Clinical Insights: June 22, 2021

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

    New Drug Approval

    Rezipres® (ephedrine hydrochloride) Injection – New Drug Approval – June 15, 2021 – Eton Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres® (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia. “We are excited to see the approval of Rezipres®, which is now our second FDA-approved ready-to-use hospital injectable product. We believe ready-to-use injectable products provide a compelling benefit to hospitals and reduce the need for hospitals to rely on unapproved compounded products,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “This innovative sulfite-free formulation has been successfully sold in Europe for years, and we are excited to make it available to U.S. patients shortly.” <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Astepro™ (azelastine hydrochloride nasal spray, 0.15%) – New Approved OTC Classification – June 17, 2021 – The U.S. Food and Drug Administration approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro™ (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older. <Read More>

    New/Updated Drug Shortage

    June 17, 2021

    New Drug Recall and Safety Alerts

    Metformin HCl Extended-Release Tablets, USP 750mg by Viona Pharmaceuticals Inc. – New Voluntary Nationwide Recall – June 11, 2021 – Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    HPV-Related Cancers Might Surpass Cervical Cancer for At-Risk Groups – June 18, 2021 – The incidence of cervical cancer in the United States has decreased annually by 1.53% in the last 17 years, which experts attribute mainly to clear screening guidelines that can identify precancers, according to data presented at the annual meeting of the American Society of Clinical Oncology (abstract 107). However, the incidence for HPV-related cancers without standardized screening, especially oropharyngeal, anal and rectal squamous cell carcinoma, increased and is projected to surpass that of cervical cancer within five years for certain at-risk groups. <Read More>

    Prostate Cancer Screening Recommended Earlier for Men With Family History of the Disease – June 18, 2021 – Researchers found that men with a family history of prostate cancer reached the screening risk threshold up to 12 years earlier than the general population. A new study in Sweden has confirmed that men with a family history of prostate cancer have a greater risk of being diagnosed with advanced or fatal disease, suggesting that screening guidelines should be adjusted to include earlier screenings in this population. Clinical guidelines for cancer screenings are intended to identify the disease early, according to the research, which was published in PLOS Medicine. Current guidelines note that men with a family history of prostate cancer have a greater risk and should begin screenings early, although the age at which these screenings should begin has remained unclear. <Read More>

    Expert Panel Makes 7 Recommendations for Vaccinations for Children With AD Receiving Dupilumab ­– June 18, 2021 – A panel of health care professionals reviewed published literature to develop a recommendation guide to advise providers on best practices when considering vaccinations for children with atopic dermatitis (AD) on dupilumab. Following a consensus meeting, health care professionals who work with patients with atopic dermatitis (AD) published 7 vaccination recommendations for pediatric patients treated with dupilumab (Dupixent™), according to an opinion piece published in the American Journal of Clinical Dermatology. “These recommendations serve to guide physicians’ decisions about vaccination in children with atopic dermatitis treated with dupilumab,” wrote the panelists. <Read More>

    On Juneteenth, APhA Reaffirms its Commitment to Racial Equity – June 18, 2021 – Juneteenth is a celebration of freedom, and as an organization, APhA rejoices along with the Black communities who observe the holiday with remembrance, prayer, food, and togetherness. We also recognize that Juneteenth is a day for us to be solemn and introspective. As we’ve seen especially clearly over the past year, even on jubilant days, Black elation is tempered by the traumas of everyday racism: daily images of violence, injustice, and health inequities; interactions marred by implicit bias; lip service paid to diversity, equity, and inclusion without substance or follow-through. APhA owns its role in the problem and is committed to being part of the solution. As the nation’s foundational pharmacy organization and the only one that represents all pharmacists in all settings, APhA has a powerful platform, and it is our responsibility to use it to make positive change. <Read More>

    Use Caution When Handling Controlled Substance Prescriptions ­– June 17, 2021 – A regular patient visits a community pharmacy with a new prescription for buprenorphine/naloxone (Suboxone™). The patient has been getting oxycodone for years and regularly talks with the pharmacy technician about everything from grandchildren to the weather. This time, however, the patient appears uncomfortable and does not talk much. Technicians are at the forefront of drug distribution in community pharmacies across the United States and are often the first point of contact in the pharmacy for patients who have been prescribed a controlled substance. The responsibilities of accepting, processing, and assisting in the distribution of these prescriptions often falls to technicians. Therefore they play a vital role in preventing drug diversion, providing care for patients, and upholding the law. In addition, technicians handle prescriptions for drugs that treat opioid use disorder (OUD), such as buprenorphine, which are critical in fighting the continuing opioid epidemic in the United States. <Read More>

