The Scottish Medicines Consortium (SMC) accepts ibrutinib (Imbruvica) for restricted use by NHS Scotland to treat 17p TP53 CLL patients

During 2016 CLLSA and patients have worked hard with other stakeholders to capture the patient and carer perspective and deliver this during the appraisal of Ibrutinib by The Scottish Medicines Consortium (SMC). Yesterday SMC announced that ibrutinib (Imbruvica) has been approved for restricted use by NHS Scotland to treat 17p TP53 CLL patients

CLLSA welcome the news that the The Scottish Medicines Consortium (SMC) has accepted a submission for ibrutinib for a sub-group of patients with chronic lymphocytic leukaemia (CLL) with a 17p deletion or TP53 mutation, as prognosis for these patients is particularly poor. It is very good to also read that the committee acknowledged that PACE participants inputs were taken up by the committee in the detailed document and advice highlighting that current treatments for treating CLL are limited, and that ibrutinib has been shown to delay progression of the disease and to offer patients a potential improvement in quality of life.

As patients we would have liked to see access to ibrutinib include those relapsing from a prior treatment and not just access coming available for those with 17p deletions or TP53 mutations. But we recognize this ensures access for a group with a particularly poor prognosis, we will keep pressing for future wider access in line with the marketing authorization as data matures.

CLLSA have provided a toolkit to help you raise awareness of the challenges patients in Scotland face, to contact your local MSP and policy makers to ensure appropriate care support and treatments do get to you and people who need them. If you wish to follow up with this you can download this from the attachment at the bottom of the page.

Yesterday's SMC announcement has now been published and available below.

The detailed advice document can be found here

Alternatively you can visit the SMC website here


Following a full submission assessed under the end of life and orphan medicine process:

ibrutinib (Imbruvica®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

SMC restriction: patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.

In an open-label, phase III study, ibrutinib significantly increased progression-free survival compared with an anti-CD20 antibody in patients with relapsed or refractory CLL.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.


News from SMC 8th August 2016

Treatments for blood cancer, skin cancer and high cholesterol among six new medicines accepted for routine use in Scotland.

The Scottish Medicines Consortium (SMC), which reviews newly licensed medicines, has today (Monday 8 August) published advice accepting six new medicines for routine use by NHS Scotland.

Ibrutinib (Imbruvica) was accepted for the treatment of mantle cell lymphoma (MCL) after consideration under SMC’s Patient and Clinician Engagement process (PACE) for medicines that treat end of life and very rare conditions. MCL is an extremely rare, incurable, aggressive form of non-Hodgkin’s lymphoma (NHL) (a cancer of the white blood cells). In the PACE meeting, patient groups and clinicians spoke of how there are limited effective treatment options for this condition, which can make MCL extremely difficult for patients and their families to deal with. Ibrutinib is a targeted treatment for MCL, and has the advantage of being an oral capsule which is easy to administer, as well as being effective and well tolerated. It has shown high response rates and may offer a survival benefit for patients in whom there are no other effective and tolerable treatment options.

The Committee also accepted a submission for ibrutinib for a sub-group of patients with chronic lymphocytic leukaemia (CLL) and rare genetic abnormalities (17p deletion or TP53 mutation). Prognosis for these patients is particularly poor. PACE participants highlighted that current treatments for this condition are limited, and that ibrutinib has been shown to delay progression of the disease and to offer patients a potential improvement in quality of life.

Nivolumab (Opdivo) is an immunotherapy that can be used to treat advanced melanoma (a form of skin cancer). The Committee accepted nivolumab for use in patients who have not been previously treated with ipilimumab (another medicine used to treat melanoma). Through PACE, patient groups highlighted that melanoma affects a disproportionate number of young adults who may have significant work and family commitments. Nivolumab has been shown to delay the progression of skin cancer and also has different side-effects to some existing medicines, increasing the range of potential options for patients

Levofloxacin (Quinsair), an antibiotic, was accepted for the treatment of long-term infections caused by the bacterium Pseudomonas aeruginosa in adults who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections. Pseudomonas aeruginosa is a frequent cause of infections in patients with cystic fibrosis. Levofloxacin is an inhaled treatment that can be used easily, enabling patients to have a better day to day quality of life.

Alirocumab (Praluent) was accepted for the treatment of high cholesterol in patients at high cardiovascular risk in whom standard drug therapy has not lowered cholesterol levels adequately. Alirocumab will be prescribed by specialists and is administered by fortnightly injections.

Secukinumab (Cosentyx) was accepted for the treatment of psoriatic arthritis, an inflammatory joint disorder associated with psoriasis (a skin disease). Psoriatic arthritis usually develops between the ages of 30 and 50, causing stiffness, pain and lack of movement in affected joints which can be irreversible and lead to disability. This can be particularly difficult for patients to deal with as they may have work and family commitments. Current treatments may improve symptoms in the shor