NAPROSYN, Naproxen Form

Naproxen oral suspension (Naprosyn®) is a non-steroidal anti-inflammatory drug (NSAID). FDA Approved Indication(s) Naprosyn suspension is indicated: • For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of polyarticular juvenile idiopathic arthritis • For the relief of the signs and symptoms of tendonitis • For the relief of the signs and symptoms of bursitis
• For the relief of the signs and symptoms of acute gout
• For the management of pain • For the management of primary dysmenorrhea Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Naprosyn oral suspension is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Request for Naprosyn Oral Suspension (must meet all):

1. Age ≥ 2 years;
   
   2. Documentation supports inability to use generic naproxen oral tablets;
   3. If request is for brand Naprosyn oral suspension, member must use generic naproxen oral suspension, unless contraindicated or clinically significant adverse effects are experienced;

2. Dose does not exceed any of the following (a or b): a. Adults: 1,500 mg per day (60 mL per day); b. Pediatrics: 15 mg/kg per day. Approval duration: 12 months Page 1 of 6

   CLINICAL POLICY
   Naproxen Oral Suspension B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. All Indications in Section I (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
6. If request is for brand Naprosyn oral suspension, member must use generic naproxen oral suspension, unless contraindicated or clinically significant adverse effects are experienced;
7. If request is for a dose increase, new dose does not exceed any of the following (a or b): a. Adults: 1,500 mg per day (60 mL per day); b. Pediatrics: 15 mg/kg per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or Page 2 of 6

   CLINICAL POLICY
   Naproxen Oral Suspension

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CABG: coronary artery bypass graft FDA: Food and Drug Administration NSAID: non-steroidal anti-inflammatory drug Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose 1,500 mg/day naproxen (Naprosyn) oral tablets Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis 250-500 mg PO BID Bursitis, Pain, Primary Dysmenorrhea, Acute Tendonitis 500 mg PO followed by 250 mg Q6-8 hrs Acute Gout 750 mg PO followed by 250 mg PO Q8 hrs until attack has subsided Juvenile Idiopathic Arthritis 10 mg/kg/day PO in two divided doses Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to naproxen or any components of the drug product; history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs; in the setting of coronary artery bypass graft (CABG) surgery • Boxed warning(s): cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation Page 3 of 6

   CLINICAL POLICY
   Naproxen Oral Suspension V. Dosage and Administration
   Indication Ankylosing spondylitis, osteoarthritis, rheumatoid arthritis Bursitis, pain, primary dysmenorrhea, acute tendonitis Acute gout Polyarticular juvenile idiopathic arthritis VI. Product Availability
   Oral suspension: 125 mg/5 mL Dosing Regimen 250-500 mg PO BID Maximum Dose 1,500 mg/day 500 mg PO followed by 250 mg Q6-8 hrs as required 1,250 mg/day 750 mg PO followed by 250 mg PO Q8 hrs until attack has subsided 10 mg/kg/day PO in two divided doses 1,250 mg/day 15 mg/kg/day VII.