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Clinical Insights: June 15, 2021

Posted on June 15, 2021 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

Prevnar 20™ (pneumococcal 20-valent conjugate vaccine) Injection – New Vaccine Approval – June 8, 2021 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following this FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults. Prevnar 20™ includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. <Read More>

Aduhelm™ (aducanumab-avwa) Injection – New Drug Approval – June 7, 2021 –  The U.S. Food and Drug Administration approved Aduhelm™ (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm™ was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. <Read More>

New Formulation Approval

Epclusa® (sofosbuvir and velpatasvir) Tablets and Oral Pellets – New Approved Formulation – June 10, 2021 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa® (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa® (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa® in children ages 3 years and older is based on weight. <Read More>

New Indication/Dosage Approval

Ultomiris® (ravulizumab-cwvz) – New Expanded Indication – June 7, 2021 – Alexion Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ultomiris® (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris®, a long-acting C5 inhibitor that offers immediate, complete and sustained complement inhibition, is now the first and only FDA-approved medicine for children and adolescents with PNH. <Read More>

 New/Updated Drug Shortage

June 14, 2021

June 11, 2021

June 10, 2021

June 09, 2021

June 08, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers – June 14, 2021 – One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as buprenorphine and naloxone. As a result, the Department of Health and Human Services (HHS) issued the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (Practice Guidelines) through a waiver of certain certification requirements prescribed by law. The Practice Guidelines remove a longtime prerequisite tied to training and counseling that several practitioners have cited as a barrier to treating patients with Opioid Use Disorder (OUD). The Practice Guidelines could not come soon enough, as a recent study indicates that individuals with OUD experienced decreased access to treatments during the pandemic. <Read More>

Successful Dispensation of Antidepressants With Psychotherapy – June 13, 2021 – Of the 1 million Dutch people who take antidepressants, an estimated 150,000 take them for a long time to prevent a relapse into depression. However, many would like to phase out its use. New research shows that short-term psychological interventions such as preventive cognitive therapy and mindfulness-based cognitive therapy provide demonstrable protection against recidivism, even if patients gradually reduce antidepressant use. This relates to research conducted by Prof. Dr. Claudie Buckting and by Dr. Josephine Breedfelt, both affiliated with the Amsterdam UMC. They were studying recently published in JAMA Psychiatry. The researchers compared continued use of antidepressants with antidepressant withdrawal while patients received psychological intervention specifically aimed at preventing relapse. They used all individual patient data from four previously published randomized controlled trials (n = 714) in the meta-analysis. They found no difference in relapse risk between the two conditions over 15 months of follow-up. <Read More>

Inflated Savings, Hidden Costs: How Vendors Who “Carve-Out” Specialty Benefits Fail to Deliver Promised Value – June 13, 2021 – In recent years, a number of niche vendors have entered the market, promising significant savings for payers if they “carve-out” specialty pharmacy services from integrated pharmacy benefits management (PBM). While the savings they claim to provide sound undeniably attractive, they are often greatly exaggerated. <Read More>   

Op-Ed: When it Comes to Prescription Drugs, PBMs Have the Power – June 12, 2021 – PBM is an acronym for Pharmacy Benefit Manager. They administer your prescription program and sets the rules and regulations. When you go to your pharmacy to get a prescription filled, which was written by your physician, you probably have a prescription card from your employer or insurance company that lists the name of the PBM they have contracted with. About 90% of the time, the PBM is either Express Scripts (ESI), CVS/Caremark or Optum…The top three PBMs listed above are all in the Top 25 of the Fortune 500 companies. They should just be paid for administration and not be involved in formularies designed to increase the PBM profits. They should never be involved in getting in the way of the patient/doctor relationship. <Read More>

