Clinical Insights: March 16, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

    New Drug Approval

    Fotivda™ (tivozanib) – New Drug Approval – March 10, 2021 – The Food and Drug Administration approved tivozanib (Fotivda™, Aveo Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Efficacy was evaluated in TIVO-3 (NCT02627963), a randomized (1:1), open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced RCC who received two or three prior systemic treatments, including at least one VEGFR kinase inhibitor other than sorafenib or tivozanib. Patients were randomized to either tivozanib 1.34 mg orally once daily for 21 consecutive days every  28 days or sorafenib 400 mg orally twice a day continuously, until disease progression or unacceptable toxicity. <Learn More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Tecentriq® (atezolizumab) – New Indication Withdrawal – March 8, 2021 – Roche announced that the company is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the US Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Roche will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq®. Roche is notifying healthcare professionals about this withdrawal. Patients being treated with Tecentriq® for prior-platinum treated mUC should discuss their care with their healthcare provider. <Read More>

    Yescarta™ (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Approved Indication – March 5, 2021 – The Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta™, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Approval in FL was based on a single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) that evaluated axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory FL after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Following lymphodepleting chemotherapy, axicabtagene ciloleucel was administered as a single intravenous infusion. <Read More>

    Actemra® (tocilizumab) – New Approved Indication – March 4, 2021 – Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved Actemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra® is the first biologic therapy approved by the FDA for the treatment of the disease. <Read More>

    Lorbrena® (lorlatinib) Tablets – New Approved Indication – March 3, 2021 – The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s supplemental New Drug Application (sNDA) for Lorbrena® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorbrena® is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program. <Read More>

    New/Updated Drug Shortage

    March 15, 2021

    March 12, 2021

    March 11, 2021

    March 10, 2021

    March 09, 2021

    New Drug Recall and Safety Alerts

    Phenylephrine Hydrochloride Injection, USP, 10 mg/mL by Sagent Pharmaceuticals, Inc. – New Voluntary Drug Recall – March 11, 2021 – Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level as the result of a customer complaint due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product. <Read More>

    Spironolactone 25 mg and 50 mg Tablets by Bryant Ranch Prepack – New Voluntary Drug Recall –  March 9, 2021 – Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of Spironolactone tablets (four different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain Spironolactone 50 mg tablets. <Read More>

    New Generic/Biosimilar Approval and Launch

    Azopt® (brinzolamide) – First-time Generic Approval – March 8, 2021 – Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced its launch of the first available generic version of Azopt® (brinzolamide ophthalmic suspension) 1%, approved by the US Food and Drug Administration to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma. Brinzolamide ophthalmic suspension 1% works by decreasing the amount of fluid within the eye. <Read More>

    Clinical and Pharmacy News

    NCCN Announces New Biosimilars Research Projects in Oncology in Collaboration with Pfizer – March 15, 2021 – The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP), in collaboration with Pfizer Inc., announces ten projects have been chosen to receive funding to support innovative approaches to improve the processes related to appropriate biosimilar adoption in oncology…”This research highlights NCCN’s commitment to exploring new avenues for increasing the availability of affordable, effective treatment options in oncology,” said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. “These projects will help us to determine best practices for using biosimilars—when safe and appropriate—and how to educate providers and patients about them.” <Read More> 

    How Should the CDC Opioid Guideline be Changed? – March 15, 2021 – It was five years ago that the Centers for Disease Control and Prevention released its controversial opioid guideline, which discourages doctors from prescribing opioids for chronic pain. “This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death,” the CDC said. Although voluntary and only intended for primary care physicians, the guideline soon became the “standard of care” in the United States, with many states, doctors, insurers, pharmacies and regulators adopting its recommendations, such as limiting opioid doses to no more than 90 morphine milligram equivalents (MME) per day. <Read More>

    CDC in Discussions With Dollar General to Accelerate Vaccine Rollout in Rural Areas – March 15, 2021 – The US Centers for Disease Control and Prevention is in talks with discount chain Dollar General Corporation to accelerate the rollout of COVID-19 vaccines in rural areas of the country. CDC Director Rochelle Walensky said last week that federal health officials are “exploring a promising collaboration” with Dollar General, one of the nation’s largest retailers, to create thousands of new vaccination sites, USA Today reported. <Read More>

