IHS Global Insight Perspective | |
Significance | The National Institute for Health and Clinical Excellence (NICE) has issued its first appraisal consultation document for four cardiovascular drugs: Pletal, Praxilene, Trental 400, and Hepoxal. |
Implications | In the guidance, NICE said that the generic version of Praxilene was considered to be cost effective for the treatment of intermittent claudication. However, the other three drugs were not cost effective in their respective indications. |
Outlook | As this is the first appraisal of the drugs, this early opinion is subject to change. The appraisal process is ongoing, and the next consultation meeting is schedule for 2 March. |
The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance for four drugs: Pletal (cilostazol; Otsuka Pharmaceuticals, Japan), Praxilene (naftidrofuryl oxalate; Merck Serono, Germany), Trental 400 (pentoxifylline; Sanofi-Aventis, France), and Hepoxal (inositol nicotinate; Genus Pharmaceuticals, U.K.). According to the guidance, Praxilene is recommended for the treatment of intermittent claudication in people with peripheral arterial disease for whom vasodilator therapy is considered clinically appropriate. However, as Praxilene is also available in generic forms, NICE added that the drug should prescribed and dispensed in its cheaper generic form. In contrast, Pletal, Trental 400, and Hepoxal have not been recommended for the treatment of intermittent claudication in people with peripheral arterial disease.
Cost-Effectiveness Analysis
According to NICE, none of the manufacturers submitted their own economic analysis. In the absence of this, the Assessment Group developed a de novo Markov economic model to estimate the cost effectiveness of Pletal, Praxilene, and Trental 400. The three drugs where compared with each other and with use of no vasoactive drugs. For Praxilene, the model used the cost of generic naftidrofuryl oxalate in the analysis. The Markov model used in the analysis had three health states: vasoactive drug treatment with one of the four drugs, no vasoactive drug treatment, and death. According to the base-case results, when compared with no vasoactive drug, Praxilene had the lowest additional cost, at £298.0 (US$483.5), while Pletal had the highest additional cost, at £964, and Trental 400 was in the middle, with an additional cost of £493. In addition, treatment with Praxilene dominated treatment with Pletal and Trental 400, as Praxilene was associated with higher total quality-adjusted life years (QALYs) and lower additional costs. The incremental cost-effectiveness ratios (ICERS) for the three drugs compared with no vasoactive drugs were estimated to be £6,070, £50,737, and £54,777 per QALY gained, respectively.
Separate analysis was conducted for Hepoxal. The evaluation of the drug therefore focused on how many QALYs it would confer for it to be considered as cost effective. The threshold analysis showed that QALY gains of 0.085 and 0.056 were needed for the ICERs for Hepoxal to be below £20,000 and £30,000 per QALY gained, respectively. Comparatively, Praxilene needed the smallest QALY gains compared with no vasoactive treatment, requiring QALY gains of 0.015 and 0.010; Trental 400 needed QALY gains of 0.025 and 0.016; and Pletal needed QALY gains of 0.048 and 0.032 to be considered cost effective. Full analysis is available here.
Outlook and Implications
This is by no means final guidance, and the appraisal is ongoing. The next appraisal meeting is scheduled for 2 March, and NICE will be taking comments on the preliminary ruling in the mean time. The costs of the drugs are as follows: the average monthly cost of Pletal is £38.26 for the 100mg dose; the average monthly cost of generic Praxilene is £4.90 for three 100-mg capsules daily or £9.79 assuming six 100-mg capsules daily; the cost of the branded version of the drug is £8.10 for an 84-capsule pack. The average monthly cost of Trental 400 is £19.90, and for Hepoxal, it stands at £56.14.