The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.
The document is developed around questions that are specific for intervention and health condition, and defines criteria for the selection of the device and characteristics of the centres allowed to perform the implantation procedure. For each question, recommendations are given according to level of evidence (I–VI) and strength (A–E).
The main recommendations are listed below:
- Deep brain stimulation (DBS) for advanced Parkinson’s disease: It needs to be considered for adults diagnosed with Parkinson’s disease since 5 years, unresponsive to medical therapy, not presenting comorbidities or clinically relevant cognitive or psychiatric alterations, responsive to levodopa and presenting disabling motor symptoms (I - B).
- Occipital nerve stimulation (ONS) for drug-resistant chronic migraine: It is not recommended (VI - D). Already at the end of 2014, the manufacturer (St. Jude Medical) producing the only ONS devices with indication for use in this condition, informed that the indications have been amended due to lack of reliable data showing effectiveness.
- Vagal nerve stimulation (VNS) for drug-resistant epilepsy: It is indicated for patients (older than 12) presenting epileptic focal seizures with or without generalisation, unresponsive to medical therapy (at least two antiepileptic drugs), and not suitable for surgical treatments or in which the surgical treatments have failed (I - B).
- Deep brain stimulation (DBS) for drug-resistant epilepsy: There is uncertainty around recommendations in favour or against this treatment for focal onset epilepsy in carefully selected adult patients, unresponsive to medical therapy (at least two antiepileptic drugs), not suitable for surgical treatments or in which the surgical treatments have failed, and not presenting severe cognitive impairment (II - C).
Criteria for the selection of the devices
- Parkinson’s disease (IV - B):
- Non rechargeable devices should be used when life expectation of the patient is less than 10 years, device replacement expected after 5 years, the patient is unable to manage the device;
- Rechargeable devices should be used when life expectation of the patient exceed 10 years, device replacement expected within 5 years, the patient is able to manage the device;
- Drug-resistant epilepsy: Only one device for VNS is on the Italian market (Therapy Pulse, Livanova); Only one device for DBS is on the Italian market (Activa PC 37601, Medtronic).
Main characteristics of the centres allowed to perform the implantation procedure
Previous experiences in performing the procedure; multi-disciplinary team able to assess patient’s eligibility; availability of properly equipped operating room and beds within the intensive care unit to manage complications; ability to follow the patient in all the phases of the therapy.
Access full document in Italian here.