Clinical Insights: February 16, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval

    CoselaTM (trilaciclib) – New Drug Approval – February 12, 2021 – The U.S. Food and Drug Administration approved CoselaTM (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. CoselaTM may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme. “For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, M.D., Ph.D., supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. <Read More> 

    EvkeezaTM (evinacumab-dgnb) Injection – New Drug Approval – February 11, 2021 – Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). EvkeezaTM is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Botox® (onabotulinumtoxinA) Injection – New Approved Indication – February 9, 2021 – Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA) has approved Botox® for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. Neurogenic detrusor overactivity occurs when the spinal cord and bladder are not able to communicate effectively, which can occur with neurologic conditions such as spina bifida and spinal cord injuries. As a result, the bladder muscle involuntarily contracts, increasing the pressure in the bladder and reducing the bladder capacity, which can cause the individual to leak urine frequently and unexpectedly. Elevated bladder pressure can also lead to bladder and kidney damage over time. <Read More>

    Libtayo® (cemiplimab-rwlc) Injection – New Approved Indication – February 9, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC. <Read More>

    New/Updated Drug Shortage

    February 12, 2021

    February 11, 2021

    February 10, 2021

    February 09, 2021

    February 08, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    LotemaxTM 0.5%  Gel – New Generic Approval – February 10, 2021 – Akorn Operating Company LLC (Akorn), a leading specialty pharmaceutical company, announced that it received approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Loteprednol Etabonate Ophthalmic Gel, 0.5%. Douglas Boothe, Akorn’s President and Chief Executive Officer, stated, “We are excited to launch yet another first-to-market generic of a complex ophthalmic. This approval comes in just over 12 months from submission to the FDA and is the result of strong collaboration among Akorn’s research and development, operations, quality, and regulatory teams.” <Read More>

    Clinical and Pharmacy News

    Study Finds CV Risk is Unknown for Many Patients With COPD – February 13, 2021 – A recent study found that the proportion of patients in the Netherlands with chronic obstructive pulmonary disease (COPD) who are being assessed for cardiovascular (CV) risk does not align with Dutch guideline recommendations. Despite guidelines recommending assessment of the risk of cardiovascular (CV) death for all patients with chronic obstructive pulmonary disease (COPD) in the Netherlands, a recent study found that 1 in 6 patients have not been assessed and many patients at high risk have not been enrolled in CV management programs. Investigators said that the results, which were published in BJBP Open, show that in the 36.1% of patients who have not had a CV risk (CVR) assessment, there is “room for improvement,” which can be accomplished by completing CVR profiles and enrolling high-risk and very-high-risk patients in CV care programs directed at chronic disease management. <Read More>

    Tapping Into ICD-10 Data Streamlines SP Care – February 12, 2021 – Specialty pharmacists at AllianceRx Walgreens Prime’s nine locations received more than a half-million data points on their chronically ill patients’ comorbidities from Inovalon DataStream since July 2020, according to the company. This robust pipeline of patient information, derived in part from the International Classification of Diseases, Tenth Revision (ICD-10), comes from numerous sources, including hospitals, physicians, laboratories and other health care silos, noted Rick Miller, MS Pharm, MBA, the vice president of clinical and professional services of AllianceRx Walgreens Prime. <Read More>

    NCPA Says DIR Fees Threaten Pharmacies – February 12, 2021 – After failing to get relief on direct and indirect remuneration fees through legislative and regulatory pathways, the National Community Pharmacists Association says it was left no choice but to file a lawsuit to stop what it says is an “existential threat” to independent pharmacies.  The lawsuit, filed in January against the U.S. Department of Health and Human Services, states that the fees are without reasonable transparency, and they conceal from patients and taxpayers the true cost of prescription drugs.  “This is not something we took lightly,” said B. Douglas Hoey, NCPA CEO and a pharmacist. “For one reason or another, Congress and the executive branch have so far failed to get it done. We aren’t giving up on those pathways but frankly, the damage caused by pharmacy DIRs escalated to an existential threat to community pharmacies.” <Read More>

