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Specialty pharmacy has been at the forefront of the pharmacy world for the past few years. Innovative new therapies are being researched and developed every day.

Some of the disease states that are often treated by specialty medications include different types of cancers, multiple sclerosis, rheumatoid arthritis, and HIV. These therapies are life changing, but is are the cost. This puts the pharmacy benefit managers (PBMs), plan sponsors, and patients in a tough position financially speaking.

Specialty pharmacy has grown at a rapid pace over the past decade. With research and development improving, as well as new disease states being discovered, there is no shortage of need for specialty medications and for good reason.

These medications prolong life and allow the patient to enjoy a semi-normal lifestyle and go to work. Let’s examine Humira, for example, with 2 injections per month able to help a patient with rheumatoid arthritis. It allows patients to complete their daily activities again, such as walking without pain, cooking, or cutting the grass, for example. I’d say that’s worth it.

This is one of the problems regarding specialty pharmacy. There is a lack of a true definition, and when you open something like this up for interpretation, it creates grey areas. Many plan sponsors would categorize specialty medicine as high cost drugs; however, although that is often true, it is not an accurate way to describe them.

To me, specialty medications are biologics or a medication that requires extreme special handling. Biologics are made from living organisms or contain components of living organisms. The special handling can be using personal protective equipment or specific temperature requirements.

Administration of the specialty medications is crucial and must be done the right way. These medications are often thought of as injectables. Although most of them are injectable or infused, they can also be oral or inhaled.

In short, yes, however, there are not a lot of generic specialty medications. And to add on to that, the newer approved branded medications often push aside the older medications, as they are more refined and have fewer adverse effects. However, there is another alternative in biosimilars.

Biosimilars are not technically generics, they are a highly similar alternative to the biological medication. Unlike generics, biosimilars are a brand name medication themselves and would require a new prescription to be dispensed because they are not interchangeable with a specialty medication.

According to multiple recent studies, specialty medications account for 50% of all drug spend. In 2019, that number was roughly $500 billion, which means that specialty medications cost approximately $250 billion. Just a few years ago specialty spend was roughly 25% of all drug spend. These numbers are growing fast and don’t seem to be slowing down any time soon.

In a word: Competition. As stated earlier, biosimilars are still brand name medications and can also be quite expensive. When there are more medications on the market, manufacturers will have to reduce costs to remain competitive.

Within the drug pipeline, more high-cost specialty medications will be coming soon. There are hundreds in clinical trials and quite a few awaiting approvals as new disease states are discovered and need treatments.

I don’t know if they have an answer, but they have a few different options.

Create or add specialty tiers to the formulary

Implement utilization management programs

The prices of these medications put a strain on both the patient and the PBM. Therefore, finding a way to balance the cost share is a huge part of the industry right now. The members are in need of help, but so are the PBMs.

Since working at a specialty pharmacy, I have been able to speak with some of these patients. One question that I always ask is “Do you feel like your medication is helping you?”

When I hear a yes on the other end of the phone, it assures me that I am in the right field of pharmacy. They often tell me how grateful they are that we are here for them. This can only brighten up your day and make you smile.

Specialty medications should not be defined by their cost and should instead be defined by their efficacy. While I understand that price is a big factor, we cannot deny patients the treatment that they need and that works for them. Specialty medications will continue to be at the forefront of every pharmacy conversation for the near future.

Ryan Fitzmaurice earned his Doctor of Pharmacy degree from Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy and earned his Masters of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. He has spent the past several years working across the industry including retail pharmacy management, specialty pharmacy, and 340B pharmacy.

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Specialty medications should not be defined by their cost and should instead be defined by their efficacy. 

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Specialty Pharmacy

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Results from the phase 2 CodeBreaK 100 clinical trial assessing sotorasib (Lumakras; Amgen) in previously treated patients with non-small cell lung cancer (NSCLC) showed that the drug presented a median overall survival (OS) of 12.5 months among 124 patients who were evaluable during the trial.

The findings, presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, focused primarily on data pertaining to OS, which was a secondary endpoint of the trial. The majority of patients in the trial had been treated with platinum-based chemotherapy and immunotherapy (81%) prior to commencement.

Additionally, the results confirmed sotorasib had an objective response rate (ORR) of 37.1%, duration of response (DoR) of 11.1 months, and disease control rate (DCR) of 80.6%. An additional patient was also able to achieve complete response, which brought the total to 4 complete responses and 42 partial responses compared to results that were previously reported.

The data presented at the 2021 ASCO Annual Meeting are updated from the previously presented results at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer in January 2021. These updated data are based on a longer follow-up time of 15.3 months.

"Patients with KRAS G12C-mutated non-small cell lung cancer face poor outcomes so we are pleased with these overall survival results and the impact LUMAKRAS may have for patients with this devastating mutation," said David M. Reese, MD, executive vice president of Research and Development at Amgen, in a press release. "The results further confirm the deep and durable responses we have seen with LUMAKRAS throughout the CodeBreaK clinical trial program, the most advanced KRAS G12C clinical trial program with the longest follow-up."

