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Florida Healthy Kids Provider Bulletin June 2021 Medical drug benefit Clinical Criteria updates

Note: State mandated criteria will take precedence over the updates/changes to the criteria posted.

The Pharmacy and Therapeutics (P&T) Committee approved the following Clinical Criteria applicable to the medical drug benefit for Florida Healthy Kids members with Simply Healthcare Plans, Inc. These policies were developed, revised, or reviewed to support clinical coding edits.

Visit Clinical Criteria to search for specific policies. If you have questions or would like additional information, use this email.

Please see the explanation/definition for each category of Clinical Criteria below:  New: newly published criteria  Revised: addition or removal of medical necessity requirements, new document number  Updates marked with an asterisk (*) notate that the criteria may be perceived as more restrictive

Please share this notice with other members of your practice and office staff.

Note: The Clinical Criteria listed below applies only to the medical drug benefits contained within the member’s medical policy. This does not apply to pharmacy services.

Effective date Document number Clinical Criteria title New or revised July 17, 2021 ING-CC-0001 Erythropoiesis Stimulating Agents Revised July 17, 2021 ING-CC-0002 Colony Stimulating Factor Agents Revised July 17, 2021 ING-CC-0003 Immunoglobulins Revised July 17, 2021 H.P. Acthar Gel (repository corticotropin ING-CC-0004 Revised injection) July 17, 2021 Hyaluronan Injections- Step Therapy and ING-CC-0005 Revised Quantity Limit July 17, 2021 ING-CC-0007 Synagis (palivizumab) Revised July 17, 2021 Proprotein Convertase Subtilisin Kexin ING-CC-0010 Revised Type 9 (PCSK9) Inhibitors July 17, 2021 ING-CC-0013 Mepsevii (vestronidase alfa) Revised July 17, 2021 Beta Interferons and Glatiramer Acetate ING-CC-0014 Revised for Treatment of Multiple Sclerosis July 17, 2021 ING-CC-0015 Infertility Agents and HCG Agents Revised July 17, 2021 Vivitrol Injections for the Treatment of ING-CC-0016 Revised Alcohol and Opioid Dependence July 17, 2021 ING-CC-0018 Lumizyme (alglucosidase alfa) Revised July 17, 2021 ING-CC-0019 Zoledronic Acid Agents Revised July 17, 2021 ING-CC-0021 Fabrazyme (agalsidase beta) Revised July 17, 2021 ING-CC-0023 Naglazyme (galsulfase) Revised July 17, 2021 ING-CC-0024 Elaprase (idursufase) Revised https://provider.simplyhealthcareplans.com Simply Healthcare Plans, Inc. is a Managed Care Plan with a Florida Healthy Kids contract. SFL-NL-0318-21 June 2021 Simply Healthcare Plans, Inc. Medical drug benefit Clinical Criteria updates Page 2 of 3

