Position Statement on the prescribing of Tadalafil (Cialis® Once-a …

Position Statement on the prescribing of Tadalafil (Cialis? Once-a-day)

SW London CCGs* do not support routine prescribing of daily tadalafil (Cialis? once-a-day) for treatment of erectile dysfunction or benign prostatic hyperplasia

Rationale The evidence suggests that tadalafil 5mg daily has similar efficacy to tadalafil 10mg or

20mg taken on demand for the treatment of erectile dysfunction (ED)1.

The evidence suggests that sildenafil, tadalafil and vardenafil have similar efficacy in treating ED1.

In the absence of robust evidence favouring a particular treatment regimen, it is reasonable to choose the treatment with the lowest acquisition cost1, where clinically appropriate.

NICE recommend prescribing a PDE5 inhibitor of lowest acquisition cost2,3, currently generic sildenafil, for men with diabetes. Daily tadalafil (2.5mg or 5mg) has the highest acquisition cost of PDE-5 inhibitors6.

For benign prostatic hyperplasia, there is not enough evidence to recommend phosphodiesterase inhibitors in routine clinical practice8.

Further information available from: NHS England. Items which should not routinely be prescribed in primary care: Guidance for CCGs. . Updated Nov 2017.

Patient information leaflets:

References

1. PrescQIPP DROP-List 2015 (Drugs to Review for Optimised Prescribing). Bulletin 144. Tadalafil once daily (Cialis? one a day). Available at:

2. NICE CKS. Erectile management. Available at: 3. NICE (NG17) Type I diabetes in adults: diagnosis and management. Available at:

4. NICE (NG28) Type 2 diabetes in adults: management. Available at:

5. SMC. Tadalafil 2.5mg and 5mg tablets Available at:

_Cialis_ 6. NHS BSA. Drug Tariff. Part VIIIB (April) Available at: 7. Electronic Medicines Compendium. Available at: 8. NICE (CG 97) Lower urinary tract symptoms in men: management. Available at .uk/guidance/cg97

*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG) Position Statement on prescribing of tadalafil once-a-day. 1

Guidance and recommendations for clinicians:

Tadalafil once daily is not initiated in any new patients. Review patients currently prescribed daily tadalafil for ED and change to an

alternative PDE-5 inhibitor taken on-demand. Choose the PDE-5 inhibitor with the lowest acquisition cost (currently generic sildenafil), the evidence suggests that sildenafil, tadalafil and vardenafil have similar efficacy in treating erectile dysfunction (ED)2. Refer to local formulary options. If previous PDE5 inhibitor on-demand treatment has not been satisfactorily effective, consider:

o If the patient received relevant counselling advice on appropriate use of PDE5 inhibitors, further information can be found at: :

o Whether the patient is aware that PDE-5 inhibitors require sexual stimulation in order to work2.

o If the patient receive eight doses of a PDE-5 inhibitor at a maximum dose with sexual stimulation before being classified as a non-responder2.

Clinicians should take into consideration contraindications and cautions, potential adverse effects and drug interactions. In addition, the dosing regimens vary for each PDE-5 inhibitor. Refer to the current BNF and manufacturer's information7 for detailed information on all these factors.

The Selective List Scheme (SLS) criteria in the Drug Tariff does not apply to generic sildenafil which may be prescribed on the NHS by a GP for any patient with ED6.

Tadalafil (Cialis?), vardenafil (Levitra?), avanafil (Spedra?) or Viagra? can only be prescribed on the NHS for patients that meet Selective List Scheme (SLS) criteria6.

Patients who cannot tolerate generic sildenafil and do not fall within the SLS criteria will not be able to have an alternative branded ED treatment prescribed on the NHS. Treatment may be obtained privately.

Review patients currently prescribed daily tadalafil for benign prostatic hyperplasia and change to alternative treatments as per local formulary options or NICE CG97 Lower urinary tract symptoms in men: management, available at .uk/guidance/cg97.

Guidance for patients

There are different PDE-5 inhibitor treatments for erectile dysfunction, the evidence of which indicates all have a similar efficacy. However, some of these treatments have a higher acquisition cost than others. Daily tadalafil has the highest acquisition cost therefore patients currently prescribed this may be reviewed. This would be carried out by your GP and may include consideration of previously prescribed PDE5 inhibitor therapy to ensure you are taking the most cost effective.

Following this review your GP may offer a suitable alternative PDE-5 inhibitor taken on-demand. As the evidence suggests that tadalafil 5mg daily has similar efficacy to tadalafil taken on demand, and other PDE-5 inhibitors, you should not experience any side effects from this change.

You should have a follow-up review with your GP practice following a change to monitor your tolerance to treatment, and discuss lifestyle and support with medications.

Further information on erectile dysfunction may be found at:

For benign prostate enlargement there are alternative treatments which your GP may consider for you. Further information on benign prostate enlargement may be found at

*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG) Position Statement on prescribing of tadalafil once-a-day. 2

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