Scottish Medicines Consortium – lenalidomide approval

10/03/2014 – SMC approves lenalidomide for MDS del 5q


Today, the Scottish Medicines Consortium (SMC) announced that they are approving the use of the drug lenalidomide (Revlimid) for the treatment of MDS del 5q patients.

MDS UK applauds this decision to recommend the drug for this specific sub-set of MDS patients.
This is wonderful news for transfusion dependent del 5q patients in Scotland.


MDS severely affects the quality of life of patients – and their families – and this treatment will help to alleviate the constraints imposed by this disease.
Patients will need fewer visits to hospital, which offers an enormous advantage compared to the frequent long and tiring trips needed for transfusions – especially in a relatively sparsely populated area such as Scotland.
This drug is an oral treatment – which also represents an enormous advantage over invasive treatment such as transfusions.


Here is the full information from the SMC website:

Briefing note: lenalidomide (Revlimid)

What is lenalidomide used for?

Lenalidomide is used to treat patients with a group of rare blood and bone marrow diseases, known as myelodysplastic syndromes (MDS). Symptoms of MDS include anaemia, a condition in which people do not make enough healthy red blood cells and need regular blood transfusions to treat low levels of these blood cells.

How does it work?

Lenalidomide increases the number of healthy red blood cells that the body produces and can reduce the need for transfusions. It is given as a capsule orally once daily on days 1 to 21 of repeated 28-day cycles.

What has SMC advised?

SMC accepted lenalidomide for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

What is the evidence to support this advice?

  • One study has shown that lenalidomide increased the proportion of patients who did not require red blood cell transfusion for at least 26 weeks compared with best supportive care. However, there was no significant improvement in overall survival.
  • An economic analysis compared lenalidomide with best supportive care. There were some limitations with the analysis but allowances were made because the medicine is for a rare disease for which there are limited treatment options (this is known as ‘orphan status’).

SMC accepted lenalidomide for use in NHSScotland because it satisfied a number of factors that the SMC can take into account about the balance of costs and benefits of medicines; these were that it has orphan status and offered substantial improvement in quality of life.


It is the second time MDS UK takes part in a SMC appraisal (our first experience was for azacitidine in 2010) as official patient group consultees. This lenalidomide submission was made together with Leukaemia Care.

However this time round, the SMC changed their process slightly by allowing patient groups to attend their deliberation meeting as observers.
MDS UK attended this meeting in Glasgow and was allowed to listen to the entire discussion between all SMC panel members.

NICE has already been holding part of these appraisal meetings publicly for a number of years – but the final decision making discussion is unfortunately still held in a closed session.

MDS UK would therefore also like to applaud the SMC for opening up their meetings to patient groups and allowing full transparency regarding these crucial deliberations.

The discussions we witnessed there were fair and objective – and the chair was particularly mindful not to influence any decision amongst members.

We particularly appreciated the fact that the panel members acting as patient representatives were given ample time to present the patient perspective and were able to read out parts of our patient group submission, as well as patient quotes.
The patient voice and information seemed to benefit from the same care and attention as the clinical and economic data presented.

This was a very positive observation, given the importance of the information and the extensive care and time MDS UK dedicates to these submissions.

MDS UK had the opportunity to get feedback from the SMC regarding this submission:

Professor Angela Timoney, SMC Chair commented: “It’s extremely important for the Scottish Medicines Consortium to have submissions from Patient Interest Groups to inform the new medicines assessment process.
These submissions bring the patient voice into our decision making and are highly valued by the members of the Consortium when making difficult decisions about the use of medicines in the NHS in Scotland.
We were delighted to receive a joint Patient Interest Group submission from MDS UK and Leukaemia CARE.
The submission drew directly upon the experience of patients showing the impact that Myelodysplastic Syndromes have on their lives and their views on lenalidomide, as the medicine under review.
The patient voice came through strongly in this submission and we would encourage more submissions of this high quality.”

MDS UK would like to encourage other patient groups to take part in such appraisals.
From our still limited experience, we have quickly realised the importance of this additional data, which only patients and their relatives can provide.
It is absolutely crucial information which truly helps panel members to get a real picture of what patients experience, day to day, living with a particular disease.

The SMC assists any patient groups with their submission – so we encourage patient groups not to hesitate and to make contact as soon as possible in the process:


Glasgow Evening Times article on the subject – Saturday 22/03/2014

New drug is a huge boost for cancer patients


“A FIREFIGHTER battling a rare blood cancer has welcomed the decision to allow patients access to a new drug.”

This article features an interview with MDS patient and MDS UK member Ally Boyle.
Ally has also done an enormous amount of work recruiting stem cell donors.  Read more on that in our previous coverage of the Anthony Nolan Awards – in our Latest News.


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