By Aoife Connors.

The ICGP has appointed Dr Brid Hollywood, a Dublin-based GP, as the GP Lead in Mental Health.

Dr Hollywood will join the 15 other GP leads who were appointed in December 2010 and June 2011.

The GP leads will be directed by GP Lead Co-ordinator Dr David Hanlon, a Kildare GP, who took up his new post in June of this year with the remit of providing support and co-ordination for the GP leads in close liaison with Dr Joe Clarke, Chair of the Primary Care Chronic Care Programme.

Dr Margaret O’Riordan, ICGP Head of Quality and Standards, announced the successful applicant for the latest round of ICGP GP Lead appointments and noted that the College was delighted with the strong field of GPs that applied for the new position. “It was a difficult selection process due to the high calibre of all the applicants,” she said.

aoife.connors@imt.ie

Dr Marie Laffoy: ‘A combined care effort between the GP and consultant’

Aoife Connors speaks to Dr Marie Laffoy about the development of the recently announced electronic GP referral forms and plans to extend the template in the near future

The HSE Quality and Clinical Care Directorate (QCCD) recently announced details of a new electronic GP referral programme to secondary care that is being established. Meanwhile, in December, the Health Information and Quality Authority (HIQA) published a draft national template for primary care patient referrals. This was done to provide national guidelines on information to be included in patient-referral forms from primary care to acute hospital services.

Following serious issues in Tallaght Hospital during 2010, with unreported radiology films and unprocessed GP referral letters, HIQA – in conjunction with the Irish College of General Practitioners (ICGP) – is currently establishing a GP referral review project advisory group. This group will provide guidelines for the improvement of referral processes between primary and secondary care.

Concurrently, an e-tender document details that an advisory group is being established by the HSE with representatives from the QCCD programmes of care (primary care and chronic disease management), the ICGP, Department of Health and patient representatives.

The overall aim of this group is to develop an electronic, generic GP referral system.

A reconfiguration team from the South West, Cork and Kerry has been appointed in the lead role to develop and manage a national pilot programme which will implement the system. This work will be carried out with close liaison between the team and a HIQA advisory group. The pilot project team will be chaired by Cork GP Dr Tom O’Callaghan. A partnership between Enterprise Ireland, UCC and a commercial company will facilitate early delivery of the project.

During reconfiguration of acute hospital services in the HSE South West, it was recognised that one of the key requirements to underpin reform within the health sector was the development of an electronic, generic referral system between general practice and the acute hospital sector.

In June 2009, a reconfiguration subgroup was established with representation from GPs, hospitals, ICT, the university sector and patient advocacy groups. The group produced a proposal document entitled ‘Electronic Single General Practitioner Referral Pathway for the Irish Healthcare System’ in November 2009.

Pilot process
This pilot process must build on the existing work being done by Healthlink, the national General Practice Information Technology (GPIT) group, and the National Cancer Control Programme (NCCP), the e-tender document stated.

The HSE tender document, seen by Irish Medical Times, stated: “The project will bring about process change to support electronic referrals from general practitioners.”

Initially, the programme will use a general referral message generated by the GP practice software system, but disease-specific referral messages and chronic disease referral messages will also be designed as part of the project by the clinical care programmes in conjunction with Healthlink, the GPIT group and GP practice software vendors. The ICGP will be involved to ensure GP ‘buy-in’ for the electronic referral system, the tender document highlighted.

The national pilot project will include hosting hospital workshops in different regions to understand the current ‘end-to-end’ referral process and develop a solution to enhance the current referral process that can be piloted in a number of locations around the country. The implementation programme entails a series of focus groups, which means it will be labour-intensive. This requires skilled and locally-devolved facilitators.

The tender states that this initiative will require an adequately resourced ‘nerve centre’ in the form of a programme office manned by a project manager and dedicated resources. The objectives of the project are categorised under ‘quality’, ‘cost’ and ‘access’.

The tender document stated that improving the referral process between primary and secondary care is a key quality improvement initiative of the QCCD. The HSE said that there is a requirement to “join up” and utilise all of the experience learned to date in the area of electronic generic GP referral and to work closely with the acute hospitals.

Specialist centres
In recent months, the GPIT group has been working with Healthlink and the NCCP to develop electronic referrals from GP practice software systems to the eight specialist cancer centres. Leading the way in this area, the NCCP has developed GP referral forms for breast, prostate and lung patients, in both print and online format. The HSE tender document stated that by using the national guidelines and referral forms developed by the NCCP, a reusable architecture has been established to enable two-way communication of referrals and responses between GPs and consultants in the eight regional cancer centres.

Dr Marie Laffoy, NCCP Community Oncology Advisor, explained: “The GP uses our guidelines and standardised referral forms to push those urgent and non-urgent patients into the cancer centres for treatment quickly. The result is that these patients will survive by and large, and GPs will see them come for their flu vaccine, blood pressure check or medications for many years to come.”

Dr Laffoy described the process involved to develop the cancer referral forms. “The NCCP held a number of consultation processes that involved all the key people: GPs, the regional cancer centres, the consultants and ourselves. They thrashed it out so that by the time the form was designed, the GPs knew it was theirs and they had their say and all that we did was put all of their views together. We did it on their behalf really, because the referral form is for their use.

“At this juncture, we have designed the GP referral guidelines for breast (March 2009), prostate (October 2009) and lung (early 2010) cancers. Now we are piloting GP guidelines for melanoma. Those guidelines will give the GP a steer as to how they can quickly recognise what could be a suspicious symptom and how quickly they can recognise that symptom within the primary care setting – how to refer the patient to the consultant; what information the consultant will want on the patient; knowing what will happen to the patient once they reach the hospital; and what tests the GP should have done prior to the patient being consulted and referred for hospital treatment.”

‘Ahead of the game’
Although the GP referral forms for cancer patients are available in both print and electronic format, not all GPs have begun sending the form electronically. But Dr Laffoy explained there are a number of GPs leading the way: “Some GPs have really embraced computerisation and they’ve been ahead of the game from the beginning, but there’s also a network of GPIT people who are helping their colleagues to use the online referral forms.”

Dr Laffoy said that “even if the GPs were to do a postal referral, they have to put the referral in an envelope and fax it or post it at a cost of €1, but when they do it electronically, it simply involves pressing a button.

