Specialty Pharmacy Continuum (May / June 2020) by McMahon Group

Serving managed care, health system and specialty decision makers Volume 9 • Number 3 • May/June 2020 • specialtypharmacycontinuum.com

CLINICAL ‘An exciting time’ to manage sickle cell disease ....................................

Community cancer care amid COVID-19 ...................

Pandemic Shakes Up Rx Marketplace

igital therapeutics that deliver evidence-based interventions to help prevent, manage or treat medical conditions can play an even more important role during the COVID-19 pandemic, when people are staying at home and not necessarily seeing their providers regularly, according to several AMCP webinar presentations. These solutions, such as software to help patients improve asthma control or a mobile application to optimize substance use therapy, can be used independently or together with medications, devices or other therapies to improve health outot comes and can empower patients with co

POLICY Pandemic and health care reform not a good mix .................

How to get the 20% add-on DRG payment for COVID-19 ......................

Will COVID-19 clog generics, biologics pipeline? ...............................

Digital Rx Ripe For Widespread COVID-19 Use

Continued on page 21

OPERATIONS & MGMT Patient support programs keeping up despite COVID-19 ............ Time is now for nonopioid pain modalities .........................

TECHNOLOGY Leveraging telehealth in the time of COVID-19 ...........

s in other areas of health care, thee COVID-19 pandemic already is shaking up the U.S. pharmaceuticals and managed care markets, an industry expert said during an AMCP webinar on 2019-2020 pharmaceutical ical marketplace trends. COVID-19 has consequences beyond infected patients, leading to potential changes in health care dynamics and outcomes, said Doug Long, MBA, the vice president of industry relations for the clinical research organization IQVIA. The virus and orders to stay at home have led to a sharp decline in office visits and lab diagnostics, he said, as well as a downward trend in new diagnoses and new therapy starts in nearly every therapeutic area and a nearly 2,000% surge in telehealth services volume. In addition, rising unemployment has pushed more patients onto Medicaid insurance plans; providers are financially strained or have temporarily closed some practices; and hospitals are losing money on treating COVID-19. In short, patient outcomes may be compromised while the health care system starts to return to normalcy, Mr. Long noted, and the pandemic could lead to a decline in overall health because fewer patients are starting therapy for diseases not related to COVID-19 (Figure and box, page 16). Continued on page 16

Review Article:

Parenteral Nutrition Safety See insert after page 12.

A clamor for hy hydroxychloroquine

COVID-19 ‘Cure’ C P Puts Pressure On Antimalarial

hen the hype over hydroxychloroquine as a potential breakthrough for COVID-19 was at its height, pharmacy benefit managers, community pharmacies and prescribers scrambled to ensure that the praise, since countered by several negative reports, didn’t take the medication out of the hands of patients who really needed it. Consider the tale of Ira Katz, RPh, who doesn’t usually have to consider politics when running his pharmacy in Continued on page 10

The Compounding Process

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

Newly approved drugs, gene therapy spark hope

‘An Exciting Time’ to Manage Sickle Cell Disease Sickle cell disease (SCD) affects approximately 100,000 people living in the United States—double the number of people who have cystic fibrosis and hemophilia combined, according to the CDC. For nearly 20 years, the hematologic disorder had only one treatment option: hydroxyurea. In the last three years, three new drugs have been approved for SCD, offering the community new hope. The FDA approved two of these drugs at the end of 2019. “It is truly an exciting time to be patients,” said Deepa caring for SCD patients,

From 1989 through 1993, an average of

75,000 hospitalizations due to SCD occurred in the United States, costing approximately

$475 million.

Manwani, MD, the director of pediatric hematology at the Children’s Hospital at Montefiore, in New York City. “With more treatment options available and in clinical trials, there is great optimism and hope.” SCD describes a spectrum of disorders, among which sickle cell anemia is the most common. A disease that primarily occurs in people of African and Afro-Caribbean descent, SCD also affects the Latin(x) community, the second largest population in which SCD predominates. SCD also affects people of Middle Eastern, Asian and Mediterranean heritage, according to the American Society of Hematology. Until recently, hydroxyurea remained the sole treatment for SCD. Approved in 1998 to treat SCD in adults, the myelosuppressive agent originally was developed as an antineoplastic and is used to treat malignancies such as leukemia, ovarian cancer and melanoma. Doctors prescribe hydroxyurea to reduce the occurrence of acute painful episodes, also known as sickle cell crises, a condition caused by irregularly shaped red blood cells aggregating and collecting in blood vessels. Hydroxyurea reduces these painful episodes, which usually require hospitalization, by 50%. While decreasing

hospitalizations helps improve overall quality of life while containing health care systems’ costs, a 50% reduction is not enough, according to John J. Strouse, MD, PhD, an associate professor in at Duke the Department of Pediatrics Pedia Medicine, in DurUniversity School of Med ham, N.C. “Many people sstill have emergency department visits and hospitalizations for pain when th they are taking hydroxyurea.” hydroxyur Common Comm side effects include ne neutropenia, elevated liver enzymes, bone marrow suppression, anorexia, anorexia gastrointestinal tina disturbances such as nausea s and vomiting, and infertility. ity However, Dr. Strouse said patients tend to tolerate tolerat the drug relatively well. Newer drugs dru on the market give physicians g additional tools to additi add to t their treatment arsenal. Despite their potential to improve quality of life for patients with SCD, only time can elucidate the full impact of these noncurative therapies, as long-term outcomes associated with novel therapies have not been studied, Dr. Manwani explained. In 2017, a branded formulation of L-glutamine (Endari, Emmaus Medical) became the first SCD drug approved in nearly 20 years in 2017, but clinicians have met the drug’s release with mixed reviews. “I think many of us in the SCD community were surprised about Endari’s approval, given some concerns about the data,” Dr. Strouse said. Among these are an unclear mechanism of action and data demonstrating moderate effectiveness at best. Moreover, some patients find its twicedaily dosing and powder formulation less convenient than swallowing a hydroxyurea pill once a day. L-glutamine also must be taken with food and drink—a feature that creates a barrier for some patients, said Stephanie Guarino, MD, a clinical director of the sickle cell program at Christiana Care’s Center for Special Health Care Needs in Wilmington, Del.

In the fall 2019, the FDA approved crizanlizumab-tmca (Adakveo, Novartis) to treat occlusive crises in patients with SCD aged 16 years and older. The P-selectin blocker prevents platelets, red blood cells and leukocytes from interacting with P-selectin glycoprotein ligand-1 on endothelial cells and platelets. Interfering with the activity of these blood components reduces painful episodes and hospital admissions. Crizanlizumab-tmca can be administered either as monotherapy or concomitantly with hydroxyurea. Common side effects include nausea, pain in the back and joints, and fever. On Nov. 25, 2019, the FDA approved another drug for SCD—only 10 days after crizanlizumab-tmca’s approval. Voxelotor (Oxbryta, Global Blood Therapeutics) inhibits the polymerization of hemoglobin S, an abnormal form of hemoglobin that causes erythrocytes to sickle. Indi-

drug costs as creating financial barriers that require a tremendous effort for providers to obtain the insurance authorizations and gain buy-in from hospital committees. She remains optimistic that the benefits these new drugs offer in terms of quality of care and cost will outweigh some of the financial hurdles. Federal interventions such as 340B pricing similar to that offered at federally funded hemophilia treatment centers could help ease some of the payor burden.

Gene Therapy Promising Gene therapy offers some hope to patients who have SCD. According to ClinicalTrials.gov, there are 18 studies on gene therapy for sickle cell either enrolling, actively recruiting or active. Among these are therapies exploring single infusions of CD34+ bone marrow and other CD34+ agents. Another therapy targets BCL11A, a gene that suppresses SCD-

‘Many people still have emergency department visits and hospitalizations for pain when they are taking hydroxyurea.’ —John J. Strouse, MD, PhD cated for patients aged 12 years and older, the oral drug is dosed once daily without regard to food. Like crizanlizumabtmca, it can be taken as monotherapy or adjunctively with hydroxyurea. Headache; gastrointestinal disturbances such as abdominal pain, diarrhea and nausea; and rash, pyrexia and fatigue are among the most common side effects. The drug also requires dose adjustments in patients who have severe hepatic impairment. Despite the new treatment options, Dr. Strouse does not foresee these new drugs replacing hydroxyurea, given its nearly 20-year history of data, high degree of patient tolerance, and affordability. He anticipates that novel treatments will serve either as options for patients who are unable to tolerate hydroxyurea or as adjunctive therapy. As with many new drugs, cost is a potential hurdle. At roughly $1,200 per 30-day supply, L-glutamine is the least expensive of the three drugs. Crizanlizumab-tmca requires weight-based dosing. Drug costs are estimated to be approximately $2,500 per vial, not including outpatient clinic use and administration fees. Heavier patients may need up to four vials per treatment. The monthly cost for voxelotor is $10,417. Hydroxyurea costs roughly $1,200 per year on the high end. Dr. Guarino foresees these high-dollar

resistant fetal hemoglobin. According to George Daley, MD, the dean of the faculty of medicine at Harvard Medical School in Cambridge, Mass., newborns express a special form of hemoglobin called fetal hemoglobin. Because fetal hemoglobin does not sickle, babies born with SCD rarely exhibit symptoms initially. However, around the 6-month mark of life, babies stop producing fetal hemoglobin and start producing adult beta globin, due to BCL11A expression. “The data suggest that blocking BCL11A expression might stop cells from sickling,” Dr. Daley said. (Some patients who carry the SCD mutation also have one or more genetic variants for hereditary persistence of fetal hemoglobin [HPFH]. SCD patients who have HPFH were found to have drastically reduced levels of BCL11A and very mild SCD.) Cost may continue to challenge patients, payors and health care systems alike, but experts agree that better outcomes and potential curative therapies on the horizon offer the SCD community an unprecedented amount of hope. —Frieda Wiley, PharmD Dr. Manwani reported financial relationships with Forma Therapeutics, GBT, Novartis, and Pfizer. Dr. Strouse reported research support from Takeda.

