The reason medicines are reimbursed is that they improve the standard of care for patients in a disease area or there is a direct improvement in the efficiency of this standard of care. Evidence and data are demanded of the biopharmaceutical industry to justify State reimbursement.
The experience of 2019 and 2020 was that, when no funding for new medicines was available, standard of care improvements weren’t happening and Ireland’s standard of care relative to other countries would have declined.
Thankfully, we have experienced two years of sustained investment in new medicines. Health Minister Stephen Donnelly and Public Expenditure Minister Michael McGrath have upweighted investment in new medicines, with €80 million in two Budgets. Further funding growth will be required over five years to make those new innovative medicines available to patients.
The value of having defined certainty of funding is hard to underestimate. It ensures Ireland keeps pace with the global medicines innovation, enhances care standards and transforms people’s lives.
Recently, we have seen overall timelines for access to medicines improve by about 20%, with extra resources for the processing of reimbursement applications.
This is welcome and puts patients and the industry on a much stronger footing.
However, it is equally fair to recognise that there is a limit to what the reimbursement system can achieve just through improved funding. While the system endeavours to achieve universal availability of medicines, the system is less agile at handling the risks that accompany medicines innovation where clinical data is rarely perfect and pure.
Almost all medicines get reimbursed, eventually. However, the one-size-fits-all nature of the reimbursement process doesn’t lend itself to faster access to new treatments, relative to other countries and health systems. The more usual practice in European health systems is to examine the medicines performance in a real-world setting against real-world evidence. This enables payers to pay directly for the performance of a medicine.
Our pricing and reimbursement system is not investing in these agile and flexible mechanisms. This limits the scope for agile and flexible arrangements that can give patients faster access to new medicines and for appropriate risk shares between the industry and the payer.
Orphan medicines, combination therapies or novel oncology treatments all have the same criteria applied to them in our system. This will create challenges for bringing the next generation of biopharmaceutical innovation to patients.
Continued dialogue and advocacy will be essential. The experience with Covid-19 vaccines demonstrates the societal importance of scientific interventions. As we get older as a population, our ability to age well as a society will be partly dependent on our ability to access innovation.
The IPHA Supply Agreement serves its purpose as a source of funding. Next year will be the 10th anniversary of the 2013 Health Act. It will be an opportune time to plot out the next decade.
It’s an opportune time for us all to take stock and see how we can best plan for the next generation of medicines innovation and investments while operating within reasonable financial discipline.
Let’s build that conversation now.
Jim McGrath is Director of Commercial Policy at the Irish Pharmaceutical Healthcare Association.