Your proposed modified REMS, submitted on May 1, 2019, and appended to this letter, is approved. and operate under the same DEA license and physical location with your Inpatient Healthcare Setting, your pharmacy will be … T: (866)293-1559 In an outpatient setting, once your patient has agreed to start SPRAVATO® treatment, you will need to enroll him or her in the program by submitting a SPRAVATO® REMS Patient Enrollment Form. SPRAVATO® REMS 1. 0000117298 00000 n Forms are updated frequently. – Patients should work with their healthcare provider to complete and sign the form. 7 Texas Health and Human Services hhs.texas.gov How do I (Patients) enroll in the SPRAVATO REMS? 0000003825 00000 n 0000008279 00000 n 0000197005 00000 n 0000004215 00000 n 0000102894 00000 n Spravato is not yet available to the public. 2. 0000242294 00000 n 0000048256 00000 n This form does not constitute a valid prescription. This form must be completed by the prescribing provider. You should become familiar with the SPRAVATO® REMS requirements before beginning the certification process. %%EOF Pharmacies must be certified in the SPRAVATO ® REMS to be able to receive and dispense SPRAVATO ®.. startxref 0000002890 00000 n 0000074407 00000 n 0000048187 00000 n Your first visit will be a consultation to discuss the details with a healthcare provider at the certified SPRAVATO® treatment center. 1. %%EOF Online enrollment is unavailable at the time of this release. 0000001865 00000 n SUBLOCADE REMS Program Healthcare Setting and Pharmacy Enrollment Form . 0000103635 00000 n 0000158899 00000 n endstream endobj 16 0 obj <> endobj 17 0 obj <>stream 0000002325 00000 n 0000242666 00000 n ����(��`�f �g1�P�;ih!�F+��#�A�h������j�c5��pFU�M�Ѝ�FH��ሮF��L�j���O�ᐮ�3��hj�nt5BM Gt5Bm��4/4M �:�0FW�U �C O��aH�^��f��=�eKtH���m�����E�@���Д�(���{N���P�t�xUA�A��&��`ߡ�)�+}��, m|��_L�GmYRd*�7���ȼ7�p���ƥ�����.�rt�2��w���o~�1\������n?��~x7������vsZ(Z{Z�� �s�� SPRAVATO™ REMS Healthcare Setting Enrollment. 0000003487 00000 n 0000117562 00000 n ��lSE��_-#:#�N��Jͨ�ߤ�[���ba~� +�(�ܷ���(k�U��?������q�H��,�货.� 0 0000158560 00000 n 0000159335 00000 n 0000205283 00000 n 0000074854 00000 n 4 65 0000009981 00000 n ®Complete this form online at www.SPRAVATOrems.com, or complete the paper form and fax to the SPRAVATO REMS at 1-877-778-0091 This section is to be completed by the Prescriber * Indicates required field Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN or the FDA at 1-800-FDA-1088 or online … 0000005392 00000 n 0000161103 00000 n or dispense/administer LEMTRADA. 0000138400 00000 n 0000181912 00000 n 0000137199 00000 n 0000002434 00000 n Modified to amend some of the data-capturing fields in the Healthcare Setting Enrollment Form, Pharmacy Enrollment Form, and Patient Monitoring Form. 0000205246 00000 n SPRAVATO™ is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. �kt˽}F!ٌ�$��%x�F���\���3z)`9v�����R�y���x�S^��պS ��Wj'�+�Ѹ:����F���C#8_M���8*"�H��2'�� 0000138331 00000 n Fill out the Adempas Hospital Program Checklist Enrollment Form. 0000047637 00000 n Then set up an intake appointment to get started. e�@�TW! %PDF-1.5 %���� 0000204533 00000 n 10.Provide public access to a database of certified healthcare settings and pharmacies. 