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

Dose Optimization Interventions Yield Significant Specialty Drug Cost Savings Rachel K. Anderson, PharmD Clinical Program Manager – Clinical Services AllianceRx Walgreens Prime Pittsburgh, Pennsylvania

Specialty medications play a significant role in driving health care costs upward.1,2 This class of drugs is used by only a small percentage of the population. But because they have high costs and complex management needs, these drugs account for a substantial proportion of overall health care spending.1 Specialty drug spending is 50% of total drug spending and is forecasted to reach 60% by 2021.3,4 Formulary management techniques work to drive down expenditures for traditional drugs, but for specialty drugs, it’s a different ball game. As more specialty medications are prescribed, innovative strategies will be needed, and specialty pharmacies and pharmacy benefit managers will play a crucial role in developing and implementing these strategies, saving payors and patients an estimated $250 billion on specialty medications and related nondrug medical costs over the next several years.5

Utilization Management Payors have implemented aggressive strategies to manage spending on

specialty drugs but still rely on existing utilization management tools to oversee both pharmacy and medical benefits for these drugs. Step therapy and prior authorization pathways are cornerstone approaches to manage total drug spending. Payors also may exclude products from their formularies or negotiate manufacturer rebates to limit costs. Other cost-curbing strategies include split-fill programs, weight-based dose rounding, quantity level limits, and focused site-of-care initiatives. The goal of these programs is to reduce or eliminate waste. Under a split-fill program, the pharmacy may dispense only a partial supply of certain drugs known to have high discontinuation rates, such as 15 days or less

for certain oral oncology products. For weight-based dose rounding, patients prescribed medications with a weightbased dosing protocol receive the most appropriate dose based on their current weight, and the dose is rounded to minimize waste, when applicable. Site-of-care programs focus on transitioning infusion patients from higher cost sites of care, such as acute care settings or hospital outpatient departments, to lower cost sites of care, such as home infusion. These approaches have been shown to be successful.1,6,7 For example, one study found that simply shifting the administration site from a hospital outpatient center to physicians’ offices or patients’ homes could cut costs by more than 50%.1,6 Although these strategies take major steps toward protecting a payor’s bottom line, there still are opportunities to further prevent waste, improve adherence, and reduce overall spending.

Dose Optimization Interventions One such approach is dose optimization, which minimizes the number of units (oral, injectable, or infused) dispensed for a prescription while providing the same appropriate dose to the

patient. For example, some manufacturers charge the same (or very similar) prices for 5- and 10-mg capsules. If a physician writes a prescription for two 5-mg capsules each day, this prescription can be more efficiently and economically dispensed with one 10-mg capsule. By helping to ensure that dispensing occurs with the most appropriate strength and quantity combination at the lowest possible cost with the fewest number of units for a patient to remember to take, dose optimization improves adherence and creates immediate transactional savings for the payor.7-9 By implementing dose optimization programs, specialty pharmacies can uncover potential areas of hidden savings. For example, when plans don’t have quantity level limits in place for various specialty drugs, this could result in significant excess cost. Specialty pharmacies are the “last line of defense” in managing the high cost of specialty drugs because they are the last entity to modify a prescription before it is dispensed. In this role, specialty pharmacies work to find and act on opportunities to help reduce the cost of therapy.9 Not all pharmacy benefit managers

14 No opportunity

12 Other

Millions, $

Patient preference

Patient not yet stable on dose

No response to outreach

4 Successful

Figure. Estimated annualized savings from specialty medications, Walgreens Study (2019). Based on reference 7.

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

Of approximately

500,000 specialty dispenses in 1 year,

45 interventions yielded

$4.5 million in actual annualized savings, or an average potential annualized cost savings of

$100,000 per prescription.

may be aware of these opportunities, and they may not always have strict quantity limits on all specialty drugs, so this presents potential for significant cost savings. In the specialty pharmacy industry, we often hear that specialty pharmacy must be practiced “one patient at a time,” because one missed intervention opportunity can have significant clinical and financial implications. Achieved Outcomes

Several studies have looked at achievable drug cost savings for traditional drugs after use of dose optimization programs or stricter quantity level limits.8,10 One dose optimization pilot program focused on reducing antidepressant spending estimated that a single antidepressant product dose optimization initiative could save approximately $1 million.10 In another study, data showed that 454 dose optimization interventions (49% of 15 targeted traditional drug categories) over 6 months yielded an estimated annualized drug cost savings of more than $390,000.8 The unit costs for specialty drugs are higher than for traditional drugs,11,12 so the potential savings are enormous. Data on dose optimization interventions in specialty are somewhat limited, but recently one specialty pharmacy reported that just 9 dose optimization interventions yielded approximately $135,000 in cost savings that was not specific to the payor or the medication.13 AllianceRx Walgreens Prime’s dose optimization program yielded almost

$13 million in potential annualized cost savings,7 and that reflected just a small percentage of opportunities. Currently, AllianceRx Walgreens Prime performs dose optimization on its entire book of business for central fill specialty claims. Commercial plans are the focus, although some Medicare/ Medicaid plans are included. From January 1, 2019, to December 31, 2019, AllianceRx Walgreens Prime’s clinical services team implemented 129 dose optimization interventions related to 460,148 claims (Figure).7 Of these, 45 interventions (35%) were successful, yielding an estimated annualized drug cost savings of $4,557,856.7 Of the 80 cases that were not successful, the majority were declined either because the patient was not yet stable on the dose or the prescriber’s office did not respond to outreach attempts.7 There also were 4 cases that the team identified that involved a dose change or a patient discontinuing therapy before pharmacists were able to intervene.7

The Pharmacist’s Role Interventions should not negatively affect the patient—financially or otherwise—and, thus, often require collaboration between the pharmacy and the payor. One hurdle we identified was authorization for split copay overrides from the plan. For example, if the optimized dose requires 2 different strengths to be dispensed, then one of the strengths we would request a copay override so the patient would not be adversely affected financially. Specialty clinicians can work with the

payor if a copay override is needed to avoid any additional out-of-pocket cost to the patient. For drugs with dose optimization opportunities, pharmacists also must consider a patient’s individual treatment plan. When a prescriber initially declines the dose optimization suggestion, the case may be revisited later, depending on the rationale provided (eg, patient is not yet stable on the dose). Sometimes, interventions also may reduce patients’ out-of-pocket costs. For example, many patients who have copay structures such that they pay a certain percentage (eg, an 80/20 program) may end up paying less out of pocket. The reduced pill burden (eg, taking only 2 pills per day instead of 6) also can make a difference. For example, some patients with a sensitive gag reflex who have difficulty swallowing pills may become more adherent to treatment if they can take fewer pills. Patients always are counseled by a pharmacist about any change in the strength or quantity of the prescription to help them understand how to appropriately take their medication.

Conclusion A dose optimization program offers an additional way for payors to control rising drug benefit expenditures.8 Specialty pharmacies are uniquely positioned to serve as a safety net, uncovering and acting on potential opportunities for cost savings. For pharmacy programs in any setting to be successful, they must be able to

better manage rising drug costs without compromising quality of care for patients.8

References 1. Hirsch BR, Balu S, Schulman KA. The impact of specialty pharmaceuticals as drivers of health care costs. Health Affairs. 2014;33(10):1714-1720. 2. Lotvin AM, Shrank WH, Singh SC, et al. Specialty medications: traditional and novel tools can address rising spending on these costly drugs. Health Affairs. 2014;33(10):1736-1744. 3. Prime Therapeutics. The inevitable increase in specialty growth. November 14, 2017. bit. ly/3fAo2gX. Accessed May 8, 2020. 4. Pharmacy Benefit Management Institute. 2019 Trends in specialty drug benefits. bit.ly/3dwc7ii. Accessed May 8, 2020. 5. Namovicz-Peat S, Trompeter E, eds. Specialty Pharmacy Trends and Strategies: 2015. 8th ed. Atlantic Information Services; 2015. 6. Vora JB. Milliman white paper. Evaluation of medical specialty medications: utilization and management opportunities. April 8, 2014. bit.ly/2yEvUgV. Accessed May 5, 2020. 7.

Data on file. AllianceRx Walgreens Prime; 2020.

8. Calabrese DC. Dose-optimization intervention yields significant drug cost savings. J Managed Care Pharm. 2002;8(2):146-151. 9. SPCMA.org. The management of specialty drugs. bit.ly/2WCL0vs. Accessed May 8, 2020. 10. F-D-C Reports. The Pink Sheet. 2001;63(18):27-28. 11. Elsevier. Managing the costs of specialty drugs. 2017. bit.ly/35KkwMC. Accessed May 5, 2020. 12. Prime Therapeutics. Focus on trend. Spring 2018. bit.ly/2WgA33K. Accessed May 5, 2020. 13. Lee S, Lapointe S, Lampi L, et al. Viability of a dose optimization program within a specialty pharmacy. Pharmacy Times. February 27, 2020. bit.ly/2SMqZBx. Accessed May 5, 2020.

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

A generic waiting in the wings could be a cost-saver

New Entrants Expand PrEP Options for HIV Managed care pharmacists and other stakeholders interested in expanded treatment options for HIV pre-exposure prophylaxis (PrEP) have some new choices, including a pending generic formulation that may offer some savings. But infectious disease experts noted that several market barriers remain, not the least of which is acceptance by health care policymakers and clinicians.

Since 2012, emtricitabine-tenofovir disoproxil fumarate (FTC/TDF; Truvada, Gilead), which had annual sales of about $3 billion, has been the only PrEP available. Last year, the FDA approved FTC-tenofovir alafenamide (FTC/TAF; Descovy, Gilead) for PrEP, but it is not indicated for cisgender women, who are at risk from receptive vaginal sex.

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Also, a generic version of FTC/TDF by Teva Pharmaceuticals is expected this fall. “The looming question is how often patients and providers use the generic version for HIV treatment and prevention,” said Rochelle Walensky, MD, MPH, the chief of infectious diseases at Massachusetts General Hospital, in Boston. An estimated 90% of patients who were taking FTC/TDF have switched to Descovy for treatment. “However, the jury is still out as to how many patients will be switched to Descovy for prevention, especially with the availability of generic Truvada,” she said. Gilead reportedly has priced the brand-name versions the same and is marketing FTC/TAF as a safer option. “Although the trials demonstrated that Descovy has slightly better biomarkers of renal and bone safety over Truvada, it is not clear if these translate into clinically meaningful differences in adverse events,” Dr. Walensky said, noting that early studies suggest increased weight gain and cardiovascular risk factors with FTC/TAF. The initial FTC/TAF trial had surrogate markers for bone mineral density and renal toxicity, “but not true meaningful end points,” Dr. Walensky said. “Nonetheless, for patients with HIV who are aging and might have comorbidities, there might be an indication for some of those patients to change from Truvada to Descovy.”

