specialty pharmacy: trending to the futureelearning.pharmacist.com/files/org/891a6284d25f43...21...

www.pharmacist.com OCTOBER 2016 • PharmacyToday 77

Abstract

Objective: To provide information on specialty pharmacies, associated condi-tions and medications, services and trends aligned within the specialty niche, and applicable challenges and opportunities.

Data sources: Product labeling supplemented selectively with published studies and drug information reference sources.

Summary: Each year, the specialty pharmaceuticals market share has grown drastically. The number of novel drugs approved by FDA has grown by appropri-ately 45%–50% from 2010 to 2015. Proportionally, the number of specialty medica-tions approved has also risen, keeping the ratio of novel drugs to specialty drugs consistently around 50%. This is also evident for approvals in 2016, in which 16 novel drugs have been approved by FDA to date, 8 of them designated as specialty medications. This growth is fueled not only by approvals in more common dis-eases such as oncology and hepatitis, but in rare or orphan diseases as well, with two of the four FDA biologic approvals categorized as specialty medications for the treatment of the rare disease hemophilia. While the proportion of specialty medications approved has remained the same, medication spending within the specialty market has increased from 24% in 2010 to 36%–38% in 2015 and is project-ed to continue to exponentially grow to about 50% by 2018. Furthermore, while the overall use of specialty prescriptions is less than 2%, the average cost per patient per year exceeds $10,000, and more than one-half of the medications cost more than $100,000.

Conclusion: Over the years, specialty pharmacy’s growth has enabled the health care industry to promote patient care through new drug therapies, more in-depth patient care, and partnerships with all stakeholders involved. Specialty medication development will continue to rise, bringing with it new or improved approaches to patient care, operational processes, and standardization.

Pharm Today. 2016;22(10):77–92

CPE

Specialty pharmacy: Trending to the future Kelly Procailo, Cara Maxwell, and Kanika Kapoor

Kelly Procailo, PharmD, BCOP, Clinical Oncology Senior Manager; Cara Maxwell, PharmD, Clinical Pharmacist; and Kanika Kapoor, PharmD, Clinical Pharmacist, Diplomat, Flint, MI

Correspondence: Kelly Procailo, 4100 S. Saginaw St., Flint, MI 48507; [email protected]

Learning objectivesAfter participating in this activity, partici-pants will be able to

■ List characteristics of specialty phar-macies and specialty pharmaceuticals.

■ Identify characteristics of specialty pharmacy models, including services offered to patients, manufacturers, and payers.

■ Describe industry trends within the specialty pharmacy marketplace.

■ Discuss challenges and opportunities associated with developing a specialty pharmacy practice.

The American Pharmacists Association (APhA) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Number assigned to this activity by the accredited provider is 0202-0000-16-191-H04-P.

Advisory board: Helen Sairany, BSc, PharmD, BCACP, Associate Director, Content Develop-ment, APhA; Lisa Kumor, PharmD, BCACP, Clinical Assistant Professor, University of Illinois at Chicago; and Joann Stubbings, BSPharm, MHCA, Assistant Director, Specialty Pharmacy Services, University of Illinois at Chicago.

Disclosures: Helen Sairany, BSc, PharmD, BCACP, and APhA’s editorial staff declare no con-flicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the APhA Accreditation Information section at www.pharmacist.com/education.

Development: This home-study CPE activity was developed by the American Pharmacists Association.

Accreditation informationProvider: American Pharmacists AssociationTarget audience: PharmacistsRelease date: October 1, 2016Expiration date: October 1, 2019Learning level: 1

ACPE number: 0202-0000-16-191-H04-PCPE credit: 2 hours (CEUs)Fee: There is no fee associated with this activity for members of the American Pharmacists As-sociation. There is a $25 fee for nonmembers.

www.pharmacytoday.org78 PharmacyToday • OCTOEBR 2016

CPE specialty pharmacy trends

ObjectiveTo develop a better understanding of the changing pharma-ceutical market, it is crucial to have a good understanding of the specialty pharmacy industry. This article covers infor-mation on specialty pharmacies, associated conditions and medications, services and trends aligned within the special-ty niche, and applicable challenges and opportunities.

BackgroundEach year, the specialty pharmaceuticals market share has grown drastically, bringing specialty medications and phar-macies into the spotlight. The number of novel drugs ap-proved by FDA has grown by approximately 45%–50% from 2010 to 2015 (Figure 1).1 Proportionally, the number of spe-cialty medications approved has also risen, keeping the ratio of novel drugs to specialty drugs consistently around 50%. This is also evident for approvals in 2016, in which 16 novel drugs have been FDA approved to date, 8 of them designated as specialty medications.2

This growth is fueled not only by approvals for the treat-ment of common diseases in oncology and hepatitis but also for treatment of rare or orphan diseases, with two of the four FDA biologic approvals categorized as specialty medications for treatment of the rare disease hemophilia.3 While the pro-portion of specialty medications approved has remained the same, medication spending within the specialty market in-creased from 24% in 2010 to 36%–38% in 2015 and is projected to continue to exponentially grow to about 50% by 2018.4,5

Furthermore, while overall use of specialty prescriptions

is less than 2% of prescriptions dispensed, the average cost per patient per year exceeds $10,000, and more than one-half of the medications cost more than $100,000 in U.S. dollars.6 That accounts for 37% of prescription drug spend in the Unit-ed States.4,5

Figure 1. FDA’s novel drug approvals from 2010 to 2015

Pharmacy Today October 2016 – Specialty Pharmacy Focus

Figures

Figure 1: FDA’s Novel Drug Approvals from 2010 to 2015

Figure 2: Common Specialty Pharmacy Services

201021 201129 201239 201327 201441 201545

Coordination of deliveries, refills, education, and access to a health care professional in collaboration with all stakeholders (i.e., payers, prescribers, caregivers)

Care coordination

24/7 availability of a highly trained clinician for questions, education, and counseling

Access to health care professionals

Care plans designed to educate and monitor medication efficacy and safety in patients with specific disease states

Condition-based care plans and outcomes

Safety strategy to manage a serious risk associated with a medication, allowing patients continued access through safe use management

Risk evaluation and mitigation strategies

Identification and reporting (i.e., via manufacturer, MedWatch) of adverse effects a patient experiences, with counseling on self-management

Adverse effect management and reporting

Clinician-provided education to patients on disease state and medication, while monitoring for adverse effects when following up at integral points in therapy

Patient education, monitoring, and follow-up

Offering services such as nursing, dietary, psychosocial assistance, suicide hotline, or translation services to patients as applicable to their condition, medication, or overall needs

Specialized services

Assisting prescribers with collecting and completing prior authorization and appeals requirementsBenefit investigation

Connecting patients with applicable methods to reduce copay amounts, such as copay cards, manufacturer programs, and/or third-party funding based on their insurance limitations

Patient assistance

Protocol for a particular drug therapy, including proactive interventions at key points in therapy to address knowledge gaps, adverse events, or adherence concerns

Adherence programs

Staff or services that help guide patients through complicated health care processes and ensure clinicians are acting in patients’ best interestPatient advocacy

