Effective September 1, 2023: Pharmacy and Biopharmacy Policies

Fecal microbiota spores, live-brpk (Vowst) (CP.PHAR.632)

Ambetter

Policy includes:

• Initial Approval Criteria:  Prevention of Clostridioides difficile Infection (must meet all):
  • Diagnosis of CDI confirmed by documentation of positive Clostridioides difficile test;
  • Age ≥ 18 years; 3. Member has recurrent CDI as evidenced by at least 2 episodes of CDI recurrence after a primary episode (i.e., total 3 episodes);
  • Member has received at least 10 consecutive days of antibiotic therapy for the current CDI (e.g., vancomycin, fidaxomicin);
  • The current CDI is controlled (< 3 unformed/loose stools/day for 2 consecutive days [i.e., diarrhea, or Bristol Stool Scale type 6-7]); 6. Vowst is prescribed with one of the following, administered prior to the first Vowst dose:
    • Magnesium citrate;
    • If member has impaired kidney function, polyethylene glycol electrolyte solution (e.g., generic GoLYTELY®);
  • Member has not previously received Vowst, Rebyota™, or prior fecal microbiota transplant;
  • Dose does not exceed 4 capsules per day for 3 consecutive days.
  • Approval duration: 3 months (1 treatment course only)

• Continued Therapy: Prevention of Clostridioides difficile Infection
  • Re-authorization is not permitted as the efficacy of repeat courses of Vowst has not been sufficiently established (see Appendix D).
  • Approval duration: Not applicable

Epcoritamab-bysp (Epkinly) (CP.PHAR.634)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy includes:

• Initial Approval CriteriaDiffuse Large B-Cell Lymphoma (DLBCL):
  • Diagnosis of DLBCL (including DLBCL not otherwise specified, DLBCL arising from indolent lymphoma, high-grade B-cell lymphoma, HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL not otherwise specified, and monomorphic post-transplant lymphoproliferative disorders);
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age ≥ 18 years; 4. Request meets one of the following:
  • Member has received ≥ 2 lines of systemic therapy;
  • Member had partial response, no response, progressive, relapsed, or refractory disease following prior systemic therapy
  • If member has histologic transformation of indolent lymphoma to DLBCL, both of the following:
    • Member does not intend to proceed to transplant;
    • Member has received systemic therapy that included an anthracycline-based regimen
  • Prescribed as a single agent;
  • Request meets one of the following:
    • Both of the following:
      • Cycle 1 step-up doses: Dose does not exceed all the following:
        • 0.16 mg on day 1;
        • 0.8 mg on day 8;
        • Two 4 mg/0.8 mL vials;
        • 48 mg per dose (one 48 mg vial;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
  • Approval duration: Medicaid/HIM – 6 months

• Continued Therapy: Diffuse Large B-Cell Lymphoma:
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Epkinly for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 48 mg per dose;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use;
  • Approval duration: Medicaid/HIM – 12 months

Nirmatrelvir-Ritonavir (Paxlovid) (CP.PMN.288)

Ambetter

Policy Includes:

• Paxlovid requests should not currently be reviewed for authorization as Paxlovid continues to be distributed for free by the U.S. government until supply is exhausted.
• Initial Approval Criteria: COVID-19 :
• Diagnosis of COVID-19;
• Age ≥ 18 years;
• Onset of COVID-19 symptom(s) (e.g., cough, fever, diarrhea, sore throat) is within 5 days;
• Member has ≥ 1 risk factor for progression to severe COVID-19:
• A second course of Paxlovid is not prescribed for the treatment of COVID-19 due to the continuation of symptoms after an initial course of Paxlovid therapy (e.g., rebound symptoms, long-COVID, post-acute sequelae of SARS-CoV-2);
• Dose does not exceed 600 mg nirmatrelvir (4 tablets) with 200 mg ritonavir (2 tablets) per day for 5 days.
  • Approval duration: 5 days

• Continued Therapy: COVID-19
  • Re-authorization for extension of an initial course of therapy is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Pazopanib (Votrient) (CP.PHAR.81)

Ambetter

Policy updates include:

• For Advanced soft tissue sarcoma (STS), added bypass of prior therapy or ineligibility for angiosarcoma and desmoid tumor (aggressive fibromatosis) subtypes,
• Added bypass of prior therapy for gastrointestinal stromal tumors (GIST) if succinate dehydrogenase (SDH)-deficient with gross residual disease
• For uterine sarcoma, added additional disease qualifiers of advanced and inoperable
• For thyroid carcinoma, revised “Hurthle cell” to “oncocytic” per updated terminology
  
  

Evolocumab (Repatha) (CP.PHAR.123)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For primary hypercholesterolemia, modified baseline and recent LDL requirements for non-genetically mediated disease to be the same as genetically mediated disease,
• For heterozygous familial hypercholesterolemia (HeFH), added pathway for baseline LDL of at least 160 mg/dL for age < 20 years.

