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Clinical Insights: January 11, 2022

Posted on January 11, 2022 By RxStrategies, Inc. -

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

Advancing Health Through Innovation: New Drug Therapy Approvals 2021 – January 2022 – Welcome to FDA’s Center for Drug Evaluation and Research’s (CDER) annual report, Advancing Health Through Innovation: New Drug Therapy Approvals, representing our 11th consecutive year of reporting CDER’s notable drug approvals. This report illustrates our role in bringing innovative drug therapies that are safe and effective to patients in need. Throughout 2021, the COVID-19 pandemic continued to present significant challenges to our entire staff. In spite of these hardships, we have approved many therapies that will advance health for the American public. As in the past, the 2021 new drug therapies span many areas of medicine and disease areas. <Read More>

Recorlev® (levoketoconazole) Capsules – New Drug Approval – December 30, 2021 – Xeris Biopharma Holdings, Inc., a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, announced the U.S. Food and Drug Administration (FDA) approval of Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative…The approval of Recorlev® was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New/Updated Drug Shortage

January 10, 2022

January 07, 2022

January 06, 2022

January 05, 2022

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Moderna to Supply 2-3 billion Booster Doses This Year – January 10, 2022 – Moderna plans to supply the world with 2 to 3 billion COVID-19 booster doses this year, including omicron-specific doses, the company’s CEO told CNBC Jan. 10. Stephane Bancel said a booster dose that targets the omicron variant will soon enter clinical trials, and the company expects to have it ready by this fall. <Read More>

How to Recognize, Capitalize on the Benefits of Price Transparency in Healthcare – January 10, 2022 – Hospital leaders who have historically viewed price transparency as potentially disastrous can tap into these three tips to leave that mindset behind and capitalize on the opportunities that price transparency provides. Healthcare leaders everywhere are concerned that price transparency will lead to price wars. But these fears miss a significant point: Price transparency actually has the potential to bolster hospitals’ financial performance. It can transform healthcare as we know it in a way that positively impacts everyone involved. How? A number of ways. Knowing competitors’ rates for specific services allows hospitals to do things like lower rates to gain market share, for example. It also enables them to strategically reduce prices in one area in order to increase volume for higher-margin services elsewhere. <Read More>

APhA Welcomes CMS’ Proposed Elimination of Retroactive DIR Fees in Potential Win for Patients and Pharmacies – January 7, 2022 – The American Pharmacists Association (APhA) is pleased to see provisions in a new Centers for Medicare and Medicaid Services (CMS) proposed rule that would eliminate pharmaceutical benefit managers’ (PBMs’) use of retroactive direct and indirect remuneration (DIR) fees, which increase patient out-of-pocket drug costs and causes harmful impacts at pharmacies…The proposed rule would move all pharmacy price concessions, including retroactive DIR fees, to the point-of-sale to benefit patients with lower cost sharing. It would increase predictability for pharmacies and address a regulatory loophole CMS opened in 2014 that allowed PBMs to have unlimited license to apply retroactive DIR fees. <Read More>

Novartis Wins One Step in the Patent Dance – January 7, 2022 – The U.S. Court of Appeals for the Federal Circuit issued a decision recently upholding the validity of one of the patents for Novartis’ fingolimod (Gilenya®), an immunosuppressive drug to treat flare-ups of multiple sclerosis. With this decision, Novartis said it expects no generic versions of the drug in the U.S. market for at least the next two years. U.S. Patent No. 9,187,405 (the ‘405 patent) covered a dosing regimen for fingolimod. In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya® patent litigation, and a permanent injunction was granted against HEC Pharm until the expiration of the ’405 patent in December 2027. This includes pediatric exclusivity, the company said in a statement. <Read More>

Implementing Injectables: Considerations for Cabotegravir-Rilpivirine Long-Acting Therapy – January 7, 2022 – Long-acting cabotegravir and rilpivirine injections are approved in Canada, Europe, and the United States. The unique pharmacokinetic and pharmacodynamics properties of long-acting cabotegravir and rilpivirine injectables allow them to be administered once monthly; the most prominent of these are long elimination half-lives with intramuscular administration (cabotegravir = 5.6-11.5 weeks and rilpivirine = 13-28 weeks). The drug–drug interaction profile of the injectable and oral formulations are different; each formulation should be checked for interactions before initiation of therapy. <Read More>

