Reason for request
Favourable opinion for maintenance of reimbursement in the MA indications, i.e. :
- as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient.
- in narcolepsy with or without cataplexy in the event of inefficacy of modafinil in adults and children over the age of 6 years.
Role in the care pathway ?
- Indication of ADHD in children aged 6 years of age and over when remedial measures alone prove insufficient
In view of the available data, the Committee considers that the role of methylphenidate in the therapeutic strategy is unchanged.
Pharmacotherapy with methylphenidate is a second-line treatment that can be initiated in children aged 6 years and over with an established diagnosis of ADHD in accordance with the MA criteria, when psychological, educational, social and family remedial measures alone prove insufficient. In this case, pharmacotherapy is part of a comprehensive treatment programme in combination with remedial measures.
As regards the prescribing conditions for methylphenidate, it is reiterated, in particular, that :
- treatment must only be initiated by a specialist in childhood and/or adolescent behavioural disorders in the context of an established ADHD diagnosis and in accordance with the MA criteria,
- comprehensive pre-treatment screening must be carried out in view of the safety profile of methylphenidate,
- treatment with methylphenidate must be started at the lowest possible dose, then gradually increased in weekly increments,
- the principle of time-limited prescription must be systematically adopted when initiating treatment,
- medicinal treatment with methylphenidate must be part of a comprehensive treatment programme, with the continuation of psychological, educational and social measures along with the pharmacotherapy,
- regular ongoing monitoring of patients on methylphenidate is required in order to reassess the efficacy of treatment, identify any adverse effects and ensure compliance and the absence of any misuse,
- efficacy and safety data are limited beyond 12 months of treatment ; consequently, it is necessary to review the continuation of treatment beyond this period.
Finally, the Committee reiterates that methylphenidate currently has no MA in the initiation of treatment in adults with ADHD ; only the continuation of treatment in adolescents whose symptoms persist into adulthood and in whom a clear benefit of treatment has been demonstrated is currently authorised for CONCERTA LP (methylphenidate) and MEDIKINET (methylphenidate) medicinal products, with the need for regular reassessment.
Concerning the integration of patients in the care pathway, in view of 2014 HAS guidelines relative to the procedure to be followed by primary care physicians in the event of a suspected diagnosis of ADHD, in particular, the following are highlighted :
- the essential role of the primary care physician, who, when confronted with a child presenting symptoms suggestive of ADHD, has the role of launching a diagnostic process, with the performance of an initial assessment (elimination of differential diagnosis, investigating for associated comorbidities, etc.) and initiating management (family information/support, treatment of comorbidities, educational support measures, etc.),
- following the initial assessment having led to a suggested diagnosis of ADHD, the importance of referral by the primary care physician to a specialist in the disorder (with expertise in the diagnosis and treatment of ADHD [child psychiatrist, psychiatrist, paediatrician, paediatric neurologist, neurologist]),
- the need for early diagnosis and appropriate treatment of ADHD to prevent any exacerbation of the psychological, educational and social impacts on the child ; this aspect is particularly emphasised in a context in which delayed access to hospital specialists in the disorder due to regional inequalities in terms of access to care have been reported by experts, patient associations and users,
- the importance of coordination between the specialist physician and the primary care physician, once the diagnosis has been made, in order to guarantee regular monitoring of patients in the context of this chronic disorder. In particular, in the event of initiation of medicinal treatment, the follow-up frequency depends on the frequency of treatment prescription renewals, which are every 28 days ;
- the importance of multidisciplinary management with hospital-community coordination between the ADHD specialist, the primary care physician (serving as the link between the various players involved), the pharmacist and other professionals treating comorbidities (psychologist, speech therapist, psychomotor therapist, etc.) and information-sharing in order to optimise patient follow-up.
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://www.methylphenidate-guide.eu) are available.
Proposed modification of prescribing conditions for methylphenidate in ADHD by the Committee
At present, medicinal products containing methylphenidate are included in the list of narcotics for which prescription is limited to 28 days. In addition, in accordance with their MA, they are subject to restricted initial annual hospital prescription reserved for specialists and/or specialised departments in neurology, psychiatry or paediatrics. Annual prescription renewals are also reserved for these same hospital specialists, while other renewals can be issued by any doctor.
Considering the available efficacy and safety data, use data, data relative to the non-conformity of certain prescriptions which could prevent a delay in treatment, the need for early diagnosis/treatment of ADHD and the need to maintain the supervision of prescriptions in the MA indication, the Committee raises the question of whether it might be appropriate the revise the initial prescription conditions defined in the MA of methylphenidate in order to guarantee better access to these treatments for patients requiring them, while at the same time maintaining the safeguards that are necessary in view of the drug’s safety profile (see Committee recommendations).
- Indication in narcolepsy with or without cataplexy in the event of inefficacy of modafinil in adults and children over the age of 6 years
Treatment is subject to restricted initial annual hospital prescription reserved for specialists and/or specialised departments in neurology, psychiatry and paediatrics, and for sleep centres.
In the absence of new data, the role of methylphenidate in the narcolepsy indication is unchanged.
Methylphenidate is a second-line treatment in narcolepsy with or without cataplexy in the event of inefficacy of modafinil in adults and children over the age of 6 years.
In particular, pre-treatment screening of cardiovascular status is recommended in patients with a personal or family history of cardiovascular disease. Similarly, routine monthly monitoring of blood pressure and heart rate must be performed during treatment with methylphenidate.
A recent French consensus in 2017 and expert opinions report that the use of prolonged-release forms in clinical practice is associated with a better safety profile, fewer end-of-dose rebound effects and potentially better compliance.
In the ADHD indication, the Committee raises the question of whether it might be appropriate the revise the prescribing conditions as defined in the MA, and, in particular, to extend initial prescription, in addition to hospital specialists, to :
- non-hospital independent-practice neurology, psychiatry or paediatrics specialists concerned by ADHD, who would be incorporated into multidisciplinary care networks for this condition,
- these same specialists practising in medico-social facilities caring for patients with ADHD and who are able to prescribe drugs.
The Transparency Committee also reiterates the importance of maintaining safeguards and specific prescribing conditions given updated data on misuse in France, as well as the efficacy and safety data.
Hence, the Committee proposes that the other conditions be maintained, in particular prescription limited to 28 days.
The Committee also encourages more uniform restructuring of current health networks focusing on learning difficulties in France in order to promote the coordination of care, which plays a key role in the management of these patients.
The Committee considers that the clinical benefit of RITALIN LP (methylphenidate) and RITALIN 10 mg tablets (methylphenidate) remains substantial as part of a comprehensive treatment programme for ADHD in children aged 6 years of age and over, when psychological, educational and social measures alone prove insufficient.