Diclofenac (Pennsaid) topical solution for osteoarthritis knee pain
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Clinical coverage policy governing medical necessity and prior authorization criteria for Pennsaid (diclofenac 2% topical solution) for treatment of osteoarthritis knee pain for members under the payer's Medicaid line of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy - Osteoarthritis Pain (knees)
Covered when ALL of the following are met:
Approval duration: 12 months
Continuation Therapy - Osteoarthritis Pain (knees)
Continued therapy covered when ALL of the following are met:
Approval duration: 12 months
Requests for use of diclofenac (Pennsaid) for non–FDA approved indications that are not specifically addressed in this policy are excluded unless the provider submits sufficient documentation of efficacy and safety in accordance with the payer's off‑label use policy (CP.PMN.53) or the member's evidence of coverage supports the use.
Coverage and administration of benefits for diclofenac (Pennsaid) are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures.
This clinical policy is provided as a guide to medical necessity and does not constitute medical advice, medical treatment, or a guarantee of payment. Providers are expected to exercise professional medical judgment and remain solely responsible for the medical care, diagnosis, and treatment decisions for their patients.
Coding and Quantity Limits
Provider Actions & Requirements
Prior Authorization Requirement
Prior authorization will be approved only when documentation shows all approval criteria are met, including diagnosis of osteoarthritis, member age, prior therapies tried and failed, and that dosing does not exceed the specified per‑knee limit.
- Must document diagnosis of OA and age ≥ 18.
- Document failure of required prior therapies where applicable.
- Confirm dose ≤ 80 mg (4 pumps) per knee per day.
Prior Authorization Guidance
This clinical policy provides medical necessity guidance to assist coverage decisions; the Health Plan may require prior authorization per its administrative policies and retains final authority on coverage.
- Policy is a guide to medical necessity but does not guarantee payment.
- Health Plan may impose prior authorization per its procedures.
Step Therapy / Preferred Alternatives
Members must trial preferred alternatives before Pennsaid: a trial of one oral generic NSAID and trial of generic diclofenac 1% topical gel are required unless contraindicated or adverse effects prevent use.
- Failure of ONE oral generic NSAID (unless clinically significant adverse effects or all are contraindicated) is required.
- Failure of generic diclofenac 1% topical gel (unless contraindicated or adverse effects) is required.
- Preferred alternatives are listed in Appendix B and must be tried prior to approval of the brand product.
Provider Action — Emphasize Clinical Justification
Providers should ensure prior‑authorization requests clearly highlight clinical justification and any exceptions (e.g., contraindications or documented adverse effects) to step‑therapy requirements to expedite review.
- State continuity-of-care provisions may apply when relevant (see continuation criteria).
- Note approval duration and dosing limits when requesting renewals or dose changes.
Required Clinical Documentation
Submit supporting clinical documentation with the prior‑authorization request, such as office chart notes, lab results, or other clinical information demonstrating the member meets all approval criteria.
- Include documentation of prior NSAID trials and any adverse reactions or contraindications.
- Include documentation of current response to therapy for continuation requests.
Provider Expectations
Providers are expected to exercise professional medical judgment; this policy is a guide to medical necessity and does not substitute for clinical decision‑making or guarantee payment.
- Providers remain responsible for the medical care and treatment decisions of members.
- Submitting a request does not ensure coverage — claims remain subject to contract terms and plan policies.
Non‑FDA Indications — Denial Risk
Requests for non–FDA approved indications will be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policy.
- Submit evidence of efficacy and safety in accordance with off‑label use policy CP.PMN.53 or applicable evidence of coverage documents.
Coverage Determinations Subject to Member Coverage Documents
Coverage decisions and benefit administration are subject to the member's coverage documents, plan terms, and applicable administrative policies; the plan may change or withdraw this policy.
- Verify member-specific coverage, exclusions, and limitations in the evidence of coverage or contract prior to submitting claims.
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | |
| Must trial preferred alternatives listed in Appendix B (therapeutic alternatives) prior to approval of the brand product; specifically, failure of one oral generic NSAID and failure of generic diclofenac 1% topical gel are required unless contraindicated or clinically significant adverse effects are experienced; member must use generic diclofenac 2% topical solution unless contraindicated. |
Definitions
Background
Diclofenac (Pennsaid) is a topical nonsteroidal anti‑inflammatory drug (NSAID) supplied as a 2% solution for topical application and is FDA‑approved for the treatment of pain of osteoarthritis of the knee(s). Prescribing information specifies administration as pumps per knee with a maximum of 80 mg (4 pumps) per knee per day.
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