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NICE – the National Institute for Health and Care Excellence – has asked Janssen to set out a case for including its leukaemia drug ibrutinib (Imbruvica) in the Cancer Drugs Fund (CDF).

Up to 1 in 10 adults with chronic lymphocytic leukaemia (CLL) have a form of cancer with genetic changes that make their disease progress quicker and more difficult to treat. The treatment options for CLL with these genetic changes (known as 17p deletion or TP53 mutation) are very limited.

NICE’s independent advisory committee felt ibrutinib could benefit patients whose CLL has these genetic changes, particularly those who have not yet received treatment. The committee recognised that with the current proposal, ibrutinib was not cost effective for these patients. However, it was also aware that available data focused on how well ibrutinib worked as a second treatment, and was mainly from people whose CLL did not have these genetic changes. The committee felt it would be important to find out whether further evidence could be collected on the 17p deletion group, and on the use of ibrutinib as the first treatment, before they made their final decision.

In draft guidance the committee set out what the case for CDF consideration would need to look like. This includes details of data collection that would address uncertainties about the clinical benefits of ibrutinib and any necessary commercial access agreements to reduce the overall cost to the NHS.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: “The incidence of chronic lymphocytic leukaemia (CLL) has been rising since the seventies, with thousands more people being diagnosed with the condition each year. Treating CLL is complex for some, options are limited and current treatments can have serious side effects. As part of our commitment to give patients faster access to promising new cancer drugs, we have invited Janssen to submit a proposal to include ibrutinib in the Cancer Drugs Fund (CDF).

“If the company puts forward a proposal that is accepted by NICE and NHS England, conditional funding will be made available for ibrutinib in the CDF while more evidence is gathered to show how well it works. This will allow us to carefully monitor and evaluate the full benefits of ibrutinib and still ensure patients have access.”

The committee also considered ibrutinib as an option for treating CLL without the 17p and TP53 genetic changes in people who have already received another treatment. Considerable uncertainty about the survival benefits and the fact it cost substantially more than treatments currently available on the NHS meant that the committee concluded that ibrutinib was not good value for money in this setting. NICE already recommends idelalisib and bendamustine for patients with CLL that has previously been treated.

Ibrutinib works by blocking the signals which help cancerous cells multiply and survive. It is an oral tablet taken daily. A year’s treatment costs more than £55,000 per patient. The company have agreed to provide ibrutinib at a discounted price to the NHS. Details of this patient access scheme are confidential

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the committee and following this meeting the next draft guidance will be issued. 

Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments.

Notes to Editors

About the guidance

1. The draft guidance is available at /guidance/indevelopment/gid-tag492/documents.
2. Ibrutinib has a marketing authorisation to treat “adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo immunotherapy”. Ibrutinib is administered orally at a daily dose of 420 mg (3 tablets) until disease progression or intolerance.
3. The number of patients with the 17p deletion or TP53 mutation that would be eligible for treatment with ibrutinib is estimated to be 189.
4. The list price for a single tablet of ibrutinib (140 mg) is £51.10 (excluding VAT; British national formulary [BNF] online, accessed February 2016). The cost of a year’s course of ibrutinib treatment is £55,954.50 (excluding VAT). The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence.
5. Based on the committee’s preferred assumptions (and based on list prices), the committee considered that:

• For patients with refractory or relapsed CLL whose disease progresses within 24 months of previous treatment, the most plausible ICER was £93,000 per QALY gained for ibrutinib compared with idelalisib plus rituximab.
• For patients with refractory or relapsed CLL whose disease progresses after 24 months of previous treatment, the most plausible ICER was £105,000 per QALY gained for ibrutinib compared with bendamustine plus rituximab.
• For patients with CLL who have a 17p deletion or TP53 mutation, the most plausible ICER was £91,000 per QALY gained for ibrutinib compared with idelalisib plus rituximab.
• When the confidential patient access schemes were applied, these ICERs remained substantially above £30,000 per QALY gained.

6. The treatment options currently used in England in the NHS for CLL are:

• for patients with refractory or relapsed CLL:
  • idelalisib plus rituximab (for those whose disease progresses within 2 years after the end of previous treatment)
  • bendamustine plus rituximab (for those whose disease progresses 24 months after the end of previous treatment)
• for patients with untreated CLL who have a 17p deletion or TP53 mutation:
  • idelalisib plus rituximab. However, there is currently provisional advice by the European Medicines Agency (EMA) on idelalisib following a number of serious adverse events in some post-marketing trials. The advice includes not starting treatment in people with a 17p deletion or TP53 mutation who had not had previous treatment. The Committee agreed that in a comparison with best supportive care would be valuable.

7. The committee concluded that the end-of-life criteria had been met for the populations in this appraisal.
8. The Scottish Medicines Consortium is expected to issue its guidance on ibrutinib for CLL in August:https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/ibrutinib_Imbruvica_CLL

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.