Will the Generic Be Accepted? As for clinicians embracing the generic PrEP medication, “providers do not generally revert to a previous drug because of costs and costs alone,” Dr. Walensky said. “Thus, it is not entirely clear once Truvada goes off patent and can be acquired much cheaper, how many practitioners will actually prescribe the generic version and how many patients will consider a switch.” Regardless, Dr. Walensky acknowledged the clever marketing by Gilead. “I also believe it is an intentional move to dissuade clinicians from using generic Truvada,” she said. “There are published data about Descovy dating back to 2001.” With more than 1 million people in the United States needing PrEP, public health interventions need to consider “whether putting people on a more expensive drug like Descovy versus generic Truvada will result in fewer people having access to PrEP, especially since we do not really understand or know the end game of Descovy’s safety profile,” she said.

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

damages claiming infringement of its patents related to PrEP and that the company profited from research funded by taxpayers. There also is a patient-driven class action lawsuit against Gilead, claiming that it knowingly sold a product (FTC/TDF) that caused bone and kidney issues when it had a safer alternative (FTC/TAF) that it did not seek approval for until its patent was expiring.

Big Challenges Ahead Meanwhile in January, the New York City Department of Public Health and Mental Hygiene announced that its drug of choice for PrEP would remain FTC/TDF. “So I think there are numerous policymakers who understand these implications, despite the marketing efforts by Gilead,” Dr. Walensky said.

A Pharmacist’s Perspective Although FTC/TAF is considered safer for kidney and bone problems, “there may be some cardiovascular concerns with the newer drug,” said Rodrigo Burgos, PharmD, a clinical assistant professor in the Section of Infectious Diseases Pharmacotherapy at the University of Illinois at Chicago College of Pharmacy. “Hence, at this stage, I do not believe we can definitively rule out using Truvada for PrEP.” Until it is proven that FTC/TAF is more cost-effective than FTC/TDF for PrEP, “it is easy to understand why an entity would prefer to use the less costly option of Truvada,” Dr. Burgos said. Similarly, because evidence of efficacy for FTC/TAF as PrEP is limited to specific populations such as men who have sex with men, “having a single agent that is effective in all populations may add appeal to Truvada when making decisions on cost and public health,” Dr. Burgos pointed out. He said generic FTC/TDF will be embraced by both patients and physicians. “Most patients do not like to change the medications on which they have been stable, specifically to a generic version,” he said. “However, any dislike is usually momentary and has not been an issue in the past when many other antiretrovirals have gone generic.” On the other hand, FTC/TAF may provide a safer treatment option for some patients, he noted, again citing the issue of kidney disease and bone disorders. “Availability of safer medications is a win-win for both patients and health care providers, and should be the goal for every medication on the market.” Dr. Burgos said he does not find it odd or suspect that Gilead is introducing a new drug for PrEP within one year of FTC/TDF becoming generic. “It is not uncommon for a company to introduce newer and better products around patent expiration of a product.” However, other people have taken

exception to Gilead’s products. The federal government sued Gilead, seeking

The biggest challenge with any other PrEP agent, regardless of whether it is

a brand-name or generic medication, “is identifying and reaching out to at-risk individuals and making PrEP available to them,” Dr. Burgos said. “Will the lower cost of generic Truvada actually translate to savings for society or extra services for our patients, or will only a handful of people benefit from that lower cost?” —Bob Kronemyer Dr. Walensky reported no relevant financial relationships. Dr. Burgos reported working on trials sponsored by GlaxoSmithKline and Merck.

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CLINICAL

Stakeholders adapt during pandemic

Community Cancer Care Amid COVID-19 When it comes to delivering cancer care amid the COVID-19 pandemic, it takes a village: Pharmacy benefit managers, Pharma, providers and clinic directors all are pulling together to ensure adequate access despite social distancing and other unprecedented pressures, experts noted during an April 3 webinar. “We can shut down the country, but we can’t shut down cancer,” said Ted Okon, the executive director of the Community Oncology Alliance (COA). “Cancer keeps going. With hospital campuses overflowing with COVID-19 patients, community oncology facilities have been essential to keeping cancer patients treated and monitored so that they are out of the hospital.” Sponsored by the Association for Value-Based Cancer Care, the webinar focused on the impact of COVID-19 on the cancer care delivery ecosystem and featured insights from more than 20 industry experts. COA has established a regularly updated COVID-19 webpage with practice resources and protocols for community oncologists, as well as a listserve for health care providers. Tennessee Oncology, one of the nation’s largest community cancer networks, has established three primary strategies to protect its patients, said the network’s president, Jeff Patton, MD: 1. Patients who are not in active treatment should stay at home and maintain checkups via telehealth. 2. Continue treatment for active-treatment patients. “We are still treating both curative and palliative patients, and keeping our clinics open and providers and patients safe is our focus,” Dr. Patton said. “Our visits for nonacute patients are down by 30%, but chemotherapy visits are off by only 2%.” 3. Acute diligence practices should be done in the clinic, including use of N95 masks and personal protective equipment for clinicians and CDC risk assessment of all patients and caregivers at the door. Only one caregiver is allowed to accompany each patient. Lucio Gordan, MD, the president of Florida Cancer Specialists (FCS), the largest independent medical oncology/hematology practice in the United States, said cancer care providers in the state are “bracing for impact.” He noted that infusion visits in the practice were down by only about 7%, but weekly follow-up visits had declined by 33% and new patient visits by almost 25%. Radiology also has declined, with CT scans down by almost 13% and PET

scans down by nearly 10%. “Telehealth is operational across our more than 100 clinic sites,” Dr. Gordan said. “We gave our chief technology officer three days to get it up and running and he had a solution in 19 hours.” The practice has the vast majority of nonclinical staff working from home with information technology support, including 85% of IT staff, 70% of the revenue cycle team, and 90% of the outpatient pharmacy group. “It was a herculean effort to get appropriate technology to allow more than 1,000 people to work from home over the course of four to five business days,” Dr. Gordan said. “But we were able to do it.”

At Florida Cancer Specialists, by early May, telehealth was operational across more than 100 of the network’s clinic sites.

Protecting Front-Line Staff FCS took additional steps to ensure its oncology pharmacy dispensing staff was protected immediately. “They have been sequestered in their own ISO 9 [clean]room with a separate entrance and its own HVAC system,” said pharmacy director Ray Bailey, BPharm, RPh. “They are masked and gloved and go through temperature checks and questionnaires at the beginning and end of their shifts.” FCS also has suspended all pickups in the pharmacy and any shipments to the clinic; everything now is being shipped by FedEx. “They have adapted and will not require physical signatures from our patients,” Mr. Bailey said. “They will ring the doorbell, and once they see the patient take the package, they sign ‘COVID-19’ on the signature pad.” He noted that for drugs with Risk Evaluation and Mitigation Strategies (REMS) requirements of periodic inperson laboratory or imaging tests— which include many cancer therapies—the FDA is temporarily allowing providers to waive such requirements during the public health emergency. (To access details on the agency’s easing of some REMS requirements, visit bit.ly/2wZ7r5j).

Expanded Telehealth Like many other providers during the COVID-19 pandemic, FCS also has expanded its telehealth program, with services now available to patients at all FCS sites. The strategy is intended to increase patients’ access to providers

while helping to reduce the potential spread of, or exposure to, illness, Telehealth visits, FCS noted, are covered by most insurance plans, and patients can expect “to pay the same or possibly less than an in-office visit.”

Minimal Supply Chain Disruptions To date, the oncology pharmacy supply chain has not experienced significant disruptions as a result of the pandemic, said webinar participants representing manufacturers and wholesalers. “We have multiple redundancy plans built out to ensure continued operations during this crisis,” said Barry Fortner, PhD, the senior vice president and president of specialty physician services at AmerisourceBergen. “The foundational oncology pharmacy space has not seen major disruptions to date, other than those we were already dealing with before this pandemic, and those specifically accentuated by COVID-19 such as hydroxychloroquine.” Brian Morrissey, the vice president of the strategic customer group for oncology at Pfizer, cited similar progress. “All of our plants in [effected] areas are fully operational, and in fact we have increased production and shifted demand to our most critical products,” he said. “We are also seeing unprecedented cooperation with regulatory authorities. Things that usually take months take weeks, and things that typically take weeks happen in days.” Eric Dozier, the vice president of

Oncology North America for Eli Lilly, said that the company is “able to maintain strong supplies across the oncology channel.” Both Mr. Dozier and Mr. Morrissey noted that while pivotal trials of new oncology agents are continuing, manufacturers have halted recruitment for new trials. “The last thing we want to do is be a burden on the system,” Mr. Dozier said.

PBMs Step In Many pharmacy benefit managers (PBMs) have adapted their policies and practices in light of the COVID-19 pandemic, said oncology pharmacy specialists participating in the webinar. “Many [PBMs] are now allowing 90-day fills and not requiring signatures from patients,” said Michael Reff, RPh, MBA, the founder and executive director of the National Community Oncology Dispensing Association. “A number of PBMs have also suspended audits, and in many cases pre-authorizations have been delayed or suspended. We really appreciate those efforts from the PBMs.” Mr. Reff noted that oncology practices also are innovating in response to the pandemic. “They are reaching out to local and state legislatures to find out if they can keep some oral therapies in-house as opposed to [using] mailorder pharmacies, to increase continuity of care.” —Gina Shaw The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum • May/June 2020

CLINICAL

Hype Over Hydroxy continued from page 1

metropolitan Atlanta. On the day the president began touting the benefits of hydroxychloroquine—an old medication normally used for malaria and autoimmune diseases such as lupus and rheumatoid arthritis (RA)—to treat COVID-19, Mr. Katz put in a larger order. He had been researching potential therapies for COVID-19 for a while, and had already tried to gather a little extra hydroxychloroquine in case it proved useful. “Then when President Trump discussed it, I reached out and ordered a bottle of 500 pills.” In the front of Mr. Katz’s mind was the small number of patients who rely on Little Five Points Pharmacy for a regular supply of hydroxychloroquine. Many people with lupus and RA have moved on to biologic therapy, but “there are some who take it,” he said. “I wanted to make sure I had it for them.”

Securing a Supply During the height of the hydroxychloroquine hype, pharmacists had to do what they could to secure a reliable supply of the drug for conventional indications. But the initial run on the medicine—and an allocation of more than 30 million doses to the federal stockpile— made their job difficult. Chuck Kray, RPh, the owner of Hershey Pharmacy and HersheyCare, in Pennsylvania, said that at the time, his pharmacy had “enough for another month probably, and then we were going to hurt a little.” Mr. Kray added that he heard of several other pharmacies that had completely sold out of their supply. Such shortages were not surprising, based on an analysis of hydroxychloroquine and chloroquine prescription data by The New York Times (nyti. ms/2YjrEO7). Soon after the president’s touting of the antimalarials, first-time prescriptions of the drugs poured into community pharmacies at more than 46 times the average weekday rate, according to the analysis. The nearly 32,000

prescriptions came from a spectrum of prescribers—rheumatologists, cardiologists, dermatologists, psychiatrists and even podiatrists, the data showed.

