Clinical Insights: September 8, 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

    Trudhesa™ (dihydroergotamine mesylate) Nasal Spray – New Drug Approval – September 3, 2021 –  Impel NeuroPharma, Inc., a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, announced that the U.S. Food and Drug Administration (FDA) approved Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa™ was previously known as INP104. Using Impel’s proprietary Precision Olfactory Delivery (POD®) technology, Trudhesa™ gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa™ bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack. The Commercial launch of Trudhesa™ is planned for early October 2021. <Read More>

    Invega Hafyera™ (paliperidone palmitate) Extended-Release Injectable Suspension – New Drug Approval – September 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to Invega Hafyera™, patients must be adequately treated with Invega Sustenna® (1-month paliperidone palmitate) for at least four months, or Invega Trinza® (3-month paliperidone palmitate) for at least one 3-month injection cycle. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Brukinsa®(zanubrutinib) Capsules – New Approved Indication – September 1, 2021 – BeiGene, Ltd., a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Brukinsa® (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “We are delighted by the FDA approval for Brukinsa® in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenström’s macroglobulinemia. As shown in the ASPEN trial, Brukinsa® can improve treatment outcomes for these patients and potentially make a positive impact on their lives,” commented Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. <Read More>

    Briviact® (brivaracetam) – New Approved Expanded Indication – August 30, 2021 – UCB announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact® (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age. This is the first time that the IV formulation of Briviact® will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly 7 years. <Read More>

    Tecentriq® (atezolizumab) – New Indication Withdrawal – August 27, 2021 – Roche announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This decision only impacts the mTNBC indication in the US. It does not affect other approved indications for Tecentriq® in the US and outside the US, including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq®. <Read More> 

    Tibsovo® (ivosidenib) Tablets – New Approved Indication – August 25, 2021 – Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, announced that the U.S. Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. Tibsovo® is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. The supplemental New Drug Application (sNDA) for Tibsovo® received Priority Review, which accelerated the review timeline and is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. <Read More>

    New/Updated Drug Shortage

    September 07, 2021

    September 03, 2021

    September 01, 2021

    August 31, 2021

    August 30, 2021

    New Drug Recall and Safety Alerts

    Lidocaine HCl Topical Solution 4% by Teligent Pharma, Inc. – New Voluntary Recall – August 27, 2021 – Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Treating Breathlessness, Improving QOL in Patients With COPD – September 6, 2021 – Dual bronchodilators have been shown to broadly improve symptoms and quality of life (QOL) in patients with chronic obstructive pulmonary disease (COPD). In patients with chronic obstructive pulmonary disease (COPD), dyspnea, or breathlessness, can greatly impact their life, but they learn to live with it and adapt rather than seek treatment for it, according to panelists during a discussion at the European Respiratory Society International Congress 2021. Many patients and clinicians fixate on exacerbations for patients with COPD, but the reality is the more mundane, day-to-day symptoms, such as dyspnea, which affect quality and quantity of life are much more common, explained Sarah Jarvis, MBE, FRCGP, general practitioner in the United Kingdom and a broadcaster with the BBC, during the discussion. <Read More>

    Decarceration Could Lead to Decrease of Outbreaks – September 6, 2021 – High incarceration rates in the United States have led to an increased risk of outbreaks, and decarceration is the best way to combat this, the results of a new study from French National Centre for Scientific Research, Northwestern Medicine, and the Toulouse School of Economics show. “If we can immediately stop jailing people for minor alleged offenses and begin building a national decarceration program to end mass incarceration, these changes will protect us from COVID-19 now and will also benefit long-term US public health and pandemic preparedness,” Eric Reinhart, MD, resident physician in the department of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine, said in a statement. <Read More>

    Anti-Viral Agents Can Eradicate COVID-19 With B-Cell Recovery, Study Results Show – September 6, 2021 – Convalescent plasma, IVIG, and remdesivir have successfully helped immunocompromised patients recover from the virus. The results of a new study published in The International Journal of Molecular Sciences shows that convalescent plasma, IVIG, and remdesivir help immunocompromised patients recover from COVID-19 without B-cell population recovery. Remdesivir inhibits the replication of the virus, while convalescent plasma promotes SARS-CoV-2 antibodies that work with the immune system to get rid of the virus. <Read More>

