DUPIXENT® (dupilumab) is an add-on maintenance therapy for your moderate-to-severe asthma patients aged 12+ with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Dupixent is already is a big seller in severe asthma in adults and adolescents but Sanofi is looking to expand the label after presenting data showing that it is the only biologic in Phase III trial to have demonstrated improved lung function in children. %PDF-1.7 %���� “Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients – those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. 2 1-month supply 3-month supply The drug acts by restraining proteins responsible for the inflammation of airways of the lungs, the root cause of asthma. Dupixent will be approved based on both of the following criteria: a. Please see Important Safety Information and full … any form of assistance from the Sanofi and Regeneron Pharmaceuticals sponsored Dupixent MyWayTM program shall be required to meet initial authorization criteria as if patient were new to therapy. �%�?��#H��)����*H^���� y�%� ~ "Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients – those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus. Dupixent (dupilumab) is a maintenance medication used in combination with other medicines to treat moderate-to-severe asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus. Dupixent ® Prior Authorization Request Form (Page 1 of 2) DO NOT COPY FOR FUTURE USE. The FDA accepts Sanofi's (SNY) sBLA for review of Dupixent for treating moderate-to-severe asthma in children aged six-11 years. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. DUPIXENT is not used to treat sudden breathing problems. Prior Authorization Request Form for Dupilumab (Dupixent) To be completed and signed by the prescriber. Asthma: DUPIXENT® (dupilumab) is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. Asthma 1. :�y���}�C��}�k����ѱD��oG�8��hK�-ݷ4���φ��8�Ѹ��h��J�m��5�G���'� > Maintenance Dose: Administer 200 mg under the skin every weeks. !`k� XX�����Dw7)��"ڋ��D�b欰cƕ )�|Ν��;wXk��d��Ϙ�����T�v�R���� ������qE�q�n*' :mD*��!T4�sh�sN�U���n'���=qk]��j����S���xڸ�=[�Ao&��e��tU�\��t�xS��:?��2$[Y�� ٺt�{��a9��[П�4x���U�z$G�}3�Yyb�SA���6��fEo:�Q�먭FW�"�[m0GR�Qq���>W�CsЏM{ g�3�u�Ȍ�of��S� �F�U�c�s����]��"�>��? Regeneron Pharmaceuticals Inc. and Sanofi have revealed that Dupixent ® (dupilumab) significantly reduced asthma attacks and improved lung function compared to standard of care (SOC) in 408 children aged six to 11 years old with uncontrolled moderate-to-severe asthma.. Asthmatics suffer from bouts of coughing, wheezing and difficulty breathing. 1532 0 obj <>stream OptumRx has partnered with CoverMyMeds to receive prior authorization requests. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT. )�Ze�]�����x6�K5������a�M��ÃW��rV/n�yy��|9mn " ������r����}�ޝ�R��*u�Nu5�m~E��[���x�����������������ݧ���ӕ����?���3�*�*��j��j�����J��DO=A��DG}A��DO=I�$ѓDO=I�$ѓDO=I��SDO=E��SDO=E��SDO=M�4��D�4ω�&���h����! A verdict from the FDA is expected on Oct 21, 2021. Individual has a diagnosis of moderate-to-severe asthma as demonstrated by the following (NHLBI 2007): A. The CHMP recommended Dupixent be approved for use in … TARRYTOWN, N.Y. and PARIS, March 1, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent ® (dupilumab) in asthma. h�씽JQ���(�FTL�k$�"C Limitation of Use: DUPIXENT is not indicated for … h��TkLW>w��G��p݅.(H�]��X�Y��Xy. a specific form of allergic reaction resulting in inflammation of your blood vessels. DUPIXENT is not used to treat sudden breathing problems. DUPIXENT is indicated as add-on maintenance treatment for patients (12+ years) with moderate-to-severe asthma with an eosinophilic phenotype, or with OCS‑dependent asthma regardless of phenotype. -Ĉ! h��[{s�F��*�S��~�r��%;�ݵ����U�SW0 I�P$�������� ��ޠ�r����5�3=�)ƙv� �=4,Z8h8&����L��Lr訽dRBG���\{ͤ���[&��;�)� U*Hh�L�;�3幆��6�4@9(����ܵ���X�2�m��cFZ����f���3�5��Y�`�dV���+f����q�}s ���9��s��ϼ��y����G潄GB��!R�B��5|�0,X�e����� !-�Ê - ��s[Z�k`!�6�R���Z���B�� /� Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. Navigate DUPIXENTHCP.COM to learn about DUPIXENT® (dupilumab), an add-on maintenance therapy for moderate-to-severe asthma patients aged 12+ with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus. They are at risk of severe asthma attacksthat could end up in emergency room visits or hospitalizations. DUPIXENT (dupilumab) is a prescription medicine used with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. SEE WHAT DUPIXENT CAN DU Member Information (required) Provider Information (required) Member Name: Provider Name: It is prescribed for people older than 12 years old whose asthma is not controlled with other asthma medications.Dupixent may help reduce the use of oral corticosteroids needed to control asthma. CVS Caremark Specialty Programs 2969 Mapunapuna Place Honolulu, HI 96819 Phone: 1-808-254-4414 Fax: 1-866-237- 5512 www.caremark.com