The Scottish Medicines Consortium (SMC) has announced that three new medicines have been approved for use in NHS Scotland.
The medicines approved are:
- Tedizolid phosphate (Sivextro), an antibiotic used to treat acute bacterial skin infections and infections of the structures beneath the skin
- Darunavir/cobicistat (Rezolsta), a combination of two medicines that can be used to treat HIV
- Tiotropium (Spiriva Respimat) for the treatment of asthma.
Tedizolid is effective against some bacteria, including MRSA, which are resistant to most standard antibiotics. A patient group submission from MRSA Action UK stated that increasing antibiotic resistance meant some patients reported persistent infections. With effective antibiotic stewardship in place tedizolid could help to reduce this, leading to shorter hospital stays. SMC accepted tedizolid for use in patients with ABSSSI caused by MRSA on the advice of local microbiologists or specialists in infectious diseases.
Darunavir/cobicistat (Rezolsta) offers an alternative treatment option for people with HIV who are unable to tolerate the side effects of currently available treatments. As a combination pill it also makes it easier for patients and their carers to manage and monitor treatment regimes.
Tiotropium is already used to treat chronic obstructive pulmonary disease (COPD) and is now the first medicine in this class to be licensed for use in combination with other treatments in patients with severe, persistent, poorly-controlled asthma, helping to increase lung function and reduce the risk of severe asthma attacks. It offers another treatment option for those who do not respond to current treatments and may help them avoid the need to progress to oral steroid treatment.
However, two drugs were not recommended for use – eribulin for breast cancer and enzalutamide for prostate cancer. Eribulin was considered under the SMC’s PACE (Patient and Clinician Engagement) process. During the PACE meeting, participants highlighted that eribulin chemotherapy can offer patients additional survival time. Eribulin also met some of the additional criteria (known as modifiers) that SMC can take into consideration when reaching a decision, as it is a medicine for a rare condition (orphan-equivalent) and offers improvement in life expectancy.
Despite the added flexibility that PACE and the modifiers brought to the decision-making process, the Committee was unable to recommend eribulin for routine use by NHS boards. There was some uncertainty surrounding the overall clinical benefit the medicine would provide for patients at the end of their lives and the Committee was concerned eribulin may not be an effective use of NHS resources. Following a meeting with SMC, the company has indicated their intention to make a resubmission.
Enzalutamide was not recommended for the treatment of prostate cancer in men who have not yet received chemotherapy. SMC has previously accepted enzalutamide for use in patients who have already received chemotherapy. This submission related to its use at an early stage in the treatment pathway. In the PACE meeting, patient groups and clinicians highlighted that enzalutamide can improve quality of life for men in the early stages of prostate cancer.
The Committee felt there was insufficient evidence about the overall benefits of using enzalutamide at this stage in the treatment pathway. A meeting has been arranged to discuss the next steps.
Dr Alan MacDonald, vice chairman of SMC, said: “We are pleased to be able to accept these three medicines for use in NHS Scotland. Tackling antibiotic resistance and HIV are high on the agenda for Scotland, and severe asthma is also a significant concern. We hope these medicines will be of benefit to patients.
“It is disappointing not to be able to recommend eribulin for breast cancer and enzalutamide for prostate cancer. While patient groups and clinicians at PACE meetings for both these medicines spoke strongly in their support, after considering all the available evidence and applying as much flexibility as we could, the committee was unable to accept them. We realise these decisions will disappoint patients and clinicians alike, but SMC has to consider clinical and cost effectiveness in making its decisions.”