Technology-driven innovations in care delivery grew rapidly in response to the pandemic, and none expanded faster than telehealth. As the need grew for new channels of safe, easily accessible care delivery, federal stimulus packages were enacted to support telehealth.

This legislation, passed in March 2020, enabled the Centers for Medicare & Medicaid Services (CMS) to make changes in telehealth policies, and many commercial payers instituted similar guidelines. Under the new regulations, providers can treat both existing and new patients virtually while being reimbursed at the same or close to the same rate as providers would be for in-office visits.

With relaxed regulations, telehealth grew dramatically as more and more providers embraced the technology. In the second quarter of 2020, virtual encounters comprised 14% of all health care visits.

Telehealth in oncology also grew. Prepandemic, only 8% of oncologists/hematologists in a recent survey reported using telehealth, but by May 2020, that number skyrocketed to 88%; 90% of oncologists/hematologists also indicated they plan to keep using telehealth postpandemic.

Telehealth is clearly here to stay, but to realize its vast potential, key stakeholders must support this care delivery channel and recognize its benefits. A look at the telehealth care delivery model over time in the specialty pharmacy context, as well as what can be done to sustain the advances made in telehealth, will be instrumental in this regard.

Lastly, the divide between medical and pharmacy benefit plans must be addressed. Health care is delivered in a variety of silos, and it is often said clinical care is a combination of many silos—each standing alone, doing what it does best.

 A patient’s medical plan is a separate silo facilitating medical services, and another silo, a pharmacy plan, manages access to drugs.

This separation increases the challenge of aligning the plans to allow for telehealth visits and guaranteed telehealth access to centers of excellence. To advance technology-driven channels of care, medical and pharmacy plans must concur on all aspects of coverage for telehealth medicine.

Can Telehealth Deliver High Quality Care?

Obviously, telehealth encounters will never completely replace face-to-face visits, but in some circumstances, they can actually drive improved patient outcomes. For instance, recent research found patients with cancer who could report symptoms on a regular facilitated call to a nurse in a telehealth visit or to a digital symptom-reporting portal lived 5 months longer on average than patients in the control group who were only able to report symptoms in a face-to-face clinical visit. 

Access to telehealth options allowed more responsive care in real time, resulting in improved symptom control that helped patients maintain mobility, a factor associated with better survival.

Although telehealth might be an acceptable care delivery mechanism when in-office visits are unsafe, some wonder if it should still play a role in health care postpandemic. Assessments of available data have resulted in a resounding yes, and a quick look at specialty pharmacy will demonstrate why—as specialty pharmacies use telehealth to drive and support quality care every day.

Specialty pharmacies have been providing superior care via telehealth long before the pandemic. In fact, experience has shown specialty pharmacies are highly efficient. 

Specialty pharmacies are experts in providing telehealth services because all their communication with patients is done by phone, text, and increasingly through online video channels. Consequently, specialty pharmacies have honed the ability to understand patients, communicate effectively with them, and efficiently manage their care without ever seeing them in person.

Specialty pharmacies position patients for success via telehealth encounters by creating and executing a personalized care path that supports adherence, reduces adverse events (AEs), enhances quality of life, and drives optimal outcomes.

Each patient is assigned a care team that is available by phone 24/7 and includes a board-certified pharmacist, a registered nurse, and, often, a certified pharmacy technician. With a dedicated team of experts, patients can request to talk to the same people every time, which helps build trust.

Members of the care team develop personalized assessments, adherence-risk evaluations, and ongoing counseling plans. Nurses constantly evaluate patients’ needs during regular check-ins over the phone, offering advice for AEs while coaching patients through any difficulties. Assessments are sent to the prescribing physician, indicating whether further action is needed or whether the patient was simply educated and assessed.

This care model—delivered entirely through telehealth mechanisms—is more scalable than in-office visits, allowing more patients to be seen and for longer visits. Specifically designed to enable frequent and consistent communication with patients, specialty pharmacy care models can serve to minimize logistical barriers, nonadherence, and unnecessary testing and medical services, which can result in reduced adversity and lower costs for all stakeholders.

