The Irish Pharmaceutical Healthcare Association (IPHA) recently released data indicating continuing lengthy timelines of two years or more for the reimbursement of new life-enhancing medicines which can be of vital benefit to patients in Ireland.
The IPHA believes these timelines can, and must be, improved significantly. Patients deserve to know that they can, through their clinicians, access the best medicines available to treat cancers, obesity, rare diseases, and many others. The challenge that industry and the HSE can address together is to improve the following issues that our research has established:
- Of the 23 medicines of IPHA member companies made available to public patients during 2023, the average time to availability from application to the HSE was 729 days, or about two years;
- For medicines which the HSE and National Centre for Pharmacoeconomics (NCPE) required a Health Technology Assessment, the average time was over 1,000 days to reach patients;
- For cancer medicines the average time was 651 days and for orphan medicines the timeframe was 759 days;
- It takes an average of one year after a health need has been recognised by the HSE Drugs Group to implement a ‘managed access protocol’ before patients can access these medicines;
- While a robust clinical and economic evaluation is needed, the Irish reimbursement system can have around twenty to thirty separate steps, depending on the medicine concerned;
- The HSE Drugs Group meets on average once a month, for two hours, and considers all medicines with a budget impact. The equivalent group in England and Wales delegates their work across four committees and meet for eight hours once a month.
- It takes approximately three-to-four months for a medicine to be considered at the HSE Drugs Group meeting after a price is agreed. It takes about six months from a final pricing offer being proposed and accepted to the medicine being made available to patients. There is clear ‘dead time’ in this process.
In most cases, clinicians are well aware of the medicines that are pending. They wish to prescribe them to patients in the public service, as they build on and improve existing standards of care and health outcomes. However, an increasing consequence of the lengthy timelines is that some private patients can avail of cancer treatments under health insurance, immediately on the granting of a licence by the European Commission. Public patients, typically wait two years after this point before accessing the same medicine.
The IPHA believes timelines can be reduced by bringing resourcing of the evaluation system up to international standards, enhancing the capacity of the HSE Drugs Group, eliminating process ‘dead time’, and developing more efficient engagement between pharmaceutical companies, and the HSE and NCPE. IPHA members are keen to work closely with these agencies to deliver improvements.
Last year, Minister for Health Stephen Donnelly announced the establishment of a working group on the reimbursement system following the publication of a report by the firm Mazars.
Speaking ahead of the annual IPHA conference held in Dublin in March,, Michael O’Connell, IPHA President said, “IPHA’s goal is to ensure a continuous flow of life-enhancing medicines and vaccines for Irish patients in a faster and fairer manner. We welcome the €20 million allocated to new medicines last December and the €10 million to be found in efficiency savings. This funding will benefit 4,000 Irish patients across a number of different therapy areas.
“The IPHA is willing to work with the State towards finding efficiency savings to ease the burden on the overall health budget. We have signified our commitment to realise savings through the IPHA agreement where we have already delivered more than €400 million in savings to the HSE in its first two years. We also look forward to engaging with the newly established Medicines Sustainability Taskforce.
“Patients need the system to work better; they deserve fundamental reform of the process. We stand ready to collaborate with all stakeholders to ensure that meaningful reform is achieved. We look forward to the outcome of the Mazars Working Group. We appreciated the Minister’s invitation to provide input to the Working Group and are very keen now to see a range of actions for urgent implementation.”
Oliver O’Connor, IPHA Chief Executive, said, “Reducing the lengthy timelines to reimbursement will improve standards of care and outcomes for patients in Ireland. Industry and the State can partner much better to improve this. It is very much a shared challenge. No one wants a public-private divide in access to medicines to grow.
“The specialist staff operating the system have faced much-increased workloads from new medicines developments and applications; they’ve been under resourced for the challenges. We hope the Minister will follow up on his funding announcements with the approval of much needed staff in the pricing and reimbursement system. These highly specialised experts are as important to the health of the nation as frontline workers.
“Ireland’s health care, health outcomes for patients, and the health status of the population have all improved. We can and should aspire to be as good as any health system in Europe. Where there are gaps, such as in timely access to medicines, we can fix them, by collaborative, purposeful work together. Ultimately, we can deliver a system where patients in Ireland will receive the best of care and treatment, with the right medicine at the right time.