Alirocumab (Praluent) (CP.PHAR.124)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For primary hypercholesterolemia, modified baseline and recent LDL requirements for non-genetically mediated disease to be the same as genetically mediated disease,
• For heterozygous familial hypercholesterolemia (HeFH), added pathway for baseline LDL of at least 160 mg/dL for age < 20 years.

Aztreonam (Cayston) (CP.PHAR.209)

Ambetter

Policy updates include:

• Updated prescriber restriction to include “expert in treatment of cystic fibrosis” to align with other policy for inhaled antibiotic (e.g. tobramycin) targeting Pseudomonas aeruginosa in cystic fibrosis
  
  

Tobramycin (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler) (CP.PHAR.211)

Ambetter

Policy updates include:

• Removed brand Kitabis Pak and brand Tobi from Ambetter disclaimer statement per HIM formulary status
  

Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• Criteria added for off-label use in autoimmune hemolytic anemia,
• Changed continued therapy approval duration from 12 months to 6 months for all indications excluding  dermatomyositis, nephrotic syndrome, and autoimmune hemolytic anemia

Nintedanib (Ofev) (CP.PHAR.285)

Ambetter

Policy updates include:

• For Idiopathic Pulmonary Fibrosis, added transbronchial lung cryobiopsy as an option to confirm diagnosis

Pirfenidone (Esbriet) (CP.PHAR.286)

Ambetter

Policy updates include:

• Added transbronchial lung cryobiopsy as an option to confirm diagnosis

Buprenorphine Injection (Sublocade, Brixadi) (CP.PHAR.289)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• For initial criteria, changed buprenorphine or buprenorphine-naloxone to buprenorphine-containing products and changed sublingual tablets or film to transmucosal buprenorphine
• Clarified oral buprenorphine as transmucosal buprenorphine
  
• Brixadi is now FDA approved – combined from previously approved pre-emptive policy CP.PHAR.498
• Clarified that at least one dose of oral buprenorphine means member should have tolerated a single 4 mg dose of or is currently being treated with a transmucosal-containing product.

Risperidone LA inj (Risperdal Consta, Perseris, Rykindo, Uzedy) (CP.PHAR.293)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• Separated bipolar disorder criteria
• Added newly approved dosage form Uzedy to policy.

Blinatumomab (Blincyto) (CP.PHAR.312)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• Added pathways for use in Ph+ B- Acute Lymphoblastic Leukemia in combination with tyrosine kinase inhibitor and for use in infant Acute Lymphoblastic Leukemia

Lutetium Lu 177 dotatate (Lutathera) (CP.PHAR.384)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

• For neuroendocrine tumor, added coverage for well-differentiated grade 3 neuroendocrine tumor and carcinoid syndrome,
• For neuroendocrine tumors other than the aforementioned two, revised required qualifiers to include recurrent or unresectable
• For pheochromocytoma/paraganglioma, revised from “metastatic or locally advanced, and unresectable” to “metastatic or locally unresectable”
• Revised dosing in criteria, approval duration (from 32 weeks to 36 weeks), and Section V, which allows for every 8 week dosing “± 1 week”
• Updated Appendix D regarding concurrent somatostatin analogs use

Pegunigalsidase alfa-iwxj (Elfabrio) (CP.PHAR.512)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• Removed requirement for initial coverage for documentation of three specific Fabry symptoms,
• Added Galafold to Fabrazyme as an excluded medication for concomitant coverage,
• Removed maximum dosing limit of 2 mg/kg every 4 weeks since the product was not ultimately approved for that dosing regimen

Dostarlimab-gxly (Jemperli) (CP.PHAR.540)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• For Endometrial Carcinoma added pathway for first-line use when prescribed in combination with carboplatin and paclitaxel for stage III-IV or recurrent disease
• For solid tumors, added gallbladder cancer and pancreatic cancer, specified types of hepatobiliary cancers,
• Added bypass of prior therapies for small bowel adenocarcinoma or pancreatic adenocarcinoma

Inclisiran (Leqvio) (CP.PHAR.568)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• For heterozygous familial hypercholesterolemia, added pathway for baseline LDL of at least 160 mg/dL for age < 20 years.

