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United Kingdom - CMA to Investigate Withdrawal of Bipolar Medication under Competition Rules

  • 07/10/2020
  • Articles

On 6 October 2020, the Competition and Markets Authority (CMA) started an inquiry into Essential Pharma to determine whether that company abused an allegedly dominant position when announcing the withdrawal from the UK market of Priadel®, a lithium based medicine indicated for the first line treatment of bipolar disorder and for the treatment and prophylaxis of recurrent depression and aggressive or self-harming behaviour (see, attached press release).  Priadel® is also prescribed for the off label treatment of cluster headaches.
The vast majority of UK patients who take a lithium based medicine rely on Priadel®. Only a small minority of the relevant patient group use other medicines such as Camcolit®, also supplied by Essential Pharma, and Liskonum®, whose marketing authorisation is held by Teofarma.
According to the CMA, the withdrawal of Priadel® raises two major issues. First, switching bipolar medication is a delicate health matter because patients should as a rule be kept on the same brand of lithium to ensure that a consistent serum lithium level is maintained. For its part, the Medicine and Healthcare Products Regulatory Agency advised in a supply disruption alert that the switching of products will require individualised determination of dose, close monitoring of serum lithium levels and vigilance for relapse and tolerability in all cases. Second, the remaining treatments on the market are more expensive.
The CMA expressed its appreciation for Essential Pharma’s decision to continue supplies of Priadel® pending pricing discussions with the UK Department of Health and Social Care.


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