POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

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 options
• 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
  

Montelukast Oral Granules (Singulair) (HIM.PA.129 )

Ambetter