July/August 2016

Bridging the gap between the hospital and alternate-site care Volume 5 • Number 4 • July/August 2016 • specialtypharmacycontinuum.com

When disaster strikes:

UP FRONT The importance of health literacy in specialty care .................

3

POLICY

CMS ‘Five-Star’ quality rating system gets few stars from critics ......

4

Part B payment model imperils SP providers ......

7

Dispensing Medications In Shadow of the Storm

OPERATIONS & MGMT Win the specialty pharmacy accreditation game! .......

12

The pros and cons of cold chain shipping prequalification ...............

14

CLINICAL

High drug costs hamper cystic fibrosis care .......... 18 The price of noncompliance in multiple sclerosis ............

19

A presidential cure puts cancer immuno Rx in spotlight .........................

21

It was about 9 p.m. on a winter evening in 2015, and Ron Geguzys, the executive vice president of operations at Avella Specialty Pharmacy, Pharmacy was having a quiet evening at home. home Then his cellphone rang.

Hospitals Reaping Benefits From SP Market Growth

M

ore health systems are establishing their own specialty pharmacies, a trend that may be boosting both patient outcomes and institutional bottom lines, according to speakers at the 2016 Asembia Specialty Pharmacy Summit.

These facilities are using the strategy to sidestep some of the shortcomings encountered when dealing with outside specialty pharmacies and restricted drug distribution systems, such as access barriers, continuity of care and burdensome paperwork (Am ( J Health Syst Pharm 2009;66[24 suppl 7]:S13-S20), noted Autumn Bagwell, PharmD, of Vanderbilt University Medical Center’s specialty pharmacy service, in Nashville, Tenn. see HEALTH SYSTEMS, page 11

Other controlled substances in mix

PBM Boosts Effort To Lessen Lethal Misuse of Opioids

“Hi, my name is Bob, and I’m a courier working with Dawson Healthcare Solutions,” the caller told the startled Mr. Geguzys. “I have this package to deliver to one of your customers, but the state police have closed the road to anybody that doesn’t have tire chains. And it’s pretty clear I can get up the mountain to this address, but not back down. Will you pay for the tire chains and my hotel so I can deliver the packages?”

“Of course,” Mr. Geguzys said. Bob promptly bought the chains and drove up the mountain.

“There he was, tromping through this lady’s front yard in the middle of a giant blizzard, ringing her doorbell and delivering her the multiple sclerosis medication,” Mr. Geguzys recalled. “A while later I get a call from her, saying, ‘I can’t believe you did this!’ I told her, ‘That’s why we’re your pharmacy and not somebody else.’”

Storms, natural disasters, blackouts and other significant disruptions—even something as benign as Pope Francis’ visit to the United States in 2015—can put major roadblocks in the path of specialty pharmacies’ commitments to provide their patients with all their needed medications on a timely basis. The often critical nature of specialty medications, combined with the temperature sensitivity of many of these drugs, means that neither snow, wind, rain, dark of night nor

ike many pharmacy benefits managers (PBMs), St. Paul, Minn.–based Prime Therapeutics has long been sending prescriber letters warning about potentially problematic prescription narcotic behavior among its members. But as the opioid overdose epidemic in the United States continues, some experts are calling on PBMs to do more to identify and mitigate risky narcotic prescribing and problematic patient behavior.

Between 1999 and 2014, more than 165,000 people died of overdoses involving opioid medications in the

see DISASTER DISPENSING, page 16

see PBMS & OPIOIDS, page 10

New Product

Mediware launches update M to CareTend workflow tracking software.

See page 3.

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3

Specialty Pharmacy Continuum • July/August 2016

UP FRONT

NEW PRODUCT

Testing the Health Literacy of Patients

New Release of CareTend

I

Mediware Information Systems Inc., a provider of comprehensive post-acute health care software, announced the next on-time release features of CareTend for the home/durable medical equipment and home infusion markets.

CareTend’s added functionality enables providers to grow their retail operations, streamline credit card processing, save costs using drop-ship features, and increase output with customized workflow and reporting tools, the company noted in a press release.

“We are thrilled to roll out the next release of CareTend,” said Paul O’Toole, the vice president and general manager of the Home Care Solutions Division of Mediware.

“The added functionality streamlines the entire post-acute patient care process so that providers can save time by eliminating manual tasks and improve patient care through fast order fulfillment and complete patient care tracking.”

For more information, visit www.mediware.com.

f patients who are managed by specalty pharmacies lack the health literacy required to understand basic counseling and education, even the best clinical management program can go astray.

That’s why it’s so important for specialty pharmacies to adequately assess the health literacy of patients and provide tailored education, noted Syed Munawer, PharmD, a recent graduate of the University of Illinois Hospital & Health Sciences System (UIHHSS), in Chicago, during a video interview with Specialty Pharmacy Continuum.

“Health literacy is such an important problem [in specialty], because these medications have special administration or the compliance is extremely important, so we want to make sure these patients are educated completely about how to administer the medication or the importance of compliance to the outcomes,” Dr. Munawer said.

While a PharmD candidate, Dr. Munawer served as a graduate extern at the UIHHSS Specialty Pharmacy Services (SPS), where he and his colleagues took stock of the health literacy of the patients the pharmacy served.

To meet URAC standards, SPS adopted two health literacy assessment tools: One enabled face-to-face assessment, and the other assessed literacy during

a telephone call. The in-person assessment used the Rapid Estimate of Adult Literacy in Medicine, Revised assessment and for the telephone interviews, the CHEW 3 test. All approved patient materials were written at an eighthgrade reading level.

“Because we have a high underserved population, we wanted to see how that correlated with health literacy,” Dr. Munawer said. “The study gave us an idea of the types of patients we are serving.”

They tested the health literacy of all 82 adult patients enrolled in SPS between April and May 2015. The pharmacy serves a diverse population that is primarily composed of minorities, and most are living below the poverty line, Dr. Munawer said. Only 20% reported having commercial or private insurance. About 43% were on Medicaid, 22% had Medicare Part B and 15% had Medicare Part D. The pharmacists found that 37 of the 82 patients (45%) were at risk for low health literacy. “That was almost half of our patients who are at risk for [low] health literacy,” he said.

Videos, Pillboxes Help As a result, the pharmacy began incorporating tools to help these patients understand their conditions and their medications. These included medica-

Read/Look For more details on Dr. Munawer’s health literacy initiative, look for our exclusive video interview at specialtypharmacycontinuum.com, under the Multimedia.

tion administration videos, injection site pictures and diagrams, as well as providing weekly or monthly pillboxes. The next step, Dr. Munawer said, is to evaluate whether the new tools are helping to improve health literacy among SPS’s patients.

To access a video on Dr. Munawer’s work, as well as interviews with other practice innovators, click on the “Multimedia” pull-down menu at specialtypharmacycontinuum.com.

—Marie Rosenthal

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Volume 5 • Number 4 • July/August 2016

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4

Specialty Pharmacy Continuum • July/August 2016

POLICY

Disease severity may not be adequately weighed

CMS Five-Star Rating System Questioned San Francisco—Health plans may be unfairly penalized by the Centers for Medicare & Medicaid Services (CMS) Five-Star Quality Rating System when serving disabled or disadvantaged members, according to a poster presented at the 2016 Academy of Managed Care Pharmacy (AMCP) annual meeting.

Members eligible for both Medicare and Medicaid tend to have many comorbidities, as well as face other challenges including poverty, homelessness and living in an area with a shortage of primary care physicians. All of these issues make it more difficult for patients to achieve good outcomes. Yet disability status, age and clinical risk factors are not currently considered by CMS when they measure, for example, high-risk medication (HRM) performance. As a result, the new research suggests, plans that serve a higher proportion of dualeligible members may be disadvantaged in star ratings.

depression, and dementia. Diabetes and disability status accounted for 35% and 26% of the disparity among the groups, respectively (Tables 1 and 2).

The researchers were surprised not to find a link between HRM use and socioeconomic factors such as income, living in poverty, education or household size.

However, they noted that factors such as depression and substance abuse may be related to some socioeconomic factors more common in the dual-eligible population, such as living in poverty.

“So, what do we do about this?” Dr. Teigland said. “HRM rates of wealthy, healthy members are going to look better,

‘We need to level the playing field to provide an accurate report of plan performance to customers.’

—Christie Teigland, PhD, Avalere Health “We found that HRM rates were 16% higher among dual-eligible members.

What’s causing these disparities? We don’t believe it’s the quality of care.

Rather, we believe much of the disparity is associated with patient characteristics that put them at far greater risk of an adverse outcome, like use of HRMs,” said Christie Teigland, PhD, the vice president of advanced analytics at Avalere Health (an Inovalon company), and lead author of the abstract (Z27).

A Deeper Data Dig Prompting the research, explained Dr. Teigland, were requests from a number of health plans for a deeper dig into the precise disparities that were driving differences in HRM performance rates.

Working closely with CMS, her team evaluated 2.2 million Medicare Advantage members from the 2013 MORE2 Registry, along with new sources of socioeconomic data of patients at the near neighborhood level.

They found dual-eligible members were more likely to use HRM compared with non–dual-eligible members (odds ratio, 1.32; 95% CI, 1.30-1.37). Explaining 71.1% of the increased likelihood of HRM use, according to the abstract, were a number of characteristics more common among dual-eligible members: rates of diabetes, disability, alcohol or other substance abuse, anxiety, bipolar or major

but that does not necessarily reflect better quality of care. We need to level the playing field to provide an accurate report of plan performance to customers.”

The researchers recommended that developers investigate whether these associations are penalizing plans serving disabled and disadvantaged Medicare Advantage members, and consider evaluating factors for adjustment or exclusion to ensure the measure provides a fair comparison of performance across plans serving different populations.

Dr. Teigland also suggested that health plans use these new data to target interventions that lower the use of HRMs in those patients with characteristics that put them at greatest risk.

Pharmacists’ Role Pharmacists, too, may be able to affect HRM rates, although they remain in a “difficult position,” Dr. Teigland said.

“They can flag these prescriptions to the physician and explain to a patient what the risks are. But they don’t have the last say.”

Overall, the new research is a step forward from previous studies that investigated effect on just one health plan and enlisted census data that only looked down to the block level. (In New York City, for example, such a wide swath would include rich and poor areas, potentially washing out any evidence

Table 1. Factors Associated With Higher Use of HRMs The main factors contributing to the performance gap between dual-eligible and non–dual-eligible beneficiaries:

a

Factor

Percent of Disparity Explained,a %

Disability or ESRD as original reason for Medicare entitlement

25.8

Diabetes

35

Bipolar/major depression

19.5

Schizophrenia

9.1

COPD

8.8

Anxiety

7.1

Alcohol/drug/substance abuse

5

Adds up to >100% because some factors work to reduce the disparity.

COPD, chronic obstructive pulmonary disease; ESRD, end-stage renal disease; HRMs, high-risk medications

Table 2. Dual-Eligible Beneficiaries Have Significantly Different Profiles Sample MA Member Characteristics, 2013 Characteristics

Dual-Eligible Members, %

Non–Dual Members, %

Disability

46.3

16.7

Alcohol/drug/substance abuse

7.0

2.3

Anxiety

12.9

9.7

Bipolar/major depression

22.1

11.8

Dementia

19.4

13.1

7+ different medications

62.9

41.2

Live in a high-poverty area

29.0

8.5

MA, Medicare Advantage

of a poverty effect.) Dr. Teigland’s team assessed 160 individual health plan contracts and got more granular—zeroing in at the nine-digit ZIP code level, or a handful of households.

Dr. Teigland, who won the AMCP’s prestigious Platinum Award for her research, suggested further investigation is still needed to untangle characteristics such as regional differences in prescribing. (The Platinum Award recognizes the top four highest rated abstracts accepted for presentation at the AMCP annual meeting.)

More on CMS Star Ratings Kristen Butterfield, MPH, the director of research and analytics at Pharmacy Quality Alliance (PQA), noted that her nonprofit organization has “recently undertaken an effort to determine if our measures used in the CMS Star Rating program should be risk-adjusted for socioeconomic factors.

“Avoiding incorrect conclusions about the quality of care delivered is important to consumers in making informed decisions about where to obtain care; to payors, health plans and providers regarding rewards and penalties; and to providers and plans in terms of reputation and the ability to improve care for the various subpopulations that they serve,” Ms. Butterfield said.

“In light of the findings in this study,” she added, “PQA will further examine the need to risk-adjust the HRM measure for clinical factors that may affect the dualeligible population, such as mental health conditions and disability status.”

—Lynne Peeples Dr. Teigland reported funding for the study from Blue Cross and Blue Shield of Minnesota and Blue Plus, CignaHealthSpring, Gateway Health, Health Care Service Corporation, Healthfirst and WellCare. Ms. Butterfield reported being employed by Pharmacy Quality Alliance.

Netupitant/palonosetron (Akynzeo®) is a recommended option in the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Antiemesis1

POWER IN PREVENTION

Power combined The first and only combination product for CINV2 90% complete response for AKYNZEO (n=135) during the overall phase compared to 77% for oral palonosetron (n=136)(p=0.003)2*

For information visit AKYNZEO.com

Indication AKYNZEO (300 mg netupitant/0.5 mg palonosetron) is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Important Safety Information Warnings and Precautions • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs Adverse Reactions • Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema Drug Interactions • Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days — Dexamethasone doses should be reduced when given with AKYNZEO. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant — Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased • Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO Use in Specific Populations • Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease *Multicenter, randomized, double-blind, double-dummy, parallel-group study. Primary endpoint: complete response (no emesis and no use of rescue medication) in the overall phase (0-120 hours). Patients received cisplatin (≥50 mg/m2 either alone or in combination with other chemotherapy agents). Randomization: AKYNZEO plus oral dexamethasone (dex) 12 mg Day 1 followed by oral dex 8 mg once daily on Days 2-4, or oral palonosetron 0.5 mg plus oral dex 20 mg on Day 1 followed by oral dex 8 mg twice daily on Days 2-4.

NCCN=National Comprehensive Cancer Network.

CINV=chemotherapy-induced nausea and vomiting.

Please see brief summary of Full Prescribing Information on the following page.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis V.1.2016. © National Comprehensive Cancer Network, Inc 2016.

