If NICE has not recommended a drug

In the absence of NICE guidance, PCTs have to make their own decisions about which treatments they will provide funding for. We often see reports in the media of patients being refused funding for anti-cancer drugs in one Primary Care Trust (PCT), while the adjacent PCT does provide funding.

Cost-effectiveness is often very complicated to evaluate”and decisions often depend on how compelling a case their clinician can make for funding (which the PCT has to evaluate against all the other funding decisions they are asked to make). In the absence of national guidance local PCTs often come to different decisions about whether or not they are satisfied that there are sufficient funds available for this treatment, and that a good enough case for cost-effectiveness has been made.

As PCTs are required by law to run all their services within an allocated budget, a choice to fund one patient’s treatment is also a choice not to fund one or more other patients’ treatment. PCTs must therefore decide, in consultation with others, which interventions to pritoritise for which groups of patients. Decision-Making Principles are employed by each PCT to help with the distribution of healthcare resources.

There are two main areas in which we believe Government action is needed:

  • To increase consistency in local decision making
  • To improve the handling of exceptional cases

Exceptional cases

Where NICE has made the decision that a certain drug is not sufficiently cost-effective to recommend its use, patients have the option to apply to their PCT on the grounds of exceptionality and have their case judged on an individual basis. These applications can be made in situations where:

  • in the absence of NICE guidance, the PCT has made a decision not to make a drug routinely available;
  • NICE has returned a negative recommendation;
  • or a patient has a rare condition for which their PCT does not have a formal policy.

An exceptions committee, within the PCT, will then judge if an individual patient is considered likely to have an exceptional ability to benefit above that of other similar patients.

Improvements to the current system

Exceptional cases are often dealt with in a closed process, and there is great disparity in procedures between different commissioning bodies. This leads to confusion and delay in many cases. We continue to see huge variations in responses across the country.

Although we accept that a process by which ‘exceptional’ individual cases are considered will necessarily vary in different areas, patients should be able to expect a standardised approach to be adopted by these committees across the country.

Currently each PCT has its own policy on what constitutes an exceptional case and how these cases are dealt with. This is not helpful to patients, who need easy to understand information on how these decisions are made. Exceptional case committees would also benefit from a clarification of their remit, which varies considerably from area to area.

Exceptional case committees must be as transparent and consistent as possible, with a focus on good communication with both the patient and their clinician.

 

Local decision-making

Where clinicians disagree with the PCT’s existing policy not to fund a particular intervention, they may apply to the Local Operational Plan prioritisation process to ask for this decision to be changed.

The creation of the Public Health Commissioning Network should help with more consistent and clearer decision making at the local level. However, whether this more co-coordinated approach to commissioning will improve access to treatments remains to be seen.

In response to proposals in the draft NHS Constitution that all patients will have the ‘right’ to “expect local decisions on funding of drugs and treatments to be made rationally” and if PCTs decide not to fund a drug “they will explain that decision”, the National Prescribing Centre (NPC) is undertaking a study to look at how local decisions are made about which drugs without NICE approval are available on the NHS. PCTs have been asked by to disclose their current arrangements for funding to the NPC, who will be developing public-facing ‘headline principles’ and ‘good practice’ guidance on these issues.