UPDATE! Lenalidomide – NICE

27 Oct. 2013

15/11/13- Special update and exceptional change to latest decision

Good news – Nice has put the current lenalidomide appraisal on hold – as the manufacturer (Celgene) has now submitted a Patient Access Scheme (PAS) for this drug.
The appraisal will re-start at a later stage.

Details on NICE website below:

http://guidance.nice.org.uk/TAG/291

Update
15 November 2013 “Since issuing the FAD, the manufacturer of lenalidomide (Celgene) has requested to submit a Patient Access Scheme (PAS). This scheme has been approved by the Department of Health and in recognition of the exceptional circumstances, NICE has agreed that the appraisal can be referred back to the Appraisal Committee.The appeal stage of this appraisal topic has therefore been suspended.  This will allow the manufacturer to submit and the Appraisal Committee to consider the DH approved PAS.  Further updates on next Committee meeting dates will be updated shortly”

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MDS UK welcomes this update and exceptional alteration to the normal procedures.

We are grateful to all stake holders involved:

  • Celgene – the manufacturer – for submitting a PAS, which lowers the overall costs of the drug to the NHS 
  • PASLU (Patient Access Scheme Liaison Unit) for recommending the PAS to Dept of Health
  • Department of Health for accepting the PAS
  • NICE for agreeing to reconsider the whole appraisal – with the new scheme – without additional delays

We hope NICE will come to a positive conclusion and will be able to approve this drug speedily, giving all the relevant MDS patients access to the drug in the very near future.

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NICE says no to Lenalidomide for del 5q MDS patients – 24th October 2013

NICE has now published its FAD (Final Appraisal Document) for Lenalidomide (Revlimid).

Although the clinical efficacy has been fully and clearly recognised, NICE have had to reject the drug, due to the cost-effectiveness ratio still being way too high.

The same drug is available to myeloma patients, thanks to a Patient Access Scheme put in place in 2009.
This patient Access Scheme was offered by Celgene and accepted by the Department of Health.
So far no Patient Access Scheme has been offered for lenalidomide in MDS.

Although lenalidomide for MDS has been rejected this time round, this situation can be reviewed in future.

MDS UK would hope that the same – or similar Patient Access Scheme could be put in place for the small number of MDS patients who urgently need this drug.  We estimate 200 patients would need the drug per year in the UK.

Fortunately, lenalidomide is currently available to MDS del5q patients in England, via the National Cancer Drug Fund.
However, this excludes patients in Wales and Northern Ireland. (Scotland has its own appraisal system – the SMC).

We therefore urge all stake holders – Celgene, Dept of Health, NICE to remain committed to finding a rapid solution, so that all patients in the UK and Northern Ireland will be able to access this crucial drug for transfusion dependent del 5q patients.

We include below all relevant links to the NICE website, as well as a media article in PM Live:

NICE

After considering the feedback from consultation, the Appraisal Committee has prepared a Final Appraisal Determination (FAD) on Lenalidomide for the treatment of myelodysplastic syndromes associated with a deletion 5q cytogenic abnormality in people with red blood cell transfusion dependence and submitted it to the Institute.
http://guidance.nice.org.uk/TAG/291/FAD

 

PM Live article
http://www.pmlive.com/pharma_news/celgenes_revlimid_knocked-back_by_nice_512518

 

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