Although companies might not typically consider the UK’s individual member countries as separate geographies for launch and communications planning purposes, those seeking to maximise chances for success will understand the importance of Scotland in determining market access for the region. Here is why: the name of the game in often-overlooked Scotland is speed. While the Scottish Medicines Consortium (SMC) may not be as well-known as the National Institute of Health and Care Excellence (NICE), it is clear and relatively rapid process means it often publishes decisions significantly earlier than NICE does. This can influence reimbursement considerations in other markets both inside and outside of the UK. Those who know the interplay between Scotland’s payer stakeholders and their UK and European counterparts will be better positioned to achieve launch success across the region.
Scotland’s Payer Stakeholders
National Health Service (NHS) Scotland is composed of 14 regional Health Boards. While the UK Parliament in Westminster sets NHS Scotland’s overall budget, the Scottish Parliament oversees allocating funds across the Health Boards. Each Health Board has an Area Drug and Therapeutics Committee (ADTC), which advises on the use of medicines in the geographic area.
The SMC was established in answer to the problem of inequitable access, in that some medicines are available in some areas but not in others within the same country. SMC is Scotland’s answer to the NICE in England and Wales. The SMC is essentially a collaboration between ADTCs, which distinguishes it from a statutory body such as NICE.
Products recommended by SMC are included in ADTC formularies, and patients in Scotland are granted access at a cost reimbursed by the NHS. Conversely, products or indications rejected by SMC are not routinely reimbursed.
The SMC process largely evolved as an attempt to create a more pragmatic and streamlined approach compared to NICE. Now, SMC can publish advice on new technologies faster than its English neighbour. In many cases, it is a precursor to NICE decisions.
The SMC also has a very clear and narrow remit compared to NICE. The SMC is essentially tasked with providing advice on any new medicines or new indications of existing medicines which are launched in Scotland. SMC may recommend a product for use as per the terms of its license, recommend a product for restricted use, or not recommend a product for use within NHS Scotland.
Important Points to Keep in Mind
The SMC process was initially so successful that NICE essentially copied it for its Single Technology Appraisal (STA) process – a new “one technology, one indication” process. At the time, SMC concurred with NICE in a large majority of cases while taking considerably less time and money to develop. Scotland’s STA decisions stand, regardless of NICE decisions.
SMC is relatively pragmatic and will work with sponsors to help them make the strongest case; however, demonstrating cost effectiveness against current Scottish medical practice is important. Both NICE and SMC favour quality-adjusted life years (QALYs) as a method for comparing the benefit of different treatments across different therapeutic areas. SMC decisions are often published within four months of the sponsor’s submission being received.
Implications for Industry
The main factor to be aware of is that SMC has a remit to appraise all new medicines and new indications. Therefore, if you seek to launch a product in Scotland and want reimbursement within the NHS you will need to prepare a submission for SMC.
The SMC process is relatively straightforward; however, knowing the payer stakeholders and establishing a communications strategy for these players is critical. It is also very important to realise that SMC will assess the technology against current Scottish clinical practice. This may not reflect the comparator technologies used in clinical trials, or even medicines being used within their licensed indications. Rather, SMC will appraise technologies against the reality of what is happening in Scottish clinics.
The set timings of the SMC process can help guide launch planning. There is the opportunity for a positive early news story by submitting in advance of license; conversely, a submission can be delayed to avoid a negative decision before other markets have published advice.
Telling your value story early and often will smooth the pathway for access and maximum reimbursement for your product. The GLOBALHealthPR team has years of experience in Scotland, all the other countries of the UK, and other EU markets and can offer valuable insights to your marketing and market access teams.
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