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Medication Policy Manual
Policy No: dru287
Topic: Pennsaid® (diclofenac 2% topical solution)
Date of Origin: November 9, 2012
Committee Approval Date: December 11, 2015
Next Review Date: December 2016
Effective Date: January 1, 2016
IMPORTANT REMINDER
This Medication Policy has been developed through consideration of medical necessity, generally
accepted standards of medical practice, and review of medical literature and government approval
status.
Benefit determinations should be based in all cases on the applicable contract language. To the
extent there are any conflicts between these guidelines and the contract language, the contract
language will control.
The purpose of medication policy is to provide a guide to coverage. Medication Policy is not
intended to dictate to providers how to practice medicine. Providers are expected to exercise their
medical judgment in providing the most appropriate care.
Description
Diclofenac solution is a topical non-steroidal anti-inflammatory drug (NSAID) used in the
treatment of osteoarthritis of the knee.
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Policy/Criteria
I.
Most contracts require prior authorization approval of diclofenac topical solution prior to
coverage. Diclofenac topical solution may be considered medically necessary when
diclofenac topical gel (Voltaren®) AND diclofenac 1.5% topical solution have been
ineffective, contraindicated, or not tolerated.
II.
Administration, Quantity Limitations, and Authorization Period
A.
OmedaRx considers diclofenac topical solution to be a self-administered
medication.
B.
When prior authorization is approved, diclofenac 2% topical solution (Pennsaid)
may be authorized in quantities of 300 ml (2 bottles) per month.
C.
Authorization may be reviewed at least annually to confirm that current medical
necessity criteria are met and that the medication is effective.
Position Statement
-
-
Diclofenac topical solution is a topical non-steroidal anti-inflammatory drug (NSAID)
used in the treatment of osteoarthritis of the knee.
Topical NSAIDs [diclofenac (Voltaren, Pennsaid, Flector®)] are likely as effective as oral
NSAIDs in relieving localized, acute pain.
There is no evidence showing that diclofenac topical solution is safer or more effective
than less costly topical medication alternatives such as diclofenac topical gel (Voltaren).
There are no studies that compare the different topical NSAID products.
Topically applied NSAIDs are generally safer and better tolerated than oral NSAIDs.
They may be an option for patients with localized pain who cannot tolerate oral therapy.
Diclofenac 2% topical solution (Pennsaid) is approved at doses of 40 mg (2 pump
actuations) rubbed into each painful knee joint two times daily.
Clinical Efficacy
There is high certainty in the body of evidence that topical NSAIDs (diclofenac-containing
products) provide similar pain relief to oral NSAIDs when used for localized pain of moderate
intensity.
-
Four high quality, well-conducted systematic reviews evaluated the evidence of efficacy
for the topical NSAIDs [diclofenac (Voltaren, Pennsaid, Flector)].[1-4]
*
One Cochrane review evaluated topical NSAIDs for acute pain in adults[3], and
another assessed topical NSAIDs for chronic pain with a focus on diclofenac
topical products. [4]
*
The authors of one review concluded that topical NSAIDs are similarly effective
to oral NSAIDs in relieving acute pain. The number needed to treat (NNT) to
achieve clinical success (i.e., 50% pain relief) is 4.5 for all topical NSAIDs.[3]
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*
In the review evaluating chronic pain conditions, such as osteoarthritis of the
knee, the authors concluded that diclofenac 1.5% topical solution provides
equivalent pain relief compared to oral NSAIDs. The NNT for clinical success
(i.e. 50% pain relief) is 6.4 for diclofenac 1.5% topical solution, and 11 for
diclofenac gel (Voltaren).[4]
There are no studies that compare the different topical NSAID products.
Safety
Overall, the NSAIDs as a class have similar safety profiles based on the type of adverse
effects (AEs) and drug-drug interactions that have been reported for each
medication[1,2,5]; however, the incidence of specific adverse effects may vary based on the
individual product and the route by which it is administered.
-
All NSAIDs are associated with an increased risk of cardiovascular complications, such
as myocardial infarction (MI) and heart failure, and cerebrovascular events.[6]
-
All NSAIDs may increase the risk of serious, gastrointestinal adverse events including
bleeding, ulceration, and perforation of the stomach or intestines. [6]
-
The topical NSAID products [diclofenac (Voltaren, Pennsaid, Flector)] are primarily
associated with local skin reactions, such as pruritus and dermatitis. Systemic AEs are
less likely to occur with topical application; however, the package labeling for these
products still carries warnings and the potential for the same AEs as oral NSAIDs.[3,4,6-8]
-
Cross References
Celebrex®, celecoxib, Medication Policy Manual, Policy No. dru041
Flector®, diclofenac topical patch, Medication Policy Manual, Policy No. dru286
Sprix®, ketorolac nasal spray, Medication Policy Manual, Policy No. dru288
Codes
Number
Description
N/A
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References
1.
2.
3.
4.
5.
6.
7.
8.
Drug class review: Nonsteroidal antiinflammatory drugs (NSAIDs). Update 4 final report.
[cited 10/16/13]; Available from: http://derp.ohsu.edu/about/final-document-display.cfm
Analgesics for Osteoarthritis: An Update of the 2006 Comparative Effectiveness Review.
Comparative Effectiveness Review No. 38. (Prepared by the Oregon Evidence-based Practice
Center under Contract No. HHSA 290 2007 10057 I) AHRQ Publication No. 11(12)-EHC076EF. Rockville, MD: Agency for Healthcare Research and Quality. October 2011. [cited
10/16/13]; Available from: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guidesreviews-and-reports/?productid=795&pageaction=displayproduct
Massey, T, Derry, S, Moore, RA, McQuay, HJ. Topical NSAIDs for acute pain in adults.
Cochrane Database Syst Rev. 2010(6):CD007402. PMID: 20556778
Derry, S, Moore, RA, Rabbie, R. Topical NSAIDs for chronic musculoskeletal pain in adults.
Cochrane Database Syst Rev. 2012;9:CD007400. PMID: 22972108
Garner, S, Fidan, D, Frankish, R, et al. Celecoxib for rheumatoid arthritis. Cochrane
Database Syst Rev. 2002(4):CD003831. PMID: 12519610
Pennsaid® topical solution [package insert]. Hazelwood, MO: Mallinckrodt Brand
Pharmaceuticals, Inc.; August 2014.
Flector® patch[package insert]. Bristol, TN: King Pharmaceuticals Inc.; August 2011.
Voltaren® gel [package insert]. Chadds Ford, PA: ENDO Pharmaceuticals; October 2009.
Revision Date
Revision Summary
12/11/2015
Step therapy with diclofenac 1.5% topical solution (generic) added
© 2015. OmedaRx. All rights reserved.
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