    Researchers Don’t Foresee Chronic Opioid Use in COVID-19 Survivors – September 3, 2021 – Faced with a novel health crisis, researchers are collecting data on the long-term impact of using opioids to treat COVID-19 pain. The National Institute on Drug Abuse estimates that about 10% of people who are on opioid therapy for their chronic pain eventually will become chronic users. However, according to a study presented at the American Society of Regional Anesthesia and Pain Medicine’s 2021 spring meeting, patients hospitalized with COVID-19 may be at low risk for chronic opioid use, even if they leave the hospital with a prescription. <Read More>

    Giant Eagle Loses Bid to Escape Ohio Opioid Claims – September 3, 2021 – Supermarket and pharmacy chain Giant Eagle has lost a bid to escape claims by two Ohio counties that it fueled opioid addiction by ignoring red flags that prescriptions were being used for illegal sales. The order Wednesday by U.S. District Judge Dan Polster in Cleveland, Ohio, means Giant Eagle will face trial next month alongside Walgreens Boots Alliance and Walmart Inc. Rite Aid Corp, which had also been a defendant in the case, recently settled. <Read More>

    Booster Dose Strategy Has Mixed Support of the ACIP Panel – September 3, 2021 – The White House Coronavirus Task Force is calling for boosters of the messenger RNA (mRNA) vaccines because data show that immunity wanes over time. The Advisory Committee for Immunization Practices (ACIP) discussed the need for a booster dose of COVID-19 mRNA vaccine at its recent meeting, but is not ready to make a recommendation. <Read More> 

    CDC Releases Guidance on Caring for ‘COVID Long-Haulers’ – September 3, 2021 – Thousands of patients have reported experiencing a wide range of physical and mental health consequences that persist after a COVID-19 infection. Patients with post-COVID-19 conditions, sometimes referred to as “COVID long-haulers,” often experience issues four or more weeks after being infected with the virus. Many of these patients routinely seek medical treatment for relief of their symptoms. In an effort to help clinicians care for these patients, CDC released interim guidance on the evaluation and management of patients with post-COVID-19 conditions or “long COVID.” <Read More>

    Evaluating Compounding Compliance Coming Out of the COVID-19 Fog – September 3, 2021 – The COVID-19 pandemic has fundamentally transformed every area of health care—from patient interactions to how drugs are prepared—and the pharmacy has been a central part of this evolution. While pharmacists rolled up their sleeves to help care for COVID-19 patients and administer vaccines to others, routine pharmacy operations including medication compounding still needed tending. As pharmacists were pulled into patient-facing roles, many hospitals were forced to scale back or make adjustments in medication compounding practices. Annual “State of Pharmacy Compounding” survey results published this summer found that the impact of COVID has been far reaching. As COVID-19 spread last year, many hospitals shut down elective surgeries and in-person visits, leading to revenue shortfall. <Read More>

    CDC Announces More Than $300 Million in Funding to Support Community Health Workers – September 3, 2021 – The Centers for Disease Control and Prevention (CDC) awarded more than $116 million in year one of a three-year, $348 million program, to organizations for community health worker (CHW) services to support COVID-19 prevention and control. CDC also awarded more than $6 million of a four-year $32 million program for training, technical assistance, and evaluation. CHWs are frontline public health workers who have a trusted relationship with the community and are able to facilitate access to a variety of services and resources for community members. Availability of this funding was announced on March 25th as part of a larger effort to improve health equity in CDC’s response to the COVID-19 pandemic. <Read More> 

    Current Guidelines May Lead to Antibiotic Overuse for SARS-CoV-2 Pneumonia – September 3, 2021 – Bacterial superinfection at time of intubation occurred in <25 percent of patients; reduced antibiotic use seen with bronchoalveolar lavage-based management versus current guidelines. Current guidelines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia would result in overuse of antibiotics at the time of intubation, according to a study published online Aug. 17 in the American Journal of Respiratory and Critical Care Medicine. <Read More>

    Maintaining Best Specialty Care Virtually – September 2, 2021 – Going virtual during the COVID-19 pandemic has not diminished the ability of health-system specialty pharmacies to meet their patients’ medication needs and provide quality care, according to the experience of several large centers. In fact, telemedicine has helped improve communication among clinical pharmacy specialists, patients and providers at some institutions. <Read More> 

