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Methylphenidate Hydrochloride Application for Inclusion to the 22nd Expert Committee on the Selection and Use of Essential Medicines: METHYLPHENIDATE HYDROCHLORIDE December 7, 2018 Submitted by: Patricia Moscibrodzki, M.P.H., and Craig L. Katz, M.D. The Icahn School of Medicine at Mount Sinai Graduate Program in Public Health New York NY, United States Contact: [email protected] TABLE OF CONTENTS Page 3 Summary Statement Page 4 Focal Point Person in WHO Page 5 Name of Organizations Consulted Page 6 International Nonproprietary Name Page 7 Formulations Proposed for Inclusion Page 8 International Availability Page 10 Listing Requested Page 11 Public Health Relevance Page 13 Treatment Details Page 19 Comparative Effectiveness Page 29 Comparative Safety Page 41 Comparative Cost and Cost-Effectiveness Page 45 Regulatory Status Page 48 Pharmacoepial Standards Page 49 Text for the WHO Model Formulary Page 52 References Page 61 Appendix – Letters of Support 2 1. Summary Statement of the Proposal for Inclusion of Methylphenidate Methylphenidate (MPH), a central nervous system (CNS) stimulant, of the phenethylamine class, is proposed for inclusion in the WHO Model List of Essential Medications (EML) & the Model List of Essential Medications for Children (EMLc) for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) under ICD-11, 6C9Z mental, behavioral or neurodevelopmental disorder, disruptive behavior or dissocial disorders. To date, the list of essential medications does not include stimulants, which play a critical role in the treatment of psychotic disorders. Methylphenidate is proposed for inclusion on the complimentary list for both children and adults. This application provides a systematic review of the use, efficacy, safety, availability, and cost-effectiveness of methylphenidate compared with other stimulant (first-line) and non-stimulant (second-line) medications. Considerable evidence has accumulated over several decades that most patients with ADHD symptoms can be successfully treated by psychopharmacotherapies. Extensive research aligns with the general consensus across pharmacopeial standards around the world - MPH consistently proves to have the best comprehensive ranking in efficacy and tolerability. Methylphenidate has fewer reported side effects and studies show less occurrence of all- cause withdrawal. Although it is associated with weight loss and sleeping problems, the overall side effect profile of methylphenidate is encouraging when compared to other ADHD medications. Methylphenidate represents a class of medication, central nervous stimulants, that should be included in the essential medications list. Within its class, the choice of methylphenidate offers a uniquely good balance of efficacy, safety, minimal monitoring and cost-effectiveness. Methylphenidate is an important treatment option that can reduce the global disease burden of attention- deficit/hyperactivity disorder. 3 2. Focal Point Person(s) in the World Health Organization Dr. Tarun Dua, MD, MPH Evidence, Research and Action on Mental and Brain Disorders (MER) Department of Mental Health And Substance Abuse World Health Organization Dr. Lorenzo Moja, Technical Officer Policies, Access and Use (PAU) Team Essential Medicines and Health Products (EMP) World Health Organization Dr. N Magrini, Medical Officer Policies, Access and Use (PAU) Team Selection and Rational Use, Group Lead Essential Medicines and Health Products (EMP) World Health Organization 4 3. Name of the Organization(s) Consulted and Supporting the Application • Eleanor Bennett, PNP, Ministry of Health, Belize • Sandip Shah, M.D. GMERS Medical College, Vadadora (Gujarat), India • Doris Keens-Douglas, Ministry of Health, Grenada • Dr. Evlyn Spencer, Ministry of Health, Grenada • Dr. Omar Hernandez Rivero, Ministry of Health, Grenada SEE APPENDIX FOR LETTERS OF SUPPORT 5 4. International Nonproprietary Name (INN, generic name) of the medicine Methylphenidate Hydrochloride ATC Code: N06BA04 6 5. Formulations of Methylphenidate Proposed for Inclusion Methylphenidate (hydrochloride) • Immediate release tablets, 10mg, 20mg 7 6. International Availability Brand Name Country Adaphen South Africa Addwize India Artige Australia Attenta Australia Cognil Paraguay Concentra Bangladesh Equasym Belgium, Switzerland, Spain, Ireland Inspiral India Belgium, Switzerland, Germany, Denmark, Estonia, Great Britain, Medikinet Ireland, Norway, Poland, Sweden Methylin Argentina Nebapul Chile Penid Republic of Korea Phenida Pakistan Prohiper Indonesia Ritaline Luxembourg United Arab Emirates, Austria, Australia, Barbados, Burkina Faso, Bahrain, Benin, Switzerland, Cote D'Ivoire, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ethiopia, Great Britain, Ghana, Gambia, Guinea, Hong