Pennsaid - Enhanced & Essential

Restricted Product(s):

Restriction applies to brand and generic products

• Pennsaid (diclofenac sodium topical solution 2%)
• Diclofenac sodium topical solution 1.5%

FDA Approved Use:

• For the treatment of osteoarthritis pain of the knee(s).

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age and older; AND
2. The patient has a diagnosis of osteoarthritis of the knee; AND
3. ONE of the following:
   1. The patient had a therapeutic failure with a one-week trial of an oral NSAID for this condition; OR
   2. The patient has had intolerable side effects or contraindications to oral NSAIDs; OR
   3. The patient is at high risk of gastric bleeding with oral NSAIDs; OR
   4. The patient cannot swallow solid oral dosage forms and is not currently taking any solid oral dosage form; AND
4. The patient is not using with an oral NSAID (includes COX-2 inhibitors) prescribed for the same condition; AND
5. The patient has tried and failed or has a contraindication/intolerance to diclofenac 1% topical gel (prescription or OTC); AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

May 2022: Criteria update: Duration of approval changed to 1 year.

January 2021: Criteria change: Require t/f diclofenac 1% topical gel (prescription or OTC).

October 2019: Criteria update: Reformatted criteria. Changed duration of approval to 3 years.

October 2018: Annual review; No change.

January 2017: Nonformulary verbiage added.

October 2016: Annual review; No change.

October 2015: Annual review; No change.

August 2014: Historical revision.