    Already Concerned With Drug Costs, Large Employers, Family Pharmacists Worry About More Middlemen – September 2, 2021 – There already were deep concerns among small pharmacists about drug middlemen known as “pharmacy benefit managers.” Now the corporations that own them appear to be creating yet another layer of middlemen. That has even the largest employers in the country worried. The operators of a regional chain of pharmacies based in this town along the Ohio River have long complained that the reimbursements they receive from the powerful middlemen are strangling their ability to stay in business. Especially in the Appalachian hills of Southeastern Ohio and in the rolling hills to the north in Amish country, low payments by middlemen through the state Medicaid program have already driven many community pharmacies out of business and threaten many more, the businesses say. <Read More>

    FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals – September 2, 2021 – “This week, the FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. This achievement highlights the success of the Competitive Generic Therapy program, which was designed to encourage the development and marketing of generic drugs for products with little to no competition. There has been incredible interest in the Competitive Generic Therapy program since its inception in 2017; hundreds of applicants have requested Competitive Generic Therapy designations, providing the ability for the FDA to approve more than 100 of these applications in less than four years, among a broad range of products and therapeutic areas. <Read More>

    Standardization a Barrier to Tech Adoption in Health Care – September 2, 2021 – The health care industry has been slower than others to adopt new technologies for many reasons. But in the case of patient assistance programs (PAPs), several e-tools are available to streamline and improve PAP offerings, speakers said during Informa’s PAP Critical Update 2021 virtual event. The biggest challenge with point-of-care health care has been standardization, said Steve Stidheim, the principal of product management for Cardinal Health. Mr. Stidheim works with the company’s Fuse Innovation Lab, a team of 350-plus experts in modern product technology, user experience design, data science and software engineering that creates PAP-specific and other commercial products in the health care space. <Read More>

    New Report Guides the Treatment of Infants With Asymptomatic Fevers – September 2, 2021 – New recommendations have been released that aim to guide the diagnosis and management of infants who develop fevers but have no other symptoms. The guidelines were developed by a team from the American Academy of Pediatrics and reviewed by the Agency for Healthcare Research and Quality. Published in Pediatrics, the guidelines attempt to offer a care path after decades of trial and error. Increasing concern over serious bacterial infections like group B streptococcus in the 1970s led to a spike in hospitalizations and antibiotic use for febrile infants, according to the report. In the decades since, clinicians have attempted to create clinical models to guide treatment of fevers in young children. Focuses in treating symptomatic children with fevers have ranged from ruling out certain serious infections to determining a child’s level of infection risk when creating a treatment plan. <Read More>

    Tip of the Week: Use Strategic Planning to Promote Success – September 2, 2021 – Nearly every business organization, including nonprofits, has a strategic plan. A strategic plan helps to ensure that the organization is doing the right things now and in the future. Strategic planning is an overarching type of planning, with operational, business, resource, organizational, and contingency planning subsumed under it. Strategic planning is often undertaken with the future in mind, usually at least several years in advance. It includes founding or changing the organization’s mission and vision, as well as its overall strategic goals. Furthermore, strategic planning actually helps define the business. For example, a pharmacy can decide whether it’s in the relatively narrow business of selling medications or in the broader business of health and wellness. This will help to define the competition and establish a framework for decision making. <Read More>

    Pharmacy Groups Call for Immediate End to Prescribing, Dispensing Ivermectin for COVID-19 Outside of Clinical Trials – September 2, 2021 – Several medical groups and pharmacy advocacy organizations have released a statement calling for an immediate end to dispensing, prescribing, and use of ivermectin for the prevention or treatment of COVID-19, outside of its use in clinical trials. The groups include the American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists. According to a press release, ivermectin is approved by the FDA for the prevention of infections caused by internal or external parasites in humans but is not approved for the prevention or treatment of COVID-19. <Read More>

    September is National Atrial Fibrillation Awareness Month: Understanding the Pharmacist’s Role in a Risky Rhythm – September 1, 2021 – Because patients may interact with a pharmacist more regularly than other health care providers, it is possible to detect potential signs and symptoms of atrial fibrillation in a patient during their encounters. September is Atrial Fibrillation Awareness Month, a month dedicated to sharing information about atrial fibrillation (Afib), how it manifests, and treatments for it. In 2018, Afib was mentioned on 175,326 death certificates and was the underlying cause of death in 25,845 of those deaths. <Read More>