    Speedier Busulfan Washout A Plus in HCT Conditioning? – June 17, 2021 – The washout period between the last dose of metronidazole and the first dose of the alkylating agent busulfan can be reduced from seven to three days, according to research from The University of Texas MD Anderson Cancer Center, in Houston. Busulfan, frequently used as part of conditioning for hematopoietic cell transplantation (HCT), has a well-established drug–drug interaction with metronidazole, which suppresses busulfan clearance and boosts treatment-related toxicity, the investigators noted. <Read More>

    Hospital Pharmacies and Budget Management: How Technology Can Help – June 17, 2021 – Hospital pharmacies are one of the busiest hubs in any health care system. In addition to dispensing and keeping track of medications, pharmacies are faced with administrative tasks that consume valuable time that could be spent focusing on crucial initiatives like patient care. One of the biggest and most time-consuming challenges they must address on a regular basis is cost control and budget management. This has always been an obstacle for health care organizations, as many facets of cost management are uncontrollable, like rising drug prices, new biologics that provide better patient outcomes, and shifting patient needs. <Read More> 

    Stakeholders Make Push for Pharmacy DIR Reform – June 17, 2021 – Hundreds of organizations representing community pharmacies, grocery store pharmacies, specialty pharmacies, chain pharmacies, patient groups, buying groups, health systems, wholesalers, and business groups are making an all-out push for legislation that would stop the abuse of pharmacy price concessions charged by third-party middlemen, which have increased 91,500 percent in recent years. The Pharmacy DIR Reform to Reduce Senior Drug Costs Act (S. 1909 / H.R. 3554) was introduced in the Senate by Sens. Jon Tester (D-Mont.) and Shelley Moore Capito (R-W.Va.), and in the House by Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.). In a letter to Congress signed by 249 organizations, they explained how pharmacy DIR fees – direct and indirect remuneration – affect seniors and pharmacies: “These fees, which lead to higher costs for beneficiaries at the pharmacy counter, impose ever‐increasing challenges on struggling seniors, putting them at risk for reduced medication adherence and poorer health outcomes. These fees also make it harder for pharmacies to continue operating and providing seniors and special needs populations with the medications and services they desperately need. Many pharmacies have closed over the past few years and have cited DIR fees as a primary cause. These pharmacy closures reduce access to vital healthcare services; especially in rural and underserved areas where healthcare options are already limited. <Read More>

    How Do We Pay for Specialty Pharmacy? – June 17, 2021 – Specialty medications should not be defined by their cost and should instead be defined by their efficacy. Specialty pharmacy has been at the forefront of the pharmacy world for the past few years. Innovative new therapies are being researched and developed every day. Some of the disease states that are often treated by specialty medications include different types of cancers, multiple sclerosis, rheumatoid arthritis, and HIV. These therapies are life changing, but is the cost. This puts the pharmacy benefit managers (PBMs), plan sponsors, and patients in a tough position financially speaking. Specialty pharmacy has grown at a rapid pace over the past decade. With research and development improving, as well as new disease states being discovered, there is no shortage of need for specialty medications and for good reason. <Read More>

    Keep Pharmaceutical Promotion Out of Doctors’ Electronic Tools – June 16, 2021 – The good news: It’s uncommon for physicians to be targeted with pharmaceutical marketing when they are using electronic health record (EHR) systems and there is no evidence that avenue to reach prescribers is gaining in popularity, says an AMA Board of Trustees report adopted at the June 2021 AMA Special Meeting. The top five EHR systems—which account for 85% of the market share—do not appear to have advertisements featured on the platforms, according to the board report. A small portion of the other 15% may generate revenue through ads, but only a handful offer partnerships with pharmaceutical companies. Still, that means some EHRs and e-prescribing programs may present opportunities for advertisers to reach doctors at that crucial point of care—and that shouldn’t be allowed to happen. <Read More>

    New AMA Policies Attempt to Revamp Prior Authorization Process – June 16, 2021 – The AMA said it has adopted new policies regarding the prior authorization process, with its outgoing president stating that maintaining the status quo may cause “life-or-death consequences.” Bringing the prior authorization process under control has long been a priority of medical organizations, including the American Academy of Family Physicians and the ACP. The AMA’s new policies involve the authorizations made during a public health emergency, and peer-to-peer (P2P) conversations between a physician and an insurance company physician employee either during the initial prior authorization process or after a prior authorization has been rejected, according to a press release. <Read More>

