Don’t neglect the potential of off-patent drugs

Thanks to research breakthroughs, huge advances have been made in the treatment and prevention of breast cancer. Drugs are more effective than ever before. But nearly 12,000 women are still dying from this disease each year in the UK, while cheap, re-purposed drugs – including some that are life saving – aren’t getting to people that need them.

For example, tamoxifen, which is primarily used to treat breast cancer, has been found to reduce the risk of the disease developing in the first place in those whose family history puts them at increased risk. Despite the National Institute for Health and Care Excellence updating its familial breast cancer guidelines in June 2013 to recommend that tamoxifen be given to at-risk healthy women as a prevention strategy (known as chemoprevention), we know that it is not being offered to everyone that could benefit.

To give another example, bisphosphonates, bone strengthening drugs, are licensed to treat osteoporosis and prevent bone loss in cancer patients with bone metastases.

‘There’s no financial incentive for pharma companies to sponsor treatments’

They have been found to reduce the risk of breast cancer spreading to the bone in post-menopausal women, and becoming incurable, by 28 per cent. 

This research has only just been published so we are yet to see if offering these drugs to women – before their breast cancer has had a chance to spread – will be commonplace, but we fear the same problems of reduced access will arise.

• High profile treatments cut from cancer drugs fund
• NHS England unveils revamp of cancer drugs fund

Significant barrier

In contrast to stories that have been prominent in the media recently, with drugs like these price isn’t the problem. In both cases the lack of a pharmaceutical company to sponsor the treatment is what presents a significant barrier to it being made routinely available.

The problem is that patents on these drugs have expired and without a patent in place to protect the investment of a pharmaceutical company, there is no financial incentive for them to sponsor the treatment through the process they would normally use to license it and ensure its adoption on the NHS.

‘There are many disincentives to the treatment being prescribed to patients’

Without a licence to act as a “kitemark”’ of safety for a treatment, and a NICE technology appraisal to give the NHS a mandate to provide it, there are many disincentives to the treatment being prescribed to patients, which result in it not being routinely available.

We first looked into this issue, as research charity Breast Cancer Campaign, when approached by chemoprevention experts who told us that there hadn’t been a sufficient change in clinical practice in light of the research.

Anecdotal evidence collected by Breakthrough Breast Cancer (our other legacy charity) was also starting to show that tamoxifen wasn’t being routinely offered to eligible people. In some instances GPs were refusing to prescribe it in this way, despite it being recommended in NICE guidelines.

Unfortunately, national data to confirm this is not collected because prescriptions in the UK do not record the indication for which the drug is being prescribed. The Department of Health ran a data query on how many times drugs that can be used for breast cancer chemoprevention had been prescribed over previous years and they found that the rate of prescriptions had stayed more or less the same since the NICE guideline was updated.

Market forces

Obviously, there are limited conclusions we can draw from this, and tamoxifen does have some unpleasant side effects that an otherwise healthy woman may decide to avoid which may explain lack of uptake - but that choice should be theirs. This is about enabling confidence in prescribers and, in turn, giving options to patients.

What’s more, we’re talking about pence, not pounds. Off-patent drugs are available at a low cost because market forces drive down the price. If zoledronic acid (a type of bisphosphonate) was implemented routinely in its new indication, it would actually save millions for the NHS each year as a preventive treatment.

We had to find a way to address the market failure at the heart of this issue and the Off-patent Drugs Bill was designed to do just that.

‘Neglecting the potential power of off-patent drugs is a huge oversight’

First presented to Parliament last year, the bill aims to put into UK law a duty on the government to step in and seek a licence for any drug proven to be clinically effective (in a published phase III clinical trial) for a new purpose after its original patent has expired, where no pharmaceutical company has commercial incentive to do so.

It could, over time, revolutionise access to treatments across a whole range of medical conditions, providing a unique opportunity to take advantage of inexpensive drugs that have benefits beyond their intended uses.

The government holds the key to this. The cancer drugs fund, which was introduced to make expensive treatments available in England when the NHS can’t afford them, is running on empty and with more cuts on the horizon, surely this is exactly the type of cost effective - and in the case of bisphosphonates, cost saving - opportunity we can’t afford to miss.

Neglecting the potential power of off-patent drugs is a huge oversight in our view, and the clinical benefits of some of these drugs go far beyond breast cancer.

With a refined version of the bill introduced by newly elected MP Nick Thomas-Symonds due for second reading on 6 November, we need as much support as possible from fellow parliamentarians on the day to make sure it gets sufficient backing to become law.

Baroness Delyth Morgan is chief executive of Breast Cancer Now