HSC 1999/148 advises doctors that one treatment a week will be appropriate for most patients treated for erectile dysfunction. If a GP exercising their clinical judgement considers that more than one treatment a week is appropriate they should prescribe that amount on the NHS.

HSC 1999/177 recommends that treatment for impotence should be available from specialist services when impotence is causing severe distress. Patients who are prescribed treatment for impotence on the NHS following the guidance in this circular need to continue to receive their treatment through specialist services. GPs cannot issue an FP10, endorsed SLS, where treatment has been started by a specialist for a patient suffering severe distress unless they also meet one of the above criteria. See Guidance on prescribing for erectile dysfunction for more information.

Erectile dysfunction is a common sequela experienced by men post prostatectomy due to cavernosal nerve damage, causing hypoxia, apoptosis, venous leak and fibrosis of the corpora cavernosa. PDE5 inhibitors promote corporal smooth muscle relaxation and blood flow and early use of these agents following surgery can reverse or minimise these adverse effects. PDE5 inhibitors are the first-line therapy in patients who have undergone surgery; treatment may need to be continued for 24-36 months to allow full recovery of erectile function. Intracavernous alprostadil injections are suggested as second line treatments when oral PDE-5 inhibitors are not adequately effective or contraindicated.

The UK Medicines Information service reports that sildenafil is the most widely studied PDE-5 inhibitor used for erectile dysfunction post prostatectomy. Sildenafil is currently the product with the lowest acquisition cost; therefore should be considered in preference to other PDE-5 inhibitors for first-line use in patients post prostatectomy. Specialist advice should be sought for guidance regarding the appropriate dosing regimen and duration of treatment on an individual patient basis.

Phosphodiesterase Type-5 inhibitors

Phosphodiesterase inhibitors are contra-indicated in patients taking any form of nitrates.

Patients should receive 8 doses of a PDE5 inhibitor at maximum dose with sexual stimulation before classifying a patient as a non-responder.

Sildenafil

• Tablets 25mg, 50mg, 100mg (£0.66 to £0.74 = 4 tablets)
• Tablets 20mg
• Oral suspension sugar free 10mg/1ml

Indication

• Management of male erectile dysfunction:
  • Initially 50mg, to be taken approximately 1 hour before sexual activity, adjusted according to response to 25–100mg (max. per dose 100mg) as required, to be taken as a single dose; maximum 1 dose per day
• Secondary Raynaud’s phenomenon / digital ulceration in systemic sclerosis in adults (off-label):
  • 25mg three times a day, increased to 50mg three times a day
• Pulmonary arterial hypertension (hospital only)

Notes

1. Generic sildenafil is no longer subject to prescribing requirements when used in the management of male erectile dysfunction, however requirements remain for Viagra brand (see Guidance on prescribing for erectile dysfunction).
2. Secondary Raynaud’s phenomenon / digital ulceration in systemic sclerosis:
   1. Treatment will be initiated and supervised by a specialist with expertise in treating systemic sclerosis; the specialist will establish the patient on a stable dose of sildenafil prior to asking the GP to take on long-term prescribing.
   2. The specialist will continue to oversee the ongoing management of systemic sclerosis (including periodic review of the need for ongoing treatment)
   3. If there are any changes in the severity of the patient's condition or concomitant medication, or if troublesome adverse reactions develop, the GP should seek advice from the specialist.
   4. Sildenafil may cause hypotension; there is no need for regular blood pressure monitoring however GPs should reduce dose and/or seek specialist advice if symptomatic hypotension develops.
3. Sildenafil is commissioned for the treatment of digital ulceration in systemic sclerosis in adults in accordance with the criteria outlined in the NHSE Commissioning Policy
4. Sildenafil is commissioned for the treatment of pulmonary hypertension in adults in accordance with the criteria outlined in the NHSE Commissioning Policy

Tadalafil (SLS)

• Tablets 10mg, 20mg (£0.93 to £0.99 = 4 tablets)

Indication

• Management of male erectile dysfunction

Notes

1. Tadalafil is subject to prescribing requirements when used in the management of male erectile dysfunction (see Guidance on prescribing for erectile dysfunction)
2. Tadalafil has a significantly longer half-life compared to the other PDE5 inhibitors.
3. The routine commissioning of Tadalafil (Cialis) 5mg tablets is not accepted in Devon for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males (see Commissioning Policy for more details)

Vardenafil (SLS)

• Tablets 5mg, 10mg, 20mg (£2.84 to £8.32 = 4 tablets)

Indication

• Management of male erectile dysfunction

Notes

1. Vardenafil is subject to prescribing requirements when used in the management of male erectile dysfunction (see Guidance on prescribing for erectile dysfunction).

Avanafil (Spedra)

The routine commissioning of avanafil is not accepted in Devon for the treatment of adult men with erectile dysfunction (ED) (see Commissioning Policy for more details)

Prostaglandins (erectile dysfunction)

Alprostadil (SLS)

• Intracavernosal injection 10microgram, 20microgram, 40microgram (£11.94 = 20microgram vial)
• Topical cream in single-use pre-filled applicator 300micrograms/100mg (£40.00 = 4 doses)
• Intraurethral delivery system 250microgram, 500microgram, 1000microgram (£11.30 = 500microgram dose)
• Intravenous solution 500micrograms/ml in alcohol, for dilution and use as an infusion 1ml ampoule

Indication

• Management of male erectile dysfunction

Notes

1. Alprostadil is subject to prescribing requirements when used in the management of male erectile dysfunction (see Guidance on prescribing for erectile dysfunction). Specialists should inform the GP of the patient's relevant 'SLS' criteria when requesting continuation of prescribing

Combination vasodilators

Invicorp

(Aviptadil with phentolamine)

• Solution for injection ampoules 25micrograms/2mg/0.35ml (£47.50 = 5 ampoules)

Indications

• Management of male erectile dysfunction in patients who meet NHS Selected List Scheme (SLS) criteria for medicines for erectile dysfunction AND who:
  • have failed to respond to eight doses at the maximum tolerated dose with sexual stimulation of two different PDE-5 inhibitors, OR
  • are unable to take PDE-5 inhibitors due to a contraindication

Notes

1. The routine commissioning of lnvicorp is accepted in Devon for the management of male erectile dysfunction only when specific criteria are met (see Commissioning Policy for more details)
2. See Guidance on prescribing for erectile dysfunction for further information on SLS criteria

Other

Papaverine

• Injection 25mg, 80mg (unlicensed)

Vacuum devices

Vacuum devices may be a cost-effective option for the management of erectile dysfunction, but only if trialled in specialist clinic first to assess acceptability. Vacuum devices should therefore be initiated by specialists. Once found to be an acceptable option to the patient, the device could therefore be continued in primary care. Specialists should inform the GP of the patient's relevant 'SLS' criteria when requesting continuation of prescribing (see Guidance on prescribing for erectile dysfunction).

The use of vacuum devices may be particularly beneficial for patients who have had a radical prostatectomy (non-nerve sparing surgery) and patients who have certain co-morbidities and infrequent sexual intercourse. They have been found to be less acceptable to men with serious spinal injury. Men who are taking anticoagulants should not use vacuum devices.