Jonathan Ogurchak, PharmD, CSP

Breast cancer continues to affect women globally, with approximately 13% developing invasive disease. New treatment regimens and options are on the horizon for breast cancer therapy. The following therapies highlight the current progression in clinical trials.

Breast cancer, specifically HER2-positive cancer, is typically considered an aggressive cancer, and is associated with poor outcomes. Trastuzumab has been the standard of care for HER2-positive breast cancer and has undoubtedly increased overall survival among patients with this type of disease. 

Due to resistance to HER2-targeted therapies in some patients, research has been directed to this area. There are 7 FDA-approved targeted therapies that are frequently used in combination with endocrine and chemotherapy. Investigators are studying new compounds: HER2-targeted tyrosine kinase inhibitors (TKIs), antibody-drug conjugates (ADCs), and monoclonal antibodies, among others.

These compounds may be more efficient at inhibiting HER2 signaling. In the meantime, combination therapy with HER2-targeted therapy and CD4 and CD6 kinase inhibitors, PIK3 inhibitors, or immunotherapy may be the way of overcoming resistance.

Adjuvant hormone therapy is still favored for up to 10 years in most patients with estrogen receptor (ER)-positive breast cancer. Endocrine therapy aids in preventing recurrence, metastatic disease, and contralateral tumors. Menopausal status aside, tamoxifen is the conventional standard of care. Benefits from hormone treatment are dependent on the extent of ER expression. 

Recently, aromatase inhibitors have been the new therapy of choice, as they can greatly reduce recurrence risk compared with that of 5 years of tamoxifen therapy. However, these agents are contraindicated in premenopausal women. The length of endocrine therapy remains patient specific, but a duration of 5 to 10 years with either an aromatase inhibitor or tamoxifen has shown benefit compared with just 5 years of tamoxifen.

Pembrolizumab (Keytruda) has been very promising against tumor activity with an added plus of a respectable safety profile. Findings from a recent study of patients with a triple-negative breast cancer diagnosis showed a significant difference in complete pathological response in patients who received neoadjuvant chemotherapy with pembrolizumab compared with those who received chemotherapy and placebo.

CDK4 and CDK6 are enzymes that play an essential role in cell division. They partake in the transition from the G1 phase to the S phase in cell division. Blocking this step may be beneficial in treating breast cancer and stopping the growth of cancer cells. The inhibition of CDK4 and CDK6 is considered to be broad spectrum because it inhibits the division of healthy cells as well as tumor cells. 

This drug class is used in patients with HER2-negative metastatic breast cancer specifically as an adjuvant to hormonal therapies. But CDK4/CDK6 inhibitors have some major adverse effects, including bone marrow suppression and an increased risk of infection, because of their effect on immune cells. Agents that belong to this class include ribociclib (Kisqali), abemaciclib (Verzenio), and palbociclib (Ibrance). All of these were FDA approved between 2015 and 2017.

PI3K is an enzyme that plays an important role in the signaling pathways of cells and cancer cells. Many studies are examining how each class plays a specific role in certain types of cancers. However, there is a specific isoform of PI3K found in breast tissues (PI3K-C2γ). Investigators have found that some females may have this mutation in the PIK3CA gene, a breast cancer mutation gene, which affects PI3K function and cancer cell growth.

Alpelisib (Piqray) is an FDA-approved PI3K inhibitor for the treatment of patients with advanced or metastatic breast cancer. It can be used for both HER2-positive and HER2-negative breast cancers, but patients must have 1 or more PIK3CA mutations in the tumor tissues.

Shams Alrubaie and Michele Kozubal are PharmD Candidates at Duquesne University in Pittsburgh, Pennsylvania, anticipated to graduate in spring 2022.

Jonathan Ogurchak, PharmD, CSP, is CEO and cofounder of STACK, a professional information management platform. He also serves as a preceptor at over 15 schools of pharmacy for a virtual advanced pharmacy practice experiential rotation for specialty pharmacy, technology, and entrepreneurship.

Articles

Breast cancer continues to affect women globally, with approximately 13% developing invasive disease. New treatment regimens and options are on the horizon for breast cancer therapy.

New Advances in Breast Cancer Therapy

As of 2020 in the United States, there are over 30 million individuals living with diabetes, around 7 million who have not received a diagnosis, and over 80 million with a diagnosis of prediabetes.