    Cancer Centers Giving Third Doses of COVID-19 Vaccine – September 1, 2021 – The National Comprehensive Cancer Network’s updated COVID-19 vaccination guidelines now recommend cancer patients receive a third dose of mRNA vaccine. Centers including Houston-based MD Anderson Cancer Center and Rochester, Minn.-based Mayo Clinic Cancer Center are following the recommendations and have started administering shots. The following groups of people should receive a third shot, according to the network’s Aug. 31 update: <Read More>

    CDC Launches COVID-19 Resources for People With Intellectual and Developmental Disabilities – September 1, 2021 – The coronavirus disease 2019 (COVID-19) pandemic has created unique challenges for people with intellectual and developmental disabilities (IDD). To address them, the Centers for Disease Control and Prevention (CDC) created a COVID-19 toolkit with communication resources explaining in plain language how people with IDD and caregivers can protect themselves from the virus. “People with intellectual and developmental disabilities can experience communication barriers that make it harder for them to understand and act on crucial health guidance,” said Karen Remley, MD, director of CDC’s National Center on Birth Defects and Developmental Disabilities. “The aim of these materials is to help people with IDD, their parents and other caregivers share critical information with their loved ones about COVID-19 and what to expect when getting a COVID-19 test or vaccine and explain how to stay safe if they are not vaccinated.” <Read More>

    Expanded Treatment Options for Multi-Drug Resistant Infections in Children – September 1, 2021 – The incidence of multi-drug resistant (MDR) infections in children is increasing.  Fortunately, novel therapeutic options have recently evolved, transforming the treatment of infections due to MDR organisms. However, optimal use of newer antibiotics in children is challenging due to limited pediatric-specific data. Ceftazidime-avibactam, approved for use in adults in 2015, combines a third-generation cephalosporin with activity against Pseudomonas species with a non-β-lactam β-lactamase inhibitor with potent activity against serine-based Ambler class A and C β-lactamases and some class D enzymes. <Read More>

    FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster – September 1, 2021 – “The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses. “The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making. Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions. <Read More>

    Nevada Seeks Formal AG Opinion Regarding Licensure for Out-of-State Pharmacists – September 1, 2021 – At its August 31, 2021 meeting, the Nevada Board of Pharmacy moved to seek a formal opinion from the Nevada Attorney General Office regarding the legality of the requirement of all non-resident pharmacists who dispense or compound prescription drugs into the state to obtain individual pharmacist licensure (regardless of whether the pharmacist performs such functions at a Nevada-licensed non-resident facility). In early August, the Nevada Board of Pharmacy announced this change after nearly 75 years of interpreting longstanding and unchanged law. The Board has now begun to require all out-of-state pharmacists who dispense and compound prescriptions in the state to obtain temporary licensure in the state. <Read More>

    FDA Requires Warnings About Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and Death for JAK Inhibitors That Treat Certain Chronic Inflammatory Conditions – September 1, 2021 – Based on a completed U.S. Food and Drug Administration (FDA) review of a large, randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz® and Xeljanz XR® (tofacitinib). This trial compared Xeljanz® with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz®. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose. <Read More>

    Low Iron Levels Affect Half of Pregnant Women, Study Results Show – August 31, 2021 – Half of pregnant women are affected by low iron levels and 1 in 4 have severe iron deficiency, according to the study results published in a paper by Blood Advances. “Despite the high prevalence of iron deficiency in pregnancy, and how easy it is to treat, we are not doing a very good job of checking for it,” Jennifer Teichman, MD, lead study author of the University of Toronto, Canada said in a statement. “It’s not top of mind, in part, because if the inconsistent recommendations for ferritin testing across clinical guidelines.” <Read More>

    How COVID-19 Impacts Pediatric Cancer Patients – August 31, 2021 – Although the delta variant has changed how COVID-19 impacts populations of all ages, SARS- CoV-2 rarely caused serious illness in healthy children . For children and teenagers with cancer, however, severe illness is more likely when caused by respiratory viruses, such as COVID-19. A recent investigation sought to find the clinical course and outcomes of COVID-19 in children and teenagers who have cancer. The investigators used data from 131 institutions in 45 countries to create the Global Registry of COVID-19 in Childhood Cancer to included de-identified data related to laboratory-confirmed infection of COVID-19 in children and adolescents aged <19 years who had either cancer or had received a hematopoietic stem-cell transplantation. Data for oncological diagnosis, clinical course, cancer therapy details, and demographics were collected. <Read More>

