October 2014 decisions news release

The Scottish Medicines Consortium (SMC), whose purpose is to review newly licensed medicines, today  announced that nine new medicines have been accepted for use in NHSScotland.

These include medicines which will help people with conditions such as multiple sclerosis, schizophrenia and hepatitis C, and will impact on patients across Scotland. Two medicines were not recommended by SMC as the committee was not satisfied about their cost effectiveness.

Today’s announcement also includes the first decisions made taking account of a new, more flexible process aimed at improving patient access to new medicines for the treatment of end of life and very rare conditions. This process (called the Patient and Clinician Engagement (PACE) process) has enabled brentuximab vedotin (Adcetris), which is used to treat Hodgkin’s Lymphoma, to be accepted for use for the first time in Scotland. The other medicine to be considered under the process, trastuzumab emtansine (Kadcyla) for HER-2 positive breast cancer, was not recommended.

Professor Jonathan Fox, Chairman of SMC, said:

“I am pleased that many patients in Scotland will be able to benefit from the medicines we have accepted for use today. Through our new PACE and ultra-orphan process we have been able to accept brentuximab for use in NHSScotland.

“The SMC has worked hard with stakeholders to develop the PACE process, aimed at increasing patient access to medicines for very rare and end of life conditions, following the review into access to newly licensed medicines.

“A key part of this process is the fact we are able to take greater account of views given by clinicians and charities who are involved in treating and working with patients on a day to day basis. Their evidence demonstrated that brentuximab is a very effective medicine which can significantly improve long term outcomes in a condition that often affects younger patients. This is of huge value to those with families and dependents, and we hope they will all benefit from the outcome of this decision.”

In addition to the nine medicines accepted for use, SMC did not recommend two submissions, trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer and golimumab (Simponi) for ulcerative colitis, on the basis of value for money.

Professor Fox said:

“We are disappointed that we have been unable to recommend trastuzumab emtansine.

“Additional input from patient groups and clinicians through the PACE process clearly showed trastuzumab emtansine is an effective medicine which would be very much welcomed by patients and clinicians alike. We took this on board and applied as much flexibility as we could in our considerations but the committee felt unable to accept it.

“While the PACE process is a determining factor when we consider medicines like this, and was designed to increase access to such medicines, that access cannot come at any price – we have to consider value for money and take account of the needs of all patients who need treatment, not just those affected by the medicine under consideration. NHSScotland does not have infinite resources.

“This is a devastating condition and we understand that this decision will be very disappointing for patients. Most of our committee members are practising clinicians who care for patients daily and the decision to not recommend a life-extending medicine is never taken lightly.”

He added:

“Local NHS boards have processes in place to allow clinicians to prescribe medicines that are not accepted for routine use by the SMC. We would welcome a resubmission for trastuzumab emtansine that takes into account the issues raised by the SMC appraisal.”

Other medicines accepted for use today are: dabigatran etexilate (Praxada) for deep vein thrombosis; empagliflozin (Jardiance) and alogliptin (Vipidia) for diabetes; lurasidone (Latuda) for schizophrenia; fingolimod (Gilenya) for multiple sclerosis; simeprevir (Olysio) for chronic hepatitis C; capsaicin (Qutenza) for peripheral neuropathic pain and misoprostol (Mysodelle) which is used for induction of labour.

SMC is introducing a number of changes to process as a result of the review into access to newly licensed medicines and we will continue to engage with and listen to feedback from stakeholders as we develop these.