Clinical Insights: December 8, 2020

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    New Drug Approval

    Gallium 68 PSMA-11 (Ga 68 PSMA-11)  – New Drug Approval – December 1, 2020 – The U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    GavretoTM (pralsetinib) Capsules – New Approved Indication – December 1, 2020 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications were approved under the FDA’s accelerated approval program based on data from the Phase I/II ARROW study. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. <Read More>

    New/Updated Drug Shortage

    December 04, 2020

    December 03, 2020

    December 02, 2020

    December 01, 2020

    New Drug Recall and Safety Alerts

    Regenecare HA Hydrogel by MPM Medical LLC – New Voluntary Recall – December 2, 2020 – MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia. Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which includes symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion and possibly death. To date, MPM Medical has not received any reports of adverse events related to this recall. <Read More>

    Happy Ducts Compress by WishGarden Herbs – New Voluntary Recall  – December 1, 2020 – WishGarden Herbs, Inc. is voluntarily recalling one lot of Happy Ducts Compress to the consumer level. After becoming aware of a possible supply chain contamination, a retained product was found to contain the Cronobacter sakazakii bacteria. WishGarden has initiated this recall due to the possible bacterial contamination of Happy Ducts Compress products of lot 53664. WishGarden Herbs has reported that no medical illnesses or harmful effects have resulted from the recalled products thus far. To date 36 of 46 units in distribution have been accounted for. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval – December 7, 2020 – The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples – December 4, 2020 – The U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit. <Read More>

    APhA Survey Results Finds Pharmacists Ready to Receive, Administer COVID-19 Vaccines – December 4, 2020 – A recent nationwide survey of 400 pharmacists conducted by the American Pharmacists Association (APhA) found that more than three-fourths of pharmacists plan to be vaccinated with 1 of the coronavirus disease 2019 (COVID-19) vaccines, with 60% planning to be set up and ready to vaccinate patients as soon as the vaccine is available…A similar survey of pharmacists conducted 2 months earlier found that only 36% of pharmacists said they would receive the vaccine as soon as possible. Further, 60% said their pharmacy practices would be ready to administer the vaccines as soon as they are available. <Read More>

    An Inside Look at Depression Treatment Among Patients With Addictive Disorders – December 4, 2020 – Major depressive disorder (MDD) is the leading cause of global disease burden. Between 2018 and 2019 the prevalence of MDD in the United States has continued to increase among all age groups. Patients with these disorders are twice as likely to suffer from a comorbid substance use disorder (SUD) compared with the general population, and the severity of the S6UD parallels that of MDD. The comorbidity poses treatment challenges, and patients have been found to have poor outcomes (eg, increased substance use, more severe disease burden, higher rates of suicide attempts and behaviors), as well as an overall increased mortality. <Read More>

    Putting Pharmacists in the Cloud – December 4, 2020 – Telepharmacy began as a pilot project to bring pharmacy services to rural North Dakota communities too small to support a fulltime pharmacist. Two decades later, telepharmacy is an everyday reality across the country. The concept remains the same: a pharmacist in one location provides services electronically to patients in another location. But pharmacists, providers, patients, prescribers, payers, and regulators are all recognizing the benefits that virtual services can bring to pharmacy. There is a wide spectrum of needs that telepharmacy can meet, according to Adam Chesler, PharmD, MBA, the director of regulatory and legislative a­ airs for Cardinal Health and former vice president of operations at TelePharm, an early telepharmacy technology provider. Cardinal acquired TelePharm in 2016 and is now among the largest telepharmacy technology providers in the United States. <Read More>

    ACIP Makes Initial COVID-19 Vaccine Recommendations – December 3, 2020 – Because there will be a limited number of doses of COVID-19 vaccine initially, the Advisory Committee on Immunization Practices made an interim recommendation about which people should be vaccinated first: health care workers (HCWs) on the front lines and residents of long-term care (LTC) facilities. “By the end of December, the number of doses available will be about 40 million, enough to vaccinate 20 million people,” Sara Oliver, MD, MSPH, an Epidemic Intelligence Service officer at the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), told the committee during a special session. <Read More>

    Hy-Vee Launches New Pharmacy Benefits Manager Subsidiary – December 3, 2020 – Hy-Vee, an employee-owned company that owns 275 supermarkets in eight Midwestern states, announced the launch of its newest subsidiary, Vivid Clear Rx. The new subsidiary will offer affordable pharmacy benefit management services to Hy-Vee’s more than 88,000 employees as well as other employers looking to maximize their employee benefits spending. “Health care spending continues to be a leading concern for employers across the country, and every business wants to make sure they are providing the best benefits for their employees at the best value,” said Randy Edeker, Hy-Vee chairman, CEO and president, in a press release. <Read More>

