Wednesday, 11 December 2019
Department of Health
Medicinal Products Availability
237. To ask the Minister for Health the reason for the continued delay in access to medication for persons with multiple sclerosis in view of the fact drugs have recently become available and accessible in other EU countries, for example, siponimod; the steps he will take to expedite access of such drugs for patients; and the timeframe for same. [52036/19]
I propose to take Questions Nos. 219, 236 and 237 together.
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.
On 14 November 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a marketing authorisation for the medicinal product siponimod (Mayzent), intended for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease. The EMA's decision on whether to grant marketing authorisation for siponimod will take into account CHMP's recommendation.
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.
My Department and the HSE are working on making greater efficiencies in medicines usage through a range of initiatives both domestically and internationally to ensure the greatest possible access to new treatments for patients in Ireland.
The HSE’s Medicines Management Programme (MMP), incorporating the Preferred Drugs initiative, is overseeing the implementation of a number of actions to bring about greater value for the taxpayer through cost-effective provision of medicines. These measures include the designation of preferred products with a focus on high-cost prescribing areas, in particular optimising the use of biosimilars.
I and officials have also been engaging over the past number of years with a number of voluntary EU forums. In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy. 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. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative which is being established as part of the work programme of Beneluxa.