All rights reserved. Accessed March 24, 2016. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 2. AKYNZEO (netupitant/palonosetron) capsules. Full Prescribing Information. ® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.

Distributed by Eisai Inc. under license of Helsinn Healthcare SA, Switzerland.

Marketed by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc. © 2016 Eisai Inc. All rights reserved. Printed in USA. AKYN-US0246 03/16

AKYNZEO® (netupitant and palonosetron) capsules, ffor oral use BRIEF SUMMARY OF PRESCRIBING INFORMATION DOSAGE AND ADMINISTRATION Highly g y Emetogenic g Chemotherapy, py, includingg Cisplatin p Based Chemotherapy py The recommended dosage in adults is one capsule of AKYNZEO administered approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1 and 8 mg orally once daily on days 2 to 4.

Anthracyclines y and Cyclophosphamide y p p Based Chemotherapy py and Chemotherapy py Not Considered Highly g y Emetogenic g The recommended dosage in adults is one capsule of AKYNZEO approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1. Administration of dexamethasone on days 2 to 4 is not necessary.

AKYNZEO can be taken with or without food.

WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HTT3 receptor antagonists.

Serotonin Syndrome: The development of serotonin syndrome has been reported with 5-HTT3 receptor antagonists.

Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of AKYNZEO and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs.

ADVERSE REACTIONS Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The overall safety of AKYNZEO was evaluated in 1538 cancer patients and healthy volunteers in clinical trials. The data described below reflect exposure to AKYNZEO in 1169 cancer patients, receiving at least one cycle of cancer chemotherapy in 3 active-controlled trials, including 782 exposed to AKYNZEO for at least 4 cycles and 321 exposed for at least 6 cycles, up to a maximum of 12 cycles of chemotherapy. The median age was 55, 79% were female, 83% were White, 13% were Asian, and 4% were Hispanic. All patients received a single oral dose of AKYNZEO 1 hour prior to the start of each chemotherapy cycle. In all studies, dexamethasone was co-administered with AKYNZEO. Cisplatin Based Highly Emetogenic Chemotherapy:: In a single-cycle study of patients receiving cisplatin-based highly emetogenic chemotherapy, 136 patients were treated with AKYNZEO. Table 1 shows adverse reactions defined as adverse events reported at an incidence of at least 3% and for which the AKYNZEO rate exceeded palonosetron alone.

Table 1: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO and Cisplatin Based Highly Emetogenic Chemotherapy (Cycle 1) Adverse Reactions Dyspepsia Fatigue Constipation Erythema

AKYNZEO Palonosetron 0.5 mg netupitant 300 mg/ palonosetron 0.5 mg (N=136) (N=136) 4% 2% 4% 2% 3% 1% 3% 2%

Anthracyclines and Cyclophosphamide Based Chemotherapy: y In a study of patients receiving anthracycline and cyclophosphamide based chemotherapy, 725 patients were treated with AKYNZEO during Cycle 1, and 635 of these patients continued for up to 8 cycles in a multiple-cycle extension. Table 2 shows adverse reactions defined as adverse events reported at an incidence of at least 3% and for which the AKYNZEO rate exceeded palonosetron alone during Cycle 1. The adverse reaction profile in subsequent cycles was similar to that observed in Cycle 1.

Table 2: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO and Anthracyclines and Cyclophosphamide Based Chemotherapy (Cycle 1) Adverse Reactions Headache Asthenia Fatigue

AKYNZEO netupitant 300 mg/ palonosetron 0.5 mg (N=725)

Palonosetron 0.5 mg (N=725)

9% 8% 7%

7% 7% 5%

In addition to the adverse reactions shown above, there were reports of concomitant elevations of transaminases > 3 x ULN and total bilirubin in both arms of the two trials that compared AKYNZEO to oral palonosetron, and the frequency of these elevations was comparable between treatment groups. See Table 3.

Table 3: Liver Function Laboratory Abnormalities Laboratory Changes AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin > ULN AST > 10 x ULN and/or ALT > 10 x ULN with Total Bilirubin > ULN AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin ≥ 2 x ULN

AKYNZEO Palonosetron 0.5 mg netupitant 300 mg/palonosetron 0.5 mg (N=861) (N=861) 3 (0.3%)

5 (0.6%)

−

2 (0.2%)

1 (0.1%)

1 (0.1%)

In a multi-cycle safety study of 412 patients, the safety profile of AKYNZEO (n = 308) was comparable to aprepitant and palonosetron (n = 104) in patients undergoing initial and repeat cycles (median 5 cycles, range of 1-14 cycles) of chemotherapy, including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens. There were no reports of concomitant elevations of transaminases > 3 x ULN and total bilirubin in this study in either arm.

In a randomized, clinical non-inferiority study, that compared oral palonosetron 0.5 mg to intravenous palonosetron 0.25 mg in cancer patients scheduled to receive highly emetogenic cisplatin (≥70 mg/m2) based chemotherapy, there were two patients (0.5%; 2/369) in the intravenous palonosetron arm who had concomitant elevations of transaminases and total bilirubin. Neither experienced transaminase elevations of > 10 x ULN. DRUG INTERACTIONS Effects of AKYNZEO on other drugs Interaction with CYP3A4 substrates: Netupitant, a component of AKYNZEO is a moderate inhibitor of CYP3A4.

AKYNZEO should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days.

Dexamethasone: A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant. The duration of the effect was not studied beyond 4 days. Administer a reduced dose of dexamethasone with AKYNZEO.

Midazolam: When administered with netupitant, the systemic exposure to midazolam was significantly increased.

Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering these drugs with AKYNZEO. Interaction with chemotherapeutic agents: The systemic exposure of chemotherapy agents metabolized by CYP3A4 can increase when administered with AKYNZEO. Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. Caution and monitoring for chemotherapeutic related adverse reactions are advised in patients receiving chemotherapy agents metabolized primarily by CYP3A4.

Interaction with oral contraceptives: Clinically significant effect of AKYNZEO on the efficacy of the oral contraceptive containing levonorgestrel and ethinyl estradiol is unlikely.

Effects of other drugs on AKYNZEO Netupitant, a component of AKYNZEO is mainly metabolized by CYP3A4.

In vitroo metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron.

CYP3A4 Inducers: Avoid concomitant use of AKYNZEO in patients who are chronically using a strong CYP3A4 inducer such as rifampin. A strong CYP3A inducer can decrease the efficacy of AKYNZEO by substantially reducing plasma concentrations of the netupitant component.

CYP3A4 Inhibitors: Concomitant use of AKYNZEO with a strong CYP3A4 inhibitor (e.g., ketoconazole) can significantly increase the systemic exposure to the netupitant component of AKYNZEO. However, no dosage adjustment is necessary for single dose administration of AKYNZEO. Serotonergic Drugs: Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy g y Category g yC Risk Summaryy: Adequate and well-controlled studies with AKYNZEO have not been conducted in pregnant women. In animal reproduction studies, no effects on embryo-fetal development were observed following daily administration of netupitant in pregnant rats during the period of organogenesis at doses up to 3.7 times the human AUC (area under the plasma concentration-time curve) at the recommended single human dose to be given with each cycle of chemotherapy.

However, a dose-dependent increase in adverse effects on embryo-fetal development was observed following daily administration of netupitant in pregnant rabbits during the period of organogenesis with doses at least 0.2 times the human AUC at the recommended single human dose to be given with each cycle of chemotherapy. Daily administration of netupitant in rats up to 3.7 times the human AUC at the recommended human dose during organogenesis through lactation produced no adverse effects in the offspring. In animal reproduction studies with palonosetron, no effects on embryo-fetal development were observed following oral administration during the period of organogenesis at doses up to 921 and 1841 times the recommended human oral dose in rats and rabbits, respectively. AKYNZEO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data: Daily administration of up to 30 mg/kg netupitant in rats (3.7 times the human AUC at the recommended single human dose to be given with each cycle of chemotherapy) during the period of organogenesis produced no effects on embryo-fetal development. However, an increased incidence of external and skeletal abnormalities in rabbit fetuses was observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher (0.2 times the human AUC at the recommended single human dose to be given with each cycle of chemotherapy) during the period of organogenesis. These abnormalities included positional abnormalities in the limbs and paws, and fused sternebrae.

Reduction in fetal rabbit weight occurred at 30 mg/kg/day. Maternal toxicity in rabbits (i.e. loss of bodyweight during the treatment period) was also observed at 30 mg/kg/day. Daily administration of up to 30 mg/kg netupitant (3.7 times the human AUC at the recommended human dose) in rats during organogenesis through lactation produced no adverse effects in the offspring.

In animal reproduction studies with palonosetron, no effects on embryo-fetal development were observed in pregnant rats given oral doses up to 60 mg/kg/day (921 times the recommended human oral dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (1841 times the recommended human oral dose based on body surface area) during the period of organogenesis.

Nursing Mothers: It is not known whether AKYNZEO is present in human milk. Because many drugs are present in human milk and because of the potential for tumorigenicity shown for palonosetron in the rat carcinogenicity study, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in patients below the age of 18 years have not been established.

Geriatric Use: Of the 1169 adult cancer patients treated with AKYNZEO in clinical studies, 18% were aged 65 and over, while 2% were aged 75 years and over. The nature and frequency of adverse reactions were similar in elderly and younger patients. Exploratory analyses of the impact of age on efficacy were performed in the two trials that compared AKYNZEO to palonosetron. In Study 1 in patients treated with cisplatin chemotherapy, among the patients less than age 65 years, 115 were treated with AKYNZEO and 116 were treated with palonosetron alone. Among the patients 65 years or older, 20 were treated with AKYNZEO and 20 were treated with palonosetron alone. The difference in Complete Response (CR) rates between AKYNZEO and palonosetron alone was similar between the two age groups in both the acute and delayed phases. In Study 2 in patients treated with anthracyclines plus cyclophosphamide chemotherapy, among the patients less than age 65 years, 608 were treated with AKYNZEO and 602 were treated with palonosetron alone. Among the patients 65 years or older, 116 were treated with AKYNZEO and 123 were treated with palonosetron alone. The difference in CR rates between AKYNZEO and palonosetron alone (4% in <65 years and 2% in ≥65 years) was similar between the two age groups in the acute phase. In the delayed phase, the difference in CR rates between AKYNZEO and palonosetron alone (9% in <65 years and 1% in ≥ 65 years) was numerically higher in patients <65 years. This difference between age groups in the delayed phase of Study 2 may be explained, in part, by higher CR in the delayed phase associated with palonosetron alone in the older age group (81%) relative to the younger patients treated with palonosetron alone (67%).

In general, use caution when dosing elderly patients as they have a a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy.

Hepatic Impairment: No dosage adjustment for AKYNZEO is necessary for patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 8). Limited data are aavailable with AKYNZEO in patients with severe hepatic impairment (Child-Pugh score >9)/ Avoid use of AKYNZEO in patients with severe hepatic impairment.

Renal Impairment: No dosage adjustment for AKYNZEO is necessary in patients with mild to moderate renal impairment. The pharmacokinetics and safety of netupitant has not been studied in patients with severe renal impairment, although severe renal impairment did not substantially affect pharmacokinetics of palonosetron. The pharmacokinetics for netupitant and palonosetron was not studied in patients with end-stage renal disease requiring hemodialysis.

OVERDOSAGE: No specific information is available on the treatment of overdosage with AKYNZEO. In the event of overdose, AKYNZEO should be discontinued and general supportive treatment and monitoring should be provided.

Because of the antiemetic activity of AKYNZEO, drug-induced emesis may not be effective. Dialysis studies have not been performed; due to the large volume of distribution, dialysis is unlikely to be an effective treatment for AKYNZEO overdose.

A total of 33 adult cancer patients were administered oral palonosetron at a dose of 90 μg/kg (equivalent to 6 mg fixed dose), as part of a dose ranging study. This is approximately 12 times the recommended oral dose of 0.5 mg palonosetron. This dose group had a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed. The highest dose of netupitant administered to 1169 cancer patients was 300 mg. The highest dose of netupitant administered to 49 healthy subjects was 600 mg. A similar incidence of adverse events was observed when compared to lower doses of netupitant in the respective populations of cancer patients and healthy subjects.

Jointly manufactured by Catalent Pharma Solutions, Somerset, NJ and Helsinn Birex Pharmaceuticals, Dublin, Ireland for Helsinn Healthcare SA, Switzerland

AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license. Distributed by Eisai Inc. under license of Helsinn Healthcare SA, Switzerland. Marketed by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc. © 2016 Eisai Inc. All rights reserved. Printed in USA. 0 /16

7

Specialty Pharmacy Continuum • July/August 2016

POLICY

Agency now open to changing embattled reimbursement model

CMS Softens Part B Payment Project Stance A controversial proposed Medicare payment model aimed at incentivizing physicians to choose lower cost drugs via new reimbursement formulas could still be adjusted, an official with the Centers for Medicare & Medicaid Services (CMS) announced during a Senate Committee on Finance hearing on June 28.

Describing the intent of the new program, CMS Deputy Administrator Patrick Conway, MD, told the committee that it would “test whether alternative drug payment designs will lead to a reduction in Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries.”

The Obama administration said it intends to implement the plan before President Barack Obama leaves office in January, and to make participation in the plan mandatory for most physicians and hospitals who provide Part B drugs to Medicare beneficiaries.

CMS’s original proposal calls for changing the 6% add-on to the Average Sales Price methodology to 2.5% plus a flat fee. In a second phase, the model would implement “value-based purchasing tools similar to those employed by commercial health plans, pharmacy benefit managers, hospitals and other entities that manage health benefits and drug utilization.”

Senators on both sides of the aisle criticized the plan on many fronts, calling it much broader than a typical demonstration project, pointing out that some drugs for which reimbursement will be cut do not have any lower cost alternatives, and noting that if physicians find themselves losing money under the new system, it could drive patients to higher cost alternative care sites such as hospitals.

Dr. Conway said CMS is reviewing the more than 1,300 comments submitted since the plan was released in March, and told the Senate committee that among the alterations the agency will consider are modifications to the scope of the test and possible adjustments to the reimbursement formula. He also indicated that CMS will consider whether the proposal limits beneficiaries’ access to medications. “We are looking closely at whether adjustments are needed because access to medications … is a priority for CMS and me personally,” he stressed.