Independent Grocery Pharmacies Need DIR Fee Reform Now – June 11, 2021 – Independent supermarkets operate over 3,000 pharmacies across the country. In many small towns and rural areas, the grocery store pharmacy is the only healthcare provider in the community. In recent years, two disturbing trends have been accelerating: Medicare Part D beneficiaries are paying higher out-of-pocket costs, and independent community pharmacies are closing. This is a direct result from pharmacies being assessed ever increasing direct and indirect remuneration (DIR) fees. These fees, often referred to as ‘rebates’ or ‘price concessions’, are abused by Part D plan sponsors and pharmacy benefit managers (PBMs) to strategically recoup funds from pharmacies long after transactions have been completed. <Read More> 

How Pharmacists Can Help Patients With Bipolar Disorder Make Informed Treatment Decisions – June 11, 2021 – One of the challenges of treating individuals who are diagnosed with bipolar disorder is mitigating their risk for stroke. Nearly 3 million Americans live with bipolar disorder, and studies suggest this disorder and other mental health conditions are associated with increased potential for stroke and higher odds of experiencing poor outcomes. One study found that the use of certain mood stabilizers may raise the potential for stroke, although more research is needed. Other factors include unhealthy lifestyle choices, poor access to care, biological factors, and chronic stress, which raises the probability of developing mood disorders and experiencing a stroke. Because bipolar disorder is most often treated with therapy and medications, it’s important to consider ways to decrease patients’ chances of developing stroke through clinical modifications. Pharmacists are essential to this effort. <Read More>

Many Surgery Patients Get Opioid Prescriptions, But Many Don’t Need to, Study Suggests – June 11, 2021 – Surgeons can ease their patients’ pain from common operations without prescribing opioids, and avoid the possibility of starting someone on a path to long-term use, a pair of new studies suggests. Treating post-surgery pain with non-opioid pain medications such as ibuprofen or acetaminophen didn’t lead to higher pain levels or more serious issues during recovery, and didn’t dampen patients’ satisfaction with their care, according to new results from a study of more than 22,000 patients who had one of seven common operations at 70 hospitals. <Read More>

Change to Gilead Assistance Program Threatens Prep Access, HIV Advocates Say – June 11, 2021 – Dr. John Carlo is concerned that patients at Prism Health North Texas who rely on the health care safety net will soon be struggling even more to stay on PrEP, a medication that prevents HIV transmission. Carlo, chief executive officer of the clinic, which runs three locations in Dallas, offers free PrEP to roughly 250 patients, he said, thanks to an assistance program run by Gilead Sciences. The drugmaker currently manufactures two PrEP medications…In April, Gilead announced it will change how much it reimburses through that assistance program. For pharmacies that contract with certain safety-net clinics, like Prism Health, the change means less reimbursement cash to pass along to the clinics. <Read More>

FDA Takes Steps to Increase Availability of COVID-19 Vaccine – June 11, 2021 – Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. The agency is announcing that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. <Read More>

AHA Blasts United Healthcare’s Plan to Retroactively Deny Emergency Claims – June 10, 2021 – The American Hospital Association (AHA) is joining the American College of Emergency Physicians to urge UnitedHealthcare to reverse its decision to retroactively deny emergency care claims. In a letter to United Healthcare’s CEO Brian Thompson, Richard J. Pollack, president and CEO of AHA, writes that hospitals and health systems are “deeply concerned” about the new policy, saying it would put patients’ health and wellbeing in jeopardy. <Read More>

The Pharmacist’s Role in Naloxone Dispensing to Combat the Opioid Epidemic – June 10, 2021 – Prescription opioids are derived from the opium poppy plant and help to relieve pain by binding opioid receptors in the brain or spinal cord. After binding with the receptor, opioids block pain by preventing the release of neurotransmitters like dopamine. Opioids are effective in this mechanism but when they are misused, it can lead to addiction and possibly death. The opioid epidemic has escalated as a result of increased opioid prescribing, forcing government officials and health care providers to take immediate action. To help combat the increasing instances of overdose, the opioid reversal agent naloxone was introduced into health care. <Read More>