Asthma. Step 1 Please complete patient and physician information (please print): Dupixent® (dupilumab) 200 mg/1.14 mL prefilled syringe -pack2 Asthma Starter Dose: Administer two syringes (total of 400 mg) subcutaneously on Day then one 1 syringe (200 mg) every 2 weeks starting on day 15 and thereafter. PARIS and TARRYTOWN, NY - May 7, 2019 - The European Commission has approved Dupixent ® (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled … Authorization will be issued for 12 months. B. Oral corticosteroids may offe… )讂���ʣR�ؠ%��bHl�V I further hereby give authorization and consent for treatment, from Princeton Allergy and Asthma and the staff, of any reactions that may occur as a result of the Acute Asthm… 1279 0 obj <> endobj 1517 0 obj <>/Filter/FlateDecode/ID[<1E40DC664F394A63AD78669307880E36><37EF5876A77B464AA8BC9A065D622A53>]/Index[1279 450]/Info 1278 0 R/Length 420/Prev 610492/Root 1280 0 R/Size 1729/Type/XRef/W[1 3 1]>>stream Dupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines. People with moderate-to-severe asthma often have uncontrolled, ongoing symptoms despite receiving appropriate standard-of-care therapy.12 This makes them good candidates for treatment with a biologic therapy. It is not known if DUPIXENT is safe and … ��0 ]����l�4� � Dupixent HMSA – 04/2020. "In the asthma clinical trial program, Dupixent reduced severe … Asthma Enrollment Form Medications A-E (Cinqair, Dupixent) Six Simple Steps to Submitting a Referral 1 PATIENT INFORMATION (Complete or include demographic sheet) Patient Name: _____Address: _____City, State, ZIP: _____ PCŔuPՅ�_�����-�{��=��X,��.ῷ(VA�u��棞�&�?��6I89c�'�?L>|y��B�4 ��^Q ߜԅ��?��M��|xvYn�j�e��b��z�eo.ؼ�l��|������ϡ��K9�&bM���"�����1]38�����㠁 Z� 8P[��vk(h� �\�=� ���q$7O�=��d/�������d��;���=��@���O���O?�{�lb������V���r=�֓2�,��_�M�2y;�D�_{_M��J��G� DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. In rare cases, patients taking an asthma medicine may develop an inflammation of blood vessels or lungs. Rarely, this can happen in people with asthma who receive Dupixent. For renewal of therapy an initial Tricare prior authorization approval is required. r��< ��s oݷ�\��ɡz�9�̜�`�OS��TO^4�Y�"k����s����^5��?� ��F endstream endobj startxref 0 %%EOF 1728 0 obj <>stream Individual is 12 years of age or older; AND II. dose for the indication of atopic dermatitis or asthma. Asthma: DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. DUPIXENT is an add-on maintenance treatment for people aged 12 and older with uncontrolled moderate-to-severe eosinophilic or oral steroid dependent asthma that improves lung function so that you can breathe better in as little as 2 weeks. Asthma:DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Office use only: Dupixent_Comm_2019Apr-W . Serious adverse reactions may occur. For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose. %PDF-1.6 %���� Dupilumab, branded as Dupixent by Regeneron and Sanofi, was cleared as an add-on maintenance treatment for moderate to severe asthma in patients 12 years of age and older. ���Mg�VI�6&��������;�� @l �7��?��Hf0t��X������W��@�6tw.�*Kt>��!./\1W�bO��o^G��y�^�����ڀw\_��8�LmHn�ݷfg��ݺީ��Luե�\ ����3 �hLj1u�G�%�}���}�17>�zm����3�/��Nm7�V��ؾ�������1�Ğ�&g���tDAx�'3щg���Zv�����b�Ա�0S��]���ښ��Cw�D~��uru�ˁ���o���[aa���?�/�?I����čZt���?af�ˇH��|���:�L.��7"#6GXH3�j��0�[ N��6�A�d�݈o"�2�d��9��3D��Ujv5܁.t�$�$�a#�;p��d��z �̕3ȆN^H@i3�+貎2y���q�*ڏ�B�. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. FORMS ARE UPDATED FREQUENTLY AND MAY BE BARCODED . �cH�c��'C:�(C��`�)d_�`e9�`��Q0��@�(� �� Ck䞂1��x� ��&`+|Ѓ�D�h�8��``L(����aQG�F�s0��0� �c8���p�>Ђ1�)c8���?�y���el�h���� d"|@y#h������ �QZTy�`\����d'y/||;(h�C �--�5�@i d,�&܃? Initial approvals expire after six months, renewal approvals are indefinite. CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients. DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT MyWay® is a patient support program that can help enable access and provide patient assistance to your eligible asthma patients aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. It is not known if DUPIXENT is safe and effective in children with asthma … DUPIXENT is not used to … k�h��8^�f�j��X��9eCa8g��!b�F�(�8`�������l��m��"����2��@�� 0��������2BI������壝T/e�@.��u�^W3�"�6/7��M��k�ث�ͼ��&������A�[�(�@� ���!�Q�c�-tW�,?��n����On䐹q&8����I�0��~1���E5�_��~w�:��w�-~����ͷ�����}�+|#� fL{��������ͳ���O-Q�R$�li����K�W��>�ϣhd�:@#D�x4DŽd�H��,�iuW���+�q��D���($�SA. The Phase III trial was evaluating the efficacy and safety of Dupixent in addition to SOC maintenance therapy of … DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known whether this is caused by Dupixent. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. APPROVAL CRITERIA Initial requests for Dupixent (dupilumab) for the treatment of asthma may be approved if the following criteria are met: I.
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