Aprepitant (Aponvie, Emend, Cinvanti), Fosaprepitant (Emend for injection) (CP.PMN.19)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• Added HCPCS code J3490 for unclassified drugs
• For prevention of nausea and vomiting associated with cancer chemotherapy added allowance for bypassing redirection if state regulations do not allow step therapy in certain oncology settings

Granisetron (Sancuso, Sustol) (CP.PMN.74)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP, Ambetter

Policy updates include:

• For prevention of nausea and vomiting associated with cancer chemotherapy added allowance for bypassing redirection if state regulations do not allow step therapy in certain oncology settings
  

Dolasetron (Anzemet) (CP.PMN.141)

Ambetter

Policy updates include:

• Removed 1 tablet quantity limit

Bempedoic acid (Nexletol), bempedoic acid-ezetimibe (Nexlizet) (CP.PMN.237)

Ambetter

Policy updates include:

• For heterozygous familial hypercholesterolemia, added pathway for baseline LDL of at least 160 mg/dL for age < 20 years

Levomilnacipran (Fetzima) (HIM.PA.125)

Ambetter

Policy updates include:

• Added vilazodone (generic Viibryd) to list of redirect opions
• Updated contraindications per prescribing information verbiage
  

Evolocumab (Repatha) (HIM.PA.156)

Ambetter

Policy updates include:

• For primary hypercholesterolemia, modified baseline and recent LDL requirements for non-genetically mediated disease to be the same as genetically mediated disease,
• For heterozygous familial hypercholesterolemia, added pathway for baseline LDL of at least 160 mg/dL for age < 20 years.

Sofosbuvir/Velpatasvir (Epclusa) (HIM.PA.SP1)

Ambetter

Policy updates include:

• Added a bypass for HCV genotype documentation if member is treatment-naïve and does not have cirrhosis
• Added accompanying rationale in Appendix E
• Eliminated adherence program participation criterion
• Corrected genotype 3 lab test scenario from “and” to “or”
  

Glecaprevir/Pibrentasvir (Mavyret) (HIM.PA.SP36)

Ambetter

Policy updates include:

• Added a bypass for HCV genotype documentation if member is treatment-naïve and has either compensated cirrhosis or no cirrhosis
• Added previous Mavyret experience to initial approval criteria scenarios
• Eliminated adherence program participation criterion
• Added asterisk to Epclusa redirection to clarify that coadministration with omeprazole up to 20 mg is not considered an acceptable medical justification for inability to use Epclusa within criteria
• Corrected continued therapy other diagnoses section template verbiage to remove redirections
  

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) (HIM.PA.SP63)

Ambetter

Policy updates include:

• Eliminated adherence program participation criterion

Ivacaftor (Kalydeco) (CP.PHAR.210)

Ambetter

Policy update includes:

• Revised criteria to include pediatric expansion and new 5.8 mg and 13.4 mg granule strengths

Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) (CP.PHAR.440)

Ambetter

Policy update includes:

• Revised criteria to include pediatric expansion and new granule formulation
• Revised initial approval criteria requiring chart notes for pulmonary function test: added “for age > 2 years” for percent predicted forced expiratory volume in 1 second, added alternative option for percent predicted forced expiratory volume in 1 second for age < 6 years to allow for LCI ≥7.4,
• revised continuation criteria to include stabilization in lung clearance index if baseline was ≥ 7.4
• Updated Appendix D to include information on LCI

Roflumilast (Daliresp, Zoryve) (CP.PMN.46)

Ambetter

Policy updates include:

• Added HIM line of business
• Added redirection to generic roflumilast for brand Daliresp requests
  

Colonoscopy Preparation Products (CP.PCH.43)

Ambetter

Policy updates include:

• Added newly approved combination product Suflave to policy

Immune Globulins (CP.PHAR.103)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For Section III, added exclusion of antiphospholipid syndrome does not apply to catastrophic antiphospholipid syndrome
• For adenosine deaminase deficiency-Severe combined immunodeficiency disorders, removed trial and failure of Adagen due to product discontinuation
• For multiple sclerosis/Lambert Eaton myasthenic syndrome and stiff person syndrome, clarified dose to be divided over 2 to 5 consecutive days.

