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‘Pay for performance strategy’ is needed on high-cost drugs — NCPE Clinical Director

In his talk on the economics of providing new treatments and medicines, Prof Barry argued for the mandatory collection of health outcome data following reimbursement of high-cost drugs.

He said State deals with pharma should involve ongoing provision of data on the impact of high-cost medicines and the State should get its money back if the drug is “not working”.

Much greater use of biosimilars, a prescribing incentive scheme for general practice and review of the long-term illness (LTI) scheme are also required, with Prof Barry being of the view that the latter scheme should be scrapped in its current form.

He said the LTI scheme was “inequitable” in terms of the medical conditions included and excluded, and noted as an example that “you could be the wealthiest diabetic in the country and you get your diabetic medicines free… ”

Prof Barry’s presentation outlined that the State was reimbursing numerous drugs far in excess of the cost-effectiveness threshold utilised by the NCPE and yet this should only happen in exceptional circumstances.

In 2016, total drugs spend was over €2 billon, increasing by 4.6 per cent on 2015.

Prof Barry said the high-tech drug scheme accounted for less than 1 per cent of items dispensed but outlay in 2016 was around one-third of the total drugs expenditure.

He said it was “right and proper” to talk about medicines and money because of the ‘opportunity cost’.

“If we spend money on medicines — millions and millions on medicines — it may not be available for our cath lab in Waterford, for correcting scoliosis in our children, looking after our elderly people at home. We’d be far better off investing some of the millions of euros we put into drugs to looking after our elderly patients — your relatives and our elderly patients — I feel strongly about that. Disabilities and mental health — yes, that is where we need to put our money, not into drugs or all drugs.”

””

Prof Michael Barry, NCPE

The NCPE, which conducts the health technology assessments (HTAs) of pharmaceutical products for the HSE, is seeing more and more high-cost medicines. The highest-cost medicine in the country is Soliris, made by Alexion. It is indicated for paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome (aHUS) and costs €582,000 per patient per year for aHUS.

“That is what we are dealing with on a regular basis now. We are now in the middle of assessment for a drug that will cost about €1 million per patient per year… ”

When the NCPE conducts HTAs, the onus is on the industry to make their case, said Prof Barry.

“It is up to the industry to prove that its product is value for money and that we should be using taxpayers’ money to pay for it… it is their challenge.”

The Centre examines the added value for the increased cost as compared to the standard of care. The quality-adjusted life year (QALY) threshold used in the HTA process is €45,000

 “So if you are below that, in other words, if you are getting good value for money, we will be saying yes, we will be recommending it… Essentially, what we know now is that if it’s above €45,000 per QALY, when we spend on that drug, someone is going to lose out.”

Prof Barry discussed the impact of media reporting and political pressure surrounding recommendations on drug reimbursements.

Among the drugs discussed by Prof Barry was Kalydeco (ivacaftor) and Orkambi (lumacaftor — ivacaftor). He noted that “we await” peer-reviewed scientific data to demonstrate the impact of these drugs on CF morbidity and mortality.

On Orkambi, at the time of assessment it was €159,050 per patient and the budget impact was €391 million over five years. It was €369,141 per QALY. “… This is why we should do cost-effectiveness analyses on drugs for rare diseases, because it shows us what price we should be getting, and in fairness to the HSE, for a lot of other drugs they use this information to ‘hard bargain’ with the company in relation to drugs, and that’s what they did on Orkambi. They didn’t get it to where we wanted, but they reduced it by about half… ”

Prof Barry referred to a “very interesting clause” in the IPHA agreement, stating that where the HSE cannot fund a drug from within existing resources, it may inform the Department of Health, which may bring a memorandum to Government in relation to the funding implications.

He expressed concern at a proposed amendment to legislation that assessment for value for money for very high-cost drugs for rare diseases (orphan medicines) was “not relevant”.

“Why were we able to reduce the price of Orkambi by nearly 50 per cent — that is in the media… the reason we were was because we were doing economic evaluation, because we were able to front-up to them.”

Prof Barry said he was “reliably informed” that the pharmaceutical industry was in Dáil Éireann “every single day”.

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Distrust over future consultant contract negotiations

Consultant members passed a motion condemning the Government and the HSE “for effectively forcing individual consultants to resort to legal action in the High Court in order to have their contractual rights” upheld under the 2008 Consultant Contract. 

