CLINICAL NEWS |
|||
|
increased to the highest point in 2016 , mainly because of rising health-care costs . “ Working Americans are using the same or less health care and are paying more and more for it every year ,” said HCCI President Niall Brennan , MPP .
Spending per person in 2016 grew 4.6 percent from 2015 to $ 5,407 , while in 2015 , spending grew 4.1 percent from the previous year . Health-care spending per person grew cumulatively by 15 percent between 2012 and 2016 .
HCCI based its findings on claims data for 39 million U . S . patients under age 65 who were enrolled in employer-sponsored health insurance from 2012 to 2016 . The data represent about one-quarter of all people covered by employer-based insurance and was obtained by insurance companies , including Aetna , Humana , Kaiser Permanente , and UnitedHealthcare .
“Working Americans are using the same or less health care and are paying more and more for it every year .” — NIALL BRENNAN , MPP , president of the Health Care Cost Institute
In 2016 , this increased spending was driven mostly by the cost of outpatient services , such as emergency room ( ER ) visits and surgeries , and prescription drug prices . Per-person spending on outpatient services reached $ 1,507 in 2016 , representing an increase of 6.2 percent from 2015 . Spending on prescription drugs totaled $ 1,030 , which was up 5.1 percent from the previous year ; however , this was less than the 10.4 percent growth seen in 2015 .
Spending on professional services , including physician visits , drug administration , anesthesia , radiology , and pathology , rose 3.5 percent to $ 1,821 .
Despite these increases , the use of most health-care services has held steady or declined overall from 2012 to 2016 . Mr . Brennan attributed this to the effects of the economic recession or the migration of workers toward high-deductible health plans , which Americans may find difficult to afford . In addition , the prices of health-care services have risen enough to offset any decreases in health-care use , the researchers found .
The study results also showed large
|
price increases for administered drugs ( up 42 % to $ 581 on average ) and outpatient ER visits ( up 31 % to $ 1,917 on average ) during the study period .
Source : Modern Healthcare , January 23 , 2018 .
Clinical Hold Placed on BPX-501 After Patients Develop Encephalopathy The FDA put a clinical hold on the investigational cellular immunotherapy BPX-501 , halting four U . S . studies assessing the drug ’ s use for cancer and orphaninherited blood disorders . The agency placed the hold after three patients developed encephalopathy that was deemed possibly related to treatment . BPX-501 is an adjunct T-cell therapy administered after allogeneic hematopoietic cell transplantation ( alloHCT ) and is designed to eliminate alloreactive BPX-501 T cells in the event of uncontrollable GVHD .
The clinical trials affected by this hold include the following phase I / II studies :
• BP-001 and BP-005 : adults with hematologic cancers receive BPX-501 after alloHCT
• BP-003 : children with orphaninherited blood disorders receive BPX-501 after alloHCT
• BP-008 : adults and children with blood cancers are treated after relapsing post-transplant and evaluated for the potential for a titrated dose of rimiducid to resolve uncontrolled graft-versus-host disease ( GVHD ), while preserving BPX-501 cells
The clinical hold does not affect the European BP-004 trial assessing BPX-501 after alloHCT in children with hematologic cancers or orphan-inherited blood disorders .
More than 240 patients have been treated with BPX-501 after alloHCT . The drug ’ s manufacturer , Bellicum Pharmaceuticals , said it is waiting for formal FDA communication to determine requirements for resuming the studies .
Results from the BP-004 study , in which researchers evaluated immune recovery and outcomes of 112 pediatric patients who underwent a haploidentical HCT ( haplo-HCT ) followed by treatment with BPX-501 , were presented at 2017 ASH Annual Meeting . At 24 months after haplo-HCT , BPX-501 cells expanded progressively , peaking at nine months after the allograft . Among 16 patients with two years of follow-up , the mean number of BPX-501 cells was 62 + 23 / μL .
|
BPX-501 received orphan-drug designation in February 2016 .
Sources : FierceBiotech , January 31 , 2018 ; Merli P , Bertaina V , Galaverna F , et al . Donor T cells genetically modified with a novel suicide gene ( inducible Caspase 9 , iC9 ) expand and persist over time after post-allograft infusion in patients given αβ T-cell and B-cell depleted HLA-haploidentical allogeneic stem cell transplantation ( αβ haplo-HSCT ) contributing to accelerate immune recovery . Abstract # 211 . Presented at the 2017 American Society of Hematology Annual Meeting , December 9 , 2017 ; Atlanta , GA .
FDA Examining Patient Deaths Associated With Extracorporeal Photopheresis Treatment The FDA published a letter to healthcare providers noting that the CELLEX ® Photopheresis System is under review following reports of venous thromboembolism ( VTE ), including pulmonary embolism ( PE ), in patients who received autologous immune cell therapy . Two deaths were observed , although “ the link between PE and death cannot be made with certainty ,” the agency cautioned .
The treatment system is an extracorporeal photopheresis ( ECP ) device approved for use in the ultraviolet-A irradiation of extracorporeally circulating leukocyte-enriched blood . It is used for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that is unresponsive to other forms of treatment . It also is used to treat GVHD and acute cardiac allograft rejection .
“ The timing of the events in these reports suggests that ECP therapy may increase [ the ] risk [ of venous thromboembolism ].” — U . S . FOOD AND DRUG ADMINISTRATION
Since 2012 , the FDA has received seven reports of PE during or soon after ECP treatment ( mean = 1.2 days ). Four of these events occurred in patients with GVHD , which includes the two patient deaths . The FDA also received two reports of deep
|
vein thrombosis ( DVT ) that occurred during or soon after an ECP session ; both occurred in patients with GVHD .
“ The timing of the events in these reports suggests that ECP therapy may increase that risk ,” the agency noted in the letter .
The FDA recommends that healthcare providers alert patients , clinical staff , and technicians about the signs and symptoms of PE and DVT ; refer to device labeling for anticoagulation use with this system and use clinical judgment in adjusting heparin doses ; and report VTE events related to ECP procedures through the FDA Safety Information and Adverse Event Reporting program , MedWatch .
Source : U . S . Food and Drug Administration news release , February 5 , 2018 .
Ferumoxytol Injection Receives Expanded Approval for Iron- Deficiency Anemia The FDA approved a supplemental new drug application for ferumoxytol injection to include all eligible adults with iron-deficiency anemia ( IDA ) who cannot tolerate or have not responded to oral iron . The drug was previously only indicated for patients with IDA and chronic kidney disease .
The decision was based on the results of two phase III trials evaluating ferumoxytol injection versus iron sucrose or placebo in patients with IDA and a randomized , double-blind , phase III trial comparing ferumoxytol injection with ferric carboxymaltose injection in 2,000 adults with IDA . In the third study , ferumoxytol injection was comparable to ferric carboxymaltose injection based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions and moderate-to-severe hypotension .
Researchers also found that ferumoxytol injection improved hemoglobin per gram of iron from baseline to week five ( 1.35 vs . 1.1 g / dL ).
AE rates were similar across treatment groups , but the incidence of severe hypophosphatemia ( defined as blood phosphorous of < 0.6 mmol / L at week 2 ) was lower in the patients receiving ferumoxytol injection , compared with ferric carboxymaltose injection ( 0.4 % vs . 38.7 %; p value not provided ). The most common AEs associated with ferumoxytol were diarrhea , headache , nausea , dizziness , hypotension , constipation , and peripheral edema . ●
Source : AMAG Pharmaceuticals press release , February 5 , 2018 .
|