Statement by Minister Simon Harris on the Funding of Orkambi for Cystic Fibrosis Patients – Seanad Eireann

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I thank the Seanad for giving me the opportunity to address this very important issue and I look forward to listening to the Senators’ contributions.

I would hope that it is clear that all of us here today share the same objective – securing access to this medicine for Irish patients at an affordable price. Irish cystic fibrosis patients should have access to innovative treatments. This is the clear objective of the HSE, which is negotiating on behalf of Irish patients. It is essential, in my view, that the HSE is fully supported by all public representatives in their efforts. We should not forget that, when it comes to negotiations such as these, there is only one party that negotiates on behalf of Irish patients – the HSE.

This is not about attacking big pharma. This is about supporting Irish patients and supporting the people who are working to get the very best deal for Irish patients.

It is unacceptable that CF patients should be used as pawns in a process like this and very regrettable that so many of them and their families have been put through such a harrowing time.

The company in this case has refused, from the outset, to put a fair and reasonable price on its treatment, in line with the price guidance provided by Professor Michael Barry and his team in the NCPE. It has refused to give absolute certainty to patients on managed access schemes or programmes that they will continue to receive their treatment for the rest of their lives, regardless of the outcome of its commercial negotiations with the HSE. And it has actively sought to place Irish CF patients in the centre of its commercial negotiations with the HSE, with a view to maximising the return for its executives and shareholders.

Unfortunately, this type of behaviour is not unique to this drug and is not unique to Ireland. Similar pricing strategies have been employed in the past and my counterparts in other member states inform me that this type of behaviour is evident in their countries also.

As you will be aware, I attended a meeting in Lisbon yesterday to discuss drug pricing, innovation and the sustainability of European health systems. I also took the opportunity to raise directly the situation of Orkambi, and the manner in which the company was treating CF patients and their families in Ireland.

What was very clear, from my discussions with health ministers from other countries, is that the current situation is not sustainable. Advances in medicines have played a key role in improving the overall health of the Irish people, but health care systems throughout Europe are quickly reaching the point where their patients cannot access new and innovative medicines because of the pricing strategy of the manufacturers.

As we have seen in the case of medicines such as Orkambi, the price that the company is seeking to charge means that innovative products may never reach the patients, as health systems cannot afford the price. They are simply unaffordable.

This can be viewed as either a funding problem or a pricing problem.

My view is that this is primarily a pricing problem. In order to ensure that innovative medicines are available to patients with unmet needs, companies such as Vertex need to fundamentally reassess their pricing model.

Let me just focus on the price for a moment, as this is the main barrier to access in this instance. Ireland’s National Centre for Pharmacoeconomics – the NCPE – independently assessed the evidence and benefits of this treatment.

Based on a detailed examination of costs and benefits, including reductions in other treatments, the NCPE considers a price of €30,000 per patient to be more appropriate.

At this price, the HSE would pay €15 million a year for Orkambi, or €75 million over the next five years. This is a very significant investment and any public statement from the company on price should be compared to these figures. There has been an attempt to undermine these figures as inappropriate for this type of treatment. However, at €30,000 per patient, per year, this treatment would still be one of the most expensive treatments in Ireland (number 6 on the high tech drugs list). This is not an attempt to undermine the benefits of the treatment, but an acknowledgement of those benefits.

Unfortunately, the price that the company has put on this product is many multiples of these figures. Despite the claims of the company, in the absence of verifiable evidence to the contrary, it would appear the main driver of the price is an estimate of the maximum amount that the country can pay and it is not connected to the health benefits of the treatment or the cost of bringing the medicine to market.

There has also been significant debate in recent days on an outcomes-based model. Put simply, this involves the company having the confidence in their product to provide the treatment to all eligible patients, but to only seek payment when the treatment delivers the benefits to Irish patients.

The HSE has also confirmed that Vertex made it clear they weren’t willing to engage in an outcomes model that addressed the HSE’s core pricing concerns. Because of the commercial confidentiality that Vertex will not release the HSE from, the HSE cannot provide this house with a transparent understanding of Vertex’s proposals in the negotiations.

Taking account of the outcome of negotiations and having considered the NCPE recommendations and other expert advice, the HSE’s Drugs Committee has not recommended reimbursement for Orkambi.

Next Steps
So where do we go from here? First of all, let me state loud and clear to CF patients that this is not the end of the process. The HSE Directorate will now consider the Drugs Committee’s recommendation, taking into consideration the manufacturer’s latest price offer. This decision will be made on objective scientific and economic grounds, in line with the 2013 Health (Pricing and Supply of Medical Goods) Act.

This is the next formal stage in the statutory assessment process. However, the HSE has made it crystal clear that it is open to meaningful engagement with the company.

No matter how often PR companies or drug companies try to assert that I won’t attend negotiations, there should be no doubt that this is a complete misrepresentation. The law of this land, passed by this House and the Dail in 2013, makes clear that the HSE is the body with statutory responsibility for decisions on pricing and reimbursement of medicines. I have been in regular contact with the HSE. They are ready to make this happen. Vertex should do the same – there isn’t one rule for Vertex and a different one for everyone else. It’s time for the spinning to stop and the talking to start, in the best interests of patients. Get back in the room and get on with it.

As I mentioned, this situation is not unique to Ireland. I am looking at every option to progress this issue and collaboration with other countries is a very viable option.

I have already contacted health ministers in four other countries, where Vertex’s very high pricing has also prevented reimbursement for CF patients. I believe there is potential for joint co-operation in seeking to positively influence the manufacturer’s pricing strategy.

As I outlined, I also raised this issue with health ministers in Lisbon yesterday and I will continue to do so, as part of moves to consider pricing for expensive drugs across Europe. Despite the claims of the company, there is very significant value achievable to patients and health system from such collaboration.

I appreciate that this is a stressful time for CF patients and their families.

I strongly urge Vertex to provide this drug at a fairer price, for the benefit of our patients.

As Professor Michael Barry has said, it is time for the company to put patients first and to significantly reduce their price to one that is fair, equitable and sustainable.

I fully support the HSE in its efforts to reduce the price of this medicine, so that our CF patients can be treated with it, and I would call on all public representatives, including the members of the Seanad, to do the same.