Speaking at the Organisation’s National Consultant Meeting, Consultant Rheumatologist in Connolly Hospital, Blanchardstown, Prof Trevor Duffy reflected on his own experiences during the negotiations for the 2008 contract.

“This stands for so much more that the simple fact of money. It just displays intent, approach and belief on behalf of the Department of Health and Government,” said Prof Duffy.

“The Government’s case on this issue is untenable… yet they are still insisting on dragging it through the High Court.

“I think the display of what that says in action is far more important than the money itself. It displays a complete contempt for consultants and for the medical profession. It is really hard to see how you can enter into good faith negotiations while this kind of thing is carried on in the background.”

Consultant in Emergency Medicine Dr Mick Molloy described the current situation as “frustrating”.

“Talks stall for various reasons, I understand that,” said Dr Molloy. 

“But when you walk out of a room with what we thought was an agreement only to find out a year later, we are told ‘well, actually, the salary wasn’t agreed’…and that they were no longer going to honour the deal a year after the fact.

 “It makes you wonder can you actually negotiate with this group at all in the future without having cast-iron guarantees in advance that a particular contract will be honoured in the future.”

Dr Molloy told the meeting that his understanding was the Government and HSE would appeal if the legal cases go against them.

“So that would be a very lengthy process, very expensive process, very unnecessary process,” he added.

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Serious concerns raised over planned public and private split

At the National Consultant Meeting, members discussed the recommendation in the Sláintecare Report to separate private practice from public hospitals. The Government is currently undertaking a review on the implications of this recommendation.

“I know what the value to our small hospitals is, from the income source from the [private] patients,” said Dr Mick Molloy, Consultant in Emergency Medicine.

“If that was taken away, I’m very concerned about how it would be replaced, and there isn’t a mechanism in place to actually cope with that lost revenue.

“And I would fear that the knock-on effect would be more patients seeing they can’t get access to public hospitals will [then] ditch private insurance and [then] there will be a greater volume of people coming into the public hospitals, with a lesser amount of money to deal with it. That is the situation that would be the worst of all scenarios.”

However, Consultant Psychiatrist Dr Matthew Sadlier questioned the very basis of the debate regarding public and private patients. He told the meeting that all reports and plans, including Sláintecare, do not take into account the complexity involved and are thus flawed.

“I’ve said this for 10 years and nobody ever listens or reports it,” said Dr Sadlier. 

“We do not have a two-tier health service. I just wish people would say this: We have a three- or four-tier service. We do not have one set of private insured patients and then those with no insurance. We have a range of insurance options that gives you a range of access to private care.

“There isn’t really a private patient and a public patient; there are many shades of private patients. Most people who take out private insurance do not take out insurance to the level that allows them access to standalone private hospitals. So this concept of 47 per cent of the population having private insurance; they don’t really, they have semi-insurance.”

Dr Sadlier told his fellow consultants that this flaw in analysis has impacted political policy towards health.

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Doctors ‘under attack’, says new IMO President

Dr Gilligan, a Consultant in Emergency Medicine at Beaumont Hospital, Dublin, delivered his inaugural address at the Organisation’s AGM in Killarney following Minister for Health Simon Harris’s speech.

The IMO President said Irish society had very significant expectations of those who wished to become doctors. However, he said doctors were being routinely dishonoured by having contracts ignored, having to tolerate different pay rates for similarly-qualified doctors doing the same job, and unreasonable delays in restoring cuts imposed during the crisis compared to other groups.

The consequences included 400 consultant posts unfilled nationally, GMS lists without a GP and “more resignations from the public hospital system than ever before in the history of the State”, he said.

“The fact that new contracts need to be negotiated for GPs, NCHDs, consultants and public health specialists is indicative of the fact that doctors in Ireland currently do not feel valued,” Dr Gilligan commented.

This issue fed directly into the unprecedented shortage of doctors in key posts across the country. Dr Gilligan recounted a personal experience of a colleague who resigned his post recently, saying that he could no longer work in a country where he was embarrassed to tell people he was a consultant. 

””

Dr Peadar Gilligan, IMO President

He also described the need to board admitted patients on trolleys and chairs in emergency departments (EDs) as “an absolute outrage”.

The IMO President maintained that Ireland is an outlier in terms of ED overcrowding internationally and called for the introduction of a six-hour standard between the time a patient arrives in an ED and the time they are admitted or discharged. The current average waiting time in EDs in Dublin is 14 hours.

