December 2021 decisions news release

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has published advice accepting six new medicines.

Olaparib (Lynparza) was accepted for the treatment of ovarian cancer with certain genetic mutations.  The medicine was considered through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. In the PACE meeting, participants highlighted that this condition is relatively rare and aggressive and has a heavy symptom burden. Olaparib is administered with bevacizumab as a maintenance treatment and extends the time to progression of the disease; preventing worsening of symptoms and delaying the need for further chemotherapy.

Ibrutinib (Imbruvica) was accepted for the treatment of Waldenström’s macroglobulinaemia, a rare and incurable cancer of white blood cells. Participants at the PACE meeting shared that patients experience extreme fatigue, recurrent infections, pain and breathlessness. This treatment is more convenient than current treatments since it can be administered at home in tablet form, potentially reducing the number of hospital visits by both patient and family/carers.

Amikacin liposomal nebuliser (Arikayce) was accepted for the treatment of a type of lung infection known as a non-tuberculous mycobacterial (NTM) infection, which is caused by a group of bacteria called Mycobacterium avium complex (MAC). This is a rare, chronic illness that causes respiratory symptoms such as cough, sputum production and breathlessness, as well as fatigue. Nebulised amikacin at home may provide a more convenient treatment option for patients than current treatments, with fewer side effects.

Nivolumab (Opdivo) was accepted for the treatment of metastatic colorectal cancer with a specific genetic mutation when used with another medicine, ipilimumab. Current treatment options for this patient group are limited and prognosis is poor. As an immunotherapy, nivolumab with ipilimumab stimulates the immune system (the body’s natural defence system) to fight the cancer. Patients report that this additional treatment choice offers them greater hope and is welcomed.

Buprenorphine implant (Sixmo) was accepted for the treatment of patients dependent on opioid drugs such as heroin, morphine or similar drugs. The implant is inserted into the arm via a minor surgical procedure and replaced after six months. When given within a framework of medical, social and psychological treatment, buprenorphine implant may enable patients to focus on recovery and return to normal routines without daily visits to a pharmacy to receive treatment.

Tirbanibulin (Klisyri) was accepted for the treatment of actinic keratosis, a common pre-cancerous condition in which rough scaly patches of skin can develop after too much exposure to sunlight. If neglected there is the possibility of squamous cell cancer occurring. Tirbanibulin is an alternative treatment for this condition which may be easier to adhere to as the treatment period is five days.

The committee was unable to accept tafamidis (Vyndaqel) for the treatment of transthyretin amyloidosis cardiomyopathy, a rare condition where protein builds up in tissues around the heart.  Tafamidis was not recommended as the evidence provided by the company was not strong enough to satisfy the committee that it offers value for money to NHSScotland.

SMC chairman Mark MacGregor said:

“The committee is pleased to be able to accept these medicines for use by NHSScotland.”

“Olaparib can delay the worsening of ovarian cancer related symptoms and as a result, can improve a patient’s physical and emotional wellbeing. Participants in the PACE meeting told us how highly they value the additional time until the disease progresses.”

“There are a limited range of therapies for Waldenström’s macroglobulinaemia, and the option to use ibrutinib as a single agent in some patients will be welcomed.”

“Amikacin liposomal nebuliser is a treatment that can be used at home so may reduce the number of hospital visits for both patient and family/carers.”

“Our decision on nivolumab means this patient group has access to a new effective treatment option.”

“We heard from patient groups the difficulties faced by people in treatment for opioid dependence and that buprenorphine implant may be a useful option for some of them.”

“Tirbanibulin provides patients with actinic keratosis with a treatment that has a shorter, more convenient treatment period.”

“We were unable to accept tafamidis as the evidence provided by the company was not strong enough to satisfy the committee of its cost effectiveness.”

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