Written answers

Thursday, 5 March 2020

Department of Health

Medicinal Products Availability

Photo of Michael McGrathMichael McGrath (Cork South Central, Fianna Fail)
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530. To ask the Minister for Health if a response will issue to a matter raised in correspondence by a person (details supplied); and if he will make a statement on the matter. [2661/20]

Photo of Seán HaugheySeán Haughey (Dublin Bay North, Fianna Fail)
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537. To ask the Minister for Health if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure that new medicines are made available to persons with MS; and if he will make a statement on the matter. [2690/20]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 530 and 537 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 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, the HSE approved 31 new medicines and 5 new indications for existing medicines for reimbursement in the public healthcare system. The approvals represent an additional investment by the HSE over five years of approximately €220m in providing access to new and innovative treatment for Irish patients.

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 an application 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. In October 2018, the NCPE recommended that ocrelizumab not be reimbursed for this indication.  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. On 10 February 2020, the NCPE sent a preliminary review to the applicant and are currently awaiting their response.

In addition, the HSE has received an application for reimbursement of siponimod (Mayzent) as indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. On 13 January 2020, the NCPE completed a rapid review and recommended a full HTA with respect to this indication.

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.

I can confirm that, as Minister for Health, I met with Multiple Sclerosis Ireland in October 2018 in order to discuss new potential medicines for treatment of MS in the public healthcare system.


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