Ferric Carboxymaltose (Injectafer) (CP.PHAR.234)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Updated FDA Approved Indications(s) section to include iron deficiency with heart failure per updated prescribing information
• Added to Section I, II, and IV for new indication

Olaparib (Lynparza) (CP.PHAR.360)

Ambetter

Policy updates include:

• Added new indication per updated prescribing information for use in combination with abiraterone and prednisone or prednisolone for deleterious or suspected deleterious mutations in the germline BRCA genes metastatic castration-resistant prostate cancer

Letermovir (Prevymis) (CP.PHAR.367)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added new indication for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk to policy

Talazoparib (Talzenna) (CP.PHAR.409)

Ambetter

Policy updates include:

• New indication of metastatic castration-resistant prostate cancer added in addition to new strength capsules

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin) (CP.PHAR.517)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added Ngenla to policy.

Odevixibat (Bylvay) (CP.PHAR.528)

Ambetter

Policy updates include:

• Added newly FDA-approved indication for Alagille syndrome

Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo) (CP.PHAR.555)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Vyvgart Hytrulo added to policy

Lumateperone (Caplyta) (CP.PMN.232)

Ambetter

Policy updates include:

• Added redirection bypass for members in a State with limitations on step therapy in certain mental health settings along with Appendix D, which includes Arkansas

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update (CP.PMN.255)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added bypass of preferred agent and combination products redirection if request is for treatment of a member in a State with limitations on step therapy in certain mental health settings along with Appendix F, which includes Arkansas

Olanzapine/Samidorphan (Lybalvi) (CP.PMN.265)

Ambetter

Policy updates include:

• Added redirection bypass for members in a State with limitations on step therapy in certain mental health settings along with Appendix D, which includes Arkansas

Sodium Oxybate (Xyrem, Lumryz) and Calcium, Magnesium, Potassium, and Sodium Oxybate (Xywav) (CP.PMN.42)

Ambetter

Policy updates include:

• Added new extended-release oral suspension formulation Lumryz to policy
• For narcolepsy with cataplexy and narcolepsy associated with excessive daytime sleepiness, updated age requirement in initial criteria to reflect minimum age Lumryz use
• Removed “antidepressant” classification for redirected agents for narcolepsy with cataplexy initial criteria since atomoxetine is not considered an antidepressant
• For narcolepsy with cataplexy and narcolepsy with excessive daytime sleepiness, added requirement for redirection to Sunosi, Wakix, and Xyrem for Lumryz requests in a step-wise fashion

Quetiapine Extended-Release (Seroquel XR) (CP.PMN.64)

Ambetter

Policy updates include:

• Added redirection bypass for members in a State with limitations on step therapy in certain mental health settings along with Appendix D, which includes Arkansas

Brexpiprazole (Rexulti) (CP.PMN.68)

Ambetter

Policy updates include:

• Added redirection bypass for members in a State with limitations on step therapy in certain mental health settings along with Appendix D, which includes Arkansas

Cariprazine (Vraylar) (CP.PMN.91)

Ambetter

Policy updates include:

• Added redirection bypass for members in a State with limitations on step therapy in certain mental health settings along with Appendix D, which includes Arkansas

Brand Name Override and Non-Formulary Medications (HIM.PA.103)

Ambetter

Policy updates include:

• Added bypass of formulary agent and combination products redirection if request is for treatment of a member in a State with limitations on step therapy in certain mental health settings along with Appendix E, which includes Arkansas

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin) (HIM.PA.161)

Ambetter

Policy updates include:

• Added Ngenla to policy

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update (HIM.PA.33)

Ambetter

Policy updates include:

• Added bypass of preferred drugs and combination products redirection if request is for treatment of a member in a State with limitations on step therapy in certain mental health settings along with Appendix F, which includes Arkansas

Biologic and Non-biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• For Rinvoq, criteria added for new FDA indication: Crohn’s disease
• Updated Appendix C to align boxed warnings among JAK inhibitors and to align with individual prescriber information
• For Cosentyx, added new dosage forms (UnoReady Pen and 300 mg/2 mL dose of pre-filled syringe) to policy