    CDC Guidelines Are a Tool for Safer Opioid Use – February 12, 2021 – Given the well-documented scope of the opioid crisis, one would think all providers have gotten the message that less is more when it comes to opioid prescribing. But overprescribing is still happening, with one recent study showing that an average of more than 50 excess pills were given to patients following total knee replacement (J Arthroplasty 2020 Feb 5. pii: S0883-5403[20]30115-7). In another study, investigators found nearly half of patients treated with opioids during their hospital stay were discharged with prescriptions for the painkillers, many of which were in violation of current treatment guidelines (JAMA Surg 2018;153[2]:e174859). <Read More>

    Antibiotics for Viral Acute Respiratory Tract Infections: Going, Going, and Hopefully Gone – February 12, 2021 – Antibiotic stewardship has been a frequent topic for studies and commentaries in our journal. Still, it can be challenging not to prescribe antibiotics even when the potential benefit is small. What do we know about delaying antibiotics to ensure that they are really needed? … The primary outcomes were symptom duration and severity and secondary outcomes were use of antibiotics in the delayed and no antibiotic categories parent satisfaction, and parent beliefs regarding the importance of using antibiotics for ARTIs. The results for all these outcomes are shared in detail in this study, but the bottom line is that there were no meaningful differences in duration or severity of symptoms regardless of group. Furthermore, only parents in the immediate prescription group that felt like antibiotics made a difference, even though there was no clinical difference. <Read More>

    Safety, Efficacy of Hepatitis A Vaccinations Consistent Across Weight Groups – February 12, 2021 – Findings from a new study showed that a live attenuated Hepatitis A virus (HAV) vaccine is safe in persons of all weight categories—including obese. Results indicated the vaccine has comparably high immunogenicity in those who are both underweight/normal weight and overweight/obese. “Presently, there is a trend to use the live HAV vaccine variant because it involves a single dose,” wrote the investigators. <Read More>

    The Hidden Players Putting Independent Pharmacies Out of Business – February 12, 2021 – Editor’s note: Many independent pharmacies say their business model is threatened by pharmacy benefit managers. To see the impact on one business, reporter Liz Tung interviewed a pharmacist over the course of many months to better understand the issues facing him. In the end, he said he wanted to share what happened to him, but only under the condition of anonymity — he was afraid of backlash from PBMs. We have verified and fact-checked his story, and decided to tell it without using his real name. We’re calling him Bill. <Read More>

    NICE Recommends Treatment Options for Severe Pregnancy Sickness in New Draft Guidance – February 11, 2021 – In many cases, at-home remedies such as ginger can help to alleviate symptoms, but in a small percentage of pregnant women, the condition can be more serious. Between 0.3 and 3.6% of pregnant women experience excessive nausea and vomiting known as hyperemesis gravidarum, which can sometimes lead to hospitalisation. In draft guidance, NICE recommends treatment options for hyperemesis gravidarum for the first time. New recommendations advise the use of pharmacological antiemetics (known as anti-sickness medicines), acupressure, and intravenous fluids to treat these extreme cases of nausea and vomiting in pregnancy, in line with guidance from the Royal College of Obstetricians and Gynaecologists. <Read More>

    Navitus Health Solutions Announces a Specialty Pharmacy Purchase From CareMetx to Expand Geographical Footprint – February 11, 2021 – Navitus Health Solutions, a full pass-through pharmacy benefit manager (PBM), announced that Lumicera Health Services, its wholly-owned specialty pharmacy, has purchased a specialty pharmacy from CareMetx, a leading technology-enabled hub services company committed to improving patient access to specialty medications. The specialty pharmacy, CareMetx Health, located in Gaithersburg, Maryland, will allow Lumicera to better serve patients located in the eastern United States. “As Navitus and Lumicera continue to grow their specialty pharmacy business, adding another specialty pharmacy to our portfolio will allow us to expand and deliver specialty services to clients throughout the U.S.,” said Brent Eberle, SVP and Chief Pharmacy Officer at Navitus. “Improving health and quality of life is the key mission of our specialty solutions, and we’re excited for the opportunity to collaborate with CareMetx to better serve our clients and their members across multiple geographies.” <Read More>

