Clinical Insights: June 29, 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

    Verkazia™ (cyclosporine) Ophthalmic Emulsion – New Drug Approval – June 23, 2021 – Santen Pharmaceutical Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Verkazia™ (Cyclosporine ophthalmic emulsion, 0.1%) for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Santen had received initial FDA filing acceptance on October 26, 2020. With this approval, Santen is now working to make a new treatment option available for patients in the United States. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Pradaxa™ (dabigatran etexilate) Capsules – New Approved Indication – June 21, 2021 – The U.S. Food and Drug Administration approved Pradaxa™ (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa™ oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa™ was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to prevent recurrent clots in patients eight years and older who completed treatment for their first venous thromboembolism. <Read More>

    Ayvakit™ (avapritinib) Tablets – New Approved Indication – June 16, 2021 – The Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Efficacy was evaluated in EXPLORER (NCT02561988) and PATHFINDER (NCT03580655), two multi-center, single-arm, open-label clinical trials enrolling patients with AdvSM. The main efficacy outcome measure was overall response rate (ORR) per modified IWG-MRT-ECNM criteria, as adjudicated by a central committee. Additional efficacy measures were duration of response (DOR), time to response, and changes in individual measures of mast cell burden. Fifty-three patients received daily doses of avapritinib, up to 200 mg. <Read More>

    New/Updated Drug Shortage

    June 28, 2021

    June 25, 2021

    June 24, 2021

    June 23, 2021

    June 22, 2021

    June 21, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    IDSA, SHEA Announce New Clostridioides Difficile Clinical Guidelines – June 24, 2021 – The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) announced it had added 3 new evidence-based guidelines for the treatment of Clostridioides difficile infection (CDI) in adults. The guidelines, developed by a multidisciplinary panel with representatives from IDSA and SHEA, include 3 recommendations on suggested treatments for patients with initial and recurring CDI episodes, based on new data for fidaxomicin and for bezlotoxumab, a monoclonal antibody targeting toxin B produced by C. difficile. <Read More>

    Cigna Offers Patients $500 Debit Card to Switch to Biosimilars – June 24, 2021 – With specialty drug costs commanding an ever-larger share of the total pharmacy spend, the pharmacy benefit manager Cigna is unrolling a shared savings program that, among its signature features, offers patients a $500 health services/products gift card for switching to a biosimilar. The plan is expected to be rolled out in July 2021 with more information presented to patients, but in announcing the program, Cigna Chief Clinical Officer Steve Miller stated that a chief goal is to reduce current spending on the infliximab originator product Remicade, which he said costs $30,000 yearly for an average regimen of infusions, “but may be much higher depending on site of administration.” <Read More>

    Manufacturers Should Heed OIG Guidance When Providing Free, Discounted Drugs – June 24, 2021 – Pharmaceutical manufacturers looking to help patients gain access to expensive drug and medical treatments need to review and follow guidance from the Department of Health and Human Services’ Office of Inspector General (OIG), according to panelists speaking at Informa Connect’s 2021 Compliance Congress for Specialty Products, held virtually. Otherwise, they could be at risk for legal action. OIG for decades has provided guidance to providers and pharmacies about waiving patients’ cost-sharing obligations, and this provides a good foundation for the government’s view on copays and deductibles, said Matthew Wetzel, JD, the former associate general counsel and chief compliance officer for Grail Inc., during a session on best practices related to patient assistance programs (PAPs), copays and foundations. <Read More>

    Jury Sides With CVS, Accused of Overcharging Insurance Customers – June 24, 2021 – A jury has sided with CVS Pharmacy Inc in a class action accusing the pharmacy chain of systematically overcharging people who bought certain generic drugs using insurance rather than cash. In a verdict handed down Wednesday following a trial that lasted a little more two weeks, the jury found that CVS did not violate the consumer protection laws of Arizona, California, Florida, Illinois, Massachusetts or New York, declining to award any damages to subclasses of plaintiffs in each of those states. <Read More>

    Transparency Among Specialty Stakeholders Key to Avoiding Federal Scrutiny – June 24, 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. These contracts can include enhanced services for specialty drugs, such as patient and prescriber outreach, Ms. Churchill noted. But the contracts may not be duplicative of core services already offered by the pharmacies, to avoid violating federal Anti-Kickback Statute (AKS) and applicable safe harbor regulations. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19 – June 24, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19. In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased. <Read More>

