Prof Michael Barry Clinical Director of the NCPE addressed the PMI on the cost effectiveness of medicines, along with the reimbursement process — a source of much continued debate in the Irish healthcare market.
The cost-containment in the area of pharmaceuticals will continue to be a priority for the HSE and looks to be an easy option for the health service, which is under pressure from the Department of Health, to balance its budget overrun for this year currently at €300m, the National Centre for Pharmaeconomics (NCPE) has warned.
Addressing a Pharmaceutical Managers’ Institute of Ireland Breakfast Seminar — Reimbursement Overview held at Finnstown Country House Hotel in Lucan, Ireland recently (September 7), NCPE’s Clinical Director said: “This is where they will go to make their savings of that €300m in The Irish Times this morning.” He was referring to an article entitled ‘HSE overspending to create €300m financial deficit’, in The Irish Times that morning (07/09/17).
“Why? This is probably one of the easier ways to go rather than reducing hospitals, cutting beds rationalising of health services or whatever,” Prof Michael Barry commented.
There will, he envisages, continue to be an increasing number of complex health technology assessment (HTA) submissions and access to medicines will remain a contentious issue in view of the price value imbalance.
“And I believe that there are many products where there is no relationship between the price being asked and the value that we will be afforded,” he remarked.
The development of the HTA process has focussed on the rapid review assessments and a third of rapid reviews now conclude as a full HTA at the submitted price.
“That’s an opportunity for you”, he told the pharmaceutical managers attending the meeting. “Don’t let it go for an HTA, look at the price, avoid the HTA and let us say yes [to reimbursing your product].”
The presentation of early phase clinical trial data was a real challenge and the call for early access in the adaptive pathways — which Prof Barry described as constituting a lowering of standards, driven by commercial interests and effectively mandating the funding of poorly tested expensive drugs — “frankly ignores the value proposition”, in his view.
“I know I am sorry to offend IPHA [Irish Pharmaceutical Healthcare Association] there, but I just think that’s on a different planet.”
He went on to say: “I don’t see adaptive pathways being instituted in this country for a long time and indeed across Europe as well. I think we have debated this topic and people get very excited and upset and anxious about it all, but that’s the reality of it.
“You have the headlines this morning saying we have €300m of savings to be made and you talk to us about adaptive pathways? Think again.”
Compassionate access schemes, Prof Barry proposed, should not be linked to reimbursement and if pharmaceutical firms are going to link the two things, then they ought to make sure everybody, particularly the patients, know at the start, not at the end.
He said the HSE was “obviously very cognisant” of the challenge of rare diseases and attempts to address this through the Drugs Management Portfolio.
Prof Barry revealed that in the previous week, he had been asked to chair the new Rare Diseases Medicinal Products Technology Review Committee, which will include patient groups, stakeholders, prescribers, industry obviously as well, in order to help us to have an input into the HTA of these products — a little bit like the National Cancer Control Programme. The NCPE report would not only go to the HSE, but would now also go to that Committee and they would have their input then into the drugs group.
Describing the National Rare Diseases Plan for Ireland 2014-2018 as one of those tedious documents, although he has read it, Prof Barry said he found it interesting that the plan states, ‘it’s possible to argue that assessing orphan medicines in the same way as other medicines may disadvantage them’.
“Is that true,” he queried. “Possibly. But in some quarters that’s really an argument for not assessing drugs at all. I don’t see that happening.”
“Anytime you are using taxpayers’ money to pay for a medicine that medicine should be assessed regardless of whether you can develop an ICER or not it should be assessed, even if it’s to look at the clinical data. So I think we need to be very clear about that,” argued Prof Barry.
He said: “We will hopefully see significant developments in the rare diseases area with the new committee, and there will be an increasing emphasis from our point of view on the post-HTA space and that’s really all about medicines management, and I can tell you that we are constantly looking at utilisation and expenditure data on the Community Drugs Schemes and when any product tends to be speeding ahead of its targets then we actually look at why this is the case and what it is being used for etc. etc?”