drugs Group recommendation. The HSE's final decision on reimbursement will take into consideration the statutory criteria contained in the 2013 Health 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. The NCPE are currently awaiting the manufacturer to supply them with information to continue the HTA process.