Skip to content

Clinical Insights: May 4, 2021

Posted on May 4, 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

Kloxxado™ (naloxone hydrochloride) Nasal Spray – New Drug Approval – April 30, 2021 – The U.S. Food and Drug Administration announced the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products… The FDA granted approval of Kloxxado™ to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. <Read More>

Zynlonta™ (loncastuximab tesirine-lpyl) Injection – New Accelerated Drug Approval – April 23, 2021 – The Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. <Read More>

New Formulation Approval

No new update.

New Indication/Dosage Approval

Ferriprox® (deferiprone) – New Approved Indication – May 1, 2021 – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced that the U.S. Food & Drug Administration (FDA) has approved Ferriprox® (deferiprone) for the treatment of transfusional iron overload due to sickle cell disease (SCD) or other anemias in adult and pediatric patients 3 years of age and older. This FDA approval expands the use of Ferriprox® for patients with SCD or other anemias as well as patients with thalassemia regardless of prior iron chelation exposure. <Read More>

Farxiga™ (dapagliflozin) Oral Tablets – New Approved Indication – April 30, 2021 – The U.S. Food and Drug Administration approved Farxiga™ (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. “Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, M.D., M.S., deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. <Read More>

New/Updated Drug Shortage

April 30, 2021

April 29, 2021

April 28, 2021

April 27, 2021

New Drug Recall and Safety Alerts

NP Thyroid® (Thyroid Tablets, USP) by Acella Pharmaceuticals, LLC – New Voluntary Drug Recall – April 29, 2021 – Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4). <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

New Patient Guidelines on Anemia and Neutropenia – May 3, 2021 – The National Comprehensive Cancer Network (NCCN) announced the publication of new NCCN Guidelines for Patients: Anemia and Neutropenia, Low Red and White Blood Cell Counts funded by the NCCN Foundation and endorsed by The Leukemia and Lymphoma Society (LLS). The free information source is designed to help people living with cancer and caregivers recognize symptoms of blood cell deficiencies caused by cancer or chemotherapy—and increase engagement with their oncology care team about management and support. <Read More> 

New Findings Suggest Hepatitis C Drugs May Multiply Effect of COVID-19 Antiviral Remdesivir – May 3, 2021 – According to new research from Rensselaer Polytechnic Institute (RPI), the antiviral remdesivir is 10 times more effective in treating cells infected with SARS-CoV-2 when combined with drugs currently used to treat hepatitis C virus (HCV). The finding raises the potential for repurposing available drugs as COVID-19 antivirals for cases in which a vaccine is not practical or effective, according to RPI chemistry and chemical professor Gaetano Montelione. “Nearly 3 million people have died worldwide from COVID-19. There are situations where the vaccine isn’t the best option and it would be helpful to have orally available antivirals,” Montelione said in a press release. “Here we see a promising synergy that, if confirmed through additional research and clinical trials, could provide a new antiviral to combat COVID-19.” <Read More>

Drug Giants go on Trial Today at ‘Ground Zero of the Opioid Epidemic’ – May 3, 2021 – Three of the largest U.S. drug distributors are set to stand trial on Monday after being charged with illegally supplying West Virginia with millions of prescription opioids, resulting in the country’s highest overdose rate. McKesson, AmerisourceBergen and Cardinal Health are being sued in a series of federal cases by Cabell County and Huntington, W.Va., for pushing opioid painkillers, leading to the rise of the opioid epidemic — the worst in U.S. history. Cabell County has been referred to as “ground zero of the opioid epidemic sweeping the nation,” where close to 100 million opioids were prescribed in the county with a population of approximately 90,000. <Read More>

Pharmacy:  The Missing Piece of the Value Puzzle – May 3, 2021 – The necessary push for the health care industry to move to whole-person care instead of condition-oriented models and tactics for applying a value-based model in pharmacy benefits. The topics of patient-centered care and value-based care (VBC) dominate a lot of health care discussions. Almost uniformly, though, those conversations leave out one of the most valuable elements of whole-person VBC: the pharmacy. How often do we hear about scenarios such as this: A heart specialist prescribes oral atorvastatin to help lower a patient’s low-density lipoprotein cholesterol. Unaware of this, a dermatologist at a completely different health system prescribes topical ketoconazole to treat the patient’s tinea versicolor—and liver damage ensues. <Read More>

