US Pharm. 2016;41(5):35-40.
ABSTRACT: The specialty pharmaceutical market is expected to increase to approximately $400 billion by 2020, yet this market is largely misconstrued by community pharmacists. Jobson Research with Pharm/alert Research conducted a survey of community pharmacists in October 2015 to determine how aware they are regarding specialty products and the medical conditions these medications are used to treat. Pharmacists were surveyed on the top 10 specialty products used in treating four conditions: hepatitis C, rheumatoid arthritis, multiple sclerosis, and cancer. Pharmacists are an integral part of the healthcare team, and a deeper understanding of specialty pharmaceuticals and the medical conditions these agents treat can help community pharmacists provide top-of-licensure, patient-centered care.
Specialty pharmaceuticals are defined as products that are used to treat chronic, high-cost, or rare diseases and are injectable, infusible, oral, or inhaled medications. This market represents the single fastest growing portion of the prescription drug market in the United States. In 2012, spending on specialty medications was about $87 billion, and it is expected to increase to almost $400 billion by 2020.1 Of the top 10 drugs sold in the U.S. in 2012, five were specialty medications, and it is predicted that by 2018, six of the top 10 medications will be specialty drugs.2 Approximately 50% of the spending for specialty medications is funded as a pharmacy benefit, and the other half is funded as a medical benefit. This split funding can lead to confusion and challenges in clinical management. Pharmacy benefits managers and other third-party payers are looking to pharmacists to improve care coordination and help increase patient adherence to specialty medications to reduce overall healthcare spending. One study demonstrated that synchronized medical and pharmacy services produced total cost savings of approximately 13% for cancer and transplant services and increased adherence for patients with cancer, multiple sclerosis, and rheumatoid arthritis.1
Specialty products tend to be more difficult to administer, store, and monitor than traditional drugs since they require closer monitoring of a patient’s overall therapy.3 The FDA does not select the medications that are deemed “specialty” drugs; insurance companies and pharmaceutical companies decide drug designations.4 The Centers for Medicare and Medicaid Services (CMS) categorizes a specialty medication as one with a monthly cost of at least $600, and other private insurers consider a specialty medication as one with a monthly cost of at least $1,200.5 Key characteristics of specialty pharmaceuticals can include frequent dosage adjustments; more severe side effects than traditional medications; special storage, handling, and/or administration requirements; narrow therapeutic index; laboratory monitoring; extra patient education; or other nondispensing services.3 Although insulin is not considered a specialty medication, it carries some of the same storage, administration, and educational requirements as specialty medications and is frequently dispensed in the community pharmacy.
Specialty pharmacy is defined as the service created to manage the handling and service requirements of specialty pharmaceuticals, including dispensing, distribution, reimbursement, case management, and other services specific to patients with rare and/or chronic diseases. Specialty pharmacy is a service that provides a mechanism to manage the cost of specialty pharmaceuticals for the patient and provides an opportunity to decrease costs for third-party payers as compared to traditional models where medications would be administered in the hospital or another provider’s office. By focusing on appropriate drug utilization and ongoing monitoring of patient progress, specialty pharmacies are able to offer services that exceed the standard of care typically offered at the community level. Community pharmacists can play a role in assisting patients with their specialty medications whether they are the ones dispensing them or not. Community pharmacists can help by assuring that patients have the necessary administration equipment such as alcohol swabs, needles, syringes, or a sharps container for disposal.4 Community pharmacists can assist patients in finding the correct syringe size, counsel patients to rotate the injection site to avoid injection-site reactions, and remind patients of proper storage conditions. Patients taking specialty medications may also be good candidates for medication therapy management (MTM) to improve care, encourage adherence, and manage side effects, making it imperative for community pharmacists to be knowledgeable in this field.4 Specialty pharmacy, although once a small portion of the marketplace, is now a booming industry. Regardless of the practice setting, pharmacists should understand the key aspects of specialty pharmacy in order to improve the quality of care provided to patients who are prescribed specialty medications.