Diabetes is an extremely prevalent disease that can lead to serious long-term complications such as cardiovascular disease, renal dysfunction, neuropathy, diabetic retinopathy, foot ulcers or infections, and even tinnitus if it is not properly managed through medications and lifestyle adjustments.

 General treatment recommendations include insulin for type 1 diabetes and several different classes of medications for type 2 diabetese, such as biguanides, sulfonylureas, thiazolidinediones, sodium-glucose cotransporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists.

Because primary indicators of well-controlled diabetes include blood glucose levels and A1C levels, it is imperative for patients to have a firm understanding of how to self-monitor and regularly check those values. In addition, they should be able to recognize the symptoms of hypoglycemia and/or hyperglycemia.

Although patients are able to check their levels at routine doctor visits, frequent monitoring can provide a more comprehensive understanding of whether or not their current treatment plan is effective. Through technological advancements, the ease of self-monitoring and of accessing tools through phones and computers has enabled patients to routinely monitor blood glucose and A1C levels in the comfort of their own homes. Particularly in recent years, several mobile apps have been introduced that contain simple ways to track and monitor relevant labs as well as diet and exercise habits.

Bluetooth capability has increased the expansion of health care apps and has allowed for 1 main platform to contain all of a patient’s relevant health information. For example, the OneTouch Verio Flex glucose meter will automatically synchronize its data with its corresponding OneTouch Reveal app, which patients can use to track their average blood glucose readings, food intake, medication dosing, and activity data. They can also set lifestyle goals, receive alerts about low and/or high blood glucose readings, and even share their data directly with their health care providers. Similarly, the Accu-Chek Guide, Guide Me, and Aviva Connect meters can connect to the mySugr app, allowing patients to enter any relevant diet and medication information, receive an analysis of glucose readings, and predict A1C levels. Other similar apps include the iHealth Smart meter and One Drop mobile app.

Patients can receive instantaneous alerts as well as predictive alerts up to 60 minutes in advance for hypoglycemia and/or hyperglycemia with Medtronic’s Guardian Connect app. The data collected, which include current glucose levels with trends and glucose history, can be shared with health care providers.

Patients who have been diagnosed with type 1 diabetes may be in need of more substantial monitoring of their insulin input and blood glucose levels. Apps such as Diabeo and Diabetes Interactive Diary contain a recording option for self-monitoring blood glucose and an insulin bolus calculator. The calculator is comprehensive, using an algorithm to consider self-monitored blood glucose values, carbohydrate intake, and physical activity. It also takes into account clinician-set parameters for the insulin-carbohydrate ratio, correction factor, and basal insulin dose. If patients routinely check their blood glucose levels with the Accu-Chek meter, they can download the Accu-Chek Connect App, which will directly sync readings and results from the meter. Patients will also be able to take advantage of the insulin bolus calculator and photographic food diary provided by the app.

Technological advances in recent years have provided incredibly innovative methods through which patients can monitor their own health. In 2017, the FDA approved the FreeStyle Libre flash glucose monitor, a disk-like sensor inserted into the upper arm and worn there for up to 14 days. Once the sensor has been inserted, a reader can be passed over it, providing real-time glucose levels, trends, and even alarms for dangerously low or high glucose levels in some versions of the monitor.

Patients who routinely administer insulin have a high probability of hypoglycemia. As a preventive measure, glucagon kits may be given to those who are prescribed insulin. Eli Lilly created and released the Lilly Glucagon Mobile App, which shows users how to properly administer glucagon, provides frequent reminders about practicing and preparing glucagon use, and contains drug safety information and indications. Because glucagon is generally not used except in emergencies, this app can be helpful for reminding patients and their caregivers how to properly administer it if there is ever a need.

In addition to medication therapy and medical management of diabetes, certain lifestyle modifications can be made to help patients better manage their symptoms and long-term outcomes. Similar to the several apps available for patients to monitor their blood glucose levels and current medications, there are lifestyle management apps that provide insight into diet and exercise (see 

This past year has posed unique challenges. Thanks to technology, we have been able to remain connected through various platforms, which have been instrumental in health care. We have seen telehealth expand, and mobile apps such as the ones mentioned throughout this article have allowed patients and their health care providers to communicate with one another on a regular basis. For patients with diabetes, an increased accessibility to self-monitor and regularly communicate with their providers may help optimize their treatment plans and decrease the risk of long-term complications.

