Scottish Medicines Consortium (SMC) decides not to approve treatment for PV patients in Scotland

The SMC has decided not to approve Besremi, also known as ropeginterferon alfa-2b, for use on the NHS in Scotland. This treatment is a monotherapy, intended to treat adult patients with polycythaemia vera (PV), without symptoms of an enlarged spleen.

Last updated: 10th July 2023

Who are the SMC and what do they do?

The SMC considers and advises on all new medicines for NHS Scotland, on evidence of clinical (how well the drug works in patients) and cost-effectiveness (whether it is better value for money than alternatives). The SMC will make its decision based on the evidence submitted by the pharmaceutical company making the drug, healthcare professionals, and also request input from patient groups such as Leukaemia Care. 

The company manufacturing the medicine provides evidence of why the medicine is effective both in how well it works and the cost to NHS Scotland compared to current treatments. Patient groups are involved in representing the views of patients by talking about any potential impact this new medicine will have on patients and carers. The healthcare professionals advise on any potential benefits of this new medicine compared to the current treatment landscape for this set of patients. Collectively, this helps the SMC make its final decision.

Why did the SMC make this decision?

The main clinical trial evidence came from two clinical studies, PROUD-PV and CONTINUATION-PV, which compared ropeginterferon alfa-2b against the existing treatment hydroxycarbamide (HU), the first treatment option given in Scotland-based clinical practice as it is relatively low cost and widely available. 

The SMC decided to reject ropeginterferon alfa-2b as they were not satisfied with the evidence from the clinical trials that ropeginterferon alfa-2b would be a more effective alternative to HU, particularly for patients who have not undergone treatment before, and those who only had a partial response to HU.

The SMC were not satisfied with the cost of ropeginterferon alfa-2b when compared to the potential health benefits of the treatment. There was further concern with the high cost of ropeginterferon alfa-2b in comparison to existing treatments such as HU and pegasys, which cost less than ropeginterferon alfa-2b

We are disappointed to see this treatment has not been approved. When the SMC asked us for our input, we stated that while there are a number of other treatment options in this setting, having a licensed alternative, such as ropeginterferon alfa-2b, would be a step forward. The licensing process looks at whether a drug is safe and effective in a particular group of patients, in this case PV. There are currently no licensed medicines in this setting for PV patients. 


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