“It doesn’t cost them anything and the GP gets an automatic response from the hospital, saying it has received the referral. Therefore the GP has no worries about the referral not being received because they get a clinical response within five working days, stating that the patient will be seen within five working days because on the basis of your referral form, the patient needs to be seen urgently.”

Dr Laffoy admits the electronic referrals are “a slow burner” amongst GPs. “Some of the centres are receiving up to 18 per cent of their referrals for breast cancer patients electronically; however, others are much lower. That’s why you can never say ‘the job is done’, because you have to keep at it and encourage the GPs to use the electronic format and encourage the hospitals to accept them.”

Dr Laffoy explained: “The whole referral process is about integrating care between primary and secondary care; you are bringing the GP closer to the consultant, so it is a combined care effort between the GP and the consultant. The GP will pick up the patient early, do the tests, send the patient in and then there will be a joint follow-up with the patient in primary and secondary care.”

The whole idea is that “the GP can refer quicker, therefore the patient gets treated sooner at an earlier stage and the ultimate outcome is better survival for the patient,” Dr Laffoy added.

“We’ve got huge support from the ICGP; their key IT support is Dr Brian O’Mahony. He worked hand-in-hand with us to initially develop the draft guidelines and forms online, following a number of GP consultation processes. The guidelines then went to the ICGP Quality and Standards Committee for formal approval, having been approved by the GPs and consultants.

“When the referral form was finally designed, everyone knew where they stood and what it looked like. The GPs knew they had what they needed and were a part of designing it.”

Once approved, the forms go electronic, with Dr O’Mahony creating a format that can be used on the GP software systems and can be recognised by the hospital.

Dr Laffoy said the NCCP links with the ICGP have been essential, with the result that the NCCP is now employing a GP: “She understands the day-to-day issues affecting GPs and what the GPs need, but she is also aware of what we need to do.”

Dr Laffoy explained that there is no other clinical programme in Ireland using a system of referral like the NCCP. Work is currently under way involving HIQA, the HSE and project stakeholders to develop a generic GP referral form that can be used for all referrals under the QCCD. “We’re working closely with HIQA; we’ve given them our forms and said ‘use them,’ if they can be useful to be adapted into the national generic referral form,” Dr Laffoy said.

“You would imagine that for other clinical leads such as diabetes and heart disease, potentially they’re going to go down the road of having something very similar, where the GPs would be referring patients to specialties on the same basis, using the same forms and the same referral system across the country.”
Dr Laffoy quipped: “We were just slightly ahead of the game and told HIQA they could tweak our forms, if suitable for the generic form!”

HIQA have a lot of work done in this area already but Dr Laffoy warned: “The key thing for the GPs is to keep it simple and not look for too much information that won’t make any difference.

“Make sure you ask for the right information, in the right way. Don’t ask for information that can be asked when the patient is referred.”

Dr Carmen Bozic

A promising assay could reduce the risk of serious brain infection in MS patients on Tysabri, Senior Vice President and Global Head, Drug Safety and Risk Management, for Biogen Idec Dr Carmen Bozic tells Lloyd Mudiwa

An investigational assay that detects anti-JC virus (JCV) may provide a means to determine which multiple sclerosis (MS) patients can safely receive Tysabri (natalizumab) with significantly reduced risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection.

According to data published in the New England Journal of Medicine, Tysabri treatment, after two years, led to a 68 per cent relative reduction in the annualised relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54 per cent, Senior Vice President and Global Head, Drug Safety and Risk Management, for Biogen Idec Dr Carmen Bozic said.

While Tysabri has advanced the treatment of MS patients with its established and powerful efficacy, its use does increase the risk of PML, an opportunistic viral infection that may lead to death or severe disability.

However, if the test were approved, it would help screen patients at a higher risk of getting PML, Dr Bozic explained.

Infection with JCV is one of a number of factors required for the development of PML. Detection of anti-JCV antibodies may be a useful tool to identify prior or ongoing JCV infection, and help physicians to better assess a patient’s potential risk for developing PML.

Exclusive data
Speaking over the phone from Massachusetts, Dr Bozic told Irish Medical Times about exclusive new data that further support the potential clinical utility of the assay that detects anti-JCV antibodies in human plasma or serum and might provide the means to segment MS patients considering receiving treatment with Tysabri and assess their risk for developing PML.

“Our hypothesis is that those who have antibodies may have perhaps up to double the risk, but those who don’t have a reduced risk. So that’s the really good news,” said Dr Bozic.

The two-step, analytically-validated, enzyme-linked immunosorbant assay (ELISA) to detect anti-JCV antibodies is currently being evaluated in large-scale, prospective clinical studies involving more than 10,000 patients from all over the world in order to determine the utility of the assay in stratifying the risk of PML in Tysabri-treated patients.

Biogen Idec and Elan Corporation first announced data supporting the potential of the assay at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, in September. Biogen told delegates at the congress about factors associated with anti-JCV antibody prevalence in a large cohort of natalizumab-treated MS patients.

Dr Bozic, who has led the development of the risk management plan for Tysabri, outlined that ELISA was used to detect anti-JCV antibodies in blood from patients enrolled in the Tysabri Global Observation Study (TYGRIS), and the Safety of Tysabri Re-dosing and Treatment (STRATA) and JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treat-ment with Tysabri (STRATIFY-1) studies. This was followed by a chi-square test used to assess associations between factors and prevalence of anti-JCV antibodies.

Together, the data from TYGRIS, STRATA and STRATIFY-1 represent one of the largest cohorts of MS patients evaluated for the presence of anti-JCV antibodies, demonstrating an overall prevalence of anti-JCV antibodies of approximately 50 to 60 percent and delineating the prevalence by factors such as age and gender.

Furthermore, the use of Tysabri and prior treatment with immunosuppressant did not appear to affect the prevalence of anti-JCV antibodies in this cohort.

Another study, which used the ELISA to evaluate more than 800 serum samples, was designed to assess the prevalence of anti-JCV antibodies in Tysabri-treated MS patients and evaluate the possible utility of anti-JCV antibodies as a means to segment, or stratify, MS patients and assess their risk for developing PML, Dr Bozic explained.