During the exploratory analyses, investigators observed that tumor response to sotorasib was consistent across multiple biomarker subgroups, such as patient subgroups stratified by baseline PD-L1 expression levels and those with STK11 mutation.

Within the patient subgroup separated by baseline programmed death-ligand 1 (PD-L1) expression (n=86), investigators observed that the tumor response and shrinkage were present across a range of baseline PD-L1 expression levels, with a response rate of 48% within the PD-L1 negative patient group (TPS <1%).

Furthermore, in the STK11 mutation group, the investigators observed an improved efficacy upon treatment of sotorasib with the concurrent wild-type KEAP1 (n=22), with an observed median progression free survival of 11.0 months and median OS of 15.3 months among this patient population.

"Sotorasib is the first KRASG12C inhibitor to show an overall survival benefit, and the data represent a major step forward for patients with KRAS G12C-mutated non-small cell lung cancer where standard of care options are suboptimal," said lead investigator Ferdinandos Skoulidis, MD, PhD, assistant professor of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, in the press release. "KRAS has been one of the most challenging therapeutic targets in cancer research, and these practice-changing results give hope to patients with the KRAS G12C mutation who previously had no targeted treatment options."

On May 28, 2021, sotorasib received FDA approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. Sotorasib also received an accelerated approval based on the positive ORR and DoR results, although the continued approval for this indication may require further verification and description of clinical benefit in a subsequent confirmatory trial.

Results From Phase 2 CodeBreaK 100 Show LUMAKRAS™ (sotorasib) Is The First And Only KRAS G12C Inhibitor With Overall Survival Data. Thousand Oaks, CA: Amgen; June 4, 2021. 

https://www.amgen.com/newsroom/press-releases/2021/06/results-from-phase-2-codebreak-100-show-lumakras-sotorasib-is-the-first-and-only-kras-g12c-inhibitor-with-overall-survival-data

Phase 2 clinical trial results assessing sotorasib in previously treated patients with NSCLC showed that the drug presented a median OS of 12.5 months among 124 patients.

Oncology

Lung Cancer

Trial Results Show Sotorasib Is First, Only KRAS G12C Inhibitor With Overall Survival Data for Non-small Cell Lung Cancer

A new treatment for Alzheimer disease (AD) provides another option to treat this progressive disease that causes the brain to atrophy.

Known as one of the most common causes of dementia in adults, AD leads to a decline in the ability to function independently, behavioral and social skills, and thinking processes.¹

About 5.8 million Americans in 2020 were living with the disease, according to CDC data.

Estimates show that this number will nearly triple to about 14 million people by the year 2060. Although the disease occurs mostly in older individuals, symptoms sometimes also occur in younger patients.²

AD is the sixth-leading cause of death in the United States and the third-leading cause of death for patients older than age 65 years.³

The disease is named after physician Alois Alzheimer, MD, who in 1906 discovered changes in the brain of a female patient who had died of mental illness. This patient suffered from language problems, memory loss, and unusual behavior. While examining her brain, Alzheimer found a few abnormal clumps, also known as amyloid plaques, and tangled bundles of fibers called neurofibrillary tangles.³

An early symptom of AD is forgetfulness. As the disease advances, the individual may develop more severe memory impairment and can become more debilitated, causing then to struggle with completing everyday tasks. Symptoms are typically noticed by close family members who interact with the individual frequently, and they may become severe to the point that the patients forget relationships and even sometimes the names of loved relatives. Changes in the brains of these patients can also affect their behavior and mood and include aggressiveness, delusions, depression, irritability, more distrust of others, and social withdrawal.¹

Causes of AD may be related to brain proteins that fail to function normally, causing neurons to not be able to perform their duties. This impairment can be caused by environment, genetics, and lifestyle. The damage starts earlier than the point that the symptoms start to show, and in late stages, the brain shrinks significantly from its normal size.¹

The proteins involved include beta-amyloid plaques, which when clumped together cause toxic effects on neurons and disrupt the cell-to-cell connection. Meanwhile, Tau proteins help carry essential minerals and nutrients to the brain, and in patients with AD, these proteins change shape and become entangled. This disrupts the nutrient transport system, affecting brain cell function.¹

Genetics play a role in a patient developing AD, specifically for those with first-degree relatives diagnosed with the disease. Gender also plays a role, with women diagnosed more often than men, though this may also be related to the fact that women tend to live longer.

