The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines.
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 a drug's clinical and cost effectiveness as a health intervention.
As a country, we invest heavily in medicines, to the tune of almost €2 billion annually. In 2019 to date, the HSE has approved 31 new medicines and 5 new indications for existing medicines for reimbursement in the public healthcare system. The approvals to date represent an additional investment by the HSE over five years of approximately €220m in providing access to new and innovative treatment for Irish patients. It is expected that over 3,000 patients will benefit from access to these new medicines over the next 5 years.
Notwithstanding the significant progress on drug costs achieved from price reductions under the pricing framework agreed with industry and commercial negotiations conducted by the HSE, the Health Service is still facing very significant challenges in relation to the affordability of medicines. The industry continues to develop very expensive products, particularly in the high-tech medicines area and the costs involved are a challenge for health systems even in countries with much greater resources than Ireland.
The HSE has received 2 applications for pricing and reimbursement of ocrelizumab (Ocrevus). 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, an agreement was reached in relation to the commercial terms which will apply to this indication. The HSE intends to progress ocrelizumab for the RMS indication, which has been approved for funding from October 2019, on a patient-specific basis for this 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. On 4 October 2018 the NCPE completed its assessment for this indication. They did not recommend that ocrelizumab be reimbursed for this indication.
The HSE and the manufacturer have had a number of rounds of commercial negotiations in relation to this indication. Commercial discussions have concluded and the medicine has been reviewed by the HSE Drugs Group. The HSE Senior Leadership Team have received the Drugs Group recommendation. The HSE's final decision on reimbursement will take into consideration the criteria contained in the 2013 Health Act.
The HSE has also received an application for reimbursement 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 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 HSE commissioned a full HTA with respect to this indication in April 2018. On 12 August 2019, the NCPE received the applicant's submission and the HTA is currently underway.
The Government wants new and innovative medicines to be available to our citizens as quickly as possible but this can only be achieved if medicines are priced by the pharmaceutical industry in a viable and sustainable manner.
In an effort to identify workable solutions to the challenges which we face, I proposed a dialogue with Industry to explore ways in which new medicines might be more easily introduced in Ireland. This invitation was built on the premise that any innovative approaches that may be tabled must be compatible with the statutory provisions which are in place and must also recognise the context of finite Exchequer resources. It was in this context that an Open Policy Forum took place in 2018 between the Department of Health, the Department of Finance, Public Expenditure and Reform and the Irish Healthcare Pharmaceutical Association (IPHA) in 2018 and an Open Dialogue meeting took place in 2019 between the Department of Health, the HSE and IPHA in relation to new medicines.