Preventive Measures Mr. Katz said he received electronic prescriptions from patients and doctors he did not know, with no diagnosis code—something he said has never happened before. “I didn’t fill them; I didn’t know the patient and I didn’t know the doctor.” Mr. Kray, for his part, said he received multiple prescription requests for hydroxychloroquine from doctors seeking personal supplies. “We set a policy that unless it’s confirmed COVID-19, we would not fill it.” Chain pharmacies also took steps to preserve their supply of hydroxychloroquine. Walgreens, for example, suggested that pharmacists who received a new prescription for chloroquine or hydroxychloroquine for patients who did not have a prior history of use should provide no more than a 14-day supply. Patients who regularly take the medication should be limited to a 30-day supply, and all active 90-day prescriptions should be changed to 30 days. These guidelines were intended “to help ensure these medicines remain available for those who need them,” Walgreens spokesperson Rebekah Pajak said. Some states made such restrictions official: In New York state, the governor signed an executive order that stipulated that pharmacists can only prescribe hydroxychloroquine for indications approved by the FDA, or for patients with COVID-19 who have documented positive test results, and no prophylactic use is permitted. Michael DeAngelis, a spokesperson for CVS Health, said the company’s retail pharmacies followed all state dispensing guidelines. In states without guidelines,

Soon after the White House touted chloroquine and hydroxychloroquine, first-time prescriptions for the drugs poured into community pharmacies at more than 46 times the average weekday rate.

the pharmacies limited hydroxychloroquine for COVID-19 patients to a 10-day supply with no refills. CVS Health’s pharmacy benefit manager, Caremark, worked with its PBM clients to set “appropriate coverage limits” on the drug for plan members being treated for COVID-19, which would not apply to plan members who have been receiving hydroxychloroquine for approved uses. “Our goal [was] to limit stockpiling of medication that could result in future shortages and gaps in care,” Mr. DeAngelis said. Such restrictions provided some relief, but not enough, Mr. Kray said. Before the surge in demand, he could purchase one pill of hydroxychloroquine for 9 to 10 cents; during the pandemic, prices have been as high as $2.75, he noted.

Taking Adverse Events to Heart The financial fallout from indiscriminate use of hydroxychloroquine or chloroquine is not the only consequence that community and managed care pharmacists should be concerned about. Recent data underscore how potentially toxic the medications can be. A cohort study of COVID-19 patients from Wuhan, China, found that nearly 20% of treated patients showed signs of cardiac injury, and those who did were significantly more likely to die (51.2% vs. 4.5% of patients without cardiac injury; P<0.001) (JAMA Cardiol 2020 Mar 25. [Epub ahead of print]. doi: 10.1001/jamacardio.2020.0950).

Due to such emerging data, in late April, the FDA issued a warning that health care professionals should closely screen and monitor patients receiving hydroxychloroquine or chloroquine to reduce the risk for an adverse event (bit. ly/2ztpQYO). Fortunately, there are steps that pharmacists, providers and other stakeholders can take to reduce those cardiovascular risks, including prescribing no more than 600 mg per day of hydroxychloroquine in divided doses, and for no more than a 10-day course, according to a guidance issued by the American College of Cardiology (bit.ly/ 3bVzzp1). The organization also urged providers to consult physician and pharmacist infectious disease specialists when prescribing these medications.

The Pressure Eases As for next steps in managing supplies of hydroxychloroquine, that job has gotten much easier. Due in part to the release of several negative clinical trails on hydroxychloroquine’s efficacy against COVID-19, the run on the drug appears to have waned. By mid-May, although it still was listed on the ASHP’s drug shortages site, some formulations were noted as being available (bit.ly/ 3bPGwrx; sidebar). —Alison McCook The sources reported no relevant financial relationships.

PBMs and the Run on Hydroxychloroquine L eading pharmacy benefit managers (PBMs) say the initial flood of demand for the antimalarial drug hydroxychloroquine, sparked by suggestions from the White House that it was an effective treatment for COVID-19, finally is showing some signs of easing. This has lessened pressures on supplies of the drug for FDA-approved indications, such as lupus and rheumatoid arthritis. Prime Therapeutics’ ongoing monitoring of utilization trends for hydroxychloroquine showed a rapid spike between March 17 and 25, which caused many community pharmacies to scramble

to maintain adequate supplies for the FDA-approved uses, as noted above. “During this time, we did receive a few escalated member inquiries regarding drug supply issues. This was primarily due to local/ regional supply chain inventory adjustments,” said David Lassen, MD, Prime’s chief clinical officer. “We assisted these members by redirecting to pharmacies with known inventory. We also took measures to limit quantities of prescriptions for new COVID-19 users to prevent further drug shortage concerns and/or potential stockpiling.” Between late April and early May, after new

reports suggested that the drug did not help hospitalized COVID-19 patients and the FDA warned against the use of hydroxychloroquine outside of the hospital setting or a clinical trial due to risk for heart rhythm problems (bit.ly/2WFOEog), Prime saw its utilization of the drug return to pre-baseline levels. This suggests that there is no longer a high demand for the product as a COVID-19 treatment in the outpatient setting, “which is consistent with the evolving clinical trial data suggesting that the risks Text continues on page 11

Specialty Pharmacy Continuum • May/June 2020

CLINICAL

Text continued from page 10

(cardiovascular) may outweigh any benefits for this drug in the treatment of COVID-19,” Dr. Lassen said. On May 7, an observational Columbia University study of more than 1,400 hospitalized patients—the largest study of hydroxychloroquine to date in COVID-19—added to the data questioning the antimalarial’s role in COVID-19. The study found that the drug was not associated with either a greatly lowered or an increased risk for the composite end point of intubation or death (N Engl J Med 2020 May 7. [Epub ahead of print]. doi: 10.1056/NEJMoa2012410).

in 100-count/200-mg dosages, while several other suppliers had the drug on allocation to customers and contracted wholesalers for approved indications. As for azithromycin, three suppliers— Athenex, Fresenius Kabi and Slate Run Pharmaceuticals—were listed as having IV lyophilized powder for injection available in 10-count packages of 500mg vials.

quantity for pharmacies in our network.”

ASHP Shortage Data Underscoring the moving target of hydroxychloroquine and azithromycin shortages, both drugs were still listed as being in short supply by the ASHP’s drug shortages website in early May. But a deeper dive into the listings shows that the drugs can be obtained, albeit in a limited range of formulations. According to ASHP’s “Current Drug Shortages” list (bit.ly/2yLFoab), Concordia and Milan had hydroxychloroquine available

—Gina Shaw The sources reported no relevant financial relationships.

Abarca’s Response The Florida- and Puerto Rico– based PBM Abarca also observed intermittent shortages of hydroxychloroquine during the mid-March utilization spike. “During that time, we continually monitored shortages and recommend strategies to prevent and address shortages, especially to protect those patients who use medications chronically,” said founder and CEO Jason Borschow, adding that the company also has seen a return to pre-pandemic demand in the past few weeks. “Despite the sharp drop-off in utilization, our clinicians continue to monitor access to hydroxychloroquine. At this point, we have not received any complaints of patients who can’t obtain their supplies due to shortages,” he said. CVS Health reported that its retail, mail service and specialty pharmacies have adequate supply of hydroxychloroquine and are taking all necessary steps to maintain those supplies. “Very early on, we implemented quantity limits (with client consent) to help meet the needs of patients with conditions such as lupus,” said spokesperson Trey Hollern. “We continue to balance the growing interest in off-label use of certain prescription medications to treat COVID-19 pneumonia (like hydroxychloroquine) with the ongoing needs” of chronic-care patients. Increased demand for other medications being prescribed to treat COVID-19 and its complications has led to some temporary shortages, Mr. Hollern added. Besides hydroxychloroquine, these medications include azithromycin, which often is given in combination with hydroxychloroquine in COVID-19 patients, as well as albuterol inhalers, which are approved for treatment of lupus, bacterial infections, HIV, rheumatoid arthritis and asthma but often are used adjunctively in COVID-19. “In addition to standard processes at the pharmacy level,” Mr. Hollern said, “CVS Health implemented new measures across our enterprise for these medications, such as adhering to state-level dispensing guidelines in our retail pharmacies and, as a PBM, setting coverage limits on

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Specialty Pharmacy Continuum • May/June 2020

POLICY

COVID-19 and Health Care Reform a Bad Mix With the COVID-19 pandemic derailing nearly every aspect of health care, experts are speculating that the ongoing crisis will reshape everything from drug pricing reform initiatives to universal health care policy debates and insurance accessibility. Health Care Reform By the time Congress gets to proposed health care reform, the political landscape may be very different from what it is today, potentially with a different president, noted Chris Sloan, an associate principal at Avalere, a health care consulting firm in Washington, D.C. “Assuming the focus remains on COVID-19, the next opportunity for major health care policy reform might not be before 2021,” Mr. Sloan said during a recent Avalere podcast. If former Vice President Joe Biden wins the election, his health care proposals will look “very different than some Republican priorities, when it comes to Medicare drug pricing negotiations, for example,” he said. (For more on drug pricing, see sidebar.)

Drug Supply Chain Weaknesses Although some initiatives are stalling due to the COVID-19 crisis, others will be prioritized because of their relevance to the current pandemic, experts believe. For example, shortages of health care supplies and a recent shutdown of pharmaceutical manufacturers in Baddi, India—a key drug manufacturing hub—likely will accelerate initiatives to fix vulnerabilities in the drug supply chain and reduce dependence on China and India, said Melissa Andel, the vice president of health policy for Applied Policy. “In fact, the third phase of the

stimulus package that Congress passed during the COVID-19 crisis included a pretty significant increase in funding that could be used by manufacturers to repatriate some of their activities back from overseas into the United States.”

Medicare for All The argument in favor of a Medicarefor-all system could be bolstered in light of an increasing number of unemployed and uninsured individuals and “negative health care experiences,” such as surprise hospital bills for COVID-19 treatment, Ms. Andel noted. However, not all agree with that assessment. According to Mr. Sloan, personal views on the topic of universal health insurance “are so heavily entrenched that even a global pandemic isn’t going to sway many people’s minds. “What I do think we may see are some state-specific efforts to widen the availability of patient health care safety nets, like Medicaid,” he said. “Losing commercial insurance coverage in New York is very different than losing it in Texas, where Medicaid is limited, so some states with less generous social programs may be pressured to expand these programs.”

