March/April 2016 by McMahon Group

M RM m ee e tin A se e g DA us Iss at bo ue ot h

Bridging the gap between the hospital and alternate-site care Volume 5 • Number 2 • March/April 2016 • specialtypharmacycontinuum.com

ASK THE EXPERT A Q&A on what it takes to succeed as an independent SP provider ..............................

CLINICAL Despite payor hassles, PCSK9s make their mark in hyperlipidemia ................. Zest builds for Zepatier in HCV therapy ...................

ACA cited as one powerful driver

Time to retire MPR, PDC?

Evolving Approaches To Rx Patient Assistance T

Adherence: A New Look At Old Problem

he pharmaceutical industry now spends around $15 billion annually on patient assistance programs (PAPs) designed to help patients afford their increasingly high medication copays, according to CareNet Foundation, a North Carolina–based PAP service organization. The national Partnership for Prescription Assistance estimates that it works with more than 475 public and private programs, including more than 200 offered by pharmaceutical companies.

Booming oral cancer drug pipeline puts spotlight on adherence ........................ 12

early 2,500 years ago, the ancient physician Hippocrates was perhaps the first caregiver to complain about medication adherence. And while today’s clinicians may not openly question the veracity of their patients’ adherence claims, theyy are starting to wonder whether conventional approaches to

POLICY FDA panel gives nod to Remicade biosimilar ................................

MAC price ‘transparency’ is anything but .....................

see ADHERENCE, page 13

Potholes Remain On Biosimilars Adoption Road

TECHNOLOGY E-health assistants act as ‘pharmacist extenders’ ..............................

Leading pharmacy services firms such as Cardinal Health and global health care solutions leader AmerisourceBergen are taking their own approaches to optimizing the benefits of PAP programs, while at the same time working to transition patients who are using these programs to more comprehensive health insurance coverage under the Affordable Care Act. “More and more regulatory and managed care restrictions are being placed on patient assistance programs, and manufacturers need to make sure they’re not running afoul of them,” said Jan Nielsen, the division president of Sonexus Health, Cardinal Health’s patient access and support business. “We saw a growing need

Alexandria, Va.—Insurers are willing to cover biosimilars, but the price and other factors have to be right, several stakeholders noted during sessions at the recent annual CBI Summit on Biosimilars. Take Blue Cross Blue Shield of Michigan as an example. When Zarxio (filgrastim-sndz, Sandoz’s biosimilar of Amgen’s Neupogen [filgrastim]) became the first FDA-approved biosimilar in the United States last March, the insurer’s pharmacy and therapeutics committee reviewed the biologic in the same way they approach any new drug—by evaluating the safety and efficacy data. The committee didn’t have any concerns there, but

see ASSISTANCE, page 19

see PRICING, page 16

DISEASE STATE SPOTLIGHT

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‘Keep watch also on the faults of the patients which often make them lie about the taking of things prescribed.’

New Product AHP la aunches new un nit-dose products. See page 14

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Specialty Pharmacy Continuum • March/April 2016

UP FRONT

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Only on the Web Visit us online for full versions of the Web-exclusive content below at specialtypharmacycontinuum.com. And be sure to log in every day for breaking news and other SPC content!

FDA Grants Breakthrough Status for Triple-Negative Breast Cancer Drug

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Tweets of Interest

The FDA awarded breakthrough therapy designation to Immunomedics’ investigational antibody-drug conjugate, sacituzumab govitecan, for the treatment of patients with triple-negative breast cancer who have failed two or more prior therapies for metastatic disease.

FDA Approves Second TAF-Based Single-Tablet HIV Regimen The FDA gave its nod to emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg, or R/F/TAF (Odefsey), Gilead’s second TAF-based regimen to receive FDA approval, which the company said represents the smallest pill of any single-tablet regimen for the treatment of HIV.

Retweeted

Hydroxychloroquine for RA And Lupus Poses Vision Risk Updated treatment guidelines for minimizing the risk for vision loss from hydroxychloroquine in rheumatoid arthritis and lupus patients have not been adopted in many ophthalmologic practices, according to recent research from the Cleveland Clinic.

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Specialty Pharmacy Continuum • March/April 2016

ASK THE EXPERT

Q&A: Armando Bardisa, PharmD

Strength Through Indep Armando Bardisa, PharmD, the owner and CEO of SMP Pharmacy Solutions, in South Miami, spent his first decade in pharmacy as a manager at Walgreens. But he became frustrated with the large chain, hoping for more opportunity to have a direct effect on patient care and clinical programs. When he walked into an independent pharmacy Armando Bardisa, PharmD in South Miami to buy film one day, he casually asked the owner whether he was looking for pharmacist coverage and walked out with a new job—and eventually, an entry into independent specialty pharmacy practice. In 2003, Dr. Bardisa bought one of the independent pharmacist’s two stores, and over the next decade, built South Miami Pharmacy, now known as SMP Pharmacy Solutions, into one of Inc. magazine’s 5,000 fastest-growing private companies in the United States. Specialty Pharmacy Continuum (SPC) recently talked with Dr. Bardisa about this journey, and what he learned both personally and professionally along the way. SPC: What have been your key strategies for building SMP into the success it is today? Dr. Bardisa: The pharmacy I first purchased had just opened and was underperforming when I started. It wasn’t easy. I put on my marketing hat and went out and did face-to-face marketing with local physicians in the nearby medical hub: infertility specialists, rheumatologists and pain management specialists. I asked them, “What would your ideal

SPC: What sets you apart? Dr. Bardisa: Custom programming and personalized service. Being small and nimble has allowed us to adapt to the changes going on in the market. We can adjust and provide new services quickly based on patient population and payor mix. Say, for example, a plan has made a formulary change. We quickly work with physicians’ offices to get the new preferred medication and begin working proactively with the patients to get them switched over before their next refill is due. We also are very on top of patient assistance programs [PAPs]: If a company has a new PAP, we’re ready to help patients access it by the end of the week. SPC: C What have been your biggest challenges? Dr. Bardisa: Like any independent specialty pharmacy, our two biggest challenges are gaining access to contracts for limited distribution drugs and closed

SMP Pharmacy Solutions specializes in fertility, rheumatology/inflammatory disease and pain management.

pharmacy look like? What kind of services would we provide?” Infertility was our first true specialty program. The fertility practices in my area were extremely busy and needed true custom programs: someone who had injection training, had these medications in stock and could deliver at all hours of the night—sometimes a woman might need to inject herself at 10 p.m., and you need to get it there.

payor networks. You have to have [covered] lives and [patient and prescriber] data, but you don’t get those without payor contracts. SPC: How can independent specialty pharmacies effectively compete for things such as limited distribution networks and preferred status with payors? Dr. Bardisa: One thing we’ve really

focused on is proving our capabilities with data. We’ve done a lot of selfvalidated data and are now moving to third-party data, which is more expensive, but it’s important because we need to be able to prove our refill rate, MPR [medication possession ratio], adherence rates, and all those statistics that PBMs [pharmacy benefits managers] and payors really want to know. We need to be able to prove it. Accreditation is another really important piece, and one accreditation body is no longer enough. Just before 2016, Catamaran said you have to have at least two accreditations, and now other larger PBMs are following suit. Finally, to get preferred status, it helps to become known as having expertise in a certain field. Once pharmaceutical companies know you in the industry, patients and prescribers are eager to get you into a payor network. Once they believe in your capabilities, that helps tremendously. SPC: C Just how important is this strategy of independent specialty pharmacies focusing on a discrete area of specialty in order to differentiate themselves? Why not pursue a broader focus? Dr. Bardisa: In my experience, staying focused is the path to success. Sure, it’s tempting to take it all, but if you try to be everything to everyone, you’re nothing to no one. Independent pharmacies need to focus on certain areas, preferably something that hits home geographically, where you already have relationships with a lot of the leading physicians. If you want to continue to grow, that’s great, but do it one by one. Don’t be all over the place. Our two key areas of expertise are fertility and rheumatology/inflammatory disease and pain management. Having a niche allows you to develop important partnerships with pharmaceutical companies. Once you’re in that position, they will come to you and pilot new programs or roundtable new initiatives. Those partnerships have made us very successful. SPC: C How do you say no to a bigger practice? Dr. Bardisa: Look, you can’t do it

all—hepatitis C, multiple sclerosis, oncology, on and on. It’s hard to turn business away, but in the long run, you have to do it. Oncology is something we’ve been asked to do several times; there’s a large oncology group in the area, and they want us to fill what they can’t fill. Their in-house pharmacy handles infusion, injectables and some orals, but some payors say they have to get certain orals at a specialty pharmacy. They want to refer those out, but they own the majority of the market here. It just wasn’t a good opportunity. At the end of the day, if a patient needs a prescription we will always fill it, but I won’t dedicate a team to something that doesn’t make sense for us. SPC: C What are some of the other mistakes that specialty pharmacies make in today’s marketplace? Dr. Bardisa: The biggest mistake that independents make is they don’t understand the cash flow and the capital needed to sustain growth. We had cash flow issues with our infertility specialty, and it took us over two years to get out of the hole. As we moved into rheumatology/ inflammatory disease, we had prepared more, forecasted and built up reserves. SPC: C What are the most significant trends that you see affecting independent specialty pharmacies in the next 10 years? Dr. Bardisa: Cost containment. The health plans are going to continue to shift more of the cost onto the patient, and so the drug companies are going to continue to have to beef up copay and financial assistance, which they’ll pay for by raising drug costs. Indirectly, the [drug] spend is going to continue to grow exponentially. There will be more payor lockouts, and the new therapies will require a lot more REMS [Risk Evaluation and Mitigation Strategies] and closed distribution networks. I do think there is still opportunity for small independent pharmacies to get into specialty and be successful today. Five to seven years from now, I don’t know what things are going to look like, but I think there’s still room to differentiate yourself today. ■

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Specialty Pharmacy Continuum • March/April 2016

CLINICAL

Despite Payor ‘Hoops,’ PCSK9s Make Their Mark Several months after the FDA’s approval of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for cholesterol management in patients who fall short of target lipidlowering goals, pharmacists working with the medications say they are well tolerated and achieving good responses. However, many providers are finding that the multiple insurance hoops they have to jump through to get the drugs approved for use have to be factored into the patient care equation. Alirocumab (Praluent, Sanofi/ Regeneron) and evolocumab (Repatha, Amgen) were approved by the FDA last July and August, respectively. Both agents are indicated for lipid lowering as an adjunct to diet and maximally tolerated statin therapy in adults with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. The primary target of these agents is to help patients who cannot achieve sufficient low-density lipoprotein (LDL) reduction despite maximally tolerated statin therapy. More than 100 patients at Vanderbilt University’s medical clinics in Nashville, Tenn., are taking the medications, according to Tara Kelley, PharmD, a clinical pharmacist at the Vanderbilt Clinic. “Even though they can be prescribed pretty widely”—by endocrinologists, cardiologists and primary care physicians in her institution—“they’re not very easy to obtain, just because of the insurance requirements to get them approved,” Dr. Kelley said. Depending on the payor, she noted, some prior authorizations require six

pages of documentation about a patient’s diagnosis and all medications previously tried. “We’ve even had to have patients call their pharmacies and give us prescription records to prove that they’ve been compliant with statins prior to taking this medication,” Dr. Kelley said. “Some payors are asking for genetic testing to prove familial hypercholesterolemia, which is not always available. It’s been a big challenge. “The payors don’t want to pay unless people have maxed out all their other statin therapy,” she added. “They want to see that they’ve tried Crestor [rosuvastatin, AstraZeneca], and they’ve tried it for a certain length of time. They want to see the Zetia [ezetimibe, Merck/Schering-Plough] add-on. We have to go through a lot of steps.” “There [have] been a few bumps in terms of access to these meds,” added Joseph Saseen, PharmD, BCPS, BCACP, a professor and the vice chair of the Department of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus, in Aurora. A handful of patients in his primary care clinic are