“Of the more than 800 patients evaluated, 54 per cent tested positive for anti-JCV antibodies,” she stated.

“Additionally, anti-JCV antibodies were detected in 20 out of 20 [100 per cent] of Tysabri-treated PML patients at least six months prior to the diagnosis of PML.”

Three laboratories had then evaluated precision, including specificity and sensitivity, of the assay. “The ability of ELISA to detect anti-JCV antibodies was robust and cross-validated by all three laboratories.

“The assay is now being used in two global clinical trials to evaluate the potential clinical utility of anti-JCV antibody status for stratifying PML risk.”

Dr Bozic said Biogen would try to make this assay more broadly acceptable and was now working to review data for its review over the next few months. “The next step,” she said, “is to submit an application in America and in Europe; then it would be up to the regulators.”

The company has had a lot of feedback from physicians who are interested and want Biogen to bring out the assay, so there was a lot of excitement at ECTRIMS. “It is something that physicians would welcome as it would be able to help them assess a patient’s risk for developing PML and in making a benefit risk assessment as to what is the best MS therapy for their patients. They are very excited about Tysabri and the promise of this assay,” said Dr Bozic.

In part two of his exclusive interview with IMT, IMO President Prof Seán Tierney tells Lloyd Mudiwa about the organisation’s pivotal role in informing health policy and ‘constructive engagement’ with the HSE and the Department of Justice on migrant doctors

Prof Sean Tierney, President, IMO

“I think what we have a responsibility to do is not just to criticise, but to constructively engage in solving problems,” IMO President Prof Seán Tierney stated, by way of explaining the organisation’s approach to industrial relations issues.
In an exclusive interview with Irish Medical Times, Prof Tierney said he believed the union’s track record on this was extremely good. “There are doctors involved in the Transformation Programme in the chronic disease management area — they are all clinically-led initiatives that have had a huge impact on our health service over the past 20 years,” he said, adding that increasing the numbers of day cases, early discharge programmes and pre-admission protocols had all been clinically-led by healthcare professionals.
“I don’t think the first route, with all due respect, is to ring you [the media] or your colleagues in the national press to say, ‘We can’t get patients in here’,” he added, on the need for change in the health service.

This was, in part, an expansion of comments Prof Tierney made at the IMO agm in April, where he stressed that much more could be achieved by speaking softly — particularly in the right ears — than would ever be achieved with a stick — a stance which some critics claimed was a dereliction of doctors’ duties to patients.
He disagrees. “I was defending that from the perception that’s out there that we need to speak out in public on every issue. I think we need to get things solved in the interests of patients and the interest of the professions and that’s often more likely to be achieved by negotiations and constructive engagement than by placing ourselves in polarised positions in public.”

Engaging the Executive
Asked whether this approach had achieved results, the IMO leader responded: “We have had constructive engagement with the HSE on a number of issues. We have had GPs appointed into Clinical Director roles and progress on a lot of issues. We have met with the new CEO and discussed a lot of our concerns with him. Our concerns in relation to transformation and healthcare spending have been aired within that structure.”

However, he stressed that this approach was a long-term rather than a short-term project. The IMO has already held a “very cordial and open discussion” with Cathal Magee, the new HSE CEO. “What we would welcome most is Magee’s approach to using 21st century-style management techniques in an area where we have been bedevilled with 19th Century techniques for the past five years, and 2010 as the year in which this would happen.

“The 19th-century management approach was very much demand and control; that workers were a tool of the management to achieve a goal. Magee has indicated that he can see that the most valuable resource we have in our health service are our skilled professionals and other staff. And it’s not just their skills we are hankering for, but it is also the goodwill and commitment of everybody in the health service which actually make it work.”

He remarked that the health service was in need of a style of management that would encourage and build on that goodwill, rather than forcing staff to fill out forms and “jump through endless bureaucratic hoops just in order to get their jobs done”.
“Now, we still have a culture and a problem like that in our health service,” said the Consultant Vascular Surgeon in AMNCH, Tallaght. “We can’t afford that anymore. Ireland can’t afford it, the health service can’t afford it, and it’s just not an efficient way of using highly-skilled people.”

Recruitment and redundancy
He believes that the new HSE redundancy and early retirement packages and the recruitment embargo, even though it did not apply to doctors, both raised concerns in that they similarly resulted in unplanned reductions in workforce. The Executive loses people based on their length of service and what their circumstances are as regards to pension entitlements, rather than focusing on the need of a certain person in a particular role in the health service, Prof Tierney said.

The recruitment embargo, he explained, had been a very blunt instrument: “Even with the Croke Park agreement, it’s all very funny, but you lose people who have a wealth of experience because they are the ones who might see better opportunities elsewhere or who will have the longest service and hence are likely to get better packages. You can redeploy people into a job, but you don’t redeploy the experience of that person. So it takes quite a lot of time before you can replace that experience.”

Competence assurance
Speaking ahead of a planned meeting with the Medical Council on professional competence (PC), Prof Tierney told IMT that the whole process of how the new Medical Practitioners Act would be put in place was an evolving process. While the IMO had no issue with the principle of the introduction of PC, he was worried that a significant cost burden could be placed on doctors in relation to complying with the requirements.

“That’s as much a matter for discussion with ourselves and the HSE and other agencies as I suppose it is a matter for the Medical Council,” he acknowledged. “But we are meeting and engaging with them [Medical Council] on this. We want to see this happen. We want to see the bureaucratic burden on doctors being as little as possible so that the time, money and effort actually goes into competence assurance rather than a form-filling and box-ticking exercise, which could happen very easily. In fact, should I say a costly form-filling, box-ticking exercise, which would be even more disappointing.”

Medical students
The IMO is represented on the National Committee of Medical Education and Training, which meets once every quarter, and has consistently advocated for the need to ensure that all those who graduate from medical schools have the opportunity of an intern post so that they could become registered. If medical students were unregistered, Prof Tierney said, they could not practise anywhere else in the world other than in other EU countries where they did their internship, so there was a huge barrier for them in terms of career progression.