NASP Not a Fan The National Association of Specialty Pharmacy (NASP) was one of the organizations that submitted comments highly critical of the proposed rule, noting that it was developed without any stakeholder input or even a request for information.

“CMS is therefore implementing a new payment model affecting many stake-

holders within the health care system, including millions of vulnerable Medicare beneficiaries that is mandatory and nationwide without any experience as to how any aspect of either Phase 1 or Phase 2 of the Payment Model will affect access to care,” the organization wrote. “NASP is concerned with this broad utilization of the agency’s demonstration authority, especially since CMS has no previous experience implementing any kind of program of this scope or nature in such a short time frame. Further, the agency had

the model is intended to test the relationship between the prescription and the money, why are our drugs included?”

The model will be financially detrimental to specialty pharmacists, Mr. Slotnik told Specialty Pharmacy Continuum. “With your typical buy-andbill drug, there are very few uncompensated services done in relationship to the drug. A third-party hub does benefit investigation, compliance and patient assistance; the physician doesn’t absorb those costs. But with drugs like oral oncolytics, inhalation therapies and clotting factors, specialty pharmacies [provide those services] without getting compensated. Their costs are subsumed within the drug profit margin and the dispensing and furnishing fee. Significantly lowering that payment could put

Total Medicare Benefit Payments

Other services 14%a

Home health h 3%

Medicare Advantage 26%

Skilled nursing facilities 5%

$597 billion a

Hospital outpatient services 7% Outpatient prescription drugs 11%

Hospital inpatient services 23%

Hospice, durable medical equipment, Part B drugs, outpatient dialysis, ambulance, lab services and other Part B services. Also includes the effect of sequestration on spending for Medicare benefits and amounts paid to providers and recovered.

Source: The Facts on Medicare Spending and Financing.

Physician payments 12%

not described how the Payment Model will improve patient outcomes or quality to be consistent with and not in opposition to other agency initiatives related to improved outcomes.”

Particularly problematic for specialty pharmacies is the fact that the model includes the limited number of Part B drugs dispensed by pharmacies, such as immunosuppressives, oral chemotherapy, oral antiemetics, inhalation drugs used with durable medical equipment and clotting factors—drugs for which no financial incentive exists, because the prescription provides no revenue to the provider.

Such agents “shouldn’t be included in a model that’s supposed to incentivize the use of lower cost drugs, because there is no connection between the prescription and money to be made off that prescription,” said Jayson Slotnik, a partner in the consultancy Health Policy Strategies, who is advising NASP on the issue. “If

specialty pharmacies underwater and places patients at risk.”

NASP has argued that such drugs should be exempt from the model. Any changes to the model will almost certainly have to be issued soon if it is to be implemented before the president leaves office, Mr. Slotnik said.

ASHP Has Concerns ASHP also has major concerns about the proposed payment model, according to Jillanne Schulte, ASHP’s director of federal regulatory affairs. “Our biggest concern is just its sheer magnitude,” Ms. Schulte told Specialty Pharmacy Continuum. “It looks more like a program change than a demonstration.

Why didn’t they test it out in a smaller area, or with drugs that they know have lower-cost alternatives?”

ASHP has polled its members about the proposed reimbursement change, and found that they are already under-

water on some Part B drugs. “Hospitals and clinics outside the hospital setting already face reimbursement challenges, including medications that are not reimbursed at cost. The new payment mechanism may exacerbate that,” Ms. Schulte said. “Some clinics have already said that they won’t be able to afford medications under this plan, which leaves hospitals as the only option for patients, and hospitals have their own resource limitations.”

A Better Value Model?

The Part B payment model stands in stark contrast with another recently developed demonstration project from CMS, the Oncology Care Model (OCM), which the Department of Health and Human Services announced June 29 had drawn twice its anticipated participation.

An OCM approach will operate on an episode-of-care system and be reimbursed based on performance. A total of 200 physician group practices and 17 health insurance companies have been selected for the model. OCM is set to run from July 1 through June 30, 2021.

“OCM holds a lot of promise,” Ted Okon, the executive director of the Community Oncology Alliance, told Specialty Pharmacy Continuum. “We’re going to do everything we can to help practices navigate that model and be successful.

While there are some aspects of the model we might quibble with, on the whole we’re very optimistic.”

With OCM, Mr. Okon said, CMS did everything that it did not do with the Part B model.

“They put three years into its development, calling in outside experts as well as payors, providers and, most important, patients,” he said. “It’s been a thoughtful, open, transparent process. The Part B model, on the other hand, has involved no outside experts or stakeholders. It was air-dropped out of a secret, nontransparent process and makes no sense from a medical standpoint.”

The two plans are also in direct conflict, Mr. Slotnik noted. “They can’t interact. If you’re a physician participating in the OCM model and receiving a monthly stipend to do so, you can’t also be participating mandatorily in a model that is testing the relationship between the prescription and a financial incentive to that prescription. They can’t coexist. It’s been discussed that physicians who have signed up for OCM would be exempt from the Part B payment model, but then that leaves the Part B payment model with a very nonrepresentative pool of oncologists.”

—Gina Shaw

8

Specialty Pharmacy Continuum • July/August 2016

POLICY

Pharma Analytics Can Thwart Part D Fraud The Department of Health and Human Services (HHS) has more than 500 pending complaints and cases involving fraud, waste or abuse in Medicare Part D prescription drug billing, a 134% increase over five years, according to the latest data from HHS’s Office of Inspector General (OIG). fraud, waste and abuse.”

Plan sponsors and PBMs, on the other hand, have all the data theyy need to help curb Part D fraud; theey just need to be able to use it. “Spo onsors and PBMs have data on mem mbers, on providers and on utilization of all types of drugs, and that data can c be used to profile patterns of abu use or drug-seeking behavior,” Dr. Bieelinski said. Given the steep growth in P Part D spending on opioids (Figure 1), the need for such oversight is clearr, she noted—especially when the data on opioid prescription dispensing in the report are con-sidered. Nationwide, commonlly abused opioids accounted for ju ust 6% of a pharmacy’s prescriptions, on n average. However, nearly 500 pharm macies flagged in the report billed forr com-

The report found that more than 1,400 pharmacies had questionable billing for Part D drugs in 2014, such as billing for extremely high numbers of prescriptions per beneficiary or for a high number of different types of drugs for each beneficiary, or providing beneficiaries with an excessive supply of a Part D drug (http://goo.gl/sc6oD4).

But since the Centers for Medicare & Medicaid Services (CMS) doesn’t require plan sponsors to report data on potential fraud and abuse, relatively few of them do—only about 35% of all plan sponsors in 2015, according to the report.

Fortunately, pharmacy benefits managers (PBMs) and plan sponsors can use advanced pharmacy analytics to reduce costs and help maintain the integrity of the Part D pharmacy benefit, according

communicate unless clients have the same ownership. So a patient may have surgery and be prescribed an injection for blood clots for home self-injection over the next week to 10 days. Their health plan has a specialty pharmacy that ships the drug to their home.

Then a day later, the patient goes for a follow-up visit to their doctor, and

thing a PBM or health plan would want to look at.”

SCIO runs these reports weekly, rather than monthly, which Dr. Bielinski said can catch fraudulent flyby-night pharmacies more effectively.

“Within the fraud world, you have the phenomenon of a ‘nominee owner’— maybe it’s the cousin of the person in

New York Lidoderm Lovaza Vascepa

Los Angeles Lovaza Vascepa

Miami Solaraze

McAllen, Texas Nexium

San Juan, Puerto Rico

Cumulative Percentage Change

15 56% 150

Solaraze

Spending for commonly abused opioids 13 36%

Spending for all drugs 125

Figure 2. Examples of geographic hot spots for certain noncontrolled drugs.

Number of beneficiaries

100

Source: Office of Inspector General analysis of Medicare Part D data, 2015.

75

68 8%

50 25 0 2006

2007

2008

2009

2010

2011

2012

2013

2014

Year

Figure 1. Growth in spending of commonly abused opioids, 2006-2014.

Source: Office of Inspector General analysis of Medicare Part D data, 2015.

to Rena Bielinski, PharmD, the senior vice president and chief pharmacy officer at SCIO Health Analytics.

“Spending for Part D drugs has more than doubled since 2006, but the OIG report found that the Medicare Drug Integrity Contractor (MEDIC) is not even taking advantage of what little data plan sponsors are voluntarily sending in,” Dr. Bielinski told Specialty Pharmacy Continuum. “As of 2011, only 10% of MEDIC’s investigations and case referrals used proactive data analysis, while the rest relied on external reports like calls to their hotline.

So Part D remains highly vulnerable to

monly abused opioids in at least 17% of their Part D prescriptions—nearly three times the national average.

Strength in Numbers Analytics vendors such as SCIO (www.sciohealthanalytics.com) can deploy PBM and sponsor data in a variety of ways to uncover fraud, waste and abuse—intentional or not. “For example, we can do a comparison of billing to identify areas where a member has received the same drug under both the pharmacy and medical benefit at the same time,” Dr. Bielinski said. “That’s usually not intentional; systems don’t

the doctor answers questions about the self-injection. They may erroneously bill for the drug also, and now the health plan has paid twice.”

Data also can be used to identify unusual or suspicious geographic and utilization patterns, such as a member who uses 20 different pharmacies and 15 different prescribers in a two- to three-month time frame, or regional prescribing patterns that raise questions about whether these drugs were medically necessary or were actually provided to beneficiaries. Several of these “hot spots” were identified in the OIG report (Figure 2).

SCIO also has used analytics to develop a pharmacy “scorecard” focused on billing patterns and other metrics such as reversal rate, generic substitution rate, average number of prescriptions per member and ingredient cost per member. “There are currently 75,000 pharmacies in the United States, with new ones popping up every day,” Dr. Bielinski said. “We monitor pharmacies for spikes or trends in any particular metric. If a pharmacy suddenly starts to increase billing of compounds outside its norm, that might be some-

charge of the scheme, who’s nowhere to be found. They get an agency to get a pharmacist licensed on duty. Or sometimes, pharmacists don’t even realize that their license is being used for such a scheme. The pharmacy bills $400,000 in high-dollar compounds over three or four weeks and gets paid on a 10-day pay cycle. With monthly or quarterly analytics, by the time the PBM or health plan identifies this, they’ve gotten paid and disappeared, setting up shop somewhere else. Weekly analytics can catch that.”

Use in the Trenches EnvisionRx, the PBM division of EnvisionRxOptions, which is owned

by Rite-Aid, has been using similar analytics to track fraud, waste and abuse in its Medicare Part D, as well as commercial and Medicaid, claims since January 2015, according to Ira Protas, BPharm, EnvisionRxOption’s director of benefit integrity. “Because there is so much adaptiveness that is occurring on the ‘perpetrator’ side of the fence, we need to be able to keep up with what’s going on. That’s where analytic tools are very important. Com-

9

Specialty Pharmacy Continuum • July/August 2016

POLICY

panies like SCIO and Envision develop tools and algorithms that we can run our claims through and come back with patterns that you just can’t see by looking at a claims run only.”

Before adopting an algorithmic approach to pharmacy analytics, Mr. Protas said, the process was done in a more manual way using Excel spreadsheets on specific claim categories.

“When there was a trigger—let’s say improper utilization of a product, with excessive quantities of medication being dispensed or billed—we would get a download of all the claims in that particular medication category, and use a more ‘basic’ database tool like Excel to help select claims for further auditing or investigation.”

Algorithmic tools offer more effective claims selection and more predictable models, he added. “We’re able to do predictive pharmacy analysis versus just historical analysis. Predictive technologies are transforming our ability to protect sponsors and patients.”

There is a very delicate balance in meeting CMS requirements “and providing Medicare clients with proper oversight for fraud, waste and abuse, while also meeting our network obligations to pharmacy chains and independent pharmacies,” Mr. Protas said.

“Making our process faster has been and will be of phenomenal value to our clients and CMS.” The improved efficiency also gives EnvisionRx claims auditors more time.

“Previously, our auditors would spend 30% to 40% of their time managing paperwork and process. Now, that’s more like 5%, and they spend 90% to 95% of their time actually working on the audit,” Mr. Protas said.

More Effective Follow-up Perhaps most important, claims are selected for further investigation much more effectively and appropriately. Before going live with the pharmacy analytics tools, only one-third of the claims selected manually by auditors were found to be problematic. For 2015, 49% of claims selected through the tool had an issue, whether they required recovery or just a verbal corrective. “We performed 5,331 desk audits, selected 19,572 claims and found 9,742 claims to have a discrepancy,” Mr. Protas said.

Only about one-fourth of those discrepancies could be attributed to true fraudulent claims—billing for services that were not provided, for example.

The other 75% were unintentional errors, erroneous billings for items such as an etanercept (Enbrel, Amgen) kit with four prefilled syringes. “Some pharmacies bill it as a kit, some as four syringes, but if the software is not set up correctly, you can end up billing for

‘Sponsors and PBMs have data on members, on providers and on utilization of all types of drugs, and that data can be used to profile patterns of abuse or drug-seeking behavior.’

—Rena Bielinski, PharmD, SCIO Health Analytics multiples erroneously,” Mr. Protas said.

“If you bill for four kits, instead of one kit with four syringes, that’s a sizable overpayment and that’s the kind of thing these tools and our auditors pick

up quite frequently.”

He acknowledged that even good pharmacies don’t like to be audited.

“No one does. It feels like an intrusion.

Look, I’m a third-generation pharma-

cist. If my grandfather saw what was going on, he’d roll over in his grave.

At my graduation, they gave us pins that said ‘Pharmacy: America’s Most Respected Profession.’ Fraud, waste and abuse tarnishes the image of pharmaceutical business. With new technologies and the right PBM processes, we can help fix that.”

—Gina Shaw None of the sources reported any relevant financial relationships other than their stated employment and use of vendor.

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Specialty Pharmacy Continuum • July/August 2016

PBMS & OPIOIDS continued from page 1

United States, according to the Centers for Disease Control and Prevention (CDC), which released its opioid prescribing guidelines in April ( (JAMA 2016;315[15]:1624-1645). The CDC noted in its guidelines that an estimated 1.9 million people abused or were dependent on prescription opioids in the United States in 2013 alone.