One genetic factor known to cause the disease is Apolipoprotein E gene, which with the e4 variation, increases the risk of AD exponentially. Additionally, patients with Down syndrome are more likely to develop AD than others. This is likely related to 3 copies of the chromosome 21, which connect with the creation of beta-amyloid.¹

Diagnosing AD may include neuropsychological testing and brain imaging, using amyloid positron emission tomography (PET), computer tomography, magnetic resonance imaging, PET scan, or Tau PET imaging.¹

Medications used to great AD include those that help with memory symptoms and treat cognitive changes. Two major types of the drugs available on the market for these patients include cholinesterase inhibitors and memantine. Cholinesterase inhibitors may help treat agitation and depression and commonly include donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon). Memantine (Namenda) and the combination of memantine and donepezil (Namzaric) combine a cholinesterase inhibitor with memantine to help with medication compliance and help slow the progression of disease symptoms.¹

On June 8, 2021, the FDA approved aducanumab injection (Aduhelm), an amyloid beta-directed antibody indicated for the treatment of AD. Aduhelm comes in 2 dosages of 170mg/1.7ml and 300mg/3ml solution. The recommended dosage for this drug is 10mg/kg as an intravenous infusion for more than 60 minutes every 4 weeks.⁴

Aduhelm provides new hope for patients diagnosed with AD to have more treatment options available to them after many years of waiting for an FDA approval. The future for research in this area is promising and holds the key to more discoveries, including a cure for AD.

Alzheimer’s disease. Mayo Clinic. December 29, 2020. Accessed June 14, 2021. https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/symptoms-causes/syc-20350447

Alzheimer’s disease and healthy aging. CDC. October 26, 2020. Accessed June 14, 2021. 

https://www.cdc.gov/aging/aginginfo/alzheimers.htm

Alzheimer’s disease fact sheet. National Institutes of Health. May 22, 2019. Accessed June 16, 2021. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet

Aduhelm. Biogen Inc; 2021. Accessed June 14, 2021. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf

The FDA recently approved the amyloid beta-directed antibody indicated for the treatment of the progressive disease.

Brain Health

Neurology

Aduhelm Is A New Option to Treat Alzheimer Disease

Hypertension arises from a gradual increase in pressure as blood pushes against the walls of arteries, veins, and capillaries.1 Incidences of hypertension are increased in the elderly due to reduced elasticity of blood vessel walls from elastin loss, increased vessel calcification, as well as the progression of atherosclerosis.

Aging can also result in the aorta becoming thick, stiff, and less flexible, because of changes to connective tissue.

 The heart has to work harder to overcome this, causing hypertrophy of the heart muscle.

 Surrounding arteries can become stiffer and may further harden as fatty plaques deposit, eventually leading to narrowing or complete blockage of the vessel.

Managing hypertension is important to minimize complications of cardiovascular disease, stroke, and renal failure. When this disease is appropriately managed, patients can significantly improve their life expectancy, as well as limit medical costs from disease progression.

Patients with the highest risk of complications from hypertension are those 65 years of age or older. Blood pressure should be frequently monitored in these patients due to patient-specific factors including decreased organ function, their risk of medication-related adverse effects, and higher occurrences of myocardial infarction or stroke. The instance of polypharmacy in older adults—use of 4 or more medications—increases the need to prioritize management of blood pressure treatment.

Pharmacists have the ability to improve patient outcomes by assisting with the use of antihypertensive medications, providing lifestyle management techniques, and identifying patient drug utilization difficulties. This article will review the frequency of hypertension in older adults, blood pressure goals in the elderly, pharmacological or nonpharmacological treatment options in this population, how to manage orthostatic hypotension, and contraindicated medications.

According to the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, patients are classified into the stage of hypertension after obtaining 2-3 blood pressure measurements, during at least 3 separate occasions. Normal blood pressure, elevated, stage 1, and stage 2 classes, are defined below.

Normal:systolic <120 mmHg and diastolic of <80 mmHg.

Elevated blood pressure: systolic between 120- 129 mmHg and diastolic <80 mmHg.

Stage 1: systolic between 130-139 mmHg or diastolic between 80-89 mmHg.

Stage 2: systolic readings > 140 mmHg or diastolic of 

A study was conducted across the United States to determine how blood pressure diagnostic criteria from the 2017 ACC/AHA guidelines impacted treatment in adults. Data were collected from a National Health and Nutrition Examination Survey (NHANES) from 9623 participants. Each patient had hypertension results pulled from 3 standardized blood pressure measurements.

Candidates were separated into several age categories, but all patients were required to be at least 20 years of age with every systolic blood pressure (SBP) and diastolic blood pressure (DBP) reading obtained at study visits. Blood pressure was measured by a trained physician using a mercury sphygmomanometer, and patients were also separated out into their risk for cardiovascular disease (CVD), with the highest risk of CVD (

10%) amongst those with a previous history of CVD.

Results of the study showed that the majority of the patients were non-Hispanic whites, had normal blood pressure (42.3%), and were 38 years of age. Those found to have elevated blood pressure were around 60 years of age (12.1%).

