Scottish Medicines Consortium August 2015 decisions news release

The Scottish Medicines Consortium (SMC) has announced today (Monday 10 August) that three new medicines have been accepted for use in NHSScotland.

Medicines for HIV, asthma and a new antibiotic for the treatment of MRSA related skin infections were all accepted by the Committee.

Two other medicines, eribulin (Halaven) for advanced breast cancer and enzalutamide (Xtandi) for the treatment of prostate cancer in men who have not yet received chemotherapy, were not recommended.

Tedizolid phosphate (Sivextro) is an antibiotic used to treat acute bacterial skin infections and infections of the structures beneath the skin (known as ABSSSI). This includes conditions such as cellulitis, skin abscesses and wound infections. 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) is a combination of two medicines that can be used to treat HIV. It offers an alternative treatment option for those patients 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.

The Committee also accepted tiotropium (Spiriva Respimat) for the treatment of asthma. Tiotropium is already in use for the treatment of 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.

SMC was unable to recommend eribulin (Halaven) for the treatment of breast 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. However, 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 a 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, after consideration under the PACE process. 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 considered enzalutamide in the context of SMC’s modifying criteria, as it offers a substantial improvement in survival and quality of life. However, the Committee felt there was insufficient evidence about the overall benefits of using enzalutamide at this stage in the treatment pathway. The cost of the medicine includes a confidential discount to NHS Scotland (called a Patient Access Scheme (PAS)) but is still substantial. Despite applying the increased flexibility that PACE and the modifiers allow, SMC was unable to recommend enzalutamide for routine use by NHS Scotland due to concerns that the benefits may not justify the price. 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.”

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