SMC recommends Bayer’s cancer treatments for NHS Scotland use

Eligible patients in Scotland will now have access to Nubeqa and Stivarga

The Scottish Medicines Consortium (SMC) has recommended Bayer’s Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in combination with  docetaxel, as well as its Stivarga (regorafenib) as a monotherapy, for use within NHS Scotland for eligible cancer patients.

Following the accelerated regulatory approval by the Medicines and Healthcare products Regulatory Agency under Project Orbis and the SMC’s recommendation, the Nubeqa regimen will be available to treat metastatic hormone-sensitive prostate cancer (mHSPC).

With around 3,394 new cases in Scotland in 2020, prostate cancer is the most common cancer in males.

Additionally, Stivarga will become available in Scotland for adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not eligible for, available therapies, including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy.

The recommendation for Nubeqa follows a submission assessed under the orphan medicines process and results from the phase 3 Arasens clinical trial, which showed that oral darolutamide and ADT in combination with docetaxel led to a significantly reduced death risk of 32.5% in mHSPC patients.

Antonio Payano, chief executive officer of Bayer UK and Ireland, said the recommendation “opens the doors to patients in Scotland who may be eligible to benefit from this innovative treatment, following the early access we agreed with NHS England at the end of 2022.”

Chiara De Biase, director, support and influencing, at Prostate Cancer UK, said: “We’ll continue to engage with healthcare professionals and researchers to help establish which men most benefit from this approach, so that every man gets the most effective treatment tailored to his disease.”

In November 2022, Nubeqa and ADT in combination with docetaxel was the first triple combination treatment to be made available by the NHS England for mHSPC patients.

Most recently, Cancer Research UK announced a £123m investment in Scotland to support research into new and improved cancer treatments and diagnosis, as well as bolstering Scotland as a major global hub for cancer research.