Kong, Indonesia, Ireland, Israel, Iraq, Iran, Iceland, Jordan, Japan, Kenya, Kuwait, Lebanon, Sri Lanka, Liberia, Ritalin Libya, Morocco, Mali, Mauritania, Malt, Mauritius, Malawi, Mexico, Malaysia, Niger, Nigeria, Norway, New Zealand, Oman, Peru, Pakistan, Qatar, Saudi Arabia, Seychelles, Sudan, Sweden, Singapore, Slovenia, Sierra Leone, Senegal, Syria, Tunisia, Taiwan, Tanzania, Uganda, Venezuela, Yemen, Zambia, Zimbabwe Ritalina Argentina, Brazil, Paraguay, Uruguay Ritaline Belgium, France, Greece 8 Argentina, Spain, Sri Lanka, Malaysia, New Zealand, Portugal, Rubifen Singapore, Thailand, Uruguay Costa Rica, Dominican Republic, Guatemala, Honduras, Mexico, Tradea Nicaragua, Panama, El Salvador Sources The above information was obtained from the following drug name databases: Lexi-Comp ONLINE (1) Up To Date (2) 9 7. Listing request Listing for methylphenidate is requested as an individual medication for both children and adults. Methylphenidate (hydrochloride), immediate release tablets, 10mg and 20mg. 10 8. Information Supporting the Public Health Relevance of Methylphenidate Central nervous system stimulants have been shown to be efficacious in treating a range of mental illnesses, including attention-deficit hyperactivity disorder (ADHD) (3), narcolepsy (4), treatment resistant depression (5) and some formulations have been used for treating obesity (6). Methylphenidate (MPH), a central nervous system (CNS) stimulant, of the phenethylamine class, is commonly used for pharmacological treatment of attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) and narcolepsy. The drug, first synthesized in 1944 and launched as Ritalin, was first used for the treatment of lethargy, narcolepsy, chronic fatigue, disorders associated with depression and what was then known as hyperactivity (7). However, its most impressive beneficial effect has been the decrease in symptoms noticed in ADHD, which is one of the most common behavioral disorders in childhood and may persist into adulthood, found in approximately 3% to 5% of the general population of school-aged children, occurring more frequently in boys (8). In 1990, when diagnosis of ADHD became more broadly accepted, MPH became the drug of choice for treatment and its prescription exceedingly increased (9). In general, it is effective, safe and widely prescribed. The mental disorders that methylphenidate is approved to treat have a high global disease burden. In 2010, mental neurological and substance use disorders accounted for 10.4% of global disability-adjusted life years (DALYs) and 28.5% of years of life lost due to disability, illness, or premature death (YLDs), making them the leading cause of YLDs (10). The Global Burden of Disease Study 2010 (GBD 2010) is the first to include conduct disorder (CD) and attention-deficit/hyperactivity disorder (ADHD) for burden quantification (11). Globally, CD was responsible for 5.75 million YLDs/DALYs with ADHD responsible for a further 491,500 (12). Collectively, CD and ADHD accounted for 0.80% of total global YLDs and 0.25% of total global DALYs (12). MPH is highly effective in improving the core symptoms of ADHD (13). Despite the high prevalence and recent increases in illicit use, prescription stimulants remain highly effective and safe medication for the majority of individuals with ADHD. Expert consensus recommends MPH as the first line medication to be used in a treatment algorithm for ADHD in children and adolescents (14). In developing countries, more than 75% of people suffering from mental disorders in the developing world receive no treatment or care (15). In the majority of countries, less than 2% of health funds are spent on mental health (15). Despite the rumored notion that ADHD is the product of Western culture, the worldwide prevalence of this disorder if 5.2% (16). The finding of Polanczyk and colleagues of a uniform prevalence rate worldwide attests that ADHD is probably not caused by the avarice of the American psychiatric profession or by permissive Western culture and that reducing our avarice and permissiveness will not make ADHD disappear (16). Similarly, a multisite trial study reported that using a uniform diagnostic protocol yields ADHD patients who are highly similar across clinics in Africa, Australia, Europe, and North America (17). The target population for methylphenidate includes children and adolescents as well as adults. Attention deficit hyperactivity disorder is a developmental disorder with an age onset prior to 12 years and can also affect adults. Children with ADHD have significantly lower ability to focus and sustain attention and also score higher on impulsivity and hyperactivity. Stimulants, such as methylphenidate, have remained the mainstay of ADHD treatment for decades with
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