White Paper

What Do Specialty Pharmacies Offer Oncology Nurses and Their Patients? By 2016, 7 of the 10 top-selling drugs in the United States are expected to be specialty pharmaceuticals. Specialty drugs have shaken up retail pharmacy, and the complexities associated with specialty drugs have prompted specialty pharmacies to broaden and enhance support services to prescribers, nurses, and patients.1,2 Independent specialty pharmacies are growing quickly, with an average three-year growth of 208%.2 The key trends that are spurring growth of specialty pharmacies include approval of novel oncology agents, declining reimbursement rates, shifts in coverage from medical to pharmacy benefits, increasingly complex drug monitoring requirements, and costcontainment strategies.3 This white paper aims to define specialty pharmacy and specialty drugs and highlight the ways in which specialty pharmacies support oncology nurses and their patients.

What Is Specialty Pharmacy?

A

ccording to the National Comprehensive Cancer Network (NCCN), defining specialty pharmacy is no clear-cut endeavor, particularly when it comes to oncology practice.4 In fact, no definition of specialty pharmacy is universally accepted, and the use of terms such as “specialty pharmacy” and “specialty drug” vary depending on the health plan, pharmacy benefit program, and organization.4,5 Further complicating a definition is the lack of mandatory certification standards for specialty pharmacies and pharmacists. Additionally, specialty pharmacy practice beyond that of standard pharmacy practice is not regulated by the federal government.4 A core feature of specialty pharmacy is the focus on chronic diseases and rare diseases and conditions. Historically, the role of the specialty pharmacy has been to coordinate the clinical, fulfillment, medication, and disease-management aspects associated with medication delivery under a single organization. The intent of specialty pharmacy has been to fill the gaps associated with pharmaceutical care provided by the traditional healthcare system. Payers or pharmaceutical manufacturers have mandated the use of a specialty pharmacy distribution channel for drugs that were costly to purchase, treated rare diseases and conditions, and were associated with complex management issues such as medication adherence.4

According to the NCCN Specialty Pharmacy Task Force, the main goals of specialty pharmacy are to4 • Optimize pharmaceutical care outcomes • Ensure appropriate use of medications • Maximize drug adherence • Avoid unwanted drug expenditure • Enhance patient satisfaction through direct interaction and delivery of information. Compared with the traditional pharmacy model, specialty pharmacy is central to patient care, and it interacts directly and collaboratively with providers, patients, and payers on a regular basis (see Figure 1).4 Not all specialty pharmacies have the same delivery model. For example, a specialty pharmacy can exist as an independent/ standalone organization or be integrated with a pharmacy benefit management (PBM) company. Specialty pharmacies may include functions of retail pharmacies or home infusion agencies, or be combined with health insurance plans. Table 1 lists the key participants within the specialty pharmacy market.4,6 Specialty pharmacies also vary in the way in which they distribute drugs. In some cases, drugs may be distributed via a closed model, in which a manufacturer or payer works with a single specialty pharmacy or selected number of specialty pharmacies to control all distribution. Infused medications may be delivered via home infusion services or shipped direct-

1 What Do Specialty Pharmacies Offer Oncology Nurses and Their Patients? • 2014

ly to a provider or a provider’s pharmacy for administration to a patient. Oral drugs and injectables for self-administration may be mail-ordered or distributed through community retail pharmacy networks.4

What Makes a Drug “Special”? Two hallmark features of specialty drugs are cost and complexity. According to the Medicare Part D drug benefit program, a specialty drug is one that costs more than $600 per month, whereas an industry survey of health plans indicated that a specialty threshold is reached at a minimum of $1,200 per month.5,7 Extensive research and development and special manufacturing requirements all contribute to the high costs. Compared with many standard therapies, specialty drugs are delicate; have limited shelf lives; and require specific storage, handling, administration, inventory management, patient monitoring, and intense support, all of which increase costs.5 In 2009, a large healthcare data company, along with a network of industry trade associations, reached consensus on what defines a specialty drug. Per their specifications, a specialty drug is one that must meet five of the following criteria.8 • Treats specific, mainly chronic, and often rare conditions • Use initiates with a specialist • Is typically not administered orally • Requires special handling • Involves unique distribution, management, and specialized paperwork • Is expensive, with costs from $6,000–$750,000 per year • Use requires high degree of patient management, such as increased supervision or counseling • Use results in patients requiring reimbursement assistance

