Accessing medicine in a time of global uncertainty

Experts recently gathered in Dublin to discuss access to medicines against the backdrop of recent major agreements. David Lynch reports

In March, the Minister for Health Jennifer Carroll MacNeill announced the signing of two new framework agreements on the supply and pricing of medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA).

The Department of Health emphasised the importance of the agreements, which it said were reached during “unprecedented uncertainty in international pharmaceutical policy”.

Implementation will “support greater certainty and consistency” in respect of Ireland’s pharmaceutical and medicines supply, according to the Department.

The agreements will “enable faster access to new innovative medicines” for patients in Ireland and help ensure “security of supply” for essential medicines.

Both agreements include a wide range of measures (see panel p4) in relation to pricing and supply. However, particularly noteworthy for many clinicians, patients, and those working in the pharmaceutical industry is the pledge to “deliver faster access for patients” to new medications.

This includes a commitment and a structured process towards achieving a 180-day timeline for reimbursement decisions by the first quarter of 2029. This, according to the Government, will accelerate patient access to new treatments.

These agreements and the 180-day pledge were discussed in-depth at the AXIS Patient Access Conference held on 30 April in Dublin.

The conference was organised by AXIS Reimbursement Experts, a specialist consultancy firm that provides advisory services on market access, pricing and reimbursement, and health technology assessment (HTA) to pharmaceutical and biotechnology companies. The event brought together representatives from the HSE, patients, industry, and clinicians.

Speaking to attendees, AXIS CEO Ms Brenda Dooley said the recent commitment to the shortened timeline for decisions on innovative medicines “is a landmark step”.

However, she insisted that its success hinges on the “urgent implementation” of a comprehensive operational roadmap.

Patient impact

AXIS highlighted how, during the last decade, it has taken an average of almost two years for new medicines to become available to public patients in Ireland.

Research published last year by the Irish Pharmaceutical Healthcare Association (IPHA) found that, among the 88 IPHA medicines reimbursed between 2022 and 2024, the average time from a medicine entering the Irish reimbursement system to patient access was 617 days.

The real-world impact of such timeframes was highlighted by doctors at the conference. 

Prof Patrick Forde, Prendergast Professor of Immuno-Oncology, Trinity College Dublin, and Consultant Medical Oncologist, St James’s Hospital, Dublin, spoke about challenges in accessing innovative oncology treatments for his patients.

“Yes, it is quite difficult in some cases,” Prof Forde told the Medical Independent (MI) following his presentation.

“Particularly for some cancer types where the drugs might be available in most, if not all, other European countries, but not Ireland. I think we are amongst the slowest in terms of our reimbursement policy and timelines. I think that does impact [the care delivered].”

He said it is particularly frustrating when a new medication is accessible in other countries, such as the UK, France, or Spain, but is not available in Ireland.

In such situations, Irish doctors may have to prescribe a drug that was approved 15 years ago or 20 years ago and which is less effective.

He noted that doctors take different approaches with their patients in discussing these access difficulties.

“My approach is that I am quite open about it with the patient and then we do the best we can with what is available to us.”

He stressed that the greatest negative impact of the current situation is felt when patients cannot access drugs that could offer long-term remission or significantly improved outcomes.

Following the agreement between the Government and industry, Prof Forde said he believed the 180-day target would improve matters.

He pointed out that, in one recent calendar year, there were 18 new medications released for lung cancer alone.

“So, it’s a very rapidly moving field. And I think 180 days is a reasonable balance between rapid turnaround and what’s actually pragmatically possible.”

Resources

Ms Linda Fitzharris, Head of the HSE Corporate Pharmaceutical Unit (CPU) and Head of HSE Pharmacy Function, outlined to attendees the various stages in the reimbursement process and the workings of the HSE CPU.

She said work and planning had begun on facilitating the 180-day target. However, she described the target as “tight”.

