By Leela Barham.
A major Inquiry into access to new medicines across Scotland by the Scottish Health and Sport Committee has come to an end. The Scottish Government has responded, and announced changes to how Scotland makes decisions on what new medicines to use across the NHS in Scotland.
A more transparent, flexible Scottish Medicines Consortium (SMC)
The Scottish Medicines Consortium (SMC) is Scotland’s own agency providing advice to the NHS in Scotland on the use of all new medicines. Their guidance isn’t mandatory, but there is an expectation that Local Health Boards (responsible for health funds to cover their local populations) follow their advice. The SMC is also important on the global stage: they are often the first HTA agency to put out a recommendation on a new medicine.
The Government has now asked SMC to adopt what is really a refined approach to what they were already doing. According to Health Secretary Alex Neil they will use “different, more flexible, approaches in the evaluation for medicines for end of life care and treating very rare conditions.” That will include a Scottish approach to value assessment, incorporating burden of illness and wider societal impact.
Plus there will be an extra £1million to make SMC “more transparent”. What that really means is meetings will be held in public, with the first meeting in public held by May 2014. The existing SMC Patient and Public Involvement Group (PAPIG) will also be more involved, helping on revamped SMC annual reports and briefings for the public.
A change that is likely to be welcomed by the industry is the chance for companies to meet with the SMC prior to decisions being made, and to attend SMC meetings so that they can clarify questions that the Committee may have.
Less welcome for industry perhaps, is asking SMC to provide guidance even when companies don’t submit a dossier on their product. That happened in 24 cases in 2012 alone, from 94 SMC appraisals. SMC automatically rejects those products now, but under the planned changes, they’ll take publicly available information to come to a view. It remains to be seen if companies will want to take part: if they don’t they can’t argue with what the SMC says.
The introduction of a ‘pause’ in the SMC process could be both an opportunity and threat. The pause could help manufacturers discuss crucial issues with SMC but the Scottish Government has also said that “The “pause” would facilitate a confidential discussion with the manufacturer, through an external negotiator, about improving the medicine’s cost-effectiveness through a new or improved Patient Access Scheme”. That brings an even closer link between SMC and pricing than we’ve had before, although pricing to the threshold must have been a consideration for some time.
Central clinically led approach to replace Individual Patient Treatment Requests
The Government also wants to move to a peer review process instead of Individual Patient Treatment Requests (IPTRs). Much like the English approach under NHS England, there will now be a single national approach. More on what this means in practice is expected in guidance coming soon.
Extension to the Rare Medicines Drug Fund
The Scottish Government has also extended the still relatively new Rare Medicines Drug Fund. It was announced only in January of 2013, and with an original end date of April 2014, but will now run until 2016.
But the Scottish Government has rejected the idea of a Scottish Cancer Drugs Fund (CDF), a policy that only applies in England.
The rationale for extending the fund seems to be that the fund needs to be in place until access is improved as SMC changes their approach: that echoes the idea that the English CDF would be a bridge to Value Based Pricing (VBP). However, even before VBP is implemented the English Government has already extended the English CDF. Taking funds away was always going to be hard to do, so perhaps the Scottish fund will stay for longer than 2016 too.
Greater transparency on implementation of SMC recommendations
The Scottish Government has also made it clear that Local Health Boards need to publish on their websites their ‘local response’ to SMC guidance either within
30 days, or if more work is required, a further 30 days after the publication of guidance from SMC. Of course, just including a drug on the formulary when SMC recommend it isn’t enough to show improved access, but it is a step in the right direction.
A Scottish model of value
But what we still don’t know, and it’s an important question given the perennial worry of postcode prescribing, is how these changes will fit into the new UK wide approach of Value Based Pricing (VBP) and whether Scottish patients will fare better, or worse, then their counterparts south of the border. The Scottish Government has described these changes as the “first step in a wider process to determine a Scottish model of value-based medicines assessment” so we can expect more changes in future. There will be a Scottish model of value, with SMC expected to share their work in progress on this before Christmas 2013.
But it seems the devolved administrations will be waiting as much as we are, for full details, as their request to be involved in negotiations on the successor to the Pharmaceutical Price Regulation Scheme (PPRS) and VBP were rejected by the UK Government.