Specialty Pharmacy Continuum - September / October 2021

Serving managed care, health-system and specialty decision makers Volume 10 • Number 5 • September/October 2021 • specialtypharmacycontinuum.com

Is Rx Utilization Worth It at $100 Billion/Year?

D

CLINICAL

Boosting adherence to oral chemotherapy .....

3

Balancing risks of chemo and COVID-19 ......

4

Can psychotropics tame COVID-19 symptoms? .....

6

The changing paradigm of new HIV therapies .......

8

OPERATIONS & MGMT Hospital-at-home model gains traction .....

12

HOSP alliance: strength in numbers ..........................

14

POLICY

A glimpse at 2022 Medicare reimbursement ...............

20

Key steps for becoming an ‘outcomes powerhouse’

Health Systems Prove Value In Specialty Care

rug utilization management programs cost physicians, patients, drug manufacturers and payors who impose these programs a collective $93.3 billion annually, according to a new report published in Health Affairs.

The authors, led by Scott Howell, the chief strategy officer of U.S. pharmaceuticals at Novartis, reviewed the literature and found that patients spend approximately $35.8 billion annually in drug cost sharing; physicians devote approximately $26.7 billion in administrative time; manufacturers spend about $24.8 billion supporting patient access; and even the payors, who are trying to reduce costs, spend approximately $6 billion each year on administering u t i l i za t i o n management programs (doi.org/ 10.1377/ hlthaff.2021.00036).

Noting that the United States spent approximately $409 billion on retail and nonretail branded drugs in 2019, they called the $93.9 billion outlay on utilization management “one of the most counterproductive uses of resources in the U.S. health care system,” and suggested that all stakeholders would benefit from a deescalation of drug utilization management, combining lower drug prices with lower barriers to patient access.

“A broader exchange of value-based price for value-based access would permit a reduction in spending on the creation and countering of utilization management,” Mr. Howell and his co-authors wrote. “It would reduce administrative burdens and frustrations for physicians while improving access and health outcomes for patients.”

How did they get to these figures? The investigators started with a comprehensive review of the available peer-reviewed literature, industry reports and “other documents.” Then they compiled estimates of spending related to drug utilization management based on the 22 publications that had what they considered to be the most reliable data and methods, covering a wide range of utilization categories.

(For more details, see sidebar.)

ith third-party payors and pharmaceutical manufacturers often requiring that specialty pharmacies obtain accreditation from multiple accrediting bodies, there’s a new player in the space: the National Committee for Quality Assurance (NCQA).

“Specialty pharmacy is growing, both nominally and as a percentage of total pharmacy spend, and we felt that this is [an opportunity] for expansion,” said Brad Ryan, MD, NCQA’s chief product officer. “For some time, we’ve had

Continued on page 16

Continued on page 13

C

ompared with other types of specialty pharmacies, those based in health systems have superior access to patients and providers, as well as information in medical records, speakers said during a session at the virtual 2021 ASHP Specialty Pharmacy Conference.

These factors can be leveraged to demonstrate value to various stakeholders.

“Metrics commonly used to measure specialty pharmacy services today focus mostly on operational requirements,” said Amber Skrtic, PharmD, CSP, AAHIVP, a clinical pharmacist with Trellis Rx at Continued on page 10

A new option in a crowded field

NCQA Launches Specialty Pharm Accreditation

W

More COVID-19 Coverage: CDC, ACIP at odds over who should get COVID-19 booster.

Page 22

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3

Specialty Pharmacy Continuum • September/October 2021

CLINICAL

Increasing Patient Adherence to Oral Chemo With more than 115 oral agents approved by the FDA to manage different types of cancer, oral oncolytics “have solidified their place in cancer treatment,” a pharmacist said at the virtual 2021 ASHP Specialty Pharmacy Conference.

However, patients must remain adherent to these therapies to maximize their effectiveness, and that’s where a collaborative effort between clinical and specialty pharmacists can have a significant impact.

There are many barriers to adherence, such as low health literacy, complex administration instructions, challenging adverse effects and high out-of-pocket costs, said Eve Segal, PharmD, BCOP, the lead clinical pharmacist at the University of Washington Medical Center/Seattle Cancer Care Alliance, during a clinical gems session. Specialty pharmacists can keep tabs on patient adherence through methods such as patient self-reports, prescription refill history, monitoring plasma levels or using medication event monitoring systems.

Unfortunately, it’s challenging to identify which strategy should be used for oncology patients, given that most data are available only in clinical trial settings, Dr. Segal said. “Ideally, a medication adherence [program] will be costeffective, user-friendly, easy to administer, highly reliable, flexible and practical. But keep in mind there is no gold standard.”

Strategies to improve adherence are not well established, Dr. Segal noted, but they should begin with patient education. Such

education can provide valuable information to patients, emphasize the benefits of remaining adherent to therapy and reduce patient anxiety. Nonadherence to oral oncolytics often is caused by symptom burden, she said; when this is the case, patients benefit from routine adherence checkups. Other strategies to use include low- and high-tech reminders, such as pill boxes and smartphone apps to address patient forgetfulness.

Materials to review during patient counseling should include the following types of information: • diagnosis; • course, duration and schedule of treatment; • drug–drug and drug–food interactions; • adverse effects; • when to contact the health care team or seek immediate attention; • safe handling and disposing of medications; and • plans for follow-up care.

Because these sessions are “jammed with a lot of information,” Dr. Segal said, routine assessments for patient adherence and drug toxicity are imperative.

Patients also should know how to obtain their medication and the role of the

specialty pharmacy and financial assistance.

Closing the Loop An integrated, closedloop, pharmacist-led oral chemotherapy management program can be an effective tool for managing these challenging patients, according to a team at the University of North Carolina (UNC) at Chapel Hill Medical Center. In 2014 to 2015, Benyam Muluneh, PharmD, BCOP, CPP, an assistant professor of pharmacotherapy and experimental therapeutics at the UNC Eshelman School of Pharmacy, helped set up a process by which patients with cancer prescribed oral chemotherapy drugs were seen in clinic by pharmacists and received their medication directly from the university’s specialty pharmacy. In the clinic, pharmacists saw patients directly after the physician, educating them about their therapy and the importance of adherence and doing a full medication review and clinical assessment. Next, the clinical pharmacists sent the prescription to the specialty pharmacy and served as a liaison, letting the pharmacy know whether to expedite the medications and about any social determinants of health to consider when delivering the drug, such as if a patient was homeless or needed instructions to be translated to a different language. The clinical pharmacists continued to follow

EDITORIAL BOARD

Jason Borschow President & CEO Abarca Health Florida and Puerto Rico

SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA Consultant Specialty Pharmacy Rocky Hill, CT Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL Rina Shah, PharmD Vice President, Pharmacy Operations Walgreens Chicago, IL

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patients throughout their care via clinic visits or phone calls, and ensure drugs and doses were still appropriate.

With the pilot program, patients’ comprehension of oral chemotherapy increased from 43% to 95%, Dr. Muluneh said. Adherence rates were 86% among gastrointestinal and breast cancer patients, and nearly 95% among hematologic oncology patients. The program also resulted in a higher molecular response rate—83%— in patients with chronic myeloid leukemia than published clinical trial rates of 40% to 60%, noted Dr. Muluneh, who is a co-author of the Hematology/Oncology Pharmacy Association’s “Best Practices for the Management of Oral Oncolytic Therapy” guideline in 2018.

With the recent “explosion of oral oncolytics” in the market, Dr. Muluneh is looking to expand and optimize the adherence intervention to include newer drugs, and to improve adaptability and sustainability. “Stay tuned,” he said.

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Volume 10 • Number 5 • September/October 2021

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4

Specialty Pharmacy Continuum • September/October 2021

CLINICAL

Navigating copays, financial assistance also a challenge

Balancing the Risks of Chemo Rx and COVID-19 Sarah E. Slater, PharmD, BCPS, BCOP Clinical Pharmacist, Hematology and Oncology Northwestern Medicine Chicago, Illinois

Amid the COVID-19 pandemic, oncology practices must grapple to balance 2 deadly diseases, also considering that oncology patients are at high risk for COVID-19.

The effort to cure or palliate a patient’s cancer is tempered with a grave understanding that oncology care practitioners must not cause additional harm by unnecessarily exposing an individual to another illness associated with high mortality. These realities weigh heavily on the minds of health care professionals working with oncology patients.

The Expanding Role Of Oncology Pharmacists Oncology pharmacists—with an extensive understanding of drug mechanisms, interactions, dosing, adverse effects (AEs), adjustments for toxicity, administration, and dosage forms—are vital members of oncology teams. Such knowledge puts oncology pharmacists in a unique position to be an expert resource for the oncology team and to provide exceptional counseling for patients beginning new anticancer regimens.

The number of oral oncolytic regimens has grown dramatically in recent years. In 2020, of the 53 novel FDA drug approvals, 10 were oral anticancer therapies.1 This trend is expected to continue, as 6,504 different anticancer drugs are reported to be in the pipeline as of 2020, with 8 of the top 10 indications of all pipeline drugs being in oncology. In addition, global spending on oncology therapeutic medicines is expected to grow 10% to 13% per year and may exceed $200 billion per year by 2022.2,3 There is a tremendous responsibility to ensure that these therapies are used judiciously and achieve optimal outcomes for patients, health care workers, and society.

Converting to Oral Oncology COVID-19 has caused a significant shift in several areas of oncology practice, most notably the reduction of patients coming into the clinic and the rise of telehealth. One strategy that facilitates this is the conversion from infused medications administered in a clinic setting to oral oncology therapies that can be taken at home.

Oral Regimens Are Not Risk-Free

Most patients prefer oral oncology regimens due to ease of administration, convenience, and the perception of fewer AEs. Although many oral anticancer therapies are associated with less neutropenia

and less nausea and vomiting than traditional IV chemotherapy, they are not without significant risks (Table). Grade 3 and 4 neutropenia is seen commonly in patients taking CDK4/6 inhibitors and oral temozolomide. Certain oral anticancer regimens carry a moderate to high risk for nausea and vomiting, in addition to a variety of other AEs. To mitigate those AEs, patients receiving these agents need extensive counseling and close monitoring from their doctors and pharmacists.