On proposals to increase the number of beds available in the system by just over 2,500, Dr Gilligan said the country needs over 7,000 new beds to deal adequately with an increasing and ageing population.

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Reform of consultant appointment process will be ‘high priority’

Speaking at a seminar for NCHDs at the IMO AGM in Killarney, Prof Murray said the decrease in the number of approved consultant posts in the last two years was “disappointing”. According to information presented by Prof Murray, there were 174 consultant posts approved in 2017, compared to 195 in 2016 and 288 in 2015.

“That is disappointing to me; that is something I am going to make a very high priority, to see what we can do to facilitate the appointment of consultants in a more easily-negotiated way.”

He outlined that Ireland required “far more consultants and general practitioners” and that “we need to look carefully at the ratio of NCHDs to others within the health service”.

Figures presented by Prof Murray showed that Ireland has 77 consultants per 100,000 population, compared with 106 in the UK. He said the number of non-training NCHDs had increased by 50 per cent in the last four-to-five years, but specialists and trainees should instead be the focus of substantial increases.

He said the “big drive” in relation to non-training NCHDs was a reflection of European Working Time Directive (EWTD) implementation and there had been a “failure to plan adequately in relation to that”.

Prof Murray said a working group would be established on the issue of non-training NCHDs. He reiterated his support for an amendment to legislation that would allow non-EU NCHDs to access the trainee division of the medical register where their internship was not deemed equivalent.

His focus would also be on progressing outstanding issues affecting trainees, including protected training time, allocation of non-core tasks, educational refunds and non-payment of overtime.

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Harris promises ‘real progress’ on GP contract as frustration mounts

However, GPs at the meeting expressed major frustration at the delays on a new contract and FEMPI reversal, with no confirmation that restoration of fees would be unconditional.

Minister Harris acknowledged that “GPs suffered a lot during the recession”.

Speaking to journalists, he said “many cuts” were made to general practice funding by successive governments “during the financial emergency”. He said “now, as we move as a country to a better economic climate, it is important to try to help general practice”.

Minister Harris said talks would commence within a month and he wanted to “move to a post-FEMPI era”.

“I want to engage with GPs. I want new services they can also provide within the community to help reform our health services, and yes, there will be significant resources available and my message to general practice tonight is, this is the moment you have been waiting for.”

””

Simon Harris, Minister for Health

This would be subject to reaching an agreement on a new contract through “intensive” talks with the IMO and other stakeholders, the Minister added.

There was also anger among GPs at claims in a Department of Health briefing document that FEMPI cuts to general practice amounted to 24 per cent, compared to the 38 per cent figure quoted widely by GP representative bodies.

Minister Harris said he was “not here to get into a row over the IMO figures and percentages”. He said it was “not under dispute” that general practice had “suffered over the years of recession”.

“We now as a Government have significant extra millions of euro that we want to spend in general practice and I want to engage with GPs on how to make this a reality, and that will happen within a month.”

The Minister would not clarify whether the unwinding of FEMPI would be conditional on “service improvement”, as suggested by Minister of State at the Department of Health Jim Daly at the NAGP AGM last month. Minister Harris told journalists he wanted “holistic” talks and stressed that new services would be resourced.

Minister Harris also insisted to the Medical Independent (MI) that the forthcoming talks would result in real progress on a new contract “within months”. He had briefed Government in late March and now had legislative powers to set fees.

“What is different now is that these are talks that are mandated by the Government, these are talks that I have been liaising very closely with the Department of [Public] Expenditure and Reform on, and they are talks backed-up by resources. Obviously, I am not going to put the figure in the public domain because that is the purpose of negotiation, but what I can say is, we are talking about wanting to spend many, many millions more in general practice over the coming years.”

Responding to questions from MI about the further expansion of free care to under-12s, as contained in the Programme for Partnership Government, Minister Harris said he would “like to see the extension of access to GP care provided”.

However, he was “also conscious that I have both the Programme for Government commitments and the Sláintecare programme as well, which talks about expanding access, and I’d like to talk in the negotiation structure about how best that can happen”.

According to Minister Harris, he had said “many times” that “the cost of going to the doctor is a factor that many parents reflect on heavily when they have a sick child”.

However, he said he wanted to make progress in a “sustainable manner”.

