SMC accepts seven new medicines for use in NHS Scotland

The Scottish Medicines Consortium (SMC) has accepted seven new medicines for use in NHS Scotland.

Two of these medicines, ofatumumab (Azerra) for the treatment of chronic lymphocytic leukaemia (CLL) and idelalisib (Zydelig) for the treatment of follicular lymphoma, were considered under SMC’s Patient and Clinician Engagement (PACE) process, which aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.

Ofatumumab is used in combination with another cancer medicine, chlorambucil, to treat CLL in previously untreated patients who cannot receive therapy based on fludarabine. In the PACE meeting, patient groups and clinicians stated that the patients most likely to benefit from ofatumumab are those who are older, less fit and have co-morbidities. These patients are less able to tolerate more aggressive treatments and consequently have limited options. Ofatumumab also gives clinicians a wider choice and the ability to tailor therapy to individual patients. SMC restricted its use to those patients who would not be considered for treatment with bendamustine, and who would receive chlorambucil-based therapy.

Idelalisib can be taken at home, offering benefits to patients and carers

Idelalisib is the first of a new class of medicines to treat patients with follicular lymphoma who have not responded to two previous courses of treatment. Idelalisib was also considered under 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 idelalisib offers patients a further treatment option that may prolong life and that it may have fewer side effects than other treatments. As idelalisib is an oral preparation which can be taken at home, it also offers benefits to patients, carers and NHS Scotland as fewer clinic visits are required.  

Entyvio has the potential to help patients avoid the need for surgery

Entyvio is used to treat moderate to severe active ulcerative colitis in adult patients when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient. A patient group submission for Entyvio highlighted that there is currently no cure for ulcerative colitis and noted that surgery which may cause complications and have a profound effect on the patient’s quality of life is often the only option when medical treatments fail.

Entyvio is the first medicine in a new class and has the potential to help patients avoid the need for surgery. SMC has recommended that patients using Entyvio should be reassessed every 12 months to determine whether ongoing treatment is still appropriate.

SMC also accepted Ozurdex, Budenofalk, Victoza and Trajenta

SMC also accepted Ozurdex for the treatment of diabetic macular oedema. The medicine comes in the form of an implant that is injected into the eye releasing Ozurdex. It can be used to treat patients who have an artificial lens after cataract surgery or patients who previously did not respond to, or are unsuitable for, other types of treatment. A patient group submission from the Royal National Institute of Blind people (RNIB) highlighted that the long acting nature of the implant means its use involves fewer clinic visits than other therapies.

Budenofalk was accepted for the treatment of autoimmune hepatitis in patients who do not have severe liver disease. The medicine, a corticosteroid, was restricted to use in patients who cannot tolerate the conventional corticosteroid, prednisolone, or who are more susceptible to its side effects. 

Also accepted for use were two medicines used to treat type 2 diabetes, Victoza and Trajenta, when given in combination with insulin. These medicines had previously been accepted by SMC for use in combination with a range of oral medicines for diabetes.

Professor Jonathan Fox, chairman of SMC, said:“SMC is pleased to be able to accept these new medicines which will benefit patients with a variety of conditions. 

“Two of these medicines were considered under our PACE process, which allows us to apply greater flexibility in our decision making. It is now a year since we first introduced a range of new processes and the hard work of all those involved in helping to develop them – especially patient groups and clinicians –  is beginning to show benefits for patients across Scotland through improved access to effective new medicines.”