American Heart Association Advises Considering Medication for Certain Patients With Stage 1 Hypertension – April 30, 2021 – Medication should be considered for patients with slightly elevated blood pressure who do not respond to 6 months of healthy lifestyle changes, according to a new statement from the American Heart Association (AHA) published in Hypertension. This statement serves to fill a gap in guideline recommendations by addressing how to manage untreated, stage 1 high blood pressure not fully addressed in the 2017 treatment guidelines. <Read More>

For Genetic Diseases, a Patient-First Approach Delivers More Precise Prognoses – April 30, 2021 – Health care practitioners and manufacturers must change practice patterns and management strategies. A growing understanding genomics and of how genetics drives health, disease, and drug responses in each patient is enabling better disease prevention strategies, more accurate diagnoses, safer drug prescriptions, and more effective treatments. Personalized medicine (PM) tailors care to each patient’s unique genetic makeup, which can improve outcomes and lower costs. For device and drug manufacturers, PM provides an opportunity to develop agents targeted for specific patient groups that don’t respond to medications.1 But effective PM requires changes in practice patterns and management strategies for health care practitioners and for manufacturers in reimbursement, regulatory practices, and knowledge sharing. What’s more, they must overcome barriers to implementation to effectively individualize diagnoses and prognoses. <Read More>

Pharmacy Fact: Amphetamines Make Things Slightly Better Until They Don’t, Inventor Finds – April 30, 2021 – In 1932, chemist Gordon Alles was investigating a new asthma medicine. Hoping to develop a better version of ephedrine, a decongestant and bronchodilator that was very successful on the market, Alles began to look further into the compound beta-phenylisopropylamine for answers. Although he didn’t know it at the time, Alles was not the first to discover this compound. Romanian chemist Lazar Edeleanu had first synthesized the drug in 1887, but upon testing it, had found it to be quite useless as it didn’t cure anything. Unaware and undeterred, Alles went ahead with his own investigation into the compound’s benefits. <Read More>

Patients With Asthma Need an Action Plan – April 30, 2021 – Pharmacists can play a vital role by offering inhaler counseling and helping improve adherence, especially during COVID-19. Asthma is a common chronic lung disease that affects more than 25 million individuals in the United States. It is especially important during the coronavirus disease 2019 (COVID-19) pandemic to ensure that patients are prepared with at least a 30-day supply of their medications at all times. Individuals with moderate to severe asthma may be at higher risk of severe COVID-19 so pharmacists should educate patients about the importance of frequent hand washing, getting the COVID-19 vaccine, social distancing, and wearing a mask. Pharmacists can play an important role in helping patients manage asthma and improving adherence (Figure). <Read More>

Flip the Pharmacy Announces Award Winners – April 30, 2021 – Flip the Pharmacy, a 5-year pharmacy transformation program directly supporting over 800 community-based pharmacies and impacting thousands more, announced the winners of its inaugural Flip the Pharmacy Awards. The year one winners are: 1) Pharmacy of the Year: Norland Avenue Pharmacy in Chambersburg, Pennsylvania, 2) Flip the Pharmacy Team of the Year: Team Pennsylvania, 3) Technology Solutions Provider of the Year: PioneerRx Pharmacy Software. “Congratulations to Team Pennsylvania, Norland Avenue Pharmacy, and PioneerRx Pharmacy Software for being selected as this year’s awardees,” announced Randy McDonough, PharmD, MS, BCGP, BCPS, FAPhA, Director of Practice Transformation for the Flip the Pharmacy program. <Read More>

Understanding Specialty Pharmacy (Part 3): Intersections With Retail Pharmacy – April 30, 2021 – If we consider the world of specialty pharmacy through the eyes of retail pharmacists, there are a few frustration points. As we touched on when introducing specialty pharmacy, there is no universal list of specialty medications, which can cause a disconnect when coordinating care between prescribers, pharmacies, payers, and patients. A physician may prescribe some specialty medications unknowingly to the local pharmacy and later the patient may find that their insurance plan requires it to be filled through a specialty pharmacy, even though the retail pharmacy has a bottle in stock. This can happen often because 1 payer may identify different drugs as specialty than another. Explaining this rejection to a patient becomes challenging and can be frustrating for pharmacists who may feel it is more practical and beneficial to fill the prescription at the retail store. <Read More>