Even if they got on the register, graduates were not, in reality, independent practitioners, he observed. To achieve independence, the graduates needed to go through specialist training and that applied to everybody.
While the HSE managed this year to provide intern posts to all medical school graduates, student numbers were going to increase from 520 to 700 a year over the next four to five years, and the health service did not have a plan as to how to accommodate these extra 200 posts, as recommended by the Fottrell Report.
This is set to become a real problem after 2011. But above and beyond that, Prof Tierney believes those 700 people a year really need an opportunity to go on to specialist level, and there also was not a plan for that.

Out of the total of 4,500 doctors in training programmes over the six years of training, at most 3,500 were in structured training programmes, he said. “So there are 1,000 posts outside that, which are not suitable for structured training at the moment. That would need significant investment, at least in terms of effort and organisation, to bring them up to scratch and ensure that those types of posts can provide adequate care.

“For instance, we don’t really have enough consultants to be training 4,500 doctors. One of the reasons we can’t train is because one of the restrictions that the colleges place is that one surgeon can train only one higher trainee and then maybe one junior trainee at a time. So if someone says, ‘We want to increase by a quarter,’ it isn’t practical to provide the same value of training unless we expand consultant numbers or imaginatively come up with solutions.”

Migrant doctors
While it did not address the training needs for NCHDs in non-training schemes, the IMO preserved within the new contracts equivalent terms and conditions for all NCHDs, whether they are in training or non-training schemes, Prof Tierney said. “We have indicated to the HSE that we think that in relation to their plans to recruit NCHDs from overseas, that it is still important that doctors continue to be treated fairly and equally.”

He said the IMO had made significant progress with the HSE and Department of Justice in relation to visas and immigration requirements for overseas doctors coming to work in Ireland, where there was a huge burden being placed on them in terms of bureaucratic barriers. Doctors had now been effectively freed to work for a period of up to two years without having to worry about re-immigration.

In addition to lobbying the HSE to endorse WHO guidelines for the ethical recruitment of health workers, Prof Tierney said there was a cohort of migrant doctors who needed training, who are relatively early on in their career. But there was also another group with more experience and seniority in Ireland for whom some further training would allow them entry onto the specialist register and to probably become formally eligible for a public consultant post.

“In fairness, I think the HSE is sympathetic to the issue, but there is a piece of work to be done to identify how many are in that category – who they are, what specialties they are in, what are their training needs, and how they will then be accommodated in the system. There is no point in training them and then to find out that they won’t have a role to play. That’s not why we are doing it.”

Gary Culliton reports on HIQA’s Health Technology Assessment Directorate, which is charged with establising the cost-effectiveness of new public initiatives.
A Health Technology Assessment (HTA) is about more than deciding whether a programme is cost-effective. HIQA’s cervical cancer HTA recently concluded that vaccinating all 12-year-old girls against HPV, would cost about €12m per year.

The broader objective of any HTA though, is to get the best outcome in terms of patient survival and quality of life. A range of preventative medicine programmes is high on Health Minister Harney’s agenda.
The BreastCheck programme has begun to be rolled out and the cervical cancer screening programme will be implemented soon. A programme of colorectal cancer screening is next on the agenda and a HIQA HTA on this is underway.
h4, Compare the effects
First the HTA will compare the effects of a screening programme with no screening programme, said Dr Máirín Ryan, HIQA’s Director for Health Technology Assessment. Then the alternative technologies will be assessed. Fecal Occult Blood Testing may be guaiac-based (a chemical test) or immunoassay-based. This involves taking a sample of the stool to see if there is blood in it (this would be an indication that the patient should go for a colonoscopy).
Flexible Sigmoidoscopy and CT colonography – where the colon is examined to see if there are polyps or pre-cancerous cells there – are the other screening options which are being evaluated. The population cohort to be screened would probably be over 55s but this would be defined by the HTA. Different types of screening programmes require different resources in terms of trained personnel, for example. Before you ask whether you can get these people, it has to be established how many would be needed.
h4. Cancers detected earlier
A colorectal screening programme will mean more cancers will be detected earlier. This will mean improved survival and improved quality of life. It would however, have an impact on the numbers of trained gastroenterologists Ireland will need. The HTA also evaluates issues such as this.
The HTA for a national colorectal cancer screening programme is being carried out by HIQA on behalf of the National Cancer Screening Service Board. It has a much broader remit that did the HTA on HPV vaccines. The clinical effectiveness, the cost-effectiveness, organisational impact (on budget, resources etc.) as well as the ethical aspects of such a programme are being examined. This HTA will thus take longer for this reason.
Most European countries have a HTA agency, which judges whether a technology is effective and cost-effective, in a given patient group.
h4. Colorectal screening
HIQA can project-manage a HTA and ensure its quality, as happened with its first two assessments. Expert Advisory Groups are typically constituted, made up of all the broad stakeholders, including clinic-ians involved in the diagnosis and care of patients. HIQA’s HTA Directorate has contracted out work on the HTA for colorectal screening.
In this instance, the National Cancer Registry (which has a research wing) has partnered with the National Pharmacoeconomic Centre in St James’s Hospital, the School of Nursing DCU and the University of Sheffield (which did a model in the UK setting). Overall a team of ten people will generate the HTA.
This is one part of the evidence that informs a policy decision. It is also about what is the best way to deliver it. The HTA on colorectal screening is expected to be completed by the start of next year and four technologies will be examined.
If you introduce a cancer screening programme, you are going to identify more cancers. Thus more costs will be incurred in managing early cancers. However you will avoid people turning up with (more expensive) end-stage cancers or requiring palliative care.
h4. Fewer advanced cases
Therefore, the cost of the screening programme plus the cost of treating more acute early-stage cases, is balanced against the savings from fewer advanced or palliative cases, where there will be decreased burden. The effectiveness and cost-effectiveness is dependent on the incidence of the disease in the population. The National Cancer Registry manage the data on colorectal cancer. Data on how effective the screening programme is at picking up cases is taken from randomised control trials in the international literature.
h4. Evidence-based process
A HTA is an evidence-based process that is about presenting the information a decision-maker needs, in order to make an investment decision. In regard to preventative medicine, the Minister also gets policy advice from the National Immunisation Advisory Committee and from the National Cancer Screening Service. When it has its full staffing, HIQA will continue to commission some work out from the academic centres. It will then do some work in-house.
The first report (on HPV vaccines) was confined to cost-effectiveness in the Irish setting. The Expert Advisory Group provided oversight and ensured the quality of the process. It gave expert opinion on how the HTA should be conducted. The National Pharmacoeconomic Centre (NPC) did the technical report (this Centre has looked at re-imbursement for new drugs coming on the market since 2006).
Other domains which may be considered in HTAs include clinical effectiveness, safety, social impact (what factors influence whether a patient will avail of a screening programme or not), budget and organisational impact, ethical and medico-legal effects (in future stem cell technologies may have such implications).
h4. Completed in six months
The NPC partnered with the Danish HTA Agency, (which had worked with universities there to come up with an economic model for Denmark). This link meant the Irish HTA could be completed in six months (it would have taken 18 months otherwise).
Once the policy decision is made, it is then up to the immunisation office in the HSE to choose between the two HPV vaccines which have been assessed.
‘Life years gained’ is the metric in the HTA model concerned with costings. This calculates the difference in the cost of having a vaccination programme, compared to the cost of having no vaccination programme, divided by the average difference in survival (in years) across the population at which you are looking. This metric allows one technology to be compared with another.
h4. €45,000 per life year gained
There is always uncertainty in modelling what will happen in the future. Thus the impact of varying the data is also assessed. For example, the cost-effectiveness ratio of the HPV vaccination programme came out at €17,383 per life year gained.
Dr Ryan considers that if the cost per quality-adjusted life-year gained goes above €45,000, there is uncertainty about the technology’s cost-effectiveness: it is not considered good value for money (in terms of improved survival and good quality of life), compared to investing in other things.
The figure is also used by the National Pharmacoeconomics Centre (the UK uses a threshold of Stg. £30,000).
h4. Clinical background
There are currently three people working in HIQA’s HTA directorate. This is expected to rise to 15, mostly technical people. Some of these staff will be from a clinical background. There will also be health economists and statisticians. Recruitment is expected to commence shortly.
The HTA will make a best estimate of what the expected cost of a programme is. There might, however, be increases in the cost of direct medical cancer care, for example. A sensitivity analysis will be carried out, which varies the costs by plus or minus 20 per cent and evaluates whether the screening programme is still cost-effective or not.
In the future, other technologies which the HTA Directorate could evaluate include drugs, medical devices, diagnostics (including radiology), surgical procedures, care pathways (shifting care from hospitals to the community) and public health interventions (such as health promotion campaigns).

