John S. Reid, PharmD
Specialty pharmacy is a growing area of pharmacy practice focused on providing drug therapy management and dispensing services for patients requiring treatment with medications that are used to treat rare, chronic, or genetic conditions. Patients taking these medications require frequent monitoring and training, coordination of care with multiple health care providers, comprehensive patient education, and adherence management to ensure appropriate utilization. By following the principles of evidence-based medicine, specialty pharmacy is able to achieve the goal most important to patients, payers, and other health care practitioners—optimizing clinical treatment outcomes at the lowest cost.
An example of how evidence-based medicine can be applied is the management of hepatitis C, a blood-borne virus that affects the liver, causing chronic inflammation that can lead to cirrhosis, liver failure, and even liver cancer.3,4 Patients are often asymptomatic, and diagnosis is usually prompted when liver abnormalities are identified during a routine medical examination.
Evidence-based guidelines indicate that key factors in successful viral eradication include the use of and adherence to the current gold standard for treating hepatitis C—pegylated interferon in combination with ribavirin for up to 48 weeks.3-5 Even with optimal medication use and adherence, there is still only a 40% to 50% success rate for genotype 1 patients, and patients who do not experience a clinical response at 12 weeks are not likely to ever achieve successful viral eradication.5 Further, side effects associated with these medications, including flu-like symptoms, depression, and blood dyscrasias, create a huge barrier to successful treatment, with many patients discontinuing therapy after the first month.
Specialty pharmacists are in a prime position to apply best clinical practices by helping patients understand the complexity of treating and living with hepatitis C, coaching them to remain adherent to and complete their treatment regimen, as well as monitoring their clinical response to ensure that those patients not responding early in the treatment cycle are identified so that other, more appropriate treatment options may be pursued.
A recent study showed that specialty pharmacists can help hepatitis C patients achieve an average adherence of 94.5% (95% confidence interval, 94.2%- 94.7%), with greater than 90% of patients remaining on therapy beyond the first month.6 Further, by monitoring early treatment response, the specialty pharmacy was able to identify that approximately 12% of the population was not responding to therapy, resulting in discontinuation of the prescribed regimen and initiation of a more appropriate option, resulting in payer cost savings of approximately $1500 per month for each nonresponder.7
Specialty pharmacy has demonstrated the ability to support the application of evidence-based medicine as part of the medication utilization and management process. Because this is the fastest-growing segment of drug spending and the largest proportion of the drug development pipeline, understanding the evolving evidence supporting the use of these treatment options and identifying their appropriate place in therapy will continue to be a focus for health care providers and payers alike. Application of evidence-based practices is critical to ensuring the safe and effective use of specialty medications, optimizing treatment outcomes, and minimizing health care costs both today and in the future.
The author would like to thank Lida Andrews, PharmD, director of Specialty Pharmacy Programs at CVS Caremark, for her contributions to this article.