Global Insight Perspective | |
Significance | The Scottish Medicines Consortium (SMC) approved Champix tablets as a National Health Service (NHS) treatment to help adults in Scotland stop smoking, but only as a component of a smoking-cessation support programme. |
Implications | At the same time, the Committee upset Scottish asthma campaigners by rejecting Xolair for the second time as add-on therapy for severe persistent allergic asthma, arguing again that the economic case for the drug had not been demonstrated. |
Outlook | Both decisions could have implications for the wider reimbursement status of Champix and Xolair in the United Kingdom and, by extension, Europe. The U.K. National Institute for Health and Clinical Excellence (NICE) is set to deliver its initial appraisals of the drugs in a few months' time. |
Reluctant smokers in Scotland can breathe more easily after the Scottish Medicines Agency approved Pfizer’s new treatment Champix tablets for use on the Scottish National Health Service (NHS). The same does not apply to asthmatics. A new option for severe persist allergic asthma, Novartis Pharmaceuticals’ injectable Xolair, was turned down by the SMC for the second time in less than a year on cost grounds.
The Committee has not wasted any time ruling on Champix. The drug, a key commercial prospect for Pfizer that is expected to bring in global sales of around US$150 million this year, was approved by the European Commission in late September 2006 and was only launched in the United Kingdom last month (see United States – European Union: 2 October 2006: Pfizer’s Champix Receives European Approval).
Champix is the first new prescription treatment for smoking cessation in nearly a decade and presents a stiff challenge to GlaxoSmithKline's (U.K.) now genericised Zyban (bupropion), which is already available on the Scottish NHS. Both products act differently from the widely used nicotine replacement therapies, with Champix targeting nicotine receptors in the brain to reduce both cravings and withdrawal symptoms.
But Champix has a more benign side-effect profile than Zyban, which has suffered from its association with the antidepressant Wellbutrin (both drugs contain the same active ingredient).Moreover, Champix has demonstrated superior efficacy to Zyban. In two of the three pivotal Phase III trials examined by the SMC, for example, the percentage of patients achieving a four-week continuous quit rate on varenicline was 44% compared with 30% for bupropion.
Another obvious reason for the swift appraisal is Scotland's determination to tackle smoking as a major threat to public health. All Scottish health boards already have smoking-cessation programmes in place offering support and therapy with bupropion or nicotine-replacement products for people wanting to quit. And Scotland is ahead of the United Kingdom in introducing a ban on smoking in all enclosed public places. Smoking prevalence in the country is less than 20% in the top socio-economic quintile but more than 40% in the bottom quintile, the most deprived socio-economic group.
The SMC's appraisal noted the high level of support given to patients in clinical trials for Champix. Accordingly, the drug's use on the NHS in Scotland is conditional on it being part of a smoking-cessation support programme. The estimated cost for a course of treatment is £164-£326 (US$323-US$641) per patient, compared with £61-£80 for bupropion and £109-£120 for nicotine patches.
While anti-smoking campaigners in Scotland have welcomed the SMC's decision, the asthma lobby was a good deal less happy with the Committee's confirmation of its advice last May, that Novartis' Xolair should not be recommended for use on the NHS in Scotland as an add-on therapy to improve asthma control in adult and adolescent patients with severe persistent allergic asthma. Once again, the SMC felt the economic case for omalizumab, which was expected to cost the NHS around £3,330-£19,980 per patient per year (for an eligible patient population of only 512), had not been demonstrated.
Support groups for asthmatics have condemned the verdict as "unjust and inhumane". They intend to carry on fighting for access to Xolair in Scotland, while Novartis has indicated that it will resubmit its dossier to the SMC. In October 2005 Xolair, which was developed by U.S. biotechs Tanox and Genentech, became the first humanised antibody to be approved for the treatment of asthma in the European Union (see Switzerland: 28 October 2005: Novartis's Xolair Receives EU Blessing for Severe Allergic Asthma Treatment).
Outlook and Implications
The SMC's verdicts on Champix and Xolair give a taste of how the drugs may fare in securing reimbursement for the wider U.K. market, and indeed in Europe overall. In this respect, the Scottish body's swift uptake of Champix despite its significant price premium over other smoking cessation treatments is particularly encouraging. The U.K. National Institute for Health and Clinical Excellence (NICE) has scheduled its first appraisal committee meeting on Champix for 18 April and on Xolair for 8 May 2007. Both drugs were placed on fast-track review by the Institute last August.