Specialty pharmaceuticalsA universal definition of specialty medication has yet to be established. CMS defines a specialty medication as a medi-cation costing more than $600 per month.7 Blue Cross Blue Shield of Michigan and Prime Therapeutics Specialty Phar-macy do not use cost as part of their definition but instead describe specialty medications as products that treat com-plex chronic conditions and require special handling, ad-ministration, and monitoring.8,9 The National Association of Chain Drug Stores (NACDS) defines specialty medications as “products used to treat chronic, high-cost, or rare diseases [that] can be injectable, infusible, oral, or inhaled medica-tions. Specialty pharmaceuticals tend to be more complex to maintain, administer, and monitor than traditional drugs; therefore they require closer supervision and monitoring of a patient’s overall therapy.”10

Another detailed definition comes from IMS Health, which incorporates prescriber type and exclusions in addi-tion to the above-mentioned components: “products that are often injectable, high-cost, biologics, or require cold-chain distribution. They are often initiated by specialists, include treatments for cancer and other chronic conditions, and often require complex patient follow-up and monitoring. Support-ive care products are not included in the oncology market.”4

With no standard definition, each specialty pharmacy uses its own definition and criteria, as applicable to the specialty pharmacy’s individualized model. Variability in the defini-tions leads to additional complexity in the specialty market-place and creates obstacles for all stakeholders involved. For example, it can affect coverage of a patient’s medication, the copay, and the pharmacies at which the medication would be available.

Characteristics that describe a specialty medication across a vast majority of the definitions include diagnosis of a chronic, complex, or rare condition; high cost; specialized storage and handling; complex administration; adverse effects/warnings; patient education and monitoring; and distribution channel. Examples of complex chronic conditions commonly treated with specialty medications are listed in Table 1.

According to an Rx Price Watch Report by the Ameri-can Association of Retired Persons, in 2013, the average an-nual price of a specialty medication ($53,384) was drastically higher than that of a brand-name prescription medication

Preassessment questionsBefore participating in this activity, test your knowledge by answer-ing the following questions. These questions will also be part of the CPE assessment.

1. Which of the following characteristics is associated with specialty medications, according to the various definitions?a. Lack of prior authorization requirementb. Limited distribution channelc. Simple administration techniquesd. Low-cost medication

2. An example of ad-hoc services offered by the specialty phar-macy to manufacturers may include which of the following?a. Hub servicesb. Pharmacy and therapeutics monograph servicesc. Formulary management servicesd. Prior authorization approval services

3. What disease states have seen the largest increase in specialty medication spend?a. Oncology, HIV, orphan diseasesb. Oncology, cystic fibrosis, hepatitisc. Oncology, hepatitis, HIVd. Oncology, hepatitis, autoimmune disorders



($2,960) and generic prescription drug ($283) by 18 times and 189 times, respectively.11 Most injectable and infused spe-cialty products, especially biologics such as tumor necrosis factor (TNF)–alpha adalimumab (Humira—AbbVie), need to be stored between 2° and 8° C to maintain their viability and integrity.12 To be compliant with the medication stability re-quirements for these drugs, the product must be maintained in a rigid temperature-sensitive environment or cold-chain distribution from time of dispensing to delivery. A Pharma-ceutical Commerce article, “The 2015 Biopharma Cold Chain Landscape,” estimated that by 2019, cold-chain drugs and biologics will overtake overall industry sales.13

Along with appropriate handling, specific specialty med-ications may also warrant disease and drug-specific patient education to explain complex administration, dosing regi-mens, and severe adverse effects, thereby encouraging medi-cation compliance. For example, it is crucial that a patient be-ing treated for metastatic, castration-resistant prostate cancer with abiraterone (Zytiga—Janssen Biotech) understands that four 250-mg tablets are to be taken once daily by mouth at the same time on an empty stomach. Educating the patient on administration can mitigate adverse effects resulting from abiraterone’s increased serum concentrations when taken with food.

In addition, ensuring that the patient is treated with a concomitant corticosteroid will assist in reducing the min-eralocorticoid level effects, such as hypertension, fluid reten-tion, and hypokalemia secondary to the cytochrome P450 17 inhibition.14 Lack of proper education can increase the risk of adverse effects and lead to treatment abandonment or in-appropriate self-modification, thereby negatively affecting overall medication compliance and patient outcomes as well as wasting medical dollars.

Distribution is the last characteristic that is part of the various specialty medication definitions. Specialty medica-tion distribution can vary at either the distributor level (e.g., AmerisourceBergen) or pharmacy level. At the distributor level, manufacturers may choose to limit availability of the medication to an authorized wholesale distributor, allowing only pharmacies in contractual agreements with the dis-tributor to order and dispense the medication. This is typi-cally called managed distribution and is seen with lapatinib (Tykerb—Novartis).15

Pharmacy-based distribution channels, on the other hand, are described as open, limited, or exclusive. Open dis-tribution allows all pharmacies to dispense a medication, such as ledipasvir/sofosbuvir (Harvoni—Gilead) for treat-ment of hepatitis C virus. For limited distribution, the man-

Table 1. Examples of conditions treated by specialty medications

Conditions Medications

Asthma Mepolizumab (Nucala), reslizumab (Cinqair)

Cardiovascular conditions Alirocumab (Repatha), alirocumab (Praluent)

Cystic fibrosis Lumacaftor/ivacaftor (Orkambi), ivacaftor (Kalydeco)

Psoriasis Apremilast (Otezla), adalimumab (Humira)

Growth hormone deficiency Somatropin (Genotropin), somatropin (Nutropin)

Hemophilia and bleeding disorders Factor IX, recombinant (Alprolix); Factor VIII, human (Nuwiq)

Hepatitis Ledipasvir/sofosbuvir (Harvoni), velpatsvir/sofosbuvir (Zepatier)

Hereditary angioedema C1 esterase inhibitor, human (Berinert); icatibant injection (Firazyr)

HIVElvitegravir, cobicistat, emtricitabine, tenofovir (Stribild); emtricitabine, rilpivirine, tenofovir alafenamide (Odefsey)

Primary immune deficienciesSubcutaneous immune globulin (HyQvia 10%), Intravenous immune globulin (Bivigam 10%)

Crohn disease, ulcerative colitis Certolizumab (Cimzia), golimumab (Simponi)

Multiple sclerosis Interferon beta-1a (Avonex), dimethyl fumarate (Tecfidera)

Oncology Everolimus (Afinitor), lenalidomide (Revlimid)

Osteoporosis Teriparatide (Forteo), denosumab (Prolia)

Alpha-1 antitrypsin deficiency lysosomal storage disorders

Alpha1-proteinase inhibitor, human (Aralast NP); agalsidase beta (Fabrazyme)

Respiratory syncytial virus Palivizumab (Synagis)

Rheumatoid arthritis Etanercept (Enbrel), abatacept (Orencia)

Transplant Mycophenolate (CellCept), tacrolimus (Prograf)



ufacturer restricts dispensing to only a few pharmacies on the basis of their service capabilities to cater to the product-specific needs and improve patient outcomes.

