NICE has given the go ahead for afatinib (also known as Giotrif and made by Boehringer Ingelheim) to be paid for by the NHS.

Afatinib is a targeted treatment for non-small-cell lung cancer known as an EGFR-TK inhibitor. It works by blocking the signal pathways, helping to slow the growth and spread of tumours. Non-small-cell lung cancer is now tested for the EGFR-TK mutation at diagnosis before people receive their first therapy to ensure that the most appropriate treatment is selected.

People who have non-small-cell lung cancer which is locally advanced or has spread to other parts of the body, and whose tumours test positive for the EGFR-TK mutation, will now be able to receive afatinib on the NHS.

Commenting on the afatinib guidance, Sir Andrew Dillon, chief executive of NICE, said: “This is the third targeted treatment that NICE has recommended for people with this form of lung cancer. NICE was able to publish this final guidance quickly - in just over 3 months since the committee first met to discuss the treatment. As afatinib was recommended in line with its licenced indication, our process allows us to exclude the consultation stage of the appraisal to speed up access.”

NICE has also published final guidance for the NHS on pemetrexed (also known as Alimta and made by Eli Lilly) for the maintenance treatment of non-squamous non-small-cell lung cancer. The guidance does not recommend pemetrexed maintenance therapy for people who have received induction therapy with pemetrexed and cisplatin if their non-small-cell lung cancer is locally advanced or has spread to other parts of the body.

Commenting on the pemetrexed guidance, Sir Andrew Dillon said: “NICE already recommends pemetrexed for maintenance treatment following a different first treatment. However, although pemetrexed is effective when given following induction treatment with pemetrexed with cisplatin, it did not offer sufficient benefit to justify the costs that Eli Lilly is asking the NHS to pay. It is disappointing not to be able to recommend pemetrexed, but we can only recommend treatments which are both clinically and cost effective.”

Ends

Notes to Editors

Explanation of terms

About the afatinib guidance

1. Afatinib is recommended as an option, within its marketing authorisation, for treating adults with locally advanced or metastatic non-small-cell lung cancer only if:

· the tumour tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and

· the person has not previously had an EGFR-TK inhibitor and

· the manufacturer provides afatinib with the discount agreed in the patient access scheme.

2. The Committee concluded that on balance, based on all the evidence considered, afatinib is considered to be a reasonable alternative treatment option compared with erlotinib and gefitinib, in people with locally advanced or metastatic EGFR mutation-positive NSCLC that has not been previously treated with an EGFR tyrosine kinase inhibitor or chemotherapy.

3. The Committee concluded that afatinib is likely to be clinically and cost effective as a second-line treatment for the minority of patients who have received chemotherapy as first-line treatment. The Committee therefore recommended afatinib as a treatment option in line with its marketing authorisation; that is, if the person has not previously had an EGFR-TK inhibitor.

4. The anticipated NHS list price, provided by the manufacturer, is £2,023.28 per pack of 28 tablets (20 mg, 30 mg, 40 mg or 50 mg). The anticipated NHS list price per course of treatment is expected to be around £22,000 per patient, based on a progression-free survival of 11 months. The manufacturer of afatinib has agreed a patient access scheme with the Department of Health in which a confidential discount is applied at the point of purchase or invoice.

5. The Scottish Medicines Consortium is yet to publish advice on the use of afatinib in Scotland -http://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/afatinib_Giotrif

About the pemetrexed guidance

1. During consultation on the second ACD, the manufacturer submitted a revision to its base case ICER (Incremental Cost Effectiveness Ratio). The revision resulted in an ICER ranging between £58,918 per QALY gained and £68,771 per QALY (Quality Adjusted Life Year) gained. The lower and upper estimates of this range were based on 2 alternative assumptions concerning the benefit of pemetrexed over placebo in the post treatment period. However, when the evidence review group reviewed the data for the post treatment period and explored the manufacturer's economic model, it estimated the ICER to be £74,500 per QALY gained.
2. NICE has already recommended pemetrexed in combination with cisplatin as a first-line treatment option for non-small-cell lung cancer and as a maintenance treatment option following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel. This appraisal is concerned with the extension to the marketing authorisation for pemetrexed as a maintenance therapy following induction therapy with pemetrexed and cisplatin.
3. The two main goals of maintenance treatment are to prolong the period of remission after first-line chemotherapy and increase the likelihood of being able to receive second-line chemotherapy.
4. The average total treatment cost is approximately £11,520, assuming 8 cycles of treatment.
5. The Committee concluded that the most plausible cost per QALY gained was approximately £74,500.
6. The Committee considered that the total population for whom pemetrexed is licensed was small enough for the end-of-life advice to apply. However, it noted that even taking into account the supplementary advice on end-of-life treatments, the most plausible cost per QALY gained was higher than that normally considered to be a cost-effective use of NHS resources.

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.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

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.

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