The study concluded that overall hypertension prevalence was more frequently diagnosed in patients using the 2017 ACC/AHA guidelines (45.6%) versus the JNC7 guideline parameters across all subgroups, and more antihypertensive medications were recommended to patients with concurrent disease states or 

Diagnosis is important because with appropriate nonpharmacological interventions and drug therapy, chances of CVD diagnosis can be substantially reduced for at-risk patients, particularly in the elderly.

Goals for lowering blood pressure may vary from patient to patient. Drastically lowering blood pressure can be dangerous in the elderly population. Blood pressure goals should be balanced with patient risk factors and the patient’s state of health. Goals may differ for patients who reside in long-term care living facilities, but for those who are noninstitutionalized, it is recommended that those older than 65 with an SBP > 130 mmHg reduce this to < 130 mmHg.

Patients who have a high number of comorbidities or short life expectancy may have better outcomes with a team-based approach that is assessing risk versus benefit of blood lowering goals and drug therapy.Most benefit has been seen in SBP-specific lowering, when SBP is

Previous randomized controlled trials have not shown that harm outweighs the benefit for treatment of hypertension in the elderly, but that antihypertensive agents are among the few treatments that reduce mortality in frail patients.

Orthostatic hypotension (OH) is a sustained reduction of SBP >20 mmHg or DBP >10 mmHg within 3 minutes of standing. Blood pressure must be collected when a person is in standing and sitting position and is important to identify in elderly patients to reduce their risk of falls.

When treating this condition, the goals are to improve symptoms versus targeting haphazard blood pressure levels.

 Pharmacological agents could be the culprit of OH. In the ALLHAT trial, first-line antihypertensive agents were compared in patients with fatal coronary heart disease or nonfatal myocardial infarction. 

Patients 65 years of age or older were separately analyzed to formulate the relative risk for falls, syncope, and OH. Approximately 23,964 patients were analyzed in this sub-analysis, with most being female (45%) and at least 69 years of age. More than 267 falls were found and 249 cases of OH.

The results of this analysis found no significant difference to cumulative events from random drug assignment, but the study did find that after a 1-year follow up with amlodipine, patients seem to have an increased chance of falls compared to using lisinopril or chlorthalidone. This study concluded that there are no specific antihypertensive medications that increase the incidence of falls or OH, but treatment should be carefully selected and monitored in each patient.

Signs and symptoms of OH should be addressed with patients and can include feelings of dizziness, blurred vision, fatigue, or headache. Other causes of OH could be anemia, dehydration, and medical conditions that impact the autonomic nervous system, such as Parkinson disease. Treatment of OH could be achieved by modifying the antihypertensive agent or using nonpharmacological treatments.

Patients may try avoidance of alcoholic beverages, slowly rising from sitting to standing, slow deep breathing, or eating small, frequent meals.

 If medications are necessary, use of fludrocortisone to increase intravascular volume, or midodrine to increase vascular resistance may be alternative options.

Nonpharmacological treatment options can be combined with medication therapies to help elderly patients better manage blood pressure. Weight loss for obese adults to ideal body weight may be helpful to reduce blood pressure by 5 mmHg. Diet may be a consideration for patients and, if appropriate, use of the DASH diet. This would be consumption of higher amounts of fruits, vegetables, whole grains, and low-fat dairy.

Sodium reduction to less than 1500 mg per day can also help to reduce blood pressure by 5-6 mmHg. Physical activity may be most beneficial for patients since this helps to improve bone health and reduces CVD. Customize diet and exercise plans to meet patient needs but aim for 150 minutes of exercise each week.

No specific agents have proven to be more effective in antihypertensive effects among the elderly; however. agents should be selected based on patient specific factors, including the impact of a drug adverse effect profile on an individual or their ethnicity.

 Agents that should be avoided in patients over 65 years of age who are at an increased risk of falls from OH include alpha-1 blockers, such as doxazosin.

Clonidine and nifedipine should also be avoided because of the high potential of hypotension. Other adverse effects of clonidine that could be dangerous in certain older populations are central nervous system effects and incidences of bradycardia.

 Pharmacists can help patients in medication adherence by educating them about the importance of taking their medications on a daily basis, assisting with creating a medication schedule to help minimize medication adverse effects, and alerting physicians when changes to therapy may be needed.

Research related to hypertension management in older adults has increased, but there is still more to be done. Current guidelines for hypertension treatment in adults have outlined treatment considerations in the elderly and numerous studies have been conducted to determine the effects of antihypertensive agents in the elderly population.

Pharmacists play a part in assisting patients by helping to modify blood pressure therapies when patients experience adverse effects or helping if a patient has difficulty remembering to take their medications. When hypertension is properly managed by all providers, it improves medication outcomes and minimizes disease-related complications.

What is High Blood Pressure? www.heart.org. https://www.heart.org/en/health-topics/high-blood-pressure/the-facts-about-high-blood-pressure/what-is-high-blood-pressure. Published October 31, 2016. Accessed June 23, 2020.

