The European debut of a pill to treat children with attention deficit hyperactivity disorder faces a major hurdle: convincing people the condition exists.
Shire Plc (SHP), the world’s biggest seller of ADHD drugs, has been rolling out the pill, Vyvanse, in eight countries while discussing the prevalence of the illness with doctors at psychiatry conferences around Europe. More than 90 percent of the Dublin-based company’s sales of ADHD drugs come from the U.S., where the illness is diagnosed about 25 times more frequently than in the U.K.
While attitudes vary by country, many European parents, teachers and doctors are resistant to using medication to treat what they see as childhood behavior problems. Those views have stymied treatment options and fueled stigmas, doctors say. ADHD, characterized by inattention, over-activity and impulsiveness, afflicts up to 7 percent of children in the U.S. and is linked to drug abuse and an increased likelihood of criminal convictions in adulthood.
“There’s been a great deal of resistance to even believing there is a disease,” said Mary Baker, president of the European Brain Council, a Brussels-based non-profit representing doctors, patients and companies including Shire that work on neurology and psychiatry issues. “Parents are loath to get their child labeled. Children are easy or difficult, that’s the diagnosis in society.”
Increasing the diagnosis would be lucrative for Shire, which had $1.8 billion in ADHD drug revenue last year. Vyvanse contributed $1 billion of that, surging 28 percent, and analysts predict the pill’s sales will reach $1.77 billion in 2016, according to the average estimate compiled by Bloomberg.
Growth in Vyvanse prescriptions has been slowing this year, in part because the drug already won so many patients last year, Deutsche Bank AG analysts said last month. Shire’s stock has returned 33 percent this year including reinvested dividends, outpacing the 21 percent return for the Bloomberg Europe Pharmaceutical Index.
The treatment, called Elvanse in Europe, became available this year in the U.K., Ireland, Denmark and Germany, and will reach the market in Spain, Finland, Sweden and Norway in early 2014 as the company reaches agreements with governments on pricing and reimbursement for the medicine.
“The next year to two years is going to be a significant educational effort on our part,” Chief Executive Officer Flemming Ornskov said in an interview in May, referring to Vyvanse in the European market. “The climate in Europe is a bit more negative. It will take us some time.”
Vyvanse, a once-a-day medicine, has an edge over other drugs because it’s long acting, releasing its active ingredient slowly into the bloodstream, according to Shire.
Methylphenidate, the main ingredient in drugs sold by Novartis AG as Ritalin and Johnson & Johnson as Concerta, is the most commonly prescribed ADHD medicine in the region. Shire’s Adderall, Adderall XR and their generic equivalents -- not approved in Europe -- account for about 41 percent of U.S. prescriptions.
Before gaining sales, Shire must first face the uphill battle of getting the disorder acknowledged and then diagnosed. European teachers are more likely than American ones to view a child’s behavior problems as a result of bad parenting, while taking drugs for mental problems often carries a social stigma, said Eric Taylor, professor of child and adolescent psychiatry at King’s College London’s Institute of Psychiatry.
Critics say U.S. doctors overdiagnose ADHD and too readily treat even mild cases with medication. Sami Timimi, a child psychiatrist who wrote “Rethinking ADHD: From Brain to Culture,” said he worries Europe is heading down the same path. His book warns of a growing trend of medicalization, or tendency to regard child behavior as a medical condition.
“The first-line treatment for all people should be psycho-social approaches,” Timimi said in an interview. “We don’t have any evidence that short-term benefits of medication can be sustained. So far, I haven’t seen any evidence that medication makes any lasting difference.”
There are signs that attitudes are shifting in Shire’s favor. In July, the U.K.’s health-cost regulator set standards for the diagnosis and treatment of ADHD, clarifying which symptoms need to be present to receive an ADHD diagnosis, and how severe those symptoms need to be before pills can be prescribed. The U.K. acts as a bellwether for the rest of Europe, so as treatment services develop and access improves the market for medicines will grow.
The path for Vyvanse may be eased in 2015 when the World Health Organization’s International Classification of Diseases is revised, according to Keyur Parekh, an analyst at Goldman, Sachs & Co. in London. The classification is used as a treatment guideline in Europe, much as the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders is used for psychiatry in the U.S.
The revision probably will align the stricter international guidelines with those in the DSM, which should help Shire’s ADHD business, Parekh said in a report to clients in May.
The U.S. still dwarfs Europe in sales of ADHD drugs, but the rest of the world has been catching up. While the U.S. consumes about 66 percent of the global supply of stimulant medication, in 2007 it consumed 83 percent, according to a study published this year by researchers at King’s College London. Scandinavian countries now outpace the U.S. in growth of prescriptions, according to data tracker IMS Health Inc.
That adds to already soaring sales from treating American kids. Almost 10 percent of U.S. school-age children have been diagnosed with ADHD, according to a survey of parents by the Centers for Disease Control and Prevention. By contrast, Taylor estimates that only about 4 of every 1,000 U.K. children have received a diagnosis.
The rest of Europe’s attitudes to ADHD are uneven, ranging from barely recognized, as in Italy, according to Taylor, to Germany, where IMS data show the use of stimulant medicines is among the highest in Europe. European sales of Concerta, the most commonly prescribed ADHD medication in the region, grew 7 percent in 2012, according to IMS.
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