IHS Global Insight Perspective | |
Significance | The positive Alimta ruling has moved Lilly a step further to securing reimbursement of the drug for the maintenance treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC). Meanwhile, the Indiana ruling guarantees Gemzar patent protection until 15 November 2010. |
Implications | The Alimta positive final determination is all the more impressive considering the drug was considered under the end-of-life criteria—under which more expensive medicines can be recommended by NICE—and is only the second drug to secure a positive NICE guidance under these criteria. |
Outlook | Lilly should expect a sizeable revenue boost from Alimta once NICE issues its final guidance for Alimta in the maintenance NSCLC setting—expected this summer. Meanwhile, the company may secure Gemzar patent protection until 2013 if it successfully litigates another Gemzar patent, which the Indiana court was not allowed to enforce in the current case. |
Alimta Secures Positive Final Appraisal Under End-of-Life Criteria
The U.K.'s health technology assessment agency the National Institute for Health and Clinical Excellence (NICE) issued a final appraisal for Eli Lilly's Alimta on 1 April. The final appraisal recommends Alimta as an option for the maintenance treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with other than predominantly squamous-cell (i.e., non-squamous) histology if disease has not progressed immediately following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel. The final appraisal document is available here.
The guidance, issued under NICE's single technology appraisal process, is based on clinical evidence from the JMEN Phase III trial indicating higher median progression-free survival in patients treated with pemetrexed plus best supportive care (4.5 months) compared with those treated with best supportive care only (2.6 months).
The acquisition cost of Alimta to the U.K.'s National Health Service (NHS) is £800 (US$1,219.6) for a 500-mg vial excluding VAT. Thus, assuming an average of eight cycles per patient and a body surface of 1.79 metres squared, the cost to the NHS per patient amounts to £12,076, according to the appraisal. The incremental cost-effectiveness ration (ICER) of pemetrexed compared with best supportive care in the non-squamous NSCLC population, in the manufacturer's base case scenario, was £39,364 per Quality-Adjusted Life Year (QALY). Based on several criticisms by NICE when it initially reviewed Alimta, Lilly provided a new cost-benefit analysis (with six different scenarios) to address the NICE concern. ICERs per QALY under these scenarios ranged from £46,137 to £50,286.
Despite the resulting high ICER per QALY (NICE normally recommends approval only in cases when the ICER is no more than £30,000 per QALY), the NICE committee recommended Alimta for approval considering the so-called end of life criteria. Under these criteria, NICE can take into account the benefit of treatments that can extend life in patients with short life expectancy or cases when the drug is licensed for indications affecting very few patients with incurable diseases.
Gemzar Given Reprieve
Late last week the U.S. District Court for the Southern District of Indiana ruled in favour of Eli Lilly, upholding the validity of the latter's compound patent for Gemzar. In accordance with the ruling, this patent's validity is in effect until 15 November 2010.
Gemzar is currently protected by a separate patent—a so called "method-of-use" patent—which expires on 7 May 2013. The Indiana court ruled that Lilly was prevented from enforcing the 2013 patent in the current Indiana litigation because the 2013 patent had had been invalidated by a Michigan court, under the U.S. doctrine of collateral estoppel. However, Lilly is appealing the Michigan ruling and if it succeeds in its appeal, the collateral estoppel issue preventing the enforcement of its 2013 Gemzar patent will be removed.
Meanwhile, Teva (Israel), the world's largest generics manufacturer, said in a press release, that it believes it is the first to file an Abbreviated New Drug Application (ANDA) for a generic copy of Gemzar with a Paragraph IV certification on the "method-of-use" patent. As a result, Teva believes that it will be able to enjoy 180-day exclusivity on its generic version of Gemzar when the compound patent expires. Whether this happens will depend on the outcome of the Michigan litigation in May and whether Lilly manages to protect the method-of-use patent in the appeal case.
Outlook and Implications
The positive final appraisal for Alimta is a very positive outcome for Lilly. The final appraisal is the second to last step in the NICE review process. NICE final guidance on Alimta for this indication is now expected to be issued in the summer and is expected to be in line with the final appraisal outcome. Once final guidance is issued, the drug will be eligible for reimbursement for this indication by the NHS. Alimta is already recommended for reimbursement by NICE as a first-line treatment in combination with cisplatin for locally advanced and metastatic non-small-cell lung cancer for patients with other than predominantly squamous-cell (non-squamous) histology, as well as a treatment for metastatic pleural mesothelioma, also used in combination with cisplatin. The new indication—once the final guidance is issued—should boost access to Alimta in the United Kingdom and Lilly's revenues from this drug.
In the wider context of the pharmaceutical industry, the Alimta final appraisal has significant implications as well. Alimta is only the second drug for which NICE has allowed reimbursement despite its high ICER per QALY under end-of-life criteria after PharmaMar's (Spain) Yondelis (trabectedin). The decision signals a more consistent approach to application of these criteria by NICE—and the potential for pharmaceutical companies to secure U.K. reimbursement despite the high cost of their medicines when end-of-life treatment criteria are met.
Meanwhile the Gemzar patent ruling provides Lilly with some breathing space until November 2010—and valuable time to appeal the method-of-use patent. Should the company succeed in overturning the Michigan court's decision with regards to that patent, it is likely to secure market exclusivity for Gemzar until 2013.