Payers generally have accepted telehealth during the pandemic because they recognize it is a lower cost, highly effective form of care. Even Medicare has gotten on board with telehealth by waiving prior restrictions so more providers can deliver telehealth.

Currently, Medicare is assessing whether to reimburse clinical interactions via telehealth and electronic symptom-reporting portals. Payers have adopted telehealth much faster than anticipated due to the pandemic, but over time, they will likely also develop robust policies governing when telehealth visits are appropriate.

For specialty pharmacy, there are immense limitations on payer reimbursement, especially for patients with cancer or complex diseases needing interventions that were not previously possible with telehealth. Most payers have been slow to create guidelines that allow for reimbursement of telehealth services, often called medication therapy management. During the pandemic, many payers, especially CMS, relaxed the stringent requirements, although it is still quite challenging to qualify for and be paid for telehealth services.

However, there is great opportunity where specialty pharmacy excels, such as in monitoring AEs and providing adherence coaching between physician visits. Payers are recognizing how specialty pharmacy utilizes telehealth to help patients comply with treatment, reduce unnecessary care services, and optimize outcomes. 

But there is more work to do. Specialty pharmacy needs to educate payers so that they better understand how these benefits provide value to patients and the plans that are paying for these services.

Several obstacles must be overcome for telehealth to continue to thrive in the future. The pandemic highlighted the lack of digital infrastructure that plagues certain geographic regions; vast regional differences emerged among providers in relation to their ability to utilize technological platforms.

To ensure the future of telehealth and other virtual channels, policymakers must support broadband investments in underserved areas. Even if providers can offer telehealth, many patients lack internet access and need reliable broadband internet, if not in their own home, then through a regional technology hub.

Policymakers must also recognize patients with cancer and other complex diseases who would benefit from access to academic medical centers via telehealth for diagnosis, treatment planning, and care coordination with local providers. Collaborating with these centers can make possible the best opportunity for an optimal outcome, as these facilities bring cutting-edge treatments to patients. 

Quality care can be greatly advanced by requiring that access to centers of excellence through telehealth be written into coverage plans as a core benefit. Payers and policymakers must agree on these issues if real progress is to be made.

Telehealth has grown tremendously during the pandemic, demonstrating it can efficiently provide safe, real-time access to specialized clinical care. Medical providers who converted to telehealth are realizing the value of this technological platform because they are still able to provide a high level of care in a very challenging environment.

It is rewarding for the specialty pharmacy industry—experts in telehealth—to see providers adopting a patient-engagement technique that specialty pharmacy has successfully used for decades. Providers are recognizing what specialty pharmacy has always known: Telehealth empowers superior, cost-effective care by highly trained clinicians, driving optimal outcomes and a better patient experience.

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Articles

The use of these services in oncology is likely here to stay.

The Path to Optimizing Telehealth in a Post–COVID-19 World

is a new-generation oral androgen receptor inhibitor indicated for patients with nonmetastatic castration-resistant prostate cancer.

Although androgen deprivation therapy is the mainstay of care for patients with advanced hormone-sensitive prostate cancer, most patients will subsequently develop castration-resistant prostate cancer.

 In 2019, the FDA approved darolutamide for these patients; the novel molecular structure of darolutamide theoretically results in fewer and less severe toxic adverse effects (AEs) than other androgen receptor inhibitors currently on the market.

Available as a 300-mg oral tablet, darolutamide is recommended to be administered to patients at a dose of 600 mg twice a day with food. Patients on darolutamide should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy; patients may continue treatment with darolutamide until disease progression, which would be assessed radiographically, or unacceptable toxicity occurs.

If a patient experiences grade 3 toxicity or higher or an intolerable reaction to darolutamide, it is important to withhold dosing or reduce the dose to 300 mg twice a day until the symptoms improve. Upon symptom improvement, patients can resume the standard regimen of 600 mg twice a day. The manufacturer does not recommend dose reduction below 300 mg twice a day.

In prostate cancer, the primary targets for treatment are androgens and androgen receptor signaling pathways. Darolutamide exerts its effects via competitive inhibition of this androgen binding, leading to the blockade of both the androgen receptor nuclear translocation and the androgen receptor–mediated transcription. This decreases signaling from androgen receptors and reduces overall serum androgen levels.

