Rapid Increase in Topical Diclofenac Use for Chronic Pain, 2011-2020

ABSTRACT

Objectives: To examine national prescribing patterns for topical diclofenac among Medicare beneficiaries with chronic pain and explore drivers of recent utilization trends, including pharmaceutical marketing and clinical guidelines.

Study Design: Retrospective analysis of 100% Medicare Parts A, B, and D administrative claims data (2011-2020) linked with CMS Open Payments data (2013-2020) and a review of clinical literature.

Methods: We identified continuously enrolled beneficiaries with documented chronic pain episodes and calculated the proportion of these episodes involving topical diclofenac prescriptions. We compared these utilization trends with the timing of pharmaceutical marketing payments to prescribers, the usage of other nonopioid substitutes, and the publication dates of relevant clinical practice guidelines and systematic reviews.

Results: The share of chronic pain episodes treated with topical diclofenac grew sharply from 0.4% in 2015 to 6.8% in 2019. This increase of 6.4 percentage points (a 1620% relative increase) outpaced that of most other nonopioid substitutes, although gabapentinoids also saw substantial growth. Notably, this surge occurred in the absence of new, distinct clinical guidelines supporting its use and despite the near-cessation of pharmaceutical marketing payments for topical diclofenac by 2017; it did occur after the publication of the 2016 CDC opioid prescribing guideline.

Conclusions: The rapid rise of topical diclofenac usage likely did not directly follow marketing efforts or new efficacy data. Instead, it may reflect therapeutic substitution resulting from national efforts to curb opioid prescribing.

Am J Manag Care. 2026;32(10):e379-e382

doi:10.37765/ajmc.2026.90034

Takeaway Points

Topical diclofenac usage increased dramatically among Medicare beneficiaries with chronic pain, potentially due to national opioid stewardship efforts.

• Topical diclofenac prescribing in Medicare Part D increased by 6.4 percentage points (relative increase of 1620%) between 2015 and 2019, outpacing other nonopioid alternatives in the study.
• This surge was likely not driven by pharmaceutical marketing, which nearly ceased by 2017, or new clinical guidelines, but potentially represents a spillover effect of opioid stewardship policies such as the 2016 CDC opioid prescribing guideline.
• Payers and health systems should anticipate continued volume expansion for diclofenac and other nonopioid analgesics and monitor for substantial off-label use, particularly for indications such as back pain.

The opioid crisis has been partly fueled by excessive prescribing of opioids for chronic pain. To mitigate this crisis, numerous federal and state regulations (eg, prescription drug monitoring programs [PDMPs]) have been instituted to monitor and prevent inappropriate opioid prescriptions for pain management.^1-3 Furthermore, numerous guidelines have recommended reductions in usage and described alternatives to opioids for chronic pain.^4,5

One such alternative is diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) that the FDA approved in topical form for treatment of acute and chronic pain associated with knee osteoarthritis in 2007 and moved to over-the-counter (OTC) status in 2020. Topical diclofenac has the advantage of providing moderate pain control,⁶ with less systemic toxicity than oral diclofenac or other oral NSAIDs.⁷

We explored trends in topical diclofenac utilization, marketing by pharmaceutical companies to prescribers, new systematic reviews, and changes in guidelines. These results may inform health policy and clinical guidelines for optimized prescribing practices.

METHODS

To assess prescription medication usage patterns, we used 100% of Medicare Parts A, B, and D administrative claims data (2011-2020) among continuously enrolled beneficiaries; beneficiaries could enter the analytic sample throughout the period but needed to remain continuously enrolled. We did not analyze trends in the last 3 quarters of 2020 because topical diclofenac was approved for OTC use in 2020, after which usage cannot be observed in claims data, and because utilization patterns changed markedly during the initial stage of the COVID-19 pandemic. We identified beneficiaries with documented chronic pain episodes using diagnosis codes from established literature⁸; each episode needed 2 diagnosis codes at least 30 days apart and was extended for 1 year after each chronic pain diagnosis. Of note, chronic pain conditions typically do not have defined end points, but we elected to use 1-year windows in this analysis to better match chronic pain diagnoses with medication usage.

We identified prescription fills for medications that