One example would be to meet the requirements of a FDA-mandated risk evaluation and mitigation strategies (REMS) program for a specific drug, such as lenalidomide (Revlimid—Celgene). Exclusive distribution is similar to limited distribution, but only a single pharmacy is selected to dispense the medication. Table 2 lists all FDA-approved specialty drugs and biologics with their associated type of pharmacy-based distribution channel for 2015 (45 medica-tions) and 2016 (16 medications).16–18 Limited distribution of-fers more control over the pharmacy distribution channel at the expense of widespread patient access to medication.

Specialty pharmacies Now that we have reviewed what specialty drugs are, it is easier to understand what a specialty pharmacy is and what components must be present to dispense these specialty medications. NACDS defines specialty pharmacy as “the service created to manage the handling and service require-ments of specialty pharmaceuticals, including dispensing, distribution, reimbursement, case-management, and other services specific to patients with rare and/or chronic dis-eases.”10 While evaluating the role of specialty pharmacy in dispensing oncolytics, the National Comprehensive Cancer Network defined the goals of a specialty pharmacy as “the optimization of pharmaceutical care outcomes through en-suring appropriate medication use, maximizing medication adherence, and optimizing economic outcomes through avoiding unwarranted drug (and medical) expenditure.”19

These goals help specialty pharmacies focus on meeting the needs of every stakeholder involved, from patient and pro-vider to payer and manufacturer. By maximizing medication use and adherence, specialty pharmacies are meeting the needs of our providers and patients to improve health outcomes. In-creasing adherence and avoiding unwarranted drug costs through proactive outreach calls, education, and monitoring benefit the payer clients. Most important, specialty pharmacies ensure patients get the health care they need while minimiz-ing repeat therapy, hospital (re)admission, and comorbidities. Last, specialty pharmacies meet the needs of manufacturers by improving adherence and helping to support patients’ medica-tion tolerance so they can continue therapy.

Specialty pharmacy models and servicesWithin this rapidly growing industry, numerous specialty pharmacies have entered the market. Specialty pharmacy models can vary on the basis of multiple factors; the common differentiators include ownership and disease state/area focus. Today, ownership of specialty pharmacies is becom-ing quite varied as a result of this growth and may include PBMs, drugstore chains, health plans, physician practices, re-tail or community pharmacies, hospital/health-system phar-macies, and independent pharmacies.20

From 2013 to 2014, the top five pharmacies had a 5% drop (68%–62%) in overall market share, which could be ac-counted for by increased growth in the market space.20,21 In 2015, the top five specialty pharmacies in specialty medica-tion market share were CVS Specialty Pharmacy (30%), Ac-credo (18%), Walgreens Specialty Pharmacy (10%), BriovaRx (7%), and Diplomat (3%).22 Their percentage of the market share increased again to 68% in 2015 because major players acquired smaller pharmacies, such as CVS Health’s acquisi-tion of Omnicare in 2015. Other variations in models may be due to specialization in a certain niche or condition, al-lowing the specialty pharmacies to be experts in that spe-cific area. For example, specialty pharmacies Onco360 and Biologics Inc. specialize in the oncology field, while BioRx and MedProRx can be deemed as experts on infusion-based medications.

Depending on the specific ownership, size, or focus, spe-cialty pharmacies may offer a diverse assortment of services for their customers (patients and prescribers) and clients (payers and manufacturers). For example, pharmacies ex-perienced in dispensing infused medications such as Factor VIII, human (Advate—Baxalta) for hemophilia A treatment would ensure availability of home or clinic nursing services for drug administration. With such complex medications, it is important to have the right services, technology, and op-erating model to appropriately dispense the drugs, educate patients, and follow up on efficacy. This process ensures pa-tients receive the care they need according to their condition and specific therapy. Because the services offered by special-ty pharmacies vary based on their model and expertise, in Figure 4 we provide a schematic of some of the most com-mon services that specialty pharmacies may offer to meet their stakeholders’ goals and commitments.

Case 1: Psoriasis—administration tips for self-injectable productsPeter is a 42-year-old man who was recently diagnosed with moder-ate plaque psoriasis and prescribed treatment with adalimumab prefilled pens. The specialty pharmacy processed his new prescrip-tion, obtained funding assistance, and set up delivery. Following delivery set-up, Peter is transferred to a pharmacist to discuss his new medication.

In terms of administration, what key practice points should the pharmacist address with Peter?

■ Confirmation of any latex allergies ■ Induction and maintenance dosing ■ Subcutaneous route definition ■ Administration technique ■ Stability (e.g., single-use vs. multiuse) ■ Supplies (e.g., alcohol pads, Sharps container) ■ Sterilization and rotation of injection site ■ Potential for injection site or hypersensitivity reactions ■ Storage (e.g., discard product if frozen, keep medication in

refrigerator or at room temperature for a maximum of 14 days if traveling)

■ Proper medication and Sharps disposal



Table 2. 2015 and 2016 FDA-approved specialty medications

Medication Indication Approval dateDistribution channel Approval type

2015 approvals

Secukinumab (Cosentyx) Plaque psoriasis 1/21/2015 Limited Novel

Parathyroid hormone (Natpara) Hypoparathyroidism 1/23/2015 Limited Novel

Cobicistat/darunavir (Prezcobix) HIV 1/29/2015 Open Combination

Atazanavir/cobicistat (Evotaz) HIV 1/29/2015 Open Combination

Palbociclib (Ibrance) Oncology: metastatic breast cancer 2/3/2015 Limited Novel

Lamivudine/raltegravir (Dutrebis) HIV 2/6/2015 Open Combination

Lenvatinib (Lenvima) Oncology: differentiated thyroid cancer 2/13/2015 Limited Novel

Panobinostat (Farydak) Oncology: multiple myeloma 2/23/2015 Limited Novel

Nivolumab (Opdivo)

Oncology: melanoma, non–small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma 3/4/2015 Open Novel

Filgrastim-sndz (Zarxio) Oncology: neutropenia 3/6/2015 Open Biosimilar

Dinutuximab (Unituxin) Oncology: neuroblastoma 3/10/2015 Open Novel

Cholic acid (Cholbam) Bile acid synthesis and peroxismal disorders 3/17/2015 Limited Novel

Ivacaftor (Kalydeco) Cystic fibrosis 3/17/2015 Limited Dosage

Deferasirox (Jadenu) Iron overload 3/30/2015 Open Formulation

Coagulation Factor IX (Ixinity) Hemophilia B 4/29/2015 Open Biological

Lumacaftor/ivacaftor (Orkambi) Cystic fibrosis 7/2/2015 Limited Novel

Gefitinib (Iressa) Oncology: non–small cell lung cancer 7/13/2015 Limited Formulation

Sonidegib (Odomzo) Oncology: basal cell carcinoma 7/24/2015 Open Novel

Daclatasvir (Daklinza) Hepatitis C virus 7/24/2015 Open Novel

Alirocumab (Praluent)Hypercholesterolemia or atherosclerotic cardiovascular disease 7/24/2015 Open Novel

Ombitasvir/paritaprevir/ritonavir (Technivie) Hepatitis C virus 7/24/2015 Open Formulation

Eltrombopag olamine (Promacta) Thrombocytopenia 8/24/2015 Open Dosage

Evolocumab (Repatha)Hypercholesterolemia or atherosclerotic cardiovascular disease 8/27/2015 Open Novel

