Our policy on cancer drugs

The National Institute for Health and Clinical Excellence (NICE)

Currently, the National Institute for Health and Clinical Excellence (NICE) provides guidance to the NHS in England and Wales on whether drugs are sufficiently cost effective to be provided on the NHS. Cost effectiveness is determined by examining whether the magnitude of the effect these treatments have in patients, when compared to alternatives, justifies the additional cost to the NHS.

Where NICE returns a positive appraisal, the NHS is required to make money available for these drugs – within three months of the final NICE decision. In the absence of a positive NICE decision it is up to local health providers to choose whether they will make a drug routinely available on the NHS.

NICE’s ‘end of life’ criteria

In response to concern that NICE’s process wasn’t approving enough end-of-life treatments, they introduced additional measures that give a greater weighting to drugs that treat certain rarer conditions used in the last few months of life. The ‘end-of-life criteria’ apply in specific cases when the population to be treated is relatively small, life expectancy does not exceed 24 months and the benefit of using the drug is deemed ‘substantial’. In practice this means that the drug offers an extension of at least 3 months. If NICE consider these conditions to be met, they will apply a higher ‘threshold’ for cost effectiveness for these drugs.

Read our detailed policy on the changes we would like to see to the NICE process

The Scottish Medicines Consortium (SMC)

Decisions on which drugs will be made available in Scotland are the responsibility of the Scottish Medicines Consortium (SMC). The SMC process differs from NICE in that it doesn’t include a public consultation phase, basing its decisions on submissions from manufacturers alone. However, many of the same principles of appraisal and issues about implementation also apply to the Scottish system.

More information on how drugs are approved for use in England and Scotland is available on our CancerHelp UK webpages.

In order to fill the gap between the current system of drug approval and the introduction of a new system of drug pricing the Coalition government has introduced an additional £200 million per year Fund to run from April 2011 to April 2014, known as the Cancer Drugs Fund. An Interim Fund has been put in place, totalling £50 million to cover the period from October 2010 to April 2011.

This fund applies to England only. However, other UK nations are currently considering whether a similar Fund should be introduced.

The fund aims to provide access to drugs which doctors recommend, but that would not otherwise be funded by the NHS. Guidance from the Department of Health states that the Fund should only be used when all other routes of funding have been exhausted. This includes the exceptional case committee route.

Early reports suggest that demand for the Fund is steadily rising, but that both demand for the Fund, and the proportion of treatments approved, varies across the country. We have asked the Government to ensure that in future there will be a more consistent approach to distributing the Fund.

Cancer Research has fed into the government’s plans for this Fund. You can read our full response here.

Where doctors feel that a particular patient is likely to benefit from a drug not routinely prescribed on the NHS, they can apply on behalf of their patient to an ‘exceptional case ‘committee. These are also known as ‘individual funding requests’.

These applications can be made in situations where:

• NICE has returned a negative recommendation;
• NICE have not made a ruling on the treatment, and the PCT has decided not to make a drug routinely available; 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 ‘exceptionally’ likely to benefit, based on their biological makeup, their condition, and response to previous treatments – over and above that of other similar patients.

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. Although 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.

We believe that exceptional case committees must be as transparent and consistent as possible, with a focus on good communication with both the patient and their clinician. The Government has done some work to improve this, but we believe that more progress can be made.

Branded medicines account for around 80 per cent of the NHS drugs bill: about £8bn a year, of which around 10% is spent on cancer drugs.

The Pharmaceutical Price Regulation Scheme

The Pharmaceutical Price Regulation Scheme (PPRS) is the current method by which the UK Departments of Health seek to control the price of these drugs, by setting a cap on the profits that each drug company can earn on its annual sales of branded medicines to the NHS. The PPRS is usually renegotiated every five years. The Scheme was established 50 years ago and, despite regular updates, it has never been significantly overhauled.

In January 2009, the Department of Health updated the PPRS to increase flexibility and the use of ‘patient access schemes’. This means that companies can reach agreement with the Department of Health on a lower than list-price at licensing to enable earlier access – with an option to increase prices at a later stage once benefit is proven.

Value Based Pricing

In the 2010 Coalition Agreement, the government announced their plans to change the way that all drugs are priced in the UK, to be introduced from April 2014. The new system, known as Value Based Pricing will apply to all drugs.

It has three main aims:

• Better access for patients to drugs
• More innovative drugs
• Better value for the NHS

The proposals include introducing new ways to assess the ‘value’ of drugs. For example, having higher thresholds for drugs which tackle disease where there is a “greater burden of illness” or for medicines that can demonstrate “wider societal benefits”. This ‘value’ with then be used in negotiations with pharmaceutical companies with the aim of ensuring that all drugs in the UK are priced at a level at which they could be considered cost-effective.

These proposals are still in the early stages. The Department of Health have published a consultation with their thoughts for how this will work in practice. We will continue to work with the Department to aim to achieve a system which gives cancer patients access to the most effective and innovative drugs on the market.