The current state of the Market Access in Ireland

The rise of the private sector, cross-border initiatives, and the post-COVID-19 landscape

Individuals who take out private health insurance have increased in Ireland from 21% in 2008 to roughly 40% in 2022. How does this drastic shift to private healthcare reflect the government’s lack of funding for new, more expensive treatments that have greater clinical efficacy? What effect, if any, has the government’s funding policy towards drug treatment caused this shift towards private healthcare?

The state pays for 80% of the medicine in Ireland through reimbursements, but the State’s budget cuts and insufficient drug access have finally left the Irish population with little alternative but to seek private healthcare.

The market access procedure in Ireland perfectly represents the issues found in the Irish Healthcare system, mainly due to lack of funding:

  1. lack of speed and efficiency due to insufficient funding and skill in the workforce

  2. lack of approvals is representative of the small budget that the HSE has to work with Where are the HSE price negotiations slowest – can I split the categories more and quantify the time

The 180-day timeline set out by the Health Service Executive (HSE) for pricing negotiations of new drugs to be completed seems efficient in practice, but this fast turnaround is currently not being achieved. On average, it takes roughly 1000 days after achieving market authorization for price reimbursements to be granted by the HSE. These delays occur due to two main reasons:

  1. The complex nature of price reimbursements for Highly Specialised Technologies (HSTs).

  2. The lack of government funds allocated for the reimbursement of new drugs and treatments.

In Ireland, the state and the Irish Pharmaceutical Healthcare Association (IPHA) periodically review the Incremental cost-effectiveness ratio (ICER) threshold for drug cost-effectiveness. Currently, the ICER threshold is 45,000 Euros per quality-adjusted life-year (QALY), where any drug that costs more than that amount per QALY gained will not be considered for reimbursement. In the UK, the National Institute for Health and Care Excellence (NICE) has a considerably higher ICER threshold specifically for Highly Specialised Technologies (HSTs) of £100,000 to £300,000. This provides access to treatments for very rare conditions that otherwise would not be considered for reimbursement.

HSTs are defined as treatments for very rare diseases where normally no more than 300 people are eligible for the technology. In Ireland, the inflexible ICER threshold for rare disease treatments prevents HTA approval from being granted as these expensive treatments will rarely satisfy the ICERthreshold.

The stress placed on the Irish healthcare system has driven the? What developments will occur with the coordination of access and P&R negotiations?

The Irish government is currently striving for greater coordination on access to medicine by joining two cross-border initiatives – the Benluxa Initiative and the Valleta Declaration, These look to drive collaboration on health technology assessments (HTAs) and price negotiations of new medicines with other European countries.

The Valletta Declaration, of which Ireland was a founding member, aims to conduct joint price negotiations for predominantly biosimilars and generics with other European countries, including Spain, Italy, Greece Portugal, Malta, Cyprus, Slovenia, Croatia and Romania. Cross-border price negotiations are difficult for innovative medicines, as there are many nation-specific factors that can influence the cost-effectiveness of a new drug. Ireland has also joined the Beneluxa Initiative, alongside Belgium, the Netherlands, Luxembourg and Austria to coordinate the price negotiations more complex, innovative therapies.

These initiatives allow for the pooling of academic resources and purchasing power in price negotiations. By joining them, Ireland is able to ensure that they are at pace with the healthcare systems of other European countries. In practice, however, variations in the healthcare systems between the countries, as well as other country specific factors, can make coordination difficult.

Despite the coordination of HTAs within Beneluxa, the price negotiations of some highly specialised technologies remain discrete for each country. Michael Barry, the Clinical Director of the National College for Pharmacoeconomics and the Health Service Executive’s Medicines Management Programme holds reservations as to how successful the European harmonisation of access and price negotiations will be. He believes that there is a risk that Ireland’s approach to P&R reform will take a back seat as they hope for a pan-European access solution to some become feasible. This may mean that the current issues will remain until the workflow of these cross-border initiatives are perfected.

Future Outlook

How will the aftermath of COVID-19 affect the Irish healthcare system? How will the post-COVID recession and government austerity affect healthcare funding? The HSE’s resources and budget will have been significantly stretched during the pandemic, leading to cuts in other areas of the healthcare system to make way for an appropriate pandemic response. As we see the start of a global recession to amend the significant costs incurred throughout the pandemic, it is likely that cuts will occur in the very sector that helped to steer us through this difficult time.

Written by Lucas Moore

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