Aging changes in the heart and blood vessels: MedlinePlus Medical Encyclopedia. (2020, July 02). Retrieved July 23, 2020, from https://medlineplus.gov/ency/article/004006.htm

A Mechanism by Which Hypertension Accelerates Atherosclerosis. (2018, November 06). Retrieved July 23, 2020, from https://www.fightaging.org/archives/2018/11/a-mechanism-by-which-hypertension-accelerates-atherosclerosis/

Whelton PK, Paul K. WheltonSearch for more papers by this author, Carey RM, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065. Published November 13, 2017. Accessed June 23, 2020.

Muntner P, Carey RM, Gidding S, et al. Potential US Population Impact of the 2017 ACC/AHA High Blood Pressure Guideline. 

. 2018;137(2):109-118. doi:10.1161/CIRCULATIONAHA.117.032582

Arnold AC, Raj SR. Orthostatic Hypotension: A Practical Approach to Investigation and Management. 

. 2017;33(12):1725-1728. doi: 10.1016/j.cjca.2017.05.007

Juraschek SP, Simpson LM, Davis BR, Beach JL, Ishak A, Mukamal KJ. Effects of Antihypertensive Class on Falls, Syncope, and Orthostatic Hypotension in Older Adults: The ALLHAT Trial. 

. 2019;74(4):1033-1040. doi:10.1161/HYPERTENSIONAHA.119.13445

By the 2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. 

. 2019;67(4):674-694. doi:10.1111/jgs.15767

Pharmacists play an important role in assisting with hypertension treatment by helping to modify blood pressure therapies when patients experience adverse effects or helping if a patient has difficulty remembering to take their medications. 

Retail

Cardiovascular Health

Weight Management

Hypertension Management in Older Adults

Results from the primary analysis of ZUMA-3 study evaluating the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (Tecartus, Gilead) showed a high response rate in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The findings led to the FDA accepting the supplemental Biologics License Application and Priority Review designation for treatment, according to a Gilead press release.

“Outcomes in adults with acute lymphoblastic leukemia are poor relative to what is observed in children, with less than half of people over 20 years of age expected to survive the illness. It is on this background that CAR T-cell therapy with brexucabtagene autoleucel was tested in adults with relapsed B-ALL in ZUMA-3,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, in a press release. “In this international, multicenter study, we observed a response rate of 71%. Importantly, the majority of these responses were associated with undetectable minimal residual disease.”

Brexucabtagene autoleucel uses the XLP manufacturing process that includes T cell enrichment, which is a crucial step in specific B-cell malignancies in which circulating lymphoblasts are a common feature.

The phase 2 trial analyzed 71 patients with relapsed or refractory disease, and out of the 55 treated patients enrolled, 47% had received 3 or more prior therapies. At the median follow-up of 16.4 months, 71% of treated patients achieved a complete response (CR) or CR with incomplete hematological recovery (CRi), with 31% in ongoing response at data cut-off. Further, 97% of the responders had deep molecular remission, with undetectable minimal residual disease and median overall survival (OS) among all responders not yet reached, according to the study authors.

Of 25 patients previously treated with blinatinumomab, the CR/CRi rate was 60%, whereas the median duration of response, relapse-free survival, and OS among all patients who were treated were 12.8 months, 11.6 months, and 18.2 months, respectively.

“The data presented at ASCO [June 4] validate the response rates seen in the phase 1 portion of the ZUMA-3 study and the transformative potential of Tecartus in adult patients with ALL,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development, in the press release. “We have already seen the impact of Tecartus for patients with relapsed or refractory mantle cell lymphoma, and these new data are a significant next step in our continued commitment in developing our therapies for patients with leukemias and lymphomas.”

Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation. Gilead. Published June 4, 2021. Accessed June 16, 2021. 

https://www.gilead.com/news-and-press/press-room/press-releases/2021/6/kites-tecartus-demonstrates-high-response-rate-in-adults-with-relapsed-or-refractory-bcell-acute-lymphoblastic-leukemia-earning-priority-review-des

Hematology

Brexucabtagene Autoleucel Demonstrates High Response Rate with Relapsed, Refractory B-cell Acute Lymphoblastic Leukemia

A study from the American Academy of Sleep Medicine indicates that trouble falling asleep was the primary symptom of insomnia that predicted cognitive impairment 14 years later, according to the press release.

The study authors examined data from the Health and Retirement Study, which included 2496 individuals who were at least 51 years of age. In 2002, the participants reported the frequency of insomnia symptoms, whereas in 2016, the participants' cognition was evaluated as part of the Harmonized Cognitive Assessment Protocol. The study was further operationalized with a comprehensive neuropsychological battery evaluating episodic memory, executive function, language, visuoconstruction, and processing speed, according to the study authors. 

