NICE says yes to new class of drug for adults with leukaemia
24 September 2015
NICE has issued final draft guidance which recommends that idelalisib (marketed as Zydelig by Gilead Sciences) should be made available on the NHS for some adults with chronic lymphocytic leukaemia (CLL).
NICE has recommended idelalisib, when given with another cancer treatment rituximab, for adults with CLL who have a specific genetic change and have not received any other treatment or for all adults with CLL if their cancer has come back less than 24 months after previous treatment.
The decision follows a preliminary decision earlier this year where NICE asked for the company to provide further information on the cost effectiveness of the drug. Gilead Sciences responded by submitting new economic analyses alongside a simple discount agreement to the list price of idelalisib.
Professor Carole Longson, NICE health technology evaluation centre director, said: "We are delighted that Gilead Sciences responded to our consultation by providing further information for our independent appraisal committee as well as agreeing to provide idelalisib to the NHS at a reduced price. For people whose cancer has returned less than 2 years after their last treatment, their options are currently limited. With this new positive recommendation, the NHS will have another clinically effective option for treating adults with chronic lymphocytic leukaemia."
Idelalisib is the first of a new class of drug that work by blocking the signals which help cancerous cells multiply and survive.
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking idelalisib will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
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Notes to Editors
Idelalisib, in combination with rituximab, is recommended:
for untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation or
for chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months.
Idelalisib is recommended only if the company provides the drug with the discount agreed in the simple discount agreement.
The draft guidance is available at /guidance/indevelopment/gid-tag488.
The Committee concluded that idelalisib could not be recommended for people whose disease had relapsed more than 24 months after previous treatment as no evidence was submitted for this group. For the other populations, the clinical effectiveness data showed that idelalisib plus rituximab statistically significantly improved progression-free survival and overall survival compared with rituximab for people whose disease is high-risk relapsed or refractory.
The Committee concluded that the most plausible ICERs for idelalisib plus rituximab compared with fludarabine, cyclophosphamide and rituximab, chlorambucil plus rituximab and bendamustine plus rituximab were within the range of approximately £36,000 per QALY gained and £46,000 per QALY gained.
The Committee concluded that the most plausible ICER for idelalisib plus rituximab compared with rituximab alone is between approximately £31,000 per QALY gained and £41,000 per QALY gained, and the most plausible ICER for the comparison with best supportive care is between approximately £40,000 per QALY gained and £50,000 per QALY gained.
The recommended dose and schedule in the summary of product characteristics is 150 mg taken orally, twice daily. Treatment is continued until disease progression or unacceptable toxicity; in most cases, treatment can be resumed at 100 mg twice daily when the adverse event has been resolved. Idelalisib is priced at £3114.75 for 60 150-mg tablets (British national formulary 2015). The mean cost of a 1 year treatment course for idelalisib is £37,922. The company has a simple discount agreement that provides a discount to the list price of idelalisib. The level of the discount is commercial in confidence.
The Committee concluded that idelalisib met the criteria to be considered under end-of-life considerations.
The Scottish Medicines Consortium have accepted idelalisib for restricted use within NHS Scotland: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1026_15_idelalisib_Zydelig/idelalisib_Zydelig.
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