Glofitamab-gxbm (Columvi) (CP.PHAR.636)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy Includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Diffuse Large B-Cell Lymphoma or Large B-Cell Lymphoma
  • Diagnosis of one of the following:
    • Diffuse Large B-Cell Lymphoma
    • Large B-Cell Lymphoma arising from follicular lymphoma
  • Prescribed by or in consultation with an oncologist
  • Age ≥ 18 years
  • Disease is refractory to or has relapsed after ≥ 2 line of systemic therapy
  • Member is prescribed obinutuzumab (Gazyva®) as pretreatment, unless contraindicated or clinically significant adverse effects are experienced
  • Request meets one of the following:
    • Cycle 1: Dose does not exceed 25 mg on Day 8 and 10 mg on Day 15
    • Cycles 2 to 12: Dose does not exceed 30 mg on Day 1 of a 21-day cycle, for a maximum of 12 cycles
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: Medicaid/HIM – 6 months
• Continued Therapy:  Diffuse Large B-Cell Lymphoma or Large B-Cell Lymphoma:
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Columvi for a covered indication and has received this medication for at least 30 days
  • Member is responding positively to therapy
  • Member has received < 12 cycles of Columvi
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 30 mg on Day 1 of a 21-day cycle, for a maximum of 12 cycles
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
    • Approval duration: Medicaid/HIM – 6 months

Nalmefene (Opvee) (CP.PHAR.638)

Ambetter

Policy Includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Opioid Overdose:
  • Member may have access to opioids
  • Age ≥ 12 years
  • Medical justification supports inability to use generic naloxone nasal spray or naloxone solution for injection (eg, contraindications or clinically adverse effects to naloxone, member is prescribed a long-acting opioid)
  • Requested quantity does not exceed two boxes (4 nasal spray devices) per prescription
  • Approval duration: 12 months

• Continued Therapy: Opioid Overdose:
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  • If request is for a dose increase, the requested quantity does not exceed two boxes (4 nasal spray devices) per prescription
  • Approval duration: 12 months

Fezolinetant (Veozah) (CP.PMN.289)

Ambetter

Policy Includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Vasomotor Symptoms:
  • Diagnosis of vasomotor symptoms associated with menopause
  • Age ≥ 18 years
  • Failure of hormonal therapy products (not contraceptives), unless contraindicated or clinically significant adverse effects are experienced
  • Dose does not exceed 45 mg per day (1 tablet per day)
  • Approval duration: 12 months

• Continued Therapy: Vasomotor Symptoms:
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  • Member is responding positively to therapy as evidenced (eg, vasomotor symptom reduction)
  • If request is for a dose increase, new dose does not exceed 45 mg per day (1 tablet per day)
  • 6 Approval duration: 12 months

Perfluorohexyloctane (Miebo) (CP.PMN.290)

Ambetter

Policy Includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Dry Eye Disease
  • Diagnosis of DED associated with meibomian gland dysfunction (MGD)
  • Age ≥ 18 years
  • Failure of any non-prescription wetting agent in the form of drops, ointments, or gels, unless clinically significant adverse effects are experienced or all are contraindicated
  • Failure of at least one ophthalmic anti-inflammatory agent up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated
  • Failure of generic ophthalmic cyclosporine emulsion 005% (generic Restasis®), unless contraindicated or clinically significant adverse effects are experienced
  • Dose does not exceed both of the following:
  • 4 drops per day in each affected eye
  • 4 bottles per 30 days
  • Approval duration: 12 months

• Continued Therapy: Dry Eye Disease:
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  • Member is responding positively to therapy
  • If request is for a dose increase, new dose does not exceed 4 bottles per 30 days
  • Approval duration: 12 months

Ciltacabtagene Autoleucel (Carvykti) (CP.PHAR.533)

Ambetter

• Following FDA approval, criteria for the pre-emptive indication will be merged with the existing clinical policy of the same policy reference number above for this drug product and its existing FDA-approved indications
• Expanded indication for use in the 2rd line setting
  • Updated serum M-protein ≥ 05 g/dL
  • Added Member has one of the following:
    • Member has lenalidomide-refractory disease and received one to three prior lines of therapy:
• A Protease inhibitor
• An immunomodulatory drug

