DC Dispatch: Drugmakers Officially Must List Prices in TV Ads

Johnson & Johnson voluntarily started putting pricing information in its ads for its blood thinner Xarelto.

The Trump administration has officially ruled that pharmaceutical companies must list drug prices in their TV commercial ads. The rule will go into effect this July. “Patients who are struggling with high drug costs are in that position because of the high list prices that drug companies set,” Department of Health and Human Services Secretary Alex Azar said in the announcement. “Making those prices more transparent is a significant step in President Trump’s efforts to reform our prescription drug markets and put patients in charge of their own healthcare.”

Drugmakers and advertisers are dissatisfied with the requirement, claiming that these prices will not reflect the true amount patients would pay after discounts, rebates, and coupon codes. There are also arguments that the “sticker shock” of these rarely paid list prices would cause many patients to skip filling important prescriptions. It remains to be seen if there will be legal retaliation.

Johnson & Johnson already started voluntarily adding price to its ads, starting with its blood thinner, Xarelto. In the ad, the company states the monthly list price is $448, but adds “most patients pay between $0 and $47 per month.”

TeleMed Texts: Accenture Launches Platform to Deliver Groundbreaking New Treatments

A recent survey by IDC Health Insights, sponsored by Accenture, found just how important the ability to use data is for pharmaceutical companies.

In response to research that shows just how little pharma and biotech use analytical data to its full potential, Accenture introduces INTIENT as a technology platform that vastly improves the continuity and flow of data across life sciences enterprises with the ultimate goal of getting new, revolutionary treatments to patients. The company developed the tool for the 98% of the execs who use data from other functional areas—yet only half have a clear path for doing so.

The ultimate goal is to achieve end-to-end connectivity for their clients. To that end, INTIENT provides advanced data security while allowing access to an external partner network. It removes barriers to entry for technology, data, and service providers. Accenture’s new product even applies artificial intelligence and advanced analytics—including robotic process automation and machine learning—to provide novel and actionable insights.

“Important insights that could lead to the discovery, development, and delivery of promising new treatments are too often trapped within the functional silos of pharmaceutical and biotechnology companies,” said Kevin Julian, a Senior Managing Director in the Accenture Life Sciences practice. “Instead, clients will be able to generate insights from research through to patient services—and even further with our plans to expand into other functions. The results will accelerate the delivery of life-changing treatments to patients.”

Discoveries/Innovations: Are Parasitic Lampreys Key to Uncovering Brain Disorder Therapies?

Parasitic lampreys easily bypass the blood-brain barrier.

A molecule that pesky sea lampreys use in their immune systems can help them bypass the human blood-brain barrier, which currently keeps many drugs from entering the central nervous system and treating brain disorders, according to researchers. While sea lampreys might be jawless parasites, they have immune systems much like our own with a key difference—they produce variable lymphocyte receptors (VLRs) instead of antibodies. These VLRs target the extracellular matrix that surrounds brain cells, rather than trying to penetrate the blood-brain barrier. During trauma, diseases, stroke, or other stresses to the brain, the extracellular matrix becomes “leaky” and provides a unique entry point for the VLRs to slip into the brain.

When researchers from the University of Texas at Austin combined the novel drug-delivery system they developed with an anti-cancer drug, they observed better treatment results in mice with brain tumors. “I’m excited about trying this strategy in different disease model systems,” said John Kuo, MD, PhD, a neurosurgeon-scientist and collaborator on the project. “We can alter the nerves or blood vessels in the skin, eye, brain, or other vital structures. Several disease processes disrupt the blood-brain barrier and we could conceive of delivering a variety of different therapies with these molecules.” This drug delivery may be able to ferry therapies into the brain for conditions such as Alzheimer’s, multiple sclerosis, and stroke.