The Value of Specialty Pharmacy as a Career Path – June 10, 2021 – Vast opportunities are opening every day for pharmacists, especially with the upcoming complex biological products that need a lot of therapeutic drug monitoring and fine adjustment of doses… Specialty pharmacy is one of the fastest growing industries in the United States. To serve this blooming industry, National Association of Specialty Pharmacy was founded in 2012. Specialty drugs were expected to account for 50% of US drug spending in year 2020.2 Dr. Scott Knoer, former chief pharmacy officer at Cleveland Clinic Ohio and current CEO of the American Pharmacist Association, believes it is a worthwhile business and advises other health systems to get into the specialty pharmacy business. <Read More>   

Quality Initiative Demonstrates the Benefits of Integrated Pharmacy Care Model – June 10, 2021 – Like others who rely on specialty medications, patients with cystic fibrosis (CF) benefit from the patient-centered, high-touch care they receive at health systems with integrated specialty pharmacy capabilities. For patients with CF, this model of care includes medication therapy management and helps address complexities surrounding pulmonary exacerbations, nutrition support, mental health, and other clinical issues. For providers, embedded specialty pharmacy staff members can ease the burden of prior authorization and other administrative requirements. They also help patients access financial resources and untangle insurance issues. <Read More>

Potassium-Sparing Agents Put a Rise in RAASis – June 10, 2021 – Newer agents are reenergizing the treatment of hyperkalemia, a serious condition characterized by elevated serum potassium levels in patients with cardiovascular, renal and metabolic diseases, several experts noted. This improvement in hyperkalemia management has yielded another key benefit: It has allowed the increased use of drugs for heart failure, such as renin–angiotensin–aldosterone system inhibitors (RAASis), which often have been avoided due to their tendency to raise potassium levels. <Read More>

Managing Medications for Mental Health in Military Personnel – June 10, 2021 – Military life is thought to be a risk factor for psychiatric problems such as posttraumatic stress disorder (PTSD), depression, generalized anxiety disorder, and panic disorder, because of working in high pressure and stressful environments. The use of psychotropic medications in the military can be associated with the presence of a psychiatric issue that requires ongoing treatment. In recent years, there has been a growing movement towards limitations or restrictions placed on the use of psychotropic medications, which can be used to manage more severe mental illnesses, among active-duty military personnel. <Read More>

Thinking of “Carving Out” Specialty Benefits? Your Questions Answered – June 10, 2021 – Payers know firsthand how much of their prescription drug spend is driven by specialty medications for complex, chronic conditions. CVS Health’s 2020 Drug Trend Report showed the outsized impact of specialty medications. Last year, 52% of money spent in the pharmacy benefit came from specialty medication even though only 2.5% of patients utilize them. Not surprisingly, many payers are looking at ways to reduce their specialty medication spend. This has led to the emergence of vendors promoting approaches that claim to help payers significantly cut costs by “carving-out” specialty pharmacy services from integrated pharmacy benefits management. But does this approach work? Or do the lofty promises cover up potential issues and offer artificially inflated savings estimates? <Read More>

ACR RA Guidelines: ‘Maximize’ Methotrexate Use Prior to Dmards, Avoid Glucocorticoids – June 10, 2021 – The American College of Rheumatology has released its updated treatment guidelines for rheumatoid arthritis, with a strong emphasis on the use of methotrexate before adding or switching to DMARDs, according to the lead author. “The key messages are to maximize use of methotrexate prior to adding or switching to disease-modifying antirheumatic drugs,” Liana Fraenkel, MD, MPH, of Berkshire Medical Center, in Pittsfield, Massachusetts, and Yale University School of Medicine, told Healio Rheumatology. “We also include specific recommendations to try to minimize side effects prior to changing DMARDs.” <Read More>

FDA Issues Updated Guidance for PROs in Cancer Trials – June 10, 2021 – New FDA guidance includes updates for assessing patient-reported outcomes in cancer trials. New draft guidance for industry highlights core patient-reported outcomes (PROs) and considerations for instrument selection and trial design in cancer clinical trials. The non-binding recommendations were developed by the Oncology Center of Excellence (OCE), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) at the FDA. Specifically, the guidance pertains to “trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy,” authors wrote. However, PRO measurement may not be feasible for all cancer trial populations and heterogeneity in PRO assessment strategies has lessened the regulatory utility of this data, they explained. <Read More>