Sandra Ryan speaks to Mr Jimmy Tolan, Chief Executive of Vhi Healthcare, about the changes taking place in the health insurance market.
New Vhi Healthcare Chief Executive Jimmy Tolan, who throughout our interview is admirably pleasant and talkative, doesn’t change his tone (or mince his words) when criticising the competition. In fact, it almost appears that Vhi Healthcare, which still dominates Ireland’s health insurance market, doesn’t even see its competitors as a real threat.

“Basically, we believe we have a higher-quality offering than Hibernian. We’ve been doing this for 50 years,” he said. “Hibernian is a very fine car insurer and general property insurer, but trying to translate that to the health market is a different story. It has no expertise in health insurance, particularly in trying to shape the delivery of medicine. The reality is we paid out D1 billion in claims last year and we think VIVAS Health, for example, may have paid out about €15 million. That’s just to put it in context.”
The VHI’s main competitors have been in the news recently for different reasons: VIVAS Health, which entered the market in 2004, has recently been taken over by insurance group Hibernian, which came under fire itself last week when it announced that 580 jobs would be transferred to Bangalore, India as part of a restructuring plan.
BUPA left the Irish market over its problems with the risk equalisation scheme and was taken over last year by the Quinn insurance group. It had unsuccessfully challenged risk equalisation, which means insurers with a lower number of elderly, high-risk subscribers have to pay compensation to insurers with a higher number of these subscribers.
Meanwhile, the Vhi generated a surplus last year of about €55 million and paid out over €1 billion for 535,000 medical procedures.
h4. Numbers have dropped
“That’s €4 million a day to put it in perspective,” said Mr Tolan. “I think we have helped to change how healthcare is delivered in Ireland over the last five years. We have gone from paying for about 400,000 medical procedures to last year paying for 535,000. Also, the setting has changed — the inpatient numbers have dropped from 180,000 to 162,000. We are in an environment where shorter stays seem to give patients better outcomes and where new drugs and treatments are constantly coming along.
“A good example is the drug Herceptin — last year, we paid out €4 million to our customers for the drug, which is €25,000 a go. That’s 35 years’ membership of Plan B for a single treatment, before including the cost of the doctor and hospital and so on.”
The VHI is also applying for an insurance licence from the regulator under new legislation. Once this is secured, it will no longer need Government approval to launch new products, allowing it to enter different areas of the wider insurance market.
“Historically, we couldn’t expand either geographically or otherwise, and we had limited powers to expand by product,” said Mr Tolan. “So, post-regulation, we believe we can examine both routes of expansion, particularly on new products — but ones based on people rather than objects. We’re unlikely to enter into either car or house insurance.” The insurer is also reportedly planning a €120 million investment in the eastern European market.
Mr Tolan explained that when the Vhi estimated its surplus for the year, it did not include money that it is currently owed, or will be due in future, from risk equalisation payments. He said it anticipates receiving between €25 million and €30 million under the scheme.
“The Court of First Instance in Luxembourg has upheld the Government’s risk equalisation plans, and that has not been appealed. Now we just await the Supreme Court decision, which will hopefully be sometime this year,” said Mr Tolan.
“Basically, it’s measured on age. We have an older membership base and we also have a far higher market share of the medically vulnerable – people in their 60s and over. It’s also measured on gender. We anticipate we should receive between €25 million-€30 million, unless the age is normalised, meaning that we all end up with the same patient profile. But that’s not likely to happen soon; at the moment, there’s a ten-year gap between ourselves and Hibernian and a seven-year gap between us and the Quinn group. The competition tends to focus on the younger customer base because they’re the profitable ones. Hibernian Health, for example, has about seven per cent of the market and about 0.7 per cent of over 60s.”
But VHI’s confidence does not mean it denies it is working in a very competitive market that will only become more so, as more and more private hospitals are developed.
“Of course, we view the market as highly competitive, and if you compare it to health insurance costs internationally, we’re at the lower end of the cost bracket. It’s important to note that the consumer has strong confidence in the product and views it as affordable,” said Mr Tolan. He does see challenges ahead, but believes dealing with issues now will prevent the worst of them.
h4. Significant investment
“One challenge is that more resources need to be put into prevention policies and primary care, particularly for things like diabetes — if up to six per cent of the population have type 2 within ten years, that’s a huge number of people and it will involve significant up-front investment, as well as adjusting medical benefits, and maybe a more sophisticated risk equalisation plan. Because we have 70 per cent of the marketplace share, (and because of our age profile) we’re probably about 85 per cent of what’s paid out at the moment. It will involve co-investment. But we’re confident.”