    Supreme Court Reinstates Barriers to Abortion by Telemedicine – March 15, 2021 – In January, the U.S. Supreme Court granted a Trump Administration request to reinstate a U.S. Food and Drug Administration (FDA) rule requiring patients seeking a medication abortion to make a medically unnecessary in-person visit to their health care provider to pick up the abortion pill mifepristone. The Court’s decision in FDA v. American College of Obstetricians and Gynecologists reverses a federal district court ruling from last July that suspended the FDA rule during the pandemic. In that lower court decision, Judge Theodore Chuang ruled that the FDA’s required in-person visit imposed a “substantial obstacle” to abortion health care that is likely unconstitutional. Judge Chuang’s order allowed clinicians to mail mifepristone to patients after a telemedicine consultation. <Read More>

    Study: Inflamed Environment is Ideal for C. diff – March 15, 2021 – Inflammation caused by clostridioides difficile (C. diff) not only creates an inhospitable environment for competing bacteria, but it also provides nutrients that allow C. diff to thrive, according to researchers from North Carolina State University. C. diff causes severe diarrhea, which can have severe or fatal consequences. As part of the bacteria’s growth cycle, it produces 2 toxins that cause inflammation and damage the stomach lining. These toxins give it the 2 advantages, according to the investigators. <Read More>

    What Science Has Learned Works and What Doesn’t in COVID-19 Treatments – March 14, 2021 – A year after the first COVID-19 patient was treated in the United States, a number of medications and approaches have been studied and found effective, while others have shown little benefit. There are 394 treatments and 241 antivirals still being developed against COVID-19, and drugs already approved by the U.S. Food and Drug Administration or readily available over-the-counter remedies are being studied to see if they make a difference. Dr. R. Scott Wright, a cardiologist and clinical trialist at the Mayo Clinic, said researchers are eager to find treatments that work. But that takes time, money, effort and patients willing to participate in trials. “There is no conspiracy to keep therapies out of the public,” he said. “Doctors and nurses are dying at the same rate as the non-medical community. We don’t want one more person to die.” <Read More>

    US Senate Unanimously Approves Two Bills Aiming to Lower Drug Prices – March 14, 2021 – The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act Thursday, two pieces of bipartisan legislation aiming to lower prescription drug prices by increasing competition. The Ensuring Innovation Act addresses loopholes used by companies to maintain the exclusive right to sell a drug. A company holds an exclusive right to sell a drug for a designated length of time when the company invents the drug. Companies will attempt to claim new inventions on that same drug to prolong their exclusivity to sell. The extended exclusivity prevents less expensive generics from being sold. <Read More>

    Pain Medications in Newly Diagnosed DPN – March 13, 2021 – How often are opioids being initiated for diabetic peripheral neuropathy (DPN) in newly diagnosed patients? About half of those living with diabetes are affected by diabetic peripheral neuropathy (DPN). Due to their demonstrated effectiveness and safety, clinical recommendations recommend using anticonvulsants, antidepressants (serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants), or topical analgesics for painful DPN. In previous research, anticonvulsants were most often administered to newly diagnosed patients with DPNP. Many patients received lower dosages than prescribed, potentially leading to poor results. Initial therapies were also discontinued, reflecting low satisfaction levels and poor tolerability. This study explored pain medication initiation among adults with newly diagnosed DPN to facilitate healthy and evidence-based pain management. <Read More>

    The NCCN Releases Updated Protocol for Management of COVID-19 in Patients with Cancer – March 12, 2021 – This week, the National Comprehensive Cancer Network (NCCN) released an updated set of guidelines for how to best manage and treat COVID-19 in patients with cancer. Using data from more than 150 studies covering various topics, these recommendations cover a range of topics including who should be tested, when to modify treatment, and more. As noted in the guidelines, individuals with cancer are at in increased risk (29.4%) for severe disease and mortality from COVID-19 compared to those without (10.2%). <Read More>

    In a Year Like no Other, Pharmacists Gather Virtually for APhA2021 – March 12, 2021 – Did you know that the base of the flagpole that sits outside the entrance of the APhA Headquarters building in Washington, DC, is dedicated to pharmacists who have lost their lives in wars? Using the historic building as a home base, APhA is hosting its 2021 Annual Meeting in an entirely virtual format. During the Opening General Session, APhA President Michael Hogue, PharmD, FAPhA, FNAP, welcomed conference attendees to this year’s meeting with a live broadcast from APhA’s Headquarters building. The theme—COVID-19 and the ways pharmacists have dedicated their lives to helping their communities during this pandemic—was inescapable. “Welcome home,” said Hogue, who noted that the virtual platform remains the best way to connect with one another right now. <Read More>