Access to Care Health care stakeholders are keeping a close eye on how much the pandemic affects health care utilization both now

Personal views on universal health insurance ‘are so heavily entrenched that even a global pandemic isn’t going to sway people’s minds.’ —Chris Sloan, Avalere and after it resolves, Mr. Sloan noted. With most clinic appointments, tests and elective procedures postponed, pharmaceutical manufacturers, insurers and payors are trying to preserve as much access as possible to treatments and are encouraging adherence to medications. “Everyone has an incentive to avoid a spike in new diagnoses and complications and a wave of uncontrolled medical costs after COVID-19 subsides,” he said. One way stakeholders have been addressing some of the gaps in care is through the use of telehealth, which saw a nearly 1,600% surge in claims at the height of the COVID-19 pandemic, according to IQVIA data presented by Doug Long, MBA, the vice president of industry relations for the firm, during a separate seminar (see page 1). These claims are being reimbursed widely, according to Mr. Sloan. Because it facilitates access to

During Pandemic, Drug Pricing Overhaul Not Likely

he COVID-19 pandemic and resulting public health emergency likely have sidelined any opportunity to implement broad drug pricing reform in 2020, a health policy expert said during an AMCP webinar. “The Trump administration and Congress’ attention is focused on mitigating the impact of the public health emergency on the nation, and this work is likely to continue beyond the immediate crisis but also up through the election,” said Melissa Andel, the vice president of health policy for Applied Policy, a consulting firm in Alexandria, Va. “Clearly, there will be massive challenges facing the economy and within health care, and immediate aid to providers and hospitals is going to take top priority.” It’s possible there could be an opportunity in November, during the lame-duck session, to include drug pricing reform in a legislative package with various health extenders, Ms. Andel said, “but that legislation is going to need to move quickly, and any compromises would need to be negotiated ahead of time.” It’s relatively unlikely that the Trump administration would take any independent executive action, she said, because that could have a negative effect on investor markets, especially in the pharmaceutical sector. There has been bipartisan agreement on restructuring the Medicare Part D benefit, as well as an inflation penalty that would be applied to drugs covered by Medicare

when their annual price outpaces inflation. House Democrats, many Senate Republicans and the president agreed to these ideas in principle, but a Senate discussion on the matter barely made it out of the committee, and it squeaked by with one vote. “Majority leader [Sen.] Mitch McConnell’s refusal to bring this to the floor for vote appears to be the one thing keeping it from being passed into law,” Ms. Andel said. “Therefore, even a slight change in the Senate makeup could influence the future of that legislation.” Mr. McConnell himself is up for reelection this fall. Senate seat elections are critical, because that will determine the ultimate fate of drug reform, Ms. Andel said: “Even if the Democrats outperform expectations and somehow win back the Senate, it’s important to keep in mind they would have a very slim majority, and they have a lot of moderate and conservative members that decrease the chance they would be amenable to a radical reform.” —Karen Blum Ms. Andel reported no relevant financial relationships.

care for underserved populations, telehealth likely will continue to be paid for and used more frequently even after the pandemic is resolved, he suggested. (For more details on telepharmacy reimbursement, see page 13.) The financial effects of current and future changes in health care utilization are keeping health plan managers up at night, Matt Kazan, a senior health policy advisor at Avalere Health, noted during the podcast. “They’re looking at how the unanticipated costs of treatment for members who develop COVID-19 weigh against any savings from reduced utilization of health care services during this time,” he said. The chronic care gap Mr. Kazan pointed to is underscored by IQVIA data: As the COVID-19 pandemic took hold at the end of March, medical claims for diagnostic visits in physician offices and institutions plunged by 63.2% and 72%, respectively, according to Mr. Long.

When Care Returns Once the health care system reopens, another set of costs will start to be felt, Mr. Kazan noted. When that happens, he explained, clinic visits, elective procedures and tests presumably will resume, and patients will start treatments for new diagnoses that had been missed during the height of the pandemic. The problem is that the increased utilization “[will come] right when plans are setting their premiums for 2021,” he said. “It’s yet to be seen how all of these costs will affect the price of insurance.” Along with the loss of insurance that tens of millions of newly unemployed Americans are facing, possible higher premiums, Mr. Kazan noted, would place health insurance further out of reach for many. —David Wild The sources reported no relevant financial relationships.

Specialty Pharmacy Continuum • May/June 2020

POLICY

One goal: getting your 20% Medicare add-on payment for COVID-19

Be Prepared, Be Innovative and Be Safe! I n the unprecedented crisis of COVID-19, the first instinct is to triage our activities, often weeding out the ones that seem to be the least important. Some of those will never surface again and just become part of the detritus left behind. However, documentation mustn’t be one of them. From a clinical standpoint, documentation is critical to caring for patients with COVID-19; it’s essential to tell the patient’s story accurately and completely. When this is done in a codable manner, it’s the key to bringing in desperately needed income and decreasing financial toxicity for the patient who’s often eligible for expanded resources. Such efforts also will help avoid medical billing and payment issues in the months and years following this pandemic. Tucked into the recent CARES Act, the Coronavirus Preparedness and Response onse Supplemental Appropriations Act (also also known as the stimulus package), is a provision that temporarily removes the Medicare sequester from May 1 through ugh Dec. 31, 2020, and extends it an additional onal year past its original end date. This his provides you with a guaranteed 2% % increase on all Medicare payments. The he caveat: The claim needs to be clean and nd complete with no inaccuracies, errors ors or missing information to be processed ed quickly and paid completely. I’m urging you to find someone within thin your department who can shoulder the responsibility of making this happen. Perhaps it’s someone, even working from ma remote location, who will be the steady eady driving force for financial solvency. The stimulus package is providing the fundunding, but it’s up to each one of you to ask for it and use it wisely to help cover COVOVID-19-related expenses and lost revenue. nue The supplement also provides a 20% add-on payment to the DRG rate for COVID-19. This Medicare add-on payment applies to patients treated at hospitals that are reimbursed through IPPS with a new ICD-10-CM diagnosis code, U07.1. An enhanced grouper assignment effective for discharges on or after April 1, 2020, corrects the underpayments possible from the original grouper assignment. Other key features include: • eliminating $8 billion in Medicaid disproportionate share hospital payment cuts in FY2020, FY2021 (a $4 billion reduction with implementation of cuts is delayed until Dec. 1, 2020); • extending Medicare and Medicaid programs set to expire on May 22 until Nov. 30, setting up a potential vehicle for legislation to ban surprise medical bills and address prescription drug prices after the 2020 election; • mandating more reporting require-

ments about where drug companies source their materials and allowing the FDA to prioritize drug applications that could help address a shortage; and • covering vaccines that meet certain effectiveness standards with no cost sharing.

Telehealth Shines! In addition to several initiatives, HHS will waive federal licensing regulations so that out-of-state physicians can treat COVID-19 patients through telehealth in states that have large outbreaks. The agency also is helping on the payment front by developing and implementing a new payment rule for federally qualified health centers and rural health clinics that provide telehealth services to eligible patients. Payment rates would be based

on the payment that currently applies to comparable telehealth services under the PFS. In addition, HHS is to issue guidance on using telehealth for home health services. This allows Medicare beneficiaries to use telehealth services regardless of whether they had seen the provider in person in the preceding three years.

Put These Into Your e-Library! On March 20, CMS released two digital telehealth tool kits, one specific to general practitioners (go.cms.gov/2XVuR6p) and the other for providers treating patients with end-stage renal disease. “Each toolkit comprises electronic links to telehealth resources to reduce the amount of time providers spend looking for answers on new regulations,” the agency stated. “The toolkits is structured to help you learn more about the general concept of virtual care, choose telehealth vendors, initiate a program and

develop documentation tools,” and also outline temporary telehealth services that could be implemented during the COVID-19 pandemic. According to CMS's March 17 fact sheet (go.cms.gov/34KhxmN), clinicians could bill immediately for dates of service starting March 6, 2020. Telehealth services are paid under the PFS at the same amount as in-person services. HHS also is waiving certain Medicare telehealth payment requirements to enable telehealth services to be provided in all settings, including a patient's home, and enables Medicare beneficiaries to use telehealth services even if they aren’t in a rural community. A range of health care providers will be able to offer telehealth to Medicare beneficiaries with services including common office visits, mental

health counseling and preventive health screenings. For a list of frequently asked questions regarding the telehealth initiative, visit bit.ly/3bu0JmR. Additionally, CMS issued a MLN Special Edition with more guidelines (go.cms.gov/2VmrjZe) and the subsequent edit to it is published in the MLN Special Edition – Friday, April 3, 2020 (go.cms.gov/2VEZ3jw). Medicaid also has telehealth provisions related to COVID-19 (bit.ly/3eur85J). On April 23, the Trump administration issued its own telehealth toolkit to accelerate states’ use of the technology (bit.ly/ 34ZRTdS). For more information on COVID-19 and telehealth, see page 22.

HIPAA Comments The HHS Office for Civil Rights (OCR) announced it will waive potential penalties for HIPAA violations against health care providers who serve patients through widely available

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered.

Bonnie Kirschenbaum, MS, FASHP, FCSHP

A Reimbursement Lexicon AMA, American Medical Association; CMS, Centers for Medicare & Medicaid Services; DRG, diagnosis-related group; FY, fiscal year; HHS, Department of Health and Human Services; ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification; IPPS, Inpatient Prospective Payment System; PFS, physician fee schedule

communication apps such as FaceTime or Skype. Officials at the OCR said the agency will exercise its enforcement discretion when providers use apps “in good faith” for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to COVID-19. “In support of this action, OCR will be providing further guidance explaining how covered health care providers can use remote video communication products and offer telehealth to patients responsibly,” OCR said. Providers are encouraged to enable all available encryption and privacy modes when using such applications. Officials noted that Facebook Live, Twitch, TikTok and similar video communication applications are public facing and should not be used to provide telehealth services, as reported in Fierce Healthcare (bit.ly/3ewIeQz). ■

Specialty Pharmacy Continuum â&#x20AC;˘ May/June 2020

POLICY

Breakthrough Therapy for Advanced Cholangiocarcinoma Approved

he FDA approved pemigatinib (Pemazyre, Incyte Corp.), the first treatment approved for adults with cholangiocarcinoma that is locally advanced or metastatic and who have tumors that have a fusion or other rearrangement in fibroblast growth factor receptor 2 (FGFR2). â&#x20AC;&#x153;This [accelerated] approval demonstrates that while we continue to focus

our efforts on addressing the COVID-19 pandemic, the FDA remains committed to the important work of reviewing treatments for patients with cancer and other serious conditions,â&#x20AC;? said Richard Pazdur, MD, the acting director of the Office of Oncologic Diseases in the FDAâ&#x20AC;&#x2122;s Center for Drug Evaluation and Research. â&#x20AC;&#x153;With Pemazyre, we considered the observed efficacy

gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy.â&#x20AC;?