“Ministers for Health in the past have just wanted to talk to GPs about one issue… I want to talk about a range of issues. I want to talk about the current level of fees. I want to talk about future services. I want to talk about how we make Sláintecare reform a reality. I want to take a multi-annual approach to this. I suppose I am in a position that many of my predecessors weren’t — that we do now have resources to make this possible if we have willing partners, and I believe we do.”

””

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Call for improved NCHD rota system and contract review at national meeting

The meeting passed a motion calling on the HSE to provide NCHDs with four weeks’ notice of their initial roster.

The HSE is contractually required to provide two weeks’ notice of the first NCHD roster of their rotation, but IMO members said this is not always happening.

“I have been a doctor for nine months now and have never had a rota with two weeks’ notice,” said Dr Neasa Conneally, “so four weeks would be great.”

NCHD Committee Chairperson Dr Paddy Hillery told the meeting that NCHDs were not working normal nine-to-five, Monday-to-Friday jobs.

“It is important that you are given proper notice, that they [HSE] take your life into account,” he said.

Also at the National NCHD Meeting, former IMO President Dr John Duddy said it was time for a review of the NCHD contract.

He recalled how the previous contract emerged eight years ago after long meetings and threats of industrial action.

“That is not the way we want to negotiate a new contract,” said Dr Duddy.

“Nobody here wants to go through that again with a year-long process; that was extremely stressful for everyone involved. A more constructive way of doing it would be to institute a more formal review with our employer.”

The meeting passed a motion calling for a contract review.

“This is what we want to be engaging on, what we want to be doing,” said Dr Hillery.

“As a union, we do not want to be dragging people out on the streets to get the basic improvements that we all agree are necessary. We want to engage proactively with our employers and work for the betterment of our patients and our practice.”

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General practice ‘will go over the cliff’

Discussing a motion that called on the Minister for Health and the HSE to acknowledge the current workforce crisis in general practice, whereby 700 GPs are due to retire in the next five-to-seven years “with no prospect of new GPs taking over practices”, Kilkenny GP Dr Tadhg Crowley said it was not only a problem of retirement and recruitment.

He said that once one doctor goes, more will follow, as the workload will be unsustainable.

“I think it will be an explosion when it happens; we will go over the cliff like we have never seen before in the country.”

Dr Michael Kelleher, GP in Lahinch, Co Clare, said “we urgently need to address capacity issues, we urgently need to restore FEMPI to repair our existing service”.

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General practice not in ‘good place’ — HSE DG

Mr O’Brien was speaking to MI following a debate on the Sláintecare Report at the IMO AGM in Killarney.

The debate heard from a number of IMO GP members, who described what they believed to be the current crisis in general practice. A number of speakers also questioned whether the intention of the Sláintecare Report to establish a primary care-focused health service was possible, considering the current state of general practice.

“General practice is vital to the future of the health system,” Mr O’Brien told MI.

“Clearly, we are not on the right track in terms of sustaining the type of general practice service that we need. So one of the things clearly articulated in Sláintecare must now be translated — that is for a vision for the future of general practice that will bring confidence to doctors.”

Mr O’Brien said doctors who are in training must be encouraged to enter into general practice and know it “has a sustainable future, appropriately funded, appropriately resourced”.

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Sláintecare statistics called into question

Chairperson of the union’s GP Committee Dr Padraig McGarry raised the issue with GP Dr Michael Harty TD, one of the authors of the Sláintecare Report.

“Some questions have been asked in relation to the gathering of statistics,” said Dr McGarry during a well-attended debate on the Sláintecare Report on the Thursday evening of the AGM.

“We know the accuracy of statistics for the production of this report is absolutely essential.”

In his response, Dr Harty admitted that there may be some problems with the statistics used regarding GP visitations.

“There is a controversy over the visitation rates in relation to general practice,” said Dr Harty.

“I have spoken to the Trinity [College] group [who worked on the report] who are willing to look at those figures. I know [Dr] William Behan has very strong views on visitation rates [figures]. I would think his figures are more accurate than those used in the [Sláintecare] Report. But those were the figures that we took from the Trinity group.”

Dr William Behan is a GP who has queried the Sláintecare Report statistics regarding general practice on his Twitter account (@DrWilliamBehan) and elsewhere.

“I think if Sláintecare is to be introduced, if there is to be an expansion of primary care, if there is to be an expansion of entitlements, those figures will have to be looked at closely,” added Dr Harty.

“I think it is in that context that they can be negotiated and reviewed.”

In response, Dr McGarry said there was “a slight urgency here” because negotiations over a new GP contract are taking place.

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