Those risks have weighed heavily on oncologists when selecting new regimens for patients who have progressed on their current anticancer therapy. Through shared decision making, oncologists and patients frequently choose oral over IV regimens. Many patients who are stable on their regimens also have been switched to oral therapies. Patients with multiple myeloma receiving either IV or subcutaneous bortezomib as maintenance therapy are good candidates to switch to the oral proteasome inhibitor ixazomib (Ninlaro, Millennium). Certain IV fluorouracil regimens can be replaced by capecitabine.

A Challenging Switch

Oral regimens tend to be complex; thus, switching to oral anticancer therapy is not appropriate for every patient, especially those who are at higher risk for nonadherence. Oral regimens often involve cycles that must be tracked, differing numbers of pills at given points in the day or week, multiple strengths that must be taken at the same time, the need for a particular medication to be taken with or without food, and interactions with other medications the patient may be taking. In addition, many of these agents are considered hazardous by the Occupational Safety and Health Administration and require special care to prevent exposure to other household members.

Beyond the complexity of oral anticancer regimens, administrative barriers can make switches challenging. First, nearly all these therapies require prior authorizations (PAs), which require significant staff time. PAs also routinely require follow-ups, as well as appeals if the original prior authorization is denied. Second, once a prior authorization is approved, these agents must be filled by a specialty pharmacy, often at the insurer’s preferred specialty pharmacy, given their complex

Table. Common Adverse Effects That Can Occur With Oral Oncolytics nature and limited distribution contracts.

On top of the logistics, patient copays for these therapies can range in the thousands of dollars per month, making them unattainable for most. Those patients must then receive evaluation to assess whether they qualify for financial assistance through grants or manufacturer financial assistance. Applying for financial assistance frequently requires tax documents from the patient and signatures from both the patient and oncologist on the application. This process can be cumbersome and timeconsuming under normal circumstances, but it has been compounded by high volumes of patients filing for assistance concurrently during the pandemic.

To limit exposure, oncology pharmacists at our institution have switched their oral and subcutaneous anticancer counseling to telephone encounters. Strong communication skills are required to appropriately explain these complex regimens, such as those that require self-injection at home. Normally, a nurse or pharmacist would provide a teaching session on those therapies in the clinic, but now they must describe the regimens over the phone, supplementing with a link to an instructional video on subcutaneous injections.

We also can email educational handouts to patients in addition to the paper handouts supplied with the medication.

Remote monitoring also presents new challenges during the pandemic. To reduce exposure of health care workers, many oncologists are forgoing some recommended monitoring for patients who are considered to be at low risk for complications. Decreasing the number of blood draws required, refraining from taking baseline ECGs or echocardiographs in patients with no cardiac history, and increasing the time between monitoring CT scans or MRIs have all been employed. However, we cannot delay all monitoring for these high-risk medications. In some cases, patients who refuse monitoring for fear of personal interaction with the health care system have had their therapies suspended.

These patients tend to be on maintenance therapy, where the risk of holding therapy is lower than in an individual with rapidly progressive disease.

Arrhythmias Electrolyte abnormalities Gastrointestinal toxicity Hand-foot syndrome Hyperglycemia Hypertension Mood disturbances Myelosuppression Nausea and vomiting Neutropenia Renal and hepatic dysfunction QTc prolongation Venous thromboembolism

Conclusion COVID-19 has produced extensive changes in the oral anticancer therapy setting and in oncology practices. It has forced the industry to adapt to significant challenges to oncology care, such as social distancing requirements, avoidance of IV therapies, and monitoring difficulties. Remote work for staff and telehealth for patients has proven to be a viable, workable option during the pandemic, and I expect it will continue in the future.

These changes in practice should be embraced and considered for incorporation into long-term strategies to provide the best possible care for patients.

References 1. FDA. Novel drug approvals for 2020. Accessed September 22, 2021. https://www.fda.gov/ drugs/new-drugs-fda-cders-new-molecularentities-and-new-therapeutic-biological-products/novel-drug-approvals-2020 2. IQVIA. Global Oncology Trends 2018. Published May 24, 2018. Accessed September 22, 2021. https://www.iqvia.com/insights/ the-iqvia-institute/reports/global-oncologytrends-2018 3. Lloyd I. Pharma R&D Annual Review 2020.

PharmaIntelligence Informa. Published March 2020. Accessed September 22, 2021. https:// pharmaintelligence.informa.com/~/media/ informa-shop-window/pharma/2020/files/ whitepapers/pharma-rd-review-2020-whitepaper-updatelr.pdf

Northwestern Medicine is a member of the Excelera Network, a nationwide network of leading US health systems with owned specialty pharmacies.

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6

Specialty Pharmacy Continuum • September/October 2021

CLINICAL

Could Psychotropic Drugs Treat COVID-19?

In the search for effective treatments for COVID-19, researchers archers in the United States and Europe are following a new lead: d: antidepressant and antipsychotic medications such as fluvoxamine, amine, fluoxetine and aripiprazole.

Research into these medications as COVID-19 therapies is still in the early stages, with just one randomized controlled trial published in a peerreviewed journal as of June 2021, but several larger trials are underway evaluating these agents as potential therapies.

“There’s more unanswered questions for me than there are answers,” said Lawrence Cohen, PharmD, BCPP, now retired from a professorship in pharmacotherapy at the University of North Texas Health Science Center College of Pharmacy, in Fort Worth, and an emeritus professorship in pharmacotherapy at Washington State University College of Pharmacy and Pharmaceutical Sciences, in Spokane.

Basic science research and genomic analyses suggest antidepressant and antipsychotic drugs could benefit patients with COVID-19 by triggering anti-inflammatory or antiviral responses. In preclinical models, fluvoxamine’s action as a sigma-1 receptor agonist reduced inflammation damage and mitigated cytokine storms in mice with sepsis (Sci Transl Med 2019;11[478]:eaau5266).

Another study found six different antidepressants could inhibit acid sphingomyelinase that plays a role in helping the SARS-CoV-2 virus enter epithelial cells (Cell Rep Med 2020;1[8];100142).

Furthermore, a genomic analysis found that 21.7% of the genes altered by aripiprazole also are changed in COVID-19 patients; in 94% of cases, those genes had their expression reverted by aripiprazole, which according to the authors suggests the drug could have a protective effect against COVID-19 (Front Pharmacol 2021;12:646701).

Observational studies provide an inconclusive picture of how patients with psychiatric illness fare against COVID-19. A 2020 cohort study indicated patients with psychiatric disorders were more likely to die from COVID-19 than other patients treated at the Yale New Haven Health System, in Connecticut (JAMA Netw Open 2020;3[9]:e2023282). A study in Spain found patients with severe mental disorders who were taking antipsychotic agents showed a lower risk for SARSCoV-2 infection. If they did become infected, they were less likely to be admitted to the hospital or ICU, or to die (Schizophr Res 2021;229:53-54).

Nicolas Hoertel, MD, PhD, MPH, an associate professor of psychiatry at the University of Paris, AP-HP, and the

National Institute for Health and Medical Research, said he becamee interested in antidepressant medications ns as possible COVID-19 treatments early in the pandemic after noticing almost st no cases of COVID-19 among his elderly rly patients with depressive and anxiety disorders, isorders, in contrast to rising case numbers bers among other hospital patients and staff. aff.

So, he and his colleagues conductnducted an observational, multicenter, nter, retrospective study at AP-HP HP Greater Paris University Hosospitals (Mol Psychiatry 2021 Feb 4. doi:10.1038/s41380-021-01021-4).

1021-4).

Of the 7,230 adults hospitalized ized for COVID-19 in the AP-HP hospital pital system, 345 (4.8%) received an n antidepressant within 48 hours off hospital admission. The team found a significant association between antidepresntidepressant use and a lower risk for intubation or death (hazard ratio, 0.56; 6; 95% CI, 0.43-0.73; P<0.001).

These encouraging findingss also were seen in the early results of a double doubleubleblind, randomized controlled olled lled trial looking at fluvoxamine as a COVID-19 C treatment. In spring 2020, rese researchsearchers from Washington University ersity ty in St. Louis had quarantining COVID-19 D-19 patients take 100 mg of fluvoxamine ine or a placebo three times per day for 15 days (JAMA 2020;234[22]:2292-2300).

By the end of the study, the researchers had 152 participants, consisting of 80 who received fluvoxamine and 72 who received placebo. None of the patients in the fluvoxamine group showed respiratory deterioration, compared with six patients in the placebo group (estimated absolute difference, 8.7%; 95% CI, 1.8%-16.4%; P=0.009).

Angela Reiersen, MD, MPE, an associate professor of psychiatry and one of the study authors, said she was surprised that no patients in the fluvoxamine group deteriorated. Now, Dr. Reiersen and her colleagues are analyzing the results from a larger, nationwide study of fluvoxamine in COVID-19 patients, although they have struggled to recruit patients for the follow-up study as vaccination rates rose across the country this spring.

The University of Washington study is limited by its small size and low number of end point events, and experts question its significance. “The results were not spectacular in any way,” Dr. Cohen told Specialty Pharmacy Continuum. Yousef Lafi, PharmD, BCIDP, an assistant professor of clinical sciences at the Keck

Graduate duate Institute School ol of Pharmacy and Health ealth Sciences, in Claremont, mont, Calif., noted that the entirely remote trial also relied on patients to report port their symptoms and that about 20% of the patient patients did not complete the final survey.

More studies aree needed to evaluate the clinical benefit of ant antipsychotic and antidepressive agents, if any, in patients with COVID-19, Dr. Lafi said. Further research also would need to take into consideration the adverse effect profile of these agents, he added.

Other researchers have been looking closely at fluvoxamine. The University of Minnesota–based COVID-OUT Trial (covidout.umn.edu) has been examining the drug, as has the international Together Trial (www.togethertrial.com).

Interim results from the Together Trial suggested fluvoxamine reduced the risk

for disease progression pr by 29%, noted lead investigator Edward Mills, PhD, Ph of McMaster University, Hamilton, Ontario, at a National in H Institutes of Health meeting in early In August (httpbit.ly/3B2sWgP). The results have not been published yet.