To address this ongoing public health crisis, Johns Hopkins Bloomberg School of Public Health issued multipronged recommendations in November 2015 (http:// bit.ly/1PMHNA5) based on results of a meeting it hosted with the Clinton Foundation. The recommendations call for action by prescribers, state prescription drug monitoring programs (PDMPs), communities and others to mitigate harm while continuing to support effective treatment of pain. The recommendations also called on PBMs to systematically evaluate their ongoing opioid safety interventions, develop consistent methods for identifying patients at risk, and use other methods to monitor and ensure safe use.

“The advantage PBMs have is they can provide population data,” said Suzanne A. Nesbit, PharmD, BCPS, CPE, a clinical pharmacy specialist in pain management in the Department of Pharmacy at The Johns Hopkins Hospital, in Baltimore, who participated in the effort to develop the recommendations.

Evidence-Based Approach Many PBMs currently use computer algorithms to identify fraudulent dispensing, prescribing or purchasing of controlled substances, according to the Johns Hopkins recommendations. It’s also common for PBMs to use their data to flag patients with excessive or concerning narcotic use, such as receiving prescriptions from multiple prescribers, multiple pharmacies, very high doses or those taking potentially dangerous drug combinations. But there are little data supporting the effects of these approaches, the report noted.

PBMs would challenge that conclusion. Prime Therapeutics, for example, presented data at the 2015 Academy of Managed Care Pharmacy annual meeting showing that each 1-point increase in the controlled substance use score it uses to assess patient risk level is associated with a $1,488 increase in a patient’s total cost of care—including a $235 increase in controlled substance drug costs, a 0.9% increase in hospitalization rates and a 1.5% increase in emergency department visits (Figure).

“We have a controlled substances scoring system—which includes opioids—in the public domain, and we encourage other PBMs to use it,” said

Average Cost Per Member in 2013, Thousands

POLICY 40

another pharmacy from time to time— for example, if they need to fill a prescription while out of town on business.

35 30

Adjusted total cost trendline equationa

25

PDMP Database Access

20 15 10

Adjusted controlled substance drug cost trendline equationb 5 0 2.5

4-<5

6-<7

8-<9

10-<11

12-<13

14-<15

16-<17

18-<19

20-<21

Fourth Quarter 2012 Controlled Substance Score a

y=$1,488.2(x) + $8,311.1; R2=0.9823; b y=$235.26(x) – $95.17; R2=0.9755

ICD-9, International Classification of Diseases, Ninth Revision

Figure. Adjusted total cost of care and controlled substances drug cost in 2013 by controlled substance score.

Pat Gleason, PharmD, the director of health outcomes at Prime Therapeutics and a co-author of the Johns Hopkins recommendations for PBMs.

Closing Information Gaps Typically, PBMs alert prescribers to problematic patient patterns of controlled substance use by letters, which have been shown to reduce member controlled substance scores and use of controlled substances, according to the

other sources. The PBMs also could help educate prescribers about harmful drug interactions, he said.

“Opioids and benzodiazepine [coprescribing] is dangerous, and a lot of physicians are not aware,” he stressed.

The goal of notifying prescribers about problematic combinations or patient behavior is strictly to ensure they are aware, said Cathy Starner, PharmD, a principal health outcomes researcher at Prime Therapeutics. She noted if

‘To solve our problem [of opioid misuse], we need everybody to be participating, and PBMs can be a part of that.’

—Lynn Webster, MD, past president of the American Academy of Pain Medicine Johns Hopkins report. But too often these letters aren’t timely enough, said Lynn Webster, MD, a past president of the American Academy of Pain Medicine and the vice president of scientific affairs at PRA Health Sciences, an addiction treatment research firm based in Raleigh, N.C. “Most of the time, the information is not timely and [thus] is not helpful,” Dr. Webster said. Additionally, he noted that the PBM is several steps removed from at-risk patients and lacks some of the information physicians need to assess patients’ risk. Dr. Webster noted, for example, that physicians have better information about the day-to-day life stressors that may increase the risk for substance misuse or overdose, such as job loss or divorce.

“No one piece of information is really enough to direct treatment or make decisions,” he said.

Dr. Webster also expressed concern about PBMs profiling physicians based on their prescribing. He noted that it can be misleading if specialty or patient population characteristics aren’t considered. Still, Dr. Webster said he supports PBMs sharing information with physicians, particularly when patients are receiving additional medications from

prescribers don’t routinely check their state PDMP, they simply may not know their patient is receiving narcotics from another prescriber as well.

“We do not tell prescribers they are doing it wrong,” Dr. Starner said. “But are you aware?”

‘Lock-in’ Programs May Help In very rare circumstances, Prime Therapeutics also uses “lock-in” programs that limit high-risk patients to one prescriber and pharmacy. It is used as required by law for a small number of patients covered under Medicaid, and for only 10 patients per million in one of the Blue Cross Blue Shield plans that Prime Therapeutics works with, Dr. Gleason said. Prime Therapeutics first reaches out to the prescriber via a letter, and eventually a phone call, to try to reduce problematic use before pursuing a lock-in, he noted.

“When we see a pattern of use that puts an individual at risk of harm, hospitalization or death, that is when we are going to reach out to the prescriber and consider lock-in,” Dr. Gleason said.

Dr. Webster said lock-ins can be useful if the patients are deemed high risk by their physician, but they need to be flexible for people who may need to use

To help close some of the information gaps that PBMs have, such as when patients purchase medications with cash, the Johns Hopkins recommendations urge state PDMPs to allow PBMs access to their data. In general, Dr. Nesbit said, there is a need for PDMPs to be interoperable and to more consistently inform prescribers and pharmacists about risky behavior so they can intervene.

“It would be nice to have one cohesive [PDMP] system,” she said.

Many community pharmacists, Dr. Nesbit said, operate in an “information vacuum” because they can’t get comprehensive data from health records systems. Instead, they are often reliant on physicians or other prescribers and patients themselves for information. “We need to get more information to community pharmacists so they can ensure optimal use of these medications,” she said.

Dr. Webster said there is a real opportunity for physicians and pharmacists to better collaborate to curb dangerous opioid use, and he encouraged physicians to make themselves available for pharmacist calls.

Warnings at Point of Sale Serve As Early Warning System Prime Therapeutics recently ran a pilot of point-of-sale notifications for pharmacists via computer if a patient’s prescription exceeds a set dose threshold or if the patient is using multiple prescribers and pharmacies, Dr. Starner said. She noted that the Centers for Medicare & Medicaid Services has called on prescription drug plans to manage narcotic prescriptions at the point of sale to reduce overutilization (http://go.cms.gov/28JFZKg).

Dr. Webster said he would also like to see PBMs advocate for the development of safer narcotic products and to include abuse-deterrent products in their formularies. Ultimately, reducing narcotic misuse and overdose is going to take efforts to ensure safe use at every level of health care, he said.

“To solve our problem,” Dr. Webster added, “we need everybody to be participating, and PBMs can be a part of that.”

—Bridget M. Kuehn Dr. Webster has done consulting or advisory work for AstraZeneca, Cara Therapeutics, Charelston Labs, Depomed, Egalet, INSYS Therapeutics, Jazz Pharmaceuticals, kaléo Pharma, KemPharm, Mallinckrodt, Marathon Pharmaceuticals, Merck, Pain Therapeutics, Proove Biosciences, SCILEX, Shionogi, Teva and Trevena. Drs. Gleason and Starner are employees of Prime Therapeutics.

11

Specialty Pharmacy Continuum • July/August 2016

POLICY

HEALTH SYSTEMS continued from page 1

Adding specialty pharmacy also may be lucrative, noted Dr. Bagwell, whose institution began assembling its specialty pharmacy team in 2012. “We’re now generating more prescriptions and treating more patients,” she said. “This was a business opportunity as well as an opportunity to provide better care to patients.”

A Growing Market About one in five hospitals now has some kind of specialty pharmacy program, according to Burt Zweigenhaft, the president of the National Association of Specialty Pharmacy, who was not involved in the session. He said more are looking to make the move. Premier Inc., an alliance of approximately 3,600 hospitals, for example, has been building out specialty pharmacy for its members.

The timing couldn’t be better. In 2015, $450 billion was spent on U.S. pharmaceuticals, with 30% of those dollars going toward specialty medications, he noted. The specialty drug market share is expected to increase to half of U.S. drug spend by 2020. “Unless you want to turn your back on 50% of the market and not service people, you need to be in the specialty pharmacy operating space,” he said.

sary visits were canceled, often because necessary workups had not been completed. This resulted in 82% and 62% drops in time-to-medication approval and timeto-medication initiation, respectively. The latter decreased to an average of just two or three days. The team also saw a more than doubling of week 4 visits and a 9% jump in new-patient visits.

“We had a 12% increase in prescription volume, which correlates to an increase in the gross margin. And this is all in just three months,” said Dr. Bagwell, who was unable to share financial figures because the team is trying to publish the results.

“I truly think that my patients’ care has been enhanced by having an on-theground pharmacist getting directly integrated in a collaborative form,” said Cody Chastain, MD, who partners with Dr. Bagwell at the viral hepatitis program in Vanderbilt’s Division of Infectious Dis-

help a pharmacist come up with the best treatment support plan.”

The UIC Approach The University of Illinois at Chicago (UIC) went live with its specialty pharmacy service and call center operations in 2012. Rebekah Hanson, PharmD, a clinical pharmacist at the UIC College of Pharmacy, said they actually started clinically managing specialty medications far sooner. Health systems have been providing specialty pharmacy services “for a number of years, [but] they just haven’t been recognized as such,” Dr. Hanson noted during the Asembia session, pointing to dedicated clinical therapy management programs that her health system has had in place since the 1990s. However, specialty pharmacy is becoming more widely recognized because of increasingly expensive drugs with difficult adherence issues, she added.

Success Is Their Specialty Before Dr. Bagwell joined Vanderbilt’s infectious disease team in July 2015, a typical patient with hepatitis C virus (HCV) had up to six visits with the prescribing provider and one with the pharmacist throughout the course of treatment. Now, thanks in part to Vanderbilt’s specialty pharmacy infrastructure, pharmacists are more involved—beginning on day 1.

“At the initial evaluation, I think it’s important for a pharmacist to do medication reconciliation, adherence readiness assessment, general medication counseling based on lab work and then to determine what’s going to be needed for the prior approval paperwork timely and efficiently,” said Dr. Bagwell, noting that the pharmacist can then complete that paperwork. “We continue pushing until they are approved, and then provide medication education over the phone or in clinic and follow-up.”

While the provider still sees the patient at week 4 and again when the patient has achieved sustained viral response for 12 or more weeks after treatment, she noted that the pharmacist is “really in charge of following up with the patient and making sure they are staying on the medication.”

In October, Vanderbilt launched a pilot study of the specialty pharmacist’s contributions to HCV care. Over three months, the pharmacist took on 28 medicationrelated visits that would have been handled previously by the provider, freeing up valuable time. An additional 12 unneces-

Adding specialty pharmacy services at Vanderbilt University Medical Center, in Nashville, Tenn., allows the team to treat more patients, preserve continuity of care and boost revenue. The team from left: Rachel Bean, CPhT; Autumn Bagwell, PharmD; Carlie Casella, NP; Cody Chastain, MD; Mary Hopkins, MD; and Erin Horst, RN.

eases. “This could be translated to other specialties or clinical programs.”

Overall, Vanderbilt now has 26 dedicated pharmacists embedded within 20 different clinics. The team also has a call center with 21 pharmacy technicians, who are key in assisting with prior authorizations, ensuring that patients receive timely refills and helping them navigate payment, including copay cards and appeals to insurance companies.

“We make sure the patients get their medication,” Dr. Bagwell said. Once they do, she added, “patients often need a little more hand-holding.”

The effort seems to have paid off. Last year, across all their clinics, Vanderbilt had a medication possession ratio (MPR) greater than 96%, much higher than the industry standard of 80%.

“They are tied at the hip with providers in helping patients succeed,” Mr. Zweigenhaft said of Vanderbilt. “If they were using an outside unrelated pharmacy, they might not have all that connectivity to the patient’s chart, which means they wouldn’t have the real-time understanding of how a patient is doing—their lab values, for instance, and other things that

The benefits reaped from such collaborations have been clearly documented.

In a study published in 2014, Dr. Hanson and her colleagues in an inflammatory bowel disease clinic at the UIC Hospital & Health Sciences System assisted with access to treatment and education, as well as participated in shared medical appointments with the patient (Am ( J Pharm Benefits 2015;7[5]:215-220). As a result, the MPR for patients who receive prescriptions for self-injectable biologics surpassed 90%. By communicating patient concerns with the physician and coordinating access and training for therapy, specialty pharmacists improved compliance, appropriate medication use and safety for a multiple sclerosis (MS) clinic at UIC, according to separate study co-authored by Dr. Hanson. In that case, the MPR rose from 85% to 93% ((Am J Health Syst Pharm 2014;71[6]:463-469).

Still, venturing into the specialty space is not easy, experts noted. “We all think that it’s the best model possible and it provides the best patient care, but there are some barriers to implementing the model,” Dr. Bagwell said.

Perhaps the most troubling of the road-

blocks is the restricted access—and subsequent fragmentation and delay—that can occur with limited distribution drugs.

Nearly half of the specialty medications that came out in 2015 were managed under limited distribution agreements.

And health systems such as UIC and Vanderbilt that have launched specialty pharmacy departments are still locked out of many of those contracts. That can become a challenge, especially when it comes to ensuring Risk Evaluation and Mitigation Strategy (REMS) compliance, according to Dr. Hanson.

As she explained, some REMS drugs have an enrollment requirement involving drug-specific referral forms that are sent to the manufacturer or other affiliated program. They, in turn, send it to the specialty pharmacy. “We have to coordinate with multiple entities just to get the medications out the door,” she said.

Many patients also may lack access because limited distribution drugs are typically only available by mail order.

Some patients are homeless or don’t get their mail regularly. “And some patients are just at the clinic a lot, and just would prefer to get all their medications from one spot,” she added.