Sandhya Vijapurapu is a PharmD candidate at Duquesne University School of Pharmacy in Pittsburgh, Pennsylvania, who anticipates graduating in spring 2021.

Jonathan Ogurchak, PharmD, CSP, is the CEO and cofounder of STACK, a pharmacy information management platform. He also serves as preceptor for a virtual advanced pharmacy practice experiential rotation for specialty pharmacy.

National Diabetes Statistics Report, 2020. CDC. August 28, 2020. Accessed April 1, 2021. 

https://www.cdc.gov/diabetes/data/statistics-report/index.html

American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: 

Standards of Medical Care in Diabetes–2021

 2021;44(suppl 1):S111-S124. doi:10.2337/dc21-S009

Doyle-Delgado K, Chamberlain JJ. Use of diabetes-related applications and digital health tools by people with diabetes and their health care providers. 

 2020;38(5):449-461. doi:10.2337/cd20-0046

Shan R, Sarkar S, Martin S.S. Digital health technology and mobile devices for the management of diabetes mellitus: state of the art. 

 2019;62(6):877-887. doi:10.1007/s00125-019-4864-7

Technology and mobile health apps can be valuable tools in diabetes management.

Digital Health Tools in Diabetes

The treatment landscape for patients with COVID-19 infections is constantly evolving, particularly as new information related to the disease is identified. The following is a current glance at several agents under investigation to keep you up-to-date with the latest advancements.

Bamlanivimab is a recombinant human IgG1K monoclonal antibody (mAb) originally developed by the National Institute of Allergy and Infectious Diseases (NIAID), AbCellera, and Eli Lilly and Company from blood samples of the first patients to recover from COVID-19 in the United States.

 The mAb targets COVID-19 spike proteins to prevent the virus from binding to angiotensin-converting enzyme 2 (ACE2) on the surface of host cells, effectively preventing entry for replication.

 A phase 1 clinical trial began in May 2020 and ended in August 2020, enrolling patients hospitalized with COVID-19 who were not mechanically ventilated to assimilate an adverse effect (AE) profile and monitor changes in viral load with the addition of bamlanivimab.

 The drug is undergoing phase 2 and phase 3 trials.

Phase 2, or BLAZE-1, started in June 2020 and is a randomized, double-blinded, placebo-controlled clinical trial targeting early treatment with bamlanivimab in over 3000 patients with mild to moderate symptomatic COVID-19. The study’s goal is to evaluate safety and efficacy with monotherapy and in combination with additional antibody treatment for 12 weeks.

 Three doses are being tested in the monotherapy treatment arms: 700 mg, 2800 mg, and 7000 mg.

 Primary outcome data were reported in September 2020 showing significant reduction in viral load and hospitalization with AEs including infusion-related reactions and anaphylaxis.

Phase 3, or BLAZE-2, is a randomized, double-blinded, placebo-controlled clinical trial and, like BLAZE-1, is in progress. The study focused on enrolled staff and patients in nursing home settings to evaluate the use of bamlanivimab for the prevention of COVID-19 in this high-risk patient population.

Based on the BLAZE-1 results, the FDA granted emergency use authorization (EUA) on November 9, 2020, for treatment with 1 administration of bamlanivimab 700 mg IV infused over 1 hour in patients 12 years and older with mild to moderate COVID-19 at high risk for hospitalization within 10 days of symptom onset.

 On February 9, 2021, bamlanivimab received another EUA in combination with etesevimab to treat patients 12 years and older with mild to moderate COVID-19 at high risk for hospitalization; dosing specified as 700 mg of bamlanivimab and 1400 mg of etesevimab infused over 16 to 21 minutes within 10 days of symptom onset.

 This additional EUA was established based on outcomes reported through the BLAZE-1 trial on January 26, 2021, demonstrating that use of bamlanivimab with etesevimab decreased hospitalizations and deaths by 70%.

