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In the past decade, obesity has been fueling a steady rise in the incidence of chronic ailments among American children and adolescents. Rampant growth of type 2 diabetes among the very young, for example, has helped tilt the scales toward an ever-rising use of specialty medications, which in turn presses the pedal on specialty pharmacy costs.
Based on drug-use statistics collected in 2009, Medco, the pharmacy benefit manager, has concluded that a third of all adolescents are now being treated for chronic conditions. And that kind of trendline calls for “additional health education and lifestyle changes that can address the obesity issue that is likely a driving force behind such conditions as type 2 diabetes and even asthma,” says Medco’s chief medical officer, Robert S. Epstein, MD.
While Medco advocates healthier living, it’s also bracing for a steadily rising demand for more powerful therapies to treat a new generation of American patients.
“There is a general trend in pharmaceuticals,” with a particular focus on the rising number of ailing juveniles who now find themselves in the specialty pharmacy arena, says Steve Russek, vice president of professional practice and chief clinical officer of Accredo Health Group, Medco’s specialty pharmacy subsidiary.
The demand for specialty drugs for younger patients is by no means limited to obesity-related conditions. As drug developers produce more and better biologics and complex small molecule therapies, physicians have been eager to turn to new therapeutic regimens. And that has added urgency to the PBM’s desire to determine when more expensive therapies are needed and when it makes sense to prevent their use. The trend also has sharpened Accredo’s skill at educating young patients on the use of specialty medications, many of which are injected.
Younger patients not only require many of the new cancer therapies coming into the market, says Russek, they’re also driving a spike in the use of biologics as a first-line therapy for juvenile rheumatoid arthritis (JRA) and juvenile psoriasis.
“If you look at guidelines for the nonsteroidal anti-inflammatories and methotrexate, we see more physicians starting with biologics as a first-line therapy,” says Russek. JRA often strikes between the ages of 4 and 10, Russek says, as well as in the mid-teens. “It can sometimes be self-limiting,” he adds, but when left untreated can often damage children’s bones and joints.
“Between 2006 and 2007, we had a 25 percent increase in the use of biologics in that category,” Russek says. “From 2007 to 2008, we saw an 18.5 percent increase. We are definitely seeing more kids using these anti-inflammatory drugs. With new therapies we’re seeing more opportunities for use — that’s a real growth area.”
Russek cites several biologics that increasingly are being used for younger patients: Etanercept (Enbrel), adalimumab (Humira), and abatacept (Orencia), and golimumab (Simponi), a once-monthly, patient-administered, antitumor necrosis factor-alpha therapy approved little more than a year ago. And with increased use comes increased concerns about the risk of side effects.
“If you look at the Enbrel and Humira Web sites, you’ll see the new FDA warnings,” says Russek. “With immunosuppressant drugs, there are precautions about an increase of juvenile cancers and onset of psoriasis in some patients. It’s a small percentage, but it’s large enough to make doctors aware of the risk. The drugs now carry these warnings, and there are continuing studies on the potential effect of long-term use.
But the PBM has to balance risks and benefits when weighing the proper use of medications.
“Using an aggressive medication may not be wrong,” Russek points out. “Biologics have fewer side effects than methotrexate, for example, and may be more effective. It is not irrational to use biologics.”
The biggest single increase in drug use among children and adolescents last year was in the antiviral category, says Medco, which isn’t surprising if you consider the H1N1 epidemic that sounded health alarms around the globe. That was only a one-time spike for that category, though, while the trendline for type 2 diabetes drugs shows a steady climb.
Use of type 2 diabetes medications among juveniles climbed 5.3 percent last year, according to Medco, the biggest single increase across all age groups. Over the last decade, the rate of diabetes-drug use grew 150 percent for boys and 200 percent for girls. In contrast, overall utilization of diabetes therapies — a big focus for biotech companies — grew only 2.3 percent.
The obesity epidemic may also be responsible for a higher prevalence of hypertension and gastroesophageal reflux disease (GERD) in youngsters, Medco notes. From 2001 to 2009, there was a 17 percent increase in the use of antihypertensives in children, with the greatest growth (29 percent) seen in boys ages 10–19. The number of children on proton pump inhibitors to treat heartburn and GERD, and in some cases prescribed for colic in infants, increased by 147 percent from 2001 to 2009.
Medco also has been tracking a growing use of atypical anti-psychotics, some of which are associated with significant weight gain.
“Atypical antipsychotics are extremely powerful drugs that are being used far too commonly — especially in children — given their safety issues and side effects,” says David Muzina, MD, a specialist in mood disorders and national practice leader of the Medco Therapeutic Resource Center for Neuroscience. “We’re seeing them prescribed for a number of different conditions, including depression and anxiety — for which there is not good evidence that they are an effective treatment; yet we’re exposing children to the possibility of extreme weight gain that could lead to a host of health problems, including diabetes.”
Russek highlights several other new biotech drugs that are appearing in the pediatric arena; for example, use of deferasirox (Exjade) for sickle cell anemia, is growing. “Patients have to have multiple transfusions,” he says, “and part of the problem is they often start retaining iron from the transfusions, which is treated with Exjade.” Palivizumab (Synagis), used for a respiratory virus in prenatal infants and sold by MedImmune, is also making a mark.
But it’s the use of growth hormones among children that warrants particularly close monitoring, Russek says. “Over the last couple of years we’ve seen an increase in the use of drugs for demonstrated growth hormone deficiency, but also for short stature,” he says. But sometimes parents seek out growth hormones to make their children better athletes, and that’s something most payers won’t countenance.
“If we look back five years,” adds Russek, “self-administration was something you only did if you were diabetic or had to. Now it’s a very accepted therapy. We have 10-year-olds who are learning how to do their own infusions, and many of them are amazingly adept at it.”
That’s one skill that is likely to grow increasingly important among America’s youth.