Pharmacies Extending Friday Hours in June to Increase Access to COVID-19 Vaccination – June 10, 2021 – Thousands of pharmacies across the country are extending their operating hours on Fridays during the month of June with the goal of getting more individuals vaccinated against COVID-19. The collaborative effort by pharmacies, which include Walgreens, CVS, and Albertsons Company stores, is part of the National Month of Action for COVID-19 vaccinations announced June 2 by President Biden. According to The White House, the campaign is an effort to have as many individuals as possible receive at least 1 dose of a COVID-19 vaccine by July 4 and it relies on mobilizing many different partners, including national organizations, businesses, and volunteers. Pharmacies are being called upon to provide more opportunity for individuals with less flexible work hours to receive the vaccine by extending their operating hours to create more convenient access. <Read More>

Biden Officials Urge States to Keep Expired Doses – June 9, 2021 – White House officials are telling states they can set aside unused Johnson & Johnson vaccine doses once they expire rather than throw them away, four sources with knowledge told Politico’s Rachel Roubein. White House aides in private calls with governors and state officials on Tuesday said the FDA is expected to examine whether the vaccine’s shelf life is longer than three months. <Read More>

AHF Salutes Biden Administration for Ordering Drug Price Discounts – June 9, 2021 – The AIDS Healthcare Foundation has published a statement commending the Biden administration for holding “shameless, greedy drug companies accountable for illegally denying price discounts on prescription drugs to nonprofit clinics and hospitals because they were using contract pharmacies.” In its press release last week, Ged Kensela, the AHF spokesperson, lauded the U.S. Health Resources Services Administration for sending six letters informing AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics their practices were unacceptable. The letters advised the companies “that they are in direct violation of the statute establishing the 340B Drug Pricing Program.” <Read More>

U.S. Health Care Should Follow This Blueprint to Boost BP Control – June 9, 2021 – There has been inadequate and worsening control of high blood pressure in the United States. This has likely been exacerbated by the COVID-19 pandemic, which exposed shortcomings of the health care delivery system. But there is a blueprint for change that clinicians and health care delivery systems can follow to improve blood-pressure control, says a new article. Published in the American Journal of Medical Quality, “Controlling High Blood Pressure: An Evidence-Based Blueprint for Change,” was co-written by Gregory Wozniak, PhD, director of outcomes analytics in Improving Health Outcomes at the AMA, and Alison P. Smith, MPH, BSN, RN, program director for the AMA and American Heart Association (AHA) Initiative to Control Blood Pressure, along with experts from Jefferson College of Population Health, Rush Medical College, University of Minnesota, Johns Hopkins University and AHA, among others. <Read More>

Louisiana Bans Insurers From Controversial ‘White Bagging’ Practice – June 9, 2021 – A new law in Louisiana will bar health insurers from implementing a pharmacy policy known as “white bagging.” White bagging is when health insurers don’t let providers procure and manage a drug for their patients, but rather require a third-party specialty pharmacy to dispense the drug to the provider. Health insurers have argued that healthcare costs can be lowered if members get prescription drugs from in-network specialty pharmacies. However, hospitals have called on lawmakers to limit the practice, which they argue can threaten care quality. <Read More>

Hospital Outcomes of Male Breast Cancer in the United States – June 8, 2021 – It is well known that there is a substantial economic burden of managed care for the female population with breast cancer in the United States. However, information on health care utilization and costs for male patients with breast cancer is sparse despite the epidemiological differences between male and female breast cancer. We found that male patients with breast cancer experienced an estimated hospital stay duration of 2.4 days and costs of $9059 per hospitalization in the United States. Metastatic status and comorbidities were the major predictors of a longer stay and higher costs. Our findings will be helpful for the allocation of health care resources for men with breast cancer. <Read More>

