Drug from Licence to the MSer

You Asked How long does it take to get NICE approval 

Before any medicines can be used in the UK they have to be licensed. Drugs are licensed for use in the UK either with a European licence or a national licence. Drugs are either licensed through the
Below there are explanations of what these two agencies do.

The Medicines and Healthcare products Regulatory Agency (MHRA)

In 2003, the Medicines Control Agency (MCA) merged with the Medical Devices Agency (MDA) to form the Medicines and Healthcare products Regulatory Agency (MHRA). They now license drugs in the UK. They support the European process as part of the EMA. They also act as the sole agents for companies who only want to license a drug in the UK. A pharmaceutical company can apply directly to the MHRA for a UK licence. Or they can apply to the EMA for a EU licence. Nearly all drugs in the EU are licensed through the EMA now. This is because a single EMA licence is valid in all the countries of the EU. Before the EMA was formed, companies had to apply to each country individually for a licence.
 The European Medicines Agency (EMA)

Applying for a Europe wide licence

There are different systems within the EMA that pharmaceutical companies can use to license drugs.
The first is called the ‘centralised system’. Any drugs for AIDS, cancer, neuro-degenerative conditions, diabetes or orphan drugs have to be licensed this way. The committee that reviews drugs for human use (the CHMP) assess the application, and then recommend whether a drug should have ‘marketing authorisation’ (a licence) or not.

The other ways that pharmaceutical companies apply for a license is either the ‘decentralised system’ or the mutual recognition system. They will use these systems for medicines that don't fit into the categories within centralised system.

With the decentralised system the company applies to several member states at the same time. One member state assesses the application (this is the MHRA in the UK). If they recommend that the drug be licensed, the other member states then either agree or object. If everyone agrees, the drug is given marketing approval. If someone objects, the CPMP will step in and decide. They then advise the EU Commission whether to license the drug or not.

The 'mutual recognition' system means that if one member state already has an existing authorisation the company can apply for the same licence in other member states. The other member states can then mutually recognise the licence using the first member states assessment or they can object.

Once a drug has EU marketing authorisation, it is ‘licensed’, ‘registered’ or ‘approved’. All these terms mean the same thing. This means the company can market the drug in any EU country - but they don’t have to. For one reason or another, they may choose to market the drug in some countries but not others.

When a drug has marketing authorisation, it is not available straight away. The company first have to apply to market their product in each individual country. In the UK, they will apply to the MHRA. When this last small step is done, the product is ‘launched’, and doctors can prescribe it.

Applying for a licence for the UK only
It is possible, but quite unusual, for pharmaceutical companies to apply for a licence in the UK alone. If they want to, the pharmaceutical company apply to MHRA for a licence. The Committee on Safety of Medicines (CSM) assess the application, and recommend whether the drug should get a licence or not.

If the CSM recommend that the drug shouldn't be licensed, the pharmaceutical company can appeal to the Medicines Commission. They are an advisory group. They look at the application again, and advise the MHRA whether to issue a licence or not.As with EU approval, when a product is given marketing authorisation (a licence) by the MHRA, it cannot be prescribed until it is ‘launched’. The time it takes from marketing authorisation to launch in the UK is one of the fastest in the world.
After a product has been launched doctors are allowed to prescribe it, either on the National Health Service (NHS) or through private health care. But only for people who meet the specific criteria of the drug’s licence. This often includes specific stages or types of a disease - for example, a drug may be licensed for one type of MS, but not for another.

In practice, some doctors are not happy to prescribe a new drug at this early stage. There may be a lack of information available about side effects or long term safety. Some doctors like to wait for more information to be published so they can be sure the drug is both safe and effective.

For prescribing on the NHS, some hospital or primary care trusts won't let their doctors prescribe new drugs until they have been approved by NICE (The National Institute for Health and Clinical Excellence) in England and Wales or the SMC (Scottish Medicines Consortium) in Scotland. These organisations look at the evidence on how well the drug works, on any drawbacks or limitations and on cost effectiveness. Unfortunately, there is such a large amount of this work to do and it is so time consuming that there is often a backlog of new treatments waiting for approval. This is particularly so for NICE. The situation sometimes occurs where the SMC has approved a new drug for use in Scotland but NICE have not yet approved it for use in England and Wales. NICE have introduced a fast track process to evaluate drugs more quickly.
There may also be difficulties after a drug has been licensed and approved by NICE. Some health authorities are still reluctant to prescribe drugs approved by NICE or the SMC because of the cost. This is an issue that is being addressed at Government level.

How Long Does this Take 

This  depends on many things but most importantly there is a cost benefit excersise and so if a drug costs alot is the benefit outweighed by the cost. For some MS drugs this was considered to be too high and so primary care trusts are reluctant to fund certain treatments. The Government and the Pharamceutical may set up Risk Sharing Schemes to allow the cost to be reduced to allow MSers to get a Drug. 

The NICE journey Gilenya followed on from reporting of the success in from the final phase III trials in early 2010 (it was submitted in 2009). This was approved by the FDA (American version of the EMA) in late 2010 and gained approval by the EMA in early 2011. It was turned down twice by NICE and following further discussion got approval very recently in March 2012 It has now been has confirmed a positive benefit-risk profile for their once-a-day orally administered drug following review by CHMP. No doubt there were negociations concerning price and Gilenya was approved for prescription of certain criteria only, so this is over 2 years, for some drugs it is longer other shorter. Pharma start negotiations with the regulators much earlier than the 1-2years.
Remember Don't shoot the Messenger
Hopefully not too many mistakes in this process. G May change.