The FDA's approval of darolutamide was based on a review of the results from the phase 3 multinational, randomized, double-blind, placebo-controlled ARAMIS trial (NCT02200614).

 The study’s primary end point was metastasis-free survival, which is the standard end point in trials involving castration-resistant prostate cancer.

During the study, median metastasis-free survival was 40.4 months in the darolutamide group versus 18.4 months in the placebo group (HR 0.41; 95% CI, 0.34 to 0.50; 

<0.001). Darolutamide reduced the risk of metastasis or death from any cause by 59%, a benefit evident across patient subgroups.

During treatment with darolutamide, the most common AEs experienced by patients are fatigue, pain in extremities, and rash (TABLE).

Serious AEs occurred in 25% of patients receiving darolutamide and in 20% of patients receiving the placebo.

In the ARAMIS trial, investigators reported that the incidence of AEs was generally similar in the darolutamide and placebo groups. Further, after adjustment for treatment duration or observation period, the differences between treatment and placebo groups in the incidences of relevant AEs either decreased or disappeared.

is a clinical staff pharmacist at LewisGale Hospital Montgomery in Blacksburg, Virginia.

Nubeqa. Prescribing Information. Bayer; 2021. Accessed October 28, 2021. http:// labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf

Fizazi K, Albiges L, Loriot Y, Massard C. ODM-201: a new-generation androgen receptor inhibitor in castration-resistant prostate cancer. 

. 2015;15(9):1007-1017. doi:10.1586/14737140.2015.1081566

Fizazi K, Shore N, Tammela TL, et al; ARAMIS Investigators. Darolutamide in nonmetastatic, castration-resistant prostate cancer. 

. 2019;380(13):1235-1246. doi:10.1056/ NEJMoa1815671

The drug's novel molecular structure may result in fewer toxic adverse effects.

Using Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer

According to the American Cancer Society, approximately 12,000 deaths were caused by multiple myeloma (MM) in 2021.

 Current drug therapies on the market to treat MM include chemotherapy, corticosteroids, immunomodulating agents, proteasome inhibitors, histone deacetylase inhibitors, monoclonal antibodies, antibody-drug conjugates, and nuclear export inhibitors.

However, the MM pipeline is continuously expanding, with a variety of drugs on the horizon. Treatment options under way for MM include several medication classes, such as naked monoclonal antibodies, bispecific antibodies, and chimeric antigen receptor (CAR) T-cell therapy.

Pharmacogenomics also has a critical role in the MM drug pipeline. For this reason, pharmacists play an important part on the interdisciplinary team as educators of other health care professionals on treatment options in the works. It is crucial that patients’ health care teams remain up-to-date with the most current drug information for treatment optimization, and pharmacists can often be looked to as the primary sources of that information.

Naked monoclonal antibodies are novel agents that target a specific protein on the surface of MM cells, enabling the patient’s immune system to eliminate the targeted myeloma cells.

Coming down the pipeline in this drug class is felzartamab (TJ202/MOR202; I-Mab), which is an investigational human monoclonal antibody directed against CD38 on the surface of MM cells that uses innovative technology derived from MorphoSys’ HuCAL.

 Patient enrollment for the phase 3 registrational trial in China of felzartamab in combination with lenalidomide (Revlimid; Bristol Myers Squibb) for second-line treatment of MM has completed, and the biologics license application is expected to be submitted to the US FDA in the near future.

The novel anti-CD38 antibody TAK-079 (Takeda) was shown to be safe and well tolerated in patients with relapsed/refractory MM, according to research presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program.

 TAK-079 is a subcutaneously adminis- tered monoclonal antibody, and patients were eligible to participate in a phase 1b study of the drug after at least 3 lines of therapy and prior exposure to immunomodulatory drugs, proteasome inhibitors, alkylating agents, and corticosteroid therapy.

 In total, 34 patients were enrolled across 5 fixed-dose cohorts, and no serious systemic infusion-related reactions were reported in the preliminary results.