How Do Specialty Pharmacies Benefit Key Stakeholders? Specialty pharmacies offer programs that are designed to address the challenges associated with drugs and biologics that are expensive, difficult to manage, and fraught with reimbursement hurdles. Specialty drugs have their own unique set of challenges for manufacturers, prescribers, patients, caregivers, pharmacies, and payers. For manufacturers, a closed distribution channel helps to control inventory and data. In addition, the advent of the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategies program—a risk management plan that goes beyond drug labeling to ensure that a drug’s benefits outweigh its risks—has fostered the need for additional data collection and reporting on such drugs.3,9 From the perspective of manufacturers, limiting the distribution of drugs increases compliance and consistency of data collection.3 Specialty pharmacy spending continues to exceed that of traditional therapies, and, as a result, managed care organizations have shifted more cost to patients. Consequently, increased cost can be a barrier to medication initiation as well as treatment adherence. In today’s economic climate, many patients require financial assistance to start or maintain treatment over the long term. To decrease time to therapy delivery and initiation, ensure treatment adherence, and curb out-of-pocket costs for patients, specialty pharmacies work with copay organizations—charitable organizations that rely on fundraising to support their missions—to help patients pay for their medications. Because they share common goals of initiating and maintaining patients on treatment, copay organizations have become close partners with specialty pharmacies. In fact, independent specialty phar-

Drug Procurement

Drug Dispensing and Administration Prescription for oral anticancer agents, self-injectable medications, etc.

Drug Manufacturer

Oncology Care Team

Specialty Pharmacy Wholesaler or Specialty Distributor

Monitoring for adherence, outcomes, etc.

Clinical services • Assessment • Monitoring • Patient education Dispensing functions • Mail-order • Community pick-up

Patient Dispensed to patient

Figure 1. Specialty Pharmacy Distribution Model Adapted with permission from 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.

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macies often have copay assistance specialists to help coordinate financial assistance on behalf of patients.10 Cost often becomes a major barrier when specialty medications are subjected to tiered pricing. One goal of specialty pharmacies is efficient treatment initiation, whereby they can overcome cost barriers by providing financial counseling and copay assistance. The goals of the patient, provider, and pharmacy align to efficiently initiate the patient on therapy. Because out-of-pocket costs are major barriers to treatment initiation, specialty pharmacies and copay organizations work together to decrease the time to approval of therapy by payers and donors and expedite actual medication delivery. Time to approval can vary widely; thus, copay organizations have fostered network relationships with specialty pharmacies to decrease this time via portals that allow patients, pharmacies, and providers to track a patient’s application status, funding balances, and medication fills and refills.10 Once a patient has initiated therapy successfully, another goal of a specialty pharmacy and partnering copay organizations is to help keep the patient on therapy. This is done by monitoring and maintaining funding allotment and funding balance to avoid unanticipated funding lapses. Most specialty pharmacies provide their own adherence programs, and copay organizations also provide complementary services. Copay organizations may request status updates for patients who have no reported drug dispenses within an anticipated time interval. If a specialty pharmacy reports that a patient is no longer on therapy, a copay organization may redirect the remaining money to other patients in need. In doing so, specialty pharmacies and copay organizations ensure that patients are adherent to prescribed treatment regimens and that limited resources are directed to patients in need. Through the use of portals, copay organizations provide patients with the ability to monitor their treatment; schedule physician visits, injections, and other treatment-related activities; and take surveys to track treatment goals. Some organizations provide prescribers with access to foundation portals to allow them to view reported dispenses, treatment survey responses, and funding balances. Apart from efficient medication access and ensured treatment adherence, specialty pharmacies may provide patient and caregiver education on10 • Self-administration of medications • Adverse drug events • Medication handling and administration guidelines • Disease-specific resources.