    In an Era of Digital Health, Where do Pharmacists Fit in? – March 12, 2021 – During APhA’s inaugural DigitalHealth.Rx Summit, experts spoke about the ways in which pharmacy can integrate digital health technologies as well as how pharmacists can lead this technological revolution for health care. The summit, chaired by Parisa Vatanka, PharmD, CTTS, senior director of corporate alliances at APhA, took place on March 11 and coincided with APhA2021 Virtual, which runs from March 12th to the 15th. The summit opened with Daniel Kraft, MD, painting a picture of what this digital future looks like with some of the available technologies—everything from wearables, virtual reality, and AI to 3D printing, just to name a few. <Read More>

    AHA Asks for Regulations on Pharmacy ‘White Bagging’ and ‘Brown Bagging’ Practices – March 12, 2021 – The American Hospital Association is asking policymakers to regulate several policies that health insurers use to manage prescription drug distribution to members. A number of large private payers use techniques called “white bagging” and “brown bagging” to manage how drugs are used in patient care, according to the association. Through white bagging, private payers don’t allow providers to procure and manage a drug for their patients but rather require a third-party specialty pharmacy to dispense the drug to the provider. Brown bagging is similar to white bagging, but the specialty pharmacy sends the drug directly to the patient, who brings it to their provider. <Read More>

    Eli Lilly Says Its COVID-19 Antibody Cocktail Reduces Hospitalization, Death Risk by 87% – March 11, 2021 – Eli Lilly said March 10 its COVID-19 antibody cocktail reduced the risk of hospitalization and death by 87 percent during a recent phase 3 study. The FDA granted emergency use authorization Feb. 9 to the antibody cocktail, a combination of antibodies bamlanivimab and etesevimab. The agency granted emergency use authorization to bamlanivimab alone Nov. 9. <Read More>

    Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, In Observance of One-Year Pandemic Milestone – March 11, 2021 – One year ago, the World Health Organization declared COVID-19 a global pandemic. The toll of this disease and the continued loss of life around the world and in our nation is heartbreaking. To so many of you who have felt the pain and loss of a loved one during this pandemic – you have suffered the ultimate loss, and we grieve with you. After a year of this fight, we are tired, we are lonely, we are impatient. There have been too many missed family gatherings, too many lost milestones and opportunities, too many sacrifices. And still, through it all, there is determination; there are stories of giving and hope, of stamina and perseverance.  We are better together, and together, we will endure. The vaccination of millions every day gives me hope. Hope that we can beat this pandemic. And hope that we can get back to being with our family, friends, and community. And soon. <Read More>

    AAM Seeks Changes to CMS Policy on Generics, Biosimilars – March 11, 2021 – Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues. Government policies for generics and biosimilars drive down prices too far and fail to incentivize the use of these lower cost medicines, the Association for Accessible Medicines (AAM), a manufacturers’ trade group, argues in a new position paper that calls for multiple revisions in public payer policy. <Read More>

    Ohio Sues Centene, Claims Misrepresented Pharmacy Expenses Cost Medicaid Millions – March 11, 2021 – Ohio Attorney General Dave Yost filed a lawsuit against Centene March 11, claiming the company’s subsidiary, Buckeye Health Plan, used a web of subcontractors to misrepresent pharmacy costs, which led to millions of dollars in overpayments by the state’s Medicaid department. Buckeye Health Plan engaged in an “elaborate scheme to maximize company profits at the expense of the Ohio Department of Medicaid,” the attorney general said in a news release. <Read More>

    AssistRx Expands CoAssist Facility to Better Serve Patients and Healthcare Providers with Automated, Affordability-Centered Therapy Initiation – March 10, 2021 –  AssistRx, the intelligent therapy initiation and patient support solutions provider, announced the expansion of its CoAssist facility. CoAssist is the only technology-driven patient onboarding pharmacy platform that automates patient affordability-centered therapy initiation to improve uptake, visibility and outcomes. CoAssist combines AssistRx technology with fulfillment services offered by CoAssist Pharmacy and its network pharmacies to automate and speed access to prescribed therapy. Upon receiving a prescription and at the direction of the physician, this interoperable, agnostic solution initiates AssistRx e-support services—e-consent, e-benefit verification, real-time e-prior authorization and more—and directs the prescription to the best therapy fulfillment option for the patient. <Read More>