    ASTRO Publishes Clinical Guidelines for Radiotherapy in Soft Tissue Sarcoma – August 31, 2021 – The American Society for Radiation Oncology (ASTRO) has published a new evidence-based guidance for the use of radiation therapy in adult patients with soft tissue sarcoma based on currently published data, according to a publication from the organization Practical Radiation Oncology. The use of radiotherapy is currently recommended among patients with soft tissue sarcoma who are at an increased risk of local recurrence of resected disease, especially if close or microscopic margins are anticipated or have occurred. Preoperative use of radiotherapy is strongly recommended over postoperative radiotherapy, where indicated. <Read More>

    Report: Physician-Patient Education Can Improve Biosimilar Acceptance – August 31, 2021 – Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education. Biosimilar uptake would be more successful and swifter if efforts were made to educate patients and providers about them, wrote Sonia T. Oskouei, vice president of Biosimilars for Cardinal Health, and Andrew R. Kusmierczyk, supervisor of Chemistry, Manufacturing, and Controls at Cardinal, in a new paper. “In order to overcome any potential hesitation with biosimilars from a scientific or clinical standpoint, education will need to be at the forefront,” they said. <Read More>

    NYC Health + Hospitals Earns National Recognition for Efforts to Improve Cardiovascular Treatment – August 31, 2021 – NYC Health + Hospitals announced that each of its 11 acute care facilities were recognized with the American Heart Association’s “Get with the Guidelines” Achievement Awards. The awards recognize the public hospital system’s commitment to ensuring patients with heart disease receive the most appropriate treatment according to nationally recognized, research-based guidelines. “Get with the Guidelines” programs have touched the lives of millions of patients since 2001 by speeding recovery and helping save lives. <Read More>

    Finding a Safe Harbor From Federal Scrutiny – August 31, 2021 – Ensuring the way that pharmaceutical manufacturers work with specialty pharmacies, advocacy groups and patients is transparent and fair can help keep companies away from federal scrutiny and expensive legal challenges, a panel of legal experts said during Informa Connect’s 2021 Compliance Congress for Specialty Products, held virtually. Manufacturers may choose to enter limited distribution network contracts with specialty pharmacies for particular products, knowing these pharmacies provide a high level of expertise and support to patients, according to Katherine Churchill, JD, a counsel of global trade controls and specialty pharma for Pfizer. <Read More>

    Six Strategies for Navigating Specialty Networks – August 31, 2021 – With specialty pharmacy now a significant driver of health care costs—spending on specialty drugs represented 49.6% of total drug expenditures in 2020, according to the latest industry figures—health-system practitioners and leaders face significant financial challenges, experts said during the 2021 virtual ASHP Specialty Pharmacy Conference… To navigate some of these network-related challenges, Michael Gannon, PharmD, an assistant director of specialty pharmacy at the University of Illinois at Chicago College of Pharmacy, shared some strategies around the contracting process. <Read More>

    Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement – August 31, 2021 – Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize the product in the US.” The agreement also provides that “Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million.” <Read More>

    Medicare Pays Heavy Price for the Generics Gap – August 31, 2021 – Dispensing a brand-name drug when an equivalent generic is available can take a heavy financial toll on the Medicare Part D program as well as on patients’ pockets, according to researchers at Johns Hopkins University. In a study released earlier this year, the investigators zeroed in on 2.5 million Part D claims for branded drugs in 2017, that originated from either prescribers’ requests (1.4 million) or patient requests (1.1 million). They found that if available generics had been substituted for all those branded products, the Medicare program could have saved $1.67 billion and patients’ out-of-pocket expenditures could have been reduced by $270 million (JAMA Netw Open 2021;4[3]:e210483). <Read More>

    Federal Government Delays Enforcement of Price Transparency Rule – August 31, 2021 – The federal government will delay for six months its enforcement of key portions of the Transparency in Coverage (TiC) final rule that goes into effect on January 1, 2022. The change was announced in guidance issued jointly by the U.S. Departments of Labor, Health and Human Services, and the Treasury on August 20. The TiC rule requires insurers and health plans to disclose, in separate machine-readable files, (i) in-network provider rates for covered items and services, (ii) out-of-network allowed amounts and billed charges for all covered items and services, and (iii) negotiated rates and historical net prices for covered prescription drugs. <Read More>