A Rare Cancer

results to be clinically meaningful and the overall risk-to-benefit assessment for patients with tumors harboring FGFR2

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Cholangiocarcinoma is a rare form of cancer that forms in the bile ducts. At diagnosis, most patients with the malignancy have advanced disease that is no longer treatable with surgery. For these patients, there have been no FDAapproved therapies; various chemotherapy drugs have been the standard initial treatment, the FDA noted in a statement announcing the drugâ&#x20AC;&#x2122;s approval. FGFR2 fusions have been found in the tumors of approximately 9% to 14% of patients with cholangiocarcinoma. Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading. The drugâ&#x20AC;&#x2122;s approval was based on the results of a clinical trial that enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement, who had received previous treatment. During the clinical trial, patients received pemigatinib once daily for 14 consecutive days, followed by seven days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects. Patients were monitored by scans every eight weeks. The trial used overall response rate (ORR) to measure the number of patients who experienced a complete or partial shrinkage of their tumors during treatment. The ORR was 36%, with 2.8% of patients having a complete response and 33% having a partial response. Of the 38 patients who had a response, 24 (63%) had a response lasting six months or longer and seven (18%) had a response lasting 12 months or longer. The most common adverse reactions occurring in 20% or more of patients who received pemigatinib were hyperphosphatemia and hypophosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain and dry skin. Ocular toxicity also was a risk of pemigatinib. â&#x20AC;&#x153;Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,â&#x20AC;? Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center in New York City, said in a press release from Incyte. â&#x20AC;&#x153;It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.â&#x20AC;? â&#x20AC;&#x201D;SPC Staff

Specialty Pharmacy Continuum • May/June 2020

POLICY

Will COVID-19 Clog Generics, Biologics Pipeline?

he drug pipeline for 2020 is heavy on generics, biosimilars and 505(b) (2) drugs that are slight variations of existing products. But whether those launches will be affected by the ongoing COVID-19 pandemic is a bit more difficult to predict, industry experts noted during an AMCP webinar. A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics. Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said. Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted. Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.

505(b)(2)s and Biosimilars In the Pipeline About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), an oral dopamine receptor agonist for the offperiods experienced by patients with Parkinson’s disease, pending approval in May. Given that 40% to 60% of these patients develop off-periods that can worsen and a transdermal product is seen as more convenient than apomorphine injection (Apokyn, US WorldMeds), this product could be used extensively, Dr. Fish said. This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September;

and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab. “We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.

New Branded Products The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a firstin-class adjunctive therapy for patients requiring additional cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.

Pandemic Pressures The COVID-19 pandemic could affect new drug approvals, Dr. Fish said during a question-and-answer period. The FDA has been back and forth, saying there would or would not be delays, she noted. As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult

now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021. —Karen Blum

The speakers were scheduled to present at AMCP’s Managed Care & Specialty Pharmacy annual meeting, which was canceled because of the COVID-19 pandemic. The organization made the information available via a webinar instead. Other than their employment, the speakers reported no relevant financial relationships.

Specialty Pharmacy Continuum • May/June 2020

POLICY

Marketplace Shakeup continued from page 1

Mr. Long cited prescription abandonment rates as an example of a particularly concerning market trend that could worsen during the COVID-19 pandemic. Bailing on a prescription is primarily a function of cost pressures, he explained: as a patient’s cost exposure rises due to copays and other cost-shifting factors, abandonment skyrockets. IQVIA data show, for example, that when patient out-of-pocket costs reach approximately $250, new patient abandonment rates approach 80%. And it’s not just a problem at the high end: even when patient

Before COVID-19, telehealth was used mostly for treating mental illness, depression and anxiety, whereas more recently it has been adopted for managing asymptomatic chronic conditions such as hypertension, type 2 diabetes and high cholesterol. Overall, telehealth claims were up about 1,000% from March 13 to March 27, Mr. Long said, mainly driven by prescribers who are new to the technology. This mode of care could become a regular part of how outpatients are treated as more people become comfortable with these visits, even after the pandemic resolves.

Vaccines, including those for flu and shingles, helped the business of new therapy starts in 2018 and 2019, particularly in the retail setting, Mr. Long noted. These vaccines made up 6.8 million of 7.5 million new starts in 2018. Other new starts in conditions such as chronic obstructive pulmonary disease, autoimmune diseases, diabetes and atopic dermatitis grew slightly in the same period. During the COVID-19 pandemic, however, fewer vaccines have been administered because more people are staying at home and not going to their doctors’ offices, he said. The top 10 therapy areas, led by antihypertensive agents, mental health and lipid regulators, are growing at about a

New therapy starts, %

5 0.3 0

–5

–4.2

Artificially inflated by Kaletraa, which is being used as a potential treatment for COVID-19 (-8.5% without Kaletra)

–4.7

–8.6

–10 –11.1

–10.7

–11.6

–11.1

–15 Autoimmune

Cholesterol

CKD/ESRD

Depression

Diabetes

Epilepsy

HIV

Hypertension

Figure. Declines in new therapy starts. CKD, chronic kidney disease; ESRD, end-stage renal disease. a

Data analysis through March 27, 2020. Source: Doug Long, IQVIA

costs are in the $50 to $75 range, abandonment rates approach 30%, according to IQVIA data. James T. Kenney, MBA, RPh, a managed care pharmacy consultant and the 2019-2020 AMCP president, who moderated the presentation, agreed that prescription abandonment is a major cause for concern, both before the COVID-19 pandemic hit and beyond. “This is something we worry about, trying to balance the benefit design with the patient’s out-of-pocket costs, and the [IQVIA] data identified a significant percentage abandonment rate starting in the $75 to $125 threshold,” Mr. Kenney said. From a health plan perspective, “you want patients to take the medications as prescribed,” he added. “But in fairness, if new treatments cost $30,000, $40,000 or $50,000 a year, insurers are not necessarily going to offer them at a $5 to $10 copay. There’s an expectation that a patient on a much higher cost medication would have to pay a bit more.”

Explosion of Telehealth Mr. Long discussed one final COVID-19 trend before moving on to a broader look at the health care market: the explosion of telehealth brought on by the pandemic.

A Broader Look Mr. Long discussed medication usage trends for 12 months ending February 2020, noting that specialty growth is outpacing traditional product growth and now has about a 48% share of the total, non-discounted drug spend. In February alone, the specialty spend grew by 10.5% while traditional spend increased just 0.3%, he said. The impact of COVID-19 on these numbers is yet to be seen. Three therapeutic areas have been responsible for two-thirds of the absolute growth and domination of new launches from 2018 to 2019: autoimmune, oncology and diabetes. Anticoagulants also are growing. By contrast, the pain and mental health categories had less volume, in part because mental health has some generics, and it is now harder to get pain prescriptions, Mr. Long said. Adjusted prescription growth rates through February 2020 were up 5%, with a bigger jump projected for March due to more people obtaining 90-day supplies of their medicines. About 90% of prescriptions for 2020 were dispensed as unbranded generics through February.

AbbVie

3% rate, while the top 10 products, led by atorvastatin, lisinopril and levothyroxine, are growing at a 4.8% rate. Real net per-capita spending on drugs grew by only $44 from 2009 to 2018, he added, even while the specialty spend nearly doubled during that time and

traditional spend declined. Generics that were launched in the U.S. market from 2009 to 2018 have generated about $375 billion in cumulative savings.

2020 Rx Pipeline a Bit Murky Drug manufacturers launched a record number of innovative medicines in 2018, bringing 59 new treatment options to patients. According to Mr. Long, 2019 also was a good year, but it is difficult to predict what will happen in 2020, with the FDA slowed down and some manufacturers choosing not to launch their products. The late-stage pipeline was dominated by oncology drugs in 2018, he said, but included specialty and niche therapies across a range of diseases. There have been slight shifts in methods of payment for prescriptions over the past two years, with cash remaining flat, declines among third-party and Medicaid payments, and a continued increase in discount cards, which now make up 4.8% of adjusted prescriptions. Several strong forces are driving changes in health care, Mr. Long noted: a steadily aging population creating more demand for mental health care, home care and assistance; an increasing prevalence of common, chronic diseases; medication nonadherence or noncompliance, which remains the largest avoidable cost for health care systems; rising cost of care and increasing scrutiny around value; and increasing connectivity and health care consumerism. In addition, he said, patients are becoming more involved in their health care decision making and more vocal about about what they want in new therapies. —Karen Blum The sources reported no relevant financial relationships.

Doug Long’s 8 Key COVID-19 Disruptions 1. A sharp decline in physician office visits and lab diagnostics 2. A downturn in new diagnoses and new therapy starts affecting nearly every therapeutic area

3. A surge in telehealth volume (falls short of total lost volume of patient visits)

4. An increase in unemployment that has been pushing more patients onto Medicaid and into economic uncertainty

5. Providers are financially strained due to decreased office and clinic visits, elective surgeries and reimbursement rates

6. Some practices have closed temporarily and physicians have stopped providing any routine care

7. Hospitals have been losing money on COVID-19 treatment; rural locations in danger of closing

8. Patients lack access to health care, diagnostics and surgeries, potentially compromising clinical outcomes

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Specialty Pharmacy Continuum • May/June 2020

OPERATIONS & MANAGEMENT

Even under the substantial pressures of the ongoing COVID-19 pandemic, patient support programs (PSPs) are making significant progress in ensuring access to affordable, timely clinical care. “We’re personalizing therapy regimens, enhancing telehealth capabilities, and providing far more holistic treatment than we were even three months ago,” said Tommy Bramley, PhD, the president of the Lash Group, an AmerisourceBergen company. “We’re understanding more each day just how interconnected health, social, economic and environmental issues are, and how they’re all impacting patients on an individual level.” Still, challenges remain, Dr. Bramley noted. He cited three main concerns that could prove to be roadblocks to health care delivery and innovation— both during the current pandemic and in the uncertain period that will follow.

1. Patient expectations don’t always match up with reality. Consumers often expect full control over who they do business with and the level of information shared during every experience, Dr. Bramley said. “These principles are now shaping patient mindsets and driving expectations in health care.” The trend has been elevated during COVID-19, he said, with more consumers seeking advice, clinical information, testing and care with heightened urgency. Empowered patients want information at their fingertips. When that information isn’t provided to them proactively, they can turn to online channels such as social media. Although these resources can be good avenues to build community or gain emotional support, Dr. Bramley said, they can present challenges for providers. Patients may not understand that their experience with a particular therapy depends on multiple factors, including their age and clinical profile. As patient expectations continue to evolve, he said, “we must adapt patient support services in real time to complement ... growing [patient] empowerment.”