    How Retail Pharmacies Plan to Handle Leftover COVID-19 Vaccine Doses – February 11, 2021 – Retail pharmacies around the U.S. are taking different approaches to making sure extra COVID-19 vaccine doses don’t go to waste, including using waiting lists or giving leftover shots to their employees and shoppers, The Wall Street Journal reported. About 6,500 pharmacies in all 50 states are set to receive a total of 1 million vaccine doses from the federal government starting Feb. 11. The pharmacies require eligible people to schedule appointments to get the vaccine, but doses can go unclaimed if people don’t show up for appointments or if vials contain more doses than expected, according to the Journal. <Read More>

    Azurity Pharmaceuticals Announces Three New Neurology Products – February 10, 2021 – Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced the purchase of the neurology portfolio from Eton Pharmaceuticals.  The product portfolio includes lamotrigine (ET-105), zonisamide (ET-104), and topiramate (ET-101). These medications are currently under review with the U.S. Food and Drug Administration as new drug applications. The three neurology products fit Azurity’s core strategy to introduce innovations that improve patient care. “Many patients have needs that are not sufficiently addressed by existing medications. Azurity aims to solve for these gaps by developing new alternatives that may benefit patients,” said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals. <Read More>

    Coupon-Program Pivot: Meeting New Legal, Operational Hurdles – February 10, 2021 – In 2020, the pharmaceutical industry witnessed a flurry of regulatory and legislative activities addressing drug pricing, distribution, and reimbursement. But while the industry and media have been captivated by high-profile reform initiatives, critical developments regarding drug manufacturer copay coupons have quietly transpired in the background. The legal treatment of coupons and copay accumulators—mechanisms used by pharmacy benefit managers (PBMs) and payers to counter coupons’ impact on plan costs—has evolved in ways that are, on balance, not favorable for manufacturers. These developments deserve closer scrutiny, given the importance of coupons as tools to facilitate access to branded drugs, the ubiquity of coupon use, and the billions of dollars at stake.1 Many manufacturers will need to modify their coupon programs to preserve their value while accommodating new challenges. <Read More>

    Herpes Zoster May be a Sign of COVID-19 in Pregnancy – February 10, 2021 – New research suggests that pregnant women appear to be at an increased risk for complications of coronavirus disease 2019 (COVID-19), including herpes zoster (HZ) infection. For this reason, experts say the clinical presentation of HZ in pregnant women should be carefully monitored and reported for further assessment, especially if it is associated with other signs of COVID-19. According to a case report presented in Cutis, COVID-19 has been associated with an array of skin manifestations, including maculopapular eruptions, morbilliform rashes, urticaria, chickenpox-like lesions, livedo reticularis, so-called “COVID toes,” erythema multiforme, and pityriasis rosea. In the case study, the authors presented a case of HZ complication in a woman who was 27 weeks pregnant and tested positive for COVID-19. <Read More>

    MFN Drug Price Plan Frozen by U.S. Courts – February 10, 2021 – Court injunctions have put the nail in the coffin of the Trump administration’s “Most Favored Nation” interim final rule aimed at lowering prescription drug prices, but experts say this probably isn’t the last we’ll see of international drug reference pricing. The rule, which was set to take effect Jan. 1, proposed to restrict costs for the top 50 physician-administered Medicare Part B drugs—which account for almost 80% of Part B spending—to no more than the lowest price that drug manufacturers receive in other similar countries. Specifically, it would have replaced the existing average sales price plus 6% formula with a new one based on international pricing information from an index of 22 different countries. <Read More>