    Pharmacists Address Pediatrician, Anti-Vaxxer Concerns Over Childhood Vaccinations – December 3, 2020 – Following the Department of Health and Human Services’ (HHS) August authorization allowing pharmacists to administer childhood vaccinations, some pediatricians have expressed concerns that this deprives children of medical care or could lead to missed vaccines; however, pharmacists say these concerns are unfounded…In an interview with Pharmacy Times, Susan DiGregorio, BS Pharm, MS, RPh, director of clinical pharmacy development at Community Care Rx, said children should still see their pediatrician annually, so missing a vaccine should not be an issue. She added that pharmacists are some of the most trusted health care professionals and allowing them to administer childhood vaccines actually expands access to health care. <Read More>

    Feds Look to Pharmacists to Boost Childhood Immunization Rates – December 3, 2020 – Torey Watson is trained as a pharmacist but aims to do more than simply fill prescriptions. Pharmax Pharmacy — a small drugstore chain where Watson works as a clinical services coordinator, about an hour and 30 minutes southwest of St. Louis — will soon allow him to offer childhood vaccines to patients without a doctor’s prescription…Federal officials are banking on pharmacists like Watson to undergo additional training and help reverse the slump in child immunization rates caused by the coronavirus pandemic. Fears over COVID-19 have led parents to avoid the doctor’s office and pediatricians to curtail in-person care. As a result, many children are missing routine vaccinations. <Read More>

    New Updates to Federal Guidelines Revamp Asthma Management – December 3, 2020 – The National Institutes of Health announced 19 recommendations in six key areas of asthma diagnosis, management and treatment. The new guidance, published in the Journal of Allergy and Clinical Immunology, represents the first updates to federal comprehensive asthma management and treatment guidelines in more than a decade, and focuses on tailored treatment interventions for specific age groups based on disease severity using inhaled corticosteroids, long-acting antimuscarinic antagonists, immunotherapy, indoor allergen mitigation, fractional exhaled nitric oxide testing, and bronchial thermoplasty. The recommendations are based on systematic reviews conducted by the Agency for Healthcare Research and Quality and input from National Asthma Education Prevention Program (NAEPP) participant organizations, medical experts, and the public. <Read More>

    The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020 – December 3, 2020 – What is already known about this topic? – Demand is expected to exceed supply during the first months of the national COVID-19 vaccination program. What is added by this report? – The Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) health care personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program. What are the implications for public health practice? – Federal, state, and local jurisdictions should use this guidance for COVID-19 vaccination program planning and implementation. ACIP will consider vaccine-specific recommendations and additional populations when a Food and Drug Administration–authorized vaccine is available. <Read More>

    Treatment Algorithms for Newly Diagnosed and Relapsed Multiple Myeloma – December 2, 2020 – Treatment algorithms for the treatment of newly diagnosed and relapsed multiple myeloma (MM) based on the best available evidence were presented in a recent publication in Blood Cancer Journal (2020;10[9]:94. doi:10.1038/s41408-020-00359-2). n“The purpose of this current treatment algorithm is to synthesize the available data in the field and provide an evidence-based approach to the current treatment of newly diagnosed and relapsed MM,” explained the study authors. <Read More>

    Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates; and Creates Two New Safe Harbors for Point-of-Service Discounts and PBM Fixed-Fee Arrangements – December 2, 2020 – On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute (“AKS”) safe harbor regulations as such regulations relate to the cost of prescription drugs as covered by the Medicare and Medicaid programs. More specifically, the Final Rule amends the AKS discount safe harbor (“Discount Safe Harbor”) at 42 C.F.R. §1001.952(h) to eliminate safe harbor protection for drug discounts and rebates offered by pharmaceutical manufacturers to pharmacy benefit managers (“PBMs”), Medicare Part D prescription drug plan (“Medicare Part D”) sponsors, and Medicaid managed care organizations (“Medicaid MCOs”).  <Read More>

    CDC Shortens Quarantine Period for COVID-19 – December 2, 2020 – The CDC reduced the 14-day quarantine period for certain people after exposure to SARS-CoV-2. Exposure to the virus is defined by the CDC as someone with close contact to an infected person. This includes being within six feet of someone with COVID-19 for 15 minutes or more; providing care for someone who is sick with COVID-19; direct physical contact, such as hugging or kissing; sharing eating or drinking utensils with an infected person; or being exposed to infectious respiratory droplets. Under the new recommendations, asymptomatic people could end their quarantine after seven days if they test negative for the virus, or after 10 days if they do not get tested, according to CDC officials. At a press briefing, they said the results from either a polymerase chain reaction or rapid test were acceptable. <Read More>

