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CMS: Prescription Drug Costs Will Rise 6.3% a Year for a Decade

Prescription drug costs are expected to see the fastest annual growth among health care expenditures over the next decade, the Centers for Medicare and Medicaid Services (CMS) predicts, rising an average of 6.3% a year due to higher drug prices and more use of specialty drugs such as those for genetic…

Roche Ends Development of Several Drugs

In an update on pharmaceutical pipeline projects tucked inside its financial results, FierceBiotech reports, Swiss drugmaker Roche announced that it was pulling the plug on several early- and late-stage candidates. The casualties: Lampalizumab (RG7417), a phase 3 drug that last fall failed two tests:…

FDA Grants Breakthrough Therapy Designation to Voxelotor for Sickle Cell Disease

The FDA has granted a breakthrough therapy designation to voxelotor (previously called GBT440, Global Blood Therapeutics) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD. The breakthrough therapy designation for voxelotor was based…

Drug Charity Sues U.S. Over Restrictions on Donor Communications

A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it, according to a Reuters report. The charity, Patient Services, Inc. (PSI), filed the lawsuit in federal…

FDA's Gottlieb Blames Industry 'Kabuki Drug Pricing' for High Costs

FDA Commissioner Scott Gottlieb, MD, criticized pharmacy benefit managers, health insurers, and drug-makers Wednesday for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers, Reuters reported. The comments, made at a conference organized by a leading U.S. health…

Briefly Noted January 2018

CMS’s Patients Over Paperwork program aims to lessen the regulatory burden on physicians. CMS administrator Seema Verma likens the effort to scraping off old layers of paint before repainting a house, reports MedPage Today. She said that requirements concerning what and how much information physicians…

CVS To Dominate Pharmacy Networks

The winners among the Part D preferred pharmacy networks are willing to trade lower prescription profit margins for larger market share. CVS pharmacies are preferred in plans that enrolled 8.5 million people in 2018, compared with the fewer than 300,000 people enrolled in CVS retail pharmacies in 2017.

It's a Century Since the 1918 Flu Pandemic. Could It Happen Again?

One hundred years ago, the deadliest influenza pandemic of all time made a ravaging march across the globe. The "Spanish" flu of 1918-19 infected an estimated one-third of the world's population and killed between 50 million and 100 million people, modern epidemiologists estimate. That raises the inevitable…

FDA Approves Single-Pill, Three-Drug Biktarvy for HIV

The FDA has approved Biktarvy (Gilead Sciences, Inc.), a once-daily, single-tablet regimen for the treatment of HIV-1 infection that includes 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide. Bictegravir is a novel, unboosted integrase strand transfer inhibitor (INSTI),…

FDA Declines to Approve Braeburn Opioid Use Disorder Treatment

The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order…

Value-Based Contracts May Lower Patients' Out-of-Pocket Costs by 28%

Commercially insured patients in health plans with value-based contracts for diabetes, high cholesterol, and human immunodeficiency virus medicines in the past two years had copays that averaged 28% lower for those medicines compared to patients in other plans, according to an analysis from the Pharmaceutical…

Trump Administration Offers New Rule That May Erode PPACA

Workers would be allowed to band together to buy health insurance under a proposed rule released by the Department of Labor, The Hill reported. The proposal was issued in response to an executive order by President Trump, which would allow associations of workers to purchase cheaper health insurance…

Clinical Decision Support Software Can Warn of Potential Stroke

New clinical decision support software designed to analyze computed tomography (CT) results may speed treatment by notifying providers of a potential stroke in their patients. The FDA has permitted marketing of Viz.AI Contact (Viz.AI), a computer-aided triage software application that uses an artificial…

FDA Turns Down a Third Generic Version of Advair

The FDA has declined to approve Novartis’ generic formulation of fluticasone propionate/salmeterol (Advair, GlaxoSmithKline), according to a report from FiercePharma. Approval of the Novartis’ generic had been anticipated for the first half of 2018. Novartis said it has received a complete response…

FDA Approves Label Update of Nilotinib, Enabling Certain Patients With CML to Stop Treatment After Sustained Response

The FDA has updated the product label for the cancer drug nilotinib (Tasigna, Novartis) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive…

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