Classified as antibody-based immunotherapy, bispecific antibodies contain 2 antibody fragments that have been fused together: One fragment targets myeloma cells (making them easier for the immune system to locate), and the other helps immune cells (by boosting their ability to find myeloma cells).

 Most agents in this class target B-cell maturation antigen (BCMA) on the myeloma cell and bind to a protein called CD3 found on the surface of T cells.

Elranatamab (PF-06863135; Pfizer Inc) is a BCMA CD3-targeted bispecific antibody being investigated in patients with relapsed/refractory MM. The phase 2 MagnetisMM-3 study (NCT04649359) is evaluating the safety of elranatamab given subcutaneously in patients with MM that is refractory to at least 1 drug therapy in each of the 3 major classes of medications approved for MM treatment, and the expected primary completion date is June.

Additionally, elranatamab has been granted fast track designation by the FDA. The phase 1 results from the study were presented at the 63rd American Society of Hematology Annual Meeting and Exposition in December 2020, with the results demonstrating that 83% of patients achieved a clinical response at the study dose, with no dose-limiting toxicities observed.

CAR T-cell therapy is a treatment in which the patient’s T cells are genetically changed to attack cancer cells.

 PHE885 (Novartis) is an investigational BCMA cell therapy infusion in phase 1 clinical trials for the treatment of relapsed/refractory MM.

The trial investigating PHE885 is currently recruiting patients, with an estimated enrollment of 40 participants. The primary outcome measure is dose-limiting toxicities during the first 28 days after administration and the incidence and severity of adverse events.

Utilizing pharmacogenomics enables treatments to be tailored through targeted therapies for MM based on patients’ genetic profile; this helps ensure an optimal response to a drug regimen. Over the years, even though survival has improved for patients with MM, most individuals eventually stop responding to treatment.

Currently, the ongoing phase 1/2 MyDRUG study (NCT03732703), which has an estimated primary completion date of February, is evaluating the following FDA-approved oncology medications targeting specific gene mutations, which could add future indications for MM

• Cobimetinib (Cotellic; Genentech USA, Inc): 

• Enasidenib (Idhifa; Celgene Corporation): 

• Abemaciclib (Verzenio; Eli Lilly and Company): CDK mutations

• Erdafitinib (Balversa; Janssen Biotech, Inc): 

• Venetoclax (Venclexta; AbbVie Inc/Genentech USA, Inc): chromosomal translocation t(11;14)

® contributor who resides in South Florida.

Key statistics about multiple myeloma. American Cancer Society. Updated January 12, 2021. Accessed December 4, 2021. 

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Clinical trials and experimental therapies. Multiple Myeloma Research Foundation. Accessed December 4, 2021. 

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Krishnan AY, Patel KK, Hari P, et al. A phase Ib study of TAK-079, an investigational anti-CD38 monoclonal antibody (mAb) in patients with relapsed/ refractory multiple myeloma (RRMM): preliminary results. 

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Pfizer initiates pivotal phase 2 MagnetisMM-3 trial of BCMA-CD3 bispecific antibody elranatamab (PF-06863135) in multiple myeloma. News release. Pfizer Inc. February 17, 2021. Accessed December 4, 2021. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-pivotal-phase-2-magnetismm-3-trial-bcma

BCMA-directed CAR-T cell therapy in adult patients with relapsed and/or refractory multiple myeloma. ClinicalTrials.gov. Updated January 6, 2022. Accessed January 13, 2022. 

https://clinicaltrials.gov/ct2/show/NCT04318327

Auclair D, Anderson KC, Avigan D, et al. The myeloma-developing regimens using genomics (MyDRUG) master protocol. 

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https://clinicaltrials.gov/ct2/show/NCT03732703

A variety of drugs from several medication classes are under investigation.

A Look at Multiple Myeloma Treatment Options in the Pipeline

Although treatment outcomes for patients with breast cancer have improved in recent years, data have shown that 1 in 8 women is likely to develop breast cancer in their lifetime.

 In 2021 alone, the United States recorded 281,550 new cases of invasive breast cancer, 49,290 new cases of noninvasive breast cancer, and 43,600 deaths from the disease.

