This is a question that has often taxed both the pharmaceutical industry and the NHS. Well should they?
Should the manufacturer of the medicine in question be a stakeholder to the review process? I almost feel silly asking the question, but at an important meeting recently most attendees said no and I felt that I needed to back down.
I probably wouldn’t have said much about this except for five recent experiences:
- I found a drugs and therapeutics committee application form with the words ‘not to be shared with the pharmaceutical industry’ written on the top in very big and conspicuous writing – yes you probably know who you are
- I heard a senior medicines manager complaining that the pharmaceutical industry help consultants to fill in the applications – often the times that I had a well completed form – but the view was that the forms were ‘tainted’
- I was shown a decision made by a committee where it was obvious that they had the wrong medicine and the wrong information – actually embarrassing
- I almost don’t want to mention the fourth, but I had a discussion with a representative that he was searching for a specialist to make an application for a primary care drug. Have you ever had an application from a consultant who said – I want this drug on the formulary, but I am unlikely to use it – actually I want the GP to try this medicine before referring the patient to me.
- We share the common ground of compliance. If the patient doesn’t take the medicine properly, we get poor outcomes and the manufacturer gets poor sales.
So perhaps we should reconsider the role of the pharmaceutical industry in the whole process:
It is now common for the medicines reviewing bodies in the NHS – not just NICE and the SMC – but NETAG, LNDG and the UKMI to offer their reviews to the manufacturer for comment. This is a good process to ensure that the statements are factual, the interpretation appropriate and the evidence complete. This is probably now standard practice and about time.
At a local level, applications from consultants sometimes are not in line with the full licenced indications – perhaps a particular group of patients or a particular point in a pathway. Here more than ever we should work with the industry to explore these requests. They may have access to data that has been presented rather than published and may be able to point us to clinicians who have experience in this use.
Let’s consider opening up the application process – it is all about securing rapid access to the right medicines to achieve the best outcomes. Consultants are busy people so let the pharmaceutical industry help with the completion of forms – actually give them instruction on what we need to see.
I know that it is radical, but have we ever considered allowing the pharmaceutical industry apply? If they think that their argument is strong – bring it on!
If we reject a medicine then they have the right to see our decisions and to present data or interpretation that we have missed. I always assume that I am not fallible and there is a possibility that I could get it wrong. The worse thing is that some patients suffer because we get things wrong.
Let’s also acknowledge that we are slow to introduce new medicines – it is not a sin – we usually just don’t have the time and resource. And when a medicine is prescribed we all win if it is taken correctly. Then consider ways in which the industry can help educate clinicians and patients to improve outcomes under our watchful eye.
At the end of the day we just need to grow up a little. They make the medicines – they should have a say in our review. If we use the right medicines in the right patients at the right time and get the best outcome, then it is a win-win-win.