Uridine triacetate (Xuriden) Hereditary orotic aciduria 9/4/2015 Open Novel

Antihemophilic Factor rAHF (Nuwiq) Hemophilia A 9/4/2015 Open Biological

Deferiprone (Ferriprox) Iron overload 9/9/2015 Limited Dosage

Trifluridine/tipiracil (Lonsurf) Oncology: colorectal cancer 9/22/2015 Limited Novel

Coagulation Factor X (Coagadex) Hereditary Factor X deficiency 10/20/2015 Limited Biological

Irinotecan liposome (Onivyde) Oncology: metastatic pancreatic cancer 10/22/2015 Open Formulation

Trabectedin (Yondelis) Oncology: Liposarcoma and leiomyosarcoma 10/23/2015 Open Novel

Asfotase alfa (Strensiq) Hypophosphatasia 10/23/2015 Limited Novel

Mepolizumab (Nucala) Asthma 11/4/2015 Limited Novel

Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide (Genvoya) HIV 11/5/2015 Open Novel

Continued on next page



Table 2. 2015 and 2016 FDA-approved specialty medications

Medication Indication Approval dateDistribution channel Approval type

Cobimetinib (Cotellic) Oncology: advanced melanoma 11/10/2015 Limited Novel

Osimertinib (Tagrisso) Oncology: non–small cell lung cancer 11/13/2015 Limited Novel

Antihemophilic factor, pegylated (Adynovate) Hemophilia A 11/13/2015 Open Biological

Daratumumab (Darzalex) Oncology: multiple myeloma 11/16/2015 Open Novel

Ixazomib (Ninlaro) Oncology: multiple myeloma 11/20/2015 Limited Novel

Necitumumab (Portrazza) Oncology: non–small cell lung cancer 11/24/2015 Limited Novel

Elotuzumab (Empliciti) Oncology: multiple myeloma 11/30/2015 Open Novel

Bendamustine (Bendeka)Oncology: chronic lymphocytic leukemia, non-Hodgkin lymphoma 12/7/2015 Open Formulation

Sebelipase alfa (Kanuma) Lysosomal acid lipase deficiency 12/8/2015 Limited Novel

von Willebrand factor (Vonvendi) von Willebrand disease 12/8/2015 Open Biological

Alectinib (Alecensa) Oncology: ALK-positive lung cancer 12/11/2015 Limited Novel

Selexipag (Uptravi) Pulmonary arterial hypertension 12/22/2015 Limited Novel

2016 approvals

Elbasvir/grazoprevir (Zepatier) Hepatitis C virus 1/28/2016 Open Novel

Tofacitinib (Xeljanz XR) Rheumatoid arthritis 2/23/2016 Open Dosage

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) HIV 3/1/2016 Open Combination

Coagulation Factor IX albumin fusion protein (Idelvion) Perioperative bleeding 3/4/2016 Open Biological

Antihemophilic factor (Kovaltry) Hemophilia A 3/16/2016 Open Biological

Ixekizumab (Taltz) Plaque psoriasis 3/22/2016 Limited Novel

Reslizumab (Cinqair) Asthma 3/23/2016 Limited Novel

Emtricitabine/tenofovir alafenamide (Descovy) HIV 4/4/2016 Open Combination

Infliximab-dyyb (Inflectra)

Crohn disease, ulcerative colitis, rheumatoid and psoriatic arthritis, anklyosing spondyli-tis, plaque psoriasis 4/5/2016 Open Biosimilar

Venetoclax (Venclexta) Oncology: chronic lymphocytic leukemia 4/11/2016 Limited Novel

Cabozantinib (Cabometyx) Oncology: renal cell carcinoma 4/25/2016 Limited Dosage

Atezolizumab (Tecentriq) Oncology: bladder cancer 5/18/2016 Open Novel

Obeticholic acid (Ocaliva) Chronic liver disease 5/27/2016 Limited Novel

Daclizumab (Zinbryta) Multiple sclerosis 5/27/2016 Limited Novel

Sofosbuvir/velpatasvir (Epclusa) Hepatitis C virus 6/28/2016 Open Novel

Dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira XR) Hepatitis C virus 7/22/2016 Open Dosage

Etanercept-szzs (Erelzi)

Rheumatoid, polyarticular juvenile idiopathic and psoriatic arthritis, anklyosing spondyli-tis, plaque psoriasis 8/30/2016 Open Biosimilar

Abbreviations used: Limited, limited or exclusive distribution channel; Novel, new molecular entity; Combination, new combination; Dosage, new dosage form; Formulation, new formulation or manufacturer; Biosimilar, biosimilar entity; Biological; biological entity.

Continued from page 81



Figure 2. Common specialty pharmacy services

Pharmacy Today October 2016 – Specialty Pharmacy Focus

Figures

Figure 1: FDA’s Novel Drug Approvals from 2010 to 2015

Figure 2: Common Specialty Pharmacy Services

201021 201129 201239 201327 201441 201545

Coordination of deliveries, refills, education, and access to a health care professional in collaboration with all stakeholders (i.e., payers, prescribers, caregivers)

Care coordination

24/7 availability of a highly trained clinician for questions, education, and counseling

Access to health care professionals

Care plans designed to educate and monitor medication efficacy and safety in patients with specific disease states

Condition-based care plans and outcomes

Safety strategy to manage a serious risk associated with a medication, allowing patients continued access through safe use management

Risk evaluation and mitigation strategies

Identification and reporting (i.e., via manufacturer, MedWatch) of adverse effects a patient experiences, with counseling on self-management

Adverse effect management and reporting

Clinician-provided education to patients on disease state and medication, while monitoring for adverse effects when following up at integral points in therapy

Patient education, monitoring, and follow-up

Offering services such as nursing, dietary, psychosocial assistance, suicide hotline, or translation services to patients as applicable to their condition, medication, or overall needs

Specialized services

Assisting prescribers with collecting and completing prior authorization and appeals requirementsBenefit investigation

Connecting patients with applicable methods to reduce copay amounts, such as copay cards, manufacturer programs, and/or third-party funding based on their insurance limitations

Patient assistance

Protocol for a particular drug therapy, including proactive interventions at key points in therapy to address knowledge gaps, adverse events, or adherence concerns

Adherence programs

Staff or services that help guide patients through complicated health care processes and ensure clinicians are acting in patients’ best interestPatient advocacy



Ad-hoc services for partnersAs mentioned previously, specialty pharmacies are entities that encompass interactions with patients, prescribers, pay-ers, and manufacturers. The complexities of specialty medi-cations and their associated conditions require high-touch services (Figure 2) for patients and their caregivers. Aside from patient-focused services, a specialty pharmacy may also offer a variety of ad-hoc services to other pharmacies, manufacturers, and payers. Again we note that a specialty pharmacy can be part of various models, such as PBMs, chain stores, retail pharmacies, or hospitals. With the exten-sive growth in the specialty medications market share, many pharmacies are constantly trying to gain access and dispense these medications.