Ohio Suits Against Drug Middlemen in for Long Haul – June 8, 2021 – Ohio has been one of the most active states litigating against drug middlemen, whom Attorney General Dave Yost accuses of bilking state agencies out of tens of millions of dollars. Other states also have been active in court against the healthcare giants. Notably, Arkansas last year squared off at the U.S. Supreme Court against the industry association representing the middlemen — and won. But Yost has been a leader in scrutinizing “pharmacy benefit managers” since 2018, when he was still state auditor. He released an audit of Ohio’s Medicaid prescription drug business concluding there wasn’t nearly enough transparency for state officials to know whether taxpayers were getting their money’s worth from the $2.5 billion annual expenditure. <Read More>

Propylene Glycol–Free Melphalan Passes Safety Test – June 8, 2021 – Toxicity issues related to propylene glycol–free melphalan in patients with multiple myeloma undergoing autologous hematopoietic cell transplant (auto-HCT) may be overblown, according to new research. Generic melphalan contains propylene glycol (PG) as a solvent. After the FDA approved PG-free melphalan (Evomela™, Acrotech™) in 2016, contradictory reports emerged about its toxicity, said Ko Maung, MD, of Duke Cancer Institute in Durham, N.C. “At Duke, we used PG-free melphalan since May 2017, but switched to generic melphalan in November 2017 due to the concern for increased toxicity. We hypothesized that PG-free melphalan is associated with more toxicity than generic melphalan,” he said. <Read More>

Advancing LGBTQ+-Inclusive Care: How Pharmacists Can Better Support Patients – June 8, 2021 – Diversity and inclusion remain a hot topic, but the embers that continue burning into the American conscience far transcend race and ethnicity. Like minority communities, the LGBTQ+ community also wrestles with its own struggles as another medically underserved population smoldering under the ashes, and pharmacists and other health care professionals who serve the LGBTQ+ community are working to establish methods to address these patients’ needs better. “Historically, the barriers to care for LGBTQ+ individuals are complex and encompass many determinants,” said Tam Phan, PharmD, AAHIVP, assistant professor of clinical pharmacy and clinical pharmacist at the Jeffrey Goodman Special Care Clinic at the USC School of Pharmacy in Los Angeles, California. <Read More>

OTC Products Are Accessible When Traditional Health Care Delivery Is Not – June 8, 2021 – Starting that fateful week in March 2020 when everyone’s life changed, health care settings closed their doors en masse. From primary care to ambulatory surgery, physical therapy to massage therapy, nearly every setting of care suspended operations, except for emergency departments connected to hospitals and pharmacies. Yes, pharmacies. More than 60,000 remained open to patients, and most pharmacists continued their role as a source for OTC products and the free-of-charge counseling that often goes with them. <Read More>

APhA Commends Biden Administration’s Announcement of Actions to Address Pharmaceutical Supply Chain Vulnerabilities – June 8, 2021 – The American Pharmacists Association (APhA) commends the Biden administration’s announcement of new actions to address vulnerabilities in the pharmaceutical supply chain and strengthen our nation’s drug supply. The administration’s announcement accompanied the release of the final report of the 100-day review called for in Executive Order (E.O.) 14017 “America’s Supply Chains.” APhA had welcomed E.O. 14017 and supports the administration’s efforts to protect our nation’s drug supply and mitigate shortages of both finished drug products and active pharmaceutical ingredients (APIs). <Read More>

Amazon Pharmacy Offers Half-Yearly Prescriptions Starting at $6 – June 8, 2021 – Amazon.com Inc said on it was now offering six-month prescriptions starting at $6 for medications of common health issues through its pharmacy. The company said prime members would get additional savings when paying without insurance. Customers can pay as low as $1 per month for select medications, including drugs to treat diabetes and blood pressure, and will get free two-day delivery. <Read More>

