Clinical Insights: August 17, 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

    Welireg™ (belzutifan) Tablets – New Drug Approval – August 13, 2021 – The Food and Drug Administration approved belzutifan (Welireg™, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Belzutifan was investigated in the ongoing Study 004 (NCT03401788), an open-label clinical trial in 61 patients with VHL-associated RCC (VHL-RCC) diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNET. Patients received belzutifan 120 mg once daily until disease progression or unacceptable toxicity. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution – New Approved Indication – August 12, 2021 – Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults. The company plans to make Xywav® available to patients with idiopathic hypersomnia later this year following Risk Evaluation and Mitigation Strategies (REMS) implementation. “We are excited that with this approval Xywav® will become the first and only medicine indicated to treat idiopathic hypersomnia, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. <Read More>

    New/Updated Drug Shortage

    August 12, 2021

    August 10, 2021

    New Drug Recall and Safety Alerts

    Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL by SterRx, LLC – New Voluntary Drug Recall – August 10, 2021 – SterRx, LLC announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL, intended to be sterile that is not sterile, could result in site specific infections as well as serious systemic infections which may be life-threatening. To date, SterRx has not received reports of any adverse events associated with this issue. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    A Readily Available Drug May Help Fight COVID-19 – August 16, 2021 – Laboratory studies indicate that a cheap generic drug reduces SARS-CoV-2 infection in human cells by up to 70%. The drug, called fenofibrate, regulates cholesterol levels but also destabilizes the spike protein on SARS-CoV-2 and inhibits binding to human cells. It was effective against all the SARS-CoV-2 variants that the scientists tested in vitro. <Read More>

    Children’s Risk for Developing ADHD May Be Associated With Access to Green Spaces – August 16, 2021 – Recent results from a study investigating the impact of green space on children’s development of attention-deficit hyperactivity disorder (ADHD) found that the amount of green space surrounding children’s homes could be a factor in the development of the disorder. At Aarhus University in Denmark, a team of researchers observed an association between the green space around the residence and the diagnosis of ADHD in children and adolescents. <Read More>

    Study: Diabetes Patients in High-Deductible Health Plans More Likely to Skip Medications – August 16, 2021 – A new study from Harvard Medical School found that Americans with diabetes who are enrolled in high-deductible health plans (HDHPs) have a substantially higher risk of not taking prescribed medications due to cost. HDHPs require patients to pay for all care out of pocket until the plan’s deductible is reached, and only after this threshold does insurance start to cover medical costs. The study showed that 20% of patients with diabetes enrolled in a HDHP reported skipping medications because of cost versus 16% of those in a traditional commercial plan, which is a 28% higher rate of missing medication for those with a high deductible. <Read More>

    FDA Issues Complete Response Letter to Bladder Cancer Treatment BLA – August 16, 2021 – The FDA issued a complete response letter (CRL) to Sesen Bio for its Biologics License Application (BLA) for oportuzumab monatox-qqrs (Vicinium™) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), which was previously granted priority review. The approval was denied pending additional clinical and statistical data and analyses requested by the FDA to potentially approve oportuzumab monatox-qqrs for this indication at a later date. In the CRL, the FDA stated that Chemistry, Manufacturing and Controls issues still must be addressed. “We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC,” said Thomas Cannell, president, and chief executive officer of Sesen Bio, in a press release. <Read More>

    Healthcare Workers, Nursing Home Residents Likely Next in Line for COVID-19 Boosters – August 16, 2021 – A COVID-19 booster plan for Americans who are not immunocompromised could come as early as this fall, people familiar with the effort told The New York Times Aug. 14. The FDA on Aug. 12 amended the emergency use authorizations for Pfizer’s and Moderna’s COVID-19 vaccines, allowing for a third booster dose in immunocompromised people. The next day, a CDC panel voted unanimously to recommend immunocompromised people receive third doses. <Read More>

    Optum Quietly Revamps Online Pharmacy, Sells Virtual Care For Cash – August 16, 2021 – UnitedHealth subsidiary Optum is offering virtual care and discounted drugs to patients who pay with cash, presenting new competition to digital health startups and telehealth providers, according to Insider. UnitedHealth said the company’s push into direct-to-consumer healthcare is a way to increase access to affordable care. The company, which is the parent of health insurer UnitedHealthcare, now is providing care and prescriptions to those who can’t afford health insurance. <Read More>

