Cannabidiol arrives at SUS in SP; find out who can request

The state government published this Wednesday (8) the clinical protocol and therapeutic guidelines for prescribing the medicine, made from Cannabis sativae, in addition to the criteria for its indication in the public health network.

The medicine is intended for patients with Dravet syndrome, Lennox-Gasteau syndrome and tuberous sclerosis complex, who face severe epileptic seizures and resistance to conventional therapies.

Those with persistence of four epileptic seizures per month are eligible for this indication, even when using two or more medications appropriately to control them for at least three months.

To recommend treatment, doctors must fill out a request form with the patient’s general data, the quantity of product requested in the first six months and the number of epileptic seizures the patient has per month. They must also sign a liability waiver.

Patients also need to present imaging tests – electroencephalogram in cases of Dravet and Lennox-Gastaut syndrome; and brain tomography or magnetic resonance imaging in cases of tuberous sclerosis;

After the prescription reaches pharmacies, it is sent to analysts at the State Health Department so that the department can evaluate the documents and send the medicine, says doctor José Luiz Gomes do Amaral, technical advisor to the department.

The São Paulo law that provides for the free distribution of cannabis-based medicines was sanctioned in January last year by governor Tarcísio de Freitas (Republicans).

The legislation provides for the continued action of a working group made up of medical experts, researchers and patient associations, with the aim of improving the policy in light of new scientific evidence on the medicinal properties of the plant.

Cannabidiol in SUS

The pharmaceutical company that will supply cannabidiol to the São Paulo public system is Ease Labs Pharma, a company based in Belo Horizonte (MG) that won a state government tender.

Each 30 ml bottle of oil will cost approximately R$135 to the public authorities – in pharmacies, the same medicine costs up to R$1,000.

According to the resolution published this Wednesday, treatment must be carried out with products that contain only cannabidiol or cannabidiol with up to 0.2% THC.

The main adverse effects associated with use are drowsiness, decreased appetite, behavioral changes, skin rashes, fatigue, sleep disturbances, dizziness, diarrhea and restlessness.

The medicine is contraindicated for drug addicts, pregnant and breastfeeding women, children under two years of age and people with hypersensitivity to any component of the formula.