‘Pharmacy Benefit Manipulators?’ – AHF to Target PBM Abuse in New Campaign – April 29, 2021 – In response to growing consolidation and increasingly monopolistic behavior in the pharmacy and health care industries, AIDS Healthcare Foundation ( AHF ) is launching a new advocacy campaign to take on pharmacy benefit managers (PBMs) that are undercutting community pharmacies and driving up drug prices. The national campaign aims to raise awareness about PBMs’ undue influence on patients’ access to the prescription drugs they may need and to educate the public and press elected officials to call out and prevent PBM abuses. The campaign also hopes to rein in the abusive industry, which broadly functions as middlemen between insurance companies and pharmacies. <Read More>

Expert: Pharmacists Are ‘The Heroes of 2021,’ Leading the Charge on Helping to Heal Our Nation – April 29, 2021 – Health care affordability and the prevention of drug abuse are critically important to the National Association of Chain Drug Stores (NACDS), making these topics the focus of a discussion led by Steven C. Anderson, FASAE, CAE, IOM, president and CEO, NACDS, during a session at the NACDS 2021 Annual Meeting. This year, Anderson noted that NACDS is able to look back and see how pharmacy’s role in health care has been redefined in light of the pharmacist’s role in saving the lives of millions of Americans through their efforts during the COVID-19 pandemic. “We have redefined for the ages what it means to save lives, to serve consumers in times of need, and to provide a truly essential health and wellness destination—all because of your response to fighting COVID-19,” Anderson said during the session. <Read More>

APhA Joins NCPA Suit Against Backdoor Pharmacy Fees – April 29, 2021 – The American Pharmacists Association (APhA) joined the National Community Pharmacists Association (NCPA) as an equal partner in a federal lawsuit challenging a confusing scheme of retroactive fees imposed on pharmacies and, indirectly, their patients. “HHS has acknowledged on multiple occasions that retroactive pharmacy DIR fees inflict harm on pharmacies and increase costs for their patients, but it has repeatedly neglected to address the problem,” said APhA Executive Vice President and CEO Scott J. Knoer, MS, PharmD, FASHP. “This lawsuit puts pharmacy in the driver’s seat. We demand that HHS meet its obligations and use its authority to stop PBMs from operating without accountability.” <Read More>

Cyltezo™ is a Contender for First Interchangeable to Humira, Boehringer Ingelheim Says – April 29, 2021 – The results of Voltaire-X could persuade the FDA to authorize automatic substitution of the adalimumab biosimilar Cyltezo™ for its reference product (Humiraä), investigators believe. Boehringer Ingelheim believes it is on its way toward gaining perhaps the first interchangeable designation for a biosimilar, based on results of VOLTAIRE-X, a phase 3 randomized study that compared pharmacokinetic properties for the adalimumab reference product (Humiraä, RP; 40 mg/0.8 mL) with those of the adalimumab biosimilar Cyltezo™ (BI 695501) in patients with moderate-to-severe chronic plaque psoriasis. Patients received RP continuously or switched between the biosimilar and RP, and investigators concluded that patients who were switched multiple times between RP and Cyltezo™ experienced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety. <Read More>

House Introduces Bill, BIOSIM Act, Designed To Lower Drug Costs – April 29, 2021 – On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”).  The bill provides for temporary increased reimbursement to hospitals and doctors for biosimilar drugs from the average sales price (ASP) of the drug plus 6% to the ASP of the drug plus 8%.  The increase would last for five years. <Read More>

Multiple Defendants Sentenced in a Major Compounding Pharmacy Fraud Conspiracy – April 29, 2021 – Chief U.S. District Judge L. Scott Coogler sentenced two dozen defendants who were part of a major conspiracy to commit health care fraud, announced U.S. Attorney Prim F. Escalona, Federal Bureau of Investigation Special Agent in Charge Johnnie Sharp, Jr., U.S. Department of Health and Human Services, Office of Inspector General, Special Agent in Charge Derrick L. Jackson, Defense Criminal Investigative Service Special Agent in Charge Cynthia Bruce, United States Postal Inspector in Charge, Houston Division, Adrian Gonzalez, and Internal Revenue Service Criminal Investigation Special Agent in Charge James E. Dorsey. The defendants sentenced included an array of company executives and managers, a prescriber, billers, and sales representatives. <Read More>