‘Some payors are asking for genetic testing to prove familial hypercholesterolemia, which is not always available. It’s been a big challenge.’ —Tara Kelley, PharmD taking the drugs. “[Insurers] are requiring strict criteria, and it’s really all about ensuring that your patient is on maximally tolerated statin therapy. Insurers want to see what other nonstatin therapies have been tried and maybe failed before approving these drugs, and also to ensure they are compliant with the FDA indications.” The drugs are only appropriate for selected patients, Dr. Saseen stressed: “Try to maximize that statin before even thinking of prescribing a PCSK9. It’s really going to be for your patient who has tried the high-intensity doses of atorvastatin and/or rosuvastatin who still, despite that, has elevated LDL cholesterol.”

Big Copays Once approved, some patients who fell into a coverage gap with Medicare were facing copays of $500 to $600 per month, Dr. Kelley said. The Patient Access Network Foundation earlier this year created a grant to help cover medications for such hypercholesterolemia patients, she said. It covers up to $12,500 per year for patients who fall below 400% poverty level. In addition, each product’s manufacturer also has copay cards available

for patients with commercial insurance who need financial assistance; Praluent’s card covers the medication fully for six months, and adds a $10 monthly copay for each prescription after that. Repatha’s card provides medication for a $5 monthly copay, Dr. Kelley said. Insurers have been concerned with controlling costs and using the drugs appropriately, said Laurie Wesolowicz, PharmD, director of pharmacy services– clinical for Blue Cross Blue Shield of Michigan, which is not one of the insurers Drs. Kelley or Saseen has dealt with. The Blues’ policy is to cover PCSK9 inhibitors only for patients who meet criteria for the appropriate indication and who have tried at least three statins if claiming statin intolerance, unless there has been a life-threatening problem, she noted. It’s partly because “statins are still the gold standard of treating high cholesterol, so you don’t want to take away those benefits,” Dr. Wesolowicz said. “[If ] a patient had muscle aches with one statin, they can certainly try another and maybe not have any side effects and then still get the benefit of having had statin therapy. “We want to cover these drugs for the right patient, as supported by the FDA

PCSK9s Show Their Worth in Diabetes

volocumab (Repatha, Amgen) reduced low-density lipoprotein (LDL) cholesterol levels by 60% in patients with type 2 diabetes, according to a new analysis of individual patient data from three 12-week, randomized controlled trials comparing the efficacy of evolocumab with ezetimibe (Zetia, Merck) and placebo in adults with and without type 2 diabetes (Lancet Diabetes Endocrinol 2016 Feb 8. [Epub ahead of print]). After 12 weeks, patients with type 2 diabetes had a 60% mean reduction in LDL compared with those on placebo, and a 39% mean reduction in LDL compared with those on ezetimibe. These reductions were similar to those seen in nondiabetic patients (66% compared with placebo and 40% compared with ezetimibe). Non– high-density lipoprotein (HDL) cholesterol, total cholesterol and lipoprotein(a) all showed reductions as well. HDL cholesterol increased by 7% compared with placebo and 8% compared with ezetimibe, according to the results of the study, which was funded by Amgen.

Joseph E. Biskupiak, PhD, a research professor in the Department of Pharmacotherapy at the University of Utah, in Salt Lake City, told Specialty Pharmacy Continuum that the findings weren’t surprising. “We know that the PCSK9 [proprotein convertase subtilisin/kexin type 9] drug inhibitors are very good at lowering LDL, and people with type 2 diabetes obviously have issues with lipids,” he said. “The real question is: Will these findings make a difference in how we treat type 2 diabetes?” Dr. Biskupiak said patients with diabetes who need significant LDL reductions should, first and foremost, be treated with statins. “They are inexpensive and we know they have a mortality benefit, and insurers will be reluctant to put patients on PCSK9s because of the price tag. But if you’ve tried a couple of different statins and optimized the dosages, and still aren’t getting results, then I think you don’t have any choice but to consider these drugs for your patient.” —Gina Shaw

Specialty Pharmacy Continuum • March/April 2016

CLINICAL

labeling,” she added. “Some health plans are a little bit looser with some criteria but we worked with cardiologists and lipid specialists in the area to develop our guidelines, and they feel very strongly as well that these drugs shouldn’t be used for everybody with high cholesterol.”

Robust LDL Reductions Despite some lingering coverage challenges, “it does look like these agents are providing the robust LDL reductions that are expected,” Dr. Saseen said. His physician colleagues have noted LDL reductions of 50%. Dr. Kelley’s physician colleagues have tracked LDL reductions of 50% to 70%. And Mary Dorholt, PharmD, a vice president and specialty clinical practice lead for Express Scripts, said that the PBM has “reports of patients achieving their cholesterol goals for the first time after starting [PCSK9] therapy.” As for adverse effects, the only issues noted so far have been injection site reactions, Dr. Kelley said. Dr. Dorholt did not cite such reactions, but did note that Express Scripts has seen some patients with upper respiratory symptoms or malaise, which is noted in the drug’s package insert. Patient factors aren’t the only consideration when taking steps to ensure

‘[Express Scripts has] reports of patients achieving their cholesterol goals for the first time after starting [PCSK9] therapy.’ —Mary Dorholt, PharmD

patients have the most effective and safest response to PCSK9 inhibitors, Dr. Dorholt added. She noted, for example, that the medications should be handled with care. “Vigorous shaking, dropping the product, etc., could cause the protein to degrade and lose some effectiveness,” she said. “In fact, the instructions for use for both products say not to use dropped or damaged medication.” Patients need instruction on proper injection technique, she noted, adding that letting the medication warm to room temperature is important for injection comfort and reducing local irritation. Dr. Dorholt stressed that patients taking PCSK9s should have their lipid levels assessed by their physician within four to eight weeks of starting therapy. But while results are encouraging, pharmacists are hanging on for clinical trial outcomes data, expected by the end of 2017, to see whether the drugs offer any reductions in cardiovascular events, Dr. Saseen said. “We are still in a waiting mode, though very hopeful.” —Karen Blum The sources reported no relevant ﬁnancial relationships other than their stated places of business.

Specialty Pharmacy Continuum • March/April 2016

CLINICAL

Some Pts Blocked From New HCV Drugs Most patients with hepatitis C virus (HCV) infection have been celebrating the ease of use and tolerability of the new directacting antiviral (DAA) drugs, but some individuals, including those who still use injection drugs, may be marginalized and left without treatment. The situation stems from a combination of payor “discriminatory” treatment limitations as well as other less deliberate barriers, but experts say this patient population needs to receive treatment if the United States is going to stop the spread of HCV. “The reality is that if we want to eliminate the virus in this country, it is essential to treat [illicit] injection drug users,” said Paulina Deming, PharmD,

GLOBALLY:

10 million people with HCV CV V are injecting drugs

to stop using prior to treatment. The position that IDUs need to stop using illicit drugs before receiving HCV treatment was codified institutionally by the National Institutes of Health (NIH) in 1997, but the agency revised its stance in 2002 to state all HCV-infected individuals should receive treatment. Several professional organizations, such as the American Association for the Study of Liver

Int J Drug Policy 2015;26(10):1014-1019

‘If we want to eliminate the virus in this country, it is essential to treat [illicit] injection drug users.’ —Paulina Deming, PharmD

an associate professor in the College of Pharmacy and assistant director of the hepatitis C programs at ECHO Institute, at the University of New Mexico Health Sciences Center, in Albuquerque, N.M. Unfortunately, despite accounting for an estimated 80% of new cases of HCV, many active injection drug users (IDUs) do not receive treatment, and the reasons are many.

Discriminatory Payor Limitations In many states, third-party payors, including Medicare, require patients to abstain from using illicit injection drugs for up to six months before qualifying for HCV treatment, and request that they undergo urine toxicology testing to confirm this. Such practices are not based on evidence but rather on the stigma surrounding use of injection drugs, making them “simply discriminatory,” according to Alain Litwin, MD, a professor in the Departments of Medicine and of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine, in New York City. “Policies that require injection drug users to stop using before they receive HCV treatment are mostly based on the incorrect belief that these individuals need to work on ‘what really matters’ first—that is, to stop using before they can be worthy of treatment,” said Dr. Litwin, noting that New York is one of several states that do not require IDUs

Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), have followed suit, issuing guidelines that state all IDUs with HCV should have access to treatment without the requirement for pretreatment abstinence and screening. The practice creates “barriers to treatment, add[s] unnecessary cost and effort, and potentially exclude[s] populations that are likely to obtain substantial benefit from therapy,” according to the guidelines.

Where Are the Data? Concerns that IDUs who continue injecting will simply be reinfected after HCV treatment are not supported by existing data, Dr. Litwin said, pointing to a 2013 meta-analysis that documented a reinfection rate of 2.4 cases per 100 person-years among HCVtreated individuals who continued to use injection drugs, compared with an incident infection rate of between 6.1 and 27.2 cases of HCV per 100 person-years in the general population of IDUs (Clin Infect Dis 2013;57[Suppl 2]:S80-S89). The studies included in the meta-analysis were conducted in the interferon era, and there is a theoretical possibility that the difficulty of treatment was a disincentive for patients to be reinfected. Dr. Litwin said with DAAs, the simpler and more tolerable treatments mean more individuals, including those injecting drugs, are seeking treatment. “Researchers are now studying what

the actual reinfection rates are in the new era of DAAs,” he noted.

Decentralized Care an Obstacle Besides the requirements and restrictions that payors are placing on individuals with HCV who use injection drugs, there are other barriers to treatment for these individuals, Dr. Litwin said. “An individual might receive addiction treatment at one location, but hepatitis treatment and primary care are offered at other locations across town,” he explained. “Communication across sites is also often poor, and most of the time these sites do not share electronic medical records.” To address these obstacles, Dr. Litwin and his colleagues developed models for “one-stop shopping” for HCVinfected individuals who use illicit injection drugs, whether they are at a syringe exchange site, a buprenorphine and methadone treatment center, a homeless shelter or a primary care center. Offering disease and medication education to providers at these sites has proven effective in increasing access to HCV care, as has a model in which individuals who have gone through drug and HCV treatment serve as navigators of the health care system. Improved provider education and the use of patient liaisons also help reduce some of the distrust that exists between providers and patients, and have also improved outcomes, Dr. Litwin said ((J Addict Med d 2010,4:20-26).