0000047612 00000 n You must be enrolled in the Janssen CarePath Savings Program before receiving a Janssen medication. Search for prescribers or healthcare facilities that are enrolled and certified in the LEMTRADA REMS and able to prescribe. 0000168176 00000 n SPRAVATO® REMS atient abel or arcode ere Patient Monitoring Form - Outpatient Use Only INSTRUCTIONS: This form is intended only for use by outpatient medical offices or clinics, excluding emergency departments. 0000010699 00000 n • ®Enroll in the SPRAVATO REMS by completing this Pharmacy Enrollment Form and submitting this form to the SPRAVATO® REMS. To help ensure the safe and appropriate use of SPRAVATO®, it is given at a certified SPRAVATO® treatment center. Yes No *If yes, provide 9-digit Savings Program medical claims member # OR 11-digit Savings Program pharmacy claims member # found on front of card *FIRST NAME *LAST NAME *ADDRESS ADDRESS LINE 2 *CITY *STATE *ZIP *SEX Male Female *DATE OF BIRTH … 0000007949 00000 n 0000007326 00000 n 0000140005 00000 n xref H���K��@���+|��L�+�qAH��EB���Oe��S��v�ŏ/���>�,��ӗç���7�~2�#�o`юa��� 0000195465 00000 n e���k�RN�ة\��˶kG�S SPRAVATO® cannot be purchased at a pharmacy. Provide the Healthcare Setting Enrollment Form and Pharmacy Enrollment Form and Prescribing Information to REMS participants who (1) attempt to dispense SPRAVATO and are not yet certified, or (2) inquire about how to become certified. Program Enrollment Form. 0000158874 00000 n H���N#7�}���C�ߎ=�P$2�j���.��mU�0�T����{�/c'd H-�����#�`���pӜ7���g��Z8�J�L��kv�jD@�Br?�0���I�M��_��s un!D�G$����Κ1#�%$ZEr$��bK�(�:�' H���Mv�0��9�O��;���ؖE￩$�&6��3��o���w��4�|�|/_˯|���|�Ju�gJ�v_�C|���#�Nk+: 4 0 obj <> endobj �$�"0�[/��� ��P��F2�g���������#s��C�\�V�喤��f���Ѿ(M0��}����zq�Z\��#J5-����;��Z)���I�����5}�굖�#���j`wW,���w�s*�6����Ҭ�l>M�//v0@�M���������i�� '�����T� 2. 0000003452 00000 n Bronx, NY 10466. 0000047167 00000 n SPRAVATO ® REMS Pharmacy Enrollment - for Outpatient Dispensing Only. 0000137429 00000 n To submit this form via fax, please complete all required fields below and fax to 844-404-8876. 0000138188 00000 n 0000001967 00000 n A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. H��V]o�6}���?%�08n. This form does not constitute a valid prescription. Forms are updated frequently. At CVS Specialty®, our goal is to help streamline the onboarding process to get patients the medication they need as quickly as possible. xref q�(�Q���R��ڵ����R�>t���#�Uvc]�Rgq��9,OR�h�W�!���JG)�\�Yӈ�i�2l̞�����S�?����S|n������X@��m�3���!�0�!��P�r�D���(������3��=�-b�4�MY|��=kR?��5)ג��A�����r=6��45����Gl�GXj Make sure patients sign and date the form. 0000012476 00000 n In addition to the Adempas Prescription and Patient Support Program Enrollment Form, fill out the Adempas REMS Form. Full Spravato REMS Pharmacy Enrollment information can be accessed here. REQUIRED: Office notes, labs and medical testing relevant to request showing medical justification to support diagnosis . 68 0 obj <>stream 0000137816 00000 n 0000000016 00000 n 0000004344 00000 n 0000242808 00000 n 0000006801 00000 n 0000075400 00000 n 0000004867 00000 n 0000196177 00000 n trailer 25 57 For more information, please reach out to us: Allure Specialty Pharmacy. 