Reference 2018-237

REF:            2018-237

Subject:        Standard operating procedures (SOPs) for the use of MabThera.

 

 

Request:

Do you have local clinical pathways or standard operating procedures (SOPs) for the use of MabThera? If so are you able to share these? For instance, is one cycle of MabThera intravenous (IV) always used before initiating the patients on MabThera subcutaneous (SC) in oncology indications?

Number of patients treated* using MabThera subcutaneous versus MabThera intravenous in oncology indications between 2016-2018, if only partial data is available please indicate the timeframe the data refers to:

Oncology
Financial Year Number of patients treated using MabThera Intravenous

(if possible, please provide number of patients excluding those who were switched to MabThera subcutaneous)

Number of patients treated using MabThera Subcutaneous
FY 2016-17    
FY 2017-18    

*if number of patients treated is not available please provide information in units that you have available (e.g. vials, preparations…)

 Total number of patients treated* with MabThera (intravenous and subcutaneous) vs Rixathon vs Truxima in oncology and rheumatology indications between 2016-2018, if only partial data is available please indicate the timeframe the data refers to:

Financial Year Drug Number of patients treated in Oncology Number of patients treated in Rheumatology
FY 2016-17 MabThera    
Truxima    
Rixathon    
FY 2017-18 MabThera    
Truxima    
Rixathon    

*if number of patients treated is not available please provide information in units that you have available (e.g. vials, preparations…)

 Do you have local clinical pathways or standard operating procedures (SOPs) for the initiation of new patient treatment regimens? If so are you able to share these?

Specifically, are new patients directly prescribed biosimilar rituximab (i.e. Truxima or Rixathon) instead of MabThera?

Are existing patients being switched from MabThera intravenous to biosimilar rituximab (i.e. Truxima or Rixathon)? If so is there a set point in their treatment pathway when patients are switched and how is this managed?

Are any existing patients being switched from MabThera subcutaneous to biosimilar rituximab (i.e. Truxima or Rixathon)? If so is there a set point in their treatment pathway when patients are switched and how is this managed?

Number of patients treated* using rituximab biosimilars (Truxima and Rixathon) instead of MabThera (intravenous and subcutaneous) between 2016-2018, if only partial data is available please indicate the timeframe the data refers to:

Financial Year Drug Oncology Rheumatology
New patients treated directly with the biosimilar instead of MabThera Existing patients switched from MabThera to the biosimlar New patients treated directly with the biosimilar instead of MabThera Existing patients switched from MabThera to the biosimlar
FY 2016-17 Truxima        
Rixathon        
FY 2017-18 Truxima        
Rixathon        

*if number of patients treated is not available please provide information in units that you have available (e.g. vials, preparations…)

 As an organisation, are you aware of any financial savings made by using biosimilar rituximab (i.e. Truxima or Rixathon) vs MabThera between 2017-2018, if only partial data is available please indicate the timeframe the data refers to and the methods used to calculate the financial savings.

Year Scheme (e.g. discounting, gainshare…) Approximate saving (£)
     
     
     
     
     
     
     

Please provide information for the current contracts for Truxima, Rixathon, MabThera intravenous (IV) or subcutaneous (SC):

Drug Contract value (£)* Volume of contract (number of vials) Is price tiered by volume?

(Yes/No)

Length of contract Renewal frequency Services included
Date of contract initiation Date of contract expiry Yes/No Which services

(e.g. biosimilar education, patient support program…)

Rixathon                
Truxima                
MabThera IV                
MabThera SC                

*if the total contract value is not available, please provide the price range for each drug

 Related to question 10, if contracts are tiered by volume, could you please provide the thresholds for each tier and what is the price percentage difference between tiers?

 

 

 

Response:

Thank you for your email of 19 April 2018 where you requested information about Standard operating procedures (SOPs) for the use of MabThera.

 

From our preliminary assessment, it is clear that we will not be able to answer your request without further clarification.

We estimate that it will take us in excess of 2.5 working days to determine appropriate material and locate, retrieve and extract the information in reference to your request. Therefore, your request will not be processed further.

Section 12 of the Act makes provision for public authorities to refuse requests for information where the cost of dealing with them would exceed the appropriate limit, which for Bolton NHS Foundation Trust is set at £450. This represents the estimated cost of one person spending 2.5 working days in determining whether the department holds the information, locating, retrieving and extracting the information.

You may wish to refine your request by narrowing its scope by being more specific about what information you particularly wish to obtain, including any dates or period of time relevant to the information required.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original letter and should be addressed to: Chief Executive, Bolton NHS Foundation Trust, The Royal Bolton Hospital, Minerva Road, Farnworth, Bolton. BL4 0JR 

Please remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF