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CMS Experimenting With New Accountable Care Organization Model
The Centers for Medicare & Medicaid Services ( CMS ) announced the Medicare− Medicaid Accountable Care Organization ( ACO ) Model , which is a new initiative designed to improve the quality of care and lower costs for beneficiaries . It builds on the Medicare Shared Savings Program , in which Medicare ACOs that hit spending and quality targets can share in the savings with CMS , and it advances efforts to partner with states in transforming the health-care delivery system .
“ This model aims to provide improved care coordination for those enrolled in both Medicare and Medicaid , allowing providers to focus more on providing care for their patients rather than administrative work ,” said Patrick Conway , MD , MSc , acting principal deputy administrator at CMS .
CMS is accepting letters of intent from states that wish to partner to design certain state-specific elements of the model and intends to enter agreements with as many as six states , with preference given to those with low saturation of providers already participating in a Medicare ACO program . Once a state is approved to participate in the model , a request for application will be released to ACOs and health-care providers in that state .
The deadlines to submit letters of intent are January 20 , 2017 , for 2018 performance start date , August 4 , 2017 , for 2019 start date , and August 3 , 2018 , for 2020 start date .
Visit cms . gov / Newsroom / MediaReleaseDatabase / Fact-sheets / 2016- Fact-sheets-items / 2016-12-15-2 . html for more information .
Source : CMS press release , December 15 , 2016 .
Proof-of-Concept Trial of Artificial Blood Product Erythromer Meets Primary Efficacy Endpoint
Results from a proof-of-concept trial of erythromer , a nanoscale biosynthetic artificial red blood cell ( RBC ) product , show that the product successfully emulated the functions of natural RBCs . If proven safe in humans , the blood substitute could be used for transfusions in cases in which stored blood is unavailable or unusable , according to the authors , led by Dipanjan Pan , PhD , of the University of Illinois at Urbana-Champaign .
“ Unfortunately , all prior blood substitutes have failed due to two flaws : poor oxygen delivery to tissue and vasoconstriction ,” co-author Allan Doctor , MD , of the Departments of Pediatrics and Biochemistry at the Washington University in Saint Louis in Missouri , said during his presentation of the results at the 2016 ASH Annual Meeting . “ Improvements in synthetic chemistry and nanomedicine have enabled us to encapsulate human hemoglobin with a suite of small molecules that we can encode with ‘ wet-ware ’ that helps coordinate normal behavior in the particle , simulating red blood cells .”
This “ wet-ware ” links erythromer ’ s oxygen binding ability to changes in blood pH , thus allowing the lungs to dispense
oxygen to tissues with the greatest need . Erythromer cells are designed to be “ freeze-dried ,” stored at ambient temperatures , and reconstituted with water when needed .
Dr . Pan and researchers conducted ex vivo and in vivo testing in rodent models to determine if the artificial RBC product could match an erythrocyte ’ s natural physiologic functions , including measures of payload retention , biocompatibility , oxygen affinity , and nitric oxide consumption . Erythromer performed well on these tests , “ suggesting that this design surmounts prior challenges ” of artificial blood product design .
Pharmacokinetic analyses showed that the distribution half-life was 26.2 ± 3.6 minutes and elimination half-life was 300 ± 12 minutes , which the authors noted would likely translate to a half-life in humans of approximately three hours .
“ Erythromer ’ s potential for extended ambient dry storage has significant implications for portability and use ,” the authors concluded . “ Next steps include testing if the formulation can be scaled up ; a detailed study of pharmacokinetics , biodistribution , and safety ; as well as [ an ] evaluation of hemorrhagic shock in large animal models .”
Source : Pan D , Rogers S , Misra S , et al . Erythromer ( EM ), a nanoscale bio-synthetic artificial red cell : Proof of concept and in vivo efficacy result . Abstract # 1027 . Presented at the ASH Annual Meeting and Exhibition , December 5 , 2016 ; San Diego , CA .
FDA Halts Phase I Trials of Vadastuximab Talirine in AML
The U . S . Food and Drug Administration ( FDA ) has placed clinical holds on several phase I trials of vadastuximab talirine ( SGN-CD33A ) in patients with acute myeloid leukemia ( AML ), according to the drug ’ s manufacturer , Seattle Genetics . The clinical holds were initiated to assess the risk of hepatotoxicity with
“ This model allows providers to focus more on providing care for their patients rather than administrative work .”
— PATRICK CONWAY , MD , MSc
vadastuximab talirine ( a CD33-directed antibody drug conjugate ) following the deaths of four patients who were treated with vadastuximab talirine along with allogeneic hematopoietic cell transplant ( alloHCT ) either prior to or following treatment . All four of these patients had veno-occlusive disease at the time of death ; two additional trial participants also had hepatotoxicity .
The drug ’ s manufacturer reported that the phase I / II trial of single-agent vadastuximab talirine in pre- and postalloHCT patients with AML has been placed on full clinical hold , while two other phase I trials have received partial clinical holds , meaning no further enrollment is allowed , but enrolled patients who consent can continue therapy . One of these trials is assessing vadastuximab talirine in combination with hypomethylating agents in older patients with AML ; the other is examining vadastuximab talirine in combination with 7 + 3 chemotherapy in patients with newly diagnosed AML .
Other ongoing trials of vadastuximab talirine ( the phase III CASCADE trial in older AML patients and phase I / II trial in myelodysplastic syndromes ) are proceeding with enrollment .
At the 2016 ASH Annual Meeting , researchers reported data from the phase Ib trial of vadastuximab talirine in combination with 7 + 3 chemotherapy , finding that the drug was safe in patients with newly diagnosed AML , with patients showing no evidence of increased toxicity or mortality when the drug was added to the standard 7 + 3 regimen . Seventysix percent of the 42 patients in this trial also achieved a response , with 60 percent achieving complete remission and 17 percent achieving remission with incomplete blood count recovery .
Source : Seattle Genetics press release , December 27 , 2016 .
FDA Grants Full Approval for Ponatinib and Its Updated Label
The FDA granted full approval of ponatinib for adults with chronic-phase ( CP ), accelerated-phase , or blast-phase chronic myeloid leukemia ( CML ) or Philadelphia chromosome-positive acute lymphocytic leukemia ( Ph + ALL ) when no other tyrosine kinase inhibitor is indicated . Ponatinib also is approved to treat adults with T315I-positive CML or T315I-positive Ph + ALL .
Ponatinib was granted accelerated approval in December 2012 .
The full approval and label update are based on results from the phase II PACE trial , in which 449 heavily pretreated patients ( refractory to dasatinib or nilotinib ) with resistant or intolerant CML or Ph + ALL were followed for 48 months ( data cutoff was on August 2015 ).
Thirty percent of all patients ( n = 133 / 449 ; median follow-up = 37.3 months ; range = 0.1-58.5 months ) and 41 percent of patients with CP-CML ( n = 110 / 270 ; median follow-up = 48.2 months ; range = 0.1-58.5 months ) remained on the study at the time of data cut-off . For patients with CP-CML , the estimated four-year progressionfree survival was 56 percent and overall survival ( OS ) was 77 percent . Patients with accelerated-phase disease had an estimated four-year OS of 51 percent , while the median OS was 6.9 months for patients with blast-phase CML / Ph + ALL ( 95 % CI 5.0-9.2 ).
12 ASH Clinical News January 2017 Annual Meeting Edition