2009 Drug Trend Insights - Prime Therapeutics

Specialty Drug ManagementSpecialty Drug Pipeline andFuture TrendsSpecialty drug research anddevelopment remain at the frontierof medical science. 58 This meansSpecialty drugs will continue tocommand high prices and will alsodrive drug spending trends in theyears to come. Because of drugsin the development pipeline aswell as a higher share of Specialtyspending, three key Specialtyclasses driving future trend willbe oral oncology, arthritis andmultiple sclerosis.+ Oral oncologyIn the near term, oncologydrugs remain a major focusin the Specialty pipeline andwill continue to contributesignificantly to future costs.Some of these products arecurrently approved in differentformulations and for othercancers. Many of the comingoncology drugs are infusions;however, there are also somepromising oral formulationsthat could be approved.Although oral oncology drugsare recognized as innovativetherapies, the costs associatedwith their use can be high,with therapies ranging from$10,000 to $100,000 per year. 59These high costs may lead todifficult cost-based treatmentdecisions for patients, health careproviders and insurers. USA Todayreports that one in eight patientsforegoes recommended cancertreatment due to cost. 60 Further,insurers and national healthcaresystems are starting to scrutinizethe cost of therapy versus the61, 62survival benefit.+ Arthritis and multiple sclerosisThere is the potential forsome new biologics to treatrheumatoid arthritis and psoriasisin the pipeline. Cimzia ® andustekinumab received completeresponse letters from the FDA inlate 2008. Actemra ® approval wasdelayed by the FDA with someadditional data required; however,this drug was recently approvedin Europe. There is a possibilitythat Actemra could be approvedin late 2009. The FDA approvedSimponi ® (golimumab) formultiple inflammatory indicationsin late April 2009. Many of thenew drug approvals submitted formultiple sclerosis and rheumatoidarthritis are similar to productsalready on the market. Thiswill create new opportunitiesfor formulary and utilizationmanagement to manage costs.Generic Opportunity forSpecialty DrugsNo generics are anticipated inthe near-term for drug classestypically considered Specialty,such as rheumatoid arthritis andmultiple sclerosis. The March2009 introduction of bipartisanlegislation to create a regulatorypathway for generic versionsof biologic products hints at afuture which may include genericSpecialty medications. 63 For thetime being, however, this futureremains distant.Adding to the uncertainty is thefact that the length of marketexclusivity brand manufacturerswould be granted under the lawis a central point of disagreement. 6456 Connect ● Create