Gary Culliton speaks to Mr Jim Canavan, UniPhar CEO, about how pharmacies have reduced in value over the last 18 months .
Pharmacies may have reduced in value by one third over the last 18 months and young pharmacists who bought businesses within the last two years may be looking at negative equity, because of changes to the HSE’s drugs reimbursement arrangements.

Healthcare distributor Uni-Phar has encouraged pharmacists at 150 outlets to buy the premises in instalments at an average cost of €1.75 million each, through its Independent Pharmacy Ownership Scheme (IPOS) over the last few years.
“Unless you bought your pharmacy within the last two years, at a price that reflected a significant ‘hit’ on the drugs margin, you would be exposed and it looks like there will be casualties,” said UniPhar Chief Executive, Mr Jim Canavan. “People who got in at the top of the market are quite vulnerable.
“There are pharmacies which won’t be able to survive two years to trade out of this. There are pharmacies that have just been keeping their head above water: this is a serious body-blow to them.”
“Even with a thirty per cent cut in the value of retail pharmacies, it might take pharmacies a couple of years to get back to where they were,” said Mr Canavan. The IPOS scheme, established just prior to the industry’s deregulation, bills itself as a facilitator to the community pharmacy sector. UniPhar is an investor in pharmacies, through IPOS. The purchasing pharmacist starts out with 16 per cent of the equity. The rest of the equity is split between UniPhar (42 per cent) and an investment company (42 per cent) set up for other pharmacists to invest in the IPOS scheme.
h4. IPOS purchase plan
The purchasing arrangement is based on ‘buybacks’ every three years. Over the course of a 10-, 12- or 15-year contract, the pharmacist becomes the 100 per cent owner of the business. Mr Canavan claimed UniPhar’s IPOS instalment purchase plan for pharmacies can support a pharmacy that is in trouble and give it the space and time to trade out of its difficulties.
Investors have been confined to pharmacists. The oldest IPOS pharmacy was purchased in 2001. There are now 150 pharmacies in the network. Over 300 pharmacists have invested in the investment vehicle which acquires the pharmacies. They do this through four funds, which in turn own a block of pharmacies.
UniPhar’s growing influence among independent pharmacists has provided a bulwark to the multi-nationals’ growth objectives. IPOS began at a time when multiples were coming in with the firepower to buy whichever pharmacies they wanted. The pharmacist working in the outlet is paid a salary, but gradually buys the shares back. It did give younger pharmacists a step onto the ladder, which might not have been possible before.
h4. Must satisfy banks
“We want to be acquisitive, but it’s of no value to us to acquire pharmacies at top prices, if we can’t get purchasing pharmacists. We have to satisfy banks and investors,” said Mr Canavan. A typical pharmacy costs between €1.5 million and €2 million. Mostly, this reflects goodwill. Pharmacies are usually valued as a multiple of turnover.
The reduction in reimbursement has a dramatically different effect on different pharmacies: the impact will be greater on high GMS pharmacies (though these will benefit from the flat fee when it comes in). Performance, location and competitive threats all affect this valuation. The mix of business is important and thus, some pharmacies are more effective at regaining that margin than others.
“Lots of pharmacies are going to be in very serious trouble because of the reimbursement changes,” said Mr Canavan. “The IPOS network can help our pharmacies trade through the difficult times. If ever there was a need for a shared-risk ownership scheme, it’s now.
“If a pharmacy had six good years in the scheme, now they’re facing a hit equivalent to two years of income,” he added. Very few deals have been done in recent months under the IPOS pharmacy purchase scheme, as changes in the HSE’s terms of trade have hit pharmacy valuations, while vendor expectations have not changed. There is a lot of anxiety. “We have our team of senior managers and financial analysts to help these pharmacies that are facing difficult times. Even if a few pharmacies struggled, that would be more than outweighed by the unrealised value of other pharmacies in the chain,” said Mr Canavan of his €250 million IPOS investment.
h4. The HSE ‘hit’
The reduction in the reimbursement is having an effect on pharmacies and, for some, it is a very significant impact. In recent times, UniPhar has been factoring in the HSE ‘hit’. “Vendors’ expectations did not change, so it was very difficult to get deals done,” said Mr Canavan. The company has acquired few businesses in the last 18 months.
Within the IPOS contract, there would be stock loans and a normal ‘working capital’ arrangement. In almost all cases, the premises is leasehold.
Catalyst is United Drug’s model for supporting their customers. It also is a funding mechanism which allows these customers to acquire businesses in the marketplace. The scheme operates using straight loans, rather than equity participation. The security of the loans and the businesses is thus the primary concern.
Through Catalyst, which is a debt-based scheme offered at a fixed rate, United Drug’s strategy has been to ensure that the same level of support is given to a pharmacist whether he or she is buying one pharmacy or a number of pharmacies. The vast majority of customers who availed of the scheme are singly-owned individual pharmacists, with 100 per cent control and ownership of their pharmacy.

Greg Baxter spoke to Mr Jim Joyce, CEO of Point of Care, a company whose specialist infusion clinics spare patients from making trips to hospital.
The opening of the second Point of Care clinic – a specialist nursing infusion centre in west Dublin marks the beginning of what is expected to be a rapid national expansion.