Ivermectin is an agent being considered for possible use in early COVID-19 treatment and is undergoing phase 3 clinical trials. Ivermectin is approved by the FDA as a broad-spectrum anthelmintic agent indicated for use in humans and animals. The primary mechanism of action targets the glutamate-gated chloride channels in nematodes, but has additional action that targets α/ß-mediated nuclear transport in many RNA viruses such as West Nile and influenza.

There has been evidence to show that the α/ß-mediated nuclear transport is considered an essential component for viral replication/transmission in the SARS-CoV strain.

 Australian researchers conducted a study that tested the effects of ivermectin on cell cultures infected with COVID-19 and determined that viral production was completely blocked for 48 hours after initial exposure to the drug; however, the study used doses up to 100 times the standard oral maximum plasma concentration.

 The National Institutes of Health released a statement on January 14, 2021, determining that ivermectin has insufficient data for current use for treatment of COVID-19 after multiple studies have shown conflicting results. As of October 1, 2020, Temple University in Philadelphia, Pennsylvania, is conducting a phase 3, randomized, parallel arm, triple-masking clinical trial (NCT04530474) studying the use of single-dose ivermectin at 0.15 to 2 mg/kg/dose (maximum 12 mg) against placebo in patients 18 years or older with an estimated completion on June 30, 2021.

Bucillamine is an antirheumatic medication commonly used in South Korea and Japan that is being researched for use in mild to moderate COVID-19 infections.

 The University of California San Francisco discerned that thiol-based medications may provide treatment for COVID-19 infection.

 Regarding the mechanism of action of SARS-COVID, it is understood that virus entry into the cell is dependent on conformational changes that occur between the disulfide and thiol structures on the surface of the virus that take place when exposed to the ACE2 receptor.

Revive Therapeutics began a phase 3 multi-center, double-blinded, randomized clinical trial (NCT04504734) for prophylactic use of bucillamine in patients with COVID-19 with mild to moderate symptoms on November 27, 2020.

 The study enrolled 1000 participants and assigned them to 3 separate arms: bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID, or placebo TID for 14 days to determine whether the drug decreases occurrence of hospitalization or death.

 The phase 3 clinical trial is estimated to have been completed on February 1, 2020.

 Previously, bucillamine was approved to be used in the expanded access protocol (EAP) by the Institutional Review Board in hospitalized COVID-19 patients without FDA approval. Revive Therapeutics released a statement on December 23, 2020, detailing aims to expand the EAP to include use of the drug in mild-moderate patient populations because of its easily accessible oral formulation.

BRII-196 and BRII-198 are 2 human mAbs used in combination to target and bind to the COVID-19 virus to prevent the spread of infection.

 Brii Biosciences Limited has reached phase 2/3 double-blinded, randomized clinical trials with combination treatment of BRII-196 and BRII-198 mAb infusions in patients with mild to moderate COVID-19 symptoms.

 The trial (NCT04518410) is a part of the ACTIV-2 protocol that partners with the NIAID to coordinate and accelerate outpatient medication research for COVID-19 treatment.

 A total of 2000 patients 12 years or older with mild to moderate COVID-19 symptoms at high risk for hospitalization were enrolled in the ACTIV-2 trial and randomly divided into 2 treatment arms, one receiving the combination mAb infusion and the other receiving the placebo and then monitored for 12 weeks.

 The primary outcome is to determine the effect on symptom duration, AEs, and patient hospitalization and/or mortality within 28 days after treatment.

Celltrion, based in South Korea, has proceeded with researching regdanvimab (CT-P59, Regkirona), a mAb selected for its ability to target COVID-19 and prevent the binding to the host cell, reducing viral load.

 Results from the randomized, double-blinded phase 2/3 clinical trials have shown promising results; as of January 13, 2021, they determined outcomes of decreased hospitalization rates, faster time to recovery, and a 54% reduction in severe COVID-19 rates that elevated to 68% in moderate symptoms of patients aged over 50 years.

 The Ministry of Food and Drug Safety in South Korea approved the use of trial medications, including regdanvimab, in hospitalized patients with severe cases of COVID-19 with no other treatment options in December; Celltrion is pursuing authorization for emergency use approval.

Kendall Haney is a PharmD candidate at Duquesne University School of Pharmacy in Pittsburgh, Pennsylvania, anticipated to graduate in spring 2021.