Apadamtase alfa (TAK-755) (CP.PHAR.635)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy Includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Congenital Thrombotic Thrombocytopenic Purpura:
  • Diagnosis of severe Congenital Thrombotic Thrombocytopenic Purpura confirmed by all of the following:
  • Genetic test confirming biallelic ADAMTS13 mutation
  • ADAMTS13 activity < 10 % of normal, unless member is currently receiving prophylactic plasma therapy
  • One of the following:
  • Absence of ADAMTS13 functional inhibitor
  • Absence of anti-ADAMTS13 antibodies
  • Prescribed by or in consultation with a hematologist
  • Failure of plasma therapy, unless contraindicated or clinically significant adverse effects are experienced
  • For prophylaxis requests, member has thrombotic thrombocytopenic purpura signs or symptoms that are persistent or recurrent
  • Dose does not exceed FDA-labeled maximum dosing
  • Approval duration: 6 months

• Continued Therapy: Congenital Thrombotic Thrombocytopenic Purpura:
  • Member meets one of the following:
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is currently receiving medication and is enrolled in a state and product with continuity of care
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Thrombocytopenia
    • Microangiopathic hemolytic anemia
    • Symptom improvement (eg, less headaches, lethargy, and/or abdominal pain)
  • If request is for a dose increase, new dose does not exceed FDA-labeled maximum dosing
  • Approval duration: 12 months

Mesenchymal stem cell-NTF (NurOwn) (CP.PHAR.637)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy Includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria:  Amyotrophic Lateral Sclerosis:
  • Diagnosis of Amyotrophic Lateral Sclerosis
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 18 years
  • Disease duration of ≤ 2 years
  • Percent predicted slow vital capacity (SVC) ≥ 65%
  • Baseline revised ALS Functional Rating Scale (ALSFRS-R) score ≥ 35 points
  • NurOwn is prescribed concurrently with riluzole (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced
  • Member does not have presence of tracheostomy or assisted ventilation (including invasive and non-invasive)
  • Dose does not exceed maximum FDA-labeled dose
  • 10 Approval duration: 6 months (total of 3 intrathecal injections)
• Continued Therapy: Amyotrophic Lateral Sclerosis
  • Re-authorization is not permitted Treatment should not exceed a total of three intrathecal injections at weeks 0, 8, and 16
  • Approval duration: Not applicable

Troriluzole (CP.PHAR.639)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy Includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Spinocerebellar Ataxia Type 3:
  • Confirmed genotypic diagnosis of Spinocerebellar Ataxia type 3 (also known as Machado-Jacob disease)
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 18 years
  • Baseline modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) score meets all of the:
    • Total score ≥ 3
    • Gait subsection score ≥ 1
    • For each individual item of the scale, score < 4
  • Mini-Mental State Examination (MMSE) score ≥ 24
  • Member is able to ambulate ≥ 8 meters without human assistance (canes and other devices are allowed)
  • BHV-4157 is not prescribed concurrently with riluzole
  • Dose does not exceed 200 mg per day
  • Approval duration: 12 months
• Continued Therapy: Spinocerebellar Ataxia Type 3:
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  • Member is responding positively to therapy
  • If request is for a dose increase, new dose does not exceed 200 mg per day
  • 4 Approval duration: 12 months

