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Licensing 

The first step of a drug being made available is for it to be granted a license. For a drug to be licensed the manufacturers must prove that it is safe for use, it is effective and any side-effects are outweighed by the benefits.

At the moment new drugs are issued with a Europe wide license by the European Medicines Agency (EMA). This will change once the UK has left the European Union as we will no longer be part of the EMA.

Approval

Once a drug has its licence the next step is for it to be approved for use in the NHS. In England this is done by the National Institute for Health and Care Excellence (NICE). NICE’s decisions are also followed in Wales and Northern Ireland. In Scotland the decision is taken by the Scottish Medicines Consortium (SMC).

Both NICE and the SMC assess the clinical (how it benefits women with ovarian cancer) and the cost (how much it is) effectiveness of new treatments and drugs. They make their decisions based on evidence supplied by health professionals, patients and carers and drug companies. Target Ovarian Cancer always submits written evidence to consultations on new treatments and regularly acts as an expert witness on committees considering new ovarian cancer drugs. [LINK]

The SMC will either decide to approve or not approve a treatment. In England NICE has three options approve, not approve or recommend for the Cancer Drugs Fund.

Cancer Drugs Fund

The Cancer Drugs Fund (CDF) is for drugs that have promising trial results but there is currently not enough clinical evidence for NICE to decide if they are cost effective. Drugs made available on the CDF are available for up to two years to allow more time for evidence to be gathered. After the two years NICE will then reconsider if the drug should be routinely commissioned or not.

The CDF is only applicable in England. However, Wales has now introduced the New Treatment Fund which offers access to those drugs approved for use on the CDF and Northern Ireland has also recently announced a similar early access scheme.