Dr. Reiersen and her co-investigators plan to publish the results of their larger nationwide study once they are available, but in the meantime, she said, “I’m not recommending for or against fluvoxamine,” noting that more data are needed.

—Jillian Mock Dr. Reiersen is an inventor on a patent application filed by Washington University in St. Louis, which is relevant to methods of treating COVID-19, including fluvoxamine.

Dr. Hoertel reported a financial relationship with Lundbeck. Drs. Lafi and Cohen reported no relevant financial disclosures.

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Specialty Pharmacy Continuum • September/October 2021

CLINICAL

Single-pill combinations, injectables and long-acting regimens expand options

New Paradigms in HIV Therapy time,” Dr. Daar said. “Now, it’s open to debate just how big an advantage this is.

Yes, less drugs mean smaller pills, fewer interactions and less toxicity, but most of the other first-line therapies have pretty small pills, few interactions and few side effects already.

Cost is another issue. While that’s not necessarily defined by how many drugs are in a regimen, DTG/3TC did come in at a lower cost than other standard regimens.”

A 2016 analysis found that DTG/3TC could save more than $500 million in antiretroviral treatment (ART) costs in the United States over five years (Clin Infect Dis 2016;62[6]:784-791).

Long-Acting Regimens Cited At MAD-ID Meeting

Near the end of the first act of Jonathan Larson’s iconic musical “Rent,” which opened on Broadway in New York City in 1996, a beeper goes off loudly. Mimi, an exotic dancer struggling with heroin addiction, tells her date (who unknown to her also has HIV), “AZT break!”

Twenty-five years later, living with HIV no longer requires constant reminders to take multiple daily pills with potentially debilitating side effects. These and other advances represent a paradigm shift in HIV management, according to interviews with HIV experts, including one who presented during a session at the Making a Difference in Infectious Disease (MAD-ID) 2021 virtual meeting.

“The biggest news in HIV management isn’t just how good our therapies are—they are great. But we’ve been there for a long time,” Eric Daar, MD, the chief of the Division of HIV Medicine at Harbor-UCLA Medical Center in Los Angeles, told Specialty Pharmacy Continuum. For virtually everyone who starts taking their HIV regimen as prescribed, their viral load will drop to undetectable levels within six months, maintaining their health and preventing transmission of the virus to sexual partners, Dr. Daar noted, citing data from the National Institute of Allergy and Infectious Diseases (bit.ly/3jHIDnV).

What is new, he said, is how easy the latest drugs are to take. “Our current regimens are incredibly well tolerated, very safe, with limited drug-drug and drug-food interactions [JAMA 2020;324(16):1651-1669]. They also come in increasingly smaller and smaller single tablets that need to be taken only once a day, and we have several regimens, so those who are unlucky to have some side effects can usually go on to one of the others with all the same advantages. It

just continues to get easier and easier for people to take these medications.”

For most people with newly diagnosed HIV, clinicians should start by reviewing the latest information from the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents (updated June 2021; bit.ly/37TXbKi). The guidelines recommend starting treatment with two nucleoside reverse transcriptase inhibitors administered in combination with a third active antiretroviral (ARV) drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor, or a protease inhibitor with a pharmacokinetic enhancer. (See box for more details.)

The latest guidelines removed raltegravir (RAL)-based regimens as initial therapy for most people because RAL has a lower barrier to resistance than BIC and DTG, and RAL-based regimens have a higher pill burden than other INSTIbased regimens. In addition, new study data (Lancet 2021;397[10281]:1276-1292) have shown the risk for neural tube defects associated with DTG use during conception is much lower than previously understood, so people of childbearing potential no longer need to choose RAL over DTG. “We’ve known for several years that people whose viral load is already suppressed on a three-drug regimen can switch to two, but now it is possible even in people starting therapy for the first

One of the most recent paradigm shifts in HIV therapy is the option for a long-acting regimen. In January 2021, the FDA approved rilpirivine (Janssen) and cabotegravir (ViiV Healthcare) as a combination called Cabenuva (ViiV Healthcare)—the first long-acting, oncemonthly injectable HIV treatment.

“This simplifies therapy in many ways,” said Roger Bedimo, MD, the chief of the Infectious Diseases Section at the VA North Texas Health Care System, during the MAD-ID meeting. “It addresses issues such as pill fatigue and the daily stigma of oral medications, and because it is administered by a health care provider, it offers ease of documenting adherence.”

The once-monthly treatment cycle for rilpirivine and cabotegravir might even be extended to once every two months soon, Dr. Daar said, citing a supplemental New Drug Application (sNDA) submitted to the FDA in February, based on results from the phase 3b ATLAS-2M study.

According to the data, the antiviral activity and safety of the antiviral combination administered once every two months was noninferior to once-monthly administration (Lancet 2020;396[10267]:1994-2005).

“That’s pretty amazing,” he said. “Patients will go from multiple pills a day, every day, to coming in six days a year and being assured that not only will your disease be suppressed, but you won’t transmit it to your partner.”

But there are limitations. Patients must first be virologically suppressed on a stable ARV regimen with no previous treatment failure, so this combination can’t be used as a first-line therapy or in treatment-resistant patients. There also is some inconvenience. “You have to come in to see your health care provider; it can’t be self-administered,” Dr. Daar said. In addition, “if you skip an injection,

you’re at pretty big risk for developing resistance. Both drugs have pretty long halflives, but one is significantly longer than the other. Skipping a dose translates into using monotherapy, and we know that always selects for resistance.”

Other products are currently in the pipeline, including a subcutaneous agent that could be given at home once every six months.

“That would be a home run, but we know you can’t do this with one drug, so you need to find another you can give every six months,” Dr. Daar said. “That’s the challenge: finding drugs that have promise to be long-acting, then figuring out how to pair them.”

Treatment Resistance Today’s ARV regimens are more effective and easier to take than ever, but there is still a small percentage of people living with HIV who are heavily treatment-experienced and are resistant to multiple classes of drugs (AIDS 2020;34[14]:2051-2059). “The proportion of people with HIV who have two or fewer drug classes available to them has declined significantly since 2000, and represents about 1% of the population today,” Dr. Bedimo said. “This group includes patients who are highly adherent but were started on nonsuppressive regimens that led to selection of highly resistant HIV—fortunately, this is a smaller group—and a somewhat larger group of patients who do not have multidrug resistance, but are nonadherent to therapy due to various challenges and still have viremia.”

There is also a pediatric cohort among treatment-resistant patients. A 2019 study of young people who recently transitioned from pediatric to adult HIV care found that 56% of participants had at least one incident of unsuppressed viremia in the year before the transition (Clin Infect Dis 2020;71[1]:133-141).

“Some of these new therapies may be able to reduce the treatment-resistant population further,” Dr. Bedimo said. “For the second group—those with nonadherence issues—we can try to simplify the pill burden, reduce frequency of dosing with long-acting injectables, or if vascular or renal tolerability is an issue, try to find agents that mitigate the impact to these

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Specialty Pharmacy Continuum • September/October 2021

CLINICAL

4 Recommended Starting Regimens 1. Bictegravir (BIC)/tenofovir alafenamide (TAF)/ emtricitabine (FTC) 2. Dolutegravir (DTG)/ abacavir (ABC)/lamivudine (3TC) 3. DTG + TAF or tenofovir disoproxil fumarate (TDF) + FTC or 3TC

study found that lenacapavir in combination with an optimized background regimen produced sustained virologic suppression in 81% of heavily pretreated patients at week 26. In the phase 2 Calibrate study (theprogramme.ias2021. org/Abstract/Abstract/2211), it also produced high rates of virologic suppression in treatment-naive patients in combination with emtricitabine/tenofovir alafenamide (F/TAF).

“The group of people who need new options for treatment because of side effects or underlying resistance is not a

first-in-class HIV attachment inhibitor approved in July 2020, for people with extensive drug resistance. It’s a twicedaily oral therapy also used in combination with other ARV drugs.

“New mechanisms of action and additional long-acting regimens are also coming soon,” Dr. Bedimo noted. For example, in early August, data on Gilead’s twice-yearly, long-acting injectable lenacapavir, the first HIV capsid inhibitor, were reported at the 11th International AIDS Society Conference on HIV Science in July. The phase 2 Capella

huge number, but for those who are dealing with it, it’s their life,” Dr. Daar said.

“These new options offer huge promise for these people, and it’s rewarding to see that companies have invested in developing treatments for them.”

—Gina Shaw Dr. Daar reported financial relationships with Gilead Sciences, Merck and ViiV Healthcare. Dr. Bedimo reported that he serves on the advisory committees/boards for Merck, Theratechnologies and ViiV Healthcare.

4. DTG/3TC—approved by the FDA in 2019, as the first two-drug regimen for patients with previously untreated HIV (JAMA 2019;321[19]:1862) Source: Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents.

organs. As our population ages, they have other non-HIV medications they have to take, so we also need to mitigate potential drug-drug interactions.”

For adherent patients who have failed second-line regimens and beyond, the challenges are even greater. “We can use past and current genotypic and phenotypic resistance and ART history in designing a new regimen,” Dr. Bedimo said. “These patients should be on at least two, and preferably three, fully active agents, but partially active drugs may be used when no other options are available as they can partially suppress progression even if they don’t totally suppress viremia.”

He cited several novel agents that either have been recently approved or are currently in the pipeline, as possible options. They include the monoclonal antibody ibilizumab (Trogarzo, TaiMed Biologics), approved in March 2018 for heavily pretreated adults with HIV, administered intravenously every two weeks and used in combination with other ARV drugs; and fostemsavir (Rukobia, ViiV Healthcare), a

DTG/3TC could save more than

$500 million in antiretroviral treatment (ART) costs in the United States over five years.

Source: Clin Infect Dis 2016;62[6]:784-791.

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

Proving Specialty Value continued from page 1

Parkview Health, in Fort Wayne, Ind. “While we perform better on these metrics, they don’t show the full impact of our integrated services. Proving our value lies in showing how our higher level of integration allows us to provide differentiated services [and improve] clinical and qualitative outcomes.”

Determining what metrics to measure is not always straightforward, especially in disease states that don’t have clinical markers, Dr. Skrtic said. She recommended looking to clinical trials, evidencebased guidelines, peer organizations and

stakeholder colleagues for guidance. One metric all stakeholders agree on is better outcomes, she noted. Once you determine outcomes to measure, then decide what activities are needed to achieve them.