Addressing Obesity in Patients Taking Antipsychotics – April 28, 2021 – Antipsychotic-induced weight gain evolves over time, leads to chronic complications, and is very difficult to reverse. Pharmacologic interventions used to tackle weight gain are modestly effective and worth considering in certain cases. Obesity is a prevalent global problem that affects patients with major mental illness disproportionately. It is associated with cardiovascular risk factors, including hypertension, dyslipidemia, and impaired glucose tolerance. Not surprisingly, the prevalence of these conditions is also high in patients with major mental illness. In fact, patients with major mental illness have a lifespan 10 to 15 years shorter than the general population, with cardiovascular mortality largely accounts for this difference. <Read More>

HHS Issues Guidelines Expanding Access to Buprenorphine Treatment – April 28, 2021 – Eligible practitioners who are licensed and registered to prescribe controlled substances are now exempt from certain statutory certification requirements related to training, counseling, and other ancillary services for prescribing buprenorphine, according to guidelines issued by the U.S. Department of Health and Human Services. Noting that addressing perceived barriers around prescribing buprenorphine by exempting practitioners from specific certification requirements may increase the availability of medication-based opioid use disorder treatment and help address barriers to care, the HHS issued practice guidelines relating to this exemption. <Read More>

Bipartisan Legislation Introduced to Increase Transparency, Use of Biosimilars in Medicare Plans – April 28, 2021 – Congressmen Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) have introduced the Star Rating for Biosimilars Act, HR 2855, which aims to create a biosimilars access measure in the Centers for Medicare and Medicaid Services’ Star Ratings Program. “In our capital region and across the nation, families are forced to pay unacceptably high prices for treatments to debilitating and even deadly diseases,” Tonko said in a press release. “Biosimilars are a safe, effective, and cost-saving option, but unjust profitable dynamics in America’s health care system are blocking access to these alternatives, forcing patients to pay a far higher price for substantially similar medical care.” <Read More>

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov – April 28, 2021 – Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all types of medical product trials, the U.S. Food and Drug Administration works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine. <Read More>

One in Five U.S. Pharmacies Blocks Access to Key Opioid Addiction Treatment – April 28, 2021 – The Biden administration has eased guidelines for prescribing a crucial addiction treatment drug, just as a new study reveals one in five U.S. pharmacies refuses to dispense the medication, called buprenorphine. “Buprenorphine is a vital, lifesaving medication for people with opioid use disorder, but improving access has been a problem for a variety of reasons,” said the study’s senior author, Daniel Hartung. He is a professor at Oregon Health & Science University/Oregon State University College of Pharmacy, in Corvallis. Under the new White House policy announced Tuesday, doctors and other health workers won’t need extra training to prescribe the drug as they do now. Also, they will no longer be required to refer patients to counseling services, the Associated Press reported. <Read More>

NSAIDS and Pharmacists Vital in Low Back Pain Management – April 28, 2021 – Patients with low back pain have been shown to respond well to non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, according to a literature review published in Pharmacy Practice by researchers at RMIT University. Following recently published Australian research finding strong evidence that paracetamol is not effective, or minimally effective, for relieving acute low back pain, NSAIDs have replaced paracetamol as the first-choice analgesic for non-specific low back pain in the current Australian Therapeutic Guidelines, as well as many international clinical guidelines. <Read More>

Feds Tell Pharmacies to Give 2nd COVID-19 Shots to Those Who Got 1st Dose Elsewhere – April 28, 2021 – Federal officials are directing retail pharmacies to give second doses of COVID-19 vaccines to anyone who got their first dose, even if they got it from a different provider, The New York Times reported April 27. The CDC has reported a growing number of people skipping their second doses, partly because of issues with access. Roughly 8 percent of people who’ve gotten one dose of a two-dose vaccine have skipped their second dose, the CDC estimates. <Read More>

A Conflicted FDA Panel Votes to Keep Atezolizumab in Metastatic TNBC While Studies Continue – April 27, 2021 – An FDA panel voted 7-2 Tuesday to keep atezolizumab (Tecentriqä) on the market for certain patients with metastatic triple negative breast cancer (TNBC), but how Genentech will move forward to show the value of the PD-L1 inhibitor in this setting remained unclear. FDA’s Oncology Drug Advisory Committee (ODAC) grappled with the conundrum it will face for 2 more days, as it reviews 6 indications in checkpoint inhibitors that were granted under the agency’s accelerated approval pathway but failed to show the same benefits in later studies. The question now, is, what should FDA do? Take the drug off the market, or let more data accumulate, given the fact that, by definition, these approvals were granted because they offered hope to cancer patients without options? <Read More>

