DC Dispatch: Supreme Court Says States Can Regulate PBMs

Before the holidays, the Supreme Court Justices unanimously ruled that Arkansas, along with the rest of the states, have the right to regulate pharmacy benefit managers (PBMs) in efforts to control healthcare costs. PBMs are intermediaries that manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. Specifically, in the Rutledge v. Pharmaceutical Care Management Association case, the Supreme Court upheld an Arkansas state law that requires PBMs to pay pharmacies no less than their acquisition costs for prescription drugs. With this ruling, the 45 states that have already passed PBM regulations, can uphold their laws without PBMs using ERISA, a federal law that until now preempted state laws that “relate to” employee benefits. All of these state laws are aimed at controlling prescription drug costs, some by banning PBM gag clauses that keep pharmacies from telling consumers about lower-cost options, while others require PBMs to disclose their price lists and manufacturer rebates, or stop PBMs from charging plans more than they reimburse pharmacies. Community pharmacies have been waiting eagerly for this ruling.

“This is a great day for pharmacists and their patients,” proclaimed Scott J. Knoer, MS, PharmD, FASHP, Executive Vice President and CEO of the American Pharmacists Association, in a statement. “For years, PBMs have threatened the sacrosanct relationship between pharmacists and their patients and have never been forced to answer to any authority for their actions. This opinion redresses that imbalance and returns the power to protect the interests of patients to the states and other local authorities, where it belongs.” States can now protect patients who receive healthcare from their employers by regulating PBMs to increase transparency, broaden fair competition, and increase pharmacy accessibility.

Discoveries/Innovations: Immunotherapies Can Get a Protein Boost

Immunotherapies fight diseases by binding to our immune cells and activating or suppressing our immune system response. As with any cell-binding response, our bodies kill off those activators and suppressors to regulate the response and allow activation of suppression at a future date, so more antibodies need to be administered regularly, limiting the effectiveness of immunotherapies.

Researchers from University of Washington and the UK’s Medical Research Council Laboratory invented a two-protein patch to combat this problem. The patch-like compound of proteins can activate a large range of cell receptors, targeting more types of immune cells while also resisting destruction by our cells. The extent of the patch’s resistance can potentially be adjusted to last for hours or even days. These researchers believe that their technology, called degronLOCKR, can help treatments be delivered at the right time in the right amount.

Trend Setting: Social Media Stories Gain Traction with Pharma

It’s no secret that social media has become a huge avenue for pharma companies to reach patients, but the Facebook and Instagram story features are expected to be the focus for 2021. The 10-30 second videos disappear after one day and will play a short “sponsored” message before allowing users to swipe up and learn more. Pharma marketers, including Novartis, AstraZeneca, and Merck, have already used the story system for unbranded ads and branded ads with scrolling safety information. According to PranifyRx, the number of pharma companies advertising on Facebook and Instagram increased 65% since June 2020.

While these numbers are an impressive trend in social media marketing, Google advertising still dominates with 336 pharma advertisers placing ads there in the second half of 2020. PranifyRx reports that the most prolific advertisers on Facebook were Merz’s Xeomin, Novartis’ Entresto, Amgen’s Neulasta, AbbVie’s Juvederm, and Sanofi and Regeneron’s Dupixent, with each placing hundreds of creative ads on the social platform.

Med Device Department: The First At-Home COVID Test Hits Virtual Shelves

LabCorp’s Pixel at-home COVID test is available to anyone to buy online.

LabCorp has received the go-ahead from the FDA for its one of a kind at-home COVID-19 testing kit. Anyone can order the Pixel testing kit from their website for $119 self-pay, though most insurances will pay for the test in full. While Everlywell and Quest Diagnostics are also trying to push their at-home kits, both require a prescription. The Pixel test requires a nose swab which is then put in a prepaid, overnight envelope with results ready in a day or so. The LabCorp patient portal can connect anyone who tests positive with a physician for treatment assistance.

While the tests are only available for order now, the company plans to stock them in stores soon. The last month has seen a sharp rise in demand for Pixel kits, as cases continue to rise nationwide, prompting the company to perform more than one million molecular tests per week. The number of orders is expected to continue to rise, as there have been no signs of cases decreasing.

Therapeutic Talk: Novel Drug Candidate for Early Alzheimer’s Emerges

Many people who develop Alzheimer’s disease start losing white matter in their brains long before they are ever diagnosed or see signs of the disease. Researchers at Case Western Reserve University School of Medicine are aiming to detect this white matter loss for early intervention. They first identified the protein that leads to white matter degeneration when overexposed in the brain as Drp1, then developed a patented small-molecule drug that may halt the process.

Too much Drp1 in the brain causes dysfunction in oligodendrocytes, the cells that make myelin sheaths to protect our brain’s neurons. Eliminating Drp1 in mice research stopped this process. They successfully repeated the experiment in brain samples of deceased Alzheimer’s patients. “There are a handful of approved Alzheimer’s drugs, but they’re not designed to get at the root of the disease,” said Andrew Pieper, Case Western professor and a co-author of the new study, in a statement. “While these medicines augment neurotransmission to provide temporary symptomatic benefit, they do nothing to slow disease progression.” Pieper and his team hope to prove their patented drug slows and even prohibits Alzheimer’s disease progression.

FDA Update

Drug Approvals

The FDA approved Orgovyx (relugolix) as the first oral hormone therapy for advanced prostate cancer. Myovant Sciences received approval for the drug as an androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. While current treatments like this are injected or implanted under the skin, this oral medication blocks the pituitary gland from making luteinizing hormones and follicle-stimulating hormones, which reduces the amount of testosterone the testicles are able to make.

Tagrisso (osimertinib) became the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation to receive FDA approval. Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide. More than 10,000 patients nationwide each year may be candidates for AstraZeneca’s Tagrisso as adjuvant therapy after tumor removal.

MacroGenics received FDA approval for Margenza to be used with chemotherapy to treat patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens. The first intravenous dose is delivered over two hours with three follow-up doses taking 30 minutes each.

Med Device Approvals

Medtronic MiniMed, Inc. got the green light from the FDA for the MiniMed 770G System, a hybrid closed-loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user’s glucose reading. The device is approved for those two years and older. The glucose sensor is a wire that is inserted under the skin of the abdomen, measuring glucose values in the tissue fluid. The insulin pump automatically changes dosages based on these values.

The FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral—or above-the-knee—amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA Implant System, manufactured by Integrum AB, is installed with two surgical procedures.

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