Negative NICE appraisal for Eli Lilly’s Alimta as maintenance therapy

UK health care guidance body the National Institute for Health and Care Excellence (NICE) has published final draft guidance that does not recommend US pharma major Eli Lilly’s (NYSE: LLY) Alimta (pemetrexed) for the maintenance treatment of locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in people whose disease has not progressed immediately following induction therapy with pemetrexed and cisplatin.

Commenting on the draft recommendations, Sir Andrew Dillon, chief executive of the NICE, said: “NICE already recommends pemetrexed for maintenance treatment following a different first-line drug. However, in this case, pemetrexed as maintenance treatment following first-line pemetrexed therapy in combination with cisplatin, although effective, did not offer sufficient benefit to justify the costs. It is disappointing not to be able to recommend pemetrexed in this final draft guidance, but we can only recommend treatments which are both clinically and cost effective.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until the NICE issues final guidance, National Health Service bodies should make decisions locally on the funding of specific treatments. This appraisal is concerned with an extension to the marketing authorization for the maintenance indication approved in 2012 which includes pemetrexed as maintenance therapy after first-line chemotherapy with pemetrexed and cisplatin.

The NICE already recommends pemetrexed in combination with cisplatin as a first-line treatment option for certain types of locally advanced or metastatic NSCLC and as a maintenance treatment option for locally advanced or metastatic non-squamous NSCLC if the disease has not progressed immediately following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel.

Treatment costs

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 two 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 ($124,318) per QALY gained.