For many traditional pharmacies, required patient ser-vices and access to specialty medications pose a major obsta-cle. To better enable these pharmacies to dispense specialty medications, traditional specialty pharmacies can form a partnership with them to provide the required clinical and operational support. In these partnerships, generally the re-tail, community, or hospital pharmacy will dispense all the open-distribution drugs themselves and have the specialty pharmacy provide the limited or exclusive drugs. In addi-tion, development of such specialty networks allows patients to obtain their medication in multiple ways, including at the retail setting, community or hospital pharmacy site, pre-scriber’s office, or directly to their home. For many retail or hospital pharmacies, partnering with these specialty phar-macies may become the first step in establishing their own internal specialty pharmacy.23

Depending on their model, specialty pharmacies may also offer manufacturers and payers additional services. For manufacturers, these can include but are not limited to hub services, patient assistance programs, and research opportu-nities. As with specialty pharmacy services, the components of hub services vary greatly. Hub services can entail either the full list of patient services depicted in Figure 2 or only a specific portion, such as benefits investigation. Depending on the manufacturer’s need, hub services can be contracted through either the manufacturer, PBM, third-party hub ser-vice provider, specialty pharmacy, or specialty distributor.24 To cater to manufacturer needs, many long-established specialty pharmacies that offer hub services may offer patient services under either the specialty pharmacy umbrella or as part of a firewalled hub service whereby the manufacturer can choose which services the patient receives “al la carte.”

In addition, specialty pharmacies collaborate with manu-facturers on noncommercial services such as quick start, Bridge support, or product replacement programs to coordinate med-ication access to patients. The purpose of quick start (at initia-tion of therapy) or Bridge (between-therapy fills) programs is to ensure quick patient access while the benefit investigation (including prior authorization or appeal process) is being pro-cessed, and until the pharmacy receives a paid claim from the patient’s insurance.25 Clinicians and care coordinators play an

integral role as a main point of contact for patients throughout their treatment journey. The specialty model allows for con-stant access to these patients to provide the support and care required to treat their complex, chronic, or rare diseases. This presents an opportunity for the specialty pharmacy to be a liaison to manufacturers by working closely with patients to capture information for research related to Phase IV trials and to improve adherence or condition-related outcomes.26 For ex-ample, the specialty pharmacy patient population can be uti-lized to assess adherence tools such as a weighted medication bottle, in which the dose is documented electronically each time a dose is taken (weight decrease in bottle). This allows for assessment in dose timing and frequency (or missed dose), ultimately ensuring the patient is adherent to therapy through various methods of technology.

Additional services generally extended to payers by spe-cialty pharmacies is secondary to their clinical expertise on medications and conditions. The market spending on spe-cialty medications increased to $150.8 billion in U.S. dollars from 2014 to 2015, with 70% from the oncology, autoimmune, hepatitis, and multiple sclerosis disease states.4 Managing oncology medications and services specifically has become a major concern for payers.27 With this unyielding increase in costs and condition-specific concerns, payers are becom-ing more anxious to increase their therapy management ef-ficiency. To do so, payers have begun to restrict the number of pharmacy networks available to a patient to obtain specialty medications, giving the payers better control and oversight of the patient’s therapy. This has also led to fostering rela-tionships in which specialty pharmacies provide utilization and formulary management to payers and optimal care to patients.

Case 2: Oncology—highlighting the value of specialty pharmacyBertha, a 72-year-old woman, has been living with multiple myeloma for more than 10 years. During her most recent visit with her hema-tologist, she was told her disease was progressing after 18 months of remission and was prescribed pomalidomide (Pomalyst—Cel-gene). Bertha’s new prescription is sent to her specialty pharmacy. A pharmacy representative, Sue, calls to inform Bertha that her medi-cation has a $250 copay and the pharmacy would like to help her find additional funding. Bertha is agreeable, as she lives on a limited income. With copay assistance from the manufacturer, Sue is able to relay to Bertha that her copay will be only $25. With funding in place, Bertha’s prescription is filled, and she is transferred to a clinician for medication counseling. Assuming you are the specialty pharmacist to whom Bertha has been transferred, what counseling points would you make sure to cover with her?

Dan, the pharmacist, talks to Bertha about her new medication (i.e., dosage, administration, adverse effects and associated mitiga-tion strategies, storage and disposal). Dan also reviews the REMS program with Bertha, explaining that the medication is associated with fetal birth defects. Although Bertha is not of childbearing poten-tial, her family members are at exposure risk because they help her keep on track with her medication schedule.



Specialty pharmacy trends Various specialty pharmacy market trends have been touched on throughout this article. In the following section, we highlight some of the more specific trends. As empha-sized previously, the specialty medications coming to mar-ket have created a surge in volume and cost. Spending on specialty medications from 2011 to 2015 has grown from $82 billion to $150.8 billion in U.S. dollars, with autoimmune dis-orders, hepatitis, and oncology seeing the largest increases.4

Autoimmune disorders, including conditions such as rheu-matoid arthritis, psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis, account for a net spending increase of $17.1 billion U.S. dollars from 2011 to 2015.4

About 3% of total U.S. market drug spending in 2015 can be attributed to two autoimmune therapies, adalimumab and enteracept (Enbrel—Amgen).4 Both medications, which are considered biologics, cost approximately $5,000 in U.S. dol-lars for a 1-month supply per patient.28,29 Biologics are prod-ucts “created by either a microorganism or mammalian cell and are large complex molecules, most of which are proteins or polypeptides.”30 Because conducting genetic research on biologics as well as developing and producing biologics are fairly complex and risky, biologics are much more expensive than chemically or synthetically derived drugs.30 Today, the majority of commonly used specialty medications indicated for treatment of autoimmune disorders, cystic fibrosis, ane-mia, hemophilia, immune deficiencies, cancer, and certain rare diseases are deemed biologics and are contributing to the increase in drug spend in the specialty market.

Recent advancements in biotechnology have led to, in layperson’s terms, the creation of a “generic” for biologics, called a biosimilar. FDA defines a biosimilar as “a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differ-ences in terms of safety and effectiveness from the reference product.”31 A biosimilar cannot be deemed equivalent to a bi-ologic because biologics are created in living organisms, and it is impossible to create an exact replica of the referenced bio-logic. This means biosimilars cannot be interchanged by the pharmacy with the reference biologic product unless certain additional FDA standards are met.

The first two biosimilars approved in the United States, filgrastim-sndz (Zarxio—Sandoz) and infliximab-dyyb (In-flectra—Pfizer), are not considered interchangeable with their reference biologic, filgrastim (Neupogen—Amgen) and infliximab (Remicade—Janssen), respectively.

Filgrastim-sndz was approved in March 2015 and launched in the market in August 2015 with a 15% discount in cost compared with its reference drug, filgrastim.32 This reduction in cost has already led to a savings of approxi-mately $72 million through the end of 2015 after attaining 5% of the sales.4 On the other hand, although it was approved in April 2016, infliximab-dyyb has not been launched in the market because of ongoing patent and legal concerns about

the biologic. The pharmaceutical pipeline currently has nu-merous biosimilars in development, including the high uti-lizers, adalimumab and enteracept, which could have a large impact on drug utilization and spend. Table 3 lists the bio-similars in the pipeline with estimated approval in 2016 or 2017.