What’s more, limited distribution agreements also can hinder comprehensive medication management. “Some pharmacies, for example, might be able to really manage effectively that one endothelin receptor antagonist,” Dr. Hanson said. “But, I’ll tell you, for patients not taking their diuretic, they’re going to end up in the hospital. And that’s one of the services that we provide, which is, unfortunately, affected by this process.”

Dr. Hanson hasn’t given up hope, however. “We have had some success in getting limited distribution drugs,” she said, referring to her team’s collaboration with Biogen to dispense the MS drugs dimethyl fumarate (Tecfidera) and peginterferon β-1a (Plegridy). “It’s not a lost cause.

We know we can help optimize use of a drug for the manufacturer.”

Mr. Zweigenhaft said it’s understandable why manufacturers are becoming more open to such partnerships. “They want their drug to perform in the real world as it did in clinical studies,” he explained. “So they are trying to identify [providers] that have the most dedicated and trained specialty staff to replicate the results. You can’t be Joe the Plumber anymore in the specialty pharmacy business.”

Is this an opportunity for health systems? “Absolutely,” Mr. Zweigenhaft said.

“Specialty pharmacy is a great venue for hospital pharmacists to step up and show their value in health care.”

—Lynne Peeples Dr. Hanson reported serving on the speaker’s bureau for United Therapeutics. The other sources reported no relevant financial relationships.

!

W IN

Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

The Accreditation Game

Specialty pharmacy accreditation “is becoming the promised land for pharmacies that want to participate in the networks developed by manufacturers and third-party payers,” wrote Drug Channels Institute CEO Adam Fein, PhD, in his March 2016 blog.

As of January 2016, Dr. Fein reported, 378 unique specialty pharmacies had achieved accreditation di i with i h at lleast one off two accrediting di i specialty i l pharmacies h i iincluded l d d iin his hi survey: URAC or the Accreditation Commission for Health Care (ACHC).

The importance of accreditation was underscored by the many sessions on the topic presented by representatives of major accrediting bodies at the 2016 Asembia Specialty Pharmacy Summit, in Las Vegas. Several of them mentioned typical mistakes that specialty pharmacies commonly make during the accreditation process, and Specialty Pharmacy Continuum followed up with them to dig a little deeper. Read their tips on avoiding errors and then ask yourself: Are you keeping your pharmacy from winning the accreditation game?

1

Not doing basic homework. It may sound

hard to believe, but Jon Pritchett, PharmD, RPh, said a surprising number of pharmacies seeking ACHC’s accreditation haven’t bothered to download their standards. “A number of pharmacies— perhaps as many as 10% of our applicants—don’t download the standards and spend time reviewing them before beginning the application process,” Dr. Pritchett said. “They may believe they’re already doing a great job and just want to demonstrate that they are operating at a high level, but they need to understand what the accrediting organization is looking for.”

Not choosing wisely. The process of accreditation costs money and time. “Spend some time getting to know the accreditation organization or organizations you are considering: what they can offer and what value they bring to the table for you,” said Dr. Pritchett. “We see some pharmacies that pursue accreditation that may not be what they’re looking for. Understand why

they’re ready for accreditation. Right now, I’m seeing a lot of people who haven’t done that. The selfassessment isn’t a requirement, but it’s an important part of planning to be accredited.”

4

Squandering preparation opportunities. Most of the accrediting bodies have

5

Relying too heavily on consultants.

Skipping the selfassessment.

Some

You’re calling every 5 minutes!

Go back 1 space.

“Accreditation consultants can really benefit applicants who need help putting structure around policy and procedure documentation,” Dr. Bonome

Be prepared.

Buy the staff pizza!

Start

3

Skimping on documentation. “That’s the No. 1 problem we see across the board,” said Sandra Canally, RN. “One area where this is a particular issue is in human resources. It’s clear that people know what they’re doing with regard to handling drugs and taking care of their patients, but when it comes to documenting the training and competencies and evaluation—how we know that

6

webinars and/or workshops that can help you prepare for the process. “When we begin the process with a new accreditation applicant, we see a very clear difference between people who have participated in our webinars and workshops and those who have not,” said Heather Bonome, PharmD. “Surprisingly, probably only about half of our applicants participate in at least one of these.”

2

you’re doing this and what you hope to get out of it.”

.said. “But you need to be working collaboratively with the consultant. We’ve had applicants who provide us with policies and procedures that look great during the desktop review phase of their application, but then we come on-site and it’s clear that the policies came from the consultant, consultant and they haven’t actuactu ally been implemented.”

Ask? Move ahead 3 spaces.

Relied too much on consultants.

Go back 3 spaces.

Document, document, document.

More pizza!

You’ll be here awhile.

Skipped the self-assessment.

Lose 1 turn.

Do your homework.

Roll the dice again.

pharmacies that are eager to jump into the accreditation process give short shrift to the planning phase, said Lynnae Mahaney, RPh, MBA. “The most important thing a potential applicant needs to do is review the standards and do a self-assessment internally to determine if

Chose wisely.

Move ahead 2 spaces.

they’re as good as they say they are—they fall short.

They don’t have it in writing. We get, ‘Oh, we did a training just last week.’ OK, but where is it documented?” Dr. Pritchett agreed with this assessment.

“Very rarely do we go in and the staff ’s not actually trained. Usually they are competent in their job and they have a good grasp of what they’re supposed to do, but there is not sufficient documentation to show how they were trained and how they were assessed,” he said.

Not asking questions. “People have a tendency to over-read the standards, or believe something that somebody heard from some-

7

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Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

body else, rather than picking up the phone and calling us,” said Margherita Labson, RN. “On any given day, someone will ask me something like, ‘Is it true that if I’m just dispensing the drug, I have to do a fall risk assessment on every patient?’ or ‘Do you really expect us to send these patients to the university to be tested?’” If a standard doesn’t sound right to you, ask the accreditor.

bodies often have tools to help with this, according to Dr. Bonome.

Not monitoring subcontractors. “If you’re contracting out some element of your clinical protocols, like the follow-up, that’s fine. Several of our customers, particularly small to mediumsized pharmacies, follow this business model: They

10

Accreditation should be about giving you a robust evaluation. Our real value is when we can tell you something you don’t know about yourself, like a best practice you were unaware of or a hidden risk you haven’t identified.”

—Gina Shaw

Asking questions constantly. Yes, you should reach out to your surveyor if somesome thing’s murky, but don’t call them every five minutes. “Don’t fire off 10 different emails in three days,” Ms. Mahaney said. “Our pharmacies have been great about accumulating a number of questions and organizing them in a manner that we can efficiently answer. Reach out to your surveyor and ask, ‘Can we set up a time to talk in the next few weeks about these five questions?’”

8

Addressed specific recommendations.

Roll again.

Did not annotate documents.

Lose 2 turns.

Learned something new about your practice. Move forward to the next red space.

You win!

Congratulations, you’re accredited!!!

Monitored subcontractors.

Move ahead to the next blue space.

The Players (in order of appearance)

Jon Pritchett, PharmD, RPh,

have the infrastructure to fill the script but not do the follow-up that is also necessary,” Ms. Canally said. “But at the end of the day, you’re responsible: You got the order and you filled it. So from a quality control standpoint, you’re responsible for what your subcontractor is doing, and you have to have documentation of that.”

11

9

Drowning your accreditor in piles of unannotated documents. “In our

instructions, we say, ‘Tell us the name of the document and the page number where this specific information can be found.’ But we’ve gotten just piles of documents for a standard with no hint of where in those documents we’ll find the information we need,” Ms. Mahaney said. “Read the instructions. Help your accreditor.” Accrediting

Responding too generally to the accreditor’s recommendations. Near

the end of the process, most accreditors will give you a report detailing the standards on which you fell short. “We expect our applicants to give us a reply within 30 days, with an action plan and a timeline for how they’re going to come into compliance,” Ms. Mahaney said. “Your answers need to be specific, directly addressing the elements of the standard that were not in compliance, and how you will remedy that.”

12

Letting the perfect be the enemy of the good. “The Joint Commission is not

just an evaluator; we are a performance improvement organization,” Ms. Labson said. “I’ve worked in this business for more than 40 years, and while there may have been programs that hit every standard perfectly, they’re a very small minority.

the associate director of pharmacy for the Accreditation Commission for Health Care (ACHC); also oversees its Pharmacy Compounding Accreditation Board

Lynnae Mahaney, RPh, MBA, the executive director of the Center for Pharmacy Practice Accreditation (CPPA).

Heather Bonome, PharmD, the director of pharmacy at URAC.

Sandra Canally, RN, the founder and president of The Compliance Team.

Margherita Labson, RN, the executive director for the Home Care Program at the Joint Commission

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Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

‘Last mile’ best practices:

Prequalified Cold Chain Shipping Considerations Las Vegas—Is a prequalified cold chain shipping system right for you? That’s the question many specialty pharmacies consider while working with accrediting bodies, regulators or auditors from pharmaceutical manufacturers as they try to secure limiteddistribution therapies. And it’s a tough question to answer, said cold chain experts at a session on “Last Mile Best Practices” at the 2016 Asembia Specialty Pharmacy Summit.

There are two things all of these entities will be looking for in a specialty pharmacy’s cold chain process, explained Jamie Chasteen, the senior product manager at Cold Chain Technologies Inc. “First, you have to prove you’re using a properly qualified package. Next, you have to prove that you have qualified processes in place guaranteeing the qualified package is used as intended, and the efficacy of the drugs is protected.”

Packaging qualification for cold chain shipping falls into three parts: 1. design qualification (DQ) 2. operational qualification (OQ) 3. performance qualification (PQ) A supplier with a prequalified, offthe-shelf system has done the “DQ” and “OQ” for you, Mr. Chasteen said. “To be properly qualified, they test three examples of each package to show repeatability, with minimum and maximum payloads or with a fully thermally mapped

Top: Cold Chain Technologies’ ISTA-certified thermal testing laboratory, where design and operational qualification testing take place. Bottom: Inside of an environmental chamber shows thermocouple wiring used to thermally map payloads during testing for a pallet shipper.

Source: Jamie Chasteen.

payload area, against each ambient temperature profile.”

Sounds good, right? But those are still generic qualifications. “It wasn’t your specific product, nor your specific distribution lanes modeled for the ambient temperature profile,” Mr. Chasteen said.

When reviewing a prequalified system, he urged specialty pharmacists to ask two key questions: First, is the profile in the test indicative of the shipping lanes and methods we’re using? Second, are the payloads used in testing representative of our product mix?

If the answer to both questions is yes, then you can perform a PQ. A PQ is a series of real-life shipments with mock drug product and data loggers. If the data are good, you now have evidence in a real-world scenario that the system worked as intended.

The experts advised against the stillcommon practice of using strictly seasonal packaging, tested to only extreme hot or extreme cold temperatures, and changing pack-outs twice a year.

“First, you’re adding costs because you’ll end up using more insulation and more refrigerant to combat the arbitrarily severe profile,” Mr. Chasteen said. He then showed animations of time versus temperature testing detailing risk to product integrity that some may have found surprising.

“Second, you’re likely doing more harm than good. Let’s assume, per your company’s SOP [standard operating procedure], you are utilizing your hot packout during a summer day, but it happens to be relatively mild outside. The amount of ice in that system is designed for very high ambient temperatures. As a result, during today’s moderate weather, the temperature inside the box drives down below the 2° C lower limit of your product.”

Conversely, on a mild winter day, the temperature may spike too high when using a cold pack-out designed for very low ambient temperatures. “Today’s best practice [employs] a universal moderate pack-out [Figure], qualified to withstand both a moderately high and moderately cold ambient profile, which can capture 60% to 80% of your real-world shipments,” Mr. Chasteen said. “You then employ an extreme hot pack-out or extreme cold pack-out only on the hottest and coldest days of the year, and not arbitrarily on a particular calendar day.”

Show Them the Data Increasingly, specialty pharmacies will be asked for data-backed documentation proving not only that a shipping system has been properly qualified, but that

proper process qualifications have been put in place as well. For example, Mr. Chasteen said, specialty pharmacies will need to be asking the following questions: “How long do you need to precondition refrigerants before use? How long can refrigerants be at the pack-out station, at room temperature, before they need to go back into preconditioning?

How are systems staged after pack-out and before carrier pickup? How and when are you triggered to employ an extreme hot or extreme cold pack-out?

Do you have data that back up why you do what you do in each of these cases, and do you have the SOPs and employee training logs that prove you are actually doing what you should be?”

by the

numbers

Fairview Specialty Pharmacy’s

120,000 sq ft facility shipped

265,000 packages in

2015 at a cost of

$2.3M average product value:

$3k-$5k Larger specialty pharmacies may have their own internal cold chain shipping qualification processes. Fairview Specialty Pharmacy, a specialty pharmacy affiliated with the University of Minnesota, ships to all 50 states, with 265,000 packages shipped in 2015, Mike Resvick, RPh, Fairview’s regional operations manager for specialty/mail-order pharmacy, said during the Asembia session.

Within an 80-mile radius of the pharmacy’s Minneapolis headquarters, a courier is used for about half of all deliveries. “That’s quite an advantage to us,” Mr. Resvick said. “We have full control of the package and when it leaves, and if it’s undeliverable we can pull it and make sure the integrity is maintained.”

Next-day shipping is done via UPS and FedEx, with environmentally friendly packaging. “The days are gone when

15

Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

25 5

doin 30 total shipments with packagdoing ing that costs less than $10, while utilizin ng affordable data loggers, the cost doessn’t have to be astronomical.”

“If I’m shipping $30,000 worth of Harrvoni [ledipasvir-sofosbuvir, Gilead], I waant to spend a little extra money to mak ke sure it gets there in good condition n,” Mr. Resvick observed.

—Gina Shaw

Temperature, C

20 0 Ambient temperature Right back corner Center Front face Right-side face

15 5 10 0

Upper limit 8.49 C (7.26 F)

5 0

Lower limit 1.5 C (34.7 ( F))

–5 5 0

4

8

12

16

20

24

28

32

36

The sources reported no relevant financial relationships beyond stated employment status.

Figure. A universal moderate pack-out strategy for cold chain shipments.

Data show that the packaging is qualified to withstand both a moderately high and moderately cold ambient profile, which can capture 60% to 80% of real-world shipments.

