Scottish Medicines Consortium November 2019 decisions

A medicine used to treat advanced breast cancer has today (Monday 11 November) been accepted by the Scottish Medicines Consortium (SMC) for use in NHSScotland.

Ribociclib (Kisqali), used in combination with another medicine, fulvestrant, was accepted for post-menopausal women living with the most common form of advanced breast cancer following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines to treat end of life and very rare conditions. In the PACE meeting, patient groups and clinicians highlighted that at this stage, existing treatment options are limited and may not be suitable for all patients. Ribociclib can increase the time before the condition progresses, allowing patients valuable additional months in the context of limited overall survival time.

Lenvatinib (Kisplyx) was also accepted through PACE for the treatment of advanced renal cell carcinoma (RCC) (kidney cancer) in those who have been previously treated with a type of cancer medicine called a ‘vascular endothelial growth factor (VEGF) inhibitor’. Lenvatinib is used together with another cancer medicine called everolimus. PACE participants spoke of how patients with advanced RCC have significant disease burden and symptoms including pain from metastatic tumours, extreme fatigue and lethargy. Lenvatinib offers a further treatment option that can extend the period before the cancer returns, and may also extend overall survival.

Pentosan polysulfate sodium (Elmiron) was accepted through PACE for the treatment of bladder pain syndrome, a condition of the bladder which causes pain and a frequent, urgent need to pass urine. In the PACE meeting, participants emphasised the significant impact the condition has on patients’ general health and their daily lives, restricting normal social activities and ability to work. Current treatment involves bladder instillation where a catheter (a plastic tube) is inserted into the bladder to administer liquid medicine. Pentosan is an oral treatment which may reduce patient use of painkillers and reduce urinary frequency, allowing improved sleep and potential to return to normal activities.

Clostridium botulinum neurotoxin type A (Xeomin) was accepted for the treatment of chronic sialorrhoea (excessive drooling) due to neurological disorders such as ataxia (a group of disorders that affect co-ordination, balance and speech), motor neurone disease and Parkinson’s. Patient group submissions highlighted the challenges of sialorrhoea, which can make it difficult for people to be understood when speaking. It can lead to choking and skin problems causing distress and embarrassment. There are currently no licensed treatment options for this condition. Clostridium botulinum neurotoxin type A, given by injection, may help reduce drooling, improving speech and increasing self-confidence.

The committee also accepted imiquimod (Zyclara) for the treatment of actinic keratosis, a precancerous, abnormal skin growth that can develop after too much exposure to sunlight. Imiquimod offers another treatment option when other skin treatments for actinic keratosis cannot be used or are not appropriate.

The committee was unable to accept atezolizumab (Tecentriq) for the treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has spread and who have not yet had chemotherapy. Atezolizumab is used in combination with the cancer medicines bevacizumab, paclitaxel and carboplatin. Despite consideration through PACE, the committee was unable to accept the medicine because of uncertainty in the company’s evidence around the benefits of using atezolizumab when compared to existing treatments.

SMC Chairman Dr Alan MacDonald said:

“I’m pleased we were able to accept five new medicines for use by NHSScotland.”

“From the testimonies given by patient groups and clinicians through our PACE process, we know that those with advanced breast cancer value the opportunity to have additional time with family and friends. We hope that our decision on ribociclib will be welcomed by them.”

“Patients with advanced renal cell carcinoma have to cope with a significant symptom burden as well as coming to terms with their condition. Lenvatinib may provide them with valuable extra time before the disease relapses and for some patients may extend their overall survival time.”

“For those with bladder pain syndrome, our decision on pentosan polysulfate sodium provides an opportunity to manage their condition and improve their quality of life without recourse to a potentially painful procedure.”

“Our decision to accept clostridium botulinum neurotoxin (Xeomin) means those with sialorrhoea as a result of a neurological disorder may be able to better manage what can be an embarrassing and difficult complication of their condition.”

“Imiquimod offers another treatment option for those with actinic keratosis.”

“Although the PACE process gives our committee members additional flexibility in their decision making, they were unable to accept atezolizumab for the treatment of NSCLC as the company’s evidence around its benefits when compared to existing treatment options was not strong enough.” 

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