    Pharmacists Are Needed to Provide Birth Control – June 16, 2021 – In the United States, almost half of pregnancies are unintended. Globally, maternal mortality has declined steadily over the past 3 decades, but tragically, the number of American women dying during childbirth continues to climb. Accessible, affordable birth control could decrease unintended pregnancies and maternal mortality by 30%. Family planning allows women to obtain college educations, pursue advanced professional degrees, and join the nation’s workforce. The American Gynecological and Obstetrical Society advocates for full unrestricted access to contraception, and pharmacists are poised to help. <Read More>

    AAD Tackles Tough Issues in Upcoming Acne Update – June 15, 2021 – American Academy of Dermatology’s updated guidelines on acne will cover dermatology’s hottest issues, from dosing and monitoring established medications to exploring new antibiotics and addressing antibiotic stewardship. Five years of innovation and research have created numerous knowledge gaps in the American Academy of Dermatology (AAD) guidelines of care for the management of acne vulgaris. A work group recently formed by the academy to update its guidance will offer best-practice recommendations and safety precautions for the therapies, treatments, and devices developed to treat acne. Originally published in 2016, the new guidelines will be released in 2023 or 2024. <Read More>

    Can PBMs No Longer Rely on ERISA Preemption to Avoid Certain State Laws? – June 15, 2021 – Recent court trends suggest that preemption under the Employee Retirement Income Security Act (ERISA) may not apply to certain state laws that regulate pharmacy benefit managers (PBMs), including state laws governing Maximum Allowable Cost (MAC), which is essentially the process used by a PBM to determine in-network pharmacy reimbursement rates for generic drugs and multi-source brands. If this trend continues, this may mean that ERISA plan administrators and PBMs will need to pay very close attention to state MAC laws, as well as certain other state laws regulating PBMs. See our interactive map below that summarizes which states currently have a MAC law in place. See further details in our legal analysis. <Read More>

    Pharmacists: Crucial Partners in the Response to HIV – June 15, 2021 – The essential role of pharmacists in supporting the Ending the HIV Epidemic in the U.S. (EHE) initiative and the Ready, Set, PrEP program was the focus of a May 5, 2021, call between the HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) and a diverse range of national pharmacy leaders. The call also covered federal plans for recognizing the 40th anniversary of the AIDS epidemic…The discussion focused on the role of pharmacists in helping to re-energize the local response to HIV in collaboration with other health care providers—especially in communities with limited access to health services. Under the guidance of RADM Bingham and in collaboration with OIDP, the United States Public Health Service has established an EHEPharmacy Taskforce to help amplify community HIV efforts. <Read More>

    Two Hospital Pharmacy Leaders on Causes of, Solutions for Drug Shortages – June 15, 2021 – Shortages of essential drugs is a challenge hospitals have always faced, but the American Society of Health-System Pharmacists has forecast that trade restrictions, pandemics and climate change will only increase the potential for more shortages. With continuing uncertainty about the stability and quality of the pharmaceutical supply chain, hospital and health system pharmacist must be prepared for “significant disruptions to normal healthcare delivery, including disruption of medication procurement,” Erin Fox, PharmD, senior director of drug information and support services at the University of Utah Health in Salt Lake City, wrote, along with Aaron Kesselheim, MD, an internal medicine physician at Brigham and Women’s Hospital in Boston, in a report published February in the American Journal of Health-System Pharmacy. <Read More>

    Centene Shells Out $143M to Settle PBM Disputes in Ohio, Mississippi – June 15, 2021 – Centene, the largest seller of Medicaid health plans, has agreed to pay $143 million to Ohio and Mississippi to resolve allegations related to the provision of pharmacy services in the safety-net insurance program. Under the terms of the agreement with the states’ attorneys general, Centene, which assumes no fault for the alleged improper practices, will pay $88 million to Ohio and $55 million to Mississippi. And the settlement could be the first of many: The St. Louis-based payer is reserving a tranche of $1.1 billion to resolve similar claims in other states. As a result of the deal, Ohio Attorney General Dave Yost is dropping his lawsuit filed in March, alleging Centene used a web of subsidiaries and contractors, including its pharmacy benefit management business Envolve Pharmacy Solutions, to overcharge the state for medications. <Read More>