NASH Dash: The Pipeline Race is on for New Agents – January 7, 2022 – The year 2022 could see, for the first time, FDA-approved medications for nonalcoholic steatohepatitis (NASH). Semaglutide (Ozempic®, Novo Nordisk), already approved for diabetes, and Lilly’s investigational diabetes drug tirzepatide are among the agents to watch, according to a poster presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. “There are many molecules under investigation for NASH in the pipeline, with key outcomes of reducing hepatic fat stores and fibrosis,” said study co-author Christine Borunda, PharmD, a global medical affairs biopharmaceutical fellow with Massachusetts College of Pharmacy and Health Sciences (MCPHS University), in Boston. <Read More>

2021 Pharmacy Award Winners, the Best of the Best – January 7, 2022 – Four winners of the SingleCare Best of the Best Pharmacy Awards joined Drug Topics® to share their knowledge with fellow pharmacists and pharmacy technicians. When Drug Topics® sat down with a group of winners of the 2021 SingleCare Best of the Best Pharmacy Awards, humbled quickly became the word of the day…For the third year, prescription savings service SingleCare held their Best of the Best Pharmacy Awards, recognizing 25 outstanding pharmacy professionals from around the United States. This year’s awards generated thousands of nominations and honored 10 pharmacists, 10 pharmacy technicians, and 5 pharmacy teams who go above and beyond on a daily basis. <Read More>

ISMP Warns About Possible Safety Issues With Newly Authorized Paxlovid™ – January 6, 2022 – The Institute for Safe Medication Practices (ISMP) issued an alert to raise awareness about possible toxicities that could occur with nirmatrelvir-ritonavir (Paxlovid™, Pfizer), the new oral treatment that was recently authorized by the FDA to treat mild to moderate COVID-19 in people who are at risk for severe disease. The product has special dispensing requirements for people with moderate renal impairment, defined as having an estimated glomerular filtration rate below 60 mL per minute, but greater than or equal to 30 mL per minute. No dosing changes are required for people with mild renal impairment, and patients with severe renal impairment should not receive the drug, according to the FDA. <Read More> 

Pharmacists’ Plates Are Piled High – January 6, 2022 – As pharmacists administer more immunizations than ever, managers must provide a larger tray (pharmacy technicians) or smaller plates (fewer responsibilities) to balance things out. January 2022 has finally rolled around, and every pharmacist’s plate is full and—in most cases—running over. I use this plate analogy knowing full well that we are in the midst of “eating season,” which starts with Thanksgiving and ends with the Super Bowl. Having fought the “Battle of the Bulge” since elementary school, gaining weight is something I am an expert in. People can gain as much as 10 pounds during the eating season, often because they overload their plates. <Read More>

FDA Biosimilar Approval Recap – 2021 – January 6, 2022 – The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as “Obamacare”).  This brings to 33 the total number of approved biosimilars, although the effects of the pandemic has been felt in the last two years.  From 2015 (when there was only a single approved biosimilar, Sandoz’s Zarxio®, see chart below), the rate of approvals rose every year (3 in 2016, 5 in 2017, 7 in 2018, and 10 in 2019), but 2020 saw only 3 approvals. <Read More>   

CMS Proposes Part D Price Concessions be Applied at Point-Of-Sale, New Requirements for MA Plans – January 6, 2022 – The Biden administration wants Medicare Part D plans to apply any price concessions they get from drugmakers to the point-of-sale and require Medicare Advantage plans to be more transparent in how they spend money on supplemental benefits. The Centers for Medicare & Medicaid Services (CMS) released a proposed rule late Thursday that outlined major regulatory changes for MA and Part D starting in 2023. The rule covers a swath of major areas that include new changes for dual-eligible special needs beneficiaries and updates to calculations of star ratings, which can affect quality bonuses delivered to plans. “The proposed actions follow our guiding principles by improving health equity and enhancing access to prescription medications,” said CMS Administrator Chiquita Brooks-LaSure in a statement. <Read More>

Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology – January 6, 2021 – Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write. A strong market and development push for “biobetters” is anticipated by authors of a review of biosimilar and new biologic drug development in ophthalmology. Whereas biosimilars have the same amino acid sequence and are highly similar to reference products, biobetters may be modified chemically and have a different amino acid sequence or purification process. This can improve shelf life and pharmacological effects. Biobetters may require a much larger investment in development than biosimilars, but “the chances of a biobetter reaching the production stage are incredibly high,” the authors write. <Read More>

