Bridging the Gap Between Clinical and Specialty Pharmacy Services
Kane Hosmer, PharmD
PGY2 Hematology/Oncology Pharmacy Resident
The University of Chicago Medicine
Regulatory agencies and insurance companies favor restricted drug distribution systems to dispense specialty drugs that make up much of the armamentarium of antineoplastic agents used today. From the U.S. Food and Drug Administration’s perspective, specialty pharmacies limit the distribution of high-risk specialty medications to pharmacies that have the most experience complying with complicated risk evaluation and mitigation strategy programs.1 From a payer perspective, specialty pharmacies create economies of scale while simplifying the distribution of expensive medications, thus reducing costs to insurance companies.2
As specialty drug prices balloon, cost containment has become increasingly important to insurance companies. It is estimated that in 2008, $54 billion was spent on specialty medications, accounting for 25%–30% of overall medical costs to health plans.1 National drug expenditure forecasts for 2014 predicted growth in specialty drugs of 13%–24%.3 Perhaps unsurprisingly, oncology practice is heavily impacted by specialty pharmacy because many antineoplastic agents fall into this high-cost, high-risk category.
In response, hospital systems have increasingly developed their own specialty pharmacies to capitalize on the financial opportunities that specialty pharmacy offers. According to an article published in Pharmacy and Therapeutics, hospital systems are hoping to purchase specialty medications at 340B prices, then bill insurance companies for the higher, nondiscounted cost.4
At least one hospital-based specialty pharmacy pro- gram has reported revenue of $7.5 million during the first year.5 Although the incentive to start a specialty pharmacy exists, health-system administrators will need to integrate specialty pharmacy into preexisting practice models to prevent fragmentation of care.
When a specialty pharmacy is being developed, one challenge is the lack of an official definition of specialty pharmacy, and services vary significantly between institutions.3 There are no mandatory certificates for accreditation, which also is problematic. There are, however, accrediting bodies that hospital systems may voluntarily seek out. Both the Accreditation Commission for Health Care and URAC (formerly the Utilization Review Accreditation Commission provide standards for performance. URAC’s measures are available online6 and focus mainly on medication adherence for nonspecialty medications; overall patient satisfaction; and distributive functions such as accurate dispensing, on-time delivery, and call center performance. URAC has not yet established a measure for specialty medication adherence.
In 2010 the National Comprehensive Cancer Network (NCCN) published a task force report on the potential advantages and risks of using specialty pharmacies to distribute oncology therapeutic agents.3 Potential advantages include appropriate selection of medication, increases in adherence, avoidance of unnecessary drug costs, and increasing patient and provider satisfaction.3,7
However, if the specialty pharmacy is not operated by the hospital system, patient care may be compromised by lack of access to a patient’s electronic medical record, poor communication between providers and the specialty pharmacy, and a breakdown in the drug’s chain of custody because medications often are delivered to a patient’s home.3
The University of Illinois at Chicago (UIC) recently published its approach to integrating existing clinical pharmacy with specialty pharmacy services.8 In the UIC model, the clinical pharmacist provides services for one-half day per week. The specialty pharmacy has pharmacists, prior authorization specialists, students, and residents to staff its 24-hour call center.
The clinical pharmacist serves on the care team and interfaces with the specialty pharmacy, bridging a gap in care that NCCN warns may occur with the introduction of specialty pharmacy services. When the provider writes a prescription, the clinical pharmacist evaluates the order for appropriateness, then sends the fill to the specialty pharmacy if the patient does not have contraindications to therapy. The clinical pharmacist also coordinates any other education the patient may need, such as injection technique training. Meanwhile, some of the responsibilities of the specialty pharmacy include verifying prescription benefits, assisting with referrals to prescription assistance programs, and sending prior authorizations appeal forms to the clinical pharmacist for justification.
If permitted, the specialty pharmacy processes the fill for the patient’s first visit with the clinical pharmacist. The clinical pharmacist continues therapeutic drug monitoring. The specialty pharmacy continues to monitor the patient for adherence and adverse effects through the use of clinical surveys, which are reported to the clinical pharmacist. The clinical pharmacist can then discuss alternate treatment options with the attending physician, if needed.
Utilizing an integrated clinical and hospital-based specialty pharmacy model offers the advantage of sharing electronic medical records, fostering closer collaboration between providers and specialty pharmacy because of closer geographic proximity, and ensuring proper storage of medications by direct delivery to clinics. Development of such models will be increasingly important as healthcare systems seek to develop their own specialty pharmacies.
1. Kirschenbaum BE. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists. Am J Health Syst Pharm. 2009;66(24 Suppl 7):S13-S20.
2. Schwartz RN, Eng KJ, Frieze DA, et al. NCCN task force report: specialty pharmacy. J Natl Compr Canc Netw. 2010(8 suppl 4):S1-S12.
3. Schumock GT, Li EC, Suda KJ, et al. National trends in prescription drug expenditures and projections for 2014. Am J Health Syst Pharm. 2014;71(6):482-499.
4. Barlas S. Specialty pharmacy networks for hospitals in the offing: absence of onsite access to specialty pharmaceuticals has care and financial implications. P T. 2014;39(2):123-143.
5. Hlubocky JM, Stuckey LJ, Schuman AD, Stevenson JG. Evaluation of a transplantation specialty pharmacy program. Am J Health Syst Pharm. 2012;69(4):340-347.
6. URAC. Specialty pharmacy [version 2.0 and 2.1, measures version 1.0]. Washington, DC: URAC Inc.; 2011.
7. URAC. Specialty pharmacy white paper. Washington, DC: URAC Inc.; 2011. www.urac.org/ Whitepaper/ PQM-Specialty_Pharmacy.pdf
8. Hanson RL, Habibi M, Khamo N, Abdou S, Stubbings J. Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis. Am J Health Syst Pharm. 2014;71(6):463-469.