    How Pharmacies are Preparing to Give Americans Covid-19 Vaccines – December 1, 2020 – In the fight against Covid-19, the US government is enlisting pharmacies to administer vaccines to hundreds of millions of Americans — an endeavor with unprecedented scale that presents a host of challenges for companies big and small across the United States. Although some companies are ready to store and administer the Covid-19 vaccine, others aren’t. Several companies are working on vaccines, each with its own particular storage and logistical challenges, and this is new territory for pharmacies, particularly when it comes to storing the Pfizer vaccine, which requires ultra-cold freezers. Drug stores, grocery stores and retailers are sorting through logistics, making space for the vaccines and buying special freezers in preparation. <Read More>

    340B in the News

    Industry Voices – It’s Time to Reevaluate 340B Intermediary Relationships and Ask Who They Serve – December 4, 2020 – The latter half of 2020 has seen the 340B program in turmoil. Citing compliance concerns, specifically duplicate discounts, several drug manufacturers took steps to reduce contract pharmacy access to 340B-priced drugs. The move has caused an outcry from covered entities, many of which depend on contract pharmacies to expand patient access, particularly in rural areas… As this conflict plays out, it’s drawn significant media attention to current challenges in the 340B program, particularly those involving intermediary organizations and contract pharmacies. It has also illuminated the dominant role that these entities have come to play in a program that was designed to benefit safety net providers who serve vulnerable patients. It’s a key time to ask: Does that role help or harm covered entities and the patients they serve? <Read More>

    CMS Finalizes Hospital OPPS Rule That Phases Out Inpatient-Only List, Preserves 340B Cuts  – December 2, 2020 – The Trump administration finalized a key payment rule that will begin to phase out a list of 1,700 procedures that Medicare only pays for when they’re performed in a hospital, part of a move to push more care to the outpatient setting. In an announcement on Wednesday afternoon, the Centers for Medicare & Medicaid Services (CMS) released the final Outpatient Prospective Payment System rule that sets payment rates for hospital services starting on Jan. 1. The rule “allows doctors and patients to make the best decisions about the most appropriate sites of care, based on what makes the most sense for the course of treatment and the patient without micromanagement from Washington,” said CMS Administrator Seema Verma in a statement… The rule also updates how star ratings are calculated and preserves a 22.4% cut to the controversial 340B program. <Read More>

    Trump Administration Issues Flurry of Last Minute Healthcare Regulations: What Will the Incoming Administration Do Next? – December 1, 2020 – On 20 November 2020, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General finalized several rules from President Trump’s health care agenda that are considered key parts of his potential legacy. The final rules seek to…implement a new “Most Favored Nation” (MFN) payment model to lower Medicare Part B payments for certain drugs… The MFN rule, in contrast, received immediate pushback from provider groups and the pharmaceutical industry since it was initially proposed. In a statement, for example, the Pharmaceutical Research and Manufacturers of America (PhRMA) said that the MFN rule would disrupt patient access to treatments, discourage investment in new medicines, and threaten jobs and economic growth, stressing that it is “considering all options to stop this unlawful onslaught on medical progress.” The AHA also expressed concern about the impact of the MFN rule on the 340B Drug Pricing Program, providing that “by cutting drug reimbursements to hospitals—by an average of 65% when fully phased in—hospitals will have to absorb losses while drug companies are free to continue their trend of charging exorbitant prices.” <Read More>

    Medicare Issues Interim Final Rule to Lower Payments to Hospitals and Physicians for Certain Drugs Starting January 1, 2021 – December 1, 2020 – On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for high-cost drugs to most hospitals and physician offices beginning January 1, 2021. The Most Favored Nation (MFN) Model will phase-in payment rates for 50 high-cost drugs based on international prices over a seven-year period. CMS published the IFC in the Federal Register on November 27, 2020… CMS estimates the impact on 340B hospitals and non-340B providers differently, given that CMS currently pays 340B hospitals a lower rate than non-340B providers. CMS does not expect 340B hospitals to face a payment reduction initially, as they are already paid less than the expected MPN Price in the first year. Under the OACT analysis, if Medicare continues to pay for 340B drugs at ASP – 22.5 percent, 340B hospitals would face a 3 percent reduction in current payment rates beginning in the second year and continuing throughout the Model. If CMS finalizes a deeper payment cut to 340B hospitals for 2021, as put forward in the 2021 Outpatient Perspective payment System (OPPS) Proposed Rule, 340B hospitals would not experience a payment reduction under the Model. Under the ASPE Analysis, 340B hospitals would not face a payment reduction. <Read More>