0000002976 00000 n 81 0 obj <>stream We are a REMs-certified pharmacy and currently dispense SPRAVATO to several pharmacies across New York State. 0000181533 00000 n REQUIRED: Office notes, labs and medical testing relevant to request showing medical justification are required to support diagnosis . REMS Certified Prescriber & Healthcare Facility Locator. Some people taking SPRAVATO ® get nausea and vomiting. Page 1 of 2. This could be a different location than your regular doctor’s office. H�\��n�0E�� Product Acquisition Plan Healthcare Setting or Pharmacy must be Risk Evaluation and Mitigation Strategy (REMS) certified prior to ordering and/or dispensing SPRAVATO®. 0000138502 00000 n Your doctor will provide a copy of the signed form to the SPRAVATO™ REMS. 0000008870 00000 n 0000010314 00000 n For pharmacies, only the REMS enrollment form … 0000015532 00000 n • Recommended dosage for Spravato 0000011196 00000 n Your healthcare provider will help you complete this form and provide you with a copy. 0000005593 00000 n 0000003665 00000 n 0000015125 00000 n endstream endobj 5 0 obj <>>> endobj 6 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 7 0 obj <> endobj 8 0 obj [/ICCBased 22 0 R] endobj 9 0 obj <>stream Spravato Nasal Spray Pharmacy Prior Authorization Request Form Do not copy for future use. startxref 0000159783 00000 n Product Acquisition Plan Healthcare Setting or Pharmacy must be Risk Evaluation and Mitigation Strategy (REMS) certified prior to ordering and/or dispensing SPRAVATO®. Spravato REMS Pharmacy Enrollment Form, and the Spravato REMS Patient Monitoring Form; the modification amends some of the data-capturing fields in these forms. 0000015638 00000 n 4. 03/05/2019 Approval of the REMS. 0000242524 00000 n Make sure patients sign and date the forms. H��VI�� ��~� 0000048357 00000 n 0000004908 00000 n forproviders/pharmacy. Make sure patients sign and date the form. Spravato ™ Nasal Spray. 0000046907 00000 n 4. 0000160611 00000 n 0000007376 00000 n Our pharmacists will work with you to ensure that the medication is delivered in a safe and timely manner. 0 You should not eat for at least 2 hours before taking SPRAVATO ® and not drink liquids at least 30 minutes before taking SPRAVATO ® . Patient REMS enrollment will differ in an inpatient vs outpatient setting. 0000009594 00000 n 0000158294 00000 n 0000138046 00000 n 0000006550 00000 n 0000139233 00000 n endstream endobj 10 0 obj <>stream 0000031928 00000 n Ketamine Therapeutics has been Certified as a Health Care Center and a Pharmacy by the SPRAVATO™ REMS program. SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults. 0000003600 00000 n 0000160807 00000 n Send your specialty Rx and enrollment form to us electronically, or by phone or fax. 0000241907 00000 n 0000015352 00000 n 0000074829 00000 n If you are an Inpatient Pharmacy (support inpatient units, emergency department, etc.) 0000001596 00000 n 0000009004 00000 n Healthcare settings must be certified in the SPRAVATO™ REMS in order to prescribe product. You can enroll online at MyJanssenCarePath.com or by calling 877-CarePath (877-227-3728). 