PUBLISHED ON: 5 September 2016

A multitude of barriers continue to prevent breast cancer patients from accessing new clinically-effective medicines. The scale of the problem is considerable – the last ten appraisals by the National Institute for Health and Care Excellence (NICE) of breast cancer drugs led to ten rejections.

This resulted in no new drugs being recommended for routine use since 2009, despite some of these medicines being very effective. Whilst some of these drugs are still available on the Cancer Drugs Fund, this will change as all the drugs are due to be re-appraised by NICE in the coming year. The report explores some of the possible reasons why so many breast cancer drugs have been rejected by NICE.

The overarching message coming out of the discussions at the Summit is that the NICE system is in need of an open review. This will ensure that the methodology and systems used are fit for purpose when it comes to assessing newer types of more targeted cancer medicines. An open review would also ensure that the drug appraisal system would have the confidence of all stakeholders affected by it and that any particular problems are identified and addressed.

The Breast Cancer Now Access to Medicines Summit Report identifies four ways in which the drug appraisal process would benefit from increased flexibility:

1. Branded and generic comparators

  • NICE currently calculates cost-effectiveness by working out the additional benefit of a potential new treatment compared to an existing treatment for that condition – and then uses the price difference between the two to see whether the benefit justifies the cost.
  • However, the price difference between new branded medicines and their generic comparators is often stark (often thousands of pounds per treatment), and no new medicines could therefore hope to compete on price against existing treatments where their comparators are generic medicines.
  • With many new breast cancer treatments having generic comparators, we run the risk of not being able to benefit from further new innovation and research progress.
  • Patients in England are also missing out on medicines, which are fast becoming available in other similar countries, according to research we published jointly with Prostate Cancer UK.

2. Innovative neo-adjuvant (pre-surgery) treatments

  • We’re currently seeing a move towards more innovative uses of existing medicines, with drugs traditionally given towards the end-of-life now showing great promise much earlier in the patient pathway as first-line treatments.
  • However this is currently posing a problem for NICE in terms of the data that can be collected to assess a drug’s effectiveness, as it would take many years to collect overall survival data from a neo-adjuvant (before surgery) treatment being administered so early in the patient pathway. Overall survival data is the gold standard used by NICE to calculate the clinical value of a new cancer medicine.
  • Progression-free-survival (the time it takes before a patient’s cancer progresses) is often an earlier indication of the effectiveness of a new drug, however this is not necessarily equivalent to overall survival benefit and NICE currently has no agreed standard way of translating progression-free survival into predicted overall survival, meaning that a treatment with only PFS receives a very small value for clinical effectiveness. Sometimes, when a treatment is shown to increase the time it takes for disease to progress, the cost-effectiveness can become worse.
  • If NICE continues to require overall survival data, this will take decades to collect and patients may miss out on these new uses of existing treatments for many years – clarity is therefore required around what other data they might accept in assessing more innovative drugs.

3. The value of quality of life

  • Similarly, participants raised the issue of the value of overall survival compared to quality of life for patients in the drug appraisal process.
  • A recent US study found that a majority of patients valued quality of life more than extra length of life, while European patients valued overall survival more. While many patients have told Breast Cancer Now that they value quality of life as much as extra life, it is crucial that more robust research is carried out into the attitudes of UK metastatic patients to find out whether the weightings currently being applied by NICE actually reflect the views of those people who are most affected by these decisions.

4. ‘End of life’ criteria

  • The ‘end of life criteria’ applies to all medicines used in the last two years of a patient’s life and a higher (more generous) cost-effectiveness threshold is allowed for these medicines.
  • Some types of metastatic breast cancer, for example, have a life expectancy of just over two years which falls just outside of this criteria. This is an arbitrarily-set cut-off point, and the end of life criteria in Scotland, for example, goes up to three years, meaning patients in England are likely to miss out on some new treatments being made available north of the border.

We desperately need to find a way for new research into effective treatments to be transferred to the clinic as quickly as possible and made available to breast cancer patients. We recently published a blog to explain all the changes to the Cancer Drugs Fund and what the changes mean for patients, which you can read here.

More information

Download the full report here.

If you would like to help us campaign on this important issue, find out more information here.