"While there is growing evidence for a link between insomnia and cognitive impairment in older adults, it has been difficult to interpret the nature of these associations given how differently both insomnia and cognitive impairment can present across individuals," said lead author Afsara Zaheed, a graduate student in clinical science within the department of psychology at the University of Michigan, in the press release. "By investigating associations between specific insomnia complaints and cognition over time using strong measures of cognitive ability, we hoped to gain additional clarity on whether and how these different sleep problems may lead to poor cognitive outcomes."

The findings showed that the symptom of having trouble falling asleep that was recorded in 2002 was linked to cognitive impairment in 2016. The study results showed a link between frequent bouts of having trouble falling asleep with worse episodic memory, executive function, language, processing speed, and visuospatial performance in later years. The results also showed that links between sleep patterns and cognition later on were partially explained by both depressive symptoms and vascular diseases in 2014 for all domains except episodic memory, which was only partially explained by depressive symptoms, according to the study authors.

"These results are important given the lack of currently available treatments for late-life cognitive disorders, like Alzheimer's disease and other dementias," Zaheed said in the press release. "Sleep health and sleep behaviors are often modifiable. These results suggest that regular screening for insomnia symptoms may help with tracking and identifying people with trouble falling asleep in mid-to-late life who might be at risk for developing cognitive impairments later in life. Additional intervention research is needed to determine whether intervening on insomnia symptoms can help prevent or slow the progression of cognitive impairments in later life."

Having trouble falling asleep predicts cognitive impairment in later life. EurekAlert! Published June 9, 2021. Accessed June 11, 2021. https://www.eurekalert.org/pub_releases/2021-06/aaos-htf060921.php

The study authors examined data from the Health and Retirement Study, which included 2496 individuals who were at least 51 years of age.

Sleep

Study Finds Sleep Troubles Associated with Cognitive Impairment in Later Life

Vitamin D is classified as a fat-soluble vitamin and is synthesized in the skin from dietary or endogenous cholesterol when an individual is exposed to sunlight or ultraviolet radiation.

The primary biologic function of vitamin D is to maintain normal blood levels of calcium and phosphorus.

 Vitamin D is added to some foods, available in dietary supplements, and presents naturally in some foods. Study results have shown a link between low levels of vitamin D and certain medical conditions such as autoimmune disorders, cardiovascular disease, dementia, depression, infectious disease, musculoskeletal decline, and some types of cancer.

Some health experts disagree that vitamin D has a role in clinical outcomes of COVID-19 cases. Nonetheless, the use of vitamin D supplements increased at the beginning of the pandemic due at least in part to study results suggesting that lower levels of the vitamin are associated with elevated rates of serious COVID-19 infections and mortality rates.

An estimated 42% of Americans have a vitamin D deficiency, according to statistics presented by the Cleveland Clinic in 2018.4 In study results published in March 2021 in Journal of Clinical Endocrinology and Metabolism, 80% of more than 200 patients hospitalized with COVID-19 had a vitamin D deficiency.

In another March 2021 publication, Meltzer et al noted that in a cohort study of 4638 individuals with a measured vitamin D level in the year before undergoing COVID-19 testing, the risk of having positive results in Black individuals was 2.64-fold greater with a vitamin D level of 30 to 39.9 ng/mL than a level of 40 ng/mL or greater, decreasing by 5% per 1 ng/ mL increase in level among individuals with a level of 30 ng/mL or greater.

 There were no statistically substantial correlations between vitamin D levels with COVID-19 positivity rates in White individuals. Investigators concluded that randomized clinical trials should be conducted to ascertain whether increasing vitamin D levels to greater than 30 to 40 ng/mL affects COVID-19 risk, especially in Black individuals.

 The investigators are recruiting participants for 2 separate clinical trials to test the efficacy of vitamin D supplements in preventing COVID-19. More information on these trials can be found at https://chess.uchicago.edu/vitd/.

In a May 2021 publication, Ma et al examined the prospective correlation between the habitual use of vitamin D supplements and the risk of
COVID-19 infection and assessed whether such an association differed according to patients’ levels of circulating and genetically predicted vitamin D.

The investigators discovered that after adjustment for covariates, the habitual use of vitamin D supplements was substantially correlated with a 34% lower risk of COVID-19 infection. Circulating vitamin D levels at baseline or genetically predicted vitamin D levels were not linked with the risk of COVID-19 infection. The correlation between the use of vitamin D supplements and the risk of COVID-19 infection did not vary according to the different levels of circulating or genetically predicted vitamin D (P = .75 and .74, respectively). The investigators concluded that their findings imply that habitual use of vitamin D supplements is related to a lower risk of COVID-19 infection, although they could not rule out the possibility that the inverse relationship is because of residual confounding or selection bias. Further clinical trials are necessary to validate these results, they noted.