A health-system specialty pharmacy should consider three critical strategies to become an “outcomes powerhouse,” Dr. Skrtic said: 1. Develop disease-specific protocols. These should account for the full patient journey, she emphasized.

It’s also important to consider patient onboarding to ensure they can afford

‘If [smaller specialty pharmacies] can work together, we’d be a force to be reckoned with.’

—Angela Ward, BSPharm, MSB

therapy and start in a timely manner, how to proactively manage refills, and how to determine what clinical activity is needed to ensure therapy is appropriate and patients receive support to remain adherent.

2. Leverage electronic health records (EHRs). EHRs can be a critical technology for deploying these protocols

Mining Claims Data Can Make Your Case

T

here is an urgency for hospital and health-system specialty pharmacies to leverage and optimize their patient care models to ensure the sustainability and growth necessary to continue to care for patients and evolve in an increasingly competitive health care market, a panel of experts said during a separate session on proving value at the 2021 ASHP Specialty Pharmacy Conference, held virtually.

Health-system specialty pharmacies do well helping patients with access to medications and education, making sure they are taking medications as directed and that they don’t have side effects, and are seeing improved outcomes in quality of life and health care costs, said Erin Hendrick, PharmD, BCPS, the senior vice president of Health System Strategy for Shields Health Solutions, in Atlanta. Now they need to show that investing in this area “really will pay off for the health system,” she said. Claims data are great to use to prove your point.

It’s key to have pharmacists embedded in physician practices and, if allowed by states, to have collaborative practice agreements, said Angela Ward, BSPharm, MSB, the senior vice president of specialty services for AmerisourceBergen, in Carrollton, Texas. “That lets the pharmacist really have that supercritical face time with the patient,” she said. A recent study (Am J Health Syst Pharm 2021;78[11]:962-971) showed that patient and provider satisfaction was significantly higher using in-house versus external specialty pharmacists.

There are opportunities to showcase specialty pharmacy

skills more broadly and creatively, said Denali Cahoon, PharmD, the chief operating officer for Trellis Rx, in Atlanta.

She mentioned seeing hospitals use this model to support patients during transitions of care or for those with common chronic conditions, such as diabetes.

Marketing efforts can signify to pharmaceutical manufacturers and payors that there are benefits to working with hospital specialty pharmacies, in areas such as lowered product abandonment, said Thomas Renshaw, RPh, MBA, MCSD, the senior director of business solutions at Acentrus Specialty, in Lewisville, Texas. “But first we need several things to get truly meaningful outcomes data,” he said: • having access to robust, clean data; • having the clinical expertise to ask the right questions from that data; and • having some type of program to alert providers at the point of care to make those insights actionable. This can change care prospectively, not retrospectively, he said.

Pharmacies tend to be insular and work on their own, Dr. Hendrick noted. Take advantage of the fact that healthsystem specialty pharmacies “have long tentacles,” she said: Being aligned with finance, network contracting, information technology and other teams provides great opportunities to leverage skills and resources across departments.

Even smaller hospitals are getting into the specialty pharmacy space, Ms. Ward added. “If we can work together, we’d be a force to be reckoned with.”

—K.B.

and workflows, Dr. Skrtic said. Ideally, the programming/protocol should trigger interventions automatically based on data captured by the EHR or the specialty pharmacy team. The programming/protocol also should collect data in a consistent, reportable fashion.

3. Embed pharmacists and liaisons on-site. The pharmacists should work closely with providers to see patients in person whenever possible, Dr. Skrtic said. The pharmacists also need access to the EHR to see pertinent information and document updates.

In one project, Dr. Skrtic and her colleagues at Parkview Health—a 10-hospital health system in Indiana and Ohio that launched integrated specialty pharmacy services in 2019 with Trellis Rx—evaluated their impact on lost work productivity among patients experiencing migraines.

These patients were covered under Parkview’s employee health plan and prescribed calcitonin gene–related peptide specialty medications for migraine.

Pharmacists routinely conducted patientreported outcome measure assessments and performed interventions, if necessary, based on the results.

Over an eight-month period, pharmacists performed 29 interventions, such as dose or therapy changes, adherence counseling, and adverse event management for 38 patients. The number of migraine days per month decreased by 55%, and lost productivity per month, including workdays missed and productivity lost during migraine attacks, decreased by 60%.

4 Steps to Demonstrating Value When using metrics and measures to demonstrate value, consider four points, said Ann McNamara, PharmD, the director of clinical development at Fairview Specialty Pharmacy, in Minneapolis: 1. Look to the Quadruple Aim for measures that describe value.

Consider metrics to prove how you lower costs, improve outcomes and the patient–provider experience, or that pursue health equity. For costs, describe how you decrease hospitalizations and emergency department (ED) visits, or how you encourage the use of less costly options, such as generics and biosimilars, when appropriate. For clinical outcomes, show cures in hepatitis C therapy completions or how you monitor disease activity, and how you document interventions when patients don’t meet treatment goals.

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

“Activity metrics such as assessments and interventions are important, and help demonstrate your pharmacy takes an active role in meeting treatment goals,” Dr. McNamara said.

2. Partner with key stakeholders.

Look for opportunities with your clinics, pharmaceutical manufacturers or payors for areas where you have mutual goals.

“Pharmacies that are part of a health system have great opportunity to collaborate with clinics to define and report metrics that can be used to demonstrate value,” she said, such as working with a hemophilia treatment center to showcase ED or medical resource utilization, or adherence to prophylactic regimens. There also are opportunities to find projects with drug manufacturers that don’t involve promoting their products. Go beyond adherence to show value.

3. Combine metrics with other information to tell a more holistic story. Use metrics along with descriptions of your process, interventions and cases. “Often, cases tell the reality of the situations, the complexity of specialty patients, and how assessments and interventions over time result in supporting patients in meeting treatment goals,” Dr. McNamara said. Describe your strategic approach, services and metrics for each disease state.

It also is important to provide metrics that are most relevant to your audience, she noted. For many payors, health equity and cost-effective use of anti-inflammatory medications are top of mind. To gain access to limited distribution drugs, think about what’s important to manufacturers, such as time to fill, patient adherence and experience.

For internal audiences, demonstrate that you are efficiently providing services that affect the Quadruple Aim. As an example, Dr. McNamara discussed a program in which the pharmacy worked with a hospital health coach and chaplain to provide extra help to patients whose needs went beyond the usual expertise of the pharmacy. This included adjusting to living with new diagnoses, the loss of loved ones or mental health issues. With the COVID-19 pandemic, many patients were isolated, gained weight or lost jobs. Together, the pharmacy, therapy management team, chaplain and health coach wrote a program description, process and services, and agreed on metrics to measure.

The health coach and chaplain intervened when necessary, referring patients to health care and other resources, therapists, physicians, palliative care, psychologists and social workers, among others.

One patient with multiple sclerosis who had lost two loved ones and was caring for four young children was connected to county services for housing, child care resources during a hospitalization and financial assistance to purchase an air

conditioner, and was able to seek grief counseling. “Cases really demonstrate how powerful the interventions are and the work that you do,” Dr. McNamara said.

In patient surveys, 100% of respondents agreed that they were satisfied with the program, with the majority (85%-97%) stating their physical and mental health were positively affected.

—Karen Blum

Pharmacist interventions decreased migraine days per month by

55% and lost productivity per month (e.g., workdays missed and productivity lost during migraine attacks) decreased by

60% Source: Parkview Health

The speakers reported no relevant financial disclosures.

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

CMS waiver extended during delta variant surge

Hospital-at-Home Model Gains Traction Before November 2020, the biggest obstacle to delivering hospitallevel care to acutely ill patients at home was a rule restricting Medicare fee-for-service payments to brick-and-mortar hospitals.

But with U.S. COVID-19 cases rising again at year-end, the Centers for Medicare & Medicaid Services (CMS) issued a waiver that effectively gave qualified hospitals the flexibility to provide acute home care to Medicare patients and get paid for it as if they were occupying a hospital bed. Community-acquired pneumonia, heart failure, asthma and chronic obstructive pulmonary disease were among the more than 60 acute conditions that CMS considered treatable at home.

The waiver was set to remain only for the duration of the public health emergency. However, the financial benefit of inpatient diagnostic-related group payments has accelerated adoption of the hospital-at-home model. By August, more than 140 hospitals in 32 states, most in large health systems, had been approved under CMS’s Acute Hospital Care at Home program. The surge in delta variant cases has all but ensured that the waiver will remain into 2022.

Mount Sinai Hospital, in New York City, and Brigham and Women’s Hospital, in Boston, were two of the six health systems first authorized under the waiver. Both hospitals have extensive experience in home-based hospital care. And at a recent Hospital at Home Users Group webinar, leaders from the two systems, including two physicians and a pharmacist, spoke about the divergent paths their programs had taken.

They also described how the addition of inpatient pharmacy oversight had increased the safety and efficiency of medication delivery to patients at home.

“When we were in the outpatient setting, we didn’t have the awesome power of our pharmacists doing a lot of the order checking,” said David Levine, MD, MPH, MA, the medical director of strategy and innovation at Brigham Health Home Hospital. But last year, the program switched to Brigham’s inpatient electronic health record system, and “with that came an inpatient build and

4 Challenges to the Hospital-at-Home Model

A

lthough multiple clinical benefits are ascribed to hospital-at-home care— including avoidance of hospital-acquired infections—challenges also exist.

Donald Mashni, PharmD, the system director of the Mount Sinai Specialty Pharmacy, in New York City, outlined some pharmacy-specific issues that need to be addressed:

Labeling. Requirements for hospital-administered medications are very different from those required for retail pharmacy drugs, Dr. Mashni said.

The regulations of state boards of pharmacy may have evolved differently for hospital-at-home patients, so it’s probably smart to label all medications for hometreated patients as outpatient medications to ensure that the strictest safety requirements are met. This is particularly important for controlled medications.

