What's Driving Cost Growth Among US Drugs? It's Not Novel Therapies, Study Says
January 8th 2019The fact that cost growth is driven largely by older products and not by new blockbuster therapies “is particularly important,” write the authors, “because in the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes. However, rising costs due to inflation do not reflect improved value for patients.”
Community Oncology Alliance Forms Biosimilars Committee Aimed at Educating Providers
January 7th 2019The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.
Eye on Pharma: Samsung Bioepis to Partner With 3SBio on Biosimilars
January 7th 2019Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced that it will partner with Chinese biopharmaceutical company 3SBio to develop and commercialize multiple biosimilars in mainland China.
New No-Deal Brexit Guidance Holds Changes for Biosimilars
January 6th 2019This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.
Administration's Direct-to-Consumer Advertising Proposal Draws Varied Feedback From Stakeholders
January 5th 2019In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.
Researchers Report Positive Early Data for SB2 in Treating IBD
January 4th 2019A recent letter, published in Alimentary Pharmacology and Therapeutics, reported on early findings from an ongoing, 18-month, multicenter, observational prospective study conducted among the cohort of the Sicilian Network for Inflammatory Bowel Disease (IBD). According to the authors of the letter, these are the first data on SB2 in treating IBD.
Pharma Companies Raise Prices on More than 250 Drugs in 2019
January 3rd 2019After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.
ACR Expresses Concern About International Pricing Index in Comments to CMS
January 2nd 2019The American College of Rheumatology (ACR) is apprehensive that “without substantial changes, the demonstration program could disrupt patient access to care, worsen the rheumatology workforce shortage, and exacerbate geographic disparities in access to medical care.”
Lack of Biosimilar Awareness Persists in the US and Europe, Review Finds
January 2nd 2019Biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice. A newly published systematic review evaluated US and European healthcare provider knowledge, perceptions, and prescribing behaviors related to biosimilars, and it found that providers are still taking a cautious approach to biosimilars in part because of a lack of awareness of these medicines.
Rituximab May Treat Early-Onset Nephrotic Syndrome
January 1st 2019In children, idiopathic nephrotic syndrome (NS) generally responds well to treatment with corticosteroids, but long-term use of steroids in children can produce adverse effects (AEs) such as growth impairment and hypertension. Calcineurin inhibitors, too, are associated with AEs, including toxicity and diabetes. Rituximab has been proposed as an option for difficult-to-treat childhood-onset NS, and a recent study evaluated the efficacy and safety of a single dose of rituximab in this setting.
Rituximab Combination Has Positive Activity in Non-Hodgkin Lymphoma
January 1st 2019Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the drug in combination with rituximab in a clinical setting.
Key Incoming Lawmakers Have Received Major Pharma Contributions
January 1st 2019As Congress prepares to begin its new term, newly elected lawmakers will convene to tackle issues such as the high cost of drugs. As they prepare to address these policy challenges, a new analysis shows that several key congressional leaders have received major contributions from the pharmaceutical industry.
Risk of TB High in Indian Patients With IBD Who Receive Infliximab
December 31st 2018Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.
Study in Patients With IBD Finds Good Long-Term Efficacy of CT-P13
December 31st 2018Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.
Stakeholders Weigh In on the Key Biosimilar Developments of 2018
December 31st 20182018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.
Study: Vedolizumab In the First Line Brings Down IBD Treatment Costs
December 29th 2018Vedolizumab is approved by the FDA for the treatment of moderate to severe Crohn disease or ulcerative colitis, both forms of inflammatory bowel disease (IBD), who have had an inadequate response or loss of response to immunomodulators, tumor necrosis factor inhibitors, or corticosteroid therapy.
High Costs Drive 1 in 4 Patients With Diabetes to Use Too Little Insulin
December 27th 2018Despite the fact that the World Health Organization classifies insulin as an essential medicine that should be available at all times at a price that patients can afford, US insulin prices have continued to climb in recent years.
Study: Pegfilgrastim May Be an Option for Patients With Germ Cell Tumors
December 26th 2018Germ cell tumors are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia related to myelosuppression has not been well investigated in patients with this tumor type.
Infliximab Could Help Adults With Kawasaki Disease
December 26th 2018While Kawasaki disease (KD) typically affects children, it can, in rare cases, affect adults, leading to coronary artery abnormalities and acquired heart disease. Given that the disease is rare in adults and that its etiology is not fully understood, diagnosis and treatment of KD in adults can be challenging.
Bevacizumab Plus Chemotherapy Improves PFS in Early Ovarian Cancer
December 25th 2018A recent study evaluated the impact of adding bevacizumab to chemotherapy treatment for patients who were newly diagnosed with ovarian cancer. The results, published in Gynecologic Oncology, found that while the addition of bevacizumab greatly improved progression-free survival (PFS), it did not improve overall survival.