The Road Map to Market Access in Ireland

Like many parts of the world, market access is a crucial component of making sure the right treatment option is available to the right patient at the right time. In Ireland, we have a very unique process to determine whether or not a new medicine will be reimbursed. Such medicines include, but are not limited to, new therapies for cancer, infectious disease, cardiovascular disease, and more.

In this article, written by the expert team at AXIS Healthcare Consulting, we cover everything you need to know about market access. For over 10 years now, AXIS Consulting is the trusted partner in helping pharmaceutical companies achieve successful access in countries like Ireland and Scotland while achieving economies of scale with resources such as time and money.

Market access, sometimes referred to as Patient Access for good reason, is the process of making sure that patients who would benefit from a particular medicine or treatment have timely and sustainable access when needed at a price that the local payer can afford. All medicines, regardless of their proposed treatment, undergo an economic evaluation in Ireland. This is done to determine whether or not a medicine is anticipated to be cost-effective for those who will benefit from it, but also that the new therapy will be clinically efficacious in the real-world setting. When it comes to market access, the bottom line is that it involves helping patients get access to medicines at an affordable price.

Market access in Ireland follows a specific process. Firstly, upon regulatory approval, a pharmaceutical company makes a formal application to the state for reimbursement of the new medicine on one of the State’s funding schemes. A “Rapid Review” assessment will be made by a national agency known as the National Centre for Pharmacoeconomics (NCPE) who is charged with issuing recommendations to the state on whether a new medicine should be reimbursed or not. The NCPE plays a key role in the evaluation processes used in Ireland and if a full Health Technology Assessment or HTA is advised, they will then assess the technology in great detail to determine both cost and clinical effectiveness. This process also includes sending a price application to the Health Services Executive, (HSE) in line with the terms of an agreement that exists between the industry group, IPHA and the state. The Health Supply Act of 2013 also governs the terms on which agreement will be reached on reimbursement supply terms and prices of various medications.

If a full health technology assessment (HTA) is not required, then the medicine will be referred to the HSE’s Corporate Pharmaceutical Unit or CPU where the HSE’s new product committee will view the recommendations from the NCPE. Typically the pharmaceutical company will be invited to a meeting for price discussions following which the commercial offer will be assessed by the HSE Drugs Group or committee. The HSE Drugs Group will either then be minded to recommend reimbursement of the drug by the HSE’s Executive Management Team or they will revert back to the HSE CPU seeking an improved commercial offer from the company.

However, if alternatively, a full HTA is advised by the NCPE, the HSE will formally commission the HTA to undertake the evaluation. Following submission by the applicant company an in-depth and robust assessment will be made of the evidence case. Preliminary questions will be issued by the NCPE approximately two months after the assessment has commenced with companies allocated one month to return responses. Following completion of the evaluation, the NCPE will issue a Factual Accuracy Check, and following input from the applicant company on aby factual inaccuracies, a final report will be issued by the NCPE to the HSE. Similar to the non-HTA route, the company will then be required to engage with the HSE – CPU on price discussions and a commercial offer will ultimately be presented to the HSE Drugs Group for their consideration.

There are two healthcare tiers in Ireland: a public healthcare system and the private healthcare system. Public healthcare, which is available to all Irish residents, is funded by social security contributions and taxation. Private healthcare, on the other hand, is funded directly through private insurance and funds. In Ireland, approximately 40% of all residents have healthcare through a private payer system. Due to a co–pay from the state on the Drugs Payment Scheme, the state ultimately finds up to 80% of the costs of pharmaceutical medicines in Ireland.

In Ireland, there are a number of different state-funded schemes including:

• General Medical Service (GMS) – Through this, patients are issued a Medical Card, which entitles them to a variety of healthcare services and medicines free of charge. A co-pay exists but it is of nominal value with a maximum monthly charge of €20.00 per family.
• Hospital only – The hospital’s Pharmacy budget pays for medicines used for in patient care.
• Drug Payment (DPS) – With the DPS, individuals, and families pay a monthly threshold that doesn’t exceed €114.
• High Tech Drugs – This facilitates the supply of expensive drugs from community pharmacies where the prescription is administered by the Hospital specialist.
• Long-Term Illness (LTI) – With this scheme, individuals who are suffering from chronic conditions such as Multiple Sclerosis, Acute Leukemia, and Cerebral Palsy are entitled to full drug reimbursement, regardless of their income.

Market access is an important part of understanding patients’ and clinicians’ needs while also delivering payer value. It is a scientific process that seeks to examine in detail all the components that will ultimately contribute to the decision-making process as to whether a new medicine will be reimbursed.

Companies tasked with securing market access will benefit enormously from working closely with subject matter experts to develop compelling submission which fully address the requirements of the various agencies who conduct economic evaluations.

Market access is integral to our way of life here in Ireland. The team at AXIS Consulting has extensive knowledge of the Irish healthcare system and how to navigate it. We are up-to-date on all the latest market access trends and apply them on a daily basis in our work with our international clientele. At AXIS Healthcare Consulting, we help pharmaceutical companies prepare all types of reimbursement applications including HTA’s. Our success rate is over 90% for positive reimbursements. Get in contact with us today at +353 1 5292768 or visit us on the web. You can also contact us by emailing us at info@axisconsulting.ie.