 Currently, the evolving treatment approaches center on manipulating and targeting each tumor’s molecular identity to effectively treat the disease.

With the use of more sensitive screening protocols and sophisticated molecular testing, survival rates of patients with breast cancer are favorable. When breast cancer is localized, survival rates can approach 99%; when the cancer is regional (eg, metastasis to neighboring/surrounding tissues), survival rates are approximately 86%.

However, when cancer metastasizes to the lung, liver, bone, or brain, survival rates for patients with breast cancer drop to 28%. For this reason, early detection, prompt treatment, individualized therapy, and more tolerable and effective regimens are crucial to improve patient outcomes.

The majority (approximately 72%) of breast cancers are hormone sensitive (hormone receptor [HR]+/HER2-).

 The second most common subtype (approxi- mately 13%) is aggressive triple-negative breast cancer (TNBC, or HR-/HER2-), followed by hormone-sensitive/HER2- sensitive breast cancer (HR+/HER2+) at approximately 10%, and HR-/HER2+ breast cancer at 5%.

When directing next steps in a treatment plan, staging is often the most important factor. Once oncologists determine the stage and main genotype, the clinical team will work collaboratively with the patient to decide the best treatment strategy.

Clinicians use a few core therapies alone or, for greater efficacy, in combination with another therapy for breast cancer treatment (See Table 1

 provides further examples of breast cancer thera- pies used for treatment.

Patients with early-stage breast cancer (stages 0, I, II, or III) generally undergo primary surgery followed by adjuvant treatment. When the cancer is late, advanced, or metastatic at stage IV, surgical interventions are usually not an option and medication therapy is the mainstay.

Molecular targets and potential future changes for combatting breast cancer are as follows:

—Recent studies found that when started early, HR regimens can be as effective as traditional chemotherapy options and minimize adverse events.

—The success of trastuzumab (Herceptin; Genentech USA, Inc) and pertuzumab (Perjeta; Genentech USA, Inc) has sparked interest in exploiting HER2 as a target. Recently, the FDA approved margetuximab-cmkb (Margenza; MacroGenics, Inc), which may be effective for select patients as well.

 Additionally, cytotoxic drug conjugates have made significant progress, with more agents undergoing clinical trials.

—The immunotherapy space, including investiga- tion into the PD-1/PD-L1 pathway, is exploding due to findings that it may deter or treat brain metastases.

—Mutations such as BRCA1/2 and PALB2 have been identified as PARP inhibitor targets, especially in the treat- ment of metastatic TNBC.

 (CDK4/6)—More research efforts are combining CDK4/6 agents with endo- crine therapies in metastatic HR+ breast cancers, which may enable patients to avoid traditional chemotherapy if proven effective.

 (TKIs)—Oral medications such as tucatinib (Tukysa; Seagen Inc), lapatinib (Tykerb; Novartis Pharmaceuticals Corporation), neratinib (Nerlynx; Puma Biotechnology, Inc), and newly developed TKIs may protect against brain metastases and have a role in HER2+ meta- static breast cancer treatment.

—Alpelisib (Piqray; Novartis Pharmaceuticals Corpora- tion) has shown promise in the SOLAR-1 (NCT02437318)11 and BYLieve (NCT03056755)12 clinical trials and may benefit patients with PIK3CA-mutated tumors or HR+ metastatic breast cancer.

—Antiangiogenesis drugs such as bevacizumab (Avastin; Genentech USA, Inc) have returned to clinical trials combined with chemotherapy/immunotherapy, which may have potential in the treatment of metastatic HR+ breast cancer.

 (histone deacetylase)—Entinostat and tucidinostat are both in clinical trials for various cancers. Tucidinostat is also currently recruiting for a phase 2 clinical trial for metastatic HR+ breast cancer treatment.

 (tumor-associated calcium signal transducer 2)—The FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences, Inc) in 2021 for the treatment of metastatic disease in TNBC; currently, more agents in this novel class are being developed, studied, and assessed.

Chemotherapy often has off-target effects due to its cytotoxic nature, but it still has a place in treatment as a monotherapy or in a combination treatment. Moving forward, investigators are formulating chemotherapy in more tolerable, convenient, and effective vehicles such as oral dosage forms or drug-antibody conjugates with targeted payload deliveries that exhibit less off-target effects.

