Tuesday, 27 September 2016
Topical Issue Debate
Medicinal Products Availability
I received a telephone call last Saturday from a gentleman in Cork in regard to his wife who suffers from lupus and has been in chronic pain for the past 20 years. The man's wife has been told by her neurologist that if she could access Sativex, which is an oral spray used typically by people who suffer from multiple sclerosis, it could help her condition. I understand that in July 2014 the use of Sativex was licensed in Ireland but that agreement on price has yet to be reached between the HSE and the manufacturers. There are many people who could benefit from treatment with this drug. When will a price on Sativex be agreed between the HSE and the manufacturer so this drug is accessible to people, particularly the wife of the man who contacted me and people suffering from multiple sclerosis?
I thank the Deputy for raising this important issue. Sativex is indicated for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits. Deputy Kenny will be aware that access to potentially beneficial drug treatments is an important issue for people with multiple sclerosis, MS, and also that MS sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE is a team of clinicians, pharmacists, pharmacologists and statisticians who evaluate the benefits and costs of medical technologies and provide advice to the HSE. The NCPE conducts health technology assessments of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process.
Since July of this year a revised and more transparent assessment process for the reimbursement of new medicines by the HSE has been in place. This process includes consideration of the budget impact of individual new medicines, the opportunity cost of the treatment and resources available to the HSE, as allocated by Dáil Éireann. The new assessment process is available on the Department of Health website.
In regard to the reimbursement of Sativex, on 11 July 2014, the Misuse of Drugs Regulations 1998 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in this State. It was then open to the holder of that authorisation to make the product available for prescription in Ireland. In early September 2014, the HSE received an application for inclusion of Sativex under the community drugs schemes high tech arrangements. A health technology assessment on Sativex was completed by the NCPE, which did not recommend reimbursement of Sativex at the submitted price, which appears to be at the core of the Deputy's question. The report by the NCPE is an important input to assist the HSE in its decision-making process and informed further engagement between the HSE and the supplier in regard to potential pricing arrangements for this product. Sativex is not currently reimbursed. The HSE is awaiting further engagement from the supplier. It is appropriate that these should not be ministerial decisions and that a scientific and evidence-based approach is taken to determining the extent to which patients would benefit from treatment with expensive new drugs and whether this represents cost-effectiveness for the health service and the taxpayer.
I understand that the cost of making the drug available is estimated to be €4,000 to €5,000 per patient per annum. Is the Minister of State saying that the manufacturer is out-pricing the HSE or that the HSE does not believe it is getting value for money?
I share the sentiments expressed by the Deputy on this important issue. The manufacturers' estimate of the eligible population in Ireland that might be considered for treatment with Sativex if reimbursement was improved is approximately 830. The Deputy is correct that the cost is estimated to be €4,000 to €5,000 per patient per annum. Using the company's population data it is predicted that the gross budget impact in year one would be €396,901, rising to €797,041 in a five-year period. The actual number of people who might qualify if reimbursement was agreed by the HSE would depend on a range of factors, including any conditions that the HSE might attach in relation to approval, including, for example, approval arrangements to be complied with or clinical criteria to be met.
It is important to note that Sativex is licensed throughout the UK but not reimbursed by the NHS. The National Institute for Health and Care Excellence, NICE, has recommended that health practitioners do not offer Sativex to treat spasticity in people with MS because it is not a cost effective treatment. This is the NICE's view. The assessment of the National Centre for Pharmacoeconomics, NCPE, of Sativex informed further engagements and negotiations between the HSE and the supplier. At this stage, the HSE is awaiting further engagement with the supplier. There is an issue with regard to the price structures and overpricing and this is the message I will bring back to the Minister, Deputy Harris, because we must all make a contribution on this. I will make the views of the Deputy known.