The Secretary of State’s Directions underpinning the guiding principles for processes supporting local decision making about medicines will come into force on 1 April 2009.  The directions are intended to make explicit PCTs’ existing legal duties.   They require PCTs to:

• Have arrangements in place for making decisions and adopting policies on health care interventions, including arrangements for dealing with individual funding requests (IFRs).
• Take account of guidance and principles published by Secretary of State.
• Give reasons in writing for policies and for IR refusal.

Local decisions about medicines should be made in the context of, and be consistent with, national policies including World Class Commissioning and local priorities, prioritisation processes and governance frameworks. Decisions should take into consideration clinical and cost effectiveness relative to other interventions commissioned by the PCT for its population, as well as the available budget.

A guiding principles document has been developed to support local decision making about medicines. It is aimed at helping PCTs improve the consistency and quality of local decision making medicines.  This includes decisions on medicines made as part of the development of the annual operating plan as well as consideration of in-year service developments and individual funding requests (IFRs). The principles are designed to cover decision making across primary and secondary care on all medicines not, or not yet, appraised by National Institute for Health and Clinical Excellence (NICE).

Our current policies and procedures are being reviewed in light of this new good practice guidance and with the new strengthening commissioning arrangements across NWL and London.

Current Position in NHS Brent

The funding of medicines is not viewed in isolation of funding of other heath services.  The annual operating plan incorporates the PCT priorities, e.g. Diabetes; CVD; and Cancer.  Care pathways have been developed, including treatment guidelines. The PCT funds medicines in line with NICE guidance; London New Drugs Group and the London Cancer New Drugs Group. 

Individual Funding Requests are required for treatments not covered within the PCTs service level agreements with existing providers. In Brent these requests are reviewed by the NHS Brent’s Treatment Outside of Service Level Agreement panel (TOSLA). This group has delegated authority to decide whether treatments should be funded or not. These decisions need to be made in the context of the duties of the Primary Care Trust (PCT).  PCTs are under a statutory duty to promote the health of the local community as well as individuals. They are also under a duty not to exceed their annual financial allocation. This inevitably means that, from time to time, difficult choices have to be made. 

NHS Brent will consider requests for NCIs based on the following principles:

• Applications will be dealt with fairly and consistently using an agreed ethical decision making framework.
• Observance of the PCT’s statutory duty to maintain and improve the quality of healthcare in Brent whilst remaining within its financial allocation.
• An assessment of the clinical effectiveness and cost of the requested intervention.
• Inclusion within the process of a right of appeal
• The processing of requests in a timely fashion.
• Consideration of the individual personal and clinical circumstances of the patient.

For the full policy on Treatment Outside of Service Level Agreement (TOSLA) please see below:

• TOSLA Policy and Panel Terms Of Reference
• TOSLA appeals committee Terms Of Reference
• TOSLA request form
• Low Priority Policy
• TOSLA low priority request form