During the clinical decision-making process around treatments, breast cancer subtypes have a direct impact on therapy options. Table 3 summarizes treatment approaches for the common HR+/ HER2- subtype.

Most breast cancer is hormone sensitive, which implies that both the estrogen receptor and progesterone receptor can be targeted to inhibit tumor growth.

Additionally, shifting from traditional chemotherapy to a more effective targeted endocrine therapy, especially when resistance to endocrine therapy develops, can have a significant impact. Comparative research, early detection, and an optimized medication repertoire may make this shift a possibility soon. Regardless, results from the TAILORx trial (NCT00310180) and guidance from the National Comprehensive Cancer Network support the integration of chemotherapy and endocrine treatment when recurrence potential is high.

Patients with both the HR+ subtype and HER2+ subtype (triple positive) can receive all the endocrine therapy options shown in Table 3; these patients can also receive all chemotherapeutic options in addition to HER2+ guided treatment plans.

 In Table 4, treatment approaches for the HER2+ subtype are included.

In HR+/HER2+ patients, trastuzumab can be combined with fulvestrant or aromatase inhibitors (AIs) with or without lapatinib, and AIs can be used with lapatinib and without trastuzumab. However, endocrine therapy is not indicated for HR- subtypes.

Cancers that lack estrogen receptor, progesterone receptor, or HER2 are difficult. Because TNBC lacks targets, the most effective treatments for early and late stage are identical to options found in Table 3.

In any stage, clinicians may use adjunctive therapy options, such as atezolizumab (Tecentriq; Genentech USA, Inc) with albumin-bound paclitaxel (with PD-L1 expression), pembrolizumab (Keytruda; Merck Sharp & Dohme Corp; with PD-1 expression), platinums, capecitabine, or sacituzumab govitecan-hziy.

The growing trend is targeted, safe, and effective therapy that aligns with the patient’s goals. Currently, there are unmet needs for therapy options that target HER2, for antibody-drug conjugates, and for more advanced-stage therapies for those with TNBC. However, it seems likely that in the future, we can expect to see more effective oral therapy options for HER+ cases.

Today, research is primarily focusing on reducing progression, propagation, and treatment-resistant genotypes; however, clinicians should remain open to the de-escalation of chemotherapy and/or invasive surgical procedures because other options may be as effective or superior.

, is a pharmacist and sterile products coordinator at St Vincent’s Medical Center in Bridgeport, Connecticut. He is a graduate of
the University of Connecticut’s School of Pharmacy.

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An emerging focus is aligning targeted, safe, and effective therapies with patient goals.

Looking Ahead: Trends in Breast Cancer Care in 2022

®, experts in the field examined multiple aspects of Waldenström macroglobulinemia (WM), including how it presents, what pharmacists should know about the disease, and how to treat it.

WM is an uncommon lymphoma, with approximately 3000 new cases reported each year in the United States.

 According to Steven P. Treon, MD, PhD, director of the Bing Center for Waldenström’s Macroglobulinemia, an attending physician for medical oncology at Dana- Farber Cancer Institute and Brigham and Women’s Hospital, and an associate professor of medicine at Harvard Medical School in Boston, Massachusetts, the disease shares features of both lymphoma and myeloma.

“As a result, the therapies that we typically use are meant to cover the clone that transcends both mature B cells and plasma cells,” Treon said during the discussion. “And so classically with chemoimmunotherapy, we’ve had to combine drug therapy that goes after lymphoma along with drug therapy that goes after myeloma so we can cover the entire clone.”

Treon also noted that WM can present several ways, with hyperviscosity syndrome being a common manifestation for patients.

“[WM] can have the IgM antibody made by tumor cells acting as autoantibodies,” Treon said. “[It] can [cause] renal failure because of the deposition of those antibodies, as well as amyloidosis. [WM] can present with classical cytopenias, and [it] can also present with bulky masses and even disease that gets into the [central nervous system (CNS)] space.”