“Right now, we’re conducting a national trial in which HCV-infected people who use injection drugs either receive assistance from patient navigators or are given HCV medications under direct observation, either at the same time as they receive their methadone or buprenorphine or in the community setting, where we have people observe them ingesting medication.” —David Wild Dr. Deming reported no relevant ﬁnancial relationships. Dr. Litwin reported having served as a consultant for Gilead Sciences, Janssen Pharmaceuticals and Merck Pharmaceuticals.

Web Only FDA Approves Zepatier To Treat HCV

he FDA approved elbasvir and grazoprevir (Zepatier, Merck) for the treatment of adults with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV). At a list price of $54,600 for a 12-week regimen, Zepatier will be priced lower than other direct-acting antiviral regimens. For more information, scan the adjacent QR code or visit specialtypharmacy continuum.com/Zepatier.

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Specialty Pharmacy Continuum • March/April 2016

CLINICAL

Will Zepatier Shake Up the HCV Market? Zepatier, Merck’s once-daily fixed-dose therapy for adults with chronic hepatitis C virus (HCV) genotypes 1 or 4, is a major new approval for specialty pharmacy providers and other stakeholders. Here’s their take on the drug’s role in patient care. First, the basics: Zepatier combines an NS5A inhibitor (elbasvir) with an NS3/4A protease inhibitor (grazoprevir), and is indicated for use both with and without ribavirin. The drug was approved in January for a treatment duration of 12 or 16 weeks, depending on factors including HCV genotype, treatment history and the presence of certain baseline NS5A polymorphisms. Most patients will be treated with the 12-week regimen, Merck has indicated. In the six clinical trials, involving a total of 1,373 patients, that formed the basis of the FDA’s approval, 95% of treatment-naive patients achieved a sustained viral response after 12 weeks of treatment; the response rate was similar in HIV-coinfected patients. In treatment-experienced patients, the response rate was 92%. “It’s great to have another highly effective interferon-free, all-oral regimen available for our patients,” said Eric Meissner, MD, PhD, an assistant professor in the Division of Infectious Diseases at the Medical University of South Carolina, in Charleston, who specialized in HCV and HIV. “Unique aspects of this regimen are that it can be used in settings of severe renal insufficiency, and does not have drug interactions with acid-reducing agents.” The big differentiator for elbasvirgrazoprevir may be its price: $54,600 for a 12-week course of treatment, according to a Merck press release, compared with $84,000 and $94,500, respectively, for Gilead’s sofosbuvir (Sovaldi) and ledipasvir-sofosbuvir (Harvoni), as well as

$83,000 for AbbVie’s ombitasvir, paritaprevir and ritonavir tablets, and dasabuvir tablets (Viekira Pak). (The latter pricing data were derived from the University of Wisconsin’s HCV medication reference site, which lists the approximate wholesale acquisition cost for each medication; http://www.hepatitisc. uw.edu/page/treatment/drugs). David Lassen, PharmD, the chief clinical officer at Prime Therapeutics, said the independent pharmacy benefits manager (PBM) was still in the process of reviewing elbasvir-grazoprevir. r “But our initial impression of the medication from a clinical perspective is that, overall, we don’t believe there is a substantial advantage over existing therapy like Harvoni, from a comparison perspective of efficacy, uniqueness and safety,” he said. “The price point has gotten a lot of press, but we are currently in negotiations with all of the manufacturers, and until we get through that process, we won’t be able

to finalize our hepatitis C management strategy,” Dr. Lassen added. Prime, on behalf of its Blue Cross and Blue Shield plans, has Harvoni as its exclusive hepatitis C therapy as of Jan. 1, 2016. (Through the end of 2015, Prime’s formulary for hepatitis C included both Harvoni and Viekira Pak, but after a 2015 pharmacy and therapeutics review, factors such as individual product utilization and pricing led Prime to choose an exclusive Harvoni formulary strategy, Dr. Lassen explained. Leading PBM Express Scripts, on the other hand, has definite interest in adding elbasvir/grazoprevir to its formulary, Steve Miller, MD, chief medical officer for Express Scripts, noted—although that may not happen immediately. “For the rest of 2016, utilization of specific hepatitis C products will largely reflect contracts that most payors and PBMs already have in place with AbbVie and Gilead for the calendar year. Zepatier will have a greater opportunity to more significantly grow its market share through 2017 formularies,” Dr. Miller said.

Added Testing Dr. Lassen acknowledged the distinction that elbasvir-grazoprevir has of being indicated for treatment in individuals with severe renal impairment, including those on dialysis. “That’s a pretty infrequent use overall, but it does suggest a small subset of the population that will potentially need to be evaluated,” he said. “On the negative side, this particular product does have a recommendation for additional testing for the NS5A polymorphism.” Could Merck’s approximately 40% lower list price for elbasvir-grazopre-

vir put price pressure on rivals Gilead and AbbVie to drop prices for their regimens? “Merck’s pricing strategy for Zepatier reflects the manufacturer’s interest in treating as many patients as possible with hepatitis C, and we applaud this approach,” Dr. Miller said. “Express Scripts will be able to leverage this more competitive landscape to bring down the cost of this class of curative treatments even further for our clients and patients.”

‘Merck’s pricing strategy for Zepatier reflects the manufacturer’s interest in treating as many patients as possible with hepatitis C, and we applaud this approach.’ —Steve Miller, MD Dr. Meissner acknowledged the complexities that underpin managed care’s role in determining drug utilization. “The economics of HCV medication cost for individual payors are not always transparent, and sometimes it is challenging to know the actual price and cost for individual regimens,” he conceded. “I would not hazard a prediction, but I do hope that with greater competition, HCV medications will become more affordable and accessible to all patients.” Merck did not respond to SPC’s requests for comment. —Gina Shaw Dr. Meissner reported that he receives institutional research grant support from Gilead Sciences, unrelated to hepatitis C virus. Drs. Lassen and Miller reported no relevant ﬁnancial relationships other than their stated employment status.

Managing the HCV Drug Spend: a Tale of Two PBMs

hen the new medications to treat hepatitis C virus (HCV) launched in 2014, they radically changed the treatment landscape, bringing the potential for a cure where none previously existed. But the high price of the drugs also placed unprecedented pressures on stakeholders to manage the drug spend. Part of that challenge was due to the larger patient population: Unlike orphan drugs, which are used for only a handful of patients, the new HCV medications were going to be prescribed to millions of individuals. As a result, pharmacy benefit

managers (PBMs) were seeing 700% cost increases for HCV treatment. “In terms of the cost for the regimen and the size of the potential population, this truly was unprecedented,” said Mary Dorholt, PharmD, Express Scripts’ senior director and clinical practice lead, specialty, in St. Louis. “We needed to look at the potential impact and do things a little differently.” The new HCV regimens also required special management to control the drug spend and ensure that patients received treatment, according to April

M. Kunze, PharmD, the director of formulary development and pipeline at Prime Therapeutics in Bloomington, Minn. “This was a challenge to manage because of the increase in costs.” Both Drs. Dorholt and Kunze discussed how their PBM companies handled the “HCV crisis.” “When we looked at the challenges around managing the costs associated with these drugs, we first went back to who do you treat,” Dr. Dorholt said. Manufacturers were comparing the cost of HCV treatment with a new

antiviral and the cost of a liver transplant (an estimated $100,000 versus $300,000), but most HCV patients do not require a liver transplant. In fact, of every 100 patients with HCV, 85 will develop a chronic infection, 17 of those will develop cirrhosis and only four will go on to cancer, transplant and death, according to the Centers for Disease Control and Prevention (CDC). “The question becomes: Who are those four people and how long will it take them to get there?” Dr. Dorholt asked. “We don’t really know.”

Specialty Pharmacy Continuum • March/April 2016

CLINICAL

The first guidance by the American Association for the Study of Liver Diseases (AASLD) suggested that the most serious patients with high degrees of fibrosis (Metavir scores of F3 or F4) should be treated first. Many organizations, including Express Scripts, decided that patients required preauthorization for treatment, and only those with Metavir scores of F3 or higher would receive authorization. The AASLD clarified its intention, stating that the sickest patients should be prioritized, but they did not mean the guideline to be a proxy for denial of care. Both PBMs decided to develop a strategy that would enable them to provide the most cost-effective care to the most patients, they said.

Express Scripts’ Approach Express Scripts developed a threepronged strategy called the Hepatitis C Cure Value Program. First, they selected a preferred agent, AbbVie’s Viekira Pak (ombitasvir-paritaprevir-ritonavir tablets plus dasabuvir tablets), which enabled them to negotiate for good pricing, Dr. Dorholt explained. They in turn expanded preauthorization requirements so more patients with lower Metavir scores could be treated, and plan sponsors could still achieve a net savings, which was the second part of the strategy. For the third step, they mandated that patients use Express Scripts’ Accredo Specialty Pharmacy. “These are expensive medications. Plan sponsors and patients need to get the most out of the drugs that they are taking,” Dr. Dorholt said. “We knew we could be very successful in managing these patients and their adherence to a treatment regimen if they came to Accredo.” Accredo leveraged pharmacists and nurses who primarily cared for HCV patients with proactive counseling, outreach to ensure that patients understood their regimen and other programs to make sure patients were adherent, Dr. Dorholt explained. The PBM had more than 4,000 HCV patients use the program, and these patients were more adherent to therapy than those who did not use the Accredo pharmacy. This resulted in significantly lower prescription costs for the most common type of HCV. Prime Therapeutics went through a similar exercise, Dr. Kunze said, but they decided to offer both Harvoni (ledipasvir and sofosbuvir, Gilead) and Viekira Pak, and to enable those with scores of F2 and higher to be treated. Offering both choices “allowed more conversations between the patient and provider in the selection of the drug, instead of Prime dictating that move,” Dr. Kunze said. To facilitate savings, formulary management was crucial, she said. Moreover, patients are managed through Prime Therapeutics’ specialty arm. More than 16% of patients are more likely to con-

tinue sofosbuvir (Sovaldi, Gilead) if they use Prime’s specialty arm, she pointed out. At first, Prime Therapeutics saw an increase in use. “In 2014, when Sovaldi hit, we saw a 760% trend in HCV [drug] use over 2013,” she said. “This

was huge—$3.2 27 per member per month spend by the en nd of 2014.” However,, as individuals are treated and cureed, they are beginning to ssee not only some leveling off, but also some decreases. “Into 2016, we d are anticipating a decline of 20% to 40%,” Dr. Kunze noted. Both pharmacists said they expect continued competition with new drug approvals, as well as shorter regimens, which may help drive HCV treatment costs down. The biggest unknown, how-

ever, is the baby boomers. The CDC has recommended that all members of that generation be tested for HCV, but experts in the field say the recommendation is not being followed. Thus, there could be a large as-yet-untreated patient pool that could affect costs. —Marie Rosenthal None of the sources reported any relevant ﬁnancial relationships other than their stated places of business. This article is based on a session at the AMCP 2015 Nexus Meeting in Orlando, Fla.

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Specialty Pharmacy Continuum • March/April 2016

CLINICAL

Improving Adherence to Oral Cancer Agents With the oral oncology drug pipeline booming, an increasing number of oral cancer drugs are coming to market. Many of these medications are complicated to manage and dispensed through specialty pharmacies. At a recent webinar sponsored by Atlantic Information Services, Gary Rice, RPh, MS, MBA, CSP, the senior vice president of clinical services, education and human resources at Diplomat, in Flint, Mich., discussed strategies for managing oral cancer drugs. Diplomat is the largest independent specialty pharmacy in the United States. “When most people think of specialty pharmacy, they think about dispensing, but that is only the tip of the iceberg,” Mr. Rice said. Specialty pharmacy helps patients find financial assistance, provides education, and encourages treatment adherence and a number of other activities (Table). Cost is a big hurdle for many cancer patients. “The drugs are expensive and patient cost sharing continues to rise,” Mr. Rice said. Financial assistance comes mes from four main sources: copay carrds, foundation assistance, manufactu urer patient assistance programs (free drug) and quick start/bridge programs (where free partial dispenses are given to patients experiencingg delays in an initial prescription). Every patient seen at Diplomat completes a financial assistance consultation. The consult can have a major influence. In 2014, the he average copay fill of a patientt at Diplomat dropped from $335.31 to $24.63 from assistance through copay cards. Foundation assistancee dropped the average copay from $704.14 to $14.16 per fill. Beckie Fenrick, PharmD, MBA, a pharmacy practice leader at Cambridge Advisory Group, in Jacksonville, Fla., also spoke during the webinar. “You want to make sure you are measuring medication use both on the pharmacy benefit as well as the medical benefit,” Dr. Fenrick said. “You want to think about how you are offering medications through formulary management, and you also want to understand the difference in costs across channels. You want to make sure you have appropriate channel management tools in place either through authorizations or preferred networks or cost share differential.” Dr. Fenrick said clinicians should remember that you can’t manage what you don’t measure. “You need to consider multiple factors when evaluating oncology drug management strategy,” she said. Specialty pharmacy can have a significant effect on treatment adherence.

Patient training and education, drug packaging, adherence phone calls, care kits and technology can help patients take their prescribed medications as directed, Mr. Rice said. All patients at Diplomat receive education about the product they are prescribed (what it is), what to do about a missed dose, what to expect in terms of side effects and how to manage them, and who to call if they have additional questions. “We have pharmacists available 24/7,” Mr. Rice said. “We get a lot of calls after hours, particularly from patients who are younger and working.” Diplomat designs its own care kits, which include over-the-counter items that can be used to manage or alleviate side effects, as well as tip cards that remind patients how to use the products. “There There are also nonmedication

intervention reminders within the tip cards,” he said. “For managing diarrhea, for example, patients are reminded to drink at least eight glasses of water or other liquids per day, eat mild foods, etc. There are a variety of behavioral things patients can do to help minimize, eliminate or prevent side effects.” Diplomat provides a medication CarePak for patients who are on multiple medications for different comorbidities or for patients on cycle therapy (i.e., 21 days on, seven days off ). The CarePak includes all the medications an individual is taking, not just cancer medications. “If the patient is on some therapies once daily, other therapies twice daily and other therapies three times a day, they would have three CarePaks,” Mr. Rice said. “Many patients like the CarePaks, because they don’t have to carry their prescription bottles around; it is more private.” As drugs start looking like they will be approved, pharmacists at Diplomat cre-

ate a management model that is based on the drug’s properties, discontinuation rates, side effects and laboratory requirements, as far as monitoring. “Based on that, there may be some modification of our core services or we may ask the manufacturer to provide additional enhanced services,” Mr. Rice said. “For example, some drugs have a high discontinuation rate on week 3 because of side effects, and we may want to have a nurse call prior to that to assess the patient and help manage the side effects at a grade 1 or grade 2 level.” Technologies such as glow caps (GlowCap, Vitality) can remind patients to take their medications and help measure adherence. “When patients either open the cap or take medication out of the bottle, that demonstrates that an activity has taken place,” Mr. Rice said. “If it hasn’t taken place, we are notified.” Diplomat does not offer automatic refills, seeing it as a chance to provide education, assess problems and encourage adherence. “Every refill, patients are called and assessed, p aand based on those assessments, there are subsequent activities,” he said. Patient assessments include a well-patient check at which patients are asked questions to identify improper administration, suboptimal adherence behaviors and side effects. “I think the other piece that is really important is we ask every patient every month, while we p aare on these phone calls, how many doses they have left,” Mr. Rice said. This can help identify adherence problems or perhaps reveal that a patient had a recent hospital stay (where they received drugs in the hospital). “As we move into more complex therapies and more interesting reimbursement methodologies, the payor pays for the drug and all of the associated activities that the pharmacy does,” Mr. Rice said. “A great area is adverse event reporting for drugs that have very high rates of side effects. Some manufacturers will reimburse pharmacy for those activities.” He pointed out that the American Pharmacists Association has worked hard on getting credentialing, so pharmacists can professionally bill clinical activities.

Consistency Is Key Rowena Schwartz, PharmD, BCOP, the vice president of clinical content and pharmacy operations for McKesson Specialty Health, in Houston, agreed with Mr. Rice that education was one of the biggest factors affecting

Table. A Checklist of Specialty Pharmacy Services ✔ Prescription intake ✔ Benefits investigation, prior authorization, appeals and funding assistance

✔ Medication and disease state education

✔ Adverse event and side-effect management reporting

✔ Refill reminder and well-patient checks by patient care coordinators

✔ Drug utilization review and utilization management

✔ Monthly assessments and drug tolerance review by patient care coordinators

✔ Fulfillment of all Risk Evaluation and Mitigation Strategy requirements when applicable

✔ Compliance packaging (i.e., CarePak) when applicable

✔ Prophylactic starter kit when applicable

✔ Adherence assessments ✔ Implementation of clinical pathways ✔ Delivery coordination ✔ Formulary management ✔ Guidelines updates ✔ Injection training ✔ Inventory management ✔ Lab reminders

treatment adherence and that education can’t be a one-time event. “Patients need continued reinforcement over time,” Dr. Schwartz said. As for the usefulness of medication care kits and technology, those tools can be effective in improving adherence, but “it is important to realize that there is not one type of patient,” she said. “For certain patients, the GlowCaps would be perfect help, but for another patient, [forgetfulness] may not be the reason they are not being adherent.” Indeed, “it may be the cost of medication or they have information that is not consistent with what their health care team is giving them.” Dr. Schwartz said communication with the health care team is crucial, and should be an ongoing process. “Throughout a course of a disease, especially with cancer, life situations change. Those changes may impact someone’s ability or willingness to take medications over time.” —Kate O’Rourke Mr. Rice is employed by Diplomat. Dr. Schwartz is employed by McKesson Specialty Health and is a stockholder. Dr. Fenrick reported no relevant ﬁnancial relationships.

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ADHERENCE continued from page 1

measuring compliance, such as medication possession ratio (MPR) and proportion of days covered (PDC), are rapidly becoming obsolete. That rethinking was at the heart of an expert panel report from the adherence solutions company HealthPrize. In “Advances in Medication Adherence: The Experts Weigh In,” a group of seven leading pharmacists, physicians, scientists, epidemiologists and statisticians shared their insights on meaningful ways to understand and improve patient medication adherence.

‘Factors influencing adherence emerge from the data, when you look at patterns of use over time.’ —Wei-Hsuan Jenny Lo-Ciganic, PhD

summarized it less well (C=0.881). (A higher C statistic indicates better discrimination between adherent and nonadherent months.)

Adherence Interventions during the last six months (11.4%); 3. those who had slowly declining adherence throughout the 15 months (11.3%); 4. those who used statins only occasionally across the 15 months (15.0%); 5. patients whose statin use rapidly

declined after initiation (19.3%); and 6. patients who had virtually no fills after their index prescription fill (23.4%) The six-group trajectory model, Dr. Franklin found, summarized long-term adherence best (C=0.938), whereas PDC

For years, patients have been classified as adherent to their medication regimen or not, generally based on whether their MPR is 80% or greater. But the GBTM model demonstrates that this yes-or-no model doesn’t capture the complexity of patients’ medication use over time, Dr. see ADHERENCE, page 15

Adherence Is Dynamic Instead of measuring adherence based on single values, experts said, longitudinal approaches—such as group-based trajectory modeling (GBTM)—may be a better way of getting a true picture of whether or not a patient is following his or her medication regimen effectively. Consider the PDC metric. Meeting a 75% PDC threshold means that if a patient has 100 days of medication use, he or she must have at least 75 days covered. “But is that concentrated in the first two months, and then the patient stops? Or do they refill only periodically?” asked Wei-Hsuan Jenny Lo-Ciganic, PhD, an assistant professor in the Department of Pharmacy Practice and Science at the University of Arizona’s College of Pharmacy, in Tucson. Those classifications can be better elucidated by GBTM—a statistical methodology first developed in the 1990s to understand risks for criminal behavior. Since then, it’s been deployed in dozens of other fields, and Dr. LoCiganic said its ability to identify patterns of use over time makes GBTM particularly well suited for illuminating predictors of adherence. “The trajectory model doesn’t use arbitrary values or set points,” Dr. LoCiganic pointed out. “Instead, the factors influencing adherence emerge from the data, when you look at patterns of use over time.” In a paper published in 2013 ((Med Care 51:789-796), a group of researchers led by Jessica Franklin, PhD, a biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, in Boston, compared GBTM with PDC as a measure of adherence in a group of more than 200,000 patients on statin therapy from the CVS Caremark claims database. The trajectory model identified six distinct adherence pattern groups: 1. patients who were nearly always adherent (23.4%); 2. those who had a brief gap in medication use or filled irregularly during the first nine months, but improved

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Specialty Pharmacy Continuum • March/April 2016

CLINICAL

Ocrelizumab Gets Breakthrough Status for MS

he FDA has granted breakthrough therapy designation for Genentech’s drug ocrelizumab in patients with primary-progressive multiple sclerosis (PPMS). Ocrelizumab is the first investigational MS compound to earn the breakthrough designation, which expedites the development and review of drugs intended to treat serious or life-threatening diseases. There are no FDA-approved treatments for PPMS, which affects about 10% of the estimated 2.3 million people worldwide with MS. Approval of ocrelizumab would be a major advance in PPMS treatment, said Ben Thrower, MD, the medical director of the MS Institute at the Shepherd Center in Atlanta, in an interview with Specialty Pharmacy Continuum. “This is a patient population that is desperate to have something to slow their disease progression. But it would also be a big player in relapsing-remitting MS as well.”

Dr. Thrower pointed out that all immunomodulatory drugs are a balance between efficacy and safety, “and you could argue that most of the current therapies have modest efficacy, but pretty good safety. Lemtrada [alemtuzumab, Genzyme] is very efficacious but has a lot of safety concerns. Now, ocrelizumab looks like it has a high degree of efficacy and a favorable safety profile as well.” Dr. Thrower predicted that the FDA may approve ocrelizumab with a black box warning for progressive multifocal leukoencephalopathy (PML), although no association has surfaced in the drug’s trials to date, simply because it has the same mechanism of action as rituximab (Rituxan, Genentech/ Biogen), which has been linked to PML. “Ocrelizumab is a humanized monoclonal antibody, while rituximab is chimeric, so reactions may be lessened, and we

Low Bleed Rate with Adynovate

o patients developed inhibitory antibodies to Adynovate, Baxalta’s long-acting recombinant factor VIII product for hemophilia A, in an uncontrolled, openlabel, multicenter Phase III pediatric study. The company released only top-line data from the Phase III study, indicating that more than 70% of the patients (all <12 years old) experienced zero joint bleeds, and almost 40% experienced zero bleeds of any kind during the six months they were followed. Adynovate was approved by the FDA in November 2015 for adolescent and adult populations. At the time the Phase III results were released, Baxalta indicated that it would seek a pediatric indication in the United States in early 2016. At the end of February, that came to fruition: On Feb. 25, Baxalta announced that it had submitted supplemental Biologics License Applications (sBLAs) to the FDA seeking approval for the use of Adynovate to treat children under the age of 12 with hemophilia A and for use in surgical settings. “These results are great, because developing inhibitors to the product is always the fear with any hemophilia drug,” said specialty pharmacy consultant Hetty Lima, RPh, FASHP, a former vice president at Diplomat Specialty Pharmacy, in Flint, Mich., in an interview with Specialty Pharmacy Continuum. “But I’d like to see them extended for at least a year so that we are comparing apples to apples with Eloctate, Biogen’s long-acting factor VIII product, which has now been on the market for more than 18 months.” Published data show that at 80.9 weeks of Eloctate treatment for adults and adolescents, and 23.9 weeks for children, patients continued low bleeding rates with no inhibitor development (Haemophilia 2015 Jul 27 [Epub ahead of print]). Bayer, CSL Behring and other pharmaceutical manufacturers also have longacting factor VIII products in the pipeline, and Ms. Lima said the growth of these products may soon influence pricing and formulary decisions. “I could see, in a couple of years, payors really starting to manage this class,” she said. “Before, you really couldn’t. But once one or two more of these long-acting factors come out, we might see payors who have a lot of hemophilia patients in their mix creating formularies.”

have not seen any cases of PML in the ocrelizumab trials so far. But the FDA may act with an abundance of caution,” Dr. Thrower said. Genentech said in an announcement that it plans to pursue marketing authorization for ocrelizumab as a treatment for both PPMS and relapsing-remitting MS, and will submit data from its three Phase III studies (ORATORIO, OPERA I and OPERA II) to the FDA by June 2016. —Gina Shaw

Tenofovir Resistance Higher Than Expected

ore than half of people who still have uncontrolled HIV despite ongoing treatment have a HIV strain of the virus that is resistant to tenofovir, a mainstay of antiretroviral therapy, according to a report published in Lancet Infectious Diseases online on Jan. 28 (http:// dx.doi.org/10.1016/S1473-3099(15)00536-8). “This result is disconcerting, because it had previously been thought that tenofovir might be less prone to o development of drug resistance than other compounds,”” wrote the group of researchers, led by HIV drug resistance experts Ravindran Gupta, MD, of University College Lond don, and Robert Shafer, MD, the medical director of the HIV antiretroti t viral testing program at Stanford University Hospital, in Stanford, Calif. The “TenoRes” collaboration included 1,926 individuals from 36 countries who experienced treatment failure between 1998 and 2015. Resistance to tenofovir ranged from about 20% to 57% among the studied populations. In Africa, tenofovir resistance was 57%; in North America, 22%; and in Europe, 20%. The authors suggested that these regional variations can be explained by a higher frequency of viral load monitoring combined with close patient follow-up and feedback, which is more common in higher-income countries and potentially allows for earlier detection of viral failure before drug resistance mutations against tenofovir can occur. Around two-thirds of patients with tenofovir-resistant strains had also become resistant to other drugs in their regimen, completely compromising their treatment. Patients who started antiretroviral therapy with a CD4 count of less than 100 cells/ mm3 were 50% more likely to have tenofovir resistance than those who began treatment with 100 cells/mm3 or higher. “Tenofovir is a critical part of our armamentarium against HIV, so it is extremely concerning to see such a high level of resistance to this drug,” Dr. Gupta said. “It is a very potent drug with few side effects, and there aren’t any good alternatives that can be deployed using a public health approach. Tenofovir is used not only to treat HIV but also to prevent it in high-risk groups, so we urgently need to do more to combat the problem of emerging resistance.”

—Gina Shaw

New Product

AHP Launches New Unit-Dose Products

merican Health Packaging (AHP) recently launched two new products in its growing unit-dose line, the company announced in a press release: • Mucinex ER Bi-layer 600 mg tablets • Imatinib Mesylate 100 mg and 400 mg tablets (AB-rated to Gleevec) Both products are only available in a unitdose, barcoded format from AHP, the company noted. AHP’s product line now stands at more than 575 SKUs, which it claims is the most

comprehensive in the industry. “AHP unit-dose launches are part of an ongoing commitment to support health systems’ BCMA [bar code medication administration] initiatives while [also] promoting efficiency in pharmacy operations,” the press release stated. With the launch of Unit Dose Plus in 2015, AHP was the first unit-dose provider to introduce a line specific to lower-volume, difficult-to-find items.

Customers had reported for some time that in addition to the higher-volume unit-dose items, they also required many lower-volume products in order to minimize in-house packaging tasks that take staff away from other more critical patient care duties. The new line from AHP features smallercount carton sizes to support customers to avoid costly waste and time-consuming returns. All AHP unit-dose items are barcoded to the dose level and feature an extended shelf life, according to the company. In addition, product cartons feature color-coded labels with “tall man” lettering to more easily distinguish them in the pharmacy prior to dispensing. For more information, visit americanhealthpackaging.com.

Specialty Pharmacy Continuum • March/April 2016

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ADHERENCE continued from page 13

Franklin said. “Some people have problems with adherence over and over again. Some always do a good job with adherence. But there are some people who are in between. They do well for a little while, then something comes up in their life and their adherence suffers. Then they come back a few months later.” These patients, Dr. Franklin explained, may be particularly receptive to adherence interventions, in contrast to the “always adherent” who don’t need them, and the “rarely or never adherent,” who may be extremely difficult to reach. But the standard classification of patients as adherent or nonadherent based on MPR at fixed time points may fail to identify some of these patients as good targets for focused interventions, if they meet a certain threshold. On the other hand, Dr. Lo-Ciganic noted that a lot of effort may be expended trying to push patients who have 78% or 79% adherence over the coveted 80% cutoff that the Centers for Medicare & Medicaid Services uses in its star ratings. But stratification of patients for adherence intervention purposes should also be based on risk, she suggested. “Some patients may start out with very poor adherence, but when they increase from 30% to 60% adherent, they’re still considered a failure. With resources so scarce, we should be identifying the patients who are at highest risk, or where there is a threshold that’s very clinically important, and try to move them to that threshold where mortality or hospitalization drops dramatically.”

effect, clinical trials for the interventions should reflect real-world populations, noted panelist Zachary Marc um, PharmD, PhD, BCPS, an assistant professor at the University of Washington’s School of Pharmacy, in Seattle. “A lot of older adults have multiple comorbid conditions, but these patients are typically not enrolled in these trials,” Dr. Marcum

said. “It’s true that they are harder to study, but there are ways to combat that challenge, such as accounting for interim events in your analyses, rather than just throwing out all their data. We need to be studying the people for whom these interventions can make the greatest difference.” —Gina Shaw

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Small Changes, Big Effects Small changes in adherence on a population level can have big effects. For example, Dr. Franklin’s colleague Niteesh K. Choudhry has published a study showing that eliminating copayments for the medications that myocardial infarction patients are prescribed after their attacks—essentially making those medications free—significantly improved adherence rates by 4 to 6 percentage points over usual coverage ((N Engl J Med d 2011;365:2088-2097). That improvement may not sound particularly dramatic, but rates of total major vascular events or revascularization were significantly reduced (21.5% in the full coverage group vs. 23.3% in the usual coverage group; P=0.03), as was the rate of the first major vascular event (11.0% vs. 12.8%; P=0.03). The elimination of copayments more than paid for itself: Patient costs for drugs and other services were significantly reduced in the full-coverage group (relative spending ratio, 0.74; P<0.001). For population-based adherence interventions to have the greatest

Dr. Franklin reported that her adherence research was funded by CVS Health and Merck. Dr. Marcum reported no relevant ﬁnancial relationships.

5 4 out of 4

Specialty Pharmacy Continuum • March/April 2016

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PRICING continued from page 1

when it looked at the net costs of Zarxio versus Neupogen using the company’s competitive pricing, the branded product was substantially less expensive, according to Laurie Wesolowicz, PharmD, the director of pharmacy services-clinical, for the insurer. As a result, the company added the biosimilar to their formulary but placed it in a nonpreferred position relative to Neupogen. There was only a 15% discount for Zarxio, Dr. Wesolowicz said, “so it really wasn’t enough for us to walk away from our pricing that we’ve been able to obtain for Neupogen. I think until we start to see more competition, more drugs in a therapeutic class, more biosimilars in a therapeutic class, and they’re at least 30% less expensive, there’s probably not going to be a lot of movement toward them.”

make their own determinations of interchangeability even in the absence of an FDA designation, using information like compendia listings, clinical studies and guidelines from the National Comprehensive Cancer Network,” Mr. Carlsen said. “Three-quarters of plans said they would be willing to do that.” In the most recent phase of the survey, conducted in January 2016, 83% of those surveyed reported no changes in coverage, management or reimbursement for Neupogen as a result of Zarxio’s availability. Two payors reported that Neupogen had preferred status over Zarxio, with one plan not covering Zarxio and the other plaacing it on a higher formulary tier, with higher patient cost sharing. Only onee plan reported changes in coverage: Fo or this one, Zarxio has preferred statu us over Neupogen, and patients must firrst fail treatment on Zarxio before Neu upogen will be covered. Payors that desiggnated

‘There’s just overarching lack of understanding surrounding biosimilars, and not just among physicians—even among pharmacists.’ —Steven Lucio, PharmD, BCPS ilar,” said Steven Lucio, PharmD, BCPS, the senior director of clinical solutions and pharmacy program development for Vizient Inc., a health care services company, who also spoke at the CBI Summit on Biosimilars. “The way in which payors/providers will respond will vary by the molecule and by the extent of which information is known about it and also the importance of its indications,”

biosimilars for an indication for which no clinical trial data are available.” In addition, she said, many biosimilars in development will fall under the medical benefit versus the pharmacy benefit,

‘Many physicians will have concerns about using biosimilars for an indication for which no clinical trial data are available.’ —Maria Lopes, PhD

While it’s tough to generalize how commercial insurers will handle biosimilars, because every payor is different and there is variability even within policies offered by large national plans, price is one of the top three factors that insurers say will affect their decisions on coverage, said John Carlsen, MHA, the vice president of access and commercial strategy for Covance Market Access Services Inc.. The other factors are the FDA’s interchangeability designation and the nature of FDA approval (the agency prefers an abbreviated biosimilar pathway vs. a full therapeutic Biologics License Application), according to a recent survey Mr. Carlsen’s firm conducted with medical and pharmacy directors at six commercial payors representing 100 million customers. Less important on the survey participants’ list were the therapeutic area covered by the biosimilar, CMS coverage, and support or opposition from either the medical community or patients. In addition, most payors reported they expected discounts of 20% to 30% on biosimilars in oncology and 20% to 40% on those in rheumatology. Further, 37% of respondents said if the FDA approved a biosimilar for some but not all of an innovator product’s indications, their plans would limit coverage to its FDAapproved indications. “What we thought was really notable was that ... payors are willing to

one of the agents as preferred oveer the other cited cost and contractting as the principal reasons for this decision, Mr. Carlsen said. “We really are not seeing a lot of changes in Neupogen coverage right now,” he said. “We’re not seeing a lot of payors rushing to force patients to use Zarxio and not seeing coverage for Neupogen hurt, but that speaks more to the part that it’s still very early in the market for biosimilars, and until multiple versions are available, we don’t truly know how the payor dynamics are going to play out.”

Generalize at Your Peril “If you have experience with a biosimilar, you have experience with one biosim-

Dr. Lucio explained, adding that payors who have numerous patients with a biosimilar’s indication may be more likely to prefer it. Insurers still have some concerns about biosimilars, said Maria Lopes, PhD, the chief medical officer for Magellan Rx Management, including the need for physician and patient education. Dr. Lucio agreed: “There’s just overarching lack of understanding surrounding biosimilars, and not just among physicians—even among pharmacists.” Similar naming conventions may prove confusing for physicians, Dr. Lopes said, and although the FDA often approves broad indications for use, “many physicians will have concerns about using

Web Only: Ronny Gal’s Take On Biosimilars LAS VEGAS—Ronny Gal, PhD, a senior analyst at Sanford C. Bernstein & Co. and a leading expert at reading the tea leaves of the worldwide biosimilars market, said the future of the drug class in the United States still depends on a few key variables, including pricing, FDA manpower shortages and prescriber acceptance. For our exclusive article on his views of this rapidly evolving drug class, based on his presentation at the 2016 MHA Business Summit, scan the adjacent QR code or visit specialtypharmacycontinuum.com/Gal.

and payors need to prepare for this in the development of medical policies. “Biosimilars have the potential to save the U.S. health care system billions of dollars over the next few decades,” Dr. Lopes said. “However, it is imperative that health plans and providers collaborate and are accepting of biosimilars in order to increase their acceptance and adoption. Without this collaboration or alignment of incentives, biosimilars may struggle to attain a meaningful market share, therefore limiting their cost-savings potential.” Consumer education also is key, Dr. Wesolowicz said. “We’ve done a lot of education to consumers over the years to help them really understand what generics are, how they’re not different than the branded product and how they can make drugs more affordable for consumers. We’re going to have some of the same challenges with biosimilars because this is a different word and a different type of disease than these drugs typically treat.” —Karen Blum None of the sources reported any relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • March/April 2016

POLICY

Will Remicade Biosimilar Get Market Moving? The first quarter of 2016 finally saw some regulatory and legislator activity on biosimilars—actions that may shake up a drug class that has stalled in the United States, despite years of successful product launches overseas. The most encouraging note was struck on Feb. 9, when the FDA’s Arthritis Advisory Committee voted 21 to 3 to recommend licensure for Celltrion and Pfizer’s CT-P13, a biosimilar version of Janssen Biotech’s Remicade (infliximab). Based on the biosimilarity of the drug to the innovator product, the FDA panel endorsed its use for all of the indications sought by Celltrion: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, adult and pediatric Crohn’s disease, and adult and pediatric ulcerative colitis—although the pediatric ulcerative colitis indication is protected by orphan drug exclusivity until September 2018. (In 2013, the European Medicines Agency [EMA] approved CT-P13 for most of the indications. The drug is marketed under the trade name Remsima.) Among the three panel members who voted no, the main stumbling block centered on considering analytical data to support the use of CT-P13 for the inflammatory bowel disease (IBD) indications. Jeffrey Curtis, MD, MS, MPH, an immunologist at the University of Alabama at Birmingham, noted that although he “had great comfort with the very robust data package that the sponsors put together,” the committee was being asked for a “blanket” endorsement of CT-P13. His “biggest residual uncertainties,” Dr. Curtis said, concerned “some of the information that might or might not be meaningful in an IBD population.” Some panel members, as well as others who testified at the meeting, also voiced concerns about the use of extrapolation, rather than clinical evidence, in seeking the approvals for multiple indications. Others wanted assurance that the FDA was prepared to carry out a robust postmarketing surveillance program to ensure safety. But the majority believed that the weight of evidence presented by Celltrion supported the conclusion that the product had met the biosimilars test of having no clinically meaningful differences from the reference product.

An Impressive Package

The evidence favoring CT-P13 included an extensive package of clinical trial and analytical data. One randomized, double-blind, parallel-group study involving approximately 600 patients with

moderate to severe rheumatoid arthritis compared the safety and efficacy of the drug with EMA–approved Remicade at

a dose of 3 mg/kg over 54 weeks. The study met its predetermined clinical end point: At week 30, approximately 61% of patients randomized to CT-P13 and 59% of those randomized to EMA-approved Remicade remained in the study and achieved an ACR20 response—an American College of Rheumatology outcome measure indicating a 20% improvement in tender or swollen joints as well as a see BIOSIMILARS, page 18

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One committee member, Donald R. Miller, PharmD, FASHP, a professor of pharmacy at North Dakota State University College of Health Professions, in Fargo, noted that “extrapolation and this kind of [abbreviated] pathway always involves some uncertainty, but I feel that the [Celltrion] package was very strong, and the experience outside the U.S. also supports that this was the right decision.”

Specialty Pharmacy Continuum • March/April 2016

POLICY

Opening a Window Into PBMs’ MAC Pricing

A CMS ruling, which went into effect on Jan. 1, requires Medicare Part D plans and their pharmacy benefits managers (PBMs) to make their MAC pricing standards available to their network pharmacies. “They are supposed to be providing useful information to the pharmacies in their network on a weekly basis, including the rationale for their pricing changes,” Alan Rosenbloom, the president and CEO of the Senior Care Pharmacy Coalition (SCPC), said in an interview with Specialty Pharmacy Continuum. “They aren’t necessarily sending the information; pharmacies have

PBMs are moving to this fee because they are now being required to update generic fluctuations in a timely manner,” they wrote. As Specialty Pharmacy Continuum reported in February (http://goo.gl/ mDr7sS), an Avalere study commissioned by the SCPC found that, as of the first quarter of 2014, reimbursement for generic drugs using MAC pricing reached negative margins. As revenues dropped while total costs continued to increase, average total revenue for all generic drugs reimbursed using MAC pricing dipped below the average total cost of the drugs.

‘We’re supportive of the [MAC transparency] legislation and working hard to try to move it forward.’ —Robert Warnock, PharmD

to request it from the PBMs. And then when they get it, it’s often in a complicated format that is not useful in trying to figure out what you’re going to get paid this week and why.” (CMS did not require plans to send the enhanced information to pharmacies in an electronic format.) In some cases, according to a letter sent by Reps. Doug Collins (R-Ga.) and Dave Loebsack (D-Iowa) to colleagues in February, PBMs also are charging an additional fee after the point of sale when the contract is being reconciled. “This fee is called direct and indirect remuneration [DIR] and we believe the

By the first quarter of 2015, average total revenue per drug was $22.33 versus an average total cost of $23.23, for a negative margin of 90 cents per 30-day prescription. Generic drugs reimbursed using a formula other than MAC (such as Average Wholesale Price) continued to have a small but consistent positive margin over the same time period, at $33.55 in revenue versus $29.34 in cost to dispense, as of the first quarter of 2015. Avalere’s research also demonstrates wide price variation among PBMs and even within PBMs. For example, a chart of MAC reimbursement for potassium chloride by the top five Medicare Part

BIOSIMILARS

uct would be marketed in the United States by Pfizer, under the proprietary name Inflectra. A decision by the FDA is expected in April.

continued from page 17

20% gain in three out of five additional parameters, including pain and ability to function. Other data were used to justify the extrapolation of data to support the biosimilarity of CT-P13 to U.S.-licensed Remicade for each of the additional conditions of use sought by Celltrion. CT-P13 would be the second biosimilar cleared for marketing in the United States after Sandoz’s Zarxio (filgrastim)—but it would be the first biosimilar monoclonal antibody. Once licensed, the prod-

Woodcock’s Staff Woes One FDA panel recommendation for a biosimilar approval does not change the fact that the agency is severely understaffed to handle the flood of applications on file. Indeed, nearly 60 products are enrolled in the FDA’s biosimilar product development program and more are on the way, Janet Woodcock, MD, the director of the FDA’s Center for Drug Evalu-

MAC Variability for Potassium Chloridea,b,c 0.60 0.50

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New requirements for more transparency in Medicare Part D Maximum Allowable Cost (MAC) drug pricing standards from the Centers for Medicare & Medicaid Services (CMS) aren’t having their intended effect so far, advocates for long-term care pharmacies say.

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Top five payors identified based on total days supply dispensed, listed alphabetically. Weighted average MAC reimbursement provided for each payor daily. COGS is the weighted average for all payors, daily. Gaps in the trend line indicate that no data are available for that payor for this drug on that day. MAC, Maximum Allowable Cost; COGS, Cost of Goods Sold; NDC, National Drug Code Source: Avalere report, “MAC Pricing Analysis,” prepared for the Senior Care Pharmacy Coalition,, November 2015.

D payors in April 2014 resembles an electrocardiogram of a patient with ventricular tachycardia, with irregular, inexplicable spikes and drops (Figure). “This raises questions about how much of this is really market driven,” Mr. Rosenbloom said. “The PBMs need to be more open about what is driving their price changes, so pharmacies have a better idea of what they’re being paid and why. The whole notion behind MAC pricing for generics is that price changes should be based on changes in market conditions.” In January 2015, Mr. Collins and Mr. Loebsack introduced H.R. 244, the MAC Transparency Act, which would require PBMs to update their MAC benchmarks every seven days to better reflect market costs and allow pharmacists to know the source by which PBMs set reimbursement. The legislation now has 37 co-sponsors, including Rep. Earl Leroy “Buddy” Carter (R-Ga.), the only practicing pharmacist in Congress. “We’re supportive of the [MAC transparency] legislation and working hard

to try to move it forward,” said Robert Warnock, PharmD, the senior vice president of pharmacy services for PruittHealth, which operates about 100 skilled care nursing facilities in the Southeast. “We’re under no illusions that this is going to be easy, but we’ve seen positive signs, with more and more members signing on, and we’re more hopeful than before that it will ultimately pass.” At press time, 13 states also had passed laws requiring PBMs to disclose information to pharmacies regarding MAC reimbursement methodologies. Legislation is only the first step, Mr. Rosenbloom noted. “Ultimately Congress has to go beyond that and, through oversight, dig into the pricing methodologies and other practices of PBMs,” he said. “We feel that they require a lot more oversight.” —Gina Shaw

ation and Research, testified before the House Committee on Energy and Commerce, Subcommittee on Health in February. And yet to date, only one—Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim)—has been cleared by the agency. “Clearly, had we had more staffing and funding at the get-go, we would be better off now,” Dr. Woodcock said. The agency has received almost $43 million in three years to accelerate the Biologics License Application review process, she said. Still, “I’m concerned ... that this program is going to explode ... [and] that we will not have the staff because we

are always waiting to catch up,” she said. Slow progress in biosimilar approvals was just one issue concerning the subcommittee. Several members contended that the Medicare reimbursement policies for biosimilars could reduce incentives for manufacturers to bring products to market and prevent providers from prescribing them. For more details on the biosimilars pricing issue and several other controversies cited during the committee hearing, visit specialtypharmacynews.com/Woodcock.

Mr. Rosenbloom and Dr. Warnock reported no relevant ﬁnancial relationships beyond their places of employment.

—Bruce Buckley and Karen Blum

Specialty Pharmacy Continuum • March/April 2016

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ASSISTANCE continued from page 1

in this environment. These roadblocks were causing frustration for physicians, for patients and for manufacturers, and we felt that we could put in place a program that would smooth the process for patients and keep manufacturers safe in this regulatory environment.” Cardinal Health’s program—which ultimately became Sonexus—started small in 2013, with one pharmacist and “a couple of eligibility folks,” Ms. Nielsen said, including a specialist with 25 years of Medicare expertise. “One of the reasons it has been so successful is that when we get a submission for free drug, we call Medicare and Medicaid and let them know that free drug has been given, so no claim should be submitted or paid out during this time. We keep the patients and physicians aware of this as well, so the free drugs can be provided in a safe legal environment.”

involved in their health care.” With the advent of the ACA, health insurance

exchange (HIX) plans and expanded Medicaaid coverage, PAP solutions proggrams are also turning their aattention to helping patients move from free drug programs to coverage that they may be newly eligible for, or now able to afford with o th he help of subsidies. “While maany manufacturers invest in PAP today, few are taking the extra steps to increase conversiion to full coverage,” Ms. Nielseen said. “Manufacturers can

take specific action steps to convert these patients to paid prescriptions, including quarterly evaluations of the patient’s progress to see if they have insurance in place, and research education about low-cost coverage options that may be available to them.”

ACA Coverage Help In 2013, Lash Group launched its ACA Coverage Expansion (ACE) Service Center, which walks patients step by step through the process of finding a HIX or see ASSISTANCE, page 20

‘[PAP] programs that in the past might have been stricter about their income guidelines are now allowing more exceptions.’ —Loreen Brown Today, of more than 350 employees in the Sonexus division, approximately 40 work in the free drug program, including 15 pharmacists and pharmacy technicians who do the dispensing, and 25 reimbursement specialists who must remain up to date on the continuum of PAP options—manufacturers, foundations, advocacy groups—and all their eligibility requirements. AmerisourceBergen’s Lash Group also offers its own copay and patient assistance program solutions, streamlining programs for manufacturers and helping them offer an increasing array of online solutions. “E-services are becoming increasingly important in PAP programs, from the ability to do live chat to e-signature of documents, like you can do when you file your taxes,” Loreen Brown, Lash Group’s senior vice president of Product, Strategy and Commercialization Excellence, told Specialty Pharmacy Continuum. There is also a growing focus on marrying adherence programs with free drug programs, Ms. Brown said. “Behavioral coaching, for example, can be very useful in this patient population, helping patients or caregivers uncover what their barriers are to staying on treatment and getting them more motivated and

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McMahon Group Acknowledges Exemplary Staff 2015 The McMahon Group annually evaluates the preceding year, noting the achievements of its various departments and the company overall. When the numbers for 2015 rolled in, we had a lot to celebrate—and so, we did. A big part of that celebration was highlighting the contributions of the following outstanding employees. We thank them for their hard work and our readers for their continued enthusiasm for our medical journalism, which has made many of our publications the best read in their specialty. SUPPORT PERSON OF THE YEAR This award is meant to acknowledge two recipients belonging to a group of departments that together serve as the backbone of the company. BLAKE DENNIS is the art director of Anesthesiology News, and provides graphics and technical support to the editorial and art departments.

SUPPORT PERSON OF THE YEAR LESTER MEJIA is a webmaster in the IT department, regulating many of the digital products, maintaining the content management system and keeping the websites in tiptop shape for our readers.

EDITOR OF THE YEAR This award is for the outstanding editor among the publication, copy and projects editorial staffs. MARIE ROSENTHAL won for her creative work enhancing Pharmacy Practice News, Specialty Pharmacy Continuum and Infectious Disease Special Edition.

SALES ACHIEVEMENT AWARD CRAIG WILSON, the classified advertising associate, serves all of the company’s publications. This year he brought in the highest amount of revenue for classified ads that the company has seen in recent years. His skills have created a successful classifieds section in our publications.

SALESPERSON OF THE YEAR RICHARD TUORTO is the senior group publication director for Anesthesiology Newss and Pain Medicine News, both of which are continuously rated as the best-read publications in their fields. He earned this award for the 10th year in a row for generating the most revenue in the calendar year.

PERSON OF THE YEAR CHAEL ENRIGHT received this award for his unrivaled commitment to and enthusiasm for his role as publication director of General Surgery News, the best-read publication in surgery. For the last two years, he has also graciously brought his expertise and positive attitude to Clinical Oncology News.

THE MCMAHON GROUP PARTNERS’ AWARD GUY GARIZIO was for over a decade an important member of the sales team at McMahon. He has since moved on to an executive sales position elsewhere, but has continued to be an exponent of and friend to the McMahon Group.

Specialty Pharmacy Continuum • March/April 2016

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ASSISTANCE continued from page 19

Medicaid plan that will cover their needs and getting enrolled. Since 2013, the ACE Service Center has contacted 235,000 patients and provided end-to-end services for 45,000 of those. Of that group, 25% were converted from PAP product to health care coverage through Medicaid or a HIX plan. “You might think that payors wouldn’t be as excited about this, since some of these patients may be heavy utilizers of care, but in many cases these are patients who were going to the emergency room before, so overall, the costs of care are going down,” Ms. Brown said. With the increasing costs of many specialty medications combined with growing out-of-pocket costs imposing heavier burdens on patients, eligibility

criteria for many PAPs are becoming more flexible, Ms. Brown said. “Much more documentation is required, of course, but programs that in the past might have been stricter about their income guidelines are allowing more exceptions,” she explained. “If the income limit is $50,000 per year, and you make $70,000 but you have $50,000 in medical debts, the programs might make an exception now. That’s happening much more often, where it wasn’t even on the table five years ago. Especially in the specialty space where the drugs are more expensive, PAPs are trying to help people with these financial burdens.” —Gina Shaw Ms. Nielsen and Ms. Brown reported no relevant ﬁnancial relationships besides their stated employment.

Coinsurance for Medicare Part D Drugs Now the Norm

he majority of prescription drugs covered by stand-alone Medicare Part D plans (PDPs) in 2016 are subject to coinsurance, rather than copayments, according to a new analysis from Avalere Health—a dramatic increase in just two years. In 2014, an average of 34.5% of covered drugs were subject to coinsurance in PDPs; in 2016, that figure had climbed to 58.1%. While most PDPs have historically applied coinsurance to high-cost drugs on the specialty tier, plans have extended coinsurance to drugs on lower tiers in recent years, including those covered on preferred and nonpreferred brand tiers. “As coinsurance becomes more common in Part D plans, consumers will find their drug costs are less predictable and will need to rely more on tools like the Medicare Plan Finder to help estimate out-of-pocket costs,” Colin Shannon, a senior manager at Avalere, told SPC. In recent years, the percentage of beneficiaries enrolled in PDPs with more than one formulary tier requiring coinsurance has spiked to 96% in 2016, up from 39% in 2014. While Medicare rules cap the amount of coinsurance for specialty tiers at 33% of the cost of the product, the maximum on nonpreferred brand tiers is 50% in 2016. By comparison, preferred brand tier coinsurance amounts are capped at 25%. “Coinsurance can be very confusing for Part D members,” Mr. Shannon said. “They often have to work out with fam-

ily members, friends and plan managers what their costs are for the multiple drugs that they are taking. Some will see their cost sharing go down, while others will see it go way up. Plans are moving toward more-aggressive designs for higher-cost drugs. At this point, most people are probably now already enrolled in plans like this, and they are dealing with the reality of these changes

and whether they will be able to find a plan that works better for them when enrollment opens up in the fall.” Plans are always going to be testing new ways to help manage costs from a beneficiary and utilization perspective, Mr. Shannon said. “What’s unique to this moment is that it’s the first time we’re really seeing coinsurance being taken up by so many Medicare Part D plans at the same time. That’s the really surprising thing: We went from very few stand-alone plans having this model to almost everybody having it. It just snowballed and everybody got on the same page at the same time.” —Gina Shaw

Specialty Pharmacy Continuum • March/April 2016

OPERATIONS & MANAGEMENT

Part 1 of a two-part series

The Beneﬁts and Challenges of SP Accreditation Las Vegas—Accreditation—one of the more powerful tools for gaining entry into the specialty pharmacy market—was a prime area of focus during a wide-ranging panel discussion on specialty pharmacy trends at the 2016 Annual MHA Business Summit in Las Vegas. Burt Zweigenhaft, the president of the National Association of Specialty Pharmacy (NASP), who moderated the panel, said achieving accreditation has become the price of admission for most specialty pharmacies. But he stressed that an organization tion needs to analyze its local market well before jumping on the accreditaation bandwagon. In New Jersey, he p pointed out, Horizon BCBS requires acccreditation by at least two recognized accreditingg organizations, wh hich he said includes URAC, the Cen nter for Pharmacy Practice Accreditation, thee Accreditation Commisssion for Health Care and the t Joint Commission. “You really need to know thatt” going in, he stresssed. Heather Bono ome, PharmD, the director of pharmacy at URAC and a mem mber of the panel, saaid the push for accreditation in sp pecialty pharmacy is undeniable. “At URAC, we accredit many different types of phaarmacy organizations, and we’ve been doing that for about 10 years,” Dr. Bonome said. Pharmacy benefits managers (PBMs), community and mail-order pharmacies, and specialty pharmacy providers have all been part of URAC’s established customer base, she noted. “But far and away, particularly in the last few years, our pharmacy team has been spending the majority of our time reviewing specialty pharmacies. That volume has been increasing exponentially, and it’s being driven by the rapid growth in the utilization of specialty drugs and by payor requirements.” Dr. Bonome explained that most if not all payors now require specialty pharmacy accreditation for an organization to gain network access. But she stressed that URAC’s accreditation standards “are not something we created so that payors could use [them]” as a barrier to entry. “We developed them because we believe the process truly leads to better and continuous quality improvement within the health care setting, and payors have recognized and embraced that.”

Given the high value that accreditation brings to an organization, Dr. Bonome noted, it’s not surprising that URAC is seeing many new types of organizations seeking specialty pharmacy accreditation. In the past, she pointed out, many

of the applications came from the larger PBM-sponsored specialty pharmacies, large independents or health plans. “Fast forward to the past few years, and now the organizations we’re seeing [applying] more often are independent community pharmacies, hospital systems, and home infusion and sometimes even long-term care pharmacies.” This broadening of the applicant pool “gives us a unique perspective on the different types of specialty pharmacies that are out there,” Dr. Bonome said. “But it’s also a challenge for us because we have a set of standards which we feel— and industry stakeholders agree—is very important, and so we’re seeing many different ways that those standards are met. This can make the accreditation review process more complicated, but it also provides us with insight into the latest innovations in pharmacy practice.”

Caveats on Consultants The entry of new provider types poses another challenge: Some orga-

nizations are using consulting firms to guide them through the accreditation process, Dr. Bonome noted. These consulting partnerships “can be very successful in many cases, but we’ve seen it not be so successful in [others],” she said. When it doesn’t work, she said, it’s usually because a consultant “will help the applicant put together policies and procedures for submission to the accreditor.” Rather than embracing that process “and taking those procedural templates and making them their own,” Dr. Bonome noted, the th companies follow more of a rotee exercise. As a result, “when we com me on site for a validation review, that’s not really the way the pharmacyy is practicing; it doesn’t connectt.” In such cases, “th hat is not going to yieeld a successful [ou utcome].” The take-home messsage on consultingg, she said, is tthis: “There are a lot of skilled consulting organizationss out there, and many orgaanizations benefit from thosse partnerships. But we alw ways caution prospective app plicants to really bmitted policies own their sub and procedures and to work collaboratively with their consultant if that’s the route you u choose towards accreditation.”

Denials Rise As more organizations seek specialty pharmacy accreditation, there has been an uptick in instances where pharmacies are unsuccessful in their pursuit of URAC accreditation, Dr. Bonome noted. As for why some providers don’t pass the test, she said, “unfortunately, there are some instances when an organization signs up for accreditation because they think it’s something they have to do, but they haven’t embraced the process.” She added: “They don’t really understand what it all involves. And then we’ve seen a couple of organizations that have achieved accreditation but haven’t committed to maintaining compliance with all of those standards. So when they come up for reaccreditation, it’s not successful.” Such cases notwithstanding, Dr. Bonome stressed, “by far and away, the majority of organizations seeking specialty pharmacy accreditation do achieve it.”

Specialization on the Horizon? Noting that “specialization counts in this current market environment,” Mr. Zweigenhaft asked Dr. Bonome whether URAC had any plans for developing accreditation standards specific to a disease state such as fertility, multiple sclerosis (MS), hemophilia or any of the many other therapeutic areas managed by specialty pharmacy. It’s an important consideration, he noted, because specialization can help organizations differentiate themselves from other providers on the basis of specialized skill sets and clinical capabilities. The testing for such an approach, he noted, would not take the form of “an overall certification process,” but instead might contain “subsections for assessing competencies and recognition for that.” “It’s certainly something that we have talked about internally at URAC, and continue to consider,” Dr. Bonome said. “It probably would not be a separate program. Rather, it might involve some sort of added-on certificate that recognizes the different needs that some patients are going to have in certain disease states. And if we do go down that path, we may start out with one of the larger therapeutic areas such as oncology, for example.

Another Path: Certification Mr. Zweigenhaft agreed that some type of recognition and review of specialization would be useful. At NASP, he noted, a related effort is underway. “We now have certification programs where you sit for a test and if you pass, are a certified as an MS Pharmacist or Oncology Pharmacist, for example, with different competencies because of the different skill sets required.” In concluding the portion of the panel discussion on accreditation, Mr. Zweigenhaft reiterated how important accreditation has become in gaining access to the increasingly competitive specialty pharmacy market. “I am starting to see manufacturers, in RFPs [requests for proposals] that they [send out], wanting to know what your accreditation status is. So for access in the future, you are definitely going to need that.” —David Bronstein Part 2: Don’t miss the second installment in the May/June issue, highlighting other hot trends in specialty pharmacy, including the push for fair market value practice models, what payors really want from their specialty pharmacy providers, the move away from dispensing to more patient-focused care models, and whether providers can keep up with the evolving needs of data reporting required by manufacturers.

Specialty Pharmacy Continuum • March/April 2016

TECHNOLOGY

A Virtual Health Agent Will Be With You Health care technology has taken on a distinctly human face with “virtual health assistants” (VHAs), which may improve the management of patients in myriad ways. “I find this technology mind-blowing,” said John Aforismo, BSc Pharm, the CEO and founder of Drug Knowledge LLC, a company based in Wethersfield, Conn., that promotes greater awareness and safe use of medications through proprietary databases. VHAs offer patients a variety of services, all behind the veneer of a human face and voice. Companies such as Next IT offer VHAs, which account for patients’ unique preferences and communication styles and deliver education, medication reminders and motivational prompts about healthy behaviors. VHAs also gather data about patients’ health conditions, medication use and health behaviors, and send the data to providers between clinic visits. “Managing a patient better means medical costs go down while health outcomes improve,” Mr. Aforismo said, pointing to the strong appeal of this type of technology in the era of bundled payments and other reimbursement schemes based on outcomes.

Help for MS Patients Nontech stakeholders also are developing VHAs, Mr. Aforismo pointed out. For example, Teva Pharmaceuticals’ “Shared Solutions” personalized support service provides users of the company’s multiple sclerosis drug, Copaxone (glatiramer acetate injection), with access to a VHA that answers disease- and drug-related questions on a wide range of topics (www.copaxone.com/shared-solutions).

“Sometimes patients react better to virtual agents than they do to live individuals,” said Nathaniel Rickles,

ton. “These virtual agents have been developed to take on some of the more personable features of a human, like a smile and a gentle voice,” he said. “In contrast, provider–patient interactions can be quite variable, and negative features can influence how people engage in their health care.”

‘Sometimes patients react better to virtual agents than they do to live individuals.’ —Nathaniel Rickles, PharmD, PhD PharmD, PhD, an associate professor of pharmacy practice and administration, Department of Pharmacy and Health Systems Sciences at Northeastern University School of Pharmacy, in Bos-

about an over-the-counter [OTC] agent,” he explained. “My colleague might say some of the same things, but also might offer some very different information. And not only is there that issue of inconsistency, but if we both forget to provide a piece of information, the information our patient gets can also be inadequate.” Dr. Rickles and his colleagues are developing a kiosk-based “virtual pharmacy agent” that provides pharmacy clients with information on OTC agents. “The idea is that the agent takes in information, such as a patient’s age, gender, symptoms and existing health conditions, and points the patient to the most appropriate product, located in whatever aisle it’s in,” said Dr. Rickles, noting that the agent currently offers advice on OTC cough and cold medications, but there are plans to cover other OTCs in the future. “If an issue arises that the agent can’t resolve, it will refer the patient to the pharmacist.” One way health systems and hospitals might use virtual agents is to provide discharge counseling, which Dr. Rickles said can be fairly similar for specific types of patients, such as those who have undergone hip replacement surgery. “It would be great,” he said, “if an agent was there to communicate instructions and even follow up with them in the outpatient setting, so that not only are they introduced to an agent during their discharge, but they have a ‘friend’ that follows them into the outpatient environment.”

One of the strengths of virtual agents is that they offer consistent communication, Dr. Rickles added. “As a pharmacist, if I’m working with a patient in the aisle, I’m going to say certain things

—David Wild Mr. Aforismo and Dr. Rickles reported no relevant ﬁnancial relationships.

Diplomat Launching Care Management Smartphone App

iplomat Pharmacy Inc. has launched AllMetRx, a new smartphone app for Diplomat caregivers and patients facing complex diseases. The app, powered by Patient IO, captures real-time treatment data to help monitor adherence, side effects and other pertinent clinical information. Diplomat says the app also will educate patients about their conditions, provide them with a daily care plan of easy-to-follow treatment instructions and allow them to contact their care team securely. “We began piloting the app in December among patients with primary immunodeficiency [PID] who were receiving immune globulin administered by a nurse in the home,” explained

Susan Faust, Diplomat’s vice president of payor strategies and new product development, in an interview with Specialty Pharmacy Continuum. “The primary goal of the app is to collect data that has not been collected, or was only collected in a narrative note, in order to demonstrate improved clinical results and cost savings.” Among the data collected in the PID pilot were patient demographics; IV immune globulin brand breakdown; side effects by brand and dose; infection occurrence; joint pain; average infusion time; adherence; and number of urgent care, hospital or unscheduled physician visits. “As we expand the app to new populations, we can add metrics specific to each new condition and therapy, like activities of daily living or lifestyle scores,” Ms.

Faust said. “It was very impressive in the pilot to see all this data pop up, where previously it was in the nurse’s narrative notes, if at all.” In the pilot, Ms. Faust noted, nurses were the primary users of the app—specifically, the nurse who administered the drug, which allows for reliable data gathering on each infusion. Future app tweaks will be “based on where we can get the highest usage, and where the therapy ... is appropriate for this type of data collection,” she said. The next disease state for launch of the app has not been finalized. “By providing tools that empower patients and caregivers to take a more active role in their care and treatment, AllMetRx has the potential to become a go-to solution for managing chronic illness, reducing readmissions and unnecessary doctor visits,” said Diplomat CEO and chairman Phil Hagerman, in a statement. —Gina Shaw

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MORE THAN A SPECIALTY PHARMACY. A TEAMMATE IN CARE. BETHANY DIPLOMAT PATIE NT

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