Jonathan Ogurchak, PharmD, CSP, is the CEO and co-founder of STACK, a pharmacy information management platform, and serves as preceptor for a virtual Advanced Pharmacy Practice Experiential Rotation for specialty pharmacy, during which this article was composed.

Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19. News release. Eli Lilly and Company. November 9, 2020. Accessed February 15, 2021. https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda

FDA. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Updated February 9, 2021. Accessed February 15, 2021. https://www.fda.gov/media/143603/download 

A study of LY3819253 (LY-CoV555) in participants hospitalized for COVID-19. ClinicalTrials.gov. Updated October 30, 2020. Accessed February 15, 2021. https://clinicaltrials.gov/ct2/show/NCT04411628

A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov. Updated February 16, 2021. Accessed March 1, 2021. https://clinicaltrials.gov/ct2/show/NCT04427501

A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in preventing SARS-CoV-2 infection and COVID-19 in nursing home residents and staff (BLAZE-2). ClinicalTrials.gov. Updated February 23, 2021. Accessed March 1, 2021. https://clinicaltrials.gov/ct2/show/NCT04497987

Lilly’s bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19. News release. Eli Lilly and Company. February 9, 2021. Accessed February 15, 2021. https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-ly-cov555-administered-etesevimab-ly-cov016

National Institutes of Health. COVID-19 treatment guidelines: ivermectin. Updated February 11, 2021. Accessed February 15, 2021. https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin

Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. 

 2020;178:104787. doi:10.1016/j.antiviral.2020.104787

Outpatient use of ivermectin in COVID-19. ClinicalTrials.gov. Updated August 28, 2020. Accessed February 15, 2021. https://clinicaltrials.gov/ct2/show/NCT04530474

National Center for Advancing Translational Sciences. Inxight: Drugs, bucillamine. Accessed February 15, 2021. https://drugs.ncats.io/drug/R80LRA5WTF

Revive Therapeutics provides update on FDA phase 3 clinical trial for bucillamine in COVID-19 with plans on emergency use access. News release. Revive Therapeutics. December 23, 2020. Accessed February 15, 2021. https://www.globenewswire.com/news-release/2020/12/23/2150036/0/en/Revive-Therapeutics-Provides-Update-on-FDA-Phase-3-Clinical-Trial-for-Bucillamine-in-COVID-19-with-Plans-on-Emergency-Use-Access.html 

Khanna K, Raymond W, Charbit AR, et al. Binding of SARS-CoV-2 spike protein to ACE2 is disabled by thiol-based drugs; evidence from 

Bucillamine in treatment of patients with COVID-19. ClinicalTrials.gov. Updated February 24, 2021. Accessed March 1, 2021. https://clinicaltrials.gov/ct2/show/record/NCT04504734?term=Bucillamine&draw=2&rank=2 

Craven J. COVID-19 therapeutics tracker. Regulatory Affairs Professionals Society. February 26, 2021. Accessed March 1, 2021. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker 

Revive Therapeutics announces IRB approval of US expanded access treatment program (compassionate use) for bucillamine in COVID-19. News release. Revive Therapeutics. September 16, 2020. Accessed February 15, 2021. https://www.globenewswire.com/news-release/2020/09/16/2094472/0/en/Revive-Therapeutics-Announces-IRB-Approval-of-US-Expanded-Access-Treatment-Program-Compassionate-Use-for-Bucillamine-in-COVID-19.html 

Statement––large clinical trial will test combination monoclonal antibody therapy for mild/moderate COVID-19. News release. National Institute of Allergy and Infectious Diseases. January 5, 2021. Accessed February 15, 2021. https://www.niaid.nih.gov/news-events/statement-large-clinical-trial-will-test-combination-monoclonal-antibody-therapy 

ACTIV-2: a study for outpatients with COVID-19. ClinicalTrials.gov. Updated January 20, 2021. Accessed February 15, 2021. https://clinicaltrials.gov/ct2/show/NCT04518410

Accelerating COVID-19 therapeutic interventions and vaccines (ACTIV). National Institutes of Health. Accessed February 15, 2021. https://www.nih.gov/research-training/medical-research-initiatives/activ

Celltrion announces positive interim results from phase I trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. News release. Healthcare Celltrion. September 11, 2020. Accessed February 15, 2021. https://www.celltrionhealthcare.com/en-us/board/newsdetail?modify_key=364&pagenumber=1&keyword=&keyword_type=

