Regulatory Focus™ > News Articles > UK Patient's Access to 'Breakthrough' Melanoma Therapies Delayed by NICE

UK Patient's Access to 'Breakthrough' Melanoma Therapies Delayed by NICE

Posted 12 November 2012 | By Ansis Helmanis

UK melanoma patients still cannot get access to BMS' Ipilimumab (Yervoy), approved for Europe-wide marketing on 13 July 2011, or Roche's Vemurafenib (Zelboraf), approved on 20 February 2012. 

The barrier to patient access has been the UK cost containment agency, the National Institute for Health and Clinical Excellence (NICE), which admits both new drugs are "breakthrough treatments" for melanoma patients.  But NICE has refused to clear the drugs for use by the National Health Service (NHS) based on its initial assessment that both drugs are not cost effective treatments. 

Then, on 2 November 2012, NICE reversed its earlier negative recommendations and issued draft guidance that now recommends use of the drugs by the NHS:

  • Ipilimumab is now recommended for use for the same indication that it was granted European marketing approval 16 months ago, treatment of advanced malignant melanoma in people who have received prior chemotherapy, and
  • Vemurafenib is now recommended for the same indication as in its European marketing approval nearly 9 months ago, treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

Some critics contend that the revised draft guidance recommendation fails to take into account the cost of lives lost during the months NICE took to deliberate the drugs' cost effectiveness, and that the agency is more focused on budgets than patients.

In the meantime, patients are still unable to access the drugs even as their approvals now seem more likely. The guidance remains in draft form, allowing further-and time consuming-appeals to be filed against the agency's recommendations.

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