Regulatory Affairs

Scotland approves new drugs for HIV, cancer and others

PBR Staff Writer Published 11 April 2017

The Scottish Medicines Consortium (SMC) has approved five new treatments for breast cancer, multiple sclerosis, leukaemia and others.

Emtricitabine / tenofovir disoproxil (Truvada) was approved to prevent sexually transmitted HIV-1 infection in adults who are at high risk of infection, a condition known as pre-exposure prophylaxis (PrEP).

Truvada should be used in combination with safer sex practices including usage of condoms as per SMC.

SMC chairman Alan MacDonald said: “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.”

A drug named Kadcyla (Trastuzumab emtansine) was approved to treat HER2 positive metastatic breast cancer, an aggressive, advanced form of breast cancer.

The approval came after consideration through the Patient and Clinician Engagement (PACE) process held by the SMC, for medicines given in end-of-life care and for very rare ailments.

MacDonald said: “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.”

The PACE process also approved ibrutinib (Imbruvica) for the treatment of chronic lymphocytic leukaemia (CLL) in patients whose disease had relapsed after previous therapy.

An oral preparation, Ibrutinib is better tolerated according to SMC in comparison to other alternatives on offer. 

In addition, the SMC has approved a new therapy, Daclizumab (Zinbryta) for multiple sclerosis (MS) covering both the severe and relapsed forms. Zinbryta has been shown to bring down the relapses frequency and the disability progression as per SMC.

For the treatment of plaque psoriasis, SMC has approved ixekizumab (Taltz) for patients who did not respond to standard therapies.

The SMC though did not approve ticagrelor (Brilique) which may be combined with aspirin to prevent conditions like heart attacks or strokes that result from blood clots and hardening of the arteries.