Unit Do s Bar Co e, ding, Pharma Nursing cy & Supp Experts ly !

we were freeing ice packs in stand-up freezers at the pharmacy and sending them out in an old-fashioned Styrofoam cooler,” Mr. Resvick said. Instead, they utilize coolers made of “a cellulose that will dissolve when put in water. We don’t have customers calling us asking what to do with a garage full of Styrofoam coolers at the end of the year.”

For Fairview, summer guidelines stipulate two frozen ice packs, shielded from the product by a layer of packaging material; winter guidelines mandate one frozen and one room temperature ice pack. “These are all seasonally adjusted,” Mr. Resvick said.

Costs Coming Down Ongoing monitoring of cold chain shipments is becoming much more costeffective, said Mark Maurice, a sales engineer for the supply chain monitoring firm Sensitech. “Look for an NIST [National Institute of Standards and Technology]–calibrated compact design that doesn’t impact the size of your shipment,” he advised. “You want a minimum of two, if not four, alarms on each package, with an intuitive LCD [liquid crystal display] design. The customer must see the obvious sign that the package is safe.”

Many audience members had questions for the panel, with a key concern being that smaller pharmacies may not have the budget to do their own qualification. Mr. Chasteen advised them that prequalified packaging is particularly appropriate in such situations, as companies can come close to a turnkey solution with something off the shelf. “They will get you through DQ and OQ, but you still have to run performance qualifications in your own distribution lanes at different times of the year. That’s really not an expensive proposition: If you’re

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Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

DISASTER DISPENSING continued from page 1

the Northeast blackout of 2003 can be allowed to delay a specialty pharmacy from its appointed dispensing rounds.

So how do they prepare?

Lessons Learned From Katrina Some pharmacies have learned the hard way. Miami’s SMP Pharmacy was barely two years in business when Hurricane Katrina battered the region in August 2005. “Our planning did not anticipate that the area would be without power for almost a month,” Brian Brito, SMP vice president, admitted. “We had about a week’s notice, so we went out and found a generator that could power our refrigerators to keep cold chain items cold, some fans and some lighting, and a server that could link us to the patients’ records for the last month.”

erators, commercial-sized, that tap right into our electrical panels. When we begin hearing that a hurricane might be headed our way, usually about a week out, we start testing that generator. We also put a lot of our power underground last year, and our internet access runs on fiberoptic cables 8 feet underground.”

The pharmacy calls patients if their refills are due within three weeks, not one. Additionally, Dr. Bardisa and Mr. Brito hold regular preparedness meetings, set up a hotline for patients and leave recorded messages for staff every night as to whether they should come to work the next day. “We do our best to be proactive and work ahead of the storm,” Mr. Brito said. “Since we also do business in other states, we have a network of pharmacies that we work

operations. “We also have a secondary contact center in Irving, Texas, where we can also dispense cold chain medications, if necessary. After four years of operations, it’s never been needed so far, but we have a business continuity plan if there ever came a day when we could not ship from our primary site.”

Diplomat holds tabletop disaster preparedness drills at least annually, involving some 20 people from every department. “We focus on a hypothetical disaster, and everyone walks through what we would do to manage it,” Mr. Fleckenstein said. “We’ve had drills on viral infections, hurricanes and earthquakes. We have an emergency preparedness plan, business continuity plan and a systems backup redundancy plan, and all three of those are integral to our ability to react to a disaster.”

Prime also has a dedicated team of employees who track severe weather

‘We have an emergency preparedness plan, business continuity plan and a systems backup redundancy plan, and all three of those are integral to our ability to react to a disaster.’

—Robert Fleckenstein, Diplomat Specialty Pharmacy

With about 100 patients whose medications were due to be refilled within the next week, Mr. Brito and SMP founder Armando Bardisa, PharmD, set their staff to making phone calls. “First, we called the insurance companies for emergency overrides of the ‘refill too soon’ block, and then we called the patients and strongly urged them to come by and pick up their medications, which were already billed,” Mr. Brito said. Most patients did as they were told, but there was just one problem: Power was out for two weeks, not one.

“We had a lot of patients, such as people with HIV, who couldn’t go even a day without their medication. We couldn’t bill credit cards, so we were just writing everything down in a notebook,” Mr. Brito said. “We placed drug orders over the phone. We hand wrote the labels with all the federal requirements, documented their credit card information and gave the drugs to the patients, saying we’d bill them when we were back up and running. Everything was manual.”

With the lessons of Katrina learned, things are very different today, Mr. Brito noted. “First, we have much larger gen-

with so that they can serve our local patients if FedEx can’t get our shipments there.”

Redundancies and Backups Many large specialty pharmacies rely on redundancy to keep their prescriptions dispensed during emergencies. “We’re fortunate; we have six core sites—our basic specialty distribution sites—and then we have infusion sites as well that we could also leverage should we have to, all on the same platform,” said Robert Fleckenstein, the senior vice president of operations at Diplomat Pharmacy Inc. “Our main site in Flint, Michigan, is licensed in all 50 states, and our other regional sites have blocks of the country they’re licensed in, so we can dispense from those alternate sites should we have to.”

Prime Therapeutics Specialty Pharmacy has similar backup plans. “Our primary specialty pharmacy is in Orlando, [Florida], and we have a secondary frontend operation in Eagan, Minnesota, and another in Albuquerque, New Mexico,” said Guillermo Sollberger, the vice president of specialty and mail pharmacy

and major events, and is often the first to inform its couriers of a potential delivery problem. “When a weather event is likely, we reach out to all members who may be in need of their medicine, well in advance of a storm to confirm their needs and overnight the medicine so their therapy isn’t interrupted,” Mr. Sollberger said.

For some emergencies, like hurricanes, one can plan ahead and refill early. For a blackout, a tornado or an earthquake, there is less warning. Working 23 days out from last fill to begin initiating prescription refills helps Prime stay ahead of the game in the event of that sort of emergency, Mr. Sollberger said. “That means we are working with members having seven days of medication still on hand, and we are extremely proud of our ability to get nearly 100% of medications out the door when we say we’re going to, with most of them sent by overnight delivery. We purposely don’t run too tight on our timeline; we have a culture of not carrying fulfillment over to the next day. Because we clear the fulfillment line every single day, it gives us the flexibility to absorb addi-

tional fills the next day and the grace of additional fill days if a catastrophic event disrupts shipping.”

Paying a Premium for Diesel If a tornado hits St. Louis and shuts down Avella’s pharmacy there without warning, any of the company’s sister facilities can immediately access that pharmacy’s system and work those prescriptions. “We’d take that prescription and transfer it to another store,” Mr. Geguzys said. “Our pharmacies in Deer Valley, Arizona, and Orlando are licensed in all 50 states, and they all have generators that can run ad infinitum, so long as we have a supply of diesel.” Anticipating the next question, he added, “We’ve gone so far as to write contracts for that diesel, and paid some pretty serious money to be first in line.

We have to ensure that we can continue to serve our patients.”

Large specialty pharmacies with a major national presence like Avella, Diplomat and Prime often contract with third-party supply chain logistics experts that specialize in ensuring that patients receive their costly, critical and/or cold chain medications on time. Dawson Logistics and its Guardian Angel pharmaceutical program is the choice of both Avella and Diplomat specialty pharmacies.

“Guardian Angel utilizes a proprietary tracking platform, where we’ve programmed logic into the system that will calculate the statistical likelihood of a package not being delivered,” said Doug Dawson, the CEO at Dawson. “In many cases, we know before UPS or FedEx that a package likely will be delayed.”

In the aftermath of hurricanes Katrina and Rita (which hit about a month later), Avella had several shipments that absolutely had to be in Houston. “The whole city was shut down and transportation companies weren’t moving,” Mr. Dawson recalled. “In those types of extreme calamities, we have a system that provides alternate routing and customized distribution modeling for each of those shipments. We had the shipments sent about 150 miles north, where we had independent couriers on standby. They drove into the hurricane situation to get those packages delivered.”

Avella called one patient in Houston to let him know that his medication was about to be dispatched by courier. “We asked, ‘Where are you, so we can get you your meds?’” Mr. Geguzys said. “He said, ‘I got the heck out! I’m in Chicago and I’m going to the World Series game.’

Doug and his crew took that package and they delivered it to him in the parking lot of the ballpark.”

—Gina Shaw None of the sources reported any relevant financial relationships.

17

Specialty Pharmacy Continuum • July/August 2016

OPERATIONS & MANAGEMENT

Zitter offers details at Asembia

Pt Satisfaction May Be SP Differentiator Las Vegas—As many as 40% of patients taking specialty drugs have switched their pharmacy. Of those, as many as 60% have switched within the last six months, according to results from the Zitter Health Insights’ (ZHI’s) Specialty Pharmacy Patient Satisfaction Survey, presented at the 2016 Asembia Specialty Pharmacy Summit.

“What’s surprising is that it’s not all health plan influenced, which is what you might expect,” Jason Rucker, the product director for ZHI, told Specialty Pharmacy Continuum after the meeting. “We are finding that probably a third of patients who switch specialty pharmacies are doing so for customer-service reasons.”

The biggest drivers of patient satisfaction with their specialty pharmacy include speed to therapy, ease of the refill process and help with financial assistance programs. “The pharmacies that do those three things well tend to have higher patient satisfaction scores,” he said.

ZHI began fielding the patient satisfaction survey in early 2015, aiming to fill a data gap for payors, manufacturers

and specialty pharmacies. “Until now, most specialty pharmacies have competed mostly on price, because it’s important and also because it’s objective, while quality measures are a bit squishier and harder to compare across pharmacies,” said CEO Mark Zitter, speaking at the Asembia session. This formed the impetus for the launch of the survey, which is fielded quarterly and has approximately 10,000 to 12,000 participants annually.

Specialty pharmacy patients take a 10- to 15-minute online survey on topics including patient choice and specialty pharmacy selection; financial assistance and reimbursement services; communication and interaction from multiple patient touchpoints; first fill/refill experience; customer service and Net Promoter Score; patient switching behavior; etc.

The service costs vary depending on the type of subscription the specialty pharmacy chooses.

“Be ready for seeing data you may not like,” warned Mike Agostino, the vice president of pharmacy innovation/business development at Hy-Vee, one of a panel of six leading specialty pharma-

cies that helped ZHI develop the survey, along with three pharmaceutical manufacturers, two payor representatives and a handful of industry consultants. “But that’s useful. You can take it back to your pharmacy and see what you can change.”

The survey continues to evolve as elements are added, Mr. Rucker said.

Jake Olson, PharmD, the owner of Skywalk Pharmacy, a small, independent pediatric pharmacy operating inside Children’s Hospital of Wisconsin, in Milwaukee, was not involved in the panel that developed the ZHI survey, but he is familiar with the value of using tools that can help establish performance benchmarks such as patient satisfaction.

“I frequently say that I know I’m doing a better job than ‘Pharmacy X,’ but I can’t prove it,” Dr. Olson said. “With the ZHI survey tool, I can prove that I have a faster speed to therapy, and more customer satisfaction with my financial assistance programs. It’s clear that metrics on patient and prescriber satisfaction are [needed] for specialty pharmacies to distinguish themselves moving forward,” he said adding that it can level the playing field.

However, the cost of getting a full patient satisfaction report could be prohibitive for some smaller specialty pharmacies, Dr. Olson cautioned. (Mr. Rucker noted that at the time Dr. Olson was interviewed for this article, ZHI had not shared any pricing information with him.)

Matt Carpenter, the senior director of specialty access solutions at Pfizer, said much of the available data on specialty pharmacy’s success have been transactional and focused on throughput.

“There’s a great opportunity with the ZHI data to augment that and help us not look just at throughput, but also [patient] satisfaction,” he said.

Pfizer began working with the ZHI data about a year ago. “We’re just about to the point where we’re comfortable to integrate it in our quarterly business reviews with our collaborators,” he said.

“We want to look at this in combination with the other data that we have, to go back to the question, ‘How do we improve the patient interactions so we have the best outcomes?’”

—Gina Shaw The sources reported no relevant financial relationships other than their stated places of business and/or association with ZHI’s patient satisfaction survey.

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18

Specialty Pharmacy Continuum • July/August 2016

CLINICAL

High Drug Costs Hinder Cystic Fibrosis Care San Francisco—Rising treatment costs, combined with a trend toward patient cost sharing, may negatively affect cystic fibrosis (CF) patients’ access to timely and lifesaving care, according to a poster presented at the 2016 Academy of Managed Care Pharmacy (AMCP) annual meeting.

“The cost of living with cystic fibrosis places a tremendous financial burden on people with CF and their families,” said Jacqueline Erdo, MPH, the manager of access policy and innovation at the Cystic Fibrosis Foundation, and an author of the abstract (E61). “It’s imperative that people with cystic fibrosis have access to the right care and treatments when they need them.”

Ms. Erdo and her colleagues decided to further investigate the link between insurance coverage and access to care and treatment for patients with CF. They sent an online survey out to 17,513 discrete email addresses in late 2015. They received 1,132 responses (7%) from 1,087 qualified respondents—patients with CF, their parents or guardians, or another family member.

In their analysis, the researchers found that although 99% of CF patients had some form of insurance, cost concerns led 22% to delay medical care and 24% to take fewer or smaller doses of prescribed medicines. Most sensitive to financial burdens were patients covered by Medicare or other publicly funded programs, those with higher out-of-pocket expenses and those with lower household income.

Paul Quinton, PhD, a professor of biomedical sciences at the University of California (UC) Riverside School of Medicine, is acutely aware of this predicament. Not only does his research focus on CF; he

also is a CF patient. Dr. Quinton, who was not involved in the AMCP abstract, noted his good fortune in having excellent health coverage through his university. He added that he continues to fall in the three-fourths of patients who have not been driven to delay or alter their CF treatment regimen, which generally includes ivacaftor (Kalydeco, Vertex).

“I’m wealthy enough to not suffer with the significant copays that I have to pay,” he said. “But I certainly could not come up with the $300,000 a year that the treatment costs.”

That price tag breaks down to about $900 a day. “It is alarming that such prices can be charged,” Dr. Quinton said.

“People in my lab and many colleagues have spent decades working on this disease—understanding [underlying mechanisms] and developing a way for pharmaceutical companies to take advantage of that knowledge and to put out a drug.”