0000004614 00000 n 0000006797 00000 n The information requested above is for benefits investigation purposes only. Download Enrollment Forms. These are the steps to take in partnership with your healthcare provider: Step 1: Read the SPRAVATO Medication Guide and Instructions for Use. 0000161499 00000 n • Patient will need transportation; they should not drive for 24 hours after treatment. 0000005459 00000 n ������П�����o��E �K�#)�F��9����L�c�VsP��f^��F�(��6RG�n`|�FoW�ȝ����1ýݔ*�}�K����:2Tzn�v}0�V&U���I&�� w4�.RYTzM�~�]��%~��AϪI�v ��N��հ͎v��,ML�j��4d5T-N�О�� S0����������a��"�tV��:eο�����L�L�H[�#{7D��Q��u%ۙ���-S L��mM����!��a���J�����Ֆ ���[�>�9� m+AD��M�T���ר�4��8Tq��(8��,�e�)�#�����g��oY�ÝV��w�:WP����M{�?kp�s0Ж�5U� . 0000103147 00000 n 0000100762 00000 n 0000015547 00000 n medication through the patient’s pharmacy benefit. �I�\?� >_/�C�+�$���eeK��Vq��n�����7���;T�`*=G�ٗ՟�=�";�����h�U+��OGB(���cf��/�B��Ń� �g���Np|5�p��$ދ9~�HG�s�wZ��8�n�f\��'~AH����7I?��YO�lׂ�f��D�:�N�!�Oe1��-{ӣTI��Ϻ��< �}��\?���1��#���v\yg�ĵǜ(�5f���ygi˕��J�\�u�x�R�'���3�����,��Q� ��6�K>业�16)�!ޮ�Z����4I�u�O�z� �aa8�C���+ȅh�#3�g�H���BP�M�i���z 0000196598 00000 n 25 0 obj <> endobj h�b``b``�f`c`,X� Ȁ ��@Q� �����CV��6��ǿ�n���N��.KU�"i ����(�P>�D f`9� �̀�,"� ���I�I���!�!�!��%�/�'�_����1i1�02�1�253e2f0�a�az����`���ߌM��}�0�e�b8�P�PƠ���k��Q�ٌ�{�/K'3�L���c��1�q=�B$�H0�\9��� ��;� endstream endobj 26 0 obj <>>> endobj 27 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 28 0 obj <> endobj 29 0 obj <> endobj 30 0 obj [/ICCBased 53 0 R] endobj 31 0 obj <> endobj 32 0 obj <> endobj 33 0 obj <> endobj 34 0 obj <> endobj 35 0 obj <>stream 0000004083 00000 n 0000003714 00000 n 0000001859 00000 n During SPRAVATO® treatment, submit the patient monitoring form and report all suspected adverse events to the SPRAVATO® REMS *To get started, find more information on how to certify as a healthcare setting and/or pharmacy, and to view all REMS requirements and attestations by type of REMS stakeholder visit www.SPRAVATOrems.com or call 1-855-382-6022 (8 AM to 8 PM ET). SPRAVATO™. Submit completed patient monitoring forms within … 2021 Patient Enrollment Form *Required 1 of 4 PATIENT INFORMATION (*Required) *Do you have a SPRAVATO® Savings Program card? <]/Prev 316502>> ���yB�3���e�%8X2ȕ*'��u��ώ_~��f� )ͯ�i�~}�4�L������\�#3� �'�#-���D��W8���HI�Ia��Pt�w֓��t���0�Nk?�������I�� iqj7H�C�d�rJO�g\�З�A�ZQ��x���w�%r�%8���saՑ"�Бr\���%(����������k�葿�"����/���/��_�2t�l���f�A1�E�v떪�Y�M��P{N�2�,A�/��ŗ����2_�~,��f$����Wj3�o�3(W|�]-fƑ`����uLM4�8K2���=�v����Nw�ކ7�%�]��o,~¹�v8��s��x�p)h�-�~*��¹9�kc�p�C�c��ٵS�mo��h��Z���m�+훅|�6��~�*��m���M�xc��*��� �9�� }�, endstream endobj 14 0 obj <> endobj 15 0 obj <>stream There are no changes … 0000001436 00000 n The information requested above is for benefits investigation purposes only. 0000241677 00000 n 4377 Bronx Blvd. 0000074141 00000 n 0000009672 00000 n REMS=Risk Evaluation and Mitigation Strategy. h�b``�c``[����| *`b�J& H�vP�� � �����������!�I���!�e>���,̌Y,�X�s90D0D2�1�0V�0�fZT����2��#c/�Ǚ�����|�W�{�_5�2��UaxØdr��=�r��:�����2�0�e�b8�P�Pjtũ��4#o0 �=(< SPRAVATO™ REMS Patient Enrollment Form. The FDA has now approved the first drug that can relieve depression in hours instead of weeks. 