Results from a study presented at the Endocrinology Society 2021 Annual Meeting held virtually in March indicated that hospitalized patients with COVID-19 and low vitamin D levels could have a decreased risk of dying or needing mechanical ventilation if they obtain at least 1000 units of vitamin D supplementation weekly.

Pharmacists are likely to encounter patients seeking guidance on the selection and use of vitamin D supplements. Pharmacists should remind patients to adhere to the recommended dosages as directed by their primary health care providers or indicated by the manufacturer. Pharmacists also serve as excellent resources in identifying possible drug/ micronutrient contraindications and interactions. Patients taking other medications and those with chronic medical conditions should always consult their primary health care provider before taking any supplements.

is a consulting pharmacist and a medical writer in Haymarket, Virginia.

Vitamin D. National Institutes of Health. Updated March 26, 2021. Accessed May 17, 2021. https://ods.od.nih.gov/factsheets/ VitaminD-HealthProfessional/

Bridgeman MM, Rollins CJ. Essential and conditionally essential nutrients. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, eds. Handbook of Nonprescription Drugs. 19th ed. American Pharmacists Association; 2017. doi:10.21019/9781582123172.ch23

Hanmin W, Weiwen C, Dongqing L, et al. Vitamin D and chronic diseases. Aging Dis. 2017;8(3):346-353. doi:10.14336/AD.2016.1021

Wheeler S. 42% percent of Americans are vitamin D deficient. Are you among them? Cleveland Clinic. July 1, 2018. Accessed May 19, 2021. https://www.cantonmercy.org/healthchat/42-percent-of-americans-are-vitamin-d-deficient/

Hernández JL, Nan D, Fernandez-Ayala M, et al. Vitamin D status in hospitalized patients with SARS-CoV-2 infection. J Clin Endocrinol Metab. 2021;106(3):e1343-e1353. doi:10.1210/clinem/ dgaa733

Meltzer DO, Best TJ, Zhang H, Vokes T, Arora VM, Solway J. Association of vitamin D levels, race/ethnicity, and clinical characteristics with COVID-19 test results. JAMA Netw Open. 2021;4(3):e214117. doi:10.1001/jamanetworkopen.2021.4117

Ma H, Zhou T, Heianza Y, Qi L. Habitual use of vitamin D supplements and risk of coronavirus disease 2019 (COVID-19) infection: a prospective study in UK Biobank. Am J Clin Nutr. 2021;113(5):1275-1281. doi:10.1093/ajcn/nqaa381

Supplements may protect those with low vitamin D levels from severe COVID-19. News release. Endocrine Society. March 20, 2021. Accessed May 19, 2021. https://www.endocrine.org/news-and-advocacy/news-room/featured-science-from-endo-2021/ supplements-may-protect-those-with-low-vitamin-d-levels-from-severe-covid19

Results of various studies show potentially promising clinical benefits associated with the use of supplementation in individuals who have the virus.

Vitamins and Supplements

Does Vitamin D Offer Protection Against COVID-19?

In this episode of the OnScript podcast, Jeremy and Jessica talk with Paul Sabatini, M.Ed, CPhT, FCSHP. Paul has worked in the pharmacy profession for 30 years. Most recently, he was recognized by the California Pharmacists Association (CPhA) and NHA as the recipient of the 2020 Pharmacy Technician of the Year Award.

His dynamic and unique career path has not only involved working in multiple pharmacy settings, but has also been a force in higher education in the state of California. As an instructor and program director of pharmacy technician educational programs, Paul has helped countless individuals to prepare for 

Recently, his mission to improve the workforce has been demonstrated through his relentless work to advocate for and organize pharmacy technicians to advance their skills and scope of practice in the state of California.

You won’t want to miss this episode, especially if you’re a technician practicing in California! 

Click here to listen to this informative episode of the OnScript podcast.

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Paul Sabatini, M.Ed, CPhT, FCSHP, was recognized by the California Pharmacists Association and NHA as the recipient of the 2020 Pharmacy Technician of the Year Award.



Pharmacy Technician

NHA Honors 2020 Pharmacy Technician of the Year

The delivery of intravenous (IV) cancer therapies in the home has been a topic of great importance since the start of the COVID-19 pandemic, Stephanie Kang, PharmD, MS, BCPS, a clinical manager from University of North Carolina (UNC) Homecare Specialists at UNC Health, said during a session at the virtual Hematology/Oncology Pharmacy Association Annual Conference 2021.

Three main ambulatory infusion locations are used for IV cancer therapies: hospital-based clinics, freestanding infusion clinics, and the patient’s home. Currently, home infusion within the larger ambulatory infusion setting poses specific advantages and disadvantages in relation to the other available options.

Of the 3 locations, hospital-based clinics have the advantage of being held to the highest regulatory standards, especially in terms of United States Pharmacopeia compliance, according to Kang. Additionally, the hospital affiliation of these clinics provides the greatest level of access to specialized care.