But now, he noted, some of those companies are using that research to drive personal and corporate profits, rather than keeping the primary focus on patients.

Dr. Quinton said he was pleased to see the new study, adding that “looking at this issue quantitatively has been seriously neglected.”

Vertex Pharmaceuticals Inc., the maker of ivacaftor and lumacaftor-ivacaftor (Orkambi), defended the price tags of its drugs, noted widespread coverage of the

cystic

fibrosis 30,000 Diagnosed U.S. cases of CF.

2,500 Babies in the U.S. born annually with CF.

1 in 2 Americans who are unaffected carriers of the abnormal “CF gene.”

Source: Centers for Disease Control and Prevention.

drug by commercial insurers and Medicaid, and pointed to patient assistance programs that help ensure patients can afford the medication whether or not they have insurance.

“We are committed to helping patients get access to Orkambi,” Stuart Arbuckle, the executive vice president and chief commercial officer at Vertex, stated in a quarterly earnings call in 2015. “We consider the many factors in setting the price of Orkambi, such as the fundamental benefit of treating the underlying cause of CF in indicated patients, the time and cost to develop the medicine, the small number of eligible patients, and our commitment to reinvest in research and development of new medicines to help the tens of thousands of other people with CF

OptiMed Takes a Holistic Approach to CF

A

ndy Reeves, RPh, the CEO of OptiM Med Specialty Pharmacy, noted the importance of add dressing the whole patient with cystic fibrosis (CF). “We look at comorbid conditions and evaluate each individuall’s specific needs,” he said. For a patient with CF, he explaiined, that would include evaluating the appropriateness and utilization of therapy, in conjunction with other drugs a patient may be taking. “Some of the high-cost drugs are only effective for specific genetic mutations,” Mr. Reeves noted. “We also o check to make sure there are no contraindications or interactions with their other medim cines or medical conditions.

“Adherence is a complex, multifaceted issue,” he added. “We want to make sure the patient perceives the benefit. But cost is also a huge factor that affects adherence: Can they afford it?”

Dedicated personnel at OptiMed, he said, help patients identify applicable financial support from their state, foundations and drug manufacturers.

Still, the top reason for nonadherence, Mr. Reeves noted, is forgetfulness. OptiMed works with patients to help them incorporate the therapy into their daily routines, as well as

know what to do if they miss a dose. “These are expensive specia alty medicines,” he said. “But the most expensiive ones are the ones patients don’t take and don’t get the benefit from. If we know that side effects may be more common within tthe first few weeks of therapy, then n we may want to initially keep contact with a patient on a weekly basis—before extending that to b every other week, or monthly—so e we c can get them the attention they need or he elp alleviate side effects.”

In addition, OpttiMed keeps open the lines of communication with a provid provider and ensures there is monitoring of lung function, lab values and adverse events. Access to monitoring tools, such as the Spiro PD (PMD Healthcare) personal spirometer, can help CF and other pulmonary patients accurately monitor their lung function and see the improvements. “This provides the motivation often needed to stay adherent,” Mr. Reeves said. “Technology like this also sends the health care providers the information, allowing the physician and pharmacist to work in tandem to drive better patient outcomes, which is where you reap the most value.”

—L.P.

who do not have a drug that treats the underlying cause.”

Brian P. O’Sullivan, MD, a professor of pediatrics and an expert in CF at Dartmouth Geisel School of Medicine, in Hanover, N.H., agreed that the problem of rising drug costs “needs to be addressed.”

He noted that he sees CF patients who have delayed or missed treatments due to the price tags. “High costs make it hard, especially for those with low income, or those on Medicaid or Medicare, to get their medicines and use them regularly,” said Dr. O’Sullivan, who also was not involved in the AMCP abstract.

He pointed to the low response rate in the survey as one limitation, suggesting that those struggling with affordability issues are probably more likely to have responded. “While the results do make a lot of sense, they should be taken with a grain of salt,” he said. At the same time, he also suggested that the full scope of the drug cost issue may be frequently hidden from physicians and researchers. “People are embarrassed to admit they can’t afford their medications.”

Pharmacists Can Help The investigators underscored the need for further research on the effects of cost sharing on clinical outcomes.

They also highlighted the power of pharmacists to aid in alleviating some of the financial burden.

“Specialty pharmacists have been great advocates for people with CF, helping them manage prescriptions and navigate coverage requirements,” Ms. Erdo said.

“Pharmacists can also support people with CF by working with clinicians and payors to improve understanding of the complex needs of the disease and to create evidence-based coverage policies.”

—Lynne Peeples Ms. Erdo and Drs. Quinton and O’Sullivan reported no relevant financial relationships.

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Specialty Pharmacy Continuum • July/August 2016

CLINICAL

Specialty drug adherence, persistence key

Keeping MS Patients out of the Hospital San Francisco—Patients with multiple sclerosis (MS) who skip doses or stop taking their medications altogether are more likely to frequent the ER and be admitted to the hospital, according to a poster presented at the 2016 Academy of Managed Care Pharmacy annual meeting.

Patients with copays greater than $25 and those who were treatment naive within six months before the study appeared to be most at risk.

“These analyses are observational and [underscore] the importance of adherence and persistent treatment in multiple sclerosis,” said Nina Thomas, MPH, a principal health economist at Genentech, and the lead author of the poster (G16).

Specialty medications are crucial to effective disease management in MS, helping to prevent debilitating episodes of relapse. They also account for a substantial portion of the medical expenditures associated with the condition ((Am J Manag Care 2014;20[11 suppl]:S242-S253).

With a potential new entrant into the MS market—the investigational drug ocrelizumab—Genentech wanted a better understanding of treatment

patterns and potential implications on the health care system, according to Ms. Thomas. So, she and her colleagues analyzed retrospective claims data over 12 months for more than 16,000 MS patients who received natalizumab (Tysabri, Biogen Idec), interferon β-1a (intramuscular and subcutaneous; Rebif, EMD Serono), interferon β-1b, glatiramer acetate or fingolimod (Gilenya, Novartis). They considered patients adherent if their medication possession ratio exceeded 0.8, and defined de ed persistence pe s ste ce as the t e duration of treeatment from initiation to d discon ntinuation or the end of the stud dy period.

The teaam fou und that 13.9% of patientts werre not adherent while on their treatment, and d 35.33% discontinued treattmentt during the follow-up p period. Also, one

in 10 patients was admitted to the hospital, and nearly one in four visited an ER. After adjusting for patient characteristics including age and health plan type, the researchers found that those who were persistent and/or adherent were significantly less likely to have an inpatient hospital stay, compared with those who were less persistent or nonadherent (odds ratio [OR], 0.50 and 0.83, respectively; P<0.001 for both) or visited an ER (OR, 0.65 and 0.86, respectively; P<0.001 for both).

Further, as they determined in an unadjusted analysis, patients who had not taken disease-modifying treatment within six months before the study had lower persistence and adherence compared with patients who had received treatment in the previous six months (77.4% vs. 84.4% and 78.6% vs. 87.6%, respectively; espect ve y; P<0.001 0.00 for both).

The reseaarrchers also analyyzzed out-ofpockeet costs, and foun nd a greater prro oportion of paatients who p were persistent and aad dherent had

copays less than $25 compared with nonpersistent or nonadherent patients (24.9% vs. 22.2% and 24.4% vs. 21%, respectively; P<0.01 for both).

‘Powerful’ Research Jacci Bainbridge, PharmD, a professor of clinical pharmacy at the University of Colorado Skaggs School of Pharmacy, in Aurora, who was not involved in the abstract, said it would have been helpful to know when the hospitalizations and ER visits happened in relation to adherence or nonadherence.

(The authors could only be certain that any event occurred within one year of nonadherence or nonpersistence.) Still, she called the new research “powerful”—even if the findings weren’t all that surprising to her.

“If people are not taking their medications,” she said, “it stands to follow that they are going to be at a high risk for morbidities.”

Dr. Bainbridge cited some further explanations for why many MS patients are not taking their medications. “Interferons cause a lot of side effects,” she explained. “If people are paying a lot of money out of pocket, suffering side see MS PATIENTS, page 20

Ocrelizumab Bests Interferon β-1a In OPERA Trials VANCOUVER, BRITISH COLUMBIA—Patients with mul-tiple sclerosis (MS) taking Roche’s experimental anti-CD20 monoclonal antibody ocrelizumab b were more likely to achieve no evidence of disease activity (NEDA) than those taking interfero on β-1a (Rebif, EMD Serono), according to an analy ysis presented by researchers from the OPERA I and d OPERA II Phase III trials at the 2016 annual meeting of the American Academy of Neurology.

NEDA is a composite endpoint that assesses level of disease control. Patients are considered to have achieved NEDA if they have no relapses, no disability progression, and no new or enlarging MRI lesions over a specified time interval, for example, two years of a clinical trial.

Each of the identical double-blind, double-placebo trials included 828 patients with relapsingremitting MS. Patients were randomly assigned to receive either ocrelizumab 600 mg IV every 24 weeks or subcutaneous interferon β-1a 44 mcg three times per week over 96 weeks. MRI at 24, 48 and 96 weeks was used to assess NEDA. At 96 weeks, 47.9% and 47.5% of patients in OPERA I and II treated with ocrelizumab achieved NEDA, vs. 29.2% and 25.1% of patients treated with interferon β-1a, representing a 64% and 89% increase (P<0.0001) in patients who achieved

NEDA in OPERA I and II, respectively. Other findings: • 80.4% (OPERA I) and 78.9% (OPERA II) of patients taking ocrelizumab were relapse free, compared with 66.7% and 64.5% of patients taking interferon β-1a.

• 92.4% and 89.4% of ocrelizumab patients, compared with 87.8% and 84.9% of interferon β-1a patients, had no confirmed disability progression.

• 91.7% and 90.2% of ocrelizumab patients, compared with 69.8% and 63.9% of interferon β-1a patients, had no new or enlarging gadolinium-enhancing T1 lesions.

• 61.7% and 60.9% of ocrelizumab patients, compared with 38.7% and 38% of interferon β-1a patients, had no new or enlarging T2 lesions.

“About double the number of ocrelizumab patients

achieved NEDA at two years compared with Rebif.

This is quite impressive,” said John Corboy, MD, the director of the Rocky Mountain MS Center at the University of Colorado Anschutz Medical Campus, in Aurora. “Going forward, the biggest concerns for all the anti-CD20 molecules—including ofatumumab [Arzerra, Novartis] and rituximab [Rituxan, Genentech] as well as ocrelizumab—will be long-term safety in the MS population. And of course, they still need long-term efficacy data.”

In February 2016, the FDA granted ocrelizumab breakthrough therapy designation for primary-progressive MS, according to the agency. The designation confers expedited review as soon as the manufacturer files for approval of the medication.

—Gina Shaw

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Specialty Pharmacy Continuum • July/August 2016

CLINICAL

MS PATIENTS continued from page 19

effects and can’t tell if the drug is working for them right now—they’re essentially an insurance policy for the future— then people are not going to do it.

“Out-of-pocket costs should be controlled,” she added, highlighting another recent study that found a 10% increase in adherence significantly decreased the likelihood of an inpatient or ER visit by 9% to 19%, days of work lost by 3% to 8%, and direct and indirect costs by 3% to 5% ((J Med Econ 2015;18[9]:711-720).

Dr. Bainbridge noted that some health plans’ formulary lists limit patients’ access to the most effective and perhaps iven the importance of affordability in drug adherence, it’s critical to educate more convenient therapies. In patients about financial assistance for their MS drugs. Most pharmaceutical comher experience, plans will only panies have assistance programs; the following nonprofit organizations also offer proallow a patient to switch to an grams for people who have insurance but who still need help with the cost of their oral medication such as fingodisease-modifying MS therapy. limod after failing one or two $ The Assistance Fund (877) 245-4412 self-injected disease-modifying $ Good Days from CDF (877) 968-7233 therapies, such as interferon β-1a or glatiramer acetate. In certain $ HealthWell Foundation (800) 675-8416 (Medicare only) cases, patients might respond $ Patient Advocate Foundation Co-Pay Relief Program (866) 512-3861 (Medicare, better—and stay more adherMedicaid, military only) ent—on an alternative therapy, $ Patient Access Network Foundation (866) 316-7263 (Medicare only) she said, but are unable to make Source: National Multiple Sclerosis Society: www.nationalmssociety.org/Treating-MS/Medications/Financial-Assistance-Programs. the switch.

A 10% increase in drug adherence can lead to a nearly 20% reduction in hospitalization rates and also mitigate days of work lost, in addition to other productivity measures.

Financial Assistance for Multiple Sclerosis

G

Evolving Treatment Although access and adherence challenges remain, Dr. Bainbridge stressed that there are many reasons for viewing MS treatment in a positive light. MS used to be considered a T-cell disease, she noted. With the recent realization that B cells also play a major role, B-cell therapies are gaining traction. Rituximab (Rituxan, Genentech), for example, a monoclonal antibody with activity against B-cell surface proteins, has been shown to have some

efficacy in MS and is relatively inexpensive. But because the drug is not yet approved for the disease, “it’s difficult to get insurers to pay for its off-label use,” she acknowledged.

Newer agents such as Roche’s investigational agent ocrelizumab also are triggering excitement in the MS treatment community, she noted, given its strong efficacy data (see page 19). Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively

target CD20-positive B cells. (CD20positive B cells are thought to be a key contributor to myelin and nerve cell damage, which can result in disability in people with MS.) In late June, the FDA granted ocrelizumab priority review status.

“Many patients are doing better on these newer therapies,” Dr. Bainbridge said, in part because of improved compliance: The agents are formulated as oral drugs or infusions that only need

Illustration depicts multiple sclerosis in nerve cells. Source: Roche.

to be administered every four weeks or even once yearly, versus the older self-injectables.

Efficacy also is improving with the newer drugs. Side effects are also changing—for better or worse, depending on the patient. In many cases, adverse reactions are now less frequent but potentially more life-threatening, Dr. Bainbridge noted, adding that in the future, “we’re going to see more medications that will provide different options for patients in terms of side-effect profile, convenience and efficacy.”

—Lynne Peeples The sources reported no relevant financial relationships other than their stated places of business.

