John Brassil (Kerry, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I welcome the opportunity to raise this issue. I thank the Office of the Ceann Comhairle for allowing it. Will the Minister for Health intervene to sanction a pilot scheme for a new system of drug reimbursement for Ocrevus, which is for primary progressive multiple sclerosis, PPMS. Ocrevus is the first medicine approved to treat PPMS. The drug has been approved to reduce the progression of physical multiple sclerosis or physical disability for PPMS patients. The manufacturer, Roche, has outlined a system of reimbursement whereby the HSE would match the price currently paid in Germany with a view to reducing the price once all 14 western European countries have negotiated a wholesale factory price. Once this is done, the average price across the 14 countries would be taken as the standard, and the company would then reimburse any overpayment made in the intervening period.

The Minister for Health, Deputy Harris, asked in this House in September 2017 whether, if we believed the current system was broken, we could start hearing what people wanted to replace it with. He said he believed it is broken also and said the conundrum is how to come up with a better model. What I am offering to the Minister of State, Deputy Jim Daly, and the Minister is a better model, something that we need to consider. Given the Minister's acceptance that the current model is broken, we need to come up with innovative ways of reimbursing orphan drugs.

In trials, people treated with Ocrevus had a 46% reduction in the risk of progressing to a wheelchair by comparison with a placebo group. For a person living with PPMS and for whom disability accumulates twice as fast as with relapsing MS, seven more years without the need for a wheelchair could extend the time he or she could live independently, live in the home or continue working and looking after his or her family. Therefore, it has very real benefits. We are talking about a population of MS sufferers in Ireland of approximately 9,000. Some 10% of this figure is 900. That is the patient population.

We have an opportunity to examine the 2013 Act to do something that is novel. Last week, the Minister was very enthused about signing an agreement with the Benelux countries. The product is available in Holland. I would quite happily accept the price currently being paid in Holland and going back to the original proposal to average out the price once the 14 western countries have approved of it. Either way, it is a novel proposal. The drug has been proven to be effective. For the 900 people with a very debilitating condition who are looking for hope, I really hope the Government will consider the proposal seriously. I hope the Minister of State will not give me the standard Department reply. I await what he has to say with interest.

Jim Daly (Cork South West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Deputy Brassil for raising this issue. Securing access to new and innovative medicines in a timely manner is a key objective of the Minister for Health and the HSE. These new products are often very expensive, however, with a significant potential impact on the health service budget. The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion, as appropriate.

The Act specifies the criteria to be applied in the making of reimbursement decisions. They include the clinical effectiveness and cost-effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE, pursuant to the community drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list. The HSE’s decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds from the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist reimbursement decisions. The NCPE uses a decision framework to assess systematically whether a drug is cost-effective as a health intervention.

I have been informed that ocrelizumab, used for the treatment of adult patients with early primary progressive multiple sclerosis and for the treatment of adult patients with relapsing forms of multiple sclerosis, is currently undergoing a full pharmacoeconomic assessment by the NCPE. The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant moneys involved, it must ensure the best price is achieved, as these commitments are often multimillion euro investments on an ongoing basis. This can lead to a protracted deliberation process.

The Minister is keen to engage with the industry to explore ways in which new medicines might be more easily introduced. However, any innovative approaches which may be tabled must be compatible with the statutory provisions in place and must also recognise the context of finite Exchequer resources. The HSE is the decision-making body on the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. It is the HSE alone which will make the final decision whether ocrelizumab will be reimbursed taking into consideration the statutory criteria as specified under the 2013 Act. This Act does not give the Minister for Health any powers in the reimbursement process. The HSE does not require approval or consent from the Minister or the Government when making a reimbursement decision.

John Brassil (Kerry, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I know and accept the way the process works. I hope the Minister has the ability to input a proposal such as this to know that it should be considered. I have a Bill to amend the 2013 Act which is waiting in the lottery system for several weeks now. I am not looking for the HSE to reimburse any medicine which it does not believe is good value for the State. However, I must impress on the Minister of State that this particular drug is approved in over 60 countries and it is under review in 20 more. I suggest it is probably a matter of time before it is approved in Ireland. What we are looking for is quick access. The proposal the company has made is fair and allows for reimbursement.

I do not like making proposals because I am aware of value for money and finite budgets. In the past, I have raised the argument for using biosimilar medical products. In my opinion, there is a low-water figure of €50 million to be saved if we used available biosimilar products which are just as effective as the original brand. For some reason, we are stalling. The money is there but it is in another pot. What could we do with a saving of €50 million? The costs of Ocrevus, Respreeza and Kuvan - the phenylketonuria, PKU, sufferers will be here tomorrow looking for its approval – could be met with this saving.

Will the Minister of State impress on the Minister, Deputy Harris, this particular point? It makes sound economic sense like the case for generic medicines. The industry argued that if we started using generic brands, the sky would fall in. We did and the sky did not fall in. The same will apply to biosimilar medical products.

Jim Daly (Cork South West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I bow to the Deputy’s better and professional knowledge of this subject. It is understood, appreciated and well-regarded. In addition, he brings sincerity to these debates on which I have had the pleasure of engaging with him.

I will take back to the Minister, Deputy Harris, as well as to the Department, the Deputy’s principal plea for expediency in the decision-making process in the HSE. He believes the merits of this case stand on its own two feet when one looks at the number of countries which have approved it, as well as those waiting to do so. I will relay this back to the HSE through the Department and the Minister for Health.

I note the potential biosimilar medical products offer to the health system and the need to engage more proactively on that front.

These two points are duly noted.