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Portuguese hospitals have already spent almost 1 million euros on CBD

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There are 26 contracts signed by various hospital entities to purchase Cannabidiol (CBD), since October 2021, with purchases of the drug Epidyolex to skyrocket in Portugal in 2023. In total, the Portuguese State's expenditure has already reached almost 1 million euros, with each unit of 100 milliliters costs more than 1.100 euros to the public coffers. The latest contract was signed by Centro Hospitalar Universitário de Santo António, in Porto, directly with Jazz Pharmaceuticals, at the end of 2023. In Portugal, there is no legally authorized CBD medicine or product, leaving doctors with no alternative to prescribing this medicine. 

There are more than a thousand euros for each bottle of Epidyolex, the only medicine available for prescription in Portugal with cannabidiol, commonly known as CBD, in this case in its isolated form. This pharmaceutical product is characterized by having a concentration of 100mg of CBD per milliliter, and is indicated for the treatment of epilepsies resistant to conventional therapies, especially in children. Each user prescribed this medication can cost the Portuguese State coffers more than 33 thousand euros, as there are no other prescription options on the regulated market. The majority of patients in Portugal still have to resort to the parallel or illicit market.

When asked about the price of each unit of Epidyolex, Infarmed responded that “since the medicine is not sold in Portugal, the cost of the medicine is not fixed under the terms established in national legislation”.

The Jazz Pharmaceuticals press office also declined to reveal to Cannareporter the public sale price of Epidyolex in Portugal, stating that “unfortunately, we cannot disclose the requested information, which is considered confidential”.

However, Cannareporter knows that, by the end of 2023, Epidyolex has already represented a cost of almost 1 million euros for the Portuguese State, through AUE's.

Evolution of the value of Epidyolex purchases by Portugal. Source: BASE Portal, which centralizes information on public contracts concluded in mainland Portugal and autonomous regions

If in 2021 the expenditure did not exceed 15 thousand euros, there was significant growth in the last two years, with the value of contracts signed and the quantity of CBD acquired by the Portuguese State soaring in 2023. In 2022, the value of acquisitions was 163.903 euros, while, in 2023, the CBD bill soared to 745.907 euros.

Treatment with Epidyolex can exceed 33 thousand euros/year

The company that had the most contracts awarded was Disfaport – Distribuidora de Produtos Farmacêuticos SA., which totaled 22 contracts, worth more than 740.000 euros. The company Dux Pharma carried out 3 contracts with the Hospital do Espírito Santo de Évora, with a total value of approximately 35.000 euros.

At the end of 2023, Portugal published its first direct public contract with Jazz Pharmaceuticals, worth 183 thousand euros, thus marking the company's first deal with a national public entity. In this particular case, Jazz began supplying 8 AUE’s (exceptional use authorizations), in this case, to the Centro Hospitalar Universitário de Santo António, in Porto. The therapy for each user could cost the Portuguese government more than 33 thousand euros per year.

Legal framework for Epidyolex in Portugal
According to clarifications sent by Infarmed to Cannareporter, Epidyolex was approved by the EMA (European Medicines Agency) “as an orphan medicine, through a centralized procedure, on 19/09/2019. By decision of the marketing authorization holder [(AIM), in this case GW Pharma, now owned by Jazz Pharmaceuticals], Epidyolex is not sold in Portugal”.

However, if the attending physician accompanying the patient considers that the use of this medicine is essential, “you can ask INFARMED I.P. a special use authorization (AUE)”, clarified Infarmed, which added that “the AUE for this type of medicine can only be granted to hospitals and clinics, public or private, that have authorization for the direct acquisition of medicines and that the request Infarmed, under the terms set out in Deliberation no. 1546/2015, of June 18, in its current wording”.

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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages ​​using an automatic translator. Some words may differ from the original and typos or errors may appear in other languages.]

 

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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages ​​using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]

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