Documentation. How to document medication administration and potential side effects is a key consideration, he said. Perhaps the greatest opportunity lies in mobile health technologies that can capture when a patient scans a barcoded prescription bottle or blister card and reports any side effects and symptoms. Dose alerts also can be transmitted via mobile devices. Timely documentation can ensure no payments will be lost. If dispensing five-day supplies, Dr. Mashni said, be assured that the charges will drop accordingly.

Storage and refrigeration. Ideally, medications that need temperature control should be stored in a dedicated, temperature-monitored refrigerator, Dr. Mashni said. Practically speaking, that may not be possible in a patient’s home, so it’s important to protect medications in plastic food storage bags and segregate them in the home refrigerator. Medications that don’t need refrigeration should be stored in a cool dry space, not a bathroom cabinet.

all of the inpatient pharmacy tools and workflows that allowed our inpatient pharmacy to directly dispense to us.

Our clinicians now have access to our inpatient pharmacy 24/7.”

Brigham pharmacists restock the “mini pharmacy” that physicians carry on home visits. “The packs contain first- and urgent-dose medications that are dispensed as needed to patients,” Dr. Levine said. They include “workhorse antibiotics, diuretics and a whole slew of other medications.”

Bringing it Inside At Mount Sinai, Linda DeCherrie, MD, the clinical director of the Hospitalization at Home initiative, said until last summer, the program was considered an outpatient practice. Oral and injectable medications were obtained from the hospital’s outpatient pharmacy, she said, and IV drugs were electronically prescribed to an outside infusion pharmacy.

The CMS waiver changed that, Dr. DeCherrie said. “Now, inpatient pharmacists review all the home orders,” she said, “and they reach out to us about any questions or concerns they have.” The change also eliminated infusion delivery delays that often held up timely treatment.

Dr. DeCherrie also said a newly adopted order set had eliminated confusion over where to electronically prescribe medications for the two classes of patients admitted into the program: those in a Medicare fee-for-service group, whose medications go to the inpatient pharmacy, and patients admitted under the hospital’s contract with insurance companies managed through Contessa Health for 30-day bundles of care. (In the latter case, these are patients who need to use an outpatient pharmacy for their oral and injectable medications, which are covered

by Medicare Part D.) The new order set allows prescribed drugs to be channeled seamlessly to the appropriate pharmacy.

A Cost-Saver Patients’ home medications. It’s important to document all medications in the home, including over-the-counter products and nutritionals, to ensure there are no potential interactions or therapeutic duplications.

—B.B. Dr. Mashni reported no relevant financial disclosures.

Research has shown that the hospitalat-home care model can reduce healthsystem costs and lower readmission rates, among other clinical and financial benefits. In one study, researchers

at Presbyterian Healthcare Services in Albuquerque, N.M., reported 19% cost savings for home-based hospital care versus inpatient stays (Health Aff 2012;31[6]:1237-1243).

At Brigham Health, a small, physicianled study found that patients who are normally hospitalized for acute conditions can achieve positive outcomes at lower costs when they are given hospitallevel treatment at home. The pilot study helped launch the Brigham program (J Gen Intern Med 2018;33[5]:729-736). A larger study later confirmed the results (Ann Intern Med 2020;172[2]:77-85).

Tech for Acute Care at Home At Brigham Health Home Hospital, the home-based clinical team of nurses and mobile integrated health paramedics has begun using a portable documentation system that uses smartphones to scan medication barcodes and transmit the information to patients’ electronic health records. “It’s another great example of an evidence-based practice leading to fewer patient safety events,” Dr. Levine said. Clinical decision making also is enhanced by the continuous biometric monitoring of patients with wearable patches.

Dr. DeCherrie said Mount Sinai patients who are discharged from an emergency department to hospital-at-home care are supplied with a telehealth kit that includes “an iPad-like device” plus a Bluetoothenabled scale, blood pressure monitor and pulse oximeter. At the beginning, she said, nurses teach the patients how to use the device, but “when they move into the monitoring phase after discharge, the patient starts engaging with the device.”

—Bruce Buckley Dr. Levine reported grants from Biofourmis and IBM. Dr. DeCherrie is a full-time employee of the Icahn School of Medicine, which has an ownership interest in a joint venture with Contessa Health, a venture that manages acute care services provided to patients in their homes through prospective bundled payment arrangements.

Dr. DeCherrie has no personal financial interest in the joint venture.

Li

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

NCQA Accreditation continued from page 1

feedback that NCQA could apply our best practices in this space.”

Still, yet another accrediting body? “We did hear that a little bit in our early days,” Dr. Ryan said. “But the fact that organizations are getting multiple accreditations is a signal that there’s an unmet need in the market. Standards have to walk a line between being specific enough that someone can assess, but not so specific that they impose particular sets of processes people might have to change. Over 30-plus years of administering accreditation processes, we’ve calibrated the way we write standards to achieve that goal.”

In developing the new accreditation, NCQA consulted 11 specialty pharmacies, nine health plans, nine drug manufacturers, six pharmacy benefit managers (PBMs) and six patient advocacy groups. A 14-member advisory committee representing those industries—plus academia and the Centers for Medicare & Medicaid Services—developed the accreditation standards.

NCQA’s specialty pharmacy accreditation standards cover four areas: patient programs; organization, administration and compliance; specialty pharmacy operations; and quality and performance improvement. Accreditation surveys, which may be virtual or in-person, will begin in early 2022.

Other organizations in the specialty accreditation field include URAC, Joint Commission, Accreditation Commission for Health Care and Center for Pharmacy Practice Accreditation, a partnership between the American Pharmacists Association, National Association of Boards of Pharmacy and ASHP. “I haven’t yet had the opportunity to review their standards to do a head-tohead comparison with ours or others,” said Lynnae Mahaney, the senior director of pharmacy accreditation at ASHP. “But NCQA is a very reputable organization and has been in accreditation for a very long time, particularly in the payor realm.

From the ASHP standpoint, we use this accreditation to validate and provide evidence that a pharmacy has strong operations [and] provides exceptional patient care services. We all exist to provide that evidence so that our pharmacies can go to the payors, manufacturers, patients and prescribers and demonstrate that value.”

creation of digital measures as benchmarking and performance-based accreditation evolve,” according to a statement from the organization.

“We’ve heard of a big unmet need in the value-based contracting space to get some consistent, standard, trusted metrics and measures to tie to those contracts,” Dr. Ryan said. “That’s a core competency with NCQA, [because] we

have done that with HEDIS [Healthcare Effectiveness Data and Information Set] in other measures and [markets].” (He added that HEDIS is the most widely used performance measurement tool in health care.)

Dr. Ryan did not reveal how many specialty pharmacies are pursuing NCQA accreditation, but he noted that some of the pharmacies that were involved in developing the program have expressed interest. “There also are a couple of PBMs that have started the process of writing our program into their

requirements and contracts,” he said.

“We want to assure specialty pharmacies that NCQA is trying to be more oriented toward value-based contract needs,” Dr. Ryan stressed. “We are hearing across industries, including this one, that there is a need for more tools for assessment and identifying and rewarding high quality.”

—Gina Shaw The sources reported no relevant financial disclosures other than their stated employment.

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

A challenge for health-system specialty pharmacies

Little Things Can Cause Big Issues in Patient Care The patient—a woman with a neuroendocrine tumor—had waited at Baystate Medical Center’s infusion center for three hours. The lanreotide (Somatuline Depot, Ipsen) injection for her tumor treatment had not arrived from the out-of-state thirdparty pharmacy as mandated by her insurance. No one at the hospital could trace it. The drug was reordered and the patient’s treatment had to be rescheduled. Although she received her treatment, the delay could have compromised her care.

In another case, IV immune globulin was scheduled for delivery at a specific address at the Baystate campus so it could be signed for and then walked over to the integrated specialty pharmacy, but it did not arrive. It was later discovered that the third-party drug supplier had used the wrong address.

(Baystate is a large system in western Massachusetts and has multiple addresses.) Eventually, the drug was found and delivered, but the amount of time and effort expended because of a clerical error was enormous and caused significant distress to the patient.

Although much attention has been given to treatment delays caused by prior authorization hurdles, sometimes patient care in specialty pharmacy is interrupted by simple clerical errors such as those in the cases above. While treatment in both cases was ultimately rescheduled as soon as possible and shipping addresses and contact information were updated, the problems could have been avoided, said Gary Kerr, PharmD, the chief pharmacy officer at Baystate Health, who noted that the health system tries to gain access and control of the shipping process so it can provide the drug directly whenever possible.

“The things that derailed treatment in these two cases were all little things. It’s basically logistics—packing, shipping and delivery issues—especially when the drug is mandated by a payor or PBM [pharmacy benefit manager] to be sourced from a supplier in another state or region. Once we have the drug in our possession, the process typically runs very smoothly.”

On a more systemic level, Dr. Kerr added, “it’s about providing more patient access and choice. We have found it makes a dramatic positive impact on the entire therapy delivery process, and more importantly, on patient care.”

Beware ‘Handoff Gaps’ Like many health systems, Baystate Health has a state-of-the-art integrated specialty pharmacy and is not immune to the industry-wide challenges posed

by drug delivery channels mandated by payors and/or PBMs. When a drug is sourced from out of state, out of region or even simply outside of preferred channels, there is a higher risk that these “handoff gaps” will occur, said Dr. Kerr, who noted that Baystate tries to work with insurance companies to reduce restrictions that limit where prescriptions can be filled.

“Our pharmacy is literally 100 yards from our cancer center, and 25% of the patient panel in our integrated specialty pharmacy is from the cancer center,” he said. “How does it make sense that we are forced to purchase a drug from a supplier in Houston or Miami when I could walk outside my door, throw a rock and hit the cancer center? When we supply the drug ourselves, if a physician writes an order at 3 p.m. Eastern time on Monday, we could start therapy on Tuesday or, worst case, on Wednesday.”

When it’s allowed to work as intended, the integrated specialty pharmacy model at Baystate has reduced fragmentation in care and improved patient outcomes across a number of metrics. According to internal data, time to start therapy in one study was cut in half (now averaging 2.2 days); prior authorization turnaround time was reduced to less than a day; and clinical metrics across a number of disease states improved.

