December 2016 decisions news release

The Scottish Medicines Consortium (SMC) has today published advice accepting a medicine used to treat advanced prostate cancer for routine use by NHSScotland.

Cabazitaxel (Jevtana), which can be used to treat late stage prostate cancer, was accepted 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. Through the PACE process, patient groups and clinicians highlighted that there are limited treatment options for patients at this stage of the disease and that the problems they may experience, such as spinal cord compression and a significant decrease in quality of life, can impact considerably on both them and their carers. Cabazitaxel is a therapeutic advance, offering patients the potential for increased survival time with manageable side effects, enabling them to have valuable additional time with their families.

Following consideration under the PACE process, the committee was unable to accept pertuzumab (Perjeta) for the routine treatment of certain types of breast cancer. Despite the added flexibility that PACE gives to the decision making process, the committee was unable to accept pertuzumab for routine use as members were concerned about the company’s evidence around the long term survival benefits of the medicine. A meeting will be held between the company and SMC to discuss next steps.

Ivacaftor (Kalydeco) for the treatment of cystic fibrosis in adults with the R117H genetic mutation was not recommended following review under the PACE process. The committee was unable to recommend ivacaftor for routine use by NHSScotland as there was too much uncertainty around the overall clinical benefits it may bring in relation to its high cost.

Pembrolizumab (Keytruda), which can be used to treat a small group of patients with advanced melanoma (skin cancer) who have previously been treated with another medicine, ipilimumab, was also not recommended. After consideration through PACE, the Committee did not recommend pembrolizumab for routine use as it was not satisfied that the company’s evidence on the long term survival benefits of the medicine was strong enough to justify its cost to the NHS.

Also not recommended following consideration through PACE was modified release hydrocortisone (Plenadren) for the treatment of adrenal insufficiency (AI). AI is a rare condition where the adrenal glands do not produce sufficient amounts of the hormones cortisol and aldosterone causing a range of symptoms including extreme fatigue. The committee did not recommend this hydrocortisone preparation for routine use due to a lack of robust evidence from the submitting company about the clinical benefits and value for money of the medicine when compared to other currently available treatments.

The committee was also unable to accept ferric maltol (Ferracru) for the treatment of iron deficiency anaemia (IDA) in patients with Inflammatory Bowel Disease (IBD). This was because of uncertainty around the evidence about the clinical and cost benefits of the medicine in relation to other currently available treatments for this condition.

Professor Jonathan Fox, chair of SMC, said:

“We are pleased that we were able to accept cabazitaxel for advanced prostate cancer. There are currently very few options for patients at this stage of treatment and as such cabazitaxel represents an advance. Having heard the evidence from patient groups and clinicians through our PACE process, we know this decision will be welcomed."

“It is disappointing that the committee was unable to accept the other medicines considered in November. Four of these medicines were considered through our PACE process and, while that gives us additional flexibility in our decision-making for medicines for end of life and very rare conditions, we have to consider value for money and take account of the needs of all patients being treated in NHSScotland, not only those affected by the condition under consideration."

He added:

“We know these decisions will be hard for patient groups and clinicians, particularly those who took part in the PACE meetings. However, when we considered all the evidence in front of us, it was not strong enough for us to be able to accept these medicines for routine use.

“SMC would welcome resubmissions for the medicines we were unable to accept, taking into account the issues raised.”