    Specialty Drug Dispensing: Flexibility Is the Key to Success During A Crisis – August 16, 2021 – “Bend, but don’t break” became the fundamental operating principle at Biologics by McKesson during the COVID-19 pandemic. As an independent specialty pharmacy, Biologics by McKesson provides specialty drugs for patients who have complex diseases, require extra care, or have expensive therapies. It specializes in quick delivery, financial aid assistance, adverse effect management, and adherence support to get medications to patients. Since COVID-19 emerged, Biologics by McKesson, like many other companies, had to become more flexible. It put aside traditional ways of doing business and found new approaches to respond to the evolving health care landscape. <Read More>

    Not So Different: Dr Gary Lyman Explains How to Ensure Physician Confidence in Biosimilars – August 15, 2021 – Gary Lyman, MD, MPH, an oncologist and hematologist, discusses some of the issues holding physicians back from prescribing biosimilars and some ways to ensure provider confidence in biosimilars. A major barrier to biosimilar adoption is physician hesitancy when it comes to prescribing these agents, especially in the oncology space. Physicians often want more clinical or real-world evidence on the safety and efficacy of biosimilars compared with reference products in patients with cancer, for whom the stakes are high when choosing a therapeutic or supportive agent. Additionally, some clinicians worry about having to stock multiple biosimilars for a single reference product. These may require different storage conditions and increase the risk of administering the wrong agent, creating financial risk for the practice. <Read More>

    Pharmacists Poised to Address Unmet Mental Health Needs – August 13, 2021 – Among the many collateral effects of COVID-19, the pandemic has exacerbated the mental health crisis in the United States. For some, the global shutdown interrupted ongoing mental health care. For others, the stress and isolation triggered new mental health issues. It was against this backdrop earlier this year that CVS started adding licensed clinical social workers trained in mental health care to MinuteClinics at select HealthHUB locations in Houston, Philadelphia, and Tampa. The move underscores pharmacists’s and pharmacies’s unique placement in the health care landscape and positions them to help close a longstanding gap in access to mental health care. Increasingly, retail pharmacies—from the corporate giants to the community independents—are harnessing their position and taking steps to address unmet mental health care needs for their patients. <Read More>

    Help Prevent and Relieve Allergy Symptoms – August 13, 2021 – Pharmacists can be essential resources for patients seeking advice on the selection and use of nonprescription medications. In a few weeks, students and teachers across the country will begin returning to the classroom to start a new school year. Although back-to-school season is exciting, individuals heading back to the classroom who are prone to allergies often face numerous challenges. Symptoms present with varying degrees of severity and often negatively affect an individual’s quality of life by causing fatigue and sleep disturbances and impairing concentration. Allergy symptoms also often contribute to absences from school and work and a loss of productivity. <Read More>

    Prescription Drug Coupons Used on Fewer Than 20% of Purchases – August 13, 2021 – Consumers use manufacturer-issued drug coupons for prescription drugs in fewer than one in five purchases at pharmacies, a study published Friday by JAMA Health Forum found. Of more than 2,500 unique, brand-name medications included in the analysis, manufacturers offered coupons intended to lower out-of-pocket costs — sometimes called co-pay offsets or discounts — for just over half of them, the data showed. However, those with private health insurance prescribed the drugs used these coupons on 16% of purchases, the researchers said. Perhaps not surprisingly, price was the key driver in coupon use, with the likelihood that consumers would take advantage of these co-pay discount offers increasing by 3% for every 10% increase in drug cost. <Read More>

    Kansas Investigates Obscure But Powerful Part of the Drug Supply Chain: Pharmacy Middlemen – August 13, 2021 – After concluding that pharmacy middlemen overcharged Medicaid programs by hundreds of millions of dollars, two states landed tens of millions in settlements from one of the wealthiest companies in the country. That company has since set aside another $1 billion for future potential payouts. Now Kansas is investigating that same industry — one that claims to drive down drug costs but that profits as prices escalate. Attorney General Derek Schmidt’s office has hired the lawyers who helped land more than $140 million in settlements for Ohio and Mississippi for alleged overcharges to their Medicaid programs. <Read More>

    Pharmacy Fact: What is Currently the Most Expensive Drug in the United States? – August 13, 2021 – Drug prices in the United States are high and rising, but some medications are truly in a class of their own. When trying to determine which drug can be called the most expensive on the market, there are 2 potential answers depending on how you define the question. In terms of drugs that can be filled by your local pharmacist, the most expensive medication available—by a considerable margin—is lonafarnib (Zokinvy™, Eiger Biopharmaceuticals). Dosage is dependent on body surface area, but most patients take 200 mg a day, which at $717 per 50 mg capsule adds up to $86,040 a month, or more than $1 million per year. <Read More>