Survey of Community Pharmacists on Specialty Pharmacy
In October 2015, Jobson Research with Pharm/alert Research conducted a quantitative online survey of community pharmacists. A total of 434 pharmacists from across the country participated in the survey. This marketing survey was designed to determine the burden of specialty products on community pharmacists. Each participant was asked five questions about specialty products and instructed to think of the following agents when considering “specialty”: Harvoni (ledipasvir/sofosbuvir), Humira (adalimumab), Enbrel (etanercept), Sovaldi (sofosbuvir), Remicade (infliximab), Copaxone (glatiramer acetate), Neulasta (pegfilgrastim), Rituxan (rituximab), Tecfidera (dimethyl fumarate), and Avastin (bevacizumab). IMS Health identified these agents as the top 10 leading specialty products as of June 2015. The demographics of the 434 retail pharmacists who responded to the survey can be found in TABLE 1.
Results of the survey are seen below in TABLE 2 and TABLE 3. No statistical analysis was conducted to compare the groups; rather, this survey was done as market research to determine the educational needs of community pharmacists. Major trends emerged from the survey, including that the majority of pharmacists indicated a general awareness of specialty medical conditions and agree that manufacturers need to better communicate and provide information to community pharmacists to engage in patient care, and that a minority of respondents felt equipped and informed to triage concerns related to specialty treatments.
A deeper analysis of the data shows that three out of 10 pharmacists are unaware of a patient’s entire medical history, which could lead to poor outcomes. For example, a patient who is prescribed erlotinib (Tarceva) may develop an acnelike rash from the medication. If the community pharmacist is unaware of the medical history or the drug, the pharmacist may recommend benzoyl peroxide to treat the acnelike rash, which may exacerbate this side effect.6 Better informing all members of the healthcare team, including the community pharmacist, will be vital as more patients are prescribed specialty medications.
However, despite the value added to understanding the patient’s entire medical history, only 71.4% of pharmacists state that it is “very important” to be aware of the specialty condition. Innately, all members of the healthcare team should indicate that awareness of the patient’s entire medical and medication history is very important. This difference could be attributed to the pharmacists not understanding the critical impact specialty medications have on drug interactions and overall health. The survey supports this assessment, because only a minority of pharmacists feel equipped to triage concerns surrounding specialty medications, yet a majority of pharmacists counsel patients on the specialty condition. In addition, a majority of pharmacists desire more communication from specialty manufacturers.
Tips on Specialty Products for Community Pharmacists
One of the major themes from this survey is that community pharmacists are often the frontline responders to patient concerns about specialty medications, but they are not equipped to provide the best care. Either the pharmacist is unaware that the patient is prescribed the medication, does not think it is important to know about the medical condition, or desires information from manufacturers about specialty products to deliver effective communication.
