Monday, March 28, 2022

Waylivra, Tecentriq and more accepted by SMC




The Scottish Medicines Consortium has published guidance on eight new medicines, accepting seven of those and rejecting one for use by NHS Scotland in its November meeting.

The SMC has assessed Akcea’s Waylivra (volanesorsen) through its ultra-orphan pathway, which is designed for medicines which treat very rare conditions.

Waylivra is a treatment for familial chylomicronaemia syndrome (FCS), a genetic condition that causes high levels of triglycerides – a type of fat – in the blood.

This results in excess fat build ups in various parts of the body, causing a range of symptoms including abdominal pain and acute pancreatitis.

Following Waylivra’s assessment on the ultra-orphan pathway, Akcea is now required to provide a plan detailing how further data on the effects of the drug will be collected.

The drug will then be made available through NHS Scotland for three years while information is gathered. After this period, the SMC will review the evidence and make a decision on routine availability in NHS Scotland.

Roche’s Tecentriq (atezolizumab) was accepted for the treatment of metastatic triple negative breast cancer and extensive stage small cell lung cancer following consideration through the SMC’s Patient and Clinician Engagement (PACE) process.

The SMC also accepted Janssen’s Yondelis (trabectedin), again following consideration through the PACE process.

Yondelis is used to treat advanced soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.

Current treatment options for the advanced stages of this disease are limited, with Yondelis offering another treatment option which gives patients the opportunity of an extended period of stable disease.

The SMC also accepted Amgen’s Evenity (romosozumab) for the treatment of severe osteoporosis in postmenopausal women. In particular, Evenity was accepted for use in patients who have had a fracture due to osteoporosis and are at risk of a further fracture within two years.

In addition, the SMC accepted Bayer’s Nubeqa (darolutamide) for the treatment of prostate cancer and Roche’s Kadcyla (trastuzumab emtansine) for the treatment of breast cancer.

Both of these treatments were accepted through an expedited approach to reduce delay in patient access after the early phase of the COVID-19 pandemic.

The only drug to be rejected by the SMC in its November guidance was Relypsa’s Veltassa (patiromer) for the treatment of hyperkalaemia, a condition which causes potassium levels to increase in the blood, leading to increased risk of cardiac arrhythmias.

The SMC was ‘not satisfied’ by the Relypsa’s evidence on the cost-effectiveness of the treatment.



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