    340B in the News

    HHS Withdraws Advisory Opinion on 340B Drug Discount Program – June 21, 2021 – On December 30, 2020, the Department of Health and Human Services (HHS) issued an advisory opinion on the 340B Program, which was established by section 340B of the Public Health Service Act. This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers. The opinion was designed to address whether drugmakers could refuse to sell drugs to those pharmacies at the “ceiling price.” In short, the act was forcing drug companies to offer significant discounts on their drugs to contract pharmacies that work with specific hospitals that usually treat primarily low-income patients. The companies affected were concerned that 340B was overextending its original goal, and how it was basically putting money into hospitals, which were themselves criticizing efforts by drug companies to stop offering the decreased prices to contract pharmacies. HHS has now withdrawn the advisory opinion “in light of ongoing confusion.” <Read More>

    Industry Voices—Why Drug Companies Should Stop Meddling in the 340B Program – June 18, 2021 – Even with drug prices skyrocketing and new drugs coming to market at astronomical starting prices, a group of drug companies continues to seek ways to boost profits even higher. By targeting drug discounts required by the 340B drug pricing program, companies are hurting safety net hospitals, health centers and public health clinics serving the Americans most in need. In his recent opinion piece, drug industry consultant Jeremy Docken demonstrates how companies are broadening their attacks on 340B. He argues the program has grown too large and needs industry intervention to rein it in, but he omits several important facts. 340B is not your typical government program. <Read More>

    Biden Administration Proposes Rescinding Rule on Community Health Center Insulin Discounts – June 17, 2021 – The Biden administration proposed rescinding a final rule introduced under the Trump administration that would require community health centers to pass on 340B drug discounts for insulin and injectable epinephrine to low-income patients. In a notice posted on its website June 16, the Department of Health and Human Services (HHS) proposed to rescind the final rule titled “Implementation of Executive Order on Access to Affordable Life-Saving Medications,” originally published in the Dec. 23, 2020, Federal Register. HHS is proposing the rescission due to “undue administrative costs and burdens” that implementation would impose on health centers. <Read More>

    Astrazeneca’s Lawsuit Over 340B Contract Pharmacies Survives After Judge Dismisses Challenge From HHS – June 17, 2021 – A federal judge has dismissed the Department of Health and Human Services’ (HHS’) bid to toss a lawsuit from drugmaker AstraZeneca over the 340B drug discount program. The decision by Judge Leonard Stark, delivered Wednesday, ensures the lawsuit over AstraZeneca’s restriction of sales to 340B contract pharmacies will continue. AstraZeneca and several other drug companies over the past year have restricted sales of 340B-discounted products to contract pharmacies, which are third-party entities that dispense the discounted drugs on behalf of covered entities. <Read More>

    Biden Scrapping Trump Plan to Shift 340B Discounts on Insulin, Epi-Pens – June 16, 2021 – The Biden administration on Tuesday moved to axe a Trump-era policy that would have targeted federal drug discounts for clinics serving low-income people. While several other controversial Trump drug pricing policies on importation, international reference pricing, and drug rebates remain in limbo, this is the second time that HHS Secretary Xavier Becerra has sided with providers at the expense of drug makers on contentious policy related to the federal 340B drug discount program. <Read More> 

    AHA Wants Express Scripts to Rescind 340B Claims Reporting Policy – June 16, 2021 – The American Hospital Association has sent a letter to Express Scripts asking the pharmacy benefit manager to rescind a policy requiring contract pharmacies to apply a unique code for claims under the 340B drug discount program. In a FAQ for providers, Express Scripts said this was not a new requirement, having requested 340B reporting from network pharmacies for several years. “In August 2020, notice was provided to inform pharmacies the Express Scripts Provider Manual was updated to reflect this requirement as mandatory,” the company said in the FAQ. <Read More>

    HHS Proposes Nixing Rule Affecting Insulin and Epipen Discounts for Community Health Centers – June 15, 2021 – The Department of Health and Human Services (HHS) proposed rescinding a Trump-era rule that required community health centers to fully pass along discounts they received from the 340B drug program for insulin and EpiPens. HHS said in a notice that the rule finalized by the Trump administration in December 2020 created too much of an administrative burden on community health centers. Back in March, the agency had delayed implementation of the rule until July. <Read More>