The next section is a brief overview of some of the major medical conditions that are considered specialty, including common therapies, assessments, major interactions, and friendly resources. TABLE 4 offers further details on hepatitis C (HCV) and rheumatoid arthritis (RA), while TABLE 5 provides details on multiple sclerosis (MS) and oncology.7-16
Hepatitis C Review and Pharmacotherapy
Hepatitis C is a viral infection that impacts approximately 3.5 million patients in the U.S. Untreated HCV can lead to cirrhosis, liver cancer, and liver failure, yet up to 50% of patients are unaware of their condition due to the absence of symptoms.17 For this reason, the United States Preventive Services Task Force recommends that all adults at high risk—defined as past or current injection drug use, receiving a blood transfusion prior to 1992, long-term hemodialysis, born to a HCV-infected mother, incarcerations, intranasal drug use, getting unregulated tattoos and other percutaneous exposure, or adults born between 1945 and 1965—be screened at least once with a grade B recommendation.18
Community pharmacists are able to recommend OTC screening for HCV, but can also help administer, interpret, and connect patients to care through screenings similar to HIV screenings. Additionally, once a patient is confirmed to have HCV, community pharmacists are the last line to ensure correct pharmacotherapy. The guideline for the treatment of HCV is constantly being updated because of the specialty market, but any community pharmacist can verify genotype and therapy.19 For example, sofosbuvir (Sovaldi) plus ribavirin is only indicated for a patient with genotype 2; if a patient presents with a prescription for this combination, the medications should not be dispensed unless the correct genotype is confirmed.19 The guidelines for HCV treatment are found through the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.19
Rheumatoid Arthritis Quick Review and Pharmacotherapy Pearls
Rheumatoid arthritis is an autoimmune disorder that causes systemic inflammation typically targeting joints, but manifests in other organ systems as well. An estimated 1.5 million adults in the U.S. are diagnosed with RA; however, these data are from 2005.20 Diagnosis occurs through physical examinations and laboratory monitoring—there is no screening available to the community pharmacy. Once diagnosed, RA is treated highly aggressively with potent medications including nonbiologic disease-modifying antirheumatic drugs and biologic agents. Two previous articles in U.S. Pharmacist cover RA in more detail.21,22
Community pharmacists can perform a vital role in the management of RA. A paucity of specialists in RA leaves routine management to family practitioners, yet the guidelines advocate for specialized care. Pharmacists can help fill the gap and provide chronic care management, such as MTM. According to the CMS, RA is one of the top 10 contracted medical conditions for MTM services.23 An effective and efficient method of caring for patients with RA is to conduct a disease activity evaluation during medication pick-up and then follow up with the results to other providers to help augment care. The most practical disease activity scale for community pharmacists is the Patient Activity Scale II (PAS-II), which can be found with the guidelines at the American College of Rheumatology website.23 Succinctly, if a patient is not considered to be in remission or experiencing low disease activity within 3 months, the medications for RA need a dose change or another agent should be added.21,22,24
Multiple Sclerosis Quick Review and Pharmacotherapy Pearls
Multiple sclerosis affects more than 2.3 million people worldwide and is an inflammatory, autoimmune disease of the central nervous system that often presents in individuals between their second and fourth decade of life.25 MS causes recurrent inflammatory destruction of the myelin sheath, which serves as a protective insulation in the brain and spinal cord. When the myelin is destroyed, this results in incomplete and poor nerve conduction.25
Disease-modifying agents are regularly used for patients with MS. These medications can reduce number of relapses and severity.25 There are many medications that are used in MS to manage symptoms such as spasticity, pain, bladder problems, fatigue, sexual dysfunction, and weakness.25 Community pharmacists can play a role in helping patients with their acute MS symptoms while preventing chronic MS symptoms (i.e., ambulation problems, cognitive impairment, heat sensitivity, mood changes).25
Oncology Quick Review and Pharmacotherapy Pearls
Cancer is among the leading causes of death worldwide. In 2016, an estimated 1,685,210 new cases of cancer will be diagnosed in the U.S.26 The most common cancers are breast cancer, lung cancer, prostate cancer, colon and rectal cancer, bladder cancer, melanoma of the skin, non-Hodgkin lymphoma, thyroid cancer, kidney and renal pelvis cancer, leukemia, endometrial cancer, and pancreatic cancer.26 National expenditure for cancer care is projected to reach $156 billion in 2020.26 Although cancer death rates have been declining and cancer survivor rates are improving, considerable amounts of research are still necessary.
Chemotherapy is usually thought of as an intravenous medication, but oral chemotherapy drugs are becoming more common. Community pharmacists are beginning to dispense more anticancer medications, especially as cancer research progresses. If not involved directly with dispensing of chemotherapy agents, community pharmacists will still be in contact with these patients. For example, many of the chemotherapy agents will cause neutropenia, placing patients at a higher risk of infection. Patients may present with a fever as the first sign of an infection, and fever in patients with cancer needs treatment right away; a simple referral to the hospital can save a patient’s life. Patients are often started on a steroid to coincide with their cancer treatment. A simple recommendation to patients about monitoring their blood glucose while on the steroid could potentially make a huge difference in a patient’s life. A productive method of treating patients with cancer is to be current with all of their medications, monitor adherence, be aware of appropriate supportive care, and confirm follow-up.