Connecticut Pharmacy Cancels 700 COVID-19 Test Appointments Over Lab Backlog – January 6, 2022 – Park Pharmacy in Waterbury, Conn., on Jan. 5 canceled all polymerase chain reaction COVID-19 tests for the week because of a backlog at the laboratory the pharmacy uses to process the tests, local NBC affiliate WVIT reported. A total of 700 tests have been canceled, pharmacy co-owner Mitual Patel told the news outlet. Park Pharmacy uses QDx Pathology Services, based in New Jersey, to process its PCR tests, “but there’s just so much demand,” he said, adding that the pharmacy was notified new tests would not be accepted at the lab until Jan. 10. <Read More>

Verdict Against Pharmacies May Herald Opioid Lawsuits Against Health Systems – January 5, 2022 – In a closely watched case, an Ohio jury found that the nation’s three largest pharmacy chains contributed to the opioid abuse crisis by failing to properly monitor prescriptions. The verdict against CVS Health Corp., Walgreens Boots Alliance Inc. and Walmart Inc. marks a broadening of opioid litigation targets beyond drug manufacturers and distributors to include those involved in the disbursement of medication. In addition to its potential legal repercussions for other cases against retail pharmacies, the verdict may portend a groundswell of lawsuits against health care providers and health systems. <Read More>

Operator of Illegal Pharmacy Pleads Guilty – January 5, 2022 – A man who illegally sold thousands of doses of controlled substances and prescription drugs pled guilty in federal court in Cedar Rapids. Jon Stidham, age 57, from McClelland, Iowa, was convicted of conspiracy to deliver, distribute or dispense methyltestosterone, a Schedule III controlled substance, by means of the Internet without a valid prescription and without complying with federal and Iowa licensing requirements, and one count of conspiracy to introduce misbranded drugs into interstate commerce with intent to defraud or mislead and to commit mail fraud. <Read More>

After Years of Decline, Drugmakers’ Price Hikes may Have Bottomed Out – January 5, 2022 – Pharmaceutical companies have raised the list prices of many of their drugs by about 5% to open 2022, roughly in keeping with recent years’ trend but significantly less than in the early and mid-2010s. Drugmakers typically take price increases on their products in the first part of January…”The median price increase for the drugs, and some anecdotes thus far in 2022, suggest slightly higher price increases behavior than in 2021,” the 46Brooklyn report concludes. <Read More>

CDC Expands Booster Shot Eligibility and Strengthens Recommendations for 12-17 Year Olds – January 5, 2022 – CDC is endorsing the Advisory Committee on Immunization Practices’ (ACIP) recommendation to expand eligibility of booster doses to those 12 to 15 years old. CDC now recommends that adolescents aged 12 to 17 years old should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series. Data show that COVID-19 boosters help broaden and strengthen protection against Omicron and other SARS-CoV-2 variants. ACIP reviewed the available safety data following the administration of over 25 million vaccine doses in adolescents; COVID-19 vaccines are safe and effective. At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for adolescents aged 12-17. <Read More>

Centene Finalizes Magellan Acquisition – January 4, 2022 – Days after securing final regulatory approval, Centene completed its $2.2 billion acquisition of Phoenix-based behavioral health provider Magellan Health, the company announced Jan. 4. The move makes Centene one of the largest behavioral health providers in the country, serving 41 million members. It also expands the payer’s government plan and pharmacy membership. <Read More>

Rx for VR: The Role of Virtual Reality in the Pharmacy – January 4, 2022 – A look at how virtual reality is making an impact on pharmacists and patient care. As an industry, virtual reality (VR) has moved far beyond a tool for gaming and entertainment: Over the last decade, VR—a market with a global value of $17.25 billion in 2020 and an anticipated growth to $184.66 billion by 20261—has gained a foothold within the larger health care industry. VR simulation is being used for everything from medical education to pain management to rehabilitation. Pharmacists—and the pharmaceutical industry—are also learning just how VR can make a difference, as well as the significant role it can play in patient care. <Read More>

Will the Need for Pharmacy Technicians Stick? – January 4, 2022 – The COVID-19 pandemic has increased the need for more helping hands in pharmacies, especially with vaccinations, and the opportunities for techs may last. On average, I receive 2 inquiries each week from pharmacy managers who want my help in seeking qualified individuals to fill open pharmacy technician positions. These are positions in community pharmacy, hospital inpatient and outpatient pharmacy, long-term-care facility pharmacy, mail order pharmacy sites, specialty compounding pharmacy, and veterinary pharmacy. Most positions offer pay on the high side of the technician pay scale, and most pharmacy managers are in a frantic state to hire technician help. <Read More>

