One Size Doesn’t Fit All: Why Irish HTA Submissions Need Local Knowledge
Market Access managers typically triage their approach to submissions to the UK and Ireland. Submissions to the National Institute for Health and Care Excellence (NICE) are the first priority – for good reason since NICE seeks to issue its guidance when the new medicine receives marketing authorisation. Next, companies usually submit to the Scottish Medicines Consortium (SMC) – although occasionally the SMC may be the first port of call for manufacturers — and then finally it’s the turn of Ireland’s National Centre for Pharmacoeconomics (NCPE).
While I can understand the reasoning behind this approach, what essentially happens is that large internationally-based vendors many of whom are located in London, frequently take a broad-brush approach to submissions to the SMC, NCPE as well as All Wales Medicines Strategy Group (AWMSG). They assume that the NICE submission can simply be repurposed and that they are helping the client achieve economies of scale with these multi-country adaptations. But this is a risky path to follow as it implies that similar criteria and decision-making processes operate across four different jurisdictions and that is not the case.
Rule 101 when it comes to bringing a product to market is to know that market inside out –local knowledge is thus absolutely critical when dealing with the Irish market. Over the years, the NCPE has developed its own highly specific processes that must be rigorously followed, and failure to comply means you jeopardise a company’s chance of successful reimbursement in Ireland. If a vendor doesn’t have feet on the ground in Ireland, they can’t possibly understand or respond to those requirements.
I liken it to building a house in England. You wouldn’t use a civil engineer from another country to handle your planning applications because you would want to work with someone who understands the nuances of the local requirements.
When it comes to making a market access submission in Ireland, your surest route to success is to work with an agency that is firmly embedded in the local market and can create a customised submission that speaks to that market’s specific needs.
What to expect with Irish submissions?
Aside from the timeframe differences, Ireland has a two-part assessment process by the NCPE – a rapid review submission and a full health technology assessment (HTA). Approximately 50 percent to 60 percent of rapid review submissions go on to have a full HTA.
There are many differences between submissions to the NCPE and other agencies with one in particular being the need to ensure that systematic literature reviews are up to date. When companies submit to NICE, the review may well have been completed 15 months to 3 years in advance. However, the NCPE requires that it be done within 6 months of the submission date, meaning typically the literature reviews underpinning the submission will need to be updated after the NICE submission. It often happens that in the intervening time new data has emerged which will need to be incorporated into the submission.
There are occasions when my company is brought in to help a client that has already made its submission to the Irish authorities and had questions raised about the systematic literature review. If the review is outdated, it effectively means the submission can’t progress, which means going back to the drawing board and commissioning a full systematic literature review update which can be very time-consuming. A full systematic literature review update requires a strict methodological process which the NCPE will critique closely, so this can add two to three months to the timeline, and then assuming nothing new is found, the submission can continue to be assessed.
There are other particulars when it comes to an NCPE submission, such as the requirement for Irish-specific data ( more on this in next blog ) to be used, but understanding these nuances is difficult for vendors that aren’t based in Ireland and don’t have that local knowledge.
The AXIS Difference
AXIS Consulting offers something unique in the marketplace. I started the business nine years ago to address the gap I saw for providing tailored market access solutions to companies seeking to bring their products to the Irish market.
The way we work with clients is to offer a highly personalised, customised service that looks at each client’s submission and offers creative solutions to the specific issues we see in order to help achieve reimbursement for Irish patients.
The other way in which AXIS stands out is in the breadth of services we offer. Often what you see is a split in vendors’ services – those offering the technical capabilities to support health economics and outcomes research and respond to systematic literature review updates and meta-analysis reviews – and those who are specialists in pricing and strategic market access who provide insights that will be essential to commercial success.
The team at AXIS, on the other hand, is a multi-disciplinary team that offers blended market access insights and strong understanding of the commercial needs of the company trying to bring products to market combined with strong technical skillset and know-how to complete a robust, comprehensive HTA. We don’t look at the technical submission in isolation; instead we work with a client from when they first tell us they have a medicine in the pipeline, helping them to prepare for their submission, all the way through to price negotiation. We follow the ethos of Stephen Covey – always start with the end in mind. That means anticipating issues and queries likely to emerge through the HTA process, to developing an appropriate commercial proposition to support price negotiation meetings.
It is often not understood that in Ireland we are on a journey with clients seeking reimbursement that doesn’t just involve an economic evaluation but a heavy focus on affordability and price negotiation which means you need a vendor with strong commercial acumen and expertise. If you are going to have success in the Irish market, that economic know-how, combined with commercial capabilities and a deep knowledge of the local market is crucial.
About the author
Brenda Dooley is CEO and founder of AXIS Consulting, which provides personalised customer service to internationally based clients that are seeking to navigate the path to reimbursement for new medicines in Ireland and Scotland. Brenda has spent more than 21 years working in market access in pharmaceutical companies and consultancies and has expert knowledge of the Irish and UK healthcare systems. She and her team have successfully developed more than 75 high-quality HTA submissions for NCPE and SMC.