Phosphodiesterase type-5 inhibitorsfor the treatment of erectile dysfunction

PAN MERSEY AREA PRESCRIBING COMMITTEE
PRESCRIBING POLICY STATEMENT
Pan Mersey
REF: 13/01 FINAL
DATE OF APPROVAL: 9 JAN 2013
PHOSPHODIESTERASE TYPE-5 INHIBITORS
for the treatment of erectile dysfunction
The pan Mersey Area Prescribing Committee recommends
sildenafil as the phosphodiesterase type-5 inhibitor of choice
for the treatment of erectile dysfunction and should only be
prescribed in the specific circumstances below.
The pan Mersey Area Prescribing Committee recommends sildenafil as the phosphodiesterase type-5 (PDE-5) inhibitor of choice for erectile dysfunction in accordance with Health Service Circular 1999/148 ‘Treatment for Impotence’ June 1999.1 Sildenafil has been chosen first line due to imminent patent expiry. These regulations added the treatment of erectile dysfunction to Schedule 11 of the Regulations (drugs to be prescribed under pharmaceutical services only in certain circumstances). This means that GPs are limited in their use of NHS prescriptions for the treatment of this condition. They may issue NHS prescriptions (endorsed “SLS”) to those men whom in their clinical judgement are suffering from erectile dysfunction and have any of the following conditions:  diabetes, multiple sclerosis, Parkinson’s disease, poliomyelitis, prostate cancer, severe pelvic injury, single gene neurological disease, spina bifida, or spinal cord injury  are receiving dialysis for renal failure  have had radical pelvic surgery, prostatectomy (including transurethral resection of the prostate, after specialist initiation), or kidney transplant  were receiving alprostadil (Caverject®, MUSE® Viridal®), moxisylyte (Erecnos®) or sildenafil (Viagra®) at the expense of the NHS on 14 September 1998. The Department of Health advises that one treatment a week will be appropriate for most patients treated for erectile dysfunction. Further guidance HSC 1999/177 ‘Treatment of Impotence – patients with severe distress’ states that
specialist centres only can prescribe PDE-5 inhibitors if the man is suffering from severe distress as a
consequence of their impotence that causes:
 significant disruption to normal social and occupational activities
 a marked effect on mood, behaviour, social and environmental awareness
 a marked effect on interpersonal relationships.
Patients who are prescribed treatment for impotence on the NHS following the guidance in HSC 1999/177
need to continue to receive their treatment through specialist services. The Department of Health advise that
the arrangements for follow-up and the provision of further treatment should be determined according to the
needs of each patient. These may include arrangements for repeat prescriptions which may or may not
include a full out-patient appointment. Arrangements should be put in place to review the continuation of NHS
prescriptions for patients whose circumstances change.2
Prescribing for patients with severe distress as defined above, that is initiated by specialist services (specialist
commissioned service) must remain with the specialist centre.
Prescribing by a GP is only possible if the patient subsequently meets the criteria laid out in HSC 1999/148
e.g. a diagnosis of diabetes is made.

References:
1. 2.
Review date: January 2015
(or earlier if there is significant new evidence relating to this recommendation)
PHOSPHODIESTERASE TYPE-5 INHIBITORS
for the treatment of erectile dysfunction
EFFECTIVENESS
There is substantial evidence from randomized Agents for the treatment of erectile dysfunction should controlled trials (RCTs) that PDE-5 inhibitors are not be used in men for whom sexual activity is effective in the treatment of erectile dysfunction.1-2 The inadvisable (e.g. patients with severe cardiovascular three PDE-5 inhibitors marketed in the UK (sildenafil, disorders such as unstable angina or severe cardiac tadalafil, and vardenafil) are likely to be equally failure). Visual defects and cases of non-arteritic effective, although there is a lack of direct head-to- anterior ischaemic optic neuropathy have been reported in connection with the intake of PDE-5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking the medicine and consult a physician immediately (for further information on contraindications, cautions drug interactions and adverse effects see the electronic medicines compendium (eMC) -5 COST (4 doses/month)
PATIENT FACTORS
Several measures are described in the literature to salvage patients, clearly identified as non Optimise treatment of concurrent diseases and frequently re-evaluate for new risk factors Consider treatment of concurrent hypogonadism. It is well established that testosterone regulates the expression of PDE-5 and the responsiveness of PDE- 5 inhibitors in the corpus cavernosum. Several studies have shown that patients can be salvaged by treating low or low-normal levels of testosterone. N.B. occasionally patients may respond to one drug Across Merseyside & Warrington the spend on drugs when another has failed. for ED April 11 to Mar 12 was £2,622,993 PRESCRIBING INFORMATION
In severe renal impairment (creatinine clearance < 30 mL/min) the lowest dose should be considered initially.
Based on efficacy and tolerability, the dose may be increased. 10mg is the maximum recommended dose of
tadalafil. Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment.
Since clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) the lowest dose should be considered. Based on efficacy and toleration, the dose may be increased. The maximum dose of vardenafil recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. IMPLEMENTATION NOTES
Please note that there are not currently commissioned services for severe distress in the Merseyside area.
REFERENCES
1.
Prodigy Clarty (formerly Clinical Knowledge Summaries) Erectile dysfunction Jan 2012.(accessed 02/01/13). British Society for Sexual Medicine. Guidelines on the management of erectile dysfunction July 2009.(accessed 02/01/13). SPC Cialis 2.5mg, 5mg ,10mg 20mg film coated tablets(accessed 02/01/13). SPC Levitra 5mg, 10mg, 20mg film coated tablets (last updated(accessed 02/01/13). SPC Viagra 25mg, 50mg, 100accessed 02/01/13).

Source: http://www.panmerseyapc.nhs.uk/recommendations/documents/13_01_pdi5_201301.pdf