January 2015 decisions news release

This month’s advice from the Scottish Medicines Consortium (SMC) features six new medicines that have been accepted for use in NHSScotland.

The accepted medicines include products used in the treatment of multiple sclerosis (MS) and chronic pulmonary disorder (COPD) as well as medicines used for the skin conditions rosacea and urticaria. Cetuximab (Erbitux) for colorectal cancer and aztreonam lysine (Cayston) for cystic fibrosis (CF), which were considered under the SMC’s new PACE (Patient and Clinician Engagement) process, were also accepted. PACE aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.

SMC was unable to accept bevacizumab (Avastin) for the front-line treatment of ovarian cancer, as the Committee was not satisfied about its cost effectiveness. Bevacizumab was also considered under the PACE process.

Cetuximab (Erbitux), a targeted medicine, has been accepted for restricted use as a first-line therapy in metastatic colorectal cancer. Colorectal cancer is the third most common cancer in Scotland, with numbers increasing by around 5% in the last 10 years. Cetuximab has been shown to extend survival and through PACE, patient groups and clinicians advised that it can allow patients to maintain a normal life, enabling them to continue working and spending valuable time with family and friends.

Aztreonam lysine was accepted under the PACE process for restricted use in the suppressive therapy of chronic lung infections caused by the organism Pseudomonas aeruginosa in patients with cystic fibrosis (CF). People with CF are highly susceptible to lung infections which can lead to acute respiratory issues that may ultimately result in respiratory failure and death. Aztreonam lysine has been shown to improve lung function and respiratory symptoms, enabling patients to undertake a more active life. This inhaled therapy has the advantages for the patient that it is easily administered and can be used away from home. It is restricted to use in patients in whom conventional treatments are ineffective or not tolerated.

The injectable therapy omalizumab (Xolair) was accepted for use in the treatment of chronic spontaneous urticaria (CSU). CSU is a serious skin condition that causes wheals or hives to appear suddenly, often with no known cause. The condition is associated with severe itching, frequently at night, causing sleep deprivation and chronic fatigue. Skin Conditions Scotland advised that omalizumab can make a significant difference to patients, helping to stabilise their condition.

Peginterferon-beta-1a (Plegridy) was accepted for the treatment of relapsing remitting MS in adults. Approximately 85% of patients with MS have the relapsing-remitting form, which is associated with unpredictable acute episodes of neurological dysfunction, followed by recovery and periods of clinical stability. A submission from the charity Multiple Sclerosis Trust highlighted that the medicine can offer patients an improved quality of life as it requires fewer injections per week than other currently available treatments.

Olodaterol respimat (Striverdi Respimat) was accepted for use in COPD, a common, preventable and treatable disease, often characterised by a chronic, intermittent cough that that worsens over time and with exercise. This can significantly restrict patients’ lives, resulting in increased disability, mortality and high economic costs. Olodaterol can improve symptoms of shortness of breath, improve exercise capacity and lead to reduced use of rescue medication.

Brimonidine gel (Mirvaso) has been accepted for restricted use in erythema (excessive reddening of the skin) that occurs on the face in rosacea, a chronic inflammatory skin condition, typically affecting adults between 30 to 50 years of age. Rosacea can cause a burning sensation, redness and pustules, which may have can be embarrassing and reduce self esteem. There is no current treatment specifically for erythema in rosacea and patients are given lifestyle advice to avoid triggers such as sunlight, alcohol and stress. A submission by Skin Conditions Campaign Scotland.indicated that brimonidine was welcomed by patients as it may help improve the psychosocial effects of rosacea.

Professor Jonathan Fox, chairman of SMC, said:

“I am pleased that this month SMC has accepted six medicines for a variety of conditions that will benefit patients in Scotland. Two of these medicines were considered through our PACE process, and patient groups and clinicians gave powerful testimony on the benefits of cetuximab for bowel cancer and aztreonam lysine in cystic fibrosis. ”

In addition to the six medicines accepted for use, SMC did not recommend a resubmission for bevacizumab (Avastin) for use in ovarian cancer, which was considered under SMC’s new processes for orphan medicines. At the PACE meeting, patient groups and clinicians highlighted the potential benefits of bevacizumab, but despite applying the considerably increased flexibility that this process allows, SMC was unable to accept bevacizumab as it did not represent good value for money for NHSScotland. The resubmission did not include a Patient Access Scheme (PAS) to improve the medicine’s cost-effectiveness.

Professor Fox said:

“We are disappointed that we were not able to accept bevacizumab for use in ovarian cancer, but after careful consideration of the views given by patient groups and clinicians at the PACE meeting, and despite applying as much flexibility as we could, the committee was not satisfied it would be a cost effective use of NHS resources.

“We encourage the manufacturer to make a resubmission for bevacizumab which takes account of the issues raised by SMC.”

For medicines that have been not recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient.