Specialty pharmacies toe the line between access, cost and outcomes

BY Sandra Levy

It seems that not a week goes by without a new specialty drug being launched. In fact, of the 46 novel drugs that the FDA approved in 2017, 18, or nearly 40%, were considered specialty drugs.

Indeed, over the past decade, specialty medicine growth has outstripped that of traditional medicines in the United States. In 2017, domestic specialty share grew to more than 41%, and it is expected to surpass half of the medicine spending in 2022, according to IQVIA data.

While there is no question that these drugs offer patients a chance to lead better and longer lives, make no mistake, they carry astronomical price tags that are often out of the reach of the average consumer. Experts said that it is not unheard of for a specialty drug to cost $500,000 for a year’s treatment, or for combined yearly treatment costs to reach $700,000.

Pharmacy chains that have carved out a niche in specialty pharmacy are under increasing pressure to find innovative ways to manage these costs, while simultaneously being on the front line of providing the clinical expertise and ongoing clinical support, education and commitment to achieving quality of care that these “high-touch” medications require.

One tactic specialty pharmacies are banking on is looking beyond their own capabilities to establish alliances or to make acquisitions to expand access to specialty drugs, many of which manufacturers provide on a limited-distribution basis.

The rationale is that providing access to these drugs and expert clinical support will enable patients to be more compliant with their drug regimens, thereby reducing healthcare expenditures from hospitalizations and emergency room visits that are often tied to poor outcomes. This becomes more important as pharmacy reimbursement is increasingly being tied to quality outcomes.

Walgreens, a longtime player in the specialty pharmacy field, is taking the lead in expanding access to limited-distribution drugs and offering robust services through Orlando, Fla.-based AllianceRx Walgreens Prime. It is a partnership that combined the drug chain’s central specialty pharmacy operations and mail order pharmacy operations with PBM Prime Therapeutics’ central specialty and mail order more than a year ago.

“The trend we’re seeing more of is drugs coming out around specialty. Half of the new drugs being approved are coming out with limited-distribution networks,” said Walgreens senior director of specialty pharmacy operations Chris Creamer. “We have limited-distribution access at our central facilities through Alliance Rx Walgreens Prime and we’ve extended access across 300 community-based specialty pharmacies nationwide that are located on hospital campuses, in clinics, oncology and HIV practices, and freestanding in communities. We work with our manufacturers and physicians to make sure we put the right drug in the right location where there are patients in need of access, and that helps with access to limited distribution.”

In the case of US Bioservices, another longtime player in the specialty pharmacy arena, being acquired by AmerisourceBergen in 2003 enabled the company to continue to expand its specialty services and therapies that it provides to patients, and to engage more directly with pharmaceutical manufacturers.

“US Bioservices participates in many limited-distribution drug networks,” said Joy Gilbert, US Bioservices’ vice president of operations. “Having AmerisourceBergen as our parent company allows us to leverage the power and scale of a company like ABC, but still remain nimble as a specialty pharmacy business.”

Emphasizing that the industry is moving towards personalized medicine, and that many of the new FDA drug approvals are for drugs that are for very small patient populations, Gilbert made it clear that the drug manufacturer bringing that drug to market has several things to consider. “If there are only several hundred patients in the country, how do I make sure the patients get consistent care and the people caring for them have the expertise?” she asked.

Specialty drugs may be intended to treat as few as 500 patients nationwide, so it is reasonable to believe that individual pharmacies will have limited knowledge about that patient or disease state when dealing with a single patient. “If you consolidate those patients into a limited number of providers, they can get deep expertise clinically in those disease states and understand the socioeconomic and psychosocial profile of those patients, so we can provide better care,” Gilbert said.
When Alnylam Pharmaceuticals selected US Bioservices as its pharmacy partner for Onpattro, or patisiran, infusion for the treatment of peripheral nerve disease, providing quality patient care was at the top of Alnylam’s priority list.

“When choosing distribution partners, it’s important they work seamlessly with our patient services team to help facilitate patient access, both by dispensing therapy to be infused in the hospital outpatient, office or infusion setting, and by providing home infusion services for patients, where covered by their insurance,” said Alnylam spokesperson Hayley Sofer. “One of the most compelling reasons we chose to work with US Bioservices is their commitment to staying with the patient during the entire infusion, which is something not every specialty infusion pharmacy partner will commit to doing.”

Helping pharmacies get specialty drugs to patients as quickly as possible is absolutely crucial, but according to ZappRx, the process of filling them can shave off necessary time between the prescription being issued and it being filled.

“Currently, the prescribing and prior authorization of specialty pharmaceuticals are highly manual and time-consuming processes, causing patients to endure critical weeks before they receive their medications,” said ZappRx vice president of solutions Karen Tirozzi. “With ZappRx, providers and specialty pharmacists can improve the overall process of getting medications to severely ill patients, significantly improving the provider, specialty pharmacy and, most importantly, patient experience.”
Armed with the goal of getting patients on therapy in 24 hours, ZappRx digitizes much of the prescription process. Pharmacies benefit from getting legible, complete scripts that improve time-to-fill by mitigating the inefficiencies caused by manual processes, Tirozzi said.

“Because ZappRx is agnostic to specific specialty pharmacies and particular medications, prescribers are adopting our platform as a one-stop-shop for all their prescribing needs, including prescription enrollment, eligibility, prior authorization and patient consent,” she said. “It makes a lot of sense for a specialty pharmacy to want to have access to this market of prescribers, and benefit from the efficiencies that the ZappRx platform offers.”

Managing costs

Diplomat Pharmacy recently made a move to extend its specialty and infusion capabilities to lower costs for payers and patients. At the end of 2017 and into this year, the Flint, Mich.-based company acquired two PBMs — National Pharmaceutical Services and LDI Integrated Pharmacy Services, which company officials said gave it the assets needed to offer claims processing and PBM processing. In April the two came together as one Diplomat brand: CastiaRx.

Pointing out that Diplomat is selling to health plans and other businesses, Diplomat’s executive vice president of sales and payer strategies Robyn Peters said by offering PBM services alongside specialty pharmacy services, it can customize its solutions to payers and employers.

“What we do on the PBM side, managing the drug trends and spend, is the same approach we follow on the specialty and infusion side of the business. We are able to impact both the medical and pharmacy benefits,” Peters said “CastiaRx enables us now to provide full cost management across not only specialty and infusion drugs, but your traditional small molecule drugs as well. It provides us with a complete solution that we can customize based on what our customers want.”

Helping patients navigate financial assistance programs is another strategy that specialty pharmacies are employing to rein in drug costs. “If patients can afford their medicines, there is a greater likelihood that they will fill their prescriptions and stay adherent to their drug regimens,” said US Bioservices’ Gilbert.
US Bioservices connects patients with resources they may not know are available, particularly at a time when they are dealing with a chronic or rare disease.
“Many patients have multiple benefit coverages available, and they may not understand how they work together. It’s not just having expertise around their pharmacy benefit, sometimes their medical plan benefit can come into play, as well as if they have secondary insurance through a spouse or supplemental coverage through Medicare or Medicaid, and making sure we can leverage all of those pieces that are available to get their out-of-pocket cost to the lowest possible number,” Gilbert said.

The company also helps patients with such paperwork as proof of income documentation, and proof of their level of medical expense. “We want to help the patient pull all those pieces together to get approval, so they can afford their medication. There’s a lot of research in the market that shows clinical outcomes are better when there are not financial or affordability issues with these medications.”

Walgreens also is proactive in helping to make specialty medications more affordable. In addition to verifying patients’ insurance, Walgreens obtains prior authorization from providers, which many payers of specialty drugs require. The pharmacy also focuses on assisting patients who qualify for financial assistance, and in many cases, the patients’ copay is zero, according to Walgreens’ Creamer.

Peters said that Diplomat also strives to help patients pay for costly drugs, from verifying their insurance benefits and determining if they are having diffi-
culty meeting copays to helping patients obtain 5013C foundation funding to administering commercial copay cards from manufacturers.
“We’re interested in helping not only our patients, but our payers and our physician providers,” she said. “We want to manage total costs and provide this high-touch clinical care model.”

Beyond such enterprise efforts as offering PBM services and working with patients around discounts, one ray of light for specialty costs are biosimilar drugs — 12 of which have been approved and four of which have been launched so far. With these products, which are 10% to 15% less expensive than branded biologics, and the FDA’s recently announced plans to ease the approval and market entry of biosimilars, the potential for lower spending across the board is there.
A lower-priced option spreads savings throughout the system, according to Diplomat’s Peters. “Biosimilars traditionally will have lower price point in the market, which helps from a copay perspective for the patient, but it also offers lower drug costs for the payers.,” she said. “Diplomat has also made strides in connecting with patients through its Centers for Excellence for various disease states, including cancer and immunology.

Walgreens also is intent on providing less expensive alternatives that have a lower copay when they are available. “Our goal is to ultimately help patients get and afford their medications and our partners help manage the costs of managing specialty. We leverage the same financial assistance resources across all of our locations,” Creamer said.

Connecting with patients

Pharmacist advising senior adult woman

To better connect with specialty care patients in innovative ways, specialty pharmacies are developing tailored disease-state programs that are intended to manage high drug costs.

Walgreens’ ConnectedCare, for example, is a disease-state tailored program in which patients are automatically enrolled. Creamer said the chain uses what it calls “branch logic technology” based on medical protocols, and it tailors the conversation and care around the patient’s challenges. A pharmacist consults with the patient during an initial assessment of a new regimen, as well as each time the patient needs his or her next refill.

“We go through a similar process, and make sure there are no (drug) side effects, no barriers and nothing we have to do to intervene with their physician,” he said. “Ultimately, we want to have the best patient outcome, keeping them adherent and have success in their therapy.”

Historically, chemotherapy and other cancer medicines have been administered by a medical professional in an outpatient clinic or in-patient hospital. However, more recently, oral cancer medicines that patients can take at home have become available. Complex treatment plans, however, are still vital to patient outcomes, especially with cancer drugs that have side effects.

Walgreens and AllianceRx Walgreens Prime specialty pharmacy teams get a set of questions and informational scripts to guide conversations with Connected Care oncology patients. Each patient interaction is customized to focus on patient-specific variables, including prescribed medication, adverse events and adherence, as well as provides the proper support to the patient, Creamer said. Walgreens and AllianceRx Walgreens Prime captures the data and provides it to the patient’s oncologist for informational purposes and continuity of care.

Diplomat also has made strides in connecting with patients through its Centers for Excellence for various disease states, including cancer and immunology.
“We know how many times we should engage a patient based on their treatment and condition, with touchpoints to ensure appropriate care coordination,” Peters said. “We get to know and understand our patients’ needs and ensure their care is coordinated with their provider so they are receiving optimal care.”
Because many of these medicines have side effects, such as nausea with certain cancer drugs, Peters said it is important for clinicians to communicate with these patients often and to work with a patient’s provider to provide optimal outcomes, which reduces healthcare costs.

“You really want to be talking with these patients a lot to make certain they aren’t ending up with hospitalizations and ER visits,” Peters said. “These are all ways we are reducing the risks for the patient and the payer providing the medical and pharmacy benefits for these individuals.”
Diplomat also offers patients the ability to connect with a person on the phone within 20-to-30 seconds of their call being placed. “We believe our patients on these medications should be able to reach a live person 24/7. Our ability to touch, our interaction with the patients are live conversations. They are not a text that tells them, ‘go get your refill,’” Peters said.

US Bioservices officials also believe strongly in offering disease state-specific programs. The company has teams dedicated to specific disease states, and they have deep expertise. One such disease it is concerned with is Duchene Muscular dystrophy, which affects a population of young boys.

Utilization management programs also are critical in managing the overall cost of specialty drugs and the trends of those drugs for payers, whether they are a health plan or an employer-funded benefit plan.

“In some cases, we are managing the specialty drugs for other PBMs that don’t have a specialty pharmacy. A lot of those utilization management programs are around making sure the drug is being shipped at the right time, is being received by the patient, and we’re not shipping too much or too little, making sure they are on the right dose, that we are refilling these prescriptions in a timely manner,” Peters said.

Diplomat said it speaks to patients on a monthly basis on a refill to see if the patient is having side effects. It also provides patient education around their disease and provides nutrition and side effect counseling. The company helps patients stay on therapy, with a 94% overall adherence rate, based on the medication possession ratio.

Exploring options
Gilbert said that in the specialty market, though there are many disease states or classes of drugs where there are fewer drug options available, some, including multiple sclerosis, have multiple products available. In that case, insurance companies employ formulary management to balance cost and impact.

“The insurance company will decide which of those products they want their members to use usually based on clinical outcomes with their patients and cost of care,” Gilbert said. “As a pharmacy, it’s our job to help the patient understand what those formulary products are and what the impact is to their cost, if they chose a formulary product versus a non-formulary product.”

Diplomat also is interested in using formulary management to help patients. “If a patient comes into Diplomat or a provider sends us a specialty medication prescription, and the physician really wants the patient on that drug, we’ll work through prior authorization and the appeals process to get the patient on the drug. If the doctor is amenable to one drug over another based upon a formulary, and it’s clinically appropriate to change the prescription, we’ll work through that, as well,” Peters said.

Since a patient may not tolerate a specialty medication as frequently happens with cancer drugs, potential cost-saving tactics for specialty pharmacies are to dispense a smaller amount of the drug, monitor a patient’s response and, if necessary, work with the patient’s doctor to switch his or her medication.
Diplomat will split-fill that dose and monitor the shipping of these drugs in a two-week interval. “That keeps the patient more compliant when we know there’s a higher opportunity for waste, or there are complications and side effects, and they may drop off the medicine,” Peters said.

Walgreens said it partners with patients’ physicians, and if they want the patient to try the medication on a shorter-term basis to make sure that the patient can tolerate it, Walgreens helps the patient to bill for the medication.

Teaching patients how to take their medications properly is another way to increase patient compliance, and it is a cost-saving tactic that pharmacies are utilizing.
With self-administered specialty drugs for such diseases as rheumatoid arthritis on the rise, patients need to understand how to use an auto-injector or pens. Diplomat provides training in the form of educational videos and materials and assists patients at their doctor’s office upon the first injection.

“They have access 24/7 to clinical pharmacists or nurses who can answer questions when you are on these complex therapies,” Peters said. “We are really supporting the patient through their journey, and are part of that connected care and clinical care team that helps these patients, and make sure they’re staying adherent,” Peters said.

With pharmacists dispensing new drugs for new diseases states, proper training is a necessity.

“We want to makes sure our pharmacists are providing great clinical care, Gilbert said. “When new drugs are launched, we work closely with the manufacturer to understand what happened in their clinical trials, what side effects patients may experience, and what are the best dosing recommendations. The manufacturer often has programs and services patients can take advantage of to address out-of-pocket costs. We want to make sure our pharmacists understand what those services available are, so patients can be connected with those services as they are starting those medications.”

Walgreens also provides ongoing training to pharmacists, so they can support patients and increase compliance.

“In specialty, the concern about nonadherence gets expounded because of the complexity of the condition that patients have to live with,” Creamer said. “Specialty drugs require a lot of extra service and support from pharmacists. We’re preparing pharmacists through the broad organization to better care for specialty patients. What used to be a specialty patient in an infusion center is now on oral self-injectable therapy walking into our regular stores, and they need extra help, care and support.”

Peering into the future, Creamer expects that more specialty drugs, which have historically provided acute treatments for conditions, will offer more in the way of cures. “The evolvement of specialty new medications and treatments is impressive because we’re able to provide care and treatment we never had. What wasn’t possible to cure yesterday, is possible tomorrow. That’s where a lot of the development continues to evolve.”

Pointing out that technology and science in drug innovation is both exciting, but also very concerning for payers that are funding these medical and pharmacy benefits, Peters said it is up to such companies as Diplomat and others to come up with the right care model to ensure that they remain diligent in keeping the drug spend trend down and making sure that we are doing it in a way that doesn’t compromise the patient’s therapy and care.

Gilbert sees a bright future too, but one focused on achieving balance between outcomes and costs.

“FDA approvals are very strong in specialty,” she said. “We have to balance that with what does that cost and how do we contribute to controlling the overall cost of care? The drug spend is only a portion of overall cost of care, but certainly an important portion.”


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CBDMedic products bring hemp-derived ingredient to shelves


Cannabidiol, or CBD, the nonpsychoactive, hemp-derived ingredient, is having a moment. The product, which is used in creams, supplements, tinctures and edibles, has seen increased consumer interest as manufacturers tout its benefits. Among those companies is Abacus Health Products, whose CBDMedic brand’s line of products includes an arthritis cream and active sport ointment, which use camphor and menthol alongside CBD. Drug Store News caught up with Perry Antelman, CEO Abacus Health Products, to discuss the opportunities for retailers in CBD.

Drug Store News: The question that most retailers probably ask themselves when it comes to CBD is: Are your products legal and safe to sell?

Perry Antelman: Yes. All CBDMedic products are produced in conformance with Food and Drug Administration requirements and registered as OTC nonprescription topical analgesics. In addition, the CBD derived from industrial hemp used in all CBDMedic products is 100% federally legal, because it complies with applicable federal laws. Menthol and camphor are the active pain-relief ingredients in our products, and no medical claims are attributed to the CBD/hemp extract. Our attorney in these matters is a former associate chief counsel at the FDA, so the guidance we receive is grounded in FDA regulations. Our products are as legally safe to market as any other FDA-compliant topical pain relief product already sold on retailers’ shelves. Further, all CBDMedic products are made with THC-free hemp extract, so there is no concern regarding any effects from or testing of THC.

DSN: Explain how is CBD/hemp legal at the federal level?

PA: The CBD in all CBDMedic products is sourced from industrial hemp plants grown in accordance with the Agricultural Act of 2014, Section 7606, of the USDA Farm Bill, passed by Congress. The farm bill, subject to renewal, carved out an exception to the Controlled Substances Act for industrial hemp when the percent of THC is 0.3% or less. CBDMedic has 0.0% THC. Each state’s department of agriculture has the option of adopting the farm bill guidelines for licensing and managing cultivation of hemp within their state. Currently, 40 states — via their legislatures — have adopted the farm bill guidelines. On June 5, 2018, the Senate adopted the 2018 U.S. farm bill legislation to permanently legalize hemp and remove it from the Controlled Substances Act. The bill is currently under review in the House/Senate SubCommittee, and passage with the hemp provisions is considered likely this year.

In addition to the USDA guidelines, the federal government’s Omnibus Appropriations Acts of 2016, 2017 and 2018 prohibited federal agencies from interfering with the interstate transport and sale of hemp.

DSN: What is the difference between marijuana and hemp?

PA: Marijuana has a high concentration of THC — the psychoactive component that produces the “high” — and a low concentration of CBD. Hemp plants are the opposite; they have a high concentration of CBD and a low concentration of THC. Hemp is not marijuana and should not be confused with marijuana. For thousands of years, hemp has been grown principally for its fiber, which can be used to make rope, clothing and other materials. CBD is extracted from hemp and is only one of hemp’s useful properties.

DSN: What should retailers look for and avoid when selecting products with CBD/hemp?

PA: First, it’s important to distinguish between oral products with CBD/hemp, such as tinctures, pills or edibles, and topicals, such as creams, ointments and gels. Oral products may be considered dietary supplements and are governed by the Dietary Supplement Health and Education Act. The FDA has authority over DSHEA and restricts claims that can be made for such products. A topical made with CBD/hemp can’t make any medical claims unless it is an FDA-registered medication produced in an FDA-registered facility and in compliance with FDA labeling requirements.

It’s important for retailers to select CBD/hemp-infused products where: A) the CBD is derived from hemp plants grown in conformance with USDA requirements — no more than 0.3% THC; B) the CBD is produced in facilities with audited quality systems to ensure consistent product quality from batch to batch; C) manufacturers can make legal claims on its label so customers understand the products’ intended benefits, and can logically be placed in a store location where customers expect to find solutions for their specific needs, such as the external analgesics section; and D) if the product is making medical claims, such as “muscle and joint pain relief,” it must be FDA registered to be sold legally.

CBDMedic’s products meet all of the above criteria.


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HDA taps Drew, Mauch to lead board of directors

BY Sandra Levy

The Healthcare Distribution Alliance, which represents primary pharmaceutical distributors, has elected Greg Drew, president of Value Drug, as chairman of HDA’s board of directors, and Bob Mauch, executive vice president and group president at AmerisourceBergen, as vice chairman.

Drew, who recently served as vice chairman, assumes the chairmanship from Cardinal Health Medical Segment CEO Jon Giacomin, who is leaving the board following two years as chairman.

“As the board of directors continues the critical work of promoting the savings, efficiencies and safety that distributors provide to the healthcare industry, it is my pleasure to welcome Greg and Bob into their new roles, while thanking Jon for his service to HDA,” HDA president and CEO John Gray said in a statement.

HDA also announced the appointment of Chad Gielen, president/CEO of Louisiana Wholesale Drug, to its executive committee.

The following were named to HDA’s board of directors: Michael Broome, CEO of Mutual Wholesale Drug; Saul Factor, president of Smith Drug; Juan Carlos Hernandez, executive vice president and general manager of Drogueria Betances; Nishit Mehta, CEO of HyGen Pharmaceuticals; and Jacob Paskes, member, CEO of BluPax Pharmaceuticals.


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Which area of the industry do you think Amazon's entry would shake up the most?