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

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

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

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
. 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
) 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.

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  • Topical today when Novartis are trying to stop a number of health authories prescribing a cancer drug off licence for the treatment of macular degeneration.
    Alemtuzumab presumably has about another 18 months to go before it is licensed for MS- hopefully RRMSers with early aggressive disease who don't want to use tysabri or fingolimod won't be too disabled by the time it comes in.

  • Licenses are a vehicle for the companies to make money, they fight to protect that vehicle.
    I am not defending this, but it is what it is.

    You can bet you bottom dollar that Sanofi-Genzymneare are dealing with the regulators at the moment as they have two drugs, terifluomide and Alemtuzumab.

    Then there is the pricing where are they going to place terifluomide next to beta intereferon and glaterimer acetate. Price above because of convenience (pill v injections) or price below and take the business from beta interferon and glaterimer acetate.

    Price below and surely it would be hard for NICE to say no.

    Then there is alemtuzumab verses tysabri and Gilenya and BG12 lurking in the wings.

    This is why companies spend alot on marketing and surveys to test the water, to see where they can place their product.

  • I'm sure that all the recent publicity might modify Novartis's stance. Let's hope so as Lucentis was a mere opportunistic (some might say cynical) move on the back of clinical findings with Avastin in wet macular degeneration.

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