SCOTTISH HOSPITAL NEWS
THREE NEW MEDICINES ACCEPTED FOR ROUTINE USE IN SCOTLAND
The Scottish Medicines Consortium (SMC) has published advice accepting three new medicines for routine use in NHS Scotland.
Bevacizumab, which can be used
to treat advanced cervical cancer, was considered under SMC’s Patient and Clinician Engagement process (PACE) for new medicines that treat end-of-life and very rare conditions. During the PACE meeting, patient groups and clinicians highlighted that cervical cancer often affects young women of working age who may have additional family responsibilities. Bevacizumab can give patients an extra three-four months’ survival time that is very important in the context of their limited remaining months. As no new medicines for this condition have been licensed in the last ten years, bevacizumab was considered to represent a significant breakthrough in treatment.
Adalimumab, meanwhile, was accepted for the treatment of hidradenitis suppurativa (HS), a painful long-term skin disease that
causes abscesses and scarring on the skin. Symptoms include recurring boil-like lumps around the groin and armpits which may leak pus. In a patient group submission, the HS Trust highlighted that patients can suffer physical pain, lack of mobility, low self esteem and depression as a result of HS. Adalimumab is the first licensed treatment for HS, and has the potential to reduce painful symptoms and improve quality of life.
Also accepted was Genvoya (a combination of four medicines: elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide fumarate) for HIV. This is a once-daily treatment and offers an alternative to current similar options but with the advantage of potentially fewer side- effects on kidneys and bones. As Genvoya is also licensed for use in adolescents, it helps to extend
treatment to a younger patient group.
‘We are pleased to be able to accept three new medicines for routine use in NHS Scotland,’ said Professor Jonathan Fox, chairman of SMC. ‘We know from the patient group submissions that they will be welcomed. Until now very few licensed treatments have been available for cervical cancer and hidradenitis suppurativa, so it is pleasing that the Committee was able to accept bevacizumab and adlimumab for routine use for these conditions. Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate for HIV is also to be welcomed as it not only offers an additional treatment that is useful for some people living with HIV, it also means there is now a treatment available for younger patients.’
NEW COMBINATION THERAPIES RECOMMENDED FOR HEP C CHALLENGE
The European Medicines Agency (EMA) has recommended the granting of marketing authorisations in the European Union (EU) for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/ velpatasvir) and Zepatier (grazoprevir/ elbasvir).
HCV infection is a major European public health challenge, affecting between 0.4 per cent and 3.5 per cent of the population in different EU member states and is the most common single cause of liver transplantation in the region.
Epclusa and Zepatier belong to a
new generation of medicines for chronic HCV infection, direct-acting antivirals, that give high rates of cure of HCV infection and that have, in the past few years, reshaped the way this disease is treated. These medicines block the action of proteins which are essential for viral replication. Epclusa targets the proteins NS5B and NS5A, while Zepatier targets the proteins NS3/4A and NS5A.
These new regimens allow cure of patients with chronic HCV infection without the need for interferons, medicines which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of HCV patients.
Epclusa contains sofosbuvir, already approved under the name Sovaldi
and as a combination therapy with ledipasvir under the name Harvoni, and velpatasvir which is a novel HCV protein inhibitor. This fixed dose combination of direct-acting antivirals targets all six genotypes of the virus.
Zepatier contains two novel HCV protein inhibitors, grazoprevir and elbasvir. This fixed-dose combination of direct-acting antivirals targets genotypes one and four of the disease.
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