Policies for the Commissioning of Healthcare

Policy for the use of sacral neuromodulation.

 

Introduction 

 

This document is part of a suite of policies that the CCG uses to drive its commissioning of healthcare. Each policy in that suite is a separate public document in its own right but will be applied with reference to other policies in that suite.

 

 

1. 

Policy

1.1

The CCG will only commission sacral neuromodulation (SNM) when the following criteria are satisfied:

1.1.1

 The patient has idiopathic chronic non-obstructive urinary retention

 

 AND

1.1.2

 the treatment is being carried out in a specialist unit by a clinical team who are experienced in the assessment, treatment and long-term care of patients with bladder dysfunction, and in the use of sacral neuromodulation

 

AND

1.1.3

for a permanent device. that a satisfactory trial with a non-permanent device has been completed

 

 

1.2

The CCG will not routinely commission the use of SNM for constipation, or any other pelvic condition, as it considers the use of this indication does not accord with the Principles of Effectiveness and Cost-Effectiveness.

 

 

2.

Scope and definitions

 

 

2.1

This policy is based on the CCGs Statement of Principles for Commissioning of Healthcare (version in force on the date on which this policy is adopted).

 

 

2.2

Sacral neuromodulation (SNM) also known as Sacral neurostimulation, Sacral nerve stimulation and Sacral nerve modulation, is a two-stage surgical intervention used for a number of conditions relating to function and symptoms in the pelvic area, particularly urinary incontinence (specified types), faecal incontinence (specific types), urinary retention, constipation, and pelvic pain due to e.g. interstitial cystitis, endometriosis, chronic anorectal pain.  It involves applying an electric current to one of the sacral nerves via an electrode placed through the sacral foramen during an operative procedure. The electrode leads are attached to an implantable pulse generator, which stimulates nerves associated with the lower urinary tract or bowel.  A trial with a non-permanent device is usually conducted, for 3 days to 4 weeks depending on device and protocol, and if positive results are found, a permanent device is fitted. 

 

 

2.3

The scope of this policy includes sacral neuromodulation for urinary retention, constipation, and pelvic pain.

 

 

2.4

The scope of this policy does not include SNM for faecal incontinence and SNM for urge incontinence and urgency-frequency, as these are commissioned by NHS England.

 

 

2.5

The CCG recognises that a patient may have certain features, such as

  • having refractory constipation, or pelvic pain;
  • wishing to have a service provided for their refractory constipation, or pelvic pain;
  • being advised that they are clinically suitable for sacral neuromodulation and
  • be distressed by their refractory constipation, or pelvic pain, and by the fact that that they may not meet the criteria specified in this commissioning policy. 

Such features place the patient within the group to whom this policy applies and do not make them exceptions to it.  

 

 

2.6

For the purpose of this policy the CCG defines refractory as persisting despite trying a number or combination of pharmacological therapies at sufficient doses for sufficient time and when the patient is measurably disabled by the condition.

   

2.7

This policy reflects NICE Guidance IPG536 Sacral nerve stimulation for idiopathic chronic non-obstructive urinary retention1

   

3

Appropiate Healthcare

 

 

3.1

The purpose of using sacral neuromodulation is to reduce the symptoms experienced; urinary retention, constipation, or pelvic pain.

 

 

3.2

The CCG regards the achievement of this purpose as according with the Principle of Appropriateness.  Therefore, this policy does not rely on the Principle of Appropriateness.  Nevertheless, if a patient is considered exceptional in relation to the principles on which the policy does rely, the CCG may consider the principle of appropriateness in the particular circumstances of the patient in question when considering an application to provide funding

 

 

4

Effective Healthcare

 

 

4.1

The policy criteria relating to the use sacral neuromodulation relies on the Principle of Effectiveness as the CCG considers there is insufficient evidence to demonstrate it is effective in reducing the symptoms of constipation, pelvic pain or urinary retention (with the exception of idiopathic chronic non-obstructive retention) including neurogenic bladder or obstruction (not an exhaustive list).

 

 

5

Cost effectiveness

 

 

5.1

The policy criteria relating to the use of sacral neuromodulation for the management of constipation, pelvic pain or urinary retention due to any other cause relies on the Principles of Cost-Effectiveness.

Nevertheless if a patient is considered exceptional in relation to the principles on which the policy does rely, the CCG may consider whether the purpose of the treatment is likely to be achieved in this patient without undue adverse effects when considering an application to provide funding.

 

 

6

Ethics

 

 

6.1

The CCG does not call into question the ethics of sacral neuromodulation for the management of refractory constipation, pelvic pain or urinary retention due to any other cause and therefore this policy does not rely on the Principle of Ethics.   Nevertheless, if a patient is considered exceptional in relation to the principles on which the policy does rely, the CCG may consider whether the treatment is likely to raise ethical concerns in this patient when considering an application to provide funding.

 

 

7

Affordability

 

 

7.1

The CCG does not call into question the affordability of sacral neuromodulation therefore this policy does not rely on the Principle of Affordability.  Nevertheless, if a patient is considered exceptional in relation to the principles on which the policy does rely, the CCG may consider whether the treatment is likely to be affordable in this patient when considering an application to provide funding.

 

 

8

Exceptions

 

 

8.1

The CCG will consider exceptions to this policy in accordance with the Policy for Considering Applications for Exceptionality to Commissioning Policies.

 

 

9

Force

 

 

9.1

This policy remains in force until it is superseded by a revised policy or by mandatory NICE guidance relating to this intervention, or to alternative treatments for the same condition.

 

 

9.2

In the event of NICE guidance referenced in this policy being superseded by new NICE guidance, then:

  • If the new NICE guidance has mandatory status, then that NICE guidance will supersede this policy with effect from the date on which it becomes mandatory.

If the new NICE guidance does not have mandatory status, then the CCG will aspire to review and update this policy accordingly.  However, until the CCG adopts a revised policy, this policy will remain in force and any references in it to NICE guidance will remain valid as far as the decisions of this CCG are concerned.

 

 

10

References

 

1.    Sacral nerve stimulation for idiopathic chronic non-obstructive urinary retention.  Interventional procedures guidance [IPG 536].  Published 2015.  www.nice.org.uk/guidance/ipg536

   
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