To evaluate the safety and efficacy of CT-P59 in patients with mild to moderate symptoms of severe acute respiratory syndrome COVID-19. ClinicalTrials.gov. Updated October 26, 2020. Accessed February 15, 2021. https://clinicaltrials.gov/ct2/show/NCT04602000

Celltrion Group announces positive top-line efficacy and safety data from global phase II/III clinical trial of COVID-19 treatment candidate CT-P59. News release. Healthcare Celltrion. January 13, 2021. Accessed February 15, 2021. https://www.celltrionhealthcare.com/en-us/board/newsdetail?modify_key=433&pagenumber=1&keyword=&keyword_type=

Lee J. S.Korea Celltrion’s candidate COVID-19 drug gets approval for special-case use. 

December 15, 2020. Accessed February 15, 2021. https://www.reuters.com/article/health-coronavirus-southkorea-celltrion/s-korea-celltrions-candidate-covid-19-drug-gets-approval-for-special-case-use-idUSKBN28P0W4

Here’s an overview of what’s in the late-stage pipeline.

COVID-19 Therapy Pipeline Update 

In recent years, breakthroughs and advances have led to wider adoption of genomic and precision medicine. Yet, there remains an abundance of unrealized potential in personalized medicine, raising the question: what boundaries still exist in providing more individualized care? This article will discuss current applications of precision medicine and what limitations still persist.

In the past few years, the realities of personalized medicine have become increasingly evident. In 2016, the Precision Medicine Initiative (PMI) launched by the National Institute of Health propelled expansion of precision medicine. Initially announced in 2015, the PMI mission was to enable a new era of medicine through research, technology, and policies to develop more individualized care. In more recent years, breakthroughs and advances in the technology and availability have led to wider adoption of genomic medicine.

 The primary disease states involved in the expansion of precision medicine include oncology, immunology, central nervous system disorders, and respiratory disorders. The growth of precision medicine has also boosted growth of the specialty and rare drug industry. Specialty pharmacies continue to grow and adjust in order to provide a higher level of care for patients with individual disease states.

In 2019, the precision medicine market size exceeded $57 billion and was estimated to grow up to $119 billion by 2026.

 Some of the drivers behind this growth include advances in cancer biology and targeted therapies, increased global adoption of gene therapy, and increased usage of data analytics in precision medicine.

 Alongside the development of targeted therapies themselves, the diagnoses of genetic diseases or genetic targets had growth as well. The availability of these tests has also played a role in the advancement of precision medicine. Some of the main pitfalls include 

the high cost associated with precision medicine, fear of genetic discrimination, misinterpretation of genetic and health data, access and availability of genetic testing, and a relatively unprepared primary care workforce.

The high cost associated with precision medicine does not only come from the research and development, but also diagnostic methods and genetic testing. However, the long-term benefits to patients can offset the upfront costs of precision medicine. One way that has been proposed to mitigate cost to a patient would be outcomes-based rebate arrangements, in which the manufacturer would provide a rebate if prespecified therapeutic outcomes are not achieved. Another proposed payment approach would be annuity payments or annual fees, that would be made as long as the therapeutic effect persists. There needs to be a development of health-plan payment systems in which risk adjustment and reinsurance can be utilized for smaller disease states that can be treated by personalized therapies to incentivize insurers to efficiently manage care and control spending.

Alongside tackling the high cost of therapies, the testing and diagnoses of potential targets are often associated with high costs as well. One way to prove cost-effectiveness would be to ensure that genetic tests are both clinically appropriate and billed correctly. Having genetic counselors to review test-orders could potentially allow health systems and providers to find ways to cut expenses and thus decrease genetic testing costs.

 The ability to invest in genetic expertise and claims may allow health plans to manage the costs associated with genetic innovation more effectively. This may be an area where pharmacists can increase their availability to determine the cost-benefit and effectiveness of targeted drug therapy.

Handling Genetic Information and Data Collection

Genetic information is defined as information about an individual's genetic tests or the genetic tests of an individual's family members, and the indication of a condition in their family members. Under the Genetic Information Nondiscrimination Act (GINA) of 2008, it is illegal to discriminate against employees or health insurance applicants because of genetic information.