    Pharmacy Chains on Hiring Sprees to Support COVID-19 Vaccination Campaign – February 10, 2021 – Pharmacy chains across the U.S. are on hiring sprees to recruit pharmacists and pharmacy technicians to help with the national COVID-19 vaccination campaign, The New York Times reported Feb. 10.  The U.S. is set to send 1 million vaccine doses to roughly 6,500 retail pharmacies Feb. 11 and aims to eventually deliver shots to 40,000 pharmacies. Pharmacies need pharmacists and pharmacy technicians to not only administer the vaccines, but to fill syringes, sign people in, answer questions, document doses given and monitor people for side effects, the Times reported.  “It’s like the job market flipped overnight,” Maurice Shaw, PharmD, a pharmacist at the University of Illinois at Chicago College of Pharmacy, told the Times. <Read More>

    New Leadership for FDA Entangled in Politics – February 10, 2021 – The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. Consumer representatives have pressed to name Joshua Sharfstein to the job, a step up from serving as FDA principal deputy commissioner during the Obama administration; research and patient organizations seek to retain acting commissioner Janet Woodcock as permanent head of the agency. The administration’s inaction so far has set up the current situation as an unofficial trial period for Woodcock to display her leadership ability and political savvy as pressures continue for resolving the coronavirus pandemic. <Read More>

    Roche’s 2020 Losses to Biosimilars Were “Worst It Can Get” – February 9, 2021 – Biosimilar competition took a $6.34 billion bite out of international revenues for Roche in 2020. It was the biggest decline so far attributable to biosimilar competition, according to Bill Anderson, CEO of Roche Pharmaceuticals. “I think we’ve seen the worst that it can get,” he said in an investor presentation. He anticipated a smaller-but-still-painful $5.1 billion biosimilar impact in 2021. Roche faces accelerating biosimilar competition, particularly in the United States, for 3 of its aging blockbusters: Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan/MabThera (rituximab). For those products in just the United States, Japan, and European Union in 2020, biosimilar competition eroded $5.68 billion in revenue, Roche said. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 – February 9, 2021 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. <Read More>

    USPSTF Updates guidelines on Smoking Cessation – February 9, 2021 – In January, the U.S. Preventive Services Task Force (USPSTF) issued recommendations for reducing tobacco use in adults, including pregnant individuals. They found strong evidence to support behavioral interventions and FDA-approved pharmacotherapy for cessation in nonpregnant adults, and behavioral interventions in pregnant adults. USPSTF could not find sufficient data to safely recommend approved smoking cessation pharmacotherapies in pregnant women who smoke. “The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined,” said the updated recommendations, which also appeared in JAMA. <Read More>

    Caffeine Consumption in Pregnancy Linked to In Utero Brain Changes – February 9, 2021 – New research finds caffeine consumed during pregnancy can change important brain pathways that could lead to behavioral problems later in life. Researchers in the Del Monte Institute for Neuroscience at the University of Rochester Medical Center (URMC) analyzed thousands of brain scans of nine and ten-year-olds, and revealed changes in the brain structure in children who were exposed to caffeine in utero. <Read More>

    New Data Show US Drug Prices Are 2.56 Times Those in Other Nations – February 9, 2021 – Recent research has found that prescription drug prices in the United States are significantly higher than those in other nations, with prices averaging 2.56 times those seen in 32 other countries. This gap is even larger for brand-name drugs, according to the RAND Corporation report. In contrast, the report found that prices for unbranded generic drugs are slightly lower in the United States than in most other nations. Unbranded generic medications account for 84% of drugs sold in the United States by volume but just 12% of spending, according to a press release. Conversely, brand-name drugs are an average 3.44 times higher in the United States than in comparator nations. <Read More>

    Optimizing Opioid Therapy with Pharmacogenetics – February 9, 2021 – The Clinical Pharmacogenetics Implementation Consortium (CPIC)* recently published a clinical practice guideline on the use of pharmacogenetic information for opioid therapy for pain control. This guideline includes recommendations for how CYP2D6 genetic test results can be used to optimize therapy for codeine, tramadol, and hydrocodone. <Read More>