Valoctocogene Roxaparvovec (Roctavian) (CP.PHAR.466)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy include:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Congenital Hemophilia A:
• *Only for initial treatment dose subsequent doses will not be covered.
  • Diagnosis of congenital hemophilia A
  • Prescribed by or in consultation with a hematologist
  • Age ≥ 18 years
  • Member has severe hemophilia A (defined as pre-treatment FVIII level < 1% or activity < 1 IU/dL)
  • Member meets both of the following (a and b):
    • Member has been adherent with use of a FVIII product for routine prophylaxis for at least 12 months as assessed and documented by provider
    • Occurrence of at least one serious spontaneous bleeding event while on routine prophylaxis (see Appendix D)
  • Member has been treated with FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days (EDs)
  • Member meets both of the following:
    • No previous documented history of a detectable FVIII inhibitor
    • Member has FVIII inhibitor level assay < 0.6 Bethesda units (BU) on 2 consecutive occasions at least one week apart within the last 12 months
  • Member has no pre-existing antibodies to AAV5 as measured by an FDA-approved test
  • Documentation of hepatic ultrasound and elastography or laboratory assessments for liver fibrosis within the last 3 months showing there is not significant hepatic fibrosis (stage 3 or 4) or cirrhosis
  • Attestation from hepatologist that member is eligible for Roctavian if any of the following (a, b, or c) baseline liver abnormalities, assessed within the last 3 months, are present:
    • Radiological liver abnormalities
    • Liver function tests (LFTs) (i.e., alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], alkaline phosphatase [ALP], total bilirubin) measuring ALT, AST, GGT, ALP and total bilirubin > 1.25 × upper limit of normal (ULN)
    • International normalized ratio (INR) ≥ 1.4
  • Provider attestation of member’s ability to receive corticosteroids and/or other immunosuppressive therapy that may be required for an extended period and that the risks associated with immunosuppression are acceptable for the individual member
  • Provider attestation that alcohol abstinence education has been completed with the member
  • Provider confirms that member will discontinue any use of hemophilia A prophylactic therapy within 4 weeks after administration of Roctavian
  • Provider agrees to monitor the member according to the FDA-approved label (i.e., FVIII level tests, ALT monitoring and steroid treatment as appropriate)
  • Provider agrees to submit ALL of the following medical information after Roctavian administration upon plan request (a, b, and c):
    • FVIII levels measured by the average of two consecutive chromogenic substrate assay or one stage assay measurements separated by one week
    • Documentation of all spontaneous bleeds after Roctavian administration
    • Documentation of any resumed continuous hemophilia A prophylaxis and duration of prophylaxis
  • Documentation of member’s body weight in kilograms
  • Dose does not exceed a single IV infusion of 6 x 10^13 vector genomes (vg) per kg.
  • Approval duration: 3 months (1 dose only)
• Continued Therapy: Congenital Hemophilia A
  • Continued therapy will not be authorized as Roctavian is indicated to be dosed one time only.

Approval duration: Not applicable

Delandistrogene moxeparvovec-rokl  (Elevidys) (CP.PHAR.593)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy include:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Duchenne Muscular Dystrophy:
  • Diagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing
  • Member does not have a deletion in exon 8 and/or 9 in the Duchenne Muscular Dystrophy gene
  • One of the following:
    • Prescribed by or in consultation with a neurologist
    • Member is being treated at a certified Duchenne care center or an muscular dystrophy association care center
  • Age ≥ 4 years and ≤ 5 years
  • Member has ambulatory function as evidenced by a 6-minute walk test (6MWT) distance ≥ 200 m within the last 30 days
  • Documentation of baseline laboratory tests demonstrating anti-AAVrh74 total binding antibody titers < 1:400 as determined by ELISA binding immunoassay
  • Member has been on a stable dose of an oral corticosteroid (e.g., prednisone, Emflaza®*) for ≥ 3 months, unless contraindicated or clinically significant adverse effects are experienced
  • Elevidys is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced
  • Member has not been previously treated with Elevidys
  • Elevidys is not prescribed concurrently with exon skipping therapies (e.g., Amondys 45™, Exondys 51®, Viltepso™, Vyondys 53™)
  • If member is currently on exon skipping therapy (e.g., Amondys 45, Exondys 51, Viltepso, Vyondys 53), both of the following (a and b):
    • Provider must submit evidence of clinical deterioration (e.g., significant decline in 6MWT, LVEF, or FVC over a period of 3 to 6 months) while on exon skipping therapy
    • Documentation of provider attestation of clinical deterioration and discontinuation of exon skipping therapy
  • Dose does not exceed 1.33 x 10^14 vector genomes (vg) per kg.
  • Approval duration: 3 months (one time infusion per lifetime)
    • Continued Therapy: Duchenne Muscular Dystrophy
  • Continued therapy will not be authorized as Elevidys is indicated to be dosed one time only.

Approval duration: Not applicable

Quantity Limit Override and Dose Optimization (CP.PMN.59)

Ambetter

Policy updates include:

• Added HIM line of business

SGLT2 inhibitors (HIM.PA.91)

Ambetter

Policy updates include:

• Updated heart failure criteria per Farxiga’s revised indication for heart failure regardless of ejection fraction
• Added Inpefa to policy
• Updated diabetes criteria per Synjardy’s pediatric extensions for age ≥ 10 years