+ Use in children under 12
+ Perioperative management
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FEATURE |
Most individuals with chronic hematologic conditions will likely reach their limits quickly , meaning they may have to pay up to $ 7,150 ( according to 2017 calculations ) within the first few months of every year they need treatment , plus monthly premiums . Also , since the ACA networks are narrow – and becoming narrower in many states – patients are sometimes forced to seek non-network care , adding to their out-of-pocket costs . |
ACA opponents contend that the high deductibles and narrow networks have actually reduced access to doctors and hospitals ; in particular , they have focused on patients ’ inability to maintain continuity with their physicians in the face of network restraints .
“ Malignant and nonmalignant hematologic disease require expensive care ,” Suzanne Leous , director of Government Relations and Practice at ASH , told ASH
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Clinical News . “ Making sure annual and lifetime out-of-pocket limits are upheld in the new legislation is vitally important for hematology patients – and something ASH strongly supports .”
Each year , ASH identifies key areas of advocacy . This year , ASH is hoping to see the following issues resolved with any new health-care legislation :
• finalizing the budget for fiscal year
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2017 and 2018 , which will set funding for medical research and other important public health programs
• chemotherapy parity for oral agents
• adequate reimbursement for cognitive physicians and guaranteed reimbursement for preventive care ( including patient education , psychological services , nutrition , and exercise physiology )
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Repeal or “ Death by a Thousand Cuts ”?
Repeal means repeal . Depending on whom you ask , though , it could mean reconciliation , or partial repeal , or repeal and delay .
On January 12 , 2017 , the U . S . Senate voted 51 to 48 to repeal the ACA – the first in a long series of steps down the road to full repeal . This vote didn ’ t seal the fate of the ACA , however ; the Senate instead passed a budget resolution to begin the process , known as reconciliation . A day later the U . S . House of Representatives also passed a budget that prepares the way for repeal , leaving an actual repeal still several steps away . 1
Created by the Congressional Budget Act in 1974 , reconciliation is a process that allows lawmakers to pass a budget bill with only a simple majority ( which the Republicans have without needing any votes from the Democrats ), meaning the bill is not subject to filibuster in the Senate . Reconciliation also exists in the House but , because it regularly passes rules that constrain debate and amendments , the process has less effect on its workings .
Reconciliation has strict rules and limits that may complicate plans . First , only provisions that directly change taxes or entitlement spending can be included in a reconciliation bill . 2 Second , such a bill cannot eliminate or amend the regulatory ( non-budgetary ) parts of the law , such as the ACA ’ s rules regarding insurance regulation .
A full repeal would most likely remove the tax penalty associated with the individual mandate , without changing the requirements for the Essential Benefits provision or the pre-existing conditions clause . A partial repeal , though , signals that legislators intend to kill the bill slowly and surely .
“ I don ’ t think this is going to be an all-or-nothing vote , but rather ‘ death by a thousand cuts ,’” Dr . Alvarnas predicted . “ The Senate will probably start to strip out the things that have been unpopular with Republicans . If those elements continue to be undermined , legislators will have subverted the sustainability and viability of the law – effectively getting rid of it .”
REFERENCES
1 . Bryan B . Here ’ s the 10-step process that the Republicans will use to repeal Obamacare . Business Insider , January 12 , 2017 . Accessed January 20 , 2017 from www . businessinsider . com / obamacare-repeal-process-senate-vote-2017-1 .
2 . Antos J , Capretta J . The problems with ‘ repeal and delay .’ Health Aff . 2017 January 3 . [ Epub ahead of print ]
ASHClinicalNews . org
For patients with Hemophilia A , the FDA has now approved ADYNOVATE ® for
+ Use in children under 12
+ Perioperative management
PROVEN PROPHYLAXIS + SIMPLE ,* TWICE-WEEKLY
DOSING SCHEDULE = moments
THEIR WAY
* ADYNOVATE allows patients to infuse on the same 2 days every week .
The pediatric study ( N = 73 ) evaluated the efficacy , PK , and safety of ADYNOVATE twice-weekly prophylaxis and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months . 1 , 2
+ Sixty-six patients ( 32 patients aged < 6 years and 34 patients aged 6 to < 12 years ) received 40-60 IU / kg of ADYNOVATE prophylactically , twice weekly 2
Indications
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in children and adults with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .
+ Children experienced a median overall ABR of 2.0 ( IQR : 3.9 ) and a median ABR of zero for both joint ( IQR : 1.9 ) and spontaneous ( IQR : 1.9 ) bleeds 1 , 3
+ 38 % ( n = 25 ) of children experienced zero total bleeding episodes ; 73 % ( n = 48 ) experienced zero joint bleeding episodes ; and 67 % ( n = 44 ) experienced zero spontaneous bleeding episodes 1
For more information , talk to a Shire representative or visit ADYNOVATEPRO . com
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Neutralizing Antibodies
Formation of neutralizing antibodies ( inhibitors ) to factor VIII can occur following administration of ADYNOVATE . Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests . Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected , or if bleeding is not controlled with expected dose .
ADVERSE REACTIONS
The most common adverse reactions ( ≥1 % of subjects ) reported in the clinical studies were headache and nausea .
Please see the following page for the Brief Summary of the ADYNOVATE full Prescribing Information .
For full Prescribing Information , visit www . ADYNOVATEPRO . com .
References : 1 . ADYNOVATE Prescribing Information . Westlake Village , CA : Baxalta US Inc . 2 . Mullins ES , Stasyshyn O , Alvarez-Román MT , et al . Extended half-life pegylated , full-length recombinant factor VIII for prophylaxis in children with severe haemophilia A . Haemophilia . 2016 Nov 27 . doi : 10.1111 / hae . 13119 [ Epub ahead of print ]. 3 . Data on file ; Shire US Inc .
© 2017 Shire US Inc ., Lexington , MA 02421 . All rights reserved . 1-800-828-2088 . SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates . ADVATE and ADYNOVATE are trademarks or registered trademarks of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . S17616 01 / 17