What Are the Benefits of Specialty Pharmacies in Oncology? Specialty pharmacies are the distribution channel for a variety of oncology agents, such as self-injectable supportive therapy (e.g., erythropoiesis-stimulating agents), oral anticancer agents, parenteral chemotherapy, and biologic agents.4 In oncology, the benefits of specialty drugs are well documented. For many, these drugs have prolonged survival and maintained quality of life. Until a few years ago, specialty

oncology agents were almost exclusively infused or injected by a healthcare professional in an office or clinic. Advances in drug design and administration have paved the way for availability of oral oncology drugs that patients can selfadminister. However, these oral agents still meet the definition of specialty because they possess the following.11 • High cost: In 2011, the average monthly cost of an oral oncology drug was $4,400. • High complexity: Oral oncology drugs may cause serious adverse events and require detailed follow-up and monitoring. • High levels of patient education to control adverse events and ensure adherence In recent years, a number of oral oncology agents have been approved to treat many different liquid and solid tumor types: leukemias and lymphomas; multiple myeloma; gastrointestinal tumors; melanoma; and cancers of the lung,

Table 1. Examples of Key Participants in the Specialty Pharmacy Market Pharmacy benefit manager

• CuraScript Specialty Pharmacy/Accredo (Express Scripts) • CVS Caremark

Retail chain

• Walgreens Specialty Pharmacy • CarePlus CVS

Independent specialty • Advanced Care Scripts • CareMed pharmacies • TLC • Amber Wholesaler

• U.S. Bioservices (AmerisourceBergen) • OncologyRx Care Advantage® (McKesson)

Physician practices

• Park Pharmacy (Tennessee Oncology) • Oncology Pharmacy Services (Texas Oncology)

Hospital practices

• Fairview Specialty Pharmacy • ExceleraRx

Fein AJ. 2011 pharmacy market share for specialty drugs. June 12, 2012. http://www.drugchannels.net/2012/06/2011pharmacy-market-share-for.html. Accessed June 2014 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.

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pancreas, thyroid, breast, and bone. The cost of some of these oral agents may exceed $10,000 per month and may undermine treatment adherence.12,13,14 Studies have shown that high out-of-pocket expenses may lead to patients’ abandonment of oral oncology treatments. In a retrospective study evaluating 1,909 insurance plan members (average age 55 years; 51.7% male), one of six patients with oral oncology out-of-pocket expenses exceeding $200 per month abandoned treatment.13 Results from another study involving 1,737 Medicare patients and 8,771 commercially insured patients showed that onequarter of patients abandoned oral oncology treatment and did not follow up with another medication within 90 days when out-of-pocket costs exceeded $500 per month. In that study, high rates of treatment abandonment were associated with higher number of prescriptions, lower income, and insurance under Medicare.14 Fortunately, specialty pharmacy programs for oral oncology medications can help decrease costs while maintaining treatment adherence. In a retrospective observational analysis of a health plan–sponsored specialty pharmacy program, a matched sample of patients assigned to use specialty pharmacies (n = 484) was compared with a sample of patients who used retail pharmacies for oral cancer therapies (n = 484). The study’s primary outcomes included overall health care and outpatient, medical, and pharmacy costs. The specialty pharmacy program encompassed the following services: clinical expertise and patient education on oncology drugs and comorbid conditions; monthly proactive adherence program with refill reminders, adherence screenings, and interventions with the patient and physician if nonadherence was detected; and clinical counseling sessions via telephone for more extensive patient education, depression screening, pharmaceutical care interventions, provider outreach, and referral to health resources.15 Compared with the retail pharmacy group, the specialty pharmacy group of patients had 13% lower mean total costs ($84,105 versus $97,196; p = 0.02), 41% lower mean outpatient hospital costs ($16,777 versus $28,629; p < 0.01), and fewer mean hospital visits (15.75 versus 19.66; p < 0.01). Adherence was better in the specialty pharmacy group as measured by weighted medication possession ratio (0.66 versus 0.58; p < 0.001) These results provide evidence that specialty pharmacy services are associated with improved oral oncology medication adherence and a decrease in overall healthcare costs.15 In the current climate, payers are able to subsidize and ensure access to newer oncology therapies that are proven to be effective by developing customized solutions that focus on value, management, and education. Beyond direct costs, value is also measured by patient outcomes. Payers aim for standardized management of access and utilization of specialty drugs and support through clinical management programs that include patient outreach and education; 24/7 access to clinicians; information on how to manage side effects, symptoms, and drug interactions; refill reminders; and adherence assessments.11 Active searching for financial assistance programs by specialty pharmacy providers may help remove a patient’s

