Alemtuzumab (MabCampath) for refractory chronic lymphocytic leukaemia

Information about the publication of Ministerial Decisions

A formal published “Ministerial Decision” is required as a record of the decision of a Minister (or an Assistant Minister where they have delegated authority) as they exercise their responsibilities and powers.

Ministers are elected by the States Assembly and have legal responsibilities and powers as “corporation sole” under the States of Jersey Law 2005 by virtue of their office and in their areas of responsibility, including entering into agreements, and under any legislation conferring on them powers.

An accurate record of “Ministerial Decisions” is vital to effective governance, including:

demonstrating that good governance, and clear lines of accountability and authority, are in place around decisions-making – including the reasons and basis on which a decision is made, and the action required to implement a decision
providing a record of decisions and actions that will be available for examination by States Members, and Panels and Committees of the States Assembly; the public, organisations, and the media; and as a historical record and point of reference for the conduct of public affairs

Ministers are individually accountable to the States Assembly, including for the actions of the departments and agencies which discharge their responsibilities.

The Freedom of Information Law (Jersey) Law 2011 is used as a guide when determining what information is be published. While there is a presumption toward publication to support of transparency and accountability, detailed information may not be published if, for example, it would constitute a breach of data protection, or disclosure would prejudice commercial interest.

A decision made (27.02.06) to approve the use of Alemtuzumab (MacCampath) for the treatment of refractory chronic lymphocytic leukaemia (CLL).

Subject:	Alemtuzumab (MabCampath®) for refractory chronic lymphocytic leukaemia (CLL)
Decision Reference:	MD-HSS-2006-0013	Exempt clause(s):			-
Type of Report: (oral (O) or written (W))	O
Telephone or email meeting?	-	Person giving report (if oral):			Dr G Prince Paul McCabe
Written Report title:	-
Name of Author:	-
Date of Report:	8 February 2006			Report File ref:
Decision(s): To approve the use of Alemtuzumab (MabCampath®) for the treatment of B cell chronic lymphocytic leukaemia in patients who have failed other therapy.
Reason(s) for decision: The use of alemtuzumab for treatment resistant CLL is supported by the Health and Social Services Drugs and Therapeutics Committee and is included in the British Committee for Standards in Haematology “Guidelines on the Diagnosis and Management of Chronic Lymphocytic Leukaemia”.
Action required:
Signature:			Date of Decision:

Alemtuzumab (MabCampath) for refractory chronic lymphocytic leukaemia

HEALTH AND SOCIAL SERVICES

Supporting Document to Decision Summary

Alemtuzumab (MabCampath®) for refractory chronic lymphocytic leukaemia (CLL)

Oral report to Minister of Health and Social Services by Dr Graham Prince, Chairman Health and Social Services Drugs and Therapeutics Committee, and Paul McCabe, Chief Pharmacist.

Decision(s):

To approve the use of Alemtuzumab (MabCampath®) for the treatment of B cell chronic lymphocytic leukaemia in patients who have failed other therapy

Reason(s) for decision:

Clinical trials have in patients who have failed first or second line treatment for CLL have demonstrated that between 30% and 40% of patients achieve a partial response to alemtuzumab. Combined data from five clinical trials demonstrate an overall response rate of 39% (9% achieving a complete response and 30% a partial response) in treatment refractory CLL with a prolonged survival time in those patients who responded to treatment. The median increased survival time in patients who responded to alemtuzumab ranged between 9 and 18 months compared to those who did not respond. Alemtuzumab is licensed for use in treatment refractory CLL.

The use of alemtuzumab for treatment resistant CLL is supported by the Health and Social Services Drugs and Therapeutics Committee and is included in the British Committee for Standards in Haematology “Guidelines on the Diagnosis and Management of Chronic Lymphocytic Leukaemia”.

Treatment with alemtuzumab for 12 weeks in line with the clinical trials and the product licence would cost approximately £10,000 per patient. It is estimated that approximately 2 or 3 patients a year would require treatment for refractory CLL at a cost of approximately £30,000 per annum.

Paul McCabe

8 February 2006