RITALINE LP (methylphenidate) (TDAH)

 Key points

Favourable opinion for reimbursement in the treatment of attention-deficit hyperactivity disorder (ADHD) in adults for whom a moderate to severe functional impairment in at least two settings (academic, and/or occupational, social including familial), is demonstrated and when the pre-existence of childhood ADHD has been clearly established, taking into consideration that pharmacological treatment is part of a comprehensive treatment programme.

What therapeutic improvement?

No clinical added value in the therapeutic strategy for ADHD in adults.

Role in the care pathway?

A European expert consensus on the diagnosis and treatment of adults with ADHD has recently been updated (2019). Management must be multimodal and multidisciplinary and initially be based on non-medicinal remedial measures, including educational, familial, rehabilitative and psychotherapeutic approaches (psychoeducation, cognitive behavioural therapy (CBT), etc.). These measures may be combined with methylphenidate-based pharmacological treatment as a second-line approach when non-medicinal measures are insufficient. The presence of comorbidities must be considered in the overall management of ADHD in adults.

Role of RITALIN LP (methylphenidate) in the care pathway:

Pharmacological treatment with RITALIN LP (methylphenidate) may be initiated as second-line therapy in the treatment of ADHD in adults or continued in the event of initiation during childhood or adolescence in strict accordance with the MA criteria and when remedial psychological, educational, social and familial measures alone prove insufficient.

Pharmacological treatment is therefore integrated into the overall management strategy, coordinated between the various players involved in the treatment of ADHD, with continuation of psychological, educational and social measures concomitantly with the pharmacological treatment.

The principle of time-limited prescription must be systematically adopted when initiating treatment.

Treatment must be initiated in accordance with the MA:

• following complete pre-treatment screening, in view of the safety profile of methylphenidate, with thorough assessment of the patient's cardiovascular status, including measurement of blood pressure and heart rate. In adults, the opinion of a cardiologist is necessary prior to treatment initiation to verify, in particular, the absence of any cardiovascular contraindications. Heart rate and blood pressure should be monitored at each prescription renewal, i.e. every month,
• under the supervision of an ADHD specialist in adults,
• at the lowest possible dose, then gradually increased in weekly increments.

Regular ongoing monitoring of patients on methylphenidate is required in order to reassess the efficacy of treatment, identify any adverse effects - particularly cardiovascular and cerebrovascular - and ensure compliance with treatment and the absence of any misuse or abuse,

Beyond 12 months of treatment, the efficacy and safety data is limited, meaning that systematic reassessment of the continuation of treatment beyond this period is necessary, with methylphenidate-free periods in order to assess the patient’s functioning.

It is reiterated that information documents aimed at patients and/or their families and a website for use by healthcare professionals to support the initiation and prescription of methylphenidate and patient monitoring (http://methylphenidate-guide.eu/fr/welcome.php) are available.