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On 29 July I wrote offering SMAC's interim advice, which was cited by the NHS Executive in its interim guidance to the NHS in mid-September when sildenafil was licensed.In August SMAC convened a working group to help prepare considered advice. This group included a range of experts working in the field of erectile dysfunction. It received from researchers in the University of Birmingham a detailed assessment of the available evidence, on which the group also questioned the manufacturers whose co-operation we acknowledge. SMAC itself, whose members are representative of the whole of the medical profession, then distilled from the many views expressed in the group the key clinical factors we believe are relevant to Ministers' consideration of the wider issues this drug raises.

EFFECTIVENESS OF SILDENAFIL

Sildenafil is effective in restoring normal sexual function in the majority of men with erectile dysfunction, and as an oral treatment is likely to be more acceptable than injections or mechanical devices and is cheaper. The health benefit is an improvement in quality of life, for the man and his partner, and the extent of this will vary according to the predisposing condition, severity and effects of his erectile dysfunction. This adds to the difficulty of calculating the benefits eg in Quality Adjusted Life Years. There may be an additional health benefit if sildenafil encourages earlier presentation with erectile dysfunction leading to earlier diagnosis and treatment of predisposing conditions (eg diabetes), of which erectile dysfunction may be the first symptom. There is also anecdotal evidence that men without erectile dysfunction may benefit from improved erections, but trials were not designed to answer this question; it cannot be considered a health benefit and should not be prescribed in these circumstances.

DIAGNOSIS OF ERECTILE DYSFUNCTION

Diagnosis of erectile dysfunction depends on self-reporting, so it may be difficult to avoid additional costs for men who do not have erectile dysfunction and who wish try to enhance normal performance. There will also be opportunity costs of the time spent in consultations in primary care and clinics in secondary care, both for men and their partners, and financial and/or opportunity costs of training NHS staff. The workload of the medical professions likely to increase whether erectile dysfunction is assessed (and sildenafil is prescribed) in secondary or in primary care. Indeed the scale of demand and importance of full clinical assessment mean that substantial medical time must be devoted to consultations, whether NHS or private. GPs often have the advantage of already knowing the patient's history and so are in a good position to make the initial assessment, with further investigation by hospital specialists as required. American experience suggests that the number of new patients will decline then stabilise after an initial period of high demand. Many patients already receiving hospital-based care (eg for diabetes or neurological disease) may have their erectile dysfunction assessed as part of the management of their disease.

TARGETING

We considered whether NHS treatment for erectile dysfunction could successfully be targeted at men with the greatest clinical need. We identified three broad aspects that might offer clinically relevant criteria: predisposing condition, severity and effect.

These criteria should, in principle, enable doctors to place patients on a continuum of need. However we identified no obvious break-points, or step-changes, in this continuum; and no easy means of measurement of need and therefore of health benefit.

DOSE, FREQUENCY, DURATION AND FOLLOW-UP

The cost-effectiveness of prescribing depends on cost which, for an individual patient, depends on dose, frequency and duration of prescribing (as well as price).

CONCLUSIONS

(i)     SMAC recognises that the aim of prescribing sildenafil is to correct the distressing condition of erectile dysfunction so that sexual function returns towards normal . In common with many treatments available under the NHS this improves quality of life, but does not save or prolong it.

(ii)     Provided that sildenafil is prescribed only to patients who have the medical condition of erectile dysfunction, SMAC sees no medical reason why it should not be available on the NHS in accordance with the terms of the summary of product characteristics in the marketing authorisation; nor why it should not be prescribed by GPs with referral to hospital specialists where appropriate.

(iii)     SMAC suggests that Ministers should consider the priority to be given to all methods of managing erectile dysfunction within the NHS relative to treatments for other conditions, but that any decision take into account equity of access as well as availability of resources. Doctors will need clear Government support and national guidance.

(iv)     Once Ministers have decided in principle on the prescribing of sildenafil, SMAC would be happy if so requested to prepare appropriate clinical guidance for doctors.