“Our multiple sclerosis relapse rates are world-class, with more than 87% of patients reporting zero flares,” Dr. Kerr added. “For our patients on HIV therapy, 91% have achieved suppression, while 97.2% of our hepatitis C patients have achieved sustained viral response. In oncology, 5.3% of our patients on service have had ED [emergency department] visits or hospitalizations related to their cancer diagnosis—significantly below the national benchmark.”

To bring attention to the quality of care delivered by health-system specialty pharmacies, Baystate and a number of other health systems launched the Health System Owned Specialty Pharmacy Alliance (HOSP) in October 2020.

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Specialty Pharmacy Continuum • September/October 2021

OPERATIONS & MANAGEMENT

This nationwide organization of leading health systems is specifically focused on the interests of health-system–owned specialty pharmacies. They advocate for an integrated model, set best practices, work on technology solutions and bring attention to key operational and clinical challenges faced by members.

In addition to Baystate Health, some of the other health systems involved in HOSP leadership include Minnesotabased Fairview Health, New York’s Northwell Health, the University of Massachusetts Memorial Medical Center and WVU Medicine in West Virginia.

Providing ‘Gold-Medal’ Service HOSP’s advocacy committee is working particularly hard on the challenges posed by “white-bagging,” when drugs are shipped from an outside pharmacy to the patient’s site of care. “Clear bagging” has typically been the term used when a health system’s own specialty pharmacy delivers medication for administration to a patient, but HOSP has coined a new phrase: “gold bagging.” This, HOSP says, exemplifies the “gold-medal” service provided when a prescription is filled at a health-system–owned specialty pharmacy by their own staff, packaged and delivered to the final place of administration

usually on the same campus as the hospital, office or infusion clinic.

“These locally managed logistics are largely foolproof when a health-system– owned specialty pharmacy is involved,” Dr. Kerr said. “Everything is done and managed within the health-system campus as opposed to trying to manage drug delivery remotely from many miles away that may not match a patient’s real-time needs. In the unlikely event of a lost order or last-minute dosage changes, the on-campus pharmacy is able to ensure a new dispense can happen in real time so that the patient appointment is not rescheduled and the treatment regimen remains intact. The ultimate aim is for the right drug, in the right dose, at the right time, [to be] provided to the right patient within their existing continuum of care.”

Another Player The HOSP Alliance isn’t the only effort to band health system specialty pharmacy stakeholders together. Another group, Excelera, seeks strength in numbers via its own network of providers.

Tim Affeldt, PharmD, the vice president for Specialty/Infusion Pharmacy Operations at Fairview Health Services, is member of both HOSP and Excelera. Asked to compare the two organizations in a

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December 2020 interview ew with Specialty Pharmacy Continuum (bit.ly/3F1tYwd), Dr. Affeldt said although ugh they share a common focus on providing viding integrated specialty pharmacy care, re, their operating models are completely letely different.

“Excelera is a for-profit fit company that helps health systems ystems start, operate and optimize mize specialty pharmacies,” s,” he explained. HOSP,, in contrast, is a nonprofit trade association that “is not going to help anyone start a pharmacy; they’re not going to help their membership run theirr operations.”

Dr. Affeldt stressed, however, that HOSP offers significant ignificant benefits to its participants. nts. “HOSP members can focus on our unique issues and commitment to patients ts and their care team. This is why Fairview iew has been very interested in HOSP from m the beginning.”

—Gina Shaw The sources reported no o relevant financial res other than their disclosures tated employment. stated

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Specialty Pharmacy Continuum • September/October 2021

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$100 Billion: Worth It? continued from page 1

For all the categories analyzed, Mr. Howell and his colleagues wrote, they believe their estimates to be conservative. For example, in their calculation of costs to payors, they did not include the cost of administering other utilization management policies aside from prior authorization, such as step edits and quantity limits, because of a lack of relevant studies. For physicians,

they did not attempt to quantify the time costs associated with discussing prior authorizations, prescription rejections and cost sharing with patients, or lost physician practice revenue because of an inability to collect required copays.

‘Kudos for Trying’ “I give them kudos for trying to do these analyses,” said Dea Belazi,

PharmD, MPH, the CEO of AscellaHealth. “Overall, the points were well taken, and while the numbers seemed high across the board, I’m sure these costs are definitely well into the billions. I don’t think they’re wrong there.”

The costs are only bound to increase, he added. “Utilization management seems to be getting more frequent.

There are more drugs on the exclusion list, more prior authorizations than ever, and, at the same time, pharmaceutical companies are launching more and more high-cost drugs than

‘If government creates policies to limit [drug] utilization management programs, which could be possible, what do you think is going to happen? Prices aren’t going to come down; they’ll go up, and patients will bear that in premiums and copays.’

—Dea Belazi, PharmD, MPH

The Health Affairs Study Calculus

H

ow did Howell et al calculate the costs of drug utilization management cited in their research?

Physicians. The authors calculated weekly time spent in practice on drug prior authorizations and formularies, by personnel type (physicians, nurses, clerical staff and administrators), as reported in physician surveys, and then multiplied that time based on hourly earnings estimates from the U.S. Census Bureau. They estimated a total of $44,829 per physician practice, which they then scaled to a national estimate by using the number of practicing physicians who work in specialties that frequently encounter prescription drug utilization management.

Patients. To calculate the cost of utilization management to patients, the group started with IQVIA’s estimated $82 billion patient out-of-pocket spending for 2019. Because Tier 1 copays and coinsurance are not considered attributable to utilization management, they subtracted those from the total. They reached their Tier 1 figure by applying the $11 average Tier 1 copay (estimated by the Kaiser

Family Foundation) to the 4.2 billion prescriptions filled annually for all generic and branded drugs, to get a total of $46.2 billion. Subtracted from $82 billion, that leaves $35.8 billion in copays and coinsurance in higher formulary tiers that “apply to branded agents and specialty drugs and are intended to influence their use,” they wrote.

Drug manufacturers. The cost of utilization management to drug manufacturers included the amount spent on direct financial support through copay cards ($13.6 billion) and drug donations supporting patients who face utilization management ($6.2 billion), along with the cost of administrative support programs such as hub services ($5 billion).

Payors. The $6 billion annual cost to payors of administering utilization management services was estimated based on the volume of rejected prior authorization requests per year and the average of the cost per rejected claim for manually and electronically submitted requests.

—G.S.

ever. They’ve almost stopped developing medications for the masses, and we’re seeing very unique, high-cost treatments for rare diseases. So, what do you do with [a huge], unsustainable snowball that’s coming down the mountain toward you? If government creates policies to limit [drug] utilization management programs, which could be possible, what do you think is going to happen? Prices aren’t going to come down; they’ll go up, and patients will bear that in premiums and copays.”

As for alternatives to government intervention, Dr. Belazi concurred with the Novartis authors about the potential for a strategy in which a manufacturer’s use of value-based pricing is linked to value-based patient access criteria from a payor. “If you buy an appliance at Best Buy and it doesn’t work, you return it and get your money back,” he said. “That’s a novel concept in health care. Our organization has established a whole model around this, where we create almost a pay-as-you-go or pay-overtime system for that expensive drug, like the $2 million gene therapy. If a drug doesn’t work or has a negative outcome, that’s absorbed by the drug company.

This could be a method to create some more sustainability, or at least kick the can out another decade or so to allow some of these amazing therapies and cures to evolve.”

—Gina Shaw The sources reported no relevant financial relationships other than their stated employment.

Read Specialty Pharmacy Continuum Anywhere, Anytime!

www.specialtypharmacycontinuum.com

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Specialty Pharmacy Continuum • September/October 2021

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Lean Thinking For CSTDs Source: ICU Medical Inc.

FRED MASSOOMI, PHARMD, RPH, BCSCP, FASHP SETH EISENBERG, RN, OCN, BMTCN JIM JORGENSON, RPH, MS, FASHP St. Paul, Minnesota Visante Inc.

L

ean management principles have been used effectively in manufacturing scenarios for decades, particularly in Japan. More recently, the use of Lean concepts in health care1 has caught the

interest of regulators, who suggest that the discipline be a guide for training pharmacists who

are involved in pharmacy compounding procedures. One of those procedures—the use of closed system drug transfer devices (CSTDs)—may well be an under-recognized area for Lean applications.

The first step is to understand the basics of Lean management principles. Lean thinking begins by driving out waste so that all work adds value and serves customers’ needs. Identifying value-added and non–value-added steps in every process is the beginning of the Lean initiative. More specifically, Lean thinking comprises five principles: 1) defining value, 2) mapping the value stream, 3) creating flow, 4) using a pull system and 5) pursuing perfection.2 Too often in our everyday work in health care, we don’t really think about these principles as we make decisions about technology or design work processes. Often, consideration for things such as value stream mapping only happens once something has broken and needs repair. But the application of Lean principles should be a consideration on the “front end” of technology selection and process design and should periodically be reevaluated for all key processes.

By dismissing Lean principles, health systems lose the opportunity to benefit from its tool kit of efficiencies, consistency, safety and waste reduction. Also lost is the opportunity to improve complex processes while delivering substantial gains to the bottom line.3 Given those benefits, it’s not surprising that the use of Lean concepts in health care has caught the interest of the Massachusetts Board of Registration in Pharmacy, which has published “An Introduction and Guide to the Practices and Implementation of Lean Concepts in a Pharmacy Setting.” The document notes that “sterile compounding, complex non-sterile compounding, and institutional sterile compounding pharmacies shall ensure their employees are trained in lean concepts before renewing their pharmacy license.”4

Making the Initial Assessment Since the introduction of the first CSTD to the U.S. market in 1998, many new CSTDs have emerged, providing organizations with a variety of options that best fit their compounding and drug administration processes (Table). Preferred

features of a CSTD, based on general Lean principles, would include intuitive connections, prebonded components to limit the number of attachment/disconnection steps, pre-purging displacement air into the system, wetting potential of filters, and locking mechanisms that clearly indicate complete connection. In addition, systems also should limit the pressure required to engage and disengage the components, thus reducing the risk for repetitive stress injuries. The risk for repetitive motion injuries is a concerning yet underappreciated issue with drug compounding.5 Each device is very unique in the number of components, component options, mechanism

of protection, integration with existing systems and costs, and, thus, should be assessed individually as a system versus generically categorizing the devices as a “CSTD.” The overall effect of integrating any device into medication safety systems must consider each end user’s use of the device(s), standard operating procedures, primary engineering controls, infusion pumps, disposal, staff perception of safety, number of components and overall costs.