Lessons Learned by a Student Pharmacist on Instagram – January 4, 2022 – There are key benefits and risks for student pharmacists to consider when approaching an Instagram account for professional pharmacy purposes. In 2019, an article in the Journal of the American College of Clinical Pharmacy titled “To tweet or not to tweet? A primer on social media for pharmacists,” encouraged pharmacists to engage professionally on social media, despite many pharmacists historically avoiding it for such purposes. With the article published 1 year after I had created my pharmacy podcast OVERxDOSE (pronounced “overdose”), I had just started a corresponding Instagram account (@overxdose), so I took an interest in the message of the article. Still today, many pharmacy students continue to primarily use LinkedIn, Facebook, and YouTube for professional development and networking. However, there remain key benefits and risks for student pharmacists to consider when approaching an Instagram account for professional pharmacy purposes. <Read More>

Projected US Savings From Biosimilars, 2021-2025 – January 3, 2021 – Biologics account for an increasing share of US prescription drug spending. Biosimilars could lower biologic prices through competition, but barriers to increasing both supply and uptake remain. We projected US biosimilar savings from 2021 to 2025 under different scenarios. We first analyzed 2014-2020 US volume and price data from IQVIA’s MIDAS database for biologics already facing biosimilar competition to inform model parameter values…Biosimilar savings from 2021 to 2025 were $38.4 billion under our main assumptions. Greater savings may be feasible if managed care and other settings increase biosimilar utilization and promote competition. <Read More>

340B in the News

AbbVie Latest Drugmaker to Impose 340B Restrictions on Sales to Contract Pharmacies – January 5, 2022 – AbbVie became the third drugmaker in recent months to restrict 340B-discounted drugs to contract pharmacies, the latest company undeterred at the prospect of federal fines. AbbVie announced Dec. 29 that starting Feb. 1 it will cut off sales of 340B-discounted products to contract pharmacies that don’t submit limited claims data. It is the 11th company to cut off sales to contract pharmacies since summer 2020. “In recent years, the 340B program has increasingly suffered from abuses that undermined that goal and call into question whether patients benefit from 340B discounts,” the company said in its notice. <Read More>

AbbVie Imposes 340B Pricing Restrictions at Community Pharmacies – January 4, 2022 – Drug company AbbVie has told safety-net hospitals it will stop offering 340B drug pricing program discounts on drugs dispensed at community-based pharmacies starting Feb. 1 if the hospitals do not agree to turn over patient claims data for those pharmacies to the company. “Beginning February 1, 2022, AbbVie will implement a 340B program integrity initiative designed to address persistent abuses caused by the unwillingness of covered entities and their contract pharmacies to provide sufficient claims data to prevent prohibited and improper duplicate discounting on AbbVie products,” the company said in a December 29 letter to 340B covered facilities. <Read More>

The 340B Program – January 3, 2022 – In a blog post titled “Ending the Epidemic Requires a Comprehensive Approach to Health Care,” AIDS United’s working group of safety net providers weighs in. Below is an edited excerpt. As members of AIDS United’s 340B Working Group, we’re working to end the HIV epidemic by the end of the decade. That isn’t fantastical thinking—it is more than possible with today’s medical science. For those of us living with HIV, there are medicines that can make the virus undetectable in our bodies. In addition to the many personal health benefits of reaching this undetectable level, it also means it’s impossible for us to pass the virus along to others. That’s what’s meant by Undetectable Equals Untransmittable, or U=U. And for those of us who are vulnerable to HIV, there is pre-exposure prophylaxis, or PrEP, a highly effective drug that prevents us from contracting the virus. <Read More>

Supply Chain Issues Make Visante’s Top 10 Practice Issues List – January 3, 2022 – Visante has released its perennial list of top 10 issues facing pharmacy, with supply chain issues appearing in the No. 4 spot for 2022. In looking to the coming year, CEO Jim Jorgenson, RPh, cited three key supply chain developments that stakeholders in health-system pharmacy should expect to see… 3) Focus on cost savings. The coming year should see health systems “placing a heightened emphasis on reducing supply costs,” he said. “This is a result of mounting financial pressures, including an increase in labor expense as health systems try to recruit nurses and other workers to keep their doors open.” Mr. Jorgenson also urged stakeholders to keep an eye on two additional issues affecting supply chain savings: the federal 340B Drug Pricing Program and biosimilars. “Many systems are dealing with unanticipated margin reductions due to changes in the 340B program,” he explained. “Pharmacy departments will be asked to reduce cost, and cost savings in the pharmacy supply chain will be vital to this effort.” <Read More>