Med Device: Microscope Performs Diagnosis and Surgery

A laser microscope capable of detecting skin diseases as well as surgically removing them without any incisions has been developed by researchers at the University of British Columbia. Researcher and co-lead of the study Yimei Huang, PhD explains, “Our technology allows us to scan tissue quickly, and when we see a suspicious or abnormal cell structure, we can perform ultra-precise surgery and selectively treat the unwanted or diseased structure within the tissue—without cutting into the skin.”

The special multiphoton excitation microscope not only digitally scans tissue cells, but heats up enough to instantly and precisely treat diseased tissue. This precision allows for treatment of pathway of blood vessels without impacting any of the surrounding vessels or tissues,” said study co-author Harvey Lui, MD, FRCPC, Professor at the Department of Dermatology and Skin Science at UBC, in a statement. “For diagnosing and scanning diseases like skin cancer, this could be revolutionary.”

Trend Setting: Digital MS Tool Hits the Mark

Novartis announced positive study results for MSProDiscuss, its one-of-a-kind algorithm-based MS Progression Discussion Tool. The digital tool aims to put patients who may be transitioning from relapsing remitting MS (RRMS) to secondary progressive MS (SPMS) in touch with HCPs quickly enough to prevent irreversible damage.

“One of the greatest challenges in MS is diagnosing the transition from RRMS to SPMS as the course of the disease is unique for every MS patient,” said Tjalf Ziemssen, MD, Professor at the Center of Clinical Neuroscience, and study investigator. “The study results are a promising step toward having a scientifically validated tool for clinical use that can facilitate physician-patient conversations and ultimately help to get ahead of MS progression.”

Eighty percent of RRMS patients transition to SPMS. Often, secondary MS is diagnosed too late. But with timely action, some irreversible damage can be stopped.MSProDiscuss uses information from patient symptoms and daily life changes in six-month increments to generate a traffic light visual output when patients transition to SPMS.

Therapeutic Talk: Smart Insulin May Prevent Hyperglycemia

Researchers have formulated a new form of insulin, called i-insulin, that prevents overdose during diabetes treatment. Those taking insulin to regulate blood sugar run the risk of accidentally taking too much leading to hyperglycemia, or a drop in blood-sugar levels.

UCLA bioengineers concocted an insulin with an additional molecule that stops the transportation of glucose from the blood to the cell when blood sugar levels are already normal. “Our new i-insulin works like a ‘smart’ key,” says the study’s lead Zhen Gu, a bioengineer at the UCLA Samueli School of Engineering. “The insulin lets glucose get into the cell, but the added inhibitor molecule prevents too much from going in when blood sugar is normal. This keeps blood sugar at normal levels and reduces the risk of hypoglycemia.”

FDA Update

Drug Approvals

The FDA expanded the approved use of Pfizer’s Fragmin, making it the first drug therapy to treat venous thromboembolism (VTE) in pediatric patients. It reduces the recurrence of symptomatic VTE with a twice daily dosage determined by age and weight.

AbbVie and Genentech receive FDA approval of their oncology drug Venclexta. The therapy treats adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Bavencio, manufactured by EMD Serono and Pfizer, is now approved for use in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).

The FDA approves Vyndaqel and Vyndamax, from Pfizer subsidiary FoldRx, for the treatment of the heart disease caused by transthyretin-mediated amyloidosis (ATTR-CM) in adults. The rare debilitating disease is caused by the buildup of abnormal deposits of amyloid proteins in organs and tissues, specifically the heart. The drugs reduce the chance of fatal outcomes due to cardiomyopathy from these buildups.

Eli Lilly’s Cyramza becomes the first FDA approved bio-marker therapy for patients with hepatocellular carcinoma (HCC). Patients with the common liver cancer and with an alpha-fetoprotein can be treated with the drug for better outcomes in halting disease progression.

Medical Device Approvals

The FDA approves Intact Vascular’s Tack Endovascular System for marketing. The device is used to repair a tear (dissection) in the inside lining of a blood vessel that may occur following a procedure. By widening a blocked or narrowed blood vessel in the leg, the result of the procedure is improved blood flow.

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