    About 60% of Nursing Home Staff Declined Covid Vaccines, Walgreens Exec Says – February 9, 2021 – About 60% of employees and 20% of residents at long-term care facilities declined Covid vaccines, said Rick Gates, Walgreens senior vice president of pharmacy and health care. The declined shots indicate another challenge the country will face, particularly as pharmacies and community clinics get more doses: Vaccine hesitancy. Gates said he expects vaccines to be more widely available at Walgreens stores in late March or early April. <Read More>

    New Swipes at Rx Industry Despite Stable Costs – February 8, 2021 – On the last full day of President Trump’s tumultuous presidency, CMS released a proposal to dramatically restrict access to Part D drugs for patients with serious medical conditions. Effective in 2022, the “Part D Payment Modernization Model” will permit Part D and Medicare Advantage plans to change therapy for patients stabilized on anticonvulsants, immunosuppressants, antidepressants, antineoplastic, and antipsychotics.  The change would apply to HIV/AIDS medications in the following year.  In addition, the proposal allows plans to restrict formularies to just one drug per therapeutic class, instead of the two drugs per class, as has been the case since Part D was enacted. <Read More> 

    340B in the News

    Drug Manufacturers Sue HHS Over 340B Advisory Opinion – February 14, 2021 – Three drug companies have filed separate lawsuits to preserve their ability to restrict offerings of 340B-discounted drugs to contract pharmacies. The lawsuits, filed in early January in different federal courts, all share the same goal: getting rid of an advisory opinion filed by the Department of Health and Human Services’ (HHS’) general counsel that says drug companies must offer 340B drugs to contract pharmacies. The companies argue that the advisory opinion alters the statute for the 340B program, which requires manufacturers to offer discounted products to safety net hospitals and other providers in exchange for participation in Medicare and Medicaid. <Read More>

    A Status Report on Prescription Drug Policies and Proposals at the Start of the Biden Administration – February 11, 2021 – In recent years, federal and state policymakers have introduced several proposals to lower prescription drug costs in an attempt to respond to the public’s ongoing concerns about high and rising drug prices. As President Biden takes the reins in Washington DC, his administration inherits a handful of final rules advanced by the Trump Administration in its final months related to Medicare, importation, and 340B pricing for insulin and epinephrine. It also seems likely that lawmakers in the new 117th Congress will push to enact some of the key drug pricing proposals related to Medicare and drug prices more generally that were voted on but not enacted into law in the previous session. In this brief, we provide a status update on these final rules and an overview of key Medicare-related drug pricing proposals supported by President Biden during the campaign that may return to the forefront of health policy discussions in the coming years. <Read More>

    Hospitals Ask Supreme Court to Take Up 340B, Site-Neutral Payments – February 11, 2021 – The American Hospital Association (AHA), joined by member hospitals and other national organizations, have filed petitions asking the Supreme Court to reverse two appeals court decisions impacting hospital payments. The first case involves a lawsuit brought on by the AHA and other organizations challenging the nearly 30 percent cut to Medicare outpatient prospective payment system drug payments for hospitals participating in the federal 340B Drug Pricing Program. <Read More>

    New York State Budget Cuts Threaten HIV Care – February 9, 2021 – A change to New York State’s budget will take hundreds of millions of dollars away from clinics and hospitals treating low-income and underserved people, including those living with HIV — and health care providers and over 40 lawmakers are calling for a reversal. The change involves the 340B Drug Pricing Program, a federal program under which certain providers serving the neediest people can obtain prescription drugs at deep discounts but bill insurance plans, including Medicaid, for the full price. The money representing the difference between the insurance payment and the discount price of the drugs can be kept by the provider to hire staff, expand services, and make other investments to improve care. This difference is known as the “spread.” <Read More>