financial barrier to filling his or her medication and improve adherence to treatment. Specialty pharmacies can also help with copayment assistance programs (e.g., manufacturer’s copay cards, rebates, coupons, drug- or company-specific patient assistance programs offering free or low-cost drugs to patients who meet certain requirements).16

Profile of a Specialty Pharmacy: Advanced Care Scripts Overview Established in 2004 and acquired by Omnicare Specialty Care Group in 2008, Advanced Care Scripts (ACS) is an independent specialty pharmacy that manages and dispenses specialty Given the numerous medications and prodand rapid advances ucts throughout the 17 United States. Ear- in cancer treatment, lier this year, ACS was today’s oncology awarded accreditation nurses are already by URAC, an independent, nonprofit, Washentrenched in ington, D.C.–based healthcare organization, specialty pharmacy. formerly known as the ACS can assist Utilization Review Acnurses in their creditation Commisresponsibilities. sion, which establishes quality standards for the healthcare industry. URAC offers the only third-party voluntary accreditation program of this scope for the PBM and prescription services industries.18

ACS’s Services ACS focuses mainly on specialty pharmacy services, giving healthcare providers, their staff, and patients with reimbursement assistance and dispensing. This encompasses prior authorization (PA) initiations, PA appeals, copay assistance, clinical management, and compliance and persistency programs. Starting with the prescriber, ACS coordinates services using a single point of contact to simplify reimbursement and delivery of therapies used to treat cancer and other diseases. In addition to dispensing leading specialty pharmacy oncology drugs, ACS also dispenses antiemetics for the management of chemotherapy-induced nausea and vomiting. The ACS customer service and comprehensive patient care model provides compliance and adherence support as well as cost-effective solutions for all classes of specialty drugs. Among the patient services that ACS provides are17 • Nursing support to help patients manage medication treatment better • Education to help patients understand disease states • Three ways to refill medications (phone, fax, and email) • Benefits investigation and coordination of benefits

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• Billing and reimbursement support • Patient assistance programs • Support for Medicare Part D • Optional blister packaging for some oral medications to simplify administration • Superior customer service • Community resources (e.g., charity participation, support groups). Services offered to healthcare providers include access to specialty therapies, management from nurses and trained pharmacists to monitor patients closely for adverse events and intervene when necessary, and written and online educational materials to provide patients with the most up-to-date information about their prescribed therapies. Moreover, ACS provides assistance from trained patient care specialists to support patients in staying adherent and controlling their therapy, reimbursement support services to help maximize insurance benefits, and coordination with healthcare providers for patients’ medication needs.17 ACS provides customized referral forms to decrease administrative burdens and ensure the highest quality pharmacy services for healthcare providers and patients. Patients can be referred to ACS in three simple steps. 1. Prescribe therapy. 2. Complete an ACS referral form (www.acs-rx.com, under the Forms tab). 3. Fax the referral form to 866-679-7131. Alternatively, nurses may work with their ACS representatives to find the best method for their practice to submit referrals (e.g., printing from electronic health records, confidential emailing).

A Commitment to Oncology Nurses

Oncology nurses are integral members of the healthcare team and are renowned for their patient advocacy, teaching skills, and high-touch care. All of these qualities can be optimized in the context of specialty pharmacy settings through education, communication, and technology. Given the numerous and rapid advances in cancer treatment, today’s oncology nurses are already charged with understanding and collaborating with specialty pharmacy. Nurses provide patient education on the safe, effective use of specialty drugs; assess patients’ expectations of treatment; provide adverse event management; emphasize the importance of treatment adherence; reach out to manufacturers, payers, patient assistance programs, and charities; and are the first point of contact for patients who are taking specialty oncology drugs. Oncology nurses follow up with patients proactively through scheduled intervals that coincide with adverse event profiles or common points of treatment discontinuation. They also evaluate medication and health histories, assess treatment adherence and response, liaise with prescribers, and provide drug rescue. Technologically speaking, oncology nurses often are responsible for19 • Reviewing refill history and adherence calculations • Utilizing mobile and web technology for patient contact

