Diclofenac (Cambia, Flector, Licart, Pennsaid, Solaraze, Zipsor, Zorvolex) Form

The following are nonsteroidal anti-inflammatory drugs (NSAIDs) requiring prior authorization: diclofenac epolamine topical system (Flector®, Licart™), diclofenac potassium (Cambia®, Zipsor®), diclofenac sodium (Pennsaid®, Solaraze®), and diclofenac (Zorvolex®). FDA Approved Indication(s) • Cambia is indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older. • Flector is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. • Licart is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. • Pennsaid is indicated for the treatment of the pain of osteoarthritis (OA) of the knee(s). • diclofenac 3% gel (Solaraze) is indicated for the topical treatment of actinic keratoses.
• Zipsor is indicated for relief of mild to moderate acute pain in adults and pediatric patients 12 years of age and older.
• Zorvolex is indicated for management of mild to moderate acute pain and for OA pain. Limitation(s) of use: • Cambia is not indicated for the prophylactic therapy of migraine. • Safety and effectiveness of Cambia is not established for cluster headache, which is present in an older, predominantly male population. 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 Cambia, Flector, Licart, Pennsaid, diclofenac 3% gel, Zipsor, and Zorvolex are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Mild to Moderate Acute Pain (must meet all):

1. Diagnosis of acute pain;

   2. Request is for Flector, Licart, Zipsor or Zovolex;
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2. One of the following (a, b, or c): a. Flector: Age ≥ 6 years;
   b. Zipsor: Age ≥ 12 years; c. Licart, Zorvolex: Age ≥ 18 years;
3. For Flector or Licart requests, member meets both of the following (a and b): a. Failure of both of the following (i and ii), unless clinically significant adverse effects are experienced or all are contraindicated: i. Two formulary oral generic NSAIDs (see Appendix B) at up to maximally indicated doses; ii. diclofenac 1% topical gel (generic Voltaren®) within the past 90 days; b. If request is for brand Flector or Licart, member must use generic diclofenac 1.3% topical system, unless contraindicated or clinically adverse effects are experienced;
4. For Zipsor or Zorvolex requests, member meets both of the following (a and b):
   a. Failure of both of the following (i and ii), unless clinically significant adverse effects are experienced or all are contraindicated:
   i. Oral generic diclofenac tablet; ii. One other preferred oral NSAID (see Appendix B) at up to maximally indicated doses; b. If request is for brand Zipsor, member must use generic diclofenac capsule; unless contraindicated or clinically adverse effects are experienced;
5. Dose does not exceed any of the following (a, b, c, or d):
   a. Flector: 2 topical systems per day; b. Licart: 1 topical system per day; c. Zipsor: 100 mg (4 capsules) per day; d. Zorvolex: 105 mg (3 capsules) per day. Approval duration: 12 months B. Osteoarthritis Pain (must meet all):
6. Diagnosis of OA;
   2. Request is for Pennsaid or Zorvolex;
   3. Age ≥ 18 years;
   4. For Pennsaid requests, member meets both of the following (a and b):
      a. Failure of both of the following (i and ii), unless clinically significant adverse effects are experienced or all are contraindicated: i. One oral generic NSAID (see Appendix B); ii. Either diclofenac 1.5% topical solution or diclofenac 1% topical gel; b. If request is for brand Pennsaid, member must use generic diclofenac 2% topical solution; unless contraindicated or clinically adverse effects are experienced;
   5. For Zorvolex requests, failure of both of the following (a and b), unless clinically significant adverse effects are experienced or all are contraindicated: a. Oral generic diclofenac; b. One other preferred NSAID (see Appendix B) at up to maximally indicated doses;

7. Dose does not exceed any of the following (a or b):
   a. Pennsaid: 80 mg (4 pumps) per knee per day;
   b. Zorvolex: 105 mg (3 capsules) per day. Page 2 of 9

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   Diclofenac Approval duration: 12 months C. Migraines (must meet all):

8. Diagnosis of migraine attacks;
   2. Request is for Cambia;
   3. Age ≥ 18 years;
   4. Failure of rizatriptan orally disintegrating tablets at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
9. Documentation supports inability to use oral generic diclofenac;
   6. Dose does not exceed 50 mg (1 packet) per day. Approval duration: 12 months D. Actinic Keratosis (must meet all):
   7. Diagnosis of actinic keratosis;
   8. Request is for diclofenac 3% gel (Solaraze);
   9. Age ≥ 18 years;
   10. Failure of 5-fluorouracil and imiquimod cream, unless clinically significant adverse effects are experienced or both are contraindicated;
   11. Prescribed quantity does not exceed 1 tube per 30 days. Approval duration: 90 days E. Other diagnoses/indications (must meet 1 or 2):
10. 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: CP.CPA.190 for commercial and 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: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or
11. 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: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
    II. Continued Therapy A. All Indications in Section I (must meet all):

