Rituximab treatment for acute TTP: Engagement Report

Topic details

Title of policy or policy statement:Rituximab for the treatment in acute Thrombotic Thrombocytopaenic Purpura (TTP) and elective therapy to prevent TTP relapse (adults and children aged 2 years and above)
Programme of Care:Blood and Infection
Clinical Reference Group:Specialised Blood Disorders

1. Summary

This report summarises the feedback NHS England received from engagement during the development of this policy proposition, and how this feedback has been considered. The policy proposition went out to stakeholder engagement between 18th February to 4th March 2022. There were 2 responses.

2. Background

This policy proposition proposes that rituximab be made available as a routine commissioning treatment option in acute TTP and as an elective therapy to prevent TTP relapse for patients of all ages. TTP is a critical medical condition requiring immediate transfer for treatment; 50% require ICU admission and without treatment, the mortality in acute TTP is > 90%.
The off-label use of rituximab for prevention and acute treatment of TTP is long established, being commissioned by clinical commissioning groups as standard of care since 2005. From 1 April 2020 commissioning responsibility transferred from CCGs to specialised commissioning via Prescribed Specialised Services Advisory Group (PSSAG). The aim of this shift in commissioning responsibility is to improve patient outcomes by establishing expert centres and clear pathways.
This policy proposition has been developed by a Policy Working Group made up of clinicians, a patient representative, a public health lead and commissioners.

3. Engagement

NHS England has a duty under Section 13Q of the NHS Act 2006 (as amended) to ‘make arrangements’ to involve the public in commissioning. Full guidance is available in the Statement of Arrangements and Guidance on Patient and Public Participation in Commissioning. In addition, NHS England has a legal duty to promote equality under the Equality Act (2010) and reduce health inequalities under the Health and Social Care Act (2012).

The policy proposition was sent for stakeholder testing for 2 weeks from 18th February to 4th March 2022. The comments have then been shared with the Policy Working Group to enable full consideration of feedback and to support a decision on whether any changes to the proposition might be recommended.

Respondents were asked the following questions:

  • Do you support the proposition for rituximab for the treatment in acute TTP and elective therapy to prevent TTP relapse to be available through routine commissioning/not for routine commissioning based on the evidence review and within the criteria set out in this document?
    • Do you believe that there is any additional information that we should have considered in the evidence review? If so, please give brief details.
    • Do you believe that there are any potential positive and/or negative impacts on patient care as a result of making this treatment option available? If so, please give details.
    • Do you have any further comments on the proposition? If Yes, please describe below, in no more than 500 words, any further comments on the proposed changes to the document as part of this initial ‘sense check’.
    • Please declare any conflict of interests relating to this document or service area.
    • Do you support the Equality and Health Inequalities Impact Assessment?

A 13Q assessment has been completed following stakeholder testing. (delete the not applicable paragraphs)

The Programme of Care has decided that the proposition offers a clear and positive impact on patient treatment, by potentially making a new treatment available which widens the range of treatment options without disrupting current care or limiting patient choice, and therefore further public consultation was not required. This decision has been assured by the Patient Public Voice Advisory Group.

4. Engagement Results

Two responses were received: from a clinician and a charitable organisation. Both respondents supported the policy proposition and deemed that it would have positive impacts upon patients. In line with the 13Q assessment it was deemed that further public consultation was not required.

5. How has feedback been considered?

Responses to engagement have been reviewed by the Policy Working Group and the Blood and Infection PoC. The following themes were raised during engagement:

Keys themes in feedbackNHS England Response
Relevant Evidence
Agreement that the relevant evidence had been reviewed and the search strategy was sound.Noted.
Impact Assessment
The positive impacts are significant for patients including a significant reduction in time spent in hospital.Noted.
The positive impact will be reducing relapse rates and providing pre-emptive treatment, reducing the need for plasma exchange and hospital admission.Noted.
Changes/addition to policy
No changes.Noted.

6. Has anything been changed in the policy proposition as a result of the stakeholder testing and consultation?

No changes have been made to the policy proposition based on the engagement response.

7. Are there any remaining concerns outstanding following the consultation that have not been resolved in the final policy proposition?