Idelalisib is now CDF listed to treat relapsed/refractory CLL through the English Cancer Drugs Fund.

[HAIRBEAR_UK]

Some more good news to start off the month.

Idelalisib for relapsed/refractory CLL is available through the Cancer Drugs Fund, it has been moved from the pending list to full CDF list

During the freeze of the opportunity for assessment and availability of new drug for CLL in the current CDF consultation process on how the CDF will appraise drugs for listing. Idelalisib has gained full CDF listing until the CDF can meet again for listing considerations

Gilead have agreed to an interim access scheme with CDF to ensure CLL patients have access to a transformational therapy during this period. of course we do not know if when CDF is able to reconvene that the original guidance will stand or be overturned? As it is suggested that the proposed new CDF scoring tools in the current consultation SOP may end up penalizing the final decision. But at least we have access to novel therapy for the relapsed refractory during the consultation.

This is especially relevant now that the compassionate access programme to Ibrutinib on a named only basis ended at the end of September. Treating clinicians in England are now able to access idelalisib using the Cancer Drug Fund.

Idelalisib listing

The treatment of relapsed/ refractory Chronic Lymphocytic

Leukaemia where all the following criteria are met:

1. Application made by and first cycle of systemic anti-cancer therapy

to be prescribed by a consultant specialist specifically trained and

accredited in the use of systemic anti-cancer therapy

2. Confirmed CLL

3. Disease progression within 24 months of last systemic therapy

4. At least one previous anti-CD 20 antibody-based treatment or 2

previous chemotherapy regimens

5. Contraindications to cytotoxic chemotherapy (severe neutropenia

or thrombocytopenia as a consequence of previous treatments) or an

estimated creatinine clearance <60 mls/min or comorbidities as

measured by a score of >6 on the Cumulative Illness Rating Scale

6. Given in combination with Rituximab at a dose of 375 mg/m2,

followed by 500 mg per square meter every 2 weeks for 4 doses and

then every 4 weeks for 3 doses, for a total of 8 infusions. Idelalisib

should be continued to progression.

7. Idelalisib is provided by the manufacturer under the terms of the

interim access scheme

NOTE: Rituximab in this indication is funded via baseline

commissioning

Revised CDF list can be found via this weblink: england.nhs.uk/wp-content/u...

This is a helpful section from Cancer research UK and explains the Cancer Drugs Fund:

cancerresearchuk.org/about-...

[splashsplash]

Thanks for this good news, it's amazing to think that all these years of talking about the 'new drugs' coming in the pipeline and now they are actually here with doses and a time regime.

[MartyR]

What tremendous news - as many readers will know - I have been lucky enough to be on a Clinical Trial with B + R and Idelalisib - (Treatment July - Dec 2013 - See other monthly posts.)

Whilst this was a "double blind" trial, it was obvious after my first blood results in Aug 13 that my Oncologist commented that my lymph node reduction and three-fold increase in circulating lymphocytes "appeared" to show that I was not on taking the placebo! (This high lymphocyte count gradually declines over the course of several weeks / months of therapy, but today still remain elevated over normal values.)

Dr Susan O'Brien in Chicago has also stated "I’ve never seen anything like this in CLL before. The shrinkage of head and neck lymph nodes is clinically apparent even from a distance of several feet after 1 week of therapy. This is sustained, powerful lymph node shrinkage. The frightening increase in circulating lymphocytes decreases over time."

This exciting listing with the CDF - supported by Gilead Sciences - hopefully will means that many more CLL sufferers will have the same positive experience as me.

Meanwhile, I would like to reiterate my thanks to this excellent website - especially to the Administrators and Contributors - who have all given freely advice, moral support and factual answers - which certainly help me during this difficult time.

Do not hesitate to contact me - for any help I can offer!!!

May your God be with you all.

Marty