• Providing electronic reminders and medication monitors • Implementing organizational methods such as reminder packaging. ACS can assist nurses in these responsibilities and genuinely cares about how oncology nurses use its services, as well as the quality of service that patients and providers receive. As a result of its commitment to nurses and patients, ACS partnered with ONS:Edge earlier this year to solicit feedback on specialty pharmacy from members of the Oncology Nursing Society (ONS) at an advisory board meeting held at ONS headquarters. What ACS learned from nurses was that every practice uses one or more specialty pharmacies to obtain oral oncology agents. Oncology nurses are the chief decision-makers in choosing which specialty pharmacy to use. In addition, high-quality and prompt service are key—oncology nurses return to specialty pharmacies that offer fast service; provide a single point of contact; and automatically perform PAs, copay assistance, and other services. Oncology nurses reported that patient and specialty pharmacy interactions are preferred at each and every stage of therapy, and such interactions often occur by telephone to monitor refills, side effects, and adherence. As a best practice, oncology nurses or practices must be informed of all contact via a standardized system, and patients should receive high-quality printed materials as part of a welcome packet or at first delivery of drug. Another key lesson from this meeting was that despite the relative familiarity with specialty pharmacies, oncology nurses want additional information so they can use such pharmacies more effectively in their daily practice. Given this feedback, and based on its commitment to oncology nurses and patients, ACS has implemented the following enhancements. • Modified printed education materials to be less bulky for nurses to use, to include patient images, to provide clearer evidence of service levels, and to make contact details more prominent and clear • Increased speed of service delivery • Developed systems for easily accessed, timely information for nurse tracking of prescriptions, benefits explanations, financial aid, and patient contacts ACS will continue to explore feedback, ideas, and innovations to enhance its suite of specialty pharmacy services for nurses and patients.

For more information about ACS, please visit www.acs-rx.com or call 877-985-MEDS (6337). For additional oncology pharmacy resources, please consult the following. • Association of Community Cancer Centers—Oncology Pharmacists Educational Network www.accc-cancer.org • Board of Pharmacy Specialties www.bpsweb.org • Community Oncology Alliance www.communityoncology.org • Hematology Oncology Pharmacy Association www.hoparx.org

5 What Do Specialty Pharmacies Offer Oncology Nurses and Their Patients? • 2014

• Navigating Dispensing Oral Oncology Drugs www.modernmedicine.com • United Healthcare Online Oncology Specialty Pharmacy Network www.unitedhealthcareonline.com • URAC www.urac.org

1. McCain J. Connecting patients with specialty products. Part 2: the future of specialty drug distribution. Biotechnol Healthc. 2012;9(3):13–16. 2. Fein AJ. 7 reasons why specialty drug dispensing will boom. May 29, 2012. http://www.specialtypharmacytimes.com/publications/specialtypharmacy-times/2012/June-2012/7-Reasons-Why-Specialty-DrugDispensing-Will-Boom. Accessed June 2014. 3. Jorgenson JA. Specialty pharmacy: status and future direction. January 11, 2011. http://www.ajmc.com/publications/ajpb/2010/AJPB_2010_ Nov/AJPB_10nov_Jorgenson_347to348. Accessed June 2014. 4. 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. 5. URAC. Specialty pharmacy white paper. The patient-centered outgrowth of specialty pharmacy: why patient management strategies are critical to 21st century providers. 2011. URAC, Washington, DC. https://www.urac.org/wp-content/uploads/2012/09/urac_pqm_specialty_white_paper.pdf. Accessed June 2014. 6. Fein AJ. 2011 pharmacy market share for specialty drugs. June 12, 2012. http://www.drugchannels.net/2012/06/2011-pharmacy-market-share-for. html. Accessed June 2014.