0000139480 00000 n 0000011333 00000 n 0000000016 00000 n Spravato Enrollment Form TREATMENT INFORMATION FOR PRESCRIBERS Spravato prescribing highlights • Spravato must be administered in health care settings certified in the Spravato REMS Program under the direct supervision of a health care provider to patients enrolled in the program. By completing this form, I agree, on behalf of the pharmacy, to comply with all REMS requirements: I will: • Review the SPRAVATO® Prescribing Information and REMS Program Overview. /�E��"EHZ��k��~@H/�ÉLX���7�R#AN��k����m�F��Ǿ�����F�/��f�]�f�i�f�=M�ͩ�. <<5B5297802E5CB240A94B24931AFDEE1C>]/Prev 258621>> Please enter street address, city, state, or ZIP Code you would like to search for. If you are submitting a pharmacy receipt and want to receive a rebate check, only complete the Pharmacy Benefit Rebate Form on the next page. For healthcare settings, there will be forms that need to be completed depending on your setting’s designation as inpatient or outpatient. Prescribers and patients: Please complete this form online at www.SPRAVATOrems.com or, once completed, fax it to the REMS at 1-877-778-0091 * Indicates Required Field. 0000161061 00000 n Outpatient Pharmacy Enrollment Form Phone: 844-267-8678 Fax: 844-404-8876 www.clozapinerems.com P RESCRIBER INFORMATION (All Fields Required Unless Otherwise Indicated) 02/2019 Page 1 of 2 For immediate certification, please go to www.clozapinerems.com. 0000168139 00000 n Complete all required fields on this form afterevery treatment session for all outpatients enrolled in the SPRAVATO® REMS. 0000005964 00000 n 0000160204 00000 n 3. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO ® . 0000001754 00000 n Pharmacies seeking certification to receive and fufill Spravato prescriptions may fill out the Spravato REMS Pharmacy Enrollment Form, and send via fax at 1-877-778-0091. The timetable for submission of assessments of the REMS remains the same as that approved on March , 2019. trailer 0000015463 00000 n %PDF-1.5 %���� endstream endobj 11 0 obj <> endobj 12 0 obj <> endobj 13 0 obj <>stream If the form is missing information, the PA will not be processed. 0000012102 00000 n �Vt�R���r ,t����X)��B?S��-ς:(0��@���0�ᴇ4X�7���R�T���bRj!&bҠ�z�L` �Ĥ�@Z�{>`q��_s�K��-��ÀKt\R�� �`��pAK��1���C'�ءw ﻱx contains three sections: • “Authorized Representative Signature” section – page 2 • “Authorized Representative Information” section – page 3 • “Healthcare Setting Information” section – page 4 For the initial enrollment, all three sections noted above must be submitted. Once our providers are made aware that it is available, along with our pharmacy having the ability to order the prescription we will let you know. 9. 0000008542 00000 n Pharmacy Enrollment Form to the REMS . If you have any questions about the SPRAVATO ® REMS or need help with certification or enrollment, call 1-855-382-6022 Monday - Friday 8AM - 8PM ET For SPRAVATO ® REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091 0000197497 00000 n 0000012898 00000 n 0000015238 00000 n 0000003010 00000 n 0000241640 00000 n 0000010960 00000 n A confirmation will be … 0000195729 00000 n 0000061647 00000 n 0000181272 00000 n • Patient must be enrolled in the SPRAVATO® REMS; they can download the REMS Patient Enrollment Form from SpravatoREMS.com. Spravato Pharmacy Prior Authorization Request Form Do not copy for future use.
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