John S. Reid, PharmD
Dr. Reid is seniorvice president ofSpecialty PharmacyOperations at CVSCaremark.
Practicing according to the principlesof evidence-based medicineinvolves the applicationof national practice guidelines, currentclinical research, and experienceto guide the diagnosis of a conditionand selection of appropriate treatment.Although this practice is important in allfields of health care today, it is becomingincreasingly important in specialtypharmacy. Given that drug spending forspecialty pharmaceuticals is growing at2.5 times the rate of nonspecialty spending1and that total health care costs forspecialty patients are 17.5 times higherthan nonspecialty patients,2 increasedfocus has been placed on the use ofspecialty medications and concern overhow to manage costs while ensuringappropriate utilization and quality care.
Specialty pharmacy is a growing areaof pharmacy practice focused on providingdrug therapy management and dispensingservices for patients requiringtreatment with medications that are usedto treat rare, chronic, or genetic conditions.Patients taking these medicationsrequire frequent monitoring and training,coordination of care with multiple healthcare providers, comprehensive patienteducation, and adherence managementto ensure appropriate utilization. By followingthe principles of evidence-basedmedicine, specialty pharmacy is ableto achieve the goal most important topatients, payers, and other health carepractitioners—optimizing clinical treatmentoutcomes at the lowest cost.
An example of how evidence-basedmedicine can be applied is the managementof hepatitis C, a blood-borne virusthat affects the liver, causing chronicinflammation that can lead to cirrhosis,liver failure, and even liver cancer.3,4Patients are often asymptomatic, anddiagnosis is usually prompted when liverabnormalities are identified during a routinemedical examination.
Evidence-based guidelines indicate thatkey factors in successful viral eradicationinclude the use of and adherence to thecurrent gold standard for treating hepatitisC—pegylated interferon in combinationwith ribavirin for up to 48 weeks.3-5Even with optimal medication use andadherence, there is still only a 40% to 50%success rate for genotype 1 patients, andpatients who do not experience a clinicalresponse at 12 weeks are not likely toever achieve successful viral eradication.5Further, side effects associated with thesemedications, including flu-like symptoms,depression, and blood dyscrasias, createa huge barrier to successful treatment,with many patients discontinuing therapyafter the first month.
Specialty pharmacists are in a primeposition to apply best clinical practicesby helping patients understand the complexityof treating and living with hepatitisC, coaching them to remain adherentto and complete their treatment regimen,as well as monitoring their clinicalresponse to ensure that those patientsnot responding early in the treatmentcycle are identified so that other, moreappropriate treatment options may bepursued.
A recent study showed that specialtypharmacists can help hepatitis Cpatients achieve an average adherenceof 94.5% (95% confidence interval, 94.2%-94.7%), with greater than 90% of patientsremaining on therapy beyond the firstmonth.6 Further, by monitoring earlytreatment response, the specialty pharmacywas able to identify that approximately12% of the population was notresponding to therapy, resulting in discontinuationof the prescribed regimenand initiation of a more appropriateoption, resulting in payer cost savingsof approximately $1500 per month foreach nonresponder.7
Specialty pharmacy has demonstratedthe ability to support the applicationof evidence-based medicine aspart of the medication utilization andmanagement process. Because this isthe fastest-growingsegment of drugspending and the largest proportion ofthe drug development pipeline, understandingthe evolving evidence supportingthe use of these treatment optionsand identifying their appropriate placein therapy will continue to be a focusfor health care providers and payersalike. Application of evidence-basedpractices is critical to ensuring the safeand effective use of specialtymedications,optimizing treatment outcomes,and minimizing health care costs bothtoday and in the future.
The author would like to thankLida Andrews, PharmD, directorof Specialty Pharmacy Programsat CVS Caremark, for her contributionsto this article.