The United States observed an exponential growth in the hepatitis market between 2013 and 2015, escalating from $1.9 billion (2013) to $18.8 billion in U.S. dollars (2015).4 The culprits for this skyrocket in spending were the direct-acting antivi-ral treatment options that show high cure rates for hepatitis C virus, which previously had limited, difficult-to-tolerate, and ineffective treatment options. Because of the extremely high costs associated with the medications (e.g., $94,500 in U.S. dollars for a 12-week treatment of ledipasvir/sofosbu-vir), most prior authorization requirements restricted treat-ment to patients who demonstrated liver damage and a fibro-sis score of greater then F2 or F3. With the recent approval of cheaper drugs and heavy rebates offered by manufacturers, some payers have loosened these restrictions.33 Furthermore, the clinical practice guidelines were also updated to no lon-ger prioritize patients on the basis of disease severity.34

As newer agents such as elbasvir and grazoprevir (Zepa-tier—Merck) have been added to the hepatitis C treatment realm, concerns related to resistance or polymorphisms have become more prominent. This has become more of a concern because patients for whom previous treatment has failed re-quire an additional 12- or 24-week treatment cycle of these new direct-acting agents, which leads to increased costs to the payer. On the other hand, manufacturers involved in the hepatitis C niche are conducting trials examining the polymorphisms detected in the proteins that direct-acting antivirals are affecting. This should help prescribers choose the best possible therapy for hepatitis C patients and thereby control costs in the future.

Oncology has experienced expansive growth, account-ing for approximately 63% of approvals in the pharmaceu-tical pipeline over the past 10 years and about one-third of the 2015 approvals.35 With these advancements in oncology treatments, there has been a focus on the development of oncology pathways to improve the clinical management and experience of patients with cancer. Oncology pathways allow prescribers to follow the extensively laid-out decision trees to determine next steps associated with taking care of the patient. According to payers, use of these pathways not only provides optimal care but also reduces overall direct and in-direct costs.36 Two separate studies on lung and colon cancer demonstrated lower attributed costs by 30%–35% without affecting the clinical result when compared with a control group not using clinical pathways.36 In EMD Serono’s Oncol-ogy Digest, 38% of payers had implemented the use of on-cology pathways, a 17% increase from 2014. In addition, 23% of payer plans are considering implementation in the near future.37

While the use of oncology pathways has clinical and



cost-savings benefits, it has also brought forth major con-cerns from the clinical society. Many clinicians have become extremely anxious about the lack of clinical evidence-based pathways, limitations on coverage for patient care, and con-sistency across the different pathway programs.36 Most of the current pathways cover aspects specific to diagnostic and treatment options, with limited coverage on supportive care, including palliative care, surgical options, and supportive therapies.

Considering these apprehensions, in January 2016, ASCO published a special article outlining the recommendations and future expectations of the pathway developments.36 Of the 18% spending increase associated with oncology medica-tions in 2015 compared with 2014, 74% were targeted options. Of these, 35% were monoclonal antibodies, 25% were protein kinase inhibitors, and 14% were other targeted therapies.4 The intention of targeted therapies is to concentrate the “at-tack” only on the specific proteins and components active in the proliferation of cancer cells, thereby leading to compara-tively fewer adverse effects for patients. This has led to many therapy options for the same cancer type, dependent on ge-netic mutations and variances.

For example, in non–small cell lung cancer with the epi-dermal growth factor receptor (EGFR) mutation, osimertinib (Tagrisso—AstraZeneca) is the drug of choice for treat-ment of a specific acquired mutation, T790M. Without this acquired mutation, other oral EGFR inhibitors, such as afa-tinib (Gilotrif—Boehringer-Ingelheim), erlotinib (Tarceva—Genentech), or gefitinib (Iressa—AstraZeneca), are therapy options. These mutation-specific targeted treatments have driven payers to require companion genetic diagnostic test-ing as a prerequisite for approval of a treatment to ensure appropriateness of therapy and efficacy.38

Besides oncology, another prominent area of research and drug development is in rare diseases, such as Duchenne muscular dystrophy and hemophilia. Recent advances in biotechnology, especially biologics, have caused an eruption of treatment options in the pipeline by both small and large pharmaceutical companies. Along with this trend, FDA has also seen a surge in drugs requested to be categorized under the orphan designation. Last year, FDA approved 355 out of 440 designation requests, with 40 of the approved drugs la-beled as orphan drugs.39 According to FDA, orphan drugs are defined as “drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of develop-ing and marketing a treatment drug.”40

A few examples of the 2016 approvals include adalim-umab for treatment of uveitis, ibrutinib (Imbruvica—Jans-sen) for treatment of small lymphocytic lymphoma, and venetoclax (Venclexta—AbbVie, Genentech) for treatment of chronic lymphocytic leukemia. Table 3 provides a complete list of expected approvals, including those indicated for or-

phan/rare indications for the remainder of 2016 through the end of 2017.

Challenges and opportunitiesDeveloping a specialty pharmacy involves overcoming the various challenges posed while optimizing the opportuni-ties present. A specialty pharmacy’s goal is to provide opti-mal care management that leads to beneficial outcomes for all the respective stakeholders: patient, prescriber, payer, and manufacturer. The following section covers specialty medi-cation access, accreditations, education and certifications, data analytics, clinical outcomes, and technology. One of the frustrating unknowns discussed previously in this article is the lack of definition surrounding specialty medications. With each stakeholder designating specialty medications ac-cording to their own criteria, determining which drugs to acquire and dispense as a pharmacy becomes difficult and confusing.

Clinical outcomes and performanceAs the specialty pharmacy market and related expenditures have grown exponentially in the past few decades, stake-holders have paid greater attention to expected clinical out-comes and performance. According to EMD Serono, in 2015, 71% of payers had been working to determine the value of specialty pharmaceuticals, ranked as the second-highest challenge.27 In addition, the prescriber, payer, and manu-facturer are constantly looking for the short- and long-term efficacy and safety of these medications. The desire to have access to this information has led to the improvement and evolution of care management and outcome measures within specialty pharmacies. Improvements in these two areas can be tied back to two main components, clinical efficacy and adherence. In real-life scenarios (postclinical trials), efficacy can be captured through direct interaction with patients or through patient-reported outcomes.41 Using condition-spe-cific assessment tools to obtain information on the patient’s status at baseline and throughout therapy helps determine the value added by ongoing treatment.

For example, patients can be assessed throughout therapy with tools such as the Harvey–Bradshaw Index to measure Crohn disease severity or the Patient Health Ques-tionnaire–2 (PHQ-2) and PHQ-9 to screen for depression in conditions associated with high depression rates (e.g., mul-tiple sclerosis).41 These tools also provide the opportunity to dig deeper into the crux of the problem and intervene when a patient experiences relapses, exacerbations, adverse effects, potential drug interactions, administration difficulties, and lack of medication efficacy, all of which affect medication ad-herence.

