April 2017 decisions news release

The Scottish Medicines Consortium (SMC), which reviews newly licensed medicines, has today published advice accepting five new medicines for routine use by NHSScotland.

Trastuzumab emtansine (Kadcyla) was accepted following consideration through SMC’s Patient and Clinician Engagement (PACE) process, for medicines used at the end of life and for very rare conditions. Trastuzumab emtansine is used to treat an aggressive, advanced type of breast cancer known as HER2 positive metastatic breast cancer. In the PACE meeting, patient groups and clinicians highlighted that treatment options are limited at this stage of breast cancer. This medicine can offer patients a significant increase in overall survival and quality of life, allowing them to spend more time with their family and in some cases return to work.

Also accepted through the PACE process was ibrutinib (Imbruvica). Ibrutinib can be used to treat chronic lymphocytic leukaemia (CLL) in patients with disease that has relapsed after previous therapy. Through PACE, patient groups and clinicians highlighted that CLL, a rare, debilitating cancer of the blood, has a significant impact on patients and their families. Ibrutinib is an oral preparation that is better tolerated than currently available alternatives. It has been shown to delay progression of the disease with potential improvement in quality of life.

Daclizumab (Zinbryta) can be used to treat severe or relapsing forms of multiple sclerosis (MS). MS is a disease where inflammation damages the protective sheath around the nerve cells in the brain and spinal cord. It is an unpredictable condition and patients may suffer flare-ups of symptoms which can impact significantly on their quality of life. Daclizumab is a disease modifying treatment option that can reduce the frequency of relapses and the progression of disability. Additionally, daclizumab can be self-administered by the patient as a monthly injection so may be more convenient than other treatment options.

Emtricitabine / tenofovir disoproxil (Truvada) was accepted to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected (‘pre-exposure prophylaxis’ [PrEP]). Emtricitabine / tenofovir disoproxil given as PrEP is one aspect of an HIV-prevention strategy and should be used in combination with safer sex practices such as using condoms. Patient groups highlighted that current prevention methods have not managed to reduce the spread of HIV in Scotland over the last ten years.

The SMC committee also accepted ixekizumab (Taltz) for the treatment of plaque psoriasis, an inflammatory skin condition which causes red scaly patches (known as plaques) on the skin. Ixekizumab extends the range of disease modifying treatment options for patients who have failed to respond to standard therapies.

The committee was unable to recommend ticagrelor (Brilique) which may be used together with aspirin to prevent problems caused by blood clots and hardening of the arteries such as heart attacks or strokes. This submission is related to its use for more than a year after a heart attack. Ticagrelor was not recommended as the committee was concerned about uncertainties around the overall clinical benefit balanced against the potential side effects seen in clinical practice. Previous advice on the use of ticagrelor for up to one year after a heart attack is unchanged.

Dr Alan MacDonald, chairman of the SMC, said:

“I am pleased we were able to accept these new medicines for routine use in NHSScotland. From the valuable testimonies given by patient groups and clinicians at our PACE meeting, we know that trastuzumab emtansine will be welcomed by patients and their families for the treatment of breast cancer. We were able to accept trastuzumab emtansine on resubmission because the company offered an improved Patient Access Scheme (PAS), a confidential discount that improves the cost effectiveness of a medicine.”

“Ibrutinib provides a valuable new treatment option for those suffering from CLL, while daclizumab for MS may help improve patients’ quality of life."

“Emtricitabine / tenofovir disproxil PrEP, when used together with safer sex practices may help to reduce the spread of HIV, which is an ongoing priority for the Scottish Government."

“Ixekizumab offers another treatment option to those patients who have not responded to previous therapies.”

“We were not able to accept ticagrelor for use in this setting as there were concerns about the relative safety of the clinical benefits it might offer.”

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