    NCPA Encourages DOJ and HHS to Defend Price Transparency Rule – August 31, 2021 – The National Community Pharmacists Association (NCPA) has urged the US Department of Health & Human Services (HHS) and the US Department of Justice (DOJ) to support legislation that would make pharmacy benefit managers (PBMs) responsible for disclosing net drug prices they negotiate with pharmaceutical manufacturers. Currently, the Pharmaceutical Care Management Association (PCMA) is lobbying against this beneficial legislation. Failure to defend the rule would perpetuate barriers and hidden fees in the prescription drug pricing system. <Read More>

    Managing Medications at School is More Than a Family Affair – August 31, 2021 – Results from an American Psychological Association survey show that teenagers feel more stress than adults during the school year. Life becomes even more complicated for the estimated 27% of children with chronic health conditions‑ because constant vigilance about their health creates additional challenges. The effects of chronic illness can range from minimally to severely limiting. Some children may require frequent doctor visits or hospitalizations, affecting academic performance, school attendance, and mental health. <Read More>

    Caution, Increased Education About Opioid Use for People With Heart Disease Urged by Experts – August 31, 2021 – A new American Heart Association Presidential Advisory outlined the ongoing opioid epidemic and the advancing science on opioid use, including its effects on heart and brain health through evidence-based research, according to a press release from the American Heart Association (AHA). The advisory notes different strategies for addressing the issue, such as:  1) Improving education and training for the public and health care professionals on how to safely manage pain and opioid overdose, and 2) Support treatment for opioid use disorder, including creating and developing partnerships with federal, state, local, and employer-based programs. <Read More>

    HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection – August 31, 2021 – An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data. The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries. The Imbokodo primary analysis was conducted 24 months after participants received their first vaccinations. The study’s primary endpoint was based on the difference in the number of new HIV infections between the placebo and vaccine groups from month seven (one month after the third vaccination timepoint) through month 24. <Read More>

    Unitedhealth, CVS Health Head to Court to Protect PBM Information: 5 Things to Know – August 31, 2021 – UnitedHealth and CVS Health pharmacy benefit managers are battling with the state of Ohio over efforts to reveal information tied to Medicaid contracts that the state believes should be — and in some cases, already is — public knowledge. Here are five things to know: 1) The conflict between the state’s Medicaid program, CVS Caremark and OptumRx, and pharmacies arose in 2017 when pharmacies claimed that the two pharmacy benefit managers were driving them out of business with low rates. Then-Gov. John Kasich helmed an inquiry into reimbursement rates and hired a third party to craft a report on it in 2018. 2) A heavily redacted version of the 2018 report was made public and brought to light reimbursement charges that cost Ohio $224 million in overcharges that were three times the going rate. <Read More>

    In a Common Genetic Disorder, Blood Test Reveals When Benign Tumors Turn Cancerous – August 31, 2021 – People with an inherited condition known as neurofibromatosis type 1, or NF1, often develop non-cancerous, or benign, tumors that grow along nerves. These tumors can sometimes turn into aggressive cancers, but there hasn’t been a good way to determine whether this transformation to cancer has happened. Researchers from the National Cancer Institute’s (NCI) Center for Cancer Research, part of the National Institutes of Health, and Washington University School of Medicine in St. Louis have developed a blood test that, they believe, could one day offer a highly sensitive and inexpensive approach to detect cancer early in people with NF1. The blood test could also help doctors monitor how well patients are responding to treatment for their cancer. <Read More>

    Dem Proposal Looks to Dramatically Decrease Price of Prescriptions, Reduce Disparities – August 30, 2021 – Wisconsin Democratic lawmakers introduced a sweeping legislative package this month with the aim of lowering prescription drug costs for consumers statewide. Key elements of the initiative include efforts to invest in community-based healthcare and reigning in pharmaceutical industry practices which disproportionately harm low-income and underinsured Wisconsinites. The “Less for Rx” plan seeks to cap insulin copayments at $50, eliminate BadgerCare copayments, establish a centralized prescription drug repository and create a new government agency to compete with insurance companies in negotiating prices–among other provisions. <Read More>

    340B in the News

    No new update.