2. Advancements in services don’t always match up with advancements in science. Manufacturers continue to develop complex new therapies, and some patient populations are getting healthier and living longer as a result, Dr. Bramley said. However, some parts of the system lag behind. For example, patients with chronic conditions often need to interact with multiple providers, including primary care physicians, specialists and

behavioral health providers, which can result in health records and data being scattered across sites of care. “To set patients up for success, we must ensure the services and systems we operate within are continuously advancing and innovating at the same rate as science, while still preserving privacy,” he said. PSPs are using tools such as electronic benefit verification and electronic prior authorization, he noted, so now is the time to think of what’s next, such as potential solutions and processes to alleviate barriers for more complex therapies.

3. Hype surrounding technology doesn’t always match up with thoughtful implementation strategies. Technology has dominated health care investments in recent years, Dr. Bramley said, with all players in the industry facing pressure to implement the latest investments. But in the quest for great technology solutions, don’t forget the “ultimate beneficiaries of our investments: patients,” he said. “The goal of technology should not necessarily be to get things done solely through technology but to improve the patient experience throughout the care journey.” Before adding new technology to workflows, he said, consider what value it will bring to patients, what roadblocks to anticipate, and what is required from the rest of the health care system to work effectively. Don’t let hype overshadow utility. “Technology must be leveraged and monitored by experts who can translate data into personalized clinical interventions infused with empathy and human connectivity,” Dr. Bramley said. “By pairing modern technology with regular clinician engagement, we can reach patients on multiple levels to encourage continued adherence.”

Patient Portals Can Help Certain technologies are trending to help enhance the PSP patient experience, which can be extra helpful during the pandemic, said Jon Kwiatkowski, RPh, the director of pharmacy services for Cardinal Health Sonexus Access and Patient Support. Online enrollment portals enable physicians to go online, do a benefit investigation for their patients, and determine whether patients are eligible for commercial PSPs. If they are,

Prescription abandonment, %

Patient Support Programs Adapt With COVID-19 80 70 Actual data

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50 40 30 20 10 0 0

$100

$200

$300

$400

$500

Out-of-pocket costs

Figure. Prescription abandonment increases 0.6% for each out-of-pocket dollar. Source: Covermymeds (bit.ly/2Wlilfi)

physicians can send all information and a prescription directly; if not, they can send patients to the manufacturer’s hub services team to collect any paperwork needed for such programs. Many state boards of pharmacy are moving to mandated electronic prescriptions, Mr. Kwiatkowski told Specialty Pharmacy Continuum, and this allows for submission of the prescription and support program application together more easily.

Real-Time Benefit Checks PSPs also are employing benefit source portals—tools that allow PSPs to perform real-time benefit check (RTBC) verification for patients, individually or in large batches. RTBCs can be a big time-saver during reenrollment time, he said, where instead of spending a 90-day period calling insurers to determine eligibility criteria, they can run a batch of thousands of patients in a day or so. Such technologies help streamline a process that formerly would have required patients to print something out and take it to their doctor to sign, Mr. Kwiatkowski said. These developments enhance the speed to get patients on their therapies and reenrolled in subsequent years. Managed care experts point to another value of RTBCs: The technology is a valuable tool to lower the cost of prescriptions for patients. That’s a critical benefit, given the strong link between out-of-pocket prescription costs and rates of prescription abandonment (Figure). HealthPartners in Minnesota, part of the largest consumer governed nonprofit health care organization in the United States, jumped on the RTBC bandwagon in 2019, and its initial successes show the power of the patient support tool. The goal, according to Lindsey Colbert, RN, the program manager of care

team efficiency at HealthPartners, was to ensure patients leave the doctor with a prescription they can afford, so they don’t become one of the millions of Americans who are nonadherent because of cost. In June 2018, HealthPartners rolled out a “soft live” and data validation phase at two clinics, in which they asked clinicians to run as many medications as possible through the system and called pharmacies to check on the accuracy of the returned pricing. The reaction was mixed: Clinicians were sometimes hesitant to quote pricing to patients, and formulary alternatives didn’t consistently display. But Ms. Colbert and her colleague, Leann McDowell, ßPharmD, the supervisor of pharmacy utilization management at HealthPartners, heard enough positive stories— such as a patient with diabetes whose monthly cost for one prescription went from $200 to $15 after her doctor ran drugs through the RTBC system—that they decided to roll it out further. More than 66% of queries involving insurance plans administered by HealthPartners via its expanded RTBC initiative returned information about alternative, often lower-priced medications, as previously reported in Specialty Pharmacy Continuum (bit.ly/2YTCQl9). When clinicians receive alternatives, Dr. McDowell said, approximately 30% change the prescription. “So we are seeing some positive change.” —Karen Blum and Alison McCook Dr. Bramley’s comments were culled from presentation materials he was scheduled to present at Informa Connect’s Patient Assistance and Access Programs 2020 conference in March, which was postponed until August because of COVID-19. The Lash Group provided the materials to Specialty Pharmacy Continuum. Mr. Bramley and Mr. Kwiatkowski reported no relevant financial relationships other than their stated employment.

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Specialty Pharmacy Continuum • May/June 2020

OPERATIONS & MANAGEMENT

The Time Is Now for Nonopioid Pain Modalities Alexandria, Va.—Our health care system needs to look beyond prescribing opioid medications for pain to consider a range of modalities based on patient preferences, speakers said at the 2020 Opioid Management Summit. “We’re not saying you can’t take opioids,” said Cheri Lattimer, RN, BSN, the executive director of the National Transitions of Care Coalition, a nonprofit organization dedicated to raising awareness about transitions of care among health care professionals. “When you have a catastrophic injury or cancer, where pain has to be controlled by medications, we don’t want to take that away. But how can we give more options to individuals, whether the patient is an adolescent with a sports injury, a veteran or a senior?” On average, 130 Americans die every day from an opioid overdose, Ms. Lattimer said, citing CDC statistics (bit.ly/39G5YxW). This includes both prescription opioids and illicit drugs, she said. Part of the problem stems from a lack of education, and U.S. patients believing they should not have any pain. The fastest-growing population taking opioids is adults aged 65 years and older, Ms. Lattimer added, and most seniors are largely unaware of their options for pain management beyond what their doctors suggest. Providers need to alter their management of pain to factor in patient preferences, social determinants of health, behavioral health and additional modalities, she said. Complicating the issue, nonopioid therapy options may be outside bundled payments, resulting in higher patient copays—or not covered at all. CDC guidelines and the National Pain Strategy are very open to nonpharmacologic care to help address the overuse of opioids, said chiropractor Sherry McAllister, MS (Ed), DC, the executive vice president of the Foundation for Chiropractic Progress. Complementary pain therapies include spinal manipulations by chiropractors, yoga, massage, acupuncture and physical therapy. “The Joint Commission, American Pain Society and American College of Physicians all want us to go with nonpharmacological options of pain control if possible, and to have discussions with patients,” Dr. McAllister said. Emerging research is demonstrating the benefits of some of these therapies in pain management, she said, including a three-part series published in the Lancet (www.thelancet.com/series/low-backpain), suggesting spinal manipulation

as a recommended approach to manage low back pain (2018;391[10137].doi. org/10.1016/S0140-6736(18)30725-6). Another paper in JAMA Network Open (2018;1[1]:e180105) demonstrated that chiropractic care, when added to usual medical care, resulted in moderate short-

modalities such as virtual physical therapy. The goal would be to determine whether such treatments could help improve patient outcomes and result in less opioid use among those enrolled. The specifics are still being discussed, Dr. Sherman said, but could be particularly helpful during the COVID-19 pandemic with people staying home. The insurer also is looking into exercises to promote mindfulness to improve how people cope with pain, conducting trainings for some members and employees, and making lessons

130 Americans die every day from an opioid overdose.

Payors and providers are encouraging the use of a variety of nonopioid pain treatments, including physical and occupational therapy, electrical stimulation, chiropractic manipulations and phonopherosis, which uses electrical currents to deliver topical medication through the skin.

term improvements in low back pain intensity and disability among active duty military personnel. Specifically, adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone for low back pain intensity (mean difference, –1.1; 95% CI, –1.4 to –0.7), disability (mean difference, –2.2; 95% CI, –3.1 to –1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1-2.8). Health plans are becoming increasingly interested in alternative pain paths, commented Michael Sherman, MD, MBA, the senior vice president and chief medical officer for Harvard Pilgrim Health Care in New England. “We’re very interested in some of the newer modalities of treating pain, specifically [modalities] that are nonopioid,” he said. For example, his company is exploring the launch of a trial of a mobile app that would educate patients about nonopioid

available virtually. It is also studying a biofeedback device that may help people alter how they respond to pain. “There is very much a willingness to look at these kinds of new approaches,” Dr. Sherman said.

Plan Covers Wide Range Of Alternative Therapies Highmark Health, an integrated delivery network in the Pittsburgh area, covers a range of modalities for pain management among its different plans, said Caesar DeLeo, MD, the company’s executive medical director and vice president of strategic initiatives. These include physical and occupational therapy, electrical stimulation and transcutaneous electrical nerve stimulation therapy, chiropractic manipulations, and phonophoresis, which uses electrical currents to deliver topical medication through the skin. Some plans cover acupuncture or

offer a discount to a network of providers offering acupuncture, tai chi, massage and other alternative therapies, or cover trigger point injections to treat painful areas of muscle, Dr. DeLeo said in a phone interview. In addition, the network includes pain management centers of excellence where some members are referred for nerve blocks, behavioral therapy and other treatments. In other tactics, the company has promoted CDC guidelines for safe prescribing of opioids, set prior authorization limits for initial duration of opioid prescriptions, and encouraged parents to talk to oral surgeons before their children are prescribed opioids for wisdom tooth extraction, he said. —Karen Blum The sources reported no relevant financial relationships.

