DrugsThe Scottish Medicines Consortium (SMC), which reviews newly licensed medicines, has published advice that includes five new medicines accepted for use in NHS Scotland.

The recommendation includes treatments for thyroid cancer, Crohn’s disease and a new antibiotic for pneumonia.

Two of the medicines, sorafenib (Nexavar), used to treat thyroid cancer, and riociguat (Adempas), which is used to treat pulmonary arterial hypertension, were accepted after consideration under the SMC’s PACE (Patient and Clinician Engagement) process. This aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.

Sorafenib is used to treat an extremely rare type of cancer called differentiated thyroid carcinoma (DTC). DTC symptoms can include breathing difficulties and problems swallowing. Sorafenib was considered under PACE and the ultra-orphan decision making process, which allows the Committee to consider the wider impact a medicine may have for patients and their carers beyond direct health benefits, and also its impact on specialist services and costs to the NHS and Personal Social Services. Through PACE, patient groups and clinicians highlighted that, as no alternative treatment options are currently available, sorafenib can be life-changing and possibly even life saving for patients as it offers the potential to relieve the most frightening symptoms of DTC, improve pain management and enhance the quality and quantity of life.

Riociguat was also accepted after a PACE meeting. It is the first of a new class of medicines used to treat pulmonary arterial hypertension (PAH). There are limited treatment options for this condition and surgical intervention is not always possible or successful. Riociguat offers patients another treatment option that may help to improve their quality of life. The Committee accepted riociguat for initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists.

The other drugs approved for use include:

  • Vedolizumab (Entyvio) to treat moderate to severe Crohn’s disease. Vedolizumab works differently to other treatments and potentially may have fewer side effects than other currently available treatments called TNF alpha inhibitors, which can have an effect on the whole immune system. The Committee accepted vedolizumab for the treatment of adult patients who have not responded to treatment with TNF alpha inhibitors
  • Tinzaparin (Innohep) is used to treat venous thrombo-embolism (VTE) a term which includes two conditions, deep vein thrombosis (affecting lower limbs) and pulmonary embolism (affecting the lungs). Tinzaparin provides a cost-effective alternative option to current treatment that may allow clinicians to better tailor treatment to individual patients
  • Ceftobiprole (Zevtera) for the treatment of hospital-acquired pneumonia caused by certain bacteria (such as MRSA) when other appropriate antibiotics cannot be tolerated by the patient.

The Committee was unable to recommend two other medicines considered under the PACE process: olaparib (Lynparza) for ovarian cancer and vinflunine (Javlor) for cancer of the bladder and the urinary tract. Rivaroxaban (Xarelto), a blood thinning medicine used to prevent blood clots in patients with acute coronary syndrome (ACS), was also rejected as it did not offer value for money when compared to a commonly used comparator treatment in NHS Scotland.

Professor Jonathan Fox, Chairman of SMC, said: “SMC is pleased to be able to accept five medicines for a variety of conditions that will benefit patients in Scotland. Two of these medicines were considered through our PACE process, and patient groups and clinicians gave powerful testimony on the benefits of sorafenib for thyroid cancer and riociguat for pulmonary arterial hypertension.”

“We are disappointed not to be able to recommend olaparib for use in ovarian cancer and vinflunine for bladder cancer. Despite the powerful additional input from patient groups and clinicians through PACE, we were unable to accept these two medicines due to uncertainty about their clinical benefits in the context of their costs. We know these decisions will disappoint patients and clinicians alike as we understand the devastating impact of these conditions.

“While the PACE process is a determining factor 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, not only those affected by the medicine under consideration. NHS Scotland does not have infinite resources.”

Further details of all medicines can be found at www.scottishmedicines.org.uk