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.