    Biden Asks Congress for Support on Pharmaceutical Price Controls – August 13, 2021 – Passage of HR 3 is shaping up as a centerpiece of President Biden’s effort to bring pharmaceutical prices under control. If drug companies won’t negotiate prices, international reference pricing would kick in. After issuing a number of directives in July targeted at lowering the cost of prescription drugs and getting biosimilars into play, President Biden has clarified his intentions with a request for Congress to take action on specific measures. The request endorses passage of the Elijah E. Cummings Lower Drug Costs Now Act, which would enable HHS to negotiate prescription drug prices for Medicare beneficiaries and, if companies refuse to negotiate, would limit drug prices to 120% of average prices in Australia, Canada, France, Germany, and the United Kingdom. <Read More>

    Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices’ Recommendation for an Additional Dose of an mRNA COVID-19 Vaccine in Moderately to Severely Immunocompromised People – August 13, 2021 – I signed CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series. This official CDC recommendation — which follows FDA’s decision to amend the emergency use authorizations of the vaccines — is an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination. Emerging data suggest some people with moderately to severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. In addition, in small studies, fully vaccinated immunocompromised people have accounted for a large proportion of hospitalized breakthrough cases (40-44%). Immunocompromised people who are infected with SARS CoV-2 are also more likely to transmit the viruspdf icon to household contacts. <Read More>

    Biosimilars Move to Center Stage – August 12, 2021 – The Holy Grail for expanding access to less costly biotech therapies has been FDA approval of interchangeable biosimilars that do not require a physician to prescribe the alternative treatment. The development and utilization of biosimilars has been slow and disappointing since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010 authorizing follow-on products in this area. FDA has approved only 30 biosimilars since then, with just 20 on the market through 2020. But in late July FDA authorized the first interchangeable biosimilar for the U.S. market, raising hopes for more affordable biotech treatments to come. It was no surprise that the first interchangeable is for an insulin therapy, predicted to reduce costs for some of the nation’s 34 million diabetics and setting the stage for what analysts expect to be a surge in the development of interchangeable products. <Read More>

    Fact Check-Animal Ivermectin Should Not be Used on Humans – August 12, 2021 – Posts on social media embracing the use of ivermectin as a treatment for COVID-19 are misleading and go against the current recommendations of U.S. public health officials. At the time of this article’s publication, the U.S. Food and Drug Administration (FDA) has not approved ivermectin to treat or prevent COVID-19 in humans. An image of the drug, commonly used as a de-wormer for horses, is visible in Facebook posts. One can be seen with the caption reading, in part, “Btw less than an hour after taking Ivermectin paste per my body weight I was mostly symptom free…. Was in bad shape until then! This shit works I don’t care what anyone else says.” Another user touting the use of the anti-parasitic said in a post visible here , “I posted that I’m taking ivermectin for protection from Covid. Several asked about how I was taking it. Several asked, how much do you take? I’m using the liquid that you can get at Tractor Supply.” <Read More>

    2020 Spend and Trend Report Shows Biosimilar Competition Led to Decreases in Originator Prices, Claims – August 12, 2021 – A 2020 trends report from Artemetrx showed how biosimilar competition has contributed to lower average sales prices and claim percentages for originator products, suggesting that biosimilars are making a difference despite slow uptake. Despite a slow increase in uptake since the first biosimilar entered the US market in 2015, biosimilars are on track to gain a meaningful place in the market, especially as more competitors for one reference product are launched, according to Artemetrx’s spend and trend report for 2020. <Read More>

    Study: Payers Play Wait-and-See Game of Biosimilar Preference – August 12, 2021 – Most payers tend to adopt a “wait and see” approach to promoting biosimilar switching strategies among providers, according to a focus group study. The approach calls for watching what other payers do rather than initiating switching incentives via policy requirements, according to payers who participated in the study. However, the payers agreed that getting providers to switch to a new biosimilar requires careful market preparation that targets physicians, health systems, pharmacists, and patients. “Discussions with network physicians about a biosimilar switch started several months before the formulary change to reach mutual agreement across stakeholders,” according to one payer participant cited in the survey. <Read More>

    Pharmacy Technicians to Play a Key Role in Upcoming Flu Season – August 12, 2021 – On August 4, 2021, the Biden administration expanded the authority of pharmacy technicians under the Public Readiness and Emergency Preparedness Act (PREP Act) to allow pharmacy technicians to administer adult flu vaccines during the 2021-2022 flu season. This declaration fills a need by empowering additional pharmacy team members to provide influenza vaccinations for adults similar to how they are allowed to provide vaccinations for those age 18 years and younger, by virtue of prior PREP Act declarations. <Read More>

