Althea secures approval of cannabis-based oil through Ireland’s MCAP

Althea’s cannabis-based oil has been given the green light from Ireland’s regulators to be prescribed free of charge through the Medical Cannabis Access Programme (MCAP). 

The global manufacturer of cannabis-based medicines has successfully secured approval from The Republic of Ireland’s Primary Care Reimbursement Service for its product to be prescribed to patients on the MCAP. 

Althea CBD12:THC10 will now be available free of charge for patients under the reimbursement scheme, having been approved for prescription in spasticity related to multiple sclerosis (MS) and chemotherapy-induced nausea and vomiting (CINV).

To date fewer than 10 products that have been approved by regulators for prescription under the MCAP.

The programme was introduced in 2019 under the former Minister for Health Simon Harris, to enable patients to more easily access medicinal cannabis, but it was not fully operational until 2021 when it enrolled its first patient. 

Currently only patients living with one of the three qualifying conditions, CINV, treatment-resistant epilepsy, and spasticity associated with MS, are able to access cannabis medicines through the scheme. It has received criticism from some for its ‘restrictive’ nature, with fewer than 100 people thought to be enrolled on the scheme so far and only limited products available.

Althea’s medical affairs team worked closely with the Irish regulator over the last 12 months to secure the approval, with the aim of increasing the options available for patients and their clinicians.

The evidence for cannabis-based medicines in MS and CINV

MS is a complex, chronic inflammatory disease of the central nervous system, affecting up to 9,000 people in Ireland and causing debilitating symptoms. A common motor symptom experienced by patients with MS is spasticity, which manifests as chronic muscle rigidity, spasms and cramps which can lead to pain and mobility restrictions, severely impacting quality of life.

Meanwhile, CINV remains one of the most distressing symptoms associated with cancer therapy and is one of the most common side effects experienced by those undergoing chemotherapy, estimated to affect between 45-61% of patients. It is associated with a decreased adherence to chemotherapy, meaning that finding an effective treatment is essential to allow patients to continue receiving life saving drugs.

Althea’s submission was based on a systematic review of existing published data looking at the effect of whole plant cannabis extracts in both MS and intractable nausea and vomiting, with a literature review on the safety of cannabinoids provided as supporting evidence.

Systematic reviews of studies examining the efficacy of whole plant cannabis extracts in the treatment of multiple sclerosis highlight a trend of reduced spasticity in treated patients. In a review of randomised controlled trials, five out of six studies concluded that cannabis extracts decrease spasticity and improve motility in patients with multiple sclerosis. 

In intractable nausea and vomiting a review of 23 randomised clinical trials found that people had a greater chance of reporting a complete absence of vomiting and complete absence of nausea and vomiting when they received cannabinoids compared with placebo. 

Giving patients another option 

Enabling patients to access the treatment at no cost was a key motivator behind Althea’s entry into the Irish market, CEO, Joshua Fegan, told Cannabis Health, as well as a desire to improve the acceptance of cannabis-based medicines among regulators. 

“Any receipt of reimbursement for a medicine in the pharmaceutical industry is a big development, even more so when the medicine happens to be cannabis-based,” he commented.

“While we operate in a number of markets globally, typically medical cannabis is only available as a private self funded option for patients who are seeking treatment following the failure of standard reimbursed treatments. The Irish market provided an opportunity to successfully work with the regulators to make this medicine available to patients with no cost.”

Fegan added: “Importantly we recognise that to help normalise the acceptance of the use of medical cannabis this should be done in conjunction with regulators and this highlights the commitment Althea has to achieve this.”

“We hope that the reimbursement of Althea 12:10 provides another option to patients with MS and intractable nauseas and vomiting associated with chemotherapy after standard therapies have failed.”

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