Ms Fitzharris said that “when you have so many stakeholders” involved in the process, it leads to a significant amount of work, which takes time to complete. 

Prof Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics (NCPE) and Clinical Lead for the HSE Medicines Management Programme, also addressed the event. 

After his speech, Prof Barry told MI the 180-day target was ambitious and would require additional resourcing.

“The real challenge will be about getting the assessments done, to get the price negotiations done in that narrow timeframe,” he said. “But look, we’re moving towards it [the 180-day target]. It’s planned to be introduced by quarter one in 2029. We will do everything we possibly can to make sure we reach that.”

He welcomed the fact that the HSE drugs group and the HSE CPU had received increased resources in recent years. However, further funding would be required.

“It will require resourcing, not only for the NCPE, but also for the HSE [CPU] and indeed the [HSE] drugs group. For all components of the reimbursement chain.”

MI questioned the Minister for Health on the issue of further resourcing on 7 May at the Irish Nurses and Midwives Organisation’s Annual Delegate Conference.

In response, the Minister pointed out the NCPE team has approximately doubled over the past two years.

“So already huge resources have gone into that,” the Minister said. “And we have to continue to work towards the 180 days.”

Speaking to MI at the IMO AGM last year, Prof Barry said the timetable for access to new drugs was “significantly” influenced by decisions by the pharmaceutical industry in terms of when to launch products in Ireland.

At the time, Prof Barry said delays in accessing cancer and rare disease treatments were heavily impacted by the time taken by industry to apply for pricing and reimbursement, as well as delays in engaging with the HTA process and subsequent pricing negotiations.

Speaking to MI last month, he noted that this was an issue, but it would not specifically affect the 180-day target.

During his address at the AXIS conference, Prof Barry outlined what he regarded as the successes of the HSE Medicines Management Programme, which covers specific high-cost drugs to help ensure cost-effective access.

Prof Barry told MI that the Programme continues to generate responses from doctors.

“We get a lot of feedback because of necessity,” he said. “[Doctors] engage with the system. To be fair, they engage very positively. Of course, we get feedback sometimes that people would like it to be easier. But generally, the support for managed access from prescribers is very welcome and it’s very favourable.”

Prof Barry said he believes doctors have an understanding of why the scheme and protocols are in place. “That’s the important thing – to understand the reasoning behind it.”

The Programme aims “to try and get the best value we can from the medications and make sure that patients who will benefit the most get access to them”.

Decisions are made “on the condition that we all understand that there is a finite health budget”.

Clinical trials

Alongside a faster reimbursement system, more clinical trials are required in Ireland, Prof Forde told the conference.

MI asked Prof Forde whether an increase in trials would help doctors working in the Irish healthcare service.

“I think it would,” Prof Forde replied. “And I think patients are starting to ask for more clinical trials. They’re aware globally the best way to access the most novel therapies is through clinical trials.”

“So, at the moment, it is about trying to build that infrastructure. We have it in certain hospitals, but it is about also trying to make it available across the country.

“For example, so that patients in more rural areas can have support for travel if needs be. Or where less complicated trials can be rolled out to more peripheral hospitals.”

Prof Larry Bacon, Consultant Haematologist, St James’s Hospital, Dublin, spoke about his experience in the development of the CAR T-cell therapy service at the hospital over the past eight years.

The creation of the service for lymphoma had witnessed a “remarkable” level of cooperation between different sectors, including clinicians and other staff, patients, the hospital board, the pharmaceutical companies, as well as with the NCPE and the HSE.

“What worked was the openness to collaboration. Talking to the right people,” he said.

“It was fairly clear from the outset that there was a clinical need.”

On the process involved in improving access to CAR T-cell therapy, Prof Bacon said, overall, “it worked well for us… it is so complex; there are so many people involved.”

However, he also said the process at times lacked “some joined-up thinking” in terms of engagement with the NCPE and HSE CPU.

“So we were putting a lot of time into it, before we even knew if it was going to be funded.”