Idelalisib gains SMC approval for NHS Scotland use + early access

Hi All,

Some good news

Idelalisib (Zydelig) has been accepted for restricted use by NHS Scotland. you can read the full guidance PDF from the download on the SMC website. scottishmedicines.org.uk/SM...

CLLSA have participated in the process it is rewarding to see this now gain approval. I write this from Bristol airport departure lounge heading to Glasgow to take part with CLLSA members in providing the patient group voice in a different appraisal in process.

SMC intitial guidance details:

following a full submission

idelalisib (Zydelig®) is accepted for restricted for use within NHS Scotland.

Indication under review: In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):

who have received at least one prior therapy, or

as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.

Idelalisib in combination with an anti-CD20 antibody significantly improves progression free survival compared with an anti-CD20 antibody alone in patients with relapsed CLL. The treatment effect across subgroups with 17p deletion and/or TP53 mutation was consistent with that of the total study population.

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

PS I am pleased to also let you know that Gilead have set up an early access scheme for patients outside of the reach of the CDF listing for NHS England access and NHS Scotland. This provides access for UK patients who would not otherwise be able to gain access to idelalisib for the EMEA licensed indication, please talk to your doctor for more information.

Initial details :Gilead have released an early access programme (supported by Idis on behalf of Gilead) in the UK (including Wales) for patients who fit within licensed indications subject to certain eligibility criteria. Patients are advised to contact their treating physician in the first instance. Their doctor may contact Idis to obtain more details on this programme, or to request a form for eligibility at this email address: idelalisib@idispharma.com.

I hope that this information is helpful and apologies that I am unable to send you more detailed information about this programme but will keep you updated.

Good luck to everyone attending the CLLSA Liverpool regional members conference/meeting tomorrow

look forward to reading the reports.

Nick.

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  • Nick,

    That great news -- hopefully it won't be long before approval spreads over the border to England then the world!!

    Then other suitable CLL sufferers will be able to have the same positive treatment that "I" has given me!!.

    Regards,

    Marty.

    (Currently - "Stable Condition" on Gilead Clinical Trial 115 - Completed B + R - Dec '13 and still taking Idelaslisib.)

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