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May 9, 2013 9:51 pm

Europe regulators not yet on board with adult ADHD due to concerns regarding diagnosis methods

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This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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Some European regions are cautious to approve any medications for attention deficit hyperactivity disorder (ADHD), while others are prudent about approving them for people diagnosed in adulthood, experts told BioPharm Insight. Seeds of doubt include a lack of recognition of the indication, concerns over accurate diagnosis in adulthood and potential for overdiagnosis, they noted.

Scientific evidence notes ADHD symptoms persist into adulthood and there is a high burden of cost associated with undertreatment, experts added. Studies suggest ADHD is a diagnosable and treatable lifelong illness for many patients, they said.

ADHD manifests in childhood and doesn’t simply stop, said Shaw Sorooshian, director, Global Medical Affairs, Shire. Yet, there are few approved treatments for those diagnosed as adults even though the National Institute for Health and Care Excellence (NICE) and the British Association of Psychopharmacology guidelines state adults deserve access to treatment, he added. NICE is a UK governance body that provides national guidance and advice to improve health and social care.

Untreated adult ADHD is associated with high sickness leave, drug abuse, accidents, criminality and failed educations, said Dr Sandra Kooij, head, PsyQ Expertise Centre Adult ADHD, The Hague, Netherlands.

Several medications are approved in Europe for ADHD children and adolescents as well as those continuing treatment into adulthood. These include stimulants such as methylphenidate formulations like Johnson and Johnson’s (NYSE:JNJ) Concerta and Novartis’ (VTX:NOVN) Ritalin as well as amphetamines such as Shire’s (LON:SHP) Adderall and Elvanse and Eli Lilly’s (NYSE:LLY) nonstimulant Strattera (atomoxetine).

The past shows regulatory resistance

Companies have previously tried to gain approval for newly diagnosed adults but have not been successful, said Dr Philip Asherson, professor in Molecular Psychiatry, Institute of Psychiatry, King’s College, London, UK. “It seems surprising” to not allow drugs in people diagnosed in adulthood, especially as they are used widely in children and adults who were diagnosed as children or adolescents, he added.

Shire is interested in the adult ADHD market in Europe but needs to identify what regulators require for approval, said Paul Beresford, LDX international launch lead, Behavioural Health Business Unit. Views on ADHD differ from one European country to another, he noted.

The first drug approved for adult ADHD was Strattera in the UK, however, it was later withdrawn for this indication because one country in the Mutual Recognition Procedure, concluded the risk-benefit profile was not appropriate, said Dr David Nutt, professor, Neuropsychopharmacology, Imperial College London, UK. The Mutual Recognition Procedure is one of the routes that can be used to gain approval for medicinal products in individual EU member states.

Various regulators also reviewed Concerta for adult ADHD, but the application was withdrawn, Asherson said, because of issues over the ability to diagnose patients accurately and concerns of overdiagnosis of ADHD in adults. There were also issues raised about the risk-benefit profile and cost implications, he added.

When a NICE review was done to examine cost-effectiveness of ADHD treatment in the absence of approved drugs specifically for adult ADHD, it found more than 100 positive studies and concluded a “resounding yes” that treatment is better than none, he added.

Accurate diagnosis in adulthood root of regulatory doubts

A valid diagnosis of adult ADHD needs careful consideration of childhood symptoms, said Dr Maite Ferrin, consultant psychiatrist, Hospital Garcia Orcoyen, Estella, Spain. This process is fairly straightforward through a clinical interview with a specialist, she added.

A spokesperson from the Netherlands Medicines Regulator (CBG) said while adult ADHD is acknowledged, there are still concerns of proper ascertainment in trials and translation in clinical practice. A criterion for ADHD diagnosis is onset in childhood, she added. This is difficult to ascertain in adults, she noted, especially since ADHD was not commonly recognized when the current generation of adults were children. Therefore, corroboration of childhood onset from objective sources or third parties is tough, she added.

The concern is that patients with disorders other than ADHD might present with symptoms that partly overlap with ADHD and might be treated with a medication that could cause more harm than benefit, she explained.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recognises adult ADHD as a condition but confirmation of childhood onset is essential for the diagnosis to be made, agreed an MHRA spokesperson.

The reason no product has so far been approved for adult ADHD is because submitted data were insufficient to establish a positive risk-benefit balance, not because of a lack of recognition of the indication, he added.

A US-based study showed up to 75% of patients with ADHD are not diagnosed until adulthood (Kessler, R.C. 2006. American Journal of Psychiatry 163(4):716-23), said Dr David Goodman, director, Adult Attention Deficit Disorder Center of Maryland. Treatments are available for adult ADHD in the US; however, what may be fuelling regional differences in Europe is longstanding opinion, he added.

Regional resistance still exists, yet attitudes slowly shifting

In France, where psychiatry is more focused toward psychological rather than pharmacological psychiatric intervention, there is still some resistance to accepting ADHD as a disorder, Kooij said. French healthcare authorities are reviewing prevalence, diagnosis and treatment of ADHD; however, they have stated adult ADHD will not be included in the review, a French ADHD expert said. Currently, there is no diagnosis for adult ADHD in France, he added.

Italy has also not embraced medical psychiatry well, with limited use of ADHD medications, Kooij noted. There is more acceptance of the disorder in Northern European countries such as Germany, Norway, Sweden, Denmark, the UK and the Netherlands, she noted. Recently, there has been a shift toward ADHD acceptance in Spain, where regulators now recognise ADHD, she added.

In Germany, the private company Medice recently received approval for its methylphenidate drug, Medikinet, in adult ADHD. Germany is the only region to successfully approve a drug for adult ADHD, Asherson noted. However, he added, it is only a matter of time before further approvals are granted. He declined to comment on specifics. Companies with ADHD franchises are considering pursuing this indication and closely watching the space, he said.

A six-month study, presented last month, investigating Ritalin for adult ADHD showed efficacy on symptom control and reduced functional impairment. When asked if this study would form the basis of an approval application, a Novartis spokesperson said, it is too early to comment on the company’s strategy.

In Sweden, regulators are looking closely at adult data for these drugs and plans to have a thorough analysis of the research using registries to assess prescriptions and side effects, said Dr Mats Johnson, chief physician, Child Neuropsychiatry Unit, Queen Silvia’s Hospital for Children, Gothenburg, Sweden.

The Medical Products Agency in Sweden did not respond to request for comment.

Psychiatrists are definitely aware of adult ADHD, and a regulatory shift is anticipated, Johnson said.

A recent publication suggests a link between lower criminality rates and patient adherence to pharmacologic ADHD treatment (Lichtenstein, P. 2012 New England Journal of Medicine. 22;367(21):2006-14), noted Dr Ylva Ginsberg, department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

Although the findings need replication, all experts interviewed suggested this study could be a game changer in highlighting the true cost of untreated adult ADHD.

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