Once in place, 20 centres will serve up to 10,000 patients per year. According to the CEO of Point of Care, Mr Jim Joyce, the company’s goal is that the centres will be within an hour’s drive of 85 per cent of the population.
The centres will treat patients who need infusion services for critical and chronic diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, multiple sclerosis and osteoporosis. While patients will be treated in the community, they will remain under the supervision of consultants.
Mr Joyce, originally from Boston, worked for several years in the pharmaceutical industry here before noticing a large gap in the Irish market – an absence of modern, specialist nursing community clinics for people, needing infusion services, who had difficulty accessing larger acute centres.
The specificity of the niche says a great deal about the private sector’s role in the delivery of healthcare – a role that, Mr Joyce suggested, is being defined as much by quiet successes as controversial failures.
Point of Care has no contract with the HSE and is currently only treating patients with private healthcare insurance, but talks are under way to work with the HSE and Mr Joyce expects progress in that area within the next 12 months.
He told Irish Medical Times that the Point of Care model remains unique, for the moment, because it will be the only specialised nursing community care service that is standardised across the country.
h4. Not fixed to facilities
When the network is complete – Mr Joyce expects that all 20 clinics will be operating within two years – up to 80 nurses will be working at them. Some may be part-time, but all will form a national team that will not be fixed to facilities, but can move from one to another.
“The most important thing is to make sure that you can hire top-quality specialist nurses,” he said.
His plan highlights one of the fundamental tensions inherent in a robust private sector working in partnership with the public sector – competition for top staff. “Point of Care will be very different than a hospital environment, and it could appeal to certain nurses who don’t want to work at night, or who want more flexibility,” he said.
Point of Care’s uniqueness is its ambition of scope and its philosophy of standardisation. The facilities are housed in existing medical space rather than constructed from the ground up, which cuts down on capital spend. Patients get care in a room with four infusion beds.
“Every location must meet strict criteria before being chosen,” said Mr Joyce. It must be easily accessible. There must be parking spots available. The building must be a clean, modern facility with wheelchair access.
Most importantly, the Point of Care clinics must be co-located with a GP who has agreed to work with Point of Care. This gives nurses a medical backup in case of emergency.
“We’re looking for innovative GPs to work with – GPs who are open to new ideas,” he said. Mr Joyce added that Point of Care is not interested in a primary care model where GPs are salaried employees, but independent GPs working beside the infusion centre.
Once a location is picked, the facility itself must meet what he called the Point of Care Standard. The guidelines ensure not only that quality remains high, but that the model can be duplicated from one centre to the next. That similarity makes it possible for nurses to work in many centres.
Critically, he said that Point of Care can provide infusion services cheaper than an acute hospital, adding that moving people from the acute sector to the community improves quality of life.
“We can do it cheaper. We’ve looked at the cost to the public system. Our nurses can move from clinic to clinic, we’ll make more efficient use of space and resources, and our facilities are already built.
“We’ve compared our cost for infusion services for a rheumatoid arthritis patient, which is €2,000 per year, with the cost for those services in a hospital, which is €3,000,” he said. Point of Care would pass that savings to the HSE, if a service level agreement were reached, he added.
h4. Less stressful
Mr Joyce said the Point of Care network could take up to 1,000 patients out of the public system per year. An infusion patient can require treatment every four weeks, which means a dozen hospital visits could be moved into the community, possibly at a more accessible location, and in an environment that is less stressful for the patient. “Visits to the hospital remind patients of the traumatic nature of their disease,” Mr Joyce explained.
He said Point of Care could expand its services to other areas that could be done by nurse specialists — including TB tests and follow-up visits. He had no doubt that a field of competitors would emerge when the benefits of a single-design, duplicatable model of community care were realised.

Greg Baxter spoke to Dr John O’Dwyer about how competition from other countries may threaten Ireland’s medical devices industry.
Ireland could lose irrevocable ground to Poland and the Czech Republic if it does not reduce bureaucracy in clinical trials for medical devices, Irish Medical Times has been told.

Dr John O’Dwyer, Medical Director, Medical Devices Division of the National Standards Authority of Ireland (NSAI), said that for all the health in Ireland’s medical devices industry – 13 of the top 25 global medical device companies have a presence here – the future is precarious.
‘Logically, Ireland should be attractive’ as a place to run clinical trials on medical devices, said Dr O’Dwyer.
There are talented bio-engineers and research and development staff. The sector has grown in size and technical ability, and the ‘indigenous talent’ here has demonstrated an ability to produce novel and high-tech products. “But it’s not,” he said.
“The European countries that are attractive for clinical trials of medical devices are Germany, Belgium and the Netherlands.” Additionally, EU Accession States, particularly Poland and the Czech Republic, have adopted models that allow clinical trials to be carried out swiftly and without red tape.
Medical device companies, most of which are US companies, have a natural attraction to European markets. “They want EU approval first, then Food and Drug Administration approval in the US. The European route is less bureaucratic, more predictable and more timely than the US system,” he said.
And companies that design and manufacture medical devices here want to get products to the market as quickly as possible. “The industry innovates every three years. Time to market is critical. Companies will look for the easiest route,” he said.
h4. Slow and complicated
Running clinical trials in Ireland, unlike elsewhere, is slow and complicated, which means that devices that are produced here are tested elsewhere, said Dr O’Dwyer. And the knock-on advantage to the local economy, and all the other advantages that go along with clinical trials, is lost to competing countries.
Those advantages include increasing knowledge base, rapid advances in technology and, importantly, long-term tie-ins between industry and third-level institutions, said Dr O’Dwyer, adding that links between industry and academic institutions make it far less likely that companies will abandon Ireland.
Likewise, if other countries take the lead in that area, it will be more difficult to lure companies back to Ireland. “We’ve got the language, the companies and the talented staff,” he said, but that’s not enough to compete. Companies, facing rapidly-increasing costs and an accelerating pace of innovation, need to get products on the market. If companies shift the clinical trials process to another country, it’s difficult to lure them back, said Dr O’Dwyer.
Much of the bureaucracy here is associated with Ireland’s messy ethics committee model. Whereas Poland and the Czech Republic – as well as Germany, Belgium and the Netherlands – have a single, centralised ethics committee for clinical trials, Ireland has more than 20.
Most major academic institutions have their own ethics committees, and approval in one means nothing to another, said Dr O’Dwyer. “The Mater Hospital will have different criteria than UCHG, St Vincent’s or CUH, for instance,” he said. “If you want to do a trial of a device, you have to go through all this red tape and bureaucracy. You have to go through all of these sites, deliver your protocol, then get the ethics committees to look at it. They may not like it.
“They are not well-informed about the technology. They have a conservative attitude towards the devices and the drug trials. There’s a public perception of risk, but they often do not understand the difference between risk and calculated risk.”
It is understood that work is under way to cut back on bureaucracy in Irish ethics committees, but Dr O’Dwyer said having a single committee is the goal.
In countries where a single ethics committee has been created, the members of the committee are generally very well informed about technology and risk.
Dr O’Dwyer said that while Ireland has a natural disadvantage in clinical trials for pharmacueticals – its small population – medical device trials require smaller numbers of patients. “Ireland can readily compete on patient population size.”
The National Standards Authority of Ireland is the notified body for medical devices, which means they approve CE marks – the declaration of comformity to European standards – for these devices.
Dr O’Dwyer spoke last week at the NSAI Information Day, where he discussed the implications of the revised Medical Devices Directive.
h4. Patient protection
The Directive sets out requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person, and that any risks associated with the device are compatible with patient health and protection.
Regulation is trying to catch up with innovation, said Dr O’Dwyer. Under the revised Directive, there is a ‘demand for more clinical trials, and higher specified clinical trials’.
“Data has to be very specifically qualified to support the approval of such high-tech technology. The data has to be very convincing.” According to Dr O’Dwyer, companies will also have to perform significant post-market surveillance done at timely intervals.

