Changes to bring about faster access to new medicines in Scotland will see cost regulators pay closer attention to patient views as part of the decision-making process.
The Scottish Government has announced that under new methodologies to be employed by the Scottish Medicines Consortium from April there will be greater patient involvement in decisions on end-of-life or orphan medicines.
On the back of suggestions made by the SMC after a review of access to such medicines last year, if it is likely that a drug will fail to meet normal cost-effectiveness thresholds it can call for a patient and clinician engagement (PACE) meeting to help it establish their views on a number of factors.
Specialist clinicians and patient groups will be asked to provide further information on the severity and level of unmet need in the condition to be treated, its perceived benefits and place in the treatment pathway, in particular how it might be used relative to current treatments.
This, says Alex Neill, Cabinet Secretary for Health and Wellbeing, will help create a system "that ensures that decisions made reflect the views of patients and the clinicians who treat them".
Also, recognising that under current SMC processes ultra-orphan medicines are unlikely to be accepted for use, a new decision-making framework will be introduced that is not based on the cost per QALY, including an option for a PACE Meeting where necessary.
In another key change that will be of particular interest to the pharma industry, manufacturers will now have the option to put forward a Patient Access Scheme (PAS) at the PACE stage, or to amend an existing PAS. Under the existing SMC process, a PAS can only be considered at time of submission.
"I see this as an important step in ensuring we have systems and processes that give opportunities to get a ‘yes’ first time," Neill stressed.
The Scottish Government has already unveiled a suite of measures to help boost access to medicines for end-of-life care or rare diseases, including the creation of a new peer approval system to enable clinicians to prescribe treatment not accepted for routine use by the SMC and extending the £20 million Rare Medicines Drug Fund to 2016.