7. American Cancer Society. Medicare Part D: things people with cancer may want to know. Last revised: January 23, 2014. http://www.cancer. org/acs/groups/cid/documents/webcontent/002567-pdf.pdf. Accessed June 2014. 8. Sauerwald PL. Changing the channel. Developments of US specialty pharmacy distribution. October 10, 2009. http://www.imshealth.com/ imshealth/Global/Content/Document/IMS%20in%20the%20News%20 Documents/Changing_the_channel_Developments_in_Distribution. pdf. Accessed June 2014. 9. U.S. Food and Drug Administration. A brief overview of risk evaluation and mitigation strategies (REMS). http://www.fda.gov/downloads/ aboutfda/transparency/basics/ucm328784.pdf. Accessed June 2014. 10. Kwiatkowski K. Copay organizations and specialty pharmacies: partnering to help patients in need. February 20, 2012. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2012/ February-2012/Copay-Organizations-and-Specialty-PharmaciesPartnering-to-Help-Patients-in-Need#sthash.db6srZQb.dpuf. Accessed June 2014. 11. Correia RJ. Oral oncology therapies: specialty pharmacy’s newest challenge. May 18, 2011. http://www.pharmacytimes.com/publications/ issue/2011/May2011/Oral-Oncology-Therapies-Specialty-PharmacysNewest-Challenge-#sthash.gMNKYoqH.dpuf. Accessed June 2014. 12. Ness S. Specialty drugs: year in review 2013. February 17, 2014. http:// www.specialtypharmacytimes.com/publications/specialty-pharmacytimes/2014/february-2014/specialty-drugs-year-in-review-2013/P-1. Accessed June 2014. 13. Starner CI, Gleason PP, Gunderson BW. Oral oncology prescription abandonment association with high out-of-pocket member expense. J Manag Care Pharm. 2010;16(2):161–162. 14. Streeter S, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. J Oncol Pract. 2011;7(suppl 3):46s–51s. 15. Tschida SJ, Aslam S, Lal LS, et al. Outcomes of a specialty pharmacy program for oral oncology medications. Am J Pharm Benefits. 2012;4(4):165–174. 16. Ness S. Medication financial assistance programs. December 5, 2011. http://www.specialtypharmacytimes.com/publications/specialtypharmacy-times/2011/May-2011/Medication-Financial-AssistancePrograms. Accessed June 2014. 17. Advanced Care Scripts, Omnicare Specialty Care Group Web site. 2014. http://www.omnicarescg.com/OmnicareSCG/ACS. Accessed June 2014. 18. Omnicare news release. Advanced Care Scripts receives URAC Specialty Pharmacy Accreditation. March 21, 2014. http://www.omnicarescg. com/OmnicareSCG/ACS/docs/default-source/default-documentlibrary/advanced-care-scripts-receives-nbsp-urac-specialty-pharmacyaccreditation.pdf?sfvrsn=0. Accessed June 2014. 19. Rice GK, Hanna HM, Carpenter N. Exploring nursing adherence programs for oral oncolytics. http://www.specialtypharmacytimes.com/ publications/specialty-pharmacy-times/2012/June-2012/ExploringNursing-Adherence-Programs-for-Oral-Oncolytics. Accessed June 2014.

125 Enterprise Drive, Suite 110 Pittsburgh, PA 15275 1-877-588-EDGE www.onsedge.com

www.acs-rx.com 877-985-MEDS (6337)

This white paper was developed by ONS:Edge in collaboration with Omnicare Specialty Care Group’s Advanced Care Scripts. All content belongs to and is copyrighted by Omnicare/ Advanced Care Scripts. ONS:Edge thanks Oncology Nurse Practitioner Rebecca Sipples, RN, APRN, MSN, AOCNP®, for review of this paper and medical writers Karen H. Golebowski, MS, of Write Rite Inc., and Pamela Oestreicher, PhD, of ONS:Edge, for their expertise. For more information about this paper or to download copies, visit www.onsedge.com. ONS:Edge can be contacted by email at [email protected] or by phone at 877-588-EDGE (3343) or 412-859-6108.

References

6 What Do Specialty Pharmacies Offer Oncology Nurses and Their Patients? • 2014