Fully Vaccinated Adults 65 and Older are 94% Less Likely to be Hospitalized with COVID-19 – April 27, 2021 – Both mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) authorized and recommended in the United States protect against COVID-19-related hospitalization among adults 65 years and older, according to a new CDC assessment that finds fully vaccinated adults 65 years and older were 94% less likely to be hospitalized with COVID-19 than people of the same age who were not vaccinated. People 65 and older who were partially vaccinated were 64% less likely to be hospitalized with COVID-19 than people who were not vaccinated. People were considered “partially vaccinated” two weeks after their first dose of mRNA vaccine and “fully vaccinated” two weeks after their second dose. <Read More>

Brown Bag Consult®: Acute Myeloid Leukemia and the Community Pharmacist’s Role – April 27, 2021 – As the most accessible member of the health care team, the pharmacist can provide patients with cancer with the information and support necessary to get through what could be the most challenging time in their lives. Affecting both males and females, acute myeloid leukemia (AML) is an aggressive hematologic cancer caused by the proliferation and accumulation of immature precursor blood cells (myeloblasts). Identifying the disease’s signs and symptoms can help patients seek prompt care and ideally reduce its impact. Pharmacists are often thought of as the most trusted and accessible health care professionals in the community. Because of this perception, they can help patients understand possible signs and symptoms of illness, and assist with follow-up care for those who are diagnosed with AML. <Read More>

The Power of a Referral Form in a Limited Distribution Specialty Pharmacy Network – April 27, 2021 – A referral form is a powerful tool that can unlock many benefits and can serve as a resource for prescribers to enhance their prescribing practices. A limited specialty drug distribution network may consist of a number of specialty pharmacies and a patient service provider. These networks are crafted by the manufacturer and are based on several factors including the quality and breadth of services provided, experience within the disease state, product special characteristics for handling, and payer contracts provided by the network constituents. In these types of models, only the contracted pharmacies have access to the product, along with the non-commercial pharmacy who may be managing free drug programs. <Read More>

Despite Predictions, Still No Sign of IG Supply Shortage – April 27, 2021 – The anticipated immunoglobulin (IG) therapy shortage resulting from the COVID-19 pandemic still has not emerged. As the pandemic swept across the United States in the spring and summer of 2020, virtually everyone involved with the IG industry anticipated that a dramatic shortage of IG supplies would follow within about a year. Collections of the blood plasma that is the essential component of IG therapies for conditions such as primary immunodeficiency syndromes, dermatologic diseases and neuromuscular disorders dropped significantly in the early months of the pandemic. <Read More>

White House: Pharmacies Giving COVID-19 Shots to “College Students” no Longer Have Residency Requirements – April 27, 2021 – The Biden administration said that the pharmacies participating in the federal pharmacy program will no longer have residency requirements as part of an effort to ensure that college students can get their second COVID-19 vaccine shots if they are away from home or school. “Most pharmacies administering shots will now offer anyone a second dose, regardless of where they got their first,” Andy Slavitt, the White House’s senior advisor for the nation’s COVID-19 response, said during a White House briefing. <Read More>

AMA to States: Stop Interfering in Health Care of Transgender Children – April 26, 2021 – The American Medical Association (AMA) urged governors to oppose state legislation that would prohibit medically necessary gender transition-related care for minor patients, calling such efforts “a dangerous intrusion into the practice of medicine.” In a letter to the National Governors Association (NGA), the AMA cited evidence that trans and non-binary gender identities are normal variations of human identity and expression, and that forgoing gender-affirming care can have tragic health consequences, both mental and physical. “Decisions about medical care belong within the sanctity of the patient-physician relationship,” the AMA wrote in its letter. “As with all medical interventions, physicians are guided by their ethical duty to act in the best interest of their patients and must tailor recommendations about specific interventions and the timing of those interventions to each patient’s unique circumstances. <Read More>