Adherence can be measured in multiple ways. The two most common approaches are medication possession ratio (MPR) and proportion of days covered (PDC). MPR is de-fined as the sum of all the days’ supply in a given time period over the total number of days in the respective time period



Table 3. Expected approvals for 2016 and 2017a

Medication Manufacturer Indication Approval typeProjected expected approval timeline

Eteplirsen Sarepta Duchenne muscular dystrophy Novel therapy Q2 2016

IGSC 20% BaxaltaPrimary immune deficiency disease Formulation change Q3 2016

Adalimumab (ABP-501) Amgen, Sandoz Refer to reference product Biosimilar Q3 2016

Human normal IVIG Green CrossPrimary immune deficiency disease Novel therapy Q3 2016

Lumacaftor/ivacaftor Vertex Cystic fibrosis Expanded indication Q3 2016

Ustekinumab Janssen Crohn disease Expanded indication Q3 2016

N9-GP/NN7999Novo Nordisk, Neose Technologies Hemophilia B Novel therapy Q4 2016

Sarilumab Regeneron, Sanofi Rheumatoid arthritis Novel therapy Q4 2016

Adalimumab (CHS-1420) Coherus Refer to reference product Biosimilar Q4 2016

Brodalumab Valeant Plaque psoriasis Novel therapy Q4 2016

Baricitinib Incyte, Lilly Rheumatoid arthritis Novel therapy Q4 2016

Telotristat etiprate Lexicon Oncology: carcinoid syndrome Novel therapy Q4 2016

Antihemophilic Factor VIII (recombinant), pegylated Baxalta, Nektar Hemophilia A Expanded indication Q4 2016

Ocrelizumab Genentech Multiple sclerosis Novel therapy Q4 2016

Binimetinib Array Oncology: melanoma Novel therapy Q4 2016

Blisibimod Amgen Systemic lupus erythmatosus Novel therapy Q4 2016

Epoetin alfa Hospira Anemia Biosimilar Q4 2016

Infliximab (SB2)Merck, Samsung Bioepis Refer to reference product Biosimilar Q4 2016

Deflazacort (MP-104) Marathon Duchenne muscular dystrophy Novel therapy Q1 2017

Rucaparib Clovis Oncology: ovarian cancer Novel therapy Q1 2017

Abaloparatide Radius Osteoporosis Novel therapy Q1 2017

Brigatinib (AP26113) AriadOncology: non–small cell lung cancer Novel therapy Q1 2017

Neratinib Puma Oncology: breast cancer Novel therapy Q1 2017

Pegfilgrastim (CHS-1701) Coherus Refer to reference product Biosimilar Q1 2017

Tenofovir alafenamide Gilead Hepatitis B virus Expanded indication Q1 2017

TLE-400 Phasebio HIV Novel therapy Q1 2017

Buparlisib Novartis Oncology: breast cancer Novel therapy Q2 2017

Dupilumab Regeneron, Sanofi Atopic dermatitis Novel therapy Q2 2017

Ibalizumab TaiMed HIV Novel therapy Q2 2017

Midostaurin NovartisOncology: acute myeloid leukemia Novel therapy Q2 2017

Momelotinib Gilead Oncology: myelofibrosis Novel therapy Q2 2017

Niraparib Tesaro Oncology: ovarian cancer Novel therapy Q2 2017

Romosozumab Amgen, UCB Osteoporosis Novel therapy Q2 2017aPipeline information as of August 2016.

Continued on next page



(Figure 3). This calculation is used by a majority of pharma-cies to estimate the patient’s adherence using fill data. One main concern with this calculation is the possibility of over-estimation, as MPR does not adjust for patients who get their medications filled early.42

In contrast, PDC is not as commonly used because the calculation is slightly more complicated to compute, but it is able to account for early fills. PDC is defined as the total num-ber of days covered within a given time period (i.e., the true number of days of medication a patient has on hand) over the total number of days within the time period (Figure 3). This measurement can also be used to evaluate a patient’s adher-ence to a multidrug regimen, which can be extremely valu-able depending on the treatment or condition (e.g., a com-bination of dabrafenib [Tafinlar—Novartis] and trametinib [Mekinist—Novartis] for treatment of metastatic melanoma). A major drawback is the difference between a prescription or adjudicated day’s supply and a therapy day’s supply, which tends to skew the results.42 A medication may be written or adjudicated for a 30-day supply, but the true therapy days’ supply could be 180 days, such as with denosumab (Pro-lia—Amgen). Thus, it is important to consider all the caveats when using either of these methods to calculate adherence for a single patient or a patient population.

These adherence measures offer a great opportunity to

evaluate the value of these medications, but being coupled with the lack of benchmarks or standards causes variability across the specialty pharmacy industry. Today, standards are set by either CMS, the Utilization Review Accreditation Commission (URAC), or other accrediting or governing or-ganizations for many nonspecialty medications, such as renin-angiotensin system antagonists or statins.43 In com-parison, there are no or limited standardized benchmarks applicable to most specialty medications. One exception is antiretroviral treatment, which has a PDC threshold set by URAC of 90% for at least two medications.43

Figure 3. Adherence measures

Medication possession ratio (MPR)Sum of days’ supply within a given time period

Total days within the time period

Proportion of days covered (PDC) Sum of days covered within a given time period

Total days within the time period

Specialty pharmacy accreditation A specialty pharmacy is required to obtain and maintain multiple accreditations. The main accreditation bodies in-clude URAC, Accreditation Commission for Health Care

Table 3. Expected approvals for 2016 and 2017a

Medication Manufacturer Indication Approval typeProjected expected approval timeline

Antroquinonol Golden BiotechnologyOncology: non–small cell lung cancer Novel therapy Q4 2017

ABT-493 + ABT-530 Abbvie Hepatitis C virus Novel therapy Q4 2017

Adalimumab (M923) Baxalta, Momenta Refer to reference product Biosimilar Q4 2017

Anacetrapib (MK-0859) Merck Atherosclerosis Novel therapy Q4 2017

Bococizumab Pfizer Hypercholesterolemia Novel therapy Q4 2017

Cerliponase alfa, BMN-190 BioMarin Batten disease Novel therapy Q4 2017

Duvelisib (IPI-145) InfinityOncology: chronic lymphocytic leukemia Novel therapy Q4 2017

Infliximab STI-002 Sorrento, Mab Tech Refer to reference product Biosimilar Q4 2017

NEOD-001 Prothena Amyloidosis Novel therapy Q4 2017

Odanacatib, MK-0822 Merck Osteoporosis Novel therapy Q4 2017

Patisiran, ALN-TTR02 Genzyme, Alnylam Amyloidosis Novel therapy Q4 2017

Pegvaliase Biomarin Phenylketonuria Novel therapy Q4 2017

Regorafenib BayerOncology: hepatocellular carcinoma Expanded indication Q4 2017

Ribociclib (LEE011) Novartis, Astex Oncology: breast cancer Novel therapy Q4 2017

Talazoparib Medivation Oncology: breast cancer Novel therapy Q4 2017aPipeline information as of August 2016.