Effective date Document number Clinical Criteria title New or revised July 17, 2021 ING-CC-0025 Aldurazyme (laronidase) Revised July 17, 2021 ING-CC-0027 Agents Revised July 17, 2021 ING-CC-0028 Benlysta (belimumab) Revised July 17, 2021 ING-CC-0029 Dupixent (dupilumab) Revised July 17, 2021 ING-CC-0032 Botulinum Toxin Revised July 17, 2021 ING-CC-0033 Xolair (omalizumab) Revised July 17, 2021 ING-CC-0034 Hereditary Angioedema Agents Revised July 17, 2021 ING-CC-0038 Human Agents Revised July 17, 2021 ING-CC-0039 GamaSTAN [immune globulin (human)] Revised July 17, 2021 ING-CC-0041 Complement Inhibitors Revised July 17, 2021 ING-CC-0042 Monoclonal Antibodies to Interleukin-17 Revised July 17, 2021 ING-CC-0043 Monoclonal Antibodies to Interleukin-5 Revised July 17, 2021 ING-CC-0044 Exondys 51 (eteplirsen) Revised July 17, 2021 ING-CC-0045 Increlex () Revised July 17, 2021 ING-CC-0047 Trogarzo (ibalizumab-uiyk) Revised July 17, 2021 ING-CC-0048 Spinraza (nusinersen) Revised July 17, 2021 ING-CC-0050 Monoclonal Antibodies to Interleukin-23 Revised July 17, 2021 Enzyme Replacement Therapy for Gaucher ING-CC-0051 Revised Disease July 17, 2021 Injectable Hydroxyprogesterone for ING-CC-0053 Revised Prevention of Preterm Birth July 17, 2021 ING-CC-0055 Fuzeon (enfuvirtide) Revised July 17, 2021 Selected Injectable 5HT3 Antiemetic ING-CC-0056 Revised Agents July 17, 2021 Octreotide Agents [can’t adopt for ING-CC-0058 Revised Sandostatin, but can adopt for Bynfezia] July 17, 2021 GnRH Analogs for the treatment of non- ING-CC-0061 Revised oncologic indications July 17, 2021 ING-CC-0062 Tumor Necrosis Factor Antagonists Revised July 17, 2021 ING-CC-0063 Stelara (ustekinumab) Revised July 17, 2021 ING-CC-0064 Interleukin-1 Inhibitors Revised July 17, 2021 Agents for Hemophilia A and von ING-CC-0065 Revised Willebrand Disease July 17, 2021 ING-CC-0066 Monoclonal Antibodies to Interleukin-6 Revised July 17, 2021 Prostacyclin Infusion and Inhalation ING-CC-0067 Revised Therapy July 17, 2021 ING-CC-0068 Revised July 17, 2021 ING-CC-0071 Entyvio (vedolizumab) Revised July 17, 2021 Selective Vascular Endothelial Growth ING-CC-0072 Revised Factor (VEGF) Antagonists July 17, 2021 ING-CC-0073 Alpha-1 Proteinase Inhibitor Therapy Revised July 17, 2021 Rituximab agents for Non-Oncologic ING-CC-0075 Revised Indications July 17, 2021 ING-CC-0077 Palynziq (pegvaliase-pqpz) Revised July 17, 2021 ING-CC-0078 Orencia (abatacept) Revised Simply Healthcare Plans, Inc. Medical drug benefit Clinical Criteria updates Page 3 of 3

Effective date Document number Clinical Criteria title New or revised July 17, 2021 ING-CC-0083 Aristata Initio (aripiprazole lauroxil) Revised July 17, 2021 ING-CC-0086 Spravato (esketamine) Nasal Spray Revised July 17, 2021 ING-CC-0087 Gamifant Revised July 17, 2021 ING-CC-0089 Mozobil (plerixafor) Revised July 17, 2021 ING-CC-0096 Asparagine Specific Enzymes Revised July 17, 2021 ING-CC-0115 Kadcyla (ado-trastuzumab) Revised July 17, 2021 ING-CC-0123 Cyramza () Revised July 17, 2021 ING-CC-0140 Zulresso (brexanolone) Revised July 17, 2021 Off Label Drug and Approved Orphan Drug ING-CC-0141 Revised Use July 17, 2021 ING-CC-0148 Agents for Hemophilia B Revised July 17, 2021 Select Clotting Agents for Bleeding ING-CC-0149 Revised Disorders July 17, 2021 ING-CC-0150 Kymriah (tisagenlecleucel) Revised July 17, 2021 ING-CC-0151 Yescarta (axicabtagene ciloleucel) Revised July 17, 2021 ING-CC-0152 Vyondys 53 (golodirsen) Revised July 17, 2021 ING-CC-0153 Adakveo (crizanlizumab) Revised July 17, 2021 ING-CC-0156 Reblozyl (luspatercept) Revised July 17, 2021 ING-CC-0160 Vyepti (eptinezumab) Revised July 17, 2021 ING-CC-0167 Rituximab agents for Oncologic Indications Revised July 17, 2021 ING-CC-0168 Tecartus (brexucabtagene autoleucel) Revised July 17, 2021 ING-CC-0170 Uplizna (inebilizumab-cdon) Revised July 17, 2021 ING-CC-0173 Enspryng (satralizumab-mwge) Revised July 17, 2021 ING-CC-0175 Proleukin (aldesleukin) Revised July 17, 2021 ING-CC-0183 Sogroya (somapacitan-beco) Revised July 17, 2021 ING-CC-0188 Imcivree (setmelanotide) Revised July 17, 2021 ING-CC-0189 Amondys 45 (casimersen) Revised