New medicines – who decides and how

People Tablets
Photo by Anna Shvets from Pexels
ViewsJuly 15th, 2014

Access to new medicines is a hot topic. Whether it’s the newest treatment for Chronic Obstructive Pulmonary Disease or psoriatic arthritis, to name but two recent introductions, the latest invention is usually welcomed by patient groups – and all too often resisted by the NHS. At least that is the conventional wisdom.

But research by the Welsh Institute for Health and Social Care, discussed at a meeting of the Assembly’s Medicines Knowledge Base group yesterday, suggests that the reality is more complex.

Crucially, while new medicines are widely seen as an additional cost burden, their potential contribution to cost savings – for example because patients do not need in-patient treatment or need to see a consultant less – is less often recognised or realised.  Yet some new treatments could in fact help in the redesign of services. As is so often the case, the enemy of change is silos – Department A bears the cost of a new drug while Department B gets the saving.

NICE or the All Wales Medicines Strategy Group – the sources of approval for new medicines – were seen as part of the problem. The research found that guidance that “X can be used to treat condition Z” didn’t go far enough.  It doesn’t say at what point in someone’s treatment that it should be used e.g. as a first resort or last resort, whether it worked with certain co-morbidities, or whether once X is introduced, use of medicine Y should stop.  NICE guidance also refers to individuals, whereas health boards are making decisions about populations.

So what to do?

The research concluded that the problem is essentially one of implementation. Although it is too polite to say it,  approving a medicine for use in the NHS simply isn’t enough. There’s a long and rocky road between approval and Mr Jones getting the new medicine for his COPD – or not.  Requiring health boards to be open about the availability of new medicines is one idea (about which we were reminded that, in NICE-speak, when a treatment should be an ‘option’ that doesn’t mean one option is ‘not available here’).  Holding health care providers to account for predicated savings is another.

More effective working between managers, clinicians, the pharmaceutical industry and patients is also important.  The research found that while the NHS is pretty good at horizon-scanning, it was, bizarrely, less good at the more immediate task of planning the introduction of a new medicine. This seems extraordinary to me – and surely something on which Welsh Government could lead.

If it really is the case that some new medicines have the potential not only to treat a condition affecting an individual more effectively but also save money, then surely Welsh Government should be championing their introduction.  This is not to say that all  new medicines should be shouted from the roof tops – it’s probably only a fraction that have the ability to transform how health services are delivered. For most, the gains are probably relatively small (if at all), but that’s not to say there are no gains.

What’s clear to me from this research is that introducing new medicines effectively is not just about better management techniques in each health board. It requires a whole new approach, in which new medicines are not seen as a cost to be controlled but a potential solution to both health and budget problems. It requires greater collaboration between pharmaceutical companies, clinicians and managers to plan the “what, when, where and how” of introducing a new medicine.

With scarcely a day passing without a warning about an ‘epidemic’ of a chronic condition – diabetes and dementia are the current favourites – the Welsh NHS can ill-afford to leave the use of new medicines to local chance.

Victoria Winckler is Director of the Bevan Foundation.

The research was commissioned from the Wales Institute for Health and Social Care by the Association of British Pharmaceutical Industries Cymru Wales, who also covered the costs of Victoria chairing the Medicines Knowledge Base meeting.    

One Response

  1. Brian Gibbons says:

    This research raises some interesting issues about the process of introducing new drugs. However it does not establish that is a major issue for the patients or the NHS in Wales. It has been funded by the pharmaceutical industry which has traditionally been critical about what it perceives as being delays in new treatments being introduced into the NHS.

    The report concludes that “ ..it is difficult to asses the extent to which NICE/AWMSG approved medicines were being introduced expeditiously and appropriately into NHS Wales” (p19). Furthermore it does not highlight any instances where there have been missed opportunities for significant patient benefit or service redesign. The availability of cancer drugs in Wales has been made a political issue by Welsh Tories but even here the report says that interviewees “set out their belief that uptake of new medicines in cancer was probably optimal already” (p16). However the issue of cancer drugs was not further studied in depth.

    The report makes clear that there is an LHB duty to make NICE/AWMSG medicines available within three months of their approval. This can create a potential problem for LHBs as they have a very short time-scale to fit these approvals into their existing care pathways. It suggests that LHBs should be better in anticipating what the potential impact of drugs under approval. This would reduce the risk of hasty or delayed implementation plans. However it is recognised that some of this work will be wasted if the drug is not approved in the end. There is also little evidence of subsequent evaluation of the impact that these new drugs have either in clinical terms for patients or in terms of its affect on the wider health care system.

    Ms Winkler is correct to point out that not all new drugs are breakthroughs for patients. The opposite is more likely to be the case with most new treatments replicating what is already on the market. Indeed the pharmaceutical industry has been criticised in some quarters at its failure to introduce really innovative drugs over the last decade or so.

    We also need to remember there are other issues in relation to new drugs such as the risk of harm. While all new agents have to go through an expensive evaluation process before being introduced into clinical care this is no guarantee that they are totally safe or that they will provide an overall positive benefit for patients. In recent years many drugs that have been introduced with a lot of publicity have failed to deliver their promised benefit or have had to be withdrawn because of the emergence of risks that were not apparent when they were launched. What is new is not always better.

Leave a Reply

Search

Search and filter the archive using any of the following fields:

  • Choose Type:

  • Choose Focus:

  • Choose Tag:

Close