Continued from page 87



(ACHC), the Joint Commission on Accreditation of Health-care Organizations, and the more recently created Center for Pharmacy Practice Accreditation. According to Adam Fein’s article, “The Specialty Pharmacy Accreditation Boom Con-tinues,” 378 unique pharmacy locations were accredited by URAC and/or ACHC as of January 2016, with the expectation that this figure will continue to increase through 2016.44

These accreditations evaluate specialty pharmacies to ensure quality patient care in four main areas: organization and administration, pharmacy operations, clinical manage-ment, and quality reporting/improvement.44 Additional ac-creditations that a specialty pharmacy may apply for include verified-accredited wholesale distributors, verified Internet pharmacy practice sites, and various others. These certifica-tions allow a specialty pharmacy to gain a higher credibility in the marketplace, thereby providing specialty pharmacies the opportunity to partner with a broader spectrum of health care providers, payers, and manufacturers to better serve their patients.

ConclusionOver the years, the specialty pharmacy’s growth has enabled the health care industry to promote patient care through new drug therapies, more in-depth patient care, and partnerships with all stakeholders involved. While some challenges re-main, such as lack of a specialty pharmaceutical definition, the opportunities far outweigh the obstacles. Accreditation, technology, and clinical education components create a pa-tient-centered approach based on quality outcomes and met-rics. Specialty medication development will continue to rise, bringing with it new or improved approaches to patient care, operational processes, and standardization.

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CPE assessmentThis assessment must be taken online; please see “CPE Information” in the sidebar below for further instructions. The online system will present these questions in random order to help reinforce the learning opportunity. There is only one correct answer to each question.

1. What percentage of approved drugs were specialty drugs in 2015?a. 25%b. 35%c. 50%d. 65%

2. What is the specialty medication spending growth predicted to be by 2018? a. 35%b. 50%c. 70%d. 55%

3. Choose the correct medication and associated condi-tion or disease state combination.a. Oncology: Lenalidomide (Revlimid—Celgene)b. Hereditary angioedema: Ledipasvir/sofosbuvir

(Harvoni—Gilead)c. Psoriasis: Lumacaftor/ivacafto (Orkambi—Vertex)d. Asthma: Everolimus (Afinitor—Novartis)

4. Which of the following characteristics is associated with specialty medications, according to the various definitions? a. Lack of prior authorization requirementb. Limited distribution channelc. Simple administration techniquesd. Low-cost medication

5. CMS defines a specialty medication as one thata. Treats chronic complex diseasesb. Is injectable

c. Has special handling requirementsd. Costs more than $600 per month

6. Which of the following pharmacies currently has the highest market share?a. Diplomatb. Walgreens Specialty Pharmacyc. Acreedod. CVS Specialty Pharmacy

7. What is the main goal of specialty pharmacy, accord-ing to the National Comprehensive Cancer Network?a. Make a high profit.b. Dispense drugs with the lowest copay possible.c. Optimize pharmaceutical care outcomes.d. Gain access to as many drugs as possible.

8. An example of a specialized service includes which of the following?a. 24/7 pharmacist accessb. Benefits investigationc. Psychosocial servicesd. Patient education

9. An example of ad-hoc services offered by the specialty pharmacy to manufacturers may include which of the following?a. Hub Servicesb. Pharmacy and therapeutics monograph servicesc. Formulary management servicesd. Prior authorization approval services

CPE informationTo obtain 2.0 contact hours (0.2 CEUs) of CPE credit for this activity, you must complete the online assessment and evaluation. A statement of credit will be awarded for a passing grade of 70% or better on the assessment. You will have two opportunities to successfully complete the assessment. Pharmacists who successfully complete this activity before October 1, 2019, can receive CPE credit. Your statement of credit will be available upon successful completion of the assessment and evaluation and will be stored in your My Training Page and on CPE Monitor for future viewing/printing.CPE instructions:1. Log in or create an account at pharmacist.com, and select LEARN from the top of the page; select Continuing Education, then Home Study

CPE to access the Library. 2. Enter the title of this article or the ACPE number to search for the article and click on the title of the article to start the home study. 3. To receive CPE credit, select Enroll Now or Add to Cart from the left navigation and successfully complete the assessment (with randomized

questions) and evaluation. 4. To get your statement of credit, click “Claim” on the right side of the page. You will need to provide your NABP e-profile ID number to obtain

and print your statement of credit.Live step-by-step assistance is available Monday through Friday from 8:30 am to 5:00 pm ET at APhA Member Services at 800-237-APhA (2742) or by e-mailing [email protected].



10. Which pair of drugs holds 3% of the total U.S. drug market spending in 2015 for autoimmune disorders?a. Adalimumab (Humira—AbbVie) and etanercept

(Enbrel—Amgen)b. Etanercept and golimumab (Simponi—Janssen)c. Adalimumab and secukinumab

(Cosentyx—Novartis)d. Golimumab and secukinumab

11. Aside from typical patient care, what are some additional services specialty pharmacies provide payer clients?a. Bridge therapy servicesb. Formulary managementc. Product replacement programsd. Hub services

12. What disease states have seen the largest increase in specialty medication spend?a. Oncology, HIV, orphan diseasesb. Oncology, cystic fibrosis, hepatitisc. Oncology, hepatitis, HIVd. Oncology, hepatitis, autoimmune disorders

13. What is a characteristic of a biologic drug?a. Created by a microorganism or mammalian cellb. Degrades in the environment to natural substancesc. Tested in animals onlyd. A drug not approved by FDA

14. What is the name for the “generic” of a biologic product?a. Genericb. Biogeneric c. Biosimilard. GEQ

15. What are the benefits of using an oncology pathway?a. Reduces costb. Decreases medication adverse effectsc. Requires less expertise from the physiciand. Helps patients understand their treatment

regimen

16. A lack of having a standard specialty drug definition poses what challenge to specialty pharmacies?a. Predicting the price for each medication in the

pipelineb. Knowing which medications to acquire and dis-

pensec. Analyzing the pipeline to predict trends in the

specialty marketd. Knowing whether the drug will be approved quickly

by FDA

17. Which of the following is one of the challenges in the specialty pharmacy market that has led to some patients having to acquire their specialty medications from multiple pharmacies?a. Decreasing number of “specialized” specialty

pharmacies in the marketb. Payers expanding their specialty pharmacy

networks for better pricingc. Standardized specialty drug definitiond. Not being able to charge the medications to a credit

card

18. What is the second-highest challenge to payers when analyzing the use of specialty pharmaceuticals?a. Creating prior authorization criteriab. Helping the patient get access to the drugsc. Determining the value of specialty medicationsd. Defining a specialty medication

19. Why does the MPR calculation have the potential to be an overestimation of adherence?a. It does not account for patients who got their medi-

cations filled early.b. It does not factor in other drugs taken by the patient.c. It begins the calculation on the day shipped, not the

day the patient begins therapy.d. It calculates days’ supply as 30 days regardless of

how long the supply will last the patient.

20. The four areas in which accreditation bodies evaluate specialty pharmacies include which of the following?a. Customer service, specialty drug management,

pharmacy operations, data reporting capabilitiesb. Clinical management, drug management, pharmacy

administration, benefit investigationc. Organization and administration, pharmacy opera-

tions, clinical management, quality reporting/im-provement

d. Quality reporting/improvement, pharmacy admin-istration, drug management, clinical management

specialty pharmacy: trending to the futureelearning.pharmacist.com/files/org/891a6284d25f43...21...

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