The disadvantages presented in hospital-based clinics include price, because they are the most expensive option for infusion, as well as inconvenience for patients. Inconvenience may especially be a factor if a clinic’s hours of operation are limited, which may also contribute to longer wait times for scheduling treatments.

Alternatively, freestanding infusion clinics may be slightly more convenient because they are dispersed around the community and also cost less than hospital-based clinics. However, if not affiliated with the patient’s primary oncology team, these location options can lead to fragmented care because of difficulties around communication between care teams.

Within the home infusion setting option, lower cost compared with hospital-based clinics poses a specific advantage, although the cost is about the same as that of freestanding infusion clinics. The convenience of being at home makes this option more advantageous for the patient than freestanding infusion clinics, which require transportation considerations.

However, if the home infusion provider is a third-party company that is external to the patient’s primary care team, the issue of fragmented care may also arise. Additionally, there are concerns regarding the patient’s limited access to their care team because removing the need to visit the clinic for each infusion reduces patients’ interactions with their provider. Another potential problem: limited access to emergency services if a negative reaction or adverse event (AE) occurs during the infusion.

Currently, 2 issues have shifted the focus toward the home infusion setting, according to Kang. First, there is the payer’s side of care mandates, which have arisen as a point of interest because of the lower cost of home infusion and freestanding infusions, moving payers toward requiring patients to receive treatments in either of these settings rather than in the hospital-based clinic setting.

Second, the COVID-19 pandemic has led to an overall push for home infusion as a way of mitigating the spread of the virus among patients and health care professionals.

To reduce COVID-19 transmission concerns, the Centers for Medicare & Medicaid Services (CMS) issued a new interim final rule during the pandemic that was intended to allow additional beneficiaries, particularly among high-risk patients, to receive home infusions. As a result, CMS made it easier for patients to receive home infusions of a wider variety of medications, including cancer therapies.

Within the past 2 years, several national oncology organizations have released position statements related to home infusion of cancer therapies.

 For example, in the position statement of the American Society of Clinical Oncology (ASCO), the organization described several safety concerns, including the lack of double checks prior to administration, the risk of life-threatening AEs, the potential for chemotherapy spills or exposure to patients without cancer in the home, the question of liability if there were an error in the drug preparation, and the lack of oncology-trained nurses going to the home.

ASCO also acknowledged some advantages to home infusion, such as increased participation in clinical trials and increased access to care, specifically for patients in rural regions.

The organization made 6 recommendations for administering cancer therapies in the home. The first advised using public funds to formally research the safety and efficacy of cancer therapies because there is currently no significant primary literature on this topic.

Second, ASCO recommended that CMS not extend the interim final rule established during the pandemic that makes available a wide variety of therapies for infusion in the home. Third, ASCO suggested that CMS work closely with oncology experts to ensure that the provider and patient agree to the home as the most appropriate setting for care.

Upon the agreement of this setting, ASCO recommended that CMS require quality reporting of oncology-specific measures to further evaluate safety and efficacy outcomes, primarily because of the lack of available data in these areas.

ASCO’s fourth recommendation would limit cancer therapies to exceptional circumstances in which the benefit to that patient outweighs the risk; the fifth would require a consultation with the oncologist before allowing delivery of preprepared cancer therapies. Lastly, ASCO recommended that payers require proof of safety protocols and precautions for home infusion providers.

Conversely, the Community Oncology Alliance (COA) released a position statement that said it fundamentally opposes the home infusion of chemotherapy, cancer immunotherapy, and supportive drugs for cancer treatment because of serious patient safety concerns.

COA gave these reasons for their opposition: Patients need face-to-face, high-touch evaluation with each treatment cycle; the number of treatments increases incidence of AEs and interactions; the specialty care-trained team is not available in the home; and home infusions have limited access to emergency medications, equipment, and personnel.

Based on these observations and recommendations from prominent oncology organizations, Kang explained that there are clearly benefits for the home infusion setting, but remaining barriers to this setting need to be addressed for this to be a successful site of care.

In light of this, the Gorski Model for Safe Home Infusion Therapy outlines 4 factors that are required for safe care in the home, although this model is more generally intended for home infusion for all medications. The requirements include appropriate patient selection, comprehensive assessment and monitoring, appropriate patient education, and interprofessional communication and collaboration.

“If I put this into my own words, I would say the safe model for home infusion therapy requires the right patient, the right regimen, [and] the right resources to the patient, as well as the right level of communication across care teams,” Kang said during the session.

Kang S. Intravenous cancer therapies in the home - innovative or dangerous? Presented at: Hematology/Oncology Pharmacy Association 2021 Virtual Annual Conference; April 14, 2021.

American Society of Clinical Oncology Position Statement Home Infusion of Anticancer Therapy. American Society of Clinical Oncology. June 23, 2020. Accessed May 14, 2021. 

Home infusion within the larger ambulatory infusion setting poses specific advantages and disadvantages in relation to other available location options.

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