    Oncology Care Pharmacy Has Promising Trends on the Horizon – March 10, 2021 – As the coronavirus disease 2019 (COVID-19) pandemic persists through 2021, it is important to recognize that adults at any age with cancer are at an increased risk of severe COVID-19.1 With 2 vaccines receiving emergency use authorization in the United States, pharmacists can play an important role to ensure oncology patients have access. Additionally, there are a variety of oncology pipeline drugs to watch for in 2021. Pharmacists may also have expanded roles in oncology patient care management as part of the health care team. <Read More>

    Treating an Opioid Use Disorder is Difficult. A Pandemic Doesn’t Help. – March 9, 2021 – Getting treatment for an opioid use disorder can be complicated, often requiring daily visits to receive addiction medication under the supervision of a provider. While guidelines have been relaxed to reduce barriers for those seeking care, it’s not clear how effective the changes have been. “Their barriers are huge here,” said Kim Brown, the founder of Quad Cities Harm Reduction (QCHR), “and they’ve been exacerbated by the pandemic.” <Read More>

    Workgroup Creates FHIR-Based Clinical Practice Guideline for COVID-19 – March 9, 2021 – A national workgroup unveiled a new evidence-based clinical care guideline to help emergency physicians determine when to admit or discharge COVID-19 patients and provide the appropriate level of care. The project leaders include the American College of Emergency Physicians, the COVID-19 Healthcare Coalition Digital Guidelines Working Group, Apervita and EvidenceCare, among others. <Read More>

    Patient-First Approach is Improving Access to Clinical Trials for Specialty Pharmacy – March 9, 2021 – The clinical trials market is projected to reach $65.2 billion by 2025, with oncology anticipated to be the fastest growing segment.1 The coronavirus disease 2019 (COVID-19) pandemic has exacerbated the high cost of these studies, as well as challenges surrounding patient recruitment. This is especially true for the rare and orphan market…A patient-first approach is sharply focused on orphan diseases to better address the patient experience, outcomes, and clinical trial requirements. It is a model that focuses on and adapts services for small patient populations, with targeted programs and services that deliver specialized expertise beyond the scope of traditional legacy care organizations. <Read More>

    CDC Issues First Set of Guidelines on How Fully Vaccinated People Can Visit Safely With Others – March 7, 2021 – The Centers for Disease Control and Prevention (CDC) issued its first set of recommendations on activities that people who are fully vaccinated against COVID-19 can safely resume. The new guidance—which is based on the latest science — includes recommendations for how and when a fully vaccinated individual can visit with other people who are fully vaccinated and with other people who are not vaccinated. This guidance represents a first step toward returning to everyday activities in our communities. CDC will update these recommendations as more people are vaccinated, rates of COVID-19 in the community change, and additional scientific evidence becomes available. <Read More>

    340B in the News

    Enabling Price Transparency and Evidence-Based Drug Purchasing With Real-Time Data – March 11, 2021 – The Covid-19 pandemic has presented the healthcare industry with a multitude of challenges that could be abated by the adoption of technology that helps organizations efficiently manage and monitor operations…Some significant first-quarter activities that can contribute to drug overspend include changing contract prices, delayed contract reloads and companies choosing not to participate in the 340B Drug Pricing Program, which requires drug manufacturers to offer outpatient drugs to eligible organizations at low prices. Additionally, keeping expenditures down while ensuring hospital staff isn’t stretched too thin—during the pandemic and beyond—is a common pain point. Having access to comprehensive, up-to-date data can help with all of this. <Read More>

    HHS Seeks to Delay Controversial Community Health Center 340B Insulin Rule Until July – March 10, 2021 – The Department of Health and Human Services wants to delay the implementation of a final rule that would require community health centers to fully pass on 340B savings for insulin to patients. The Biden administration filed a proposed delay until July of the effective date of the rule on March 10 in the Federal Register. The delay is part of a freeze implemented by the White House to review and approve last-minute regulations finalized by the Trump administration. HHS initially sought to delay the implementation date of the rule, originally expected to take effect on Jan. 22, until March 22. Now it wants another delay until July 20 to give the agency “additional opportunity for review and consideration of the new rule,” the filing said. <Read More>

    MCIT Program Not Seen as Being at Risk Under Becerra at HHS – March 8, 2021 – The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services…Another area where Becerra was previously active was as part of a multi-state attorney general effort regarding discounts for the Medicare 340B drug program. His position on this issue “clearly dovetails around long-time support for that program Democrats have had” for some time, Roehrenbeck said. “I don’t think we’re going to see Becerra going out and doing a lot that isn’t consistent with what the Biden administration has set for its agenda.” <Read More>