Community pharmacists are poised to make a difference in the care of patients receiving specialty medications. Based on the survey, more communication between specialty pharmacies, manufacturers, and community pharmacists is needed to help fully educate and care for patients.
1. The growth of specialty pharmacy: current trends and future opportunities. www.unitedhealthgroup.com/~/media/uhg/pdf/2014/unh-the-growth-of-specialty-pharmacy.ashx. Accessed January 14, 2016.
2. World Preview 2013, Outlook to 2013, EvaluatePharma, July 2013.
3. National Association of Chain Drug Stores. Specialty pharmacy in community pharmacy: the time is now—and how! www.nacds.org/pdfs/membership/white_paper_speciality_pharmacy.pdf. Accessed January 14, 2016.
4. Specialty drugs: a primer for pharmacists and technicians. Pharmacist’s Letter. http://pharmacistsletter.therapeuticresearch.com/ce/cecourse.aspx?pc=14-306&AspxAutoDetectCookieSupport=1. Accessed January 14, 2016.
5. American Pharmacist’s Association; Hagerman J, Freed S, Rice G. Specialty pharmacy: a unique and growing industry. www.pharmacist.com/node/265027?is_sso_called=1. Accessed January 14, 2016.
6. OSI Pharmaceuticals. Tips for managing your treatment with Tarceva. www.tarceva.com/patient/taking-tarceva/tips-for-managing-treatment. Accessed March 10, 2016.
7. Ledinasvir/sofobuvir. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
8. Sofosbuvir. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
9. Etanercept. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
10. Adalimumab. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
11. Infliximab. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc; Accessed April 2, 2016.
12. Glatiramer acetate. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
13. Dimethyl fumarate. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Accessed April 2, 2016.
14. Pegfilgrastim. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
15. Rituximab. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
16. Bevacizumab. Lexi-Comp Online. Hudson, OH: Lexi-Comp, Inc (Lexi-Drugs). Lexi-Comp, Inc. Accessed April 2, 2016.
17. CDC. Viral hepatitis-hepatitis C information. www.cdc.gov/hepatitis/hcv/index.htm. Accessed March 10, 2016.
18. U.S. Preventive Services Task Force. Hepatitis C: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/hepatitis-c-screening. Accessed March 10, 2016.
19. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. www.hcvguidelines.org. Accessed March 10, 2016.
20. CDC. Rheumatoid arthritis. www.cdc.gov/arthritis/basics/rheumatoid.htm. Accessed March 10, 2016.
21. Eaton AT, Davis PN, Ndefo UA, Ebiogwu A. Update on pharmacotherapeutic options for rheumatoid arthritis. US Pharm. 2013;38(10):44-48.
22. Murphy E, Newsome R, Galdo JA. Specialty pharmacy: rheumatoid arthritis pharmacotherapy review. US Pharm. 2014;39(3)(Oncology suppl):3-6.
23. CMS. 2014 Medicare Part D Medication Therapy Management Programs. Fact sheet summary of the 2014 MTM programs. August 21, 2014. www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/CY2014-MTM-Fact-Sheet.pdf. Accessed June 5, 2015.
24. American College of Rheumatology. 2015 guidelines for the treatment of rheumatoid arthritis. www.rheumatology.org/Portals/0/Files/ACR%202015%20RA%20Guideline.pdf. Accessed March 10, 2016.
25. National MS Society. http://www.nationalmssociety.org/For-Professionals/Clinical-Care/Managing-MS/Symptom-Management. Accessed March 28, 2016.
26. National InstituteS of Health: National Cancer Institute. www.cancer.gov/about-cancer/what-is-cancer/statistics. Accessed March 28, 2016.
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