My medicine: The availability of medicines

When licensing a new medicine, the regulators focus on quality, safety, and how well it works. They do not take into account the cost effectiveness or value for money of a medicine, or its impact on NHS budgets.

But the rising costs of development often mean that new medicines tend to be more expensive than existing treatments—at least until their patent runs out and cheaper versions, called generics, can be made.

With so many treatments in use, and new ones becoming available all the time, it can be difficult for busy healthcare professionals to know which ones work the best and are most suitable for their patients. And those in charge of limited healthcare finances need to know which ones offer the best value for money.

To help them weigh up the health and financial pros and cons of a treatment, independent agencies in each of the UK countries recommend which treatments to use, based on what is known about how well they work and how much they cost to prescribe.

Which agencies are responsible?

• In England, this role falls to the National Institute for Health and Clinical Excellence (NICE) (external link)
• The Scottish Medicines Consortium (SMC) (external link), NHS Quality Improvement for Scotland, and The Scottish Intercollegiate Guidelines Network (SIGN) take on this role in Scotland
• The All Wales Medicines Strategy Group (external link) is the responsible agency in Wales, but tends to follows NICE guidance
• The Department of Health, Social Services and Public Safety (DHSSPNI) adapts NICE guidance for patients in Northern Ireland

They aim to:

• Clear up any confusion about similar medicines used for the same condition
• Find out whether a new and expensive medicine offers value for money
• Advise on how a particular and/or neglected condition should best be treated
• Make sure that all patients with the same condition are treated equally, irrespective of where they live

Which treatments are reviewed?
Broadly speaking, criteria include the need to:

• Tackle emerging public health issues, such as obesity
• Reduce differences in the health of different groups according to sex, race, or wealth, for example
• Treat a disease with high levels of disability and/or death
• Improve patients’ or carers’ quality of life
• Assess a wide range of similar treatments
• Improve care

In the case of NICE, the Department of Health draws up a list of topics from among its own priorities for the NHS and suggestions from healthcare professionals and the public. These can be made:

• Online at topicsuggestions@nice.org.uk
• By phone on 0845 003 7781

Before narrowing down the list, a wide range of organisations is consulted, including those representing healthcare professionals, carers, and patients.

Not all medicines will be assessed. The availability of certain medicines in the NHS will be influenced by other factors, such as local treatment priorities and budgets.

Sifting through all the evidence takes time, but NICE now has a fast track process for life saving drugs that have already been licensed and for new medicines that are about to come on to the market.

The principles involved
Each agency has its own procedures, but they are all guided by the need to be
thorough, independent, open and fair. They involve variously:

• Independent review of the evidence
• Expert panels
• Evidence from specialists, patients, carers, and manufacturers
• Public consultation
• Stated time frame to revisit the topic

Patients and other interested parties can challenge the final recommendations NICE intends to issue, for example, by lodging a formal appeal. This facility is built into the process.

Understandably, patients for whom a particular drug could mean extended or improved quality of life, and manufacturers who have worked hard to develop a new medicine, don’t always agree with recommendations to restrict the availability of a medicine or treatment in the NHS.

Decisions are reviewed after a couple of years to take account of new information on the usefulness and value for money of a particular medicine or treatment.

Putting the recommendations into practice
Once recommendations have been issued, local health organisations should put them into practice within three months, if they are not already doing so.

If you are not able to receive a medicine or treatment that is recommended by one of these national assessment bodies, you should contact the Patient Advice and Liaison Service (PALS) of your local primary care trust (PCT) in England and Wales, or your health board if you live in Scotland.

The equivalent in Northern Ireland is the Health and Social Services Board (external link).

Special cases
In certain circumstances, doctors may feel that they can best help their patients by prescribing a medicine that is not licensed for use in the UK, but which has been licensed for use in another country, such as the USA, for example.

In these cases, the doctor applies to the MHRA to import it on an individual named patient basis.

Find out more...

The Association of the British Pharmaceutical Industry (external link)
UK Medicines Information (external link)
Department of Health (external link)
Royal Pharmaceutical Society of Great Britain (external link)
Scottish Health on the Web (external link)
National Institute for Health and Clinical Excellence (external link)
Scottish Medicines Consortium (external link)
NHS Quality Improvement for Scotland (external link)
The Scottish Intercollegiate Guidelines Network (external link)
The All Wales Medicines Strategy Group (external link)
Department of Health, Social Services and Public Safety (DHSSPS) Northern Ireland (external link)