Another factor to consider is the FDA’s clearance code for CSTDs, “ONB.” The code is applied to devices that have indications for use with antineoplastic and other hazardous drugs. Regardless

Table. Closed System Drug Transfer Devices Device

Manufacturer

FDA Cleared

BD PhaSeal

Becton Dickinson and Company

1998

Spiros

ICU Medical Inc

2005

ChemFort or OnGuard with Tevadaptor

Simolivia Healthcare Ltd. B. Braun (U.S. distributor) TEVA Medical Ltd (manufacturer)

2006

ChemoClave

ICU Medical Inc

2006

Equashield

Equashield LLC

2008

ChemoLock

ICU Medical Inc

2013

EquaShield II

Equashield LLC

2014

Halo

Fresenius Kabi (U.S. distributor) Corvida Medical Inc (manufacturer)

2015

Arisure

Baxter International Inc

2017

BD PhaSeal Optima

Becton Dickinson and Company

2018

NeoShield

JMS North America

2018

ProSeal

Epic Medical Pte. Ltd

2020

Source: Visante.

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Specialty Pharmacy Continuum • September/October 2021

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of their technology, all devices cleared by the FDA under the ONB code are considered CSTDs.

Future application of CSTDs includes use outside of hazardous drugs handling, where the noted Lean advantages can be applied to all sterile compounding, and the application of the devices to minimize potential medication waste through drug vial optimization programs.7 As the individual devices continue to evolve and the demand for sterile compounding continues to increase, CSTDs can serve as tools for growth.

Lean Attributes of CSTDs Within updated USP Chapter <800> standards6 and nursing and pharmacy guidelines, the introduction of CSTDs was mandated for antineoplastic drug administration and recommended for compounding of hazardous drugs. In deciding which CSTD to deploy and how to effectively integrate a CSTD into compounding and administration processes, it is useful to think about these processes in the context of the five Lean principles.

1. Defining Value

Figure. Almost all CSTD manufacturers make options that allow connecting integrated CSTD tubing with the IV bag.

When these direct spikes (shown above) are used in compounding, they eliminate the need to prime tubing in the biological safety cabinet.

Value at the simplest level is the quality delivered plus the customer satisfaction at a defined cost. It is imperative for a new technology such as a CSTD to meet the actual needs of the users. To select the optimal product and integrate that most effectively and efficiently into pharmacy and nursing practices, end-users have to clearly understand what they want and the price they can afford. For a CSTD, this can be challenging because the technology has two main user groups in nursing and pharmacy, both of which come with different needs and elements driving satisfaction. The primary value proposition for both health care professionals in regard to choosing a CSTD is protection—for their patients and for themselves.

Compounding and administering medications require diligence in balancing timeliness and expected attributes while ensuring safety from needlesticks and exposure to hazardous drugs.

the moment a CSTD is integrated from the vial, it is in a system of “flow” from compounding, to delivery, to administration and, finally, to disposal. Health systems that employ CSTDs minimize angst by not having to worry about needlesticks, drug vaporous sprays, lapses in aseptic technique and Luer line disconnections and spills, which can lead to delays in therapy and loss of revenue.

Further aiding flow, almost all CSTD manufacturers make options that allow connecting integrated CSTD tubing with the IV bag. When these direct spikes are used in compounding, they eliminate the need to prime tubing in the biological safety cabinet. This not only frees up pharmacy or technician time but also removes large, bulky items from the sterile compounding area. Examples of direct spikes can be seen in the Figure.

2. Mapping the Value Stream

4. Establishing Pull

In value stream or process mapping, the goal is to use the customer’s defined value as the desired end point and then to identify and map all the activities in the processes that contribute to these values. Activities that do not add value to the end user would be identified as waste. The waste can be further delineated into two categories: non-value added but necessary and nonvalue added and unnecessary. The first category should be reduced as much as possible, and the second category is just pure waste and should be eliminated to the maximum extent possible.

By reducing and eliminating unnecessary processes or steps in compounding and administration, including the steps for CSTD application, users can improve the likelihood that they are getting exactly what they want while reducing their costs. In compounding, eliminating the concern for possible needlesticks, overpressurized drug vials resulting in spills/sprays, and lapses in aseptic technique due to individual variations with the use of traditional compounding tools (ie, syringe in combination with a needle) are non-valued waste that may be eliminated by a CSTD.

Inventory is considered one of the biggest wastes in any production system. The goal of a pull-based system is to limit inventory and workin-process items while ensuring that the requisite materials and information are available for a smooth workflow. The uniqueness of each CSTD brings a significant variation in the number of components required for use. It is important to understand each component of CSTD systems to determine which components are required for a site’s medication management processes. Value stream mapping is a valuable tool to visualize the number of steps requiring CSTD components and which components are required. If you do not have all required components, this will result in delays, frustrations and safety issues. The importance of nursing and pharmacy defining the specific CSTD components and putting them together helps to understand what works for a particular site.

3. Creating Flow After reducing wastes from the value stream, the next consideration is to ensure that the flow of the remaining implementation steps runs smoothly, without interruptions or delays. From

5. Pursuing Perfection Waste is prevented or minimized through the achievement of the first four Lean steps. The fifth step of pursuing perfection makes Lean thinking a continuous process improvement endeavor.

Pharmacy and nursing should actively promote and encourage continuous learning. As such, they always should look to find ways to use CSTDs to make the process of hazardous drug compounding and administration safer, more efficient and more cost-effective.

Standard Work Another hallmark of Lean management is eliminating variations in practice that can lead to increased waste and decreased quality and safety. CSTD components are designed to be modular and integrated in such a way as to standardize a specified method of drug compounding and drug administration. In addition, a well-designed CSTD provides a safe method for flushing tubing after the drug has been administered.8 Since nurses do not have the benefit of working in the same type of contained, controlled environment associated with compounding, the proper use of CSTDs helps to prevent widespread environmental contamination in the patient care areas. In addition, the more intuitive a system is to use, the easier it is to lessen variances in compounding and to facilitate effective training.

The device that integrates into pharmacy and nursing practices with perceived protection from both disciplines is the ideal CSTD. Other Lean attributes to consider are devices with the least number of components, packaging, steps for user-to-device interfacing, steps for device-todevice interfacing and drug transfer. These attributes should be fully vetted and validated at each site to ensure the advertised benefits of a specific CSTD meet the expectations of the staff using the devices. Ultimately, a CSTD should meet the efficiency needs of pharmacy and nursing with the benefits of saving time, controlling costs, minimizing line items and training.

References 1.

Going Lean in Health Care. IHI Innovation Series white paper. Institute for Healthcare Improvement; 2005.

2. Womack JP, Jones DT, Roos D. The Machine That Changed the World. Free Press; 2007.

3. Shaw G. The ‘Gemba walk’ and its role in compounding quality assurance. Pharmacy Practice News. June 25, 2020.

Accessed March 16, 2021. bit.ly/3tsYxV0 4. The Commonwealth of Massachusetts; Executive Office of Health and Human Services; Department of Public Health; Bureau of Health Professional Licensure; Massachusetts Board of Registration in Pharmacy; Policy No. 2016013: An Introduction and Guide to the Practices and Implementation of Lean Concepts in a Pharmacy Setting.

August 2016. Accessed March 13, 2021. bit.ly/3luAl1F 5. Abbot L, Johnson T. Minimizing pain resulting from the repetitive nature of aseptic dispensing. Hosp Pharm.

2002;9:77-79.

6. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. Accessed April 6, 2021. www.usp.org/ compounding/general-chapter-hazardous-drugs-handlinghealthcare 7. Buckley B, Buckley J. Is drug vial optimization set to expire? Pharmacy Practice News. June 8, 2018. Accessed March 17, 2021. bit.ly/3qUg9aI 8. Polovich M, Olsen M. ONS Safe Handling of Hazardous Drugs. 3rd ed. Oncology Nursing Society; 2018.

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Transparency, pain management among puzzle pieces in play

CY 2022 Proposed OPPS/ASC Payment Rules B oth of the proposed 2022 OPPS/ ASC and PFS rule sets affect pharmacy practice. Common prevailing themes emphasize health equity and patient access to “create a health care system resulting in better accessibility, quality, affordability, empowerment and innovation, touching on multiple facets of health-care, from price transparency

requirements to increased reimbursement rates for ASCs to a variety of health equity and patient safety efforts.”

The underlying message is that pharmacists involved in reimbursement must upgrade their reimbursement skill sets, become players aligned with the directions being taken and recognize the implications of their

decisions, especially if these currently are made in a silo without knowing payor requirements.

What strategies are you going to use to survive and thrive in continuing disruptions of health care involving multiple sites of care? After a period of comment, the rules will be finalized in late fall for a Jan. 1, 2022 start.

“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

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Transparency: New enforcement rules for hospital price transparency for standard charges continue to mandate hospitals to publish payor-specific negotiated rates and other pricing information on their public websites, with penalties for failure to comply increasing dramatically to as much as a minimum civil monetary penalty of $300 per day for smaller hospitals (bed count, ≤30) and $10 per bed per day for hospitals with bed counts greater than 30, up to $5,500 daily (maximum penalty per hospital increasing from $110,000 annually to >$2 million annually). Only 5.6% of U.S. hospitals are fully compliant with CMS’s price disclosure rule, according to a PatientRightsAdvocate.org study (bit. ly/2TUmyIt). A ban on coding to hide prices is addressed in the clampdown on special coding, preventing search engines from displaying pricing in search results.

IPO list changes: CMS proposed a halt to eliminating the IPO list that dictates services only payable by Medicare if performed in the inpatient setting. CY 2021 OPPS rules began a phasing out by removing nearly 300 of 1,700 services to improve restricted patient choice for surgery sites.

Both the proposed rollback of the IPO

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Specialty Pharmacy Continuum • September/October 2021

POLICY

list’s elimination and reversal of services removed in 2021 are based on stakeholder comments. Reinstated safety criteria for ASC services and removal of 267 procedures from the ASC Covered Procedures List added in CY 2021 also are included.

