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Bipolar drug withdrawal paused as competition watchdog investigates

Essential Pharma has paused its withdrawal of bipolar medicine Priadel while the Competition and Markets Authority (CMA) investigates suspected anti-competitive practices.

The CMA has opened an investigation into the manufacturer for “suspected anti-competitive practices in the supply of drugs used to treat bipolar disorder,” it announced yesterday (October 6).

The competition watchdog will investigate whether Essential Pharma “has abused a dominant position in relation to lithium-based medicines for treating bipolar disorder…by proposing to withdraw the supply of Priadel to UK patients”, it said.

Essential Pharma announced earlier this year (August 19) that it would discontinue its Priadel (lithium carbonate) 200mg and 400mg prolonged-release tablets from April 2021, a "difficult decision" it said was down to pricing restrictions making the manufacture of the drug "unviable".

However, it has since informed the DH that it will continue to supply the drug to “facilitate discussions on pricing, removing the immediate threat to patients,” according to the CMA.

Essential Pharma chief executive Ingvild Liborg said in a statement yesterday (October 6) that the company “looks forward” to working with the CMA and DH “towards a positive outcome that…results in the sustainable supply of Priadel to patients in the UK”.

If Priadel was withdrawn as planned, “thousands of patients” on the medication would need to swap to an alternative and more expensive, form of lithium such as  Camcolit – also manufactured  by Essential Pharma – the CMA said.

Despite Essential Pharma’s decision to continue supplying Priadel, the CMA investigation will remain open, as the “threat of withdrawal remains unless a satisfactory agreement is reached on price”, the competition watchdog said.

The CMA explained that while it “has reasonable grounds to suspect that Essential Pharma may have infringed the chapter II prohibition of the Competition Act 1998”, no decision has yet been made as to whether the law has been broken.

Essential Pharma: Priadel is loss-making in UK

Ms Liborg said Essential Pharma sells Priadel “at a loss in the UK and at a price lower than in other European markets”.

“At the heart of Essential Pharma’s business is ensuring the sustainable supply of low volume, established products – but this is not possible when they are loss-making and pricing restrictions do not always provide for viable solutions,” she added.

Essential Pharma said it had “attempted to establish a sustainable price for Priadel” in discussions with the DH, but this was “unsuccessful” – leading to its decision to withdraw the drug from the market.

The company hopes the decision to pause the discontinuation of Priadel will enable it to “re-engage in a productive and constructive dialogue” with the DH, Ms Liborg said

CMA chief executive Andrea Coscelli said the organisation  “welcomes Essential Pharma’s decision to continue supply for the time being, while it tries to reach an agreement with the DH on price”.

"Thousands of people across the UK rely on lithium-based drugs to manage bipolar disorder, so it’s important that we protect their interests by scrutinising potential competition concerns to reach a fair conclusion as quickly as possible,” he added.

Last month (September 22), 12 healthcare bodies wrote to health secretary Matt Hancock asking that he “personally intervene” in the proposed withdrawal of the Priadel brand of lithium carbonate.

The letter, which was signed by senior figures at  healthcare organisations including the Royal Pharmaceutical Society, raised concerns about  increased costs to the NHS if Priadel was  to be withdrawn, and potential harm to patients as key issues.

What do you make of the CMA's investigation?

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