NEW PRODUCT

McKesson Launches Optimization Toolkit

M

cKesson Specialty Health has announced the enhancement of its in-office dispensing pro-

gram for oncology practices by launching an Optimization Toolkit to drive improved financial performance and patient care excellence.

The new Optimization Toolkit adds unique components to the McKesson In-Office Dispensing program, including data analytics and dedicated oncology pharmacy expertise, as well as high touch operational support across marketing, workflow training and legal guidance.

“More than half of the current phase III oncology pipeline is comprised of oral therapies, and the future will bring even more of these innovative treatments to the forefront,” said Randy Hyun, senior vice president and general manager of

Provider Solutions for McKesson Specialty Health.

“McKesson’s In-Office Dispensing program, along with the Optimization Toolkit, can help practices take advantage of this dramatic increase in oral oncolytics and identify revenue growth opportunities while supporting the delivery of safe, efficient high-quality care for patients.”

optimization engagement analytics to measure success.

• Strategic engagement opportunities with pharmacy experts designed to help practices diagnose opportunities and affect positive change.

• A suite of customizable tools and templates and expert guidance for practices looking to market their services to patients and prescribers.

The Optimization Toolkit provides several components to drive financial performance and exceptional care, according to the company, including:

• Advanced workflow and pharmacy training courses to enable practices to increase efficiency.

• Diagnostic data analytics that deliver useful, actionable intelligence by analyzing key metrics to uncover opportunities for business optimization.

• Exclusive legal platform with guidance on state regulations for physician dispensing and retail pharmacy models.

• Benchmarking, goal setting and post

For more information, visit www.mckessonspecialtyhealth.com.

21

Specialty Pharmacy Continuum • July/August 2016

CLINICAL

Cancer Immunotherapy Comes of Age Las Vegas—Immunotherapy is becoming an integral player in cancer treatment, and with so many products in clinical trials, that role will just increase, speakers said at the 2016 Asembia Specialty Pharmacy Summit. Although fewer than a dozen are approved for cancer treatment, hundreds are in clinical trials.

Perhaps, the best-known drug right now is pembrolizumab (Keytruda, Merck), because it has yielded remarkable results for former President Jimmy Carter’s metastatic melanoma. Stories like President Carter’s are compelling.

He announced last fall that his melanoma had spread to his brain. But despite expectations, today he is still teaching Sunday school every week and recently traveled to London.

Plus, results from a new study of pembrolizumab, presented at the 2016 annual meeting of the American Society of Clinical Oncology, indicate that the former president is not alone. In a trial of 655 patients with advanced melanoma—75% of whom had seen their cancers advance under other therapies—median survival was 24.4 months, and 40% of patients were still alive at three years ((J Clin Oncol 2016;34[13]:1510-1517).

“We confirm that pembrolizumab provides long-term survival benefit in

patients with melanoma, with 41% of patients alive at three years, which is so different from what we have come from,” Caroline Robert, MD, PhD, of Institut Gustave Roussy in Villejuif, France, said during a press briefing before the meeting. “We have durable responses in one-third of patients, and we have complete responses that are durable even after stopping.” Historically, she noted, advanced melanoma patients have a median survival rate of about one year.

The Challenges These advances, exciting as they are, also introduce a new era of toxicity management to oncology—an era that oncology pharmacist Patrick Medina, PharmD, BCOP, called a “pharmacy director’s nightmare: very expensive and challenging,” in a continuing education session on the evolving role of specialty pharmacists in cancer immunotherapy.

“These agents can yield remarkable

6 Pillars of Toxicity Management anagement 1 Prevent That can be difficult with immunotherapies. a

2 Anticipate Some side effects, such as colitis at we e 5 on eek ipilimumab, should not be a surprise.

3 Detect Baseline laboratory values are very important. If there is no baseline liver function test, how will you know if your patient is having declining liver function at week 7?

4 Treat—and Treat Aggressively Act immediately. Don’t wait for signs and symptoms to worsen. Managing ea ac ch of these toxicities is a little different, but with w many, it’s similar to graft-versus-host dissease: Treat them by suppressing the immune system.

5 Monitor Provide the appropriate ongoing tests such as liver function, serum creatinine or thyroid function.

6 Know When To Stop If the toxicities are grade 3 or 4, discontinue the agent.

Source: Patrick Medina, PharmD, BCOP.

results,” said Dr. Medina, a professor in the Department of Medicine at Stephenson Cancer Center at the University of Oklahoma, in Oklahoma City. “But they can be very complicated to administer.

As an example, he pointed to talimogene laherparepvec (Imlygic, Amgen), approved by the FDA in October 2015 for the treatment of melanoma in patients with inoperable tumors. It is the first oncolytic viral therapy, a genetically modified herpes simplex virus type 1, designed to replicate within tumors and produce an immunostimulatory protein called ll d ggra granulocyte macrophage colony-sttim mulating factor. ““T This agent is injected dirrectly into the skin lesion,” d Dr. Medina said. “If the D rresponse occurs correctly, yyou should get systemwide deestruction of the cancer d evveen with the virus injected in o on ne spot.”

As of May, his center was treatingg one patient with talimogene laheerp parepvec, and had already learned so om me important lessons about the unussu ual challenges associated with this d drrug. “It’s shipped frozen at –70 F,” Dr.. Medina said. “We realized that we haad d to adjust our procedures when the p paatient arrived for treatment and the ageen nt still had to be thawed for 48 hours.”

Because iit involves injecting a live virus into a patient’s lesion, talimogene laherparepvec also poses the risk for accidental exposure to herpetic infections in pharmacists, nurses and other health care professionals involved with patient care, mandating significant exposure precautions.

A unique type of immunotherapy is sipuleucel-T (Provenge, Dendreon), a highly personalized approach to treating prostate cancer using autologous

CD54-positive cells that are obtained through leukapheresis. The cells are then infused back to the patient and stimulate an immune response against the tumor. “One of our key concerns with this drug is severe hypersensitivity reactions that usually occur within the first 24 hours after an infusion,” said Alison Meagher, PharmD, a clinical pharmacy specialist of the thoracic service at Roswell Park Cancer Institute, in Buffalo, N.Y., in an interview with Specialty Pharmacy Continuum. “There needs to be strict protocols to premedicate patients to prevent these reactions and to observe the patients for at least 30 minutes after the end of the infusion.

In addition, this is considered a blood product, and universal precautions must be observed to avoid potentially transmissible infectious diseases.”

However, not all reactions are immediate. For oncology pharmacists who are used to observing adverse events and toxicities early during treatment with chemotherapy and biologics, the side-effect profile and timing of these effects can be surprising. “For many of these agents, it can take three months before toxicities start to show up,” Dr. Medina said. “In many cases, nothing occurs for about a month, and people think it’s going very well. Counseling about this is very important from a pharmacy perspective. You want to make sure that the patient is prepared that these events are likely to crop up later down the line, and ensure that they are getting supportive care.”

Each side effect, in each drug, has a unique time to presentation. “It’s not like chemotherapy, where you give it, it destroys cells and then you recover,” he said. For example, he noted, with ipilimumab (Yervoy, Bristol-Myers Squibb), rash and pruritus, which occur see IMMUNO RX, page 22

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Specialty Pharmacy Continuum • July/August 2016

CLINICAL

HCV Rx Barriers Take a Toll on Older Patients San Francisco—Significant restrictions in the treatment of Medicaid patients with chronic hepatitis C virus (HCV) are compromising patient outcomes and adding to already unsustainable health care costs, especially as patients age into the Medicare program, a new study suggests.

treat patients with more advanced cases right away, and then “open up the treatment option for patients with milder disease. Otherwise, those patients will simply develop advanced disease.”

CMS’s Position The Centers for Medicare & Medicaid Services (CMS) declined to comment, but directed Specialty Pharmacy Continuum to a set of November 2015 letters sent to states and drug manufacturers (https://goo.gl/xYgUJo). In a letter advising states on the coverage of drugs for Medicaid beneficiaries living with HCV, they expressed concern that some states are “imposing conditions for coverage that may unreasonably restrict access to these [medications].”

Although CMS acknowledged the “budgetary impact” of the drugs on Medicaid programs, they encouraged states to “negotiate supplemental rebates or other pricing arrangements with manufacturers” to cut costs. The other letters asked drugmakers for information on the “challenges manufacturers face when offering these types of arrangements to state Medicaid agencies.” CMS noted in the letter that manufacturers “have a role to play in ensuring access and affordability.”

Lifting those restrictions could yield huge savings, according to Zobair Younossi, MD, the executive director of the Center for Liver Diseases at Inova Fairfax Hospital, in Falls Church, Va., and lead author of the abstract (B10), which was presented at the 2016 Academy of Managed Care Pharmacy (AMCP) annual meeting. Treating all Medicaid patients with HCV would save $6.4 billion across their life spans, due in part to avoided liver transplants and other adverse effects of inadequately treated infections.

“In my view, the best strategy for the nation would be to eradicate [HCV],” Dr. Younossi said. For that to happen, he noted, “these restrictions should be lifted.”

Dr. Younossi said those savings may sound high, but not when one considers the size of the patient population in question. “We have a disproportionately high number of patients infected with hepatitis C who are receiving government-sponsored insurance, as well as a large number who are uninsured,” he explained, adding that chronic HCV affects Medicaid patients at 7.5-fold the rate of commercially insured patients.

While some state-run Medicaid programs provide chronic HCV coverage, many others either don’t cover it at all or have heavy restrictions in place. That diversity in coverage creates significant equity and economic issues, suggested Rachel Beckerman, PhD, the principal and owner at Maple Health Group LLC, and a senior author of the abstract.

To assess the economic effects of removing those barriers, the researchers followed 120,982 treatment-naive Medicaid patients with chronic HCV genotype 1, all treated with ledipasvirsofosbuvir (Harvoni, Gilead), for eight or 12 weeks, depending on cirrhotic sta-

tus and viral load. They then compared treatment under state-specific restrictions by METAVIR stage and treatment without restrictions. Untreated patients were assumed to age into Medicare at 65 years, at which point they were treated without restriction.

The investigators found that 4.2%, 49.6% and 6.8% of patients could access treatment at METAVIR stages F2, F3 and F4, respectively, given current restrictions. Without those restrictions, however, they calculated that treating all eligible Medicaid patients regardless of fibrotic stage would result in 38,670 fewer cases of cirrhosis, 1,847 fewer liver transplants, 8,686 fewer cases of HCV, 17,234 fewer HCV-related deaths, 2.15 additional perpatient life-years and 2.31 additional perpatient quality-adjusted life-years.

Under current restrictions, 9,568 patients eligible for eight-week treatment are projected to age into Medicare as compensated cirrhotics and become more difficult to treat; 27,844 patients are projected to age into Medicare with decompensated cirrhosis, hepatocellular carcinoma or liver transplants—making them, too, more difficult to treat with antivirals.

New oral antivirals cure chronic HCV for more than 95% of patients. “It’s a simple regimen, with very few side effects,” Dr. Younossi said. He suggested that this ease of use leads to relatively high adherence rates ((J Viral Hepat 2016 Mar 14.

[Epub ahead of print]) and better sustained virologic response. And the avoided downstream medical costs more than make up for the high up-front pharmacy costs, he said, helping to make the drugs cost-effective over time.

Dr. Younossi acknowledged that it’s not possible to treat all patients at once. So, he suggested that Medicaid enact a policy to

Vincent Lo Re III, MD, an assistant professor at the University of Pennsylvania School of Medicine, in Philadelphia, echoed the researchers’ call “for all HCV patients to be eligible for HCV treatment and allowed to be treated—if the patient and prescriber agree that it’s [the best approach].”

Dr. Lo Re published a study in April, which found significant disparities in access to direct-acting antiviral-based HCV treatment according to insurance type (Clin Gastroenterol Hepatoll 2016 Apr 5. [Epub ahead of print]). Nearly half of patients on Medicaid were denied coverage, versus 5% and 10% of those on Medicare or commercial insurance, respectively.

“I understand why certain payors are

IMMUNO RX

able toxicities, the patterns are not set in stone. “Interestingly, the sideeffect profile for the checkpoint inhibitors varies slightly among the patient populations (NSCLC [non-small cell lung cancer], melanoma and renal cell carcinoma),” Dr. Meagher noted. “And although the median onset for many of the immune-related side effects is one to three months, they can occur within days of starting treatment or after many months of treatment. For clinicians, this means we have to be very vigilant

during the entire treatment interval and start steroids when needed, or even hold or discontinue treatment for grade 3 or higher side effects.”

Patients and clinicians alike also must be prepared for a unique aspect of immunotherapy: pseudoprogression. “With Imlygic, for example, more than half of patients experienced a greater than 255[mm] increase in the size of their lesions, or appearance of new lesions, before achieving a response,” she said. “This understandably can freak people out.

continued from page 21

in approximately half of patients, begin to appear just before four weeks on treatment, peak just after six weeks and end around 10 weeks ((J Clin Oncol 2012;30[21]:2691-2697). Liver toxicity, which is much less common, occurring in less than 2% of patients, has a typical onset shortly after six weeks of treatment, ending around 14 weeks.

Although there are some predict-

HCV

treatment Treating all eligible Medicaid patients for HCV would result in

38,670 fewer cases of cirrhosis

1,847 fewer liver transplants

8,686 fewer case of HCV

17,234 fewer HCV-related deaths

$6.4 billion in savings Source: Zobair Younossi, MD; Rachel Beckerman, PhD.

Treatment Disparities

restricting access to treatment. It’s an economic decision,” added Dr. Lo Re. “However, the fact that mortality rates from hepatitis C are continuing to rise, coupled with this abstract, suggests that a strategy of treating diagnosed cases would prevent adverse outcomes like cirrhosis, liver cancer or liver death.”

—Lynne Peeples Dr. Younossi reported consulting for AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Intercept.

Dr. Beckerman reported receiving funding from Gilead Sciences. Dr. Lo Re reported no relevant financial relationships.

“As opposed to traditional cytotoxic chemotherapy, where we would ordinarily look for changes in therapy, we will likely see continuation of immunotherapy for these patients,” Dr. Meagher said. “As pharmacists who are counseling these patients, we need to be prepared to explain this phenomenon and put their minds at ease.”

—Gina Shaw Drs. Robert, Medina and Meagher reported no relevant financial relationships.

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