    Biosimilar Semglee® Could Spell Massive Changes for Net Cost of Insulin – August 11, 2021 – The FDA’s approval of the insulin glargine biosimilar Semglee® (insulin glargine-yfgn; Viatris) could potentially result in a considerable decrease in expenses for patients with diabetes who are dependent on insulin. Projecting how this approval could affect the cost of care for patients with diabetes requires an understanding of the current price for insulin in the United States, the mechanics causing it to rise, and what Semglee’s approval as an interchangeable biosimilar means for pharmacists and patients. Prices for insulin have been rising in the United States at an unprecedented rate, nearly tripling between 2002 and 2013 and increasing by 15% to 17% per year between 2012 and 2016. Average gross spending per person on insulin for patients with type 1 diabetes (T1DM) increased by $2841 between 2012 and 2016, and the percentage of those patients’ total health care spending for insulin alone rose from 23% to 31% across that same period. <Read More>

    Updates in the First-Line Treatment of Advanced Renal Cell Carcinoma – August 11, 2021 – The treatment of advanced renal cell carcinoma (aRCC) has drastically changed over the past 30 years. In 1992, the FDA approved the first immunotherapy in aRCC, interleukin 2. More than a decade later, the FDA approved the first targeted agent, sorafenib (Nexavar®; Bayer). Since the mid-2000s, the treatment armamentarium for aRCC has expanded with approvals of additional immuno- and targeted therapies. Current guideline recommendations include various combinations of targeted therapy with immunotherapy.4 So far in 2021, results from a pair of phase 3 trials—CLEAR (NCT02811861) and CheckMate 9ER (NCT03141177)—were published; the trials evaluated the combination of 2 different tyrosine kinase inhibitors (TKIs) with immunotherapy. <Read More>

    Survey: Parents Cite Insurance Headaches, Knowledge Barriers Around Rare Disease Management – August 11, 2021 – Patients with rare diseases may benefit from time limits for processing coverage decisions, increased transparency in the claims and preauthorization processes, and more expansive authorizations for continual needs, according to findings of a qualitative study that assessed experiences of both patients and parents. Results were published in the Orphanet Journal of Rare Diseases. Although it is estimated that more than 6800 rare diseases collectively affect between 25 million and 30 million Americans, these conditions are often difficult to diagnose, have few available treatment options, and tend to have limited research on the diseases’ natural history, authors explained. “There is a complicated balance between decreasing health care costs and meeting patient needs,” they said, noting the lack of research on parents’ perspectives on their experiences with health insurance companies or on how policies may impede care for their children. <Read More>

    New CDC Data: COVID-19 Vaccination Safe for Pregnant People – August 11, 2021 – CDC has released new data on the safety of the COVID-19 vaccines in pregnant people and is recommending all people 12 years of age and older get vaccinated against COVID-19. “CDC encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19,” said CDC Director Dr. Rochelle Walensky. “The vaccines are safe and effective, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.” <Read More>

    Seven Ways to Modernize Statistical Analytics to Drive Innovations for Patients – August 10, 2021 – The increasing number of data sources collected as part of drug development and commercialization has vastly increased the amount and types of data biopharmaceutical companies collect. This has increased the need and urgency for technology that can process large amounts of structured and unstructured data to support regulatory filings. Many companies have existing standard operating procedures for common off-the-shelf commercial offerings. However, the increasing complexity of data analysis that is now required often means that companies need to modernize their statistical offerings through nontraditional (e.g., open source) software. <Read More>

    Getting Familiar With Lung Cancer and Its Therapy Options – August 10, 2021 – A number of prescription medications are indicated for the treatment of this aggressive disease. Lung cancer is an aggressive form of cancer that is one of the leading causes of death worldwide and in the United States. This disease may affect anyone, including smokers and nonsmokers. However, the rate of cancer in those with no smoking history is lower. Lung cancer was first identified in 1761 as a distinct disease, although the disease was still rare through the 19th century. In 1929, German physician Fritz Lickint first recognized the potential connection between lung cancer and smoking. The American Cancer Society linked smoking and cancer by 1954 and, a decade later, the US Surgeon General declared smoking a cause for lung and laryngeal cancers. <Read More>

    Kroger Health & AssureCare® Implement Patient-Centric Integrated Care Platform for Payers, Providers, and Pharmacies – August 10, 2021 – AssureCare® announces the implementation of an industry leading patient-centric, highly configurable, connected care and medication management platform, MedCompass® with Kroger Health, enabling greater access to pharmacists and their services, while better serving their patients. Built on AssureCare®’s core connected platform, MedCompass® provides unparalleled medication management and adherence capabilities reducing medication risk and increasing the quality of care provided by the pharmacy. Kroger Health collaborated with AssureCare®, to support the expansion of Kroger Health clinical services and the integration of community pharmacy and dietitian services. <Read More>

