Health bodies make ‘urgent’ call to Matt Hancock to intervene in the proposed withdrawal of bipolar drug

The Royal Pharmaceutical Society and nine other bodies wrote to health secretary Matt Hancock, urging him to ensure that Priadel remains available in the UK.

priadel

The health secretary, Matt Hancock, has been urged to “personally intervene” so that bipolar drug Priadel remains available in the UK with an appropriate pricing structure.

The Royal Pharmaceutical Society (RPS), and nine other health bodies, wrote to Hancock following an announcement in August 2020 from the Medicines and Healthcare products Regulatory Agency that Essential Pharma would discontinue production of Priadel 200mg and 400mg — used as a first-line treatment for bipolar disorder — in April 2021 “due to restrictions on permitted pricing”, making the product “no longer viable”.

In a subsequent supply disruption alert, the Department of Health and Social Care advised prescribers to switch patients to one of three alternatives: Camcolit 400mg, Liskonum 450mg or Essential Pharma’s generic lithium carbonate 250mg — all of which cost more than the Priadel products.

Priadel currently costs £4.02 for a pack of 400mg tablets, whereas Camcolit, the other brand of lithium owned by Essential Pharma, costs almost 12 times as much at £48.18 per pack of 400mg tablets. Essential Pharma’s generic lithium carbonate 250mg costs £87 per pack of 100. 

The other suggested alternative to Priadel — Liskonum — is manufactured by Teopharma and costs £11.84 per pack of 100.

The letter, also signed by the Royal College of Psychiatrists, the Royal College of GPs and mental health charity Mind, said that the proposed withdrawal of Priadel would increase cost to the NHS, and add pressure on “already stretched” primary and secondary care services.

“Lithium is an essential medication recommended by NICE [National Institute for Health and Care Excellence]; it is proven to treat bipolar disorder and to prevent suicide. If it is stopped suddenly there is a significant risk of rebound relapse. If levels become toxic, it can cause permanent kidney damage and can be fatal,” the letter stated.

Ciara Ni Dhubhlaing, president of the College of Mental Health Pharmacy, another signatory of the letter, said: “We are deeply concerned about the withdrawal of this essential treatment for this vulnerable patient group. This will cost the NHS millions more each year at a time when finances and services are already stretched due to COVID-19.”

Ian Maidment, reader in clinical pharmacy at Aston University and spokesperson for the RPS, said: ”We want the secretary of state to personally intervene to maintain supplies of Priadel so patients with bipolar disorder can still get this vital medicine.”

As well as asking the health secretary to ensure that Priadel remains available in the UK with appropriate pricing structure, the organisations have requested that the issue be referred to the Office of Fair Trading.

“Finally, if both these approaches prove unsuccessful, we are seeking special dispensation to import Priadel from overseas for use as an unlicensed product,” it added.

In a statement, Essential Pharma said that discontinuing the supply of Priadel was a “difficult decision”.

“We have sought to minimise disruption to patients and to allow time for the transfer to suitable alternative lithium products by providing the Department of Health with an extended notice period of such discontinuance,” it said.

“The Department of Health and the Royal College of Psychiatrists are developing relevant guidelines for healthcare professionals and patients to aid such transition, and we will ensure that sufficient supply of Priadel remains available until 6 April 2021 to match local demand for the product until such date.”

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Citation
The Pharmaceutical Journal, PJ September 2020, Vol 305, No 7941;305(7941):DOI:10.1211/PJ.2020.20208369