 But the battle of GINA continues today as it still excludes other forms of insurance outside of health insurance, including life insurance, long-term care insurance, and disability insurance. Being able to eliminate the risk of genetic discrimination and protect the privacy of an individual’s genetic information still remains an issue in the realm of precision medicine. One major success came in July of 2020 when Florida became the first state to enact a DNA privacy law. Florida’s House Bill 1189: Genetic Information for Insurance Purposes prohibits life, disability, and long-term care insurance companies from using genetic tests for coverage purposes.

 The law blocks companies from requiring or soliciting genetic information from individuals and forbids DNA testing companies from providing genetic information to insurers without their permission. This bill should serve as a model for other states and future legislature to help eliminate the risks of genetic discrimination.

In addition to handling genetic information, access to real-world data and patient outcomes are of equal importance. The momentum of personalized medicine relies heavily on developing genetically targeted therapies based on large populations of data. Forming collaborative networks to share patient data while also maintaining patient privacy is needed to deliver widespread therapeutic advancements. Pharmacies can play a role in sharing patient data and outcomes in order to advance precision medicine.

With the advancement and availability of genetic testing and an increased number of medications with genetic considerations comes along with the need to prepare primary care providers and workers for the role of precision medicine in broader populations. To prove that pharmacogenomics and personalized medicine are worthwhile, it would need to be implemented on a wider scale. Creating appropriate teachable moments and training for health networks and providers to implement could create better genomic-based prescribing practices.

 Furthermore, establishing better precision medicine practices would help adapt to the growing market for genetically guided therapy. Precision medicine had historically been considered too complex, expensive, and inaccessible to underserved populations; therefore, it was hard to find a place for it in primary care. Now that precision medicine is becoming increasingly incorporated into evidence-based treatments, it is time to adapt and adjust practice patterns. Pharmacists can advance their knowledge in pharmacogenomics and precision medicine by taking certificate programs provided by the American Society of Health-System Pharmacists or National Association of Chain Drug Stores and applying these concepts and principles to their practice sites.

Precision medicine is here to stay. Although advancements and breakthroughs in the realm of personalized medicine have been bountiful, barriers still exist. The obstacles discussed in this article are only a few areas that pharmacists and other health care professionals can look to in the coming years to expand the practice of precision medicine.

Phil Huber is a PharmD candidate at Duquesne University School of Pharmacy, anticipated to graduate in spring 2021.

Jonathan Ogurchak, PharmD, CSP, is the CEO and cofounder of STACK, a pharmacy information management platform, and serves as preceptor for a virtual Advanced Pharmacy Practice Experiential Rotation for specialty pharmacy, during which this article was composed.

Collins FS, Varmus H. A new initiative on precision medicine. 

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https://www.gminsights.com/industry-analysis/precision-medicine-market

Lapteva L, Purohit-Sheth T, Serabian M, Puri RK. Clinical development of gene therapies: The first three decades and counting. 

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Geruso M, Jena AB, Layton TJ. Will personalized medicine mean higher costs for consumers? Harvard Business Review. March 1, 2018. Accessed December 11, 2020. 

https://hbr.org/2018/03/will-personalized-medicine-mean-higher-costs-for-consumers

Rizk E. The price of precision medicine: 3 ways for health plans to manage genetic-testing costs. Healthcare Financial Management Association. July 31, 2019. Accessed December 11, 2020. 

https://www.hfma.org/topics/payment-reimbursement-and-managed-care/article/the-price-of-precision-medicine--3-ways-for-health-plans-to-mana.html

The Genetic Information Nondiscrimination Act of 2008 (GINA). U.S. Department of Labor. 2009. Accessed December 11, 2020. https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/fact-sheets/gina.pdf

Sprowls C, Williamson J. HB 1189: Genetic information for insurance purposes. The Florida Senate. July 1, 2020. Accessed December 11, 2020. https://www.flsenate.gov/Session/Bill/2020/1189

Vitone E. Precision medicine for the masses: Mylynda Massart brings genomics to primary care. PittMed. Summer 2019. Accessed December 11, 2020. 

https://www.pittmed.health.pitt.edu/story/precision-medicine-masses

Despite breakthroughs for personalized medicine, barriers still exist in real-world application.  