12. 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); Page 3 of 9

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13. Member is responding positively to therapy;
    3. For diclofenac 3% gel requests, one of the following (a or b):
       a. Request is for additional treatment of a new lesion; b. Request is to complete initial treatment of the same lesion and member has not received more than 90 days of treatment;
14. If request is for a dose increase, new dose does not exceed any of the following (a-g):
    a. Cambia: 50 mg per day (1 packet per day); b. Flector: 2 topical systems per day; c. Licart: 1 topical system per day; d. Pennsaid: 80 mg (4 pumps) per knee per day; e. Diclofenac 3% gel: 1 tube per 30 days; f. Zipsor: 100 mg (4 capsules) per day;
    g. Zorvolex: 105 mg (3 capsules) per day. Approval duration: 12 months (up to 90 days for diclofenac 3% gel) B. Other diagnoses/indications (must meet 1 or 2):
15. 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: CP.CPA.190 for commercial and 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: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

16. 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: CP.CPA.09 for commercial and 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 policy – CP.CPA.09 for commercial and 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
    OA: osteoarthritis Page 4 of 9

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    Diclofenac 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. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Oral NSAIDs diclofenac (Voltaren)
    etodolac (Lodine) fenoprofen (Nalfon)
    ibuprofen (Motrin)
    indomethacin (Indocin) indomethacin SR (Indocin SR) ketoprofen (Orudis) meloxicam (Mobic)
    naproxen (Naprosyn)
    naproxen sodium (Anaprox, Anaprox DS) oxaprozin (Daypro) piroxicam (Feldene) salsalate (Disalcid) sulindac (Clinoril) tolmetin DS (Tolectin) 50 mg PO TID 400 – 500 mg PO BID 400 – 600 mg PO TID to QID 400 – 800 mg PO TID to QID 25 – 50 mg PO BID to TID 75 mg PO QD to BID 50 mg PO QID or 75 mg PO TID 7.5 mg – 15 mg PO QD 250 – 500 mg PO BID 275 – 550 mg PO BID 600 – 1,200 mg PO QD 10 – 20 mg PO QD 500 – 750 mg PO TID, titrated up to 1,000 mg TID or 1500 mg BID 150 mg – 200 mg PO BID 400 mg PO TID maintenance 200-600 mg TID 150 mg/day 1,200 mg/day 3,200 mg/day 3,200 mg/day 200 mg/day 150 mg/day 300 mg/day 15 mg/day 1,500 mg/day for up to 6 months 1,650 mg/day for up to 6 months 1,800 mg/day 20 mg/day 3,000 mg/day 400 mg/day 1,800 mg/day 32 g/day 160 drops/knee/day 5 or 10 mg PO QD 40 drops QID on each painful knee 2 – 4 g applied to affected area QID Topical NSAIDs diclofenac 1.5% (Pennsaid) solution diclofenac 1% gel (Voltaren Gel) Anti-Migraine Agents rizatriptan orally disintegrating tablet (Maxalt MLT) Actinic Keratoses Treatments 5-fluorouracil (Efudex®, Carac®) 0.5% or 5% topical cream imiquimod (Aldara®) topical cream 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. Apply topically to affected areas QD or BID Apply topically twice weekly at bedtime Twice daily for 4 weeks Twice weekly for 16 weeks 30 mg/day Page 5 of 9

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    Diclofenac Appendix C: Contraindications/Boxed Warnings • Contraindications(s) known hypersensitivity to diclofenac or any components of the drug product; history of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDS; in the setting of coronary artery bypass graft (CABG) surgery o Flector, Licart and Solaraze: use on non-intact or damaged skin o Zipsor: contains gelatin and should not be given to patients with known hypersensitivity to bovine protein • Boxed warning(s): cardiovascular thrombotic events; use in the setting of CABG; gastrointestinal bleeding, ulceration, and perforation Appendix D: General Information • Different dose strengths and formulations of oral diclofenac are not interchangeable. This difference should be taken into consideration when changing strengths or formulations. • For actinic keratosis, complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. V. Dosage and Administration Drug Name Diclofenac potassium (Cambia) Diclofenac epolamine (Flector) Diclofenac epolamine (Licart) Diclofenac sodium (Pennsaid) Diclofenac sodium (Solaraze) Indication Migraine Acute pain due to minor strains, sprains, and contusions Acute pain due to minor strains, sprains, and contusions Pain of OA of the knee(s) Actinic keratoses Diclofenac potassium (Zipsor) Diclofenac (Zorvolex) Mild to moderate acute pain Mild to moderate acute pain or OA Dosing Regimen One packet (50 mg) PO QD 1 topical system BID Maximum Dose 50 mg/day 2 topical systems /day 1 topical system QD 1 topical system /day 40 mg (2 pump actuations) topically BID per knee Apply to lesion areas BID. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. 25 mg PO QID 80 mg/knee/day (4 pumps/knee/ day) BID for 60-90 days 100 mg/day 18 or 35 mg PO TID 105 mg/day VI. Product Availability Drug Name Diclofenac potassium (Cambia) Diclofenac epolamine (Flector) Diclofenac epolamine (Licart) Availability
    Packets: 50 mg in a soluble powder Topical system: 1.3% Topical system: 1.3% Page 6 of 9

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    Diclofenac Drug Name Diclofenac sodium (Pennsaid) Diclofenac sodium (Solaraze) Diclofenac potassium (Zipsor) Diclofenac (Zorvolex) Availability
    Topical solution: 2% Topical gel: 3% in tubes of 100 g Capsule: 25 mg Capsules: 18 mg, 35 mg VII.