Specialty Exceeds Traditional in Drug Spend – June 7, 2021 – Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, according to Prem Shah, executive vice president of specialty pharmacy and product innovation at CVS Health. Specialty drugs used to be the boutique part of the drug spend: expensive, yes, but unusual. Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, according to Prem Shah, executive vice president of specialty pharmacy and product innovation at CVS Health. But the CVS Caremark 2020 Drug Trend Report shows that specialty drugs accounted for more than half (52%) of the pharmacy spend last year. <Read More>

 Is Competition the Way to Bring Down the Price of Diabetes Drugs? – June 7, 2021 – List prices for brand-name drugs have risen sharply in recent years, but it is more complicated with net prices — the prices paid after rebates and other discounts have factored in. The rise isn’t nearly as steep, and it’s not uniform. Many in the drug and PBM industry say it is the net prices that matter because those actually get paid, not the list price. And there’s an argument that the answer to rising drug prices could be more competition within drug classes because that would drive down net prices as manufacturers compete. A team of Harvard researchers conducted a study of three classes of diabetes drugs to examine that argument. Their results, published in the May 2021 issue of Health Affairs, produced a mixed verdict — and more evidence that drug pricing in the United States is nothing if not complex. <Read More>

EMA Highlights Guidance Not to Use Heparin for COVID-19 Vaccine-Linked Clots – June 7, 2021 – The European Medicines Agency (EMA) on Monday pushed guidance for doctors not to use the blood thinner heparin to treat rare blood clots and low blood platelets in people who got AstraZeneca’s or Johnson & Johnson’s COVID-19 shots. Europe’s drugs regulator, seeking to ensure proper treatment, highlighted the International Society on Thrombosis and Haemostasis (ISTH) interim guidance. In April, the ISTH concluded “management should be initiated with non-heparin anticoagulation upon suspicion” of vaccine-linked clotting and low platelets. <Read More>

Court Orders Toledo Pharmacy and Two Pharmacists to Stop Dispensing Dangerous Doses and Combinations of Opioids and Other Controlled Substances – June 7, 2021 – A federal court in Ohio ordered a Toledo pharmacy and two of its pharmacists to pay a $375,000 civil penalty and imposed restrictions related to the dispensing of opioids and other controlled substances. Pursuant to an agreed consent judgment and permanent injunction, the court enjoined Shaffer Pharmacy, along with pharmacist-owner Thomas Tadsen and pharmacist Wilson Bunton, from dispensing certain opioid prescriptions, including combination opioid and benzodiazepine prescriptions. The order also mandates that the defendants undergo periodic comprehensive reviews of their dispensing practices to ensure compliance with the order and the Controlled Substances Act. The consent decree resolves a civil complaint the government filed on Jan. 6, 2021, in the Northern District of Ohio. The complaint alleged that the defendants repeatedly dispensed opioids and other controlled substances in violation of the Controlled Substances Act by ignoring “red flags” – that is, obvious indications of drug diversion and drug-seeking behavior. <Read More>

CDC COVID-19 Study Shows mRNA Vaccines Reduce Risk of Infection by 91 Percent for Fully Vaccinated People – June 6, 2021 – A new CDC study finds the mRNA COVID-19 vaccines authorized by the Food and Drug Administration (Pfizer-BioNTech and Moderna) reduce the risk of infection by 91 percent for fully vaccinated people. This adds to the growing body of real-world evidence of their effectiveness. Importantly, this study also is among the first to show that mRNA vaccination benefits people who get COVID-19 despite being fully vaccinated (14 or more days after dose 2) or partially vaccinated (14 or more days after dose 1 to 13 days after dose 2). <Read More>