    Counterfeit HIV Meds Found in the U.S. – August 10, 2021 – Gilead Sciences warned that tampered and counterfeit versions of its HIV medications, Biktarvy® and Descovy®, are in circulation within U.S. drug distribution networks. Biktarvy® is a combination of bictegravir, emtricitabine (FTC) and tenofovir alafenamide (TAF) that is given once daily for HIV treatment. Descovy® is a combination of FTC and TAF that is used for HIV preexposure prophylaxis and treatment. Unauthorized distributors have sold these counterfeits to pharmacies in genuine Gilead bottles that have been tampered with a counterfeit foil induction seal or label and contain fake tablets. <Read More>

    Ten Pharmacy Execs Share What They Tell Patients Who Are Prescribed Expensive Drugs – August 10, 2021 – The costs of prescription drugs in the U.S. is rapidly rising, with more brand-name drugs increasing their list price in the first half of 2021 than all of 2020. Below, 10 health system pharmacy executives share what they tell patients who are unable to afford their medication… “We would first evaluate the prescription for clinical appropriateness and determine if there was a less expensive therapeutic equivalent. If the medication is the best option for the patient, our team collaborates with members of the interprofessional care team to resolve outstanding payor-related issues, such as prior authorizations…Our team works diligently to educate our patients about eligibility and facilitate patient enrollment across all applicable programs to lower out-of-pocket expenses. It is important to reassure our patients that we are committed to minimizing the many barriers to effective care so that they can focus on their health and well-being.” <Read More>

    Op-Ed: Independent Pharmacies Wrong to Blame PBMs for Their Plight – August 10, 2021 – The newspaper recently published a guest opinion by an independent pharmacist arguing that their problem with continued viability was the unfair dominance of pharmacy benefit management (PBM) organizations…The independent pharmacy author argued that they need “adequate reimbursement” to cover “their costs” in order to serve their customers and patients effectively. The success of PBMs is not the core problem of independent pharmacies. Their customers and patients are electing PBM prescription solutions because they provide better access and more convenience at a lower price. PBMs and leading healthcare systems have created new methods to fill prescriptions, have implemented sophisticated technology to meet patient educational needs and to answer questions all at lower prices to the patients. <Read More>

    CMS Releases CY 2022 OPPS and ASC Proposed Rule – August 10, 2021 – The Centers for Medicare & Medicaid Services (CMS) on July 19, 2021, released its calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. CMS proposes a positive 2.3 percent payment update for hospitals that satisfy quality reporting requirements and would use 2019 data for rate-setting because of the pandemic. Also, CMS proposes to reverse previous policies to move hundreds of inpatient services to the outpatient setting. It will add back 298 services to the OPPS inpatient only list and remove 258 services that were added to the ASC covered procedures list. <Read More>

    NIH Launches Study of Third COVID-19 Vaccine Dose in Kidney Transplant Recipients – August 10, 2021 – A pilot study has begun to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. <Read More>

    340B in the News

    Merck Joins its Peers With Plan to Cut Access to Discounted Drugs for Contract Pharmacies – August 16, 2021 – Back in May, HHS looked like it was taking control of its 340B drug discount program, which requires drugmakers to provide massive price discounts to hospitals that treat low-income patients…Effective Sept. 1, Merck said it will no longer voluntarily honor 340B discounts or chargebacks for contract pharmacies that have not begun to provide 340B claims data, unless the hospital-covered entity lacks its own in-house pharmacy and designates a contract pharmacy of its choice. <Read More>

    What’s Worse than Most Favored Nation – Budget Reconciliation – August 10, 2021 – The Centers for Medicare and Medicaid Services (CMS) has proposed a rule that would rescind the Trump administration’s Most Favored Nation (MFN) drug pricing demonstration for Medicare Part B.  Citizens Against Government Waste (CAGW) expressed strong opposition to MFN, including a coalition letter to CMS, but is somewhat surprised this decision is being made by the Biden administration, since Democrats favor the kind of price controls that would have occurred under the MFN through its adoption of drug prices based their costs in countries that have socialized healthcare systems… CAGW has stated many times the government does not “negotiate” prices.  It institutes price controls, as it has in Medicaid, the Department of Veterans Affairs, the 340B safety-net program, and Medicare Part B.  Medicare Part D, which has proven to be less expensive than anticipated and is enormously popular with seniors, uses private negotiations that are protected under the “non-interference” clause found in Medicare law. <Read More>