For this reason, Treon explained, it is important to keep in mind from the pharmacy perspective that there can be multicompartment disease.

“Sometimes even the dosimetry of some of the therapies that we use, and even the therapies themselves, can be very much affected by what compartment we’re looking to treat,” he said.

Additionally, the panel discussed methods of identifying the disease. They noted that although the 

mutation is carried by 95% to 97% of patients with WM, it is not unique to the disease because a small percentage of patients with marginal zone lymphoma also present with the mutation.

 Further, it is extremely common for individuals with primary CNS lymphoma to harbor a 

“What’s fairly unique to [WM] is [the] IgM protein because the IgM that’s made by the tumor cells can mediate a lot of the morbidity,” Treon said. “And as a result, when you’re thinking about therapy, you want to think about ways that you can actually turn that IgM off—how you can target the tumor cells in a way that you can get that IgM down and, many times, get it down very rapidly, especially with somebody with hyperviscosity syndrome.”

According to Treon, approximately 30% of patients with WM do not require immediate treatment. If a patient with WM is feeling well and has no symptoms of clinical significance, he said health care professionals can “watch and wait” before initiating any treatment. Guidelines from the National Comprehensive Cancer Network define points at which providers should shift to active treatment.

“It is important to recognize that a fair number of patients...meet the diagnostic criteria but are relatively asymptomatic,” Treon said during the discussion. “We tend to treat people who have very high IgM levels. If they’re above 6000 mg/dL, we’ll treat them because the data that we have when we’ve published seem to suggest that they’re more likely to get into trouble than not, and, therefore, why wait until somebody gets into trouble? Because the manifestations of hyperviscosity sometimes are irreversible, like bleeding in the retina.”

1. IMBRUVICA® (ibrutinib) in Combination with Rituximab Showed Greater Efficacy Compared to Placebo Plus Rituximab in Patients with Waldenström’s Macroglobulinemia, a Rare and Incurable Form of Non-Hodgkin’s Lymphoma. Chicago, IL: Janssen Pharmaceutical Companies; June 1, 2018. Accessed January 10, 2022. 

https://www.jnj.com/media-center/press-releases/imbruvica-ibrutinib-in-combination-with-rituximab-showed-greater-efficacy-compared-to-placebo-plus-rituximab-in-patients-with-waldenstroms-macroglobulinemia-a-rare-and-incurable-form-of-non-hodgkins-lymphoma

2. Gachard N, Parrens M, Soubeyran I, et al. IGHV gene features and MYD88 L265P mutation separate the three marginal zone lymphoma entities and Waldenström macroglobulinemia/lymphoplasmacytic lymphomas. 

 27,183–189(2013). doi: 10.1038/leu.2012.257

The uncommon disease shares features of both lymphoma and myeloma.

Waldenström Macroglobulinemia: Common Presentations, Treatment Strategies

for oncology medications made up just 3% of total drug expenditures in the United States. In 2020, that number climbed to 15%. Oncology medication is now one of the single largest drivers of specialty spending—increasing on a net basis by an astonishing 316% since 2011. In the next 5 years alone, 100 new oncology medications are expected to reach the global market, culminating in over $300 billion in oncology drug spending by 2026.

Oncology treatment is rapidly evolving. So, too, are the needs of patients, prescribers, pharmaceutical manufacturers, and payors. As the health care industry in the United States pivots toward a value-based system, specialty pharmacies play an increasingly important role in advancing positive health outcomes, controlling costs, and providing real-world insights into the impact of specialty medications used to treat cancer. This article examines the evolution of specialty pharmacy to meet the needs of patients and other health care stakeholders in the oncology space.

Effective specialty pharmacies learn to meet the changing needs of patients and stakeholders.

February 2022

The Path to Optimizing Telehealth in a Post–COVID-19 World

Using Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer

A Look at Multiple Myeloma Treatment Options in the Pipeline

Looking Ahead: Trends in Breast Cancer Care in 2022

Waldenström Macroglobulinemia: Common Presentations, Treatment Strategies

The Evolution of the Oncology Pharmacy

Trends in Oncology Pharmacy in 2022

In Memoriam: Michael J. Hennessy Sr.