340B in the News

Biden Halts Program That Brings Down Cost of Insulin, Epipens – June 11, 2021 – One focus during the Trump administration was lowering prescription drug costs, especially for low-income individuals. When he struck a deal with Big Pharma to lower the cost of insulin and epinephrine (EpiPens) for low-income patients, the White House rightly celebrated the accomplishment. Now the Biden administration has halted that initiative. Why does Joe Biden want to raise the price of such lifesaving drugs to those in greatest economic need? The White House budget office cleared the Biden proposal to pause the Trump action that linked insulin and EpiPen discounts. Trump’s rule required certain 340B health centers to pass the discounts along to its patients in need. The rule wasn’t even a wide-sweeping order. It was a narrowly targeted act that only pertained to roughly 1,000 health care facilities. Some 340B groups argue it increases administrative burdens and may limit access. HHS is expected to publish the retraction next week. <Read More>

HHS Secretary Becerra Testifies Before Key Committees – June 11, 2021 – Health and Human Services (HHS) Secretary Xavier Becerra, JD, testified before the House Ways and Means Committee on June 8; the Senate Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies (Labor-HHS) on June 9; and the Senate Finance Committee on June 10 to discuss the Biden administration’s proposed fiscal year (FY) 2022 budget request for the HHS [refer to Washington Highlights, June 4]… Labor-HHS subcommittee member Sen. Joe Manchin (D-W.Va.) asked Becerra about the next steps following recent letters that the Health Resources and Services Administration (HRSA) sent to six major drug manufacturers that have been withholding 340B discounts on eligible drugs purchased at contract pharmacies [refer to Washington Highlights, May 21]. Becerra responded, “We didn’t just say it verbally; we put out in writing a clear message to these six manufacturers that we believe that they’re violating the law. You violate the law; you pay the consequences.” <Read More>

Biden Budget Offers Potential Oversight Tool on 340B Program – June 11, 2021 – Citizens Against Government Waste (CAGW) has called for reforming the 340B program since 2014.  The 340B safety net program was created in 1992 and derives its name from Section 340B of the Public Health Service Act.  It is administered by the Health Resources and Services Administration (HRSA), a division within the Department of Health and Human Services (HHS).   A June 8, 2021, Inside Health Policy article discusses a proposal in President Biden’s fiscal year (FY) 2022 Budget that would provide $17 million for oversight of the program, including establishing a dispute resolution process, which is $7 million more than FY 2021. <Read More> 

A Timeline of the 340B Conflict Between Hospitals, Drugmakers – June 10, 2021 – Since last summer, drugmakers and hospitals participating in the 340B drug pricing program have been locked in a battle over whether drugmakers are required to give hospitals discounts on drugs that are dispensed through contract pharmacies. The 340B program was created in 1992 and requires drugmakers to offer discounts on all outpatient drugs to hospitals and clinics that serve indigent populations. About 2,500 hospitals around the country participate in the program. Drugmakers argue that giving discounts on drugs dispensed at contract pharmacies forces them to waste money by giving duplicate discounts. Hospitals say drugmakers are required under federal law to provide the discounts and failing to do so inhibits access to healthcare for the indigent populations 340B hospitals serve. A timeline of the conflict: <Read More>

Industry Voices—The 340B Drug Program Grew Faster Than the Infrastructure That Supports It. Here’s How to Tackle That Challenge – June 9, 2021 – The past year has seen a great deal of controversy surrounding the 340B Drug Pricing Program, in which drug manufacturers make prescription drugs available to safety net healthcare providers at deeply discounted prices. Many people with passing knowledge of the program—even lawmakers and healthcare industry insiders—appear surprised by the passion this debate has generated. How could the challenges in this seemingly small program make such a major impact? In fact, the 340B program has grown and evolved rapidly over the past 10 years, and the widespread perception of a “small program” no longer matches reality. As the program has grown, the challenges it faces have become more pronounced, and the consequences to ignoring these challenges more dire. <Read More>

Under ‘Threat’ of Fines, Novartis Sues HHS Over Drug Pricing Program – June 7, 2021 – The biopharma industry is not taking the threat of even modest civil monetary penalties lightly, as Novartis last week sued the Biden administration’s HHS over plans to assess such penalties for changes that the companies made in regard to a small but high-profile drug discount program for hospitals. <Read More>