Tadalafil (5 mg only) represents an additional drug option for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia, and is the only drug in its class licensed for this. Assessing its likely place in therapy in relation to current drug therapies is difficult because there are few published randomised trials of first-line, second-line or combination therapies (tadalafil plus another drug) compared with current best practice.
The 2 studies (Roehrborn et al. 2008 and Donatucci et al. 2011) in this evidence summary used tadalafil as either a first- or second-line (after alpha blockers) monotherapy. Trials have also been undertaken of tadalafil in combination with alpha blockers; for example, 2 randomised controlled trials were identified in Gacci et al. (2012). However, the total number of men in the combination arm who completed the study is too small (34 men) to draw valid conclusions.
When making decisions about the use of tadalafil, localities will need to take this evidence of marginal clinical effectiveness into account alongside the one year data on tolerability. The lack of studies comparing tadalafil alone with an active comparator further limits the usefulness of these data. The acquisition cost of tadalafil is also higher than other treatment options.
The prescribing of tadalafil for erectile dysfunction in England is subject to statutory prescribing restrictions through Schedule 2 of the NHS (general medical services contracts) (prescription of drugs etc.) regulations 2004 and the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. These prescribing restrictions do not apply to tadalafil when it is prescribed in primary care on the NHS for benign prostatic hyperplasia (Department of Health: personal communication October 2013).