This site change could have a major effect on the 340B pricing program.

Other key areas focus on requests for information for Rural Emergency Hospital provider types outlined in the Consolidated Appropriations Act of 2021 and implementation of the Radiation Oncology Model.

Nonopioid product payment (Section 6082 SUPPORT Act): This proposed rule requires payment review under OPPS/ASC for opioids and evidence-based nonopioid alternatives for pain management to ensure no financial incentives are in place to use opioids instead of nonopioids. CY 2022 proposed separate or modified payment for nonopioid pain management drugs/biologicals functioning as supplies in ASC settings when those products meet certain CMS criteria (currently two products).

Incident-to Pharmacist-Provided E/M Services: CY2021 clarification remains that reimbursement for pharmacist-provided E/M services is limited to CPT99211. The definition of splitshare billing changes to apply only in institutional settings with no availability in OP settings, because the “incident-to” regulations govern situations “where a non-physician practitioner (NPP) works with a physician who bills for the visit, rather than billing under the NPP’s own provider number,” CMS stated in a guidance on this policy. Other proposed changes address new and established patient visits, critical care and certain Skilled Nursing Facility E/M visits.

Medicare Diabetes Prevention Program: Provider enrollment application fees are waived for all organizations seeking to enroll in Medicare as a Medicare Diabetes Prevention Program.

Vaccine Provision and Reimbursement: CMS is reviewing payments for COVID-19 and other preventive vaccines (e.g., influenza, shingles, pneumonia) and seeking feedback from vaccine providers regarding vaccine provision costs, including supplies and resources.

COVID-19: CMS is seeking provider input on what qualifies as the “home” in its preliminary policy to pay a $35 add-on for certain beneficiaries receiving COVID-19 vaccines at home, and whether COVID-19 monoclonal antibody products should be treated as other physician-administered drugs and biologics are under Medicare Part B. Electronic Prescribing of Controlled Substances (EPCS). CMS plans to implement the second phase of its EPCS rule for Medicare Part D, with some exceptions, including exceptions for prescribers in natural disaster areas and

an extraordinary-circumstances waiver.

Compliance effective dates are extended by one year to Jan. 1, 2023 (Jan. 1, 2025 for long-term care Medicare Part D drugs).

Telehealth Services The new proposed payment rules also include several updates involving telepharmacy. Here are four proposed rules to watch: 1. Pay providers for certain mental and behavioral health care services provided via audio-only telehealth calls under certain services (opioid

treatment counseling or therapy).

2. Eliminate geographic restrictions as barriers to telehealth services for mental health; access telehealth in patients’ own homes.

3. Cover telehealth used for diagnosis, E/M and treatment of mental disorders; pay physicians for mental health visits delivered via telehealth to rural and vulnerable patient populations.

4. Allow certain services added to the Medicare telehealth list to remain covered through Dec. 31, 2023, so “there is a glide path to evaluate

whether the services should be permanently added to the telehealth list following the COVID-19 public health emergency.”

Other key issues are an Appropriate Use Criteria penalty phase delay, Quality Payment Program changes, Medicare Shared Savings Program updates and changes to split-share billing, among others. In addition, be sure to track how CMS is basing its 2022 Payment for Drugs and Biologicals (see Table in online version at www.specialtypharmacycontinuum.com).

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Specialty Pharmacy Continuum • September/October 2021

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CDC, ACIP at Odds Over COVID-19 Boosters The CDC Director Rochelle P. Walensky, MD, MPH, endorsed the CDC’s Advisory Committee on Immunization Practices’ recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine for certain populations.

But she also recommended a booster dose for those in high-risk occupational and institutional settings. The CDC’s endorsement aligns with the FDA’s amended emergency use authorization (EUA) but rejects one of the ACIP recommendations; the ACIP did not recommend the booster for those with an occupational risk for COVID-19.

The CDC director’s endorsement is typically a formality, so it is highly unusual for the director to overturn the ACIP’s recommendations. She explained herself in a statement. “As CDC Director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health.

In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” Dr. Walensky said.

“I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19.

This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot,” she added.

Steven J. Martin, PharmD, BCPS, the dean and a professor at the Rudolph H. Raabe College of Pharmacy, Ohio Northern University, in Ada, noted that separate and independent scientific bodies reviewed the data and offered opinions about boosters. “Although the CDC

director, Dr. Walensky, chose a broader path for the Pfizer-BioNTech booster use than the CDC Advisory Committee on Immunization Practices, she recognized that her job is to ‘recognize where actions can have the greatest impact,’” Dr. Martin said.

“My sense is that we would have eventually seen the expansion of the booster recommendations to younger individuals in high-risk situations, so making that call from the outset seems prudent.

“I do think we have the public health infrastructure in place to readily provide boosters to all who qualify. Anything we can do at this point to reduce the spread of the virus and decrease the likelihood of another spike later in the year or winter flu season is a step forward,” he added.

But not everyone agrees with her.

“I was disappointed by Dr. Walensky’s decision,” said Paul Offit, MD, the director of the Vaccine Education Center and an attending infectious disease pediatrician at the Children’s Hospital of Philadelphia. “The ACIP was concerned about giving a third dose of mRNA [messenger RNA] vaccines to people as young as 18 years of age because of fear of increased risk of myocarditis, which is immunologically mediated.”

Dr. Offit explained that the third dose was more immunogenic than the second dose, so the concern is not misplaced.

“While the ACIP was willing to do this for younger people who were at high risk of serious infection, they weren’t willing to do this for those not

The Recommendation

T

he interim guidance from the CDC means that millions of Americans who are at highest risk for COVID-19 should receive a PfizerBioNTech COVID-19 booster shot to increase their protection. The CDC recommends: • people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series; • people aged 50-64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series; • people aged 18-49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks; and • people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission due to occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

—Marie Rosenthal

at high risk of serious disease but who worked in occupations or institutions where viral transmission was high,” said Dr. Offit, who is also a voting member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPRAC). “I think we should be testing the water with one foot here when it comes to people less than 30 years of age.

That’s what the ACIP was trying to do.”

There is a significant decline in vaccine effectiveness against infection during the delta surge, according to Ruth Link-Gelles, PhD, MPH, the co-lead of the CDC’s Vaccine Effectiveness Team.

After some discussion, most agreed that those 50 to 64 years of age should receive a booster if they have an underlying medical condition that puts them at risk for severe COVID-19.

A Roller Coaster Ride

Debating Benefits in Younger Pts

It’s been a roller coaster ride for the new booster indication, reminiscent of the original EUAs granted in 2020.

Pfizer-BioNTech applied for a Supplemental Biologics License Application for Comirnaty, the only FDA-approved COVID-19 vaccine, for a booster dose for everyone 16 years of age and older, claiming that immunity is waning.

VRBPRAC met on Sept. 17 to assess the request, and heard presentations from the company, the FDA and representatives from the United Kingdom and Israel, which are already giving boosters.

Although VRBPAC agreed that boosters are warranted for some individuals, the panel did not think they are necessary for all. There was considerable concern about the serious, although rare, side effect of myocarditis in younger recipients. VRBPAC recommended the vaccine for those 65 and older, and then added a caveat: The booster also should be given to those with an occupational risk for exposure. VRBPAC was concerned about health care workers in particular because many hospitals are filled to capacity with COVID-19 cases due to the surging delta variant. Healthy health care workers (HCWs) are sorely needed right now.

In a statement, Gerald E. Harmon, MD, the president of the American Medical Association, reiterated that sentiment: “We await further reviews of the evidence on booster doses in this population, which we believe could help preserve our nation’s health care capacity so we can continue providing care to our patients.”

On Sept. 22, the FDA updated the EUA for the vaccine to allow boosters for those 65 and older as well as those with an occupational exposure, which includes not only HCWs but also a broad group of others, such as grocery store clerks, first responders and teachers.

On Sept. 23, the ACIP met to decide how the amended EUA would be carried out. In a unanimous decision, the ACIP recommended that boosters should be given to those 65 and older, and those in long-term care. A CDC analysis revealed clear evidence of the need for a booster among those 65 and older receiving a booster dose six months after the primary series because of waning immunity.

There was a lengthy discussion about adults 18 to 49 years of age with an underlying medical condition that could put them at risk for severe COVID-19. In a much narrower vote (9-6), the panel agreed that those people could receive the booster, but the decision should be based on an assessment of their individual risk versus benefit.

But the panel stopped short of recommending a booster dose for those with an occupational risk, because they thought that recommendation was too broad.

“With high rates of SARS-CoV-2 infections and complications in many regions, and the need to keep things running as openly as possible in anticipation of colder weather, vaccination is a scalable and sustainable tool for reducing rates of infection, transmission, hospitalization and death as well as reducing the number of people who suffer with ... post–COVID-19 symptoms,” said Stuart C. Ray, MD, a professor in the Department of Medicine, Division of Infectious Diseases at Johns Hopkins University School of Medicine, in Baltimore. “Vaccinated high-risk workers are less likely to get infected, and if they do get infected will be infectious more briefly and infect fewer contacts. It makes sense to maximize their immunity.”

Dr. Ray said there are major gaps in the mitigation strategies that need to be addressed to maximize the effectiveness of COVID-19 interventions. Those gaps “are represented by people who have never been vaccinated, as well as our underutilization of high-quality masks, rapid tests and lack of standardization of reliable correlate measures of immunity.”

Some ACIP panel members thought that public health officials should spend their time devising strategies for vaccinating the unvaccinated, because those unprotected individuals are most at risk for COVID-19 and only 55% of eligible Americans are fully vaccinated.

This recommendation only applies to the Pfizer-BioNTech vaccine. The ACIP noted that people could mix and match the mRNA vaccines. According to the CDC, 2.37 million people have received an additional dose since Aug. 13.

—Marie Rosenthal

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1. Health and Human Services, Federal Drug Administration, 510(k) Clearance Letter, July 24, 2015.

2. Bartel SB, Tyler TG, Power LA, Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs, Am J Health-Syst Pharm. 2018; 75:199-211.

3. NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. http://www.cdc.gov/niosh/docs/2004-165/ Publication No. 2004-165. Washington DC: NIOSH; 2004.

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