Greg Baxter heard good news about the progress of the national radiotherapy plan, when he spoke with Prof Donal Hollywood at the sixth International Cancer Conference.
The chairman of one of the most important strategy documents in the history of Irish healthcare stood before a mostly empty room in Dublin Castle last week (it was early, and the weather was excruciatingly nice) to deliver some of the best news that’s hit the health service in a long time. Prof Donal Hollywood, who chaired the National Expert Group on Radiation Oncology and is now directing the implementation of the group’s document – the so-called Hollywood Report – told the sixth International Cancer Conference that after all the scepticism and pessimism, things were on schedule.

Phase I of the radiotherapy plan, which involves the two Dublin sites at St James’s and Beaumont hospitals, will be complete by 2010. By 2014, the co-located radiotherapy facilities at University College Hospital Galway (UCHG) and Cork University Hospital (CUH), and their integrated satellite units in Limerick and Waterford, will be fully operational.
After his talk, Prof Hollywood, speaking with Irish Medical Times, said: “A lot of people thought it wouldn’t happen this soon, but we’re going to do it.” If Phase I, like Prof Hollywood said, is completed by 2010, radiotherapy capacity will double. When Phase II is finished, the HSE will have enough capacity to provide all radiotherapy in the country, which will effectively make private radiotherapy facilities redundant.
According to Prof Hollywood, Phase I will be procured and funded by the HSE, with the tender process beginning at the end of this month. The building phase will start in the first quarter of 2009, and the service will be fully staffed, equipped and operational by 2010.
Phase II will be developed under public-private partnership (PPP), and Prof Hollywood has stressed that the lack of PPP experience in the health sector should be acknowledged. Before Phase II begins, the State must ensure that it gets the right technical, legal and financial advice.
According to Prof Hollywood, PPP schemes can ‘be effective’ – but he pointed to motorways as an example of how they might go wrong.
h4. Ethical in nature
Prof Hollywood told the conference that the relationship between radiotherapy and the private sector was, at the moment, ethical in nature. “We have undercapacity there. It would be unethical not to use the private sector,” he said.
But in his presentation, he defined the emergence of the private sector in radiotherapy services as a ‘complexity’. Ultimately, a public radiotherapy service should be able to meet 100 per cent of the demand, he said. This is the only way to ensure some of the key fundamental goals of the Second National Cancer Strategy, which is Government policy: that there be equitably accessible, state-of-the-art treatment centres; and that Ireland should become an internationally-recognised location for education about cancer.
According to Prof Hollywood, the test of equitable public service is whether it can meet 100 per cent of demand, but quality of care is as important as equity of access.
He believes that in the area of radiation oncology, the public sector is more suited to ongoing excellence.
Public facilities have licensing and accreditation issues to face, they have proper and transparent measurements for quality, and ‘money will follow production’, he said.
“We can’t do that with the private sector,” he added.
While there are some minimum guidelines for the treatment of public patients in private facilities, there is no statutory mechanism to control quality standards, he said, adding that the goal, again, is to have world-class, internationally recognised teaching institutions as well as a safe, quality assured and equitable service.
Prof Hollywood’s good news – if he’s right – was delivered in a sobering context of the challenges Ireland faces in dealing with massive increases for demand in cancer services: the cancer caseload will increase by 107 per cent between 2000 and 2020, and currently 50 per cent of patients die within five years of diagnosis. Still, compared to a decade ago, Ireland has come a long way. Following the publication of the Hollywood Report, progress has been – relative to progress before the report – accelerating.
Although it was delayed, the Second National Cancer Strategy was published and became Government policy. The National Cancer Control Plan (NCCP) was launched, and within that, a National Programme for Radiation Oncology. A national director for the NCCP has been recruited — Prof Tom Keane. And eight centres of excellence have been identified.
With progress — particularly the designation of centres of excellence and the removal of cancer services from smaller hospitals — comes controversy. Prof Hollywood urged colleagues to accept the challenge of the public information deficit about the relationship between volume and outcomes in most cancers.
h4. Parochial feel
While attendance was low on the morning of Prof Hollywood’s speech — early on the conference’s second day — the annual International Cancer Conference continues to draw top oncologists from around the world to Dublin, and features some of the most prominent Irish consultants and scientists. Yet it’s impossible to ignore the fact that the pool of internationally recognised oncologists in Ireland is small — small enough to give the conference a misleadingly parochial feel.
Prof Hollywood spoke with optimism about the next generation of consultant oncologists and the fact that, of the new consultants being recruited by the HSE, a third of them will work in oncology.
As the radiotherapy plan developed, it was important to prioritise workforce planning above equipment, he said. “There is a disproportionate focus on equipment,” he told the conference.