COVID-19 Pandemic Causes Dramatic Shifts in Prescription Drug Spending – April 26, 2021 – According to the American Society of Health-System Pharmacists (ASHP)’s National Trends in Prescription Drug Expenditures and Projections for 2021, the COVID-19 pandemic heavily influenced spending on prescription drugs in the United States in 2020. Further, shifts in care related to the pandemic will continue to be a significant driver of drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs, and increased approvals of specialty medications. Prescription drug spending in 2020 grew at a moderate rate of 4.9% to $535.3 billion, whereas increased utilization drove the growth, which accounted for 2.9% of the total increase, spending on new drugs accounted for 1.8% of the increase, and price changes accounted for 0.3%. <Read More>

Pharmacist’s View: Independent Pharmacies Threatened by Middle Men – April 26, 2021 – COVID-19 continues to spotlight the importance of pharmacies for communities across Minnesota. From the first days of the pandemic, pharmacists understood their role as many patients’ closest and most trusted health care provider. From providing patients with COVID-19 tests to dispensing prescriptions and giving critical medical advice, they sprang into action…Minnesota has seen more pharmacies close in the last decade than any other state, and the strain on the remaining businesses has only grown during the pandemic. It’s particularly concerning when underserved and rural communities lose access to their closest, most reliable provider. While there are a number of factors leading to the decline in community pharmacies, the biggest threat is pharmacy benefit managers, or PBMs. Unfortunately, PBMs’ unchecked influence has led to them controlling nearly all parts of the prescription-drug market, at the detriment of community pharmacies, plan sponsors, and patients. <Read More>

340B in the News

Has Pharma Missed the Boat? – April 28, 2021 – A year ago, amid deep concern over COVID-19 and frantic work to develop vaccines, some of pharma’s heaviest hitters saw the possibility of reputational enhancement. Novartis AG chief executive (CEO) Vas Narasimhan dubbed it a “remarkable, perhaps once-in-a generation opportunity” back in April during the company’s first quarter earnings call. Eli Lilly CEO David Ricks, meanwhile, closely echoed this sentiment, stating the sector had a “once in a generation opportunity to reset” its reputation… Negative perceptions of affordability and pricing extend beyond issues relating to COVID-19, of course. Price hikes by AbbVie, Bristol Myers Squibb, GSK, Pfizer, Sanofi and Teva in late January have contributed towards the narrative shift to more negative territory. Hot on the heels of this spike in negative news, meanwhile, came the refusal of nine companies – Amgen, AZ, Eli Lilly, Merck, Novartis and Novo Nordisk among them – to sell therapies at the price legally required by section 340B of the US Public Health Services Act. <Read More>

The Courts and Healthcare Policy – April 2021 – April 28, 2021 – 2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare payment policies, price transparency, how the Medicaid program can change and whether Medicaid beneficiaries can sue over curtailed benefits, and immigration changes affecting access to programs like Medicaid. In 2021, the courts will continue to play an important role… 340B cuts. One lawsuit challenges the agency’s 2018 and 2019 reimbursement cuts for drugs in the 340B drug discount program. Hospitals argued that the agency did not have the authority to make those cuts, and a federal district judge agreed. Oral arguments were heard in Nov. 2019. On July 31, 2020, the Court of Appeals for the D.C. Circuit overturned the 2018 district court decision that found the Department of Health and Human Services (HHS) exceeded its statutory authority when it reduced 2018 and 2019 Medicare payment rates by 30 percent for many of the hospitals in the 340B Drug-Pricing Program.  <Read More>

Eli Lilly and Company (LLY) Q1 2021 Earnings Call Transcript – April 27, 2021 – … In addition, we were pleased with the uptake for new patients at ESI at the contracted rate and we expect that that population will grow meaningfully over time. There is always a near-term impact when we have a significant step-up in access and this win nearly doubled our commercial access. We’re encouraged by the volume growth we saw in the first quarter and believe Taltzä will return to net sales growth in the second quarter, which should continue to accelerate as we move through the year as the volume growth from the major access upgrades outpaces the related pricing headwinds. Beyond Taltzä, segment mix was not a major of US price performance in the first quarter as increased utilization in the more highly rebated government segments was offset by lower utilization in the 340B segment, primarily for the diabetes portfolio. While mid-term trends are stable at present, given the increase in variability and payer mix, we continue to expect quarterly variability in reported net price changes. We also expect Taltzä price impact to moderate as we move through the year and overall low-to-mid single digit total net price decline in the US for the full year. <Read More>