July 2023 decisions news release
The Scottish Medicines Consortium (SMC), which advises on newly-licensed medicines for use by NHSScotland, has today (Monday, July 10) published advice on six medicines.
Polatuzumab vedotin (Polivy®) was accepted to treat a type of lymphoma in patients who have received previous treatment and are unsuitable for a stem cell transplant. The medicine was accepted on an interim basis in September 2020 as there were uncertainties in the evidence when the medicine received its licence. Following full marketing authorisation and reassessment through SMC’s Patient and Clinician Engagement (PACE) process (used for medicines for end of life and rare conditions), it has now been fully accepted.
An initial assessment report has been published for belumosudil (Rezurock®), as a treatment for chronic graft-versus-host disease (GvHD). Chronic GvHD is a severely debilitating condition that affects multiple organs causing pain and mobility issues and problems with sight and eating. Chronic GvHD is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted donor cells attack the transplant recipient’s body.
Belumosudil has been assessed through the ultra-orphan pathway for medicines to treat extremely rare conditions. It will be available for three years while further information is gathered to help address key uncertainties with the clinical and cost effectiveness assessments. Following this, SMC will review the evidence and make a decision on routine availability in NHSScotland.
Oral azacitidine (Onureg®) was accepted via the PACE process, as a treatment for patients with acute myeloid leukaemia who are in remission.
Avalglucosidase alfa (Nexviadyme®) was accepted as long-term enzyme replacement therapy for the treatment of patients with Pompe disease, a rare genetic disorder that causes progressive weakness to the heart and skeletal muscles.
Apalutamide (Erleada®) was accepted for the treatment of patients with non-metastatic prostate cancer whose disease is no longer responding to hormone treatment and are at high risk of developing metastatic disease.
The committee was unable to accept ropeginterferon (Besremi®) for the treatment of polycythaemia vera, a rare and incurable cancer where too many red blood cells are produced by the body. Ropeginterferon was not recommended for use as the company’s evidence around the clinical and cost effectiveness of the treatment compared to currently available options was not sufficient.
SMC Chair, Dr Scott Muir, said: “Following ongoing evaluation we are pleased to be able to fully accept polatuzamab vedotin. The additional data supplied by the company at reassessment provided reassurance that polatuzumab vedotin is a beneficial treatment.”
“The Scottish Government will announce when belumosudil will be available for prescribing. The company will then gather more evidence to inform a decision in three years. The cost of belumosudil is high relative to the expected benefits; this additional time will give the company the opportunity to collect more evidence around the benefits for patients.”