    States With the Most, Least Pharmacies per Capita – June 22, 2021 – There are more than 26,000 pharmacies in the U.S., yet many Americans struggle to access one. One in 3 neighborhoods in the country’s 30 largest cities lack convenient access to a pharmacy, an issue much more prevalent among Black and Latinx communities, according to a Health Affairs study published in May. Below are the 50 states and Washington, D.C., ranked by how many pharmacies they have per 10,000 residents, according to research released by pharmacy discount company USA Rx. <Read More>

    WHO Releases Pediatric Chronic Pain Guidelines, Advocates for Biopsychosocial Approach – June 22, 2021 – New guidelines released by the World Health Organization advise for the use of physical therapy and psychological therapies alongside pharmacologic treatment to manage pediatric chronic pain, highlighting the need for a biopsychosocial approach to pain management in children. The pediatric guidelines, which define children as 0 to 19 years of age, had goals to guide practitioners to good patient outcomes, while avoiding the pitfalls of medication misuse or treatment complications, for example. However, the dearth in pediatric research available for analysis complicated those goals. <Read More>

    Leading Pharmacy Organizations Assert Pharmacists’ Fundamental Workplace Responsibilities and Rights – June 22, 2021 – The boards of the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA) have released principles that outline the fundamental responsibilities and rights of pharmacists in workplace settings, to enable pharmacists to fulfill their professional responsibilities while serving their patients. Pharmacist’s Fundamental Responsibilities and Rights states that pharmacists have fundamental responsibilities, built on principles embodied by the Oath of a Pharmacist, and the Pharmacist Code of Ethics: 1) To practice with honesty and integrity, 2) To seek employment that aligns with their professional goals and personal values and needs, 3) To be lifelong learners to maintain professional competency and engage in the profession, 4) To educate their patients and the public to enhance public health, 5) To make decisions and seek resolutions regarding workplace concerns without fear of intimidation or retaliation from their employer or supervisors. <Read More>

    340B in the News

    Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion – June 25, 2021 – Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate program and 340B, we at Medicaid and the Law cover relevant 340B topics for our readers. Today, we are discussing the “340B Contract Pharmacy Saga” in light of the Department of Health and Human Services (HHS) Office of General Counsel’s (OGC’s) June 18 announcement withdrawing Advisory Opinion 20-06.  On December 30, 2020, OGC (under former HHS Secretary Alex Azar) issued this Advisory Opinion, which sided with 340B covered entities in the midst of long-simmering tension between 340B covered entities (including DSH hospitals, FQHCs, and others) and manufacturers over the participation of contract pharmacies in the 340B program. <Read More>

    Drugmakers Dig in and Signal Fight Over HRSA’s Demands to Reverse 340B Contract Pharmacy Policies – June 23, 2021 – Several drugmakers are digging in and refusing to reverse policies that cut off sales of 340B drugs to contract pharmacies despite a federal directive to do so. The Health Resources and Services Administration (HRSA), which oversees 340B, wrote to the six companies on May 17 calling for them to resume sales to contract pharmacies and giving the companies until June 1 to respond with a plan to do so. But three of the companies refused HRSA’s request, and two others have sued the Department of Health and Human Services (HHS) over the issue. The responses signal that drugmakers are not budging in a nearly yearlong feud with providers and the federal government over making sales to contract pharmacies, which are third-party entities that dispense drugs on behalf of 340B-covered entities. <Read More>

    Court Sides with Drug Manufacturers in Ongoing 340B Litigation – June 22, 2021 – Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related enforcement actions were prompted by multiple drug manufacturers which, beginning in 2020, asserted that discounted 340B pricing would no longer be available for their drugs when the drugs are dispensed through covered entity arrangements with contracted pharmacies, or, in some cases, to limit 340B covered entities to arrangements with a single contract pharmacy. Last week, a district court sided with one of the drug manufacturers and rejected the Government’s motion to dismiss, concluding that the 340B statute did not unambiguously support the use of 340B contract pharmacies. In response, the Government posted a notice stating that, while it does not agree with the court’s decision, it is withdrawing its prior Advisory Opinion upholding the use of contract pharmacies, although enforcement actions against drug manufacturers will continue. (See AstraZeneca Pharmaceuticals LP v. Azar et al, No. 21-cv-00027-LPS (D. Del. Jan. 12, 2021.) (Notice of Withdrawal, June 18, 2021, ECF No. 81-1.) <Read More>