Specialty Pharmacy Continuum • May/June 2020

TECHNOLOGY

Digital Therapeutics continued from page 1

their care, said Theresa Juday, RPh, the director of specialty product for CVS Health, during a webinar on understanding this emerging product class. “All of us in managed care pharmacy are really focused on” considering a patient’s unique needs to personalize their care, Ms. Juday said. “Digital therapeutics can help accomplish that in a number of ways, such as providing care based on the patient’s schedule and in their setting.” These remote therapies “are critically important in today’s COVID-19 world, when patients can’t get to a physician’s office,” she stressed. In April, the FDA issued guidance to more readily allow the distribution of computerized behavioral therapy and other digital therapeutic devices for psychiatric and mental health disorders during the pandemic (bit. ly/34Y0VrS). The use of these tools “may improve mental health and wellbeing of patients with psychiatric conditions during periods of shelter-inplace, isolation, and quarantine,” the FDA wrote in its guidance (box). The technology, the agency added, has the potential to facilitate social distancing and ease the burden on hospitals and care providers. Several companies, such as Akili Interactive, jumped at the opportunity. Shortly after the FDA guidance was issued, the firm released Endeavor, a digital attention treatment for children with attention deficit hyperactivity disorder delivered via a video game. Akili is offering it free for a limited time to qualifying families, said Jeff Abraham, MBA, the company’s vice president for market access and trade, at a virtual press briefing on digital therapeutics. In a company trial, Akili gave AKL-T01 or a similar tablet-based game that used different stimuli to 348 children aged 8 to 12 years old. After four weeks, patients using AKL-T01 showed improvements based on an attention

performance index, which was the study’s primary end point (P=0.006). “Because of the pandemic situation and we don’t know the future, there is a need for us to find alternatives to what our traditional medical system was using,” Mr. Abraham said. “We may not be getting back to that anytime soon.”

Addiction Medicine Yuri Maricich, MD, the chief medical officer at Pear Therapeutics, said some digital therapeutics provide an option for patients who otherwise may not have a solution. For example, products offered by his firm manage addiction to cannabis, cocaine and other stimulants “for which there are no therapies approved,” he said. “The only option they have now is a prescription digital therapy.” Usage records reviewed by his company indicate patients are using the therapies for addiction around the clock as they need them, not just during 9-to-5 office hours. “That’s a really unique thing right now in the time of COVID,” Dr. Maricich said. Defining value, making sure all stakeholders are educated on proper use of the therapies, and evaluating the technologies present ongoing challenges, speakers noted. “This is basically a new way of providing medicine, and evaluating that can be challenging,” Mr. Abraham said. “For some of these products, there’s not going to be a comparator.” The digital therapeutics space is “exciting, but also chaotic, because there are hundreds of thousands of solutions available for patients and payors today,” said Mark Bini, MBA, the chief patient experience officer at the pharmacy benefit manager Express Scripts, during the press briefing. “This poses a problem for [determining] what works and what doesn’t.” Last December, the company launched a digital health formulary, which works like a drug formulary, to help its clients

Digital Devices Are FDAApproved for 8 Mental Health Conditions 1. Obsessive-compulsive disorder 2. Generalized anxiety disorder 3. Insomnia disorder 4. Major depressive disorder 5. Substance use disorder 6. Post-traumatic stress disorder 7. Autism spectrum disorder 8. Attention deficit hyperactivity disorder

Akili Interactive’s AKL-T01 digital medicine program uses the same storytelling and reward mechanisms as standard video games—but adds algorithms that dial the level of stimuli up or down to meet the needs of the patient.

evaluate digital health solutions based on their clinical effectiveness and usability, and negotiate value and return on investment. The first cohort of products includes solutions for diabetes, pulmonary conditions, cardiovascular and behavioral health, with plans to expand to women’s health, oncology, inflammatory conditions and musculoskeletal disorders. “People confined to their homes during the COVID-19 pandemic can really benefit from having a solution in the palm of their hand,” Mr. Bini said. An Express Scripts review of its mental health claims data showed a 21% or higher increase in usage of antidepressants, antianxiety and insomnia medications from mid-February to mid-March 2020, Mr. Bini said. “While there are medications that can help treat these conditions, we also believe there are digital solutions we can put in the hands of people to help manage these conditions, as well.”

Start Where You Are There is no need to reinvent the wheel when evaluating these products, said Patty Taddei-Allen, PharmD, the senior director of clinical analytics at WellDyne, a pharmacy benefit manager. “We already have processes in place to evaluate premarket medications, so a similar framework should shou be applied when evaluating dig digital therapeutics,” she said during a webinar. Important factors to consider safety and efficacy, Dr. iinclude in clude safe Taddei-Allen Taddei-Alle said. There may not be a randomized controlled ra trial, but there should be peerreviewed literature that review evaluates products based on evaluat parameters. Also conthese p benefit coverage, which sider be require conversations may req with a cclient on improving altering their benefit plan or alterin Finally, patient access design. Fin and usability must be considered, along with product safety and security.

Companies can employ comparative effectiveness research methods when evaluating digital therapeutics, Dr. Taddei-Allen noted. Online tools are available to help synthesize a body of evidence that exists for a particular product. In addition, managed care organizations may have extensive access to medical and administrative claims to allow them to conduct ongoing observations of how a digital therapeutic is working. Digital therapeutics face an additional hurdle: There is not yet a formulary evaluation framework that is widely accepted by most organizations. “In fact, they may not have a process in place to evaluate these products or even know they exist,” Dr. Taddei-Allen said. Decisions also need to be made whether to place the products under the medical or pharmacy benefit, which may affect beneficiaries’ share of the cost. In addition, many organizations lack the infrastructure to collect clinical outcomes associated with digital therapeutics. Ongoing evaluation is key for these therapeutics, Dr. Taddei-Allen said. “Postmarket surveillance is required, but there are not many reports of that occurring,” she said. “If possible, organizations should collect and review clinical outcomes and determine if the outcome is due to the digital therapeutic or any other confounding variables. It takes a lot of education. There’s a lack of understanding among providers, patients and plan sponsors on where digital therapeutics fit in the care of patients.” —Karen Blum Ms. Juday’s presentation was supported by an unrestricted educational grant from Novo Nordisk, Inc. The remaining sources reported no relevant financial relationships other than their stated employment.

Specialty Pharmacy Continuum • May/June 2020

TECHNOLOGY

Leveraging Telehealth in the Time of COVID-19 Lake Cumberland Pharmacy, in rural Russell Springs, Ky., operates in the epicenter of the nation’s opioid epidemic. Incidence rates there of acute hepatitis C virus (HCV) infections, largely contracted through dirty needles, are more than twice the national average. The pharmacy’s owner, Jonathan Grider, PharmD, estimates the 10-county Lake Cumberland district he serves has 15,000 patients with untreated HCV. He expanded his five-year-long relationship with St. Matthew’s Specialty Pharmacy—a Louisville provider two hours away by car and the only independent specialty pharmacy in the state accredited by both URAC and the Accreditation Commission for Health Care (ACHC)—in May 2019, to together bring necessary medical care and pharmaceutical treatments to these patients. That’s when Dr. Grider enlisted telehealth technology to establish a virtual mini-clinic at Russell County Hospital, a 25-bed acute care facility much closer to his store and where the patients live. He has used Zoom and GoToMeeting so far, but expects to shift soon to the ERxDirect platform as soon as it is available to the 1,800 pharmacies within EPIC Pharmacies’ (Nottingham, Md.) managed pharmacy network, possibly by July. Dr. Grider arranged for hepatologist and gastroenterologist Bennet Cecil, MD, to conduct 25 telesessions from his Louisville practice office every other Tuesday. Patients infected with HCV go to an outpatient clinic on hospital grounds for the virtual sessions. Dr. Cecil also commutes to this facility on alternate Tuesdays to conduct in-person

appointments with his large cohort of geographically distant patients. Summaries of each telesession help Dr. Grider deliver personalized pharmaceutical care in collaboration with the physician. He said the ERxDirect platform will help him delve more deeply into the complex carerequired by these patients by providing ready access to their health records. The system also offers transparent drug pricing information that he noted is so valuable for high-cost specialty medications, and also provides billing codes and support for his collaborative practice agreements with providers. The virtual telemedicine setup also supports full digital medical instrumentation, including tele-stethoscopes, fundus cameras to detect eye disease, and otoscopes to examine ears. Dr. Grider is convinced the health care team he pulled together is improving care for a vastly underserved population “that would otherwise be left untreated because of few convenient care alternatives. Our upcoming annual review will make data available.” A study funded by the CDC (bit.ly/ 2Wez5Uc) showed that 95% HCV treatment success rates are common

In the ERxDirect platform, patients sit in a virtual clinic where they video-chat with remote providers.

since 2018—a finding that sparked Dr. Grider to consider using the ERxDirect system to identify and engage more patients who are infected with HCV. “Kentuckians hate ordering refills by a 1-800 number. They want to feel closer to their pharmacist,” he said. The ERxDirect station in the hospital clinic could attract up to 40 patients daily for telesessions with Dr. Cecil and other distant medical providers in other specialty care areas such as rheumatology, oncology and mental health, Dr. Grider said. The system will ping him when necessary to log in to ERxDirect promptly on his store’s computer for virtual medication consults with these patients. “We could potentially build a

Community Pharmacies Also Beneficiaries of Telehealth h

rian Slusser, the cofounder of ERxDirect, sees the technology playing ying a pivotal role not only in mini-clinics in rural hospitals, but also in comommunity pharmacies during the current COVID-19 pandemic. Mr. Slusser said he sees telemedicine as important to “better outcomes es of complex patients in the COVID-19 period because it puts a professional’s eyes on them and builds trust more than phone calls. They’re sheltered in place stockpiling 90-day supplies of medications that get delivered, yet they may experience adverse reactions or dosage or stor-age questions that require answers given in a personal way. Our platform positions community pharmacists as members of the health care team focused on outcomes instead of just as suppliers of medications, and could ould set a path for them to eventually be paid for patient consultations.” —A.H.

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stream of new complex-care patients through these virtual sessions,” he said. Dr. Grider already is replicating what he did with Dr. Cecil for HCV at two other hospitals, one in May 2020 and the other on July 1, depending on COVID-19 public restrictions. “It’s hardest for us to get patients to their first virtual visit with the doctor. Once they do that, they comply 90% of the time, and that means a predictable revenue stream for the pharmacy,” he added. Autumn Zuckerman, PharmD, the program director of specialty pharmacy at Vanderbilt University Medical Center, in Nashville, Tenn., called Dr. Grider’s efforts “a really incredible opportunity to bring health care to a rural/ underserved environment. Specialty pharmacy telehealth in this population can improve patient access and adherence to treatment, and significantly help address a disparity in our ability to end the HCV epidemic. “Patients often have several comorbidities requiring several medications. Being able to view the [electronic medical record] and connect with patients virtually enables pharmacists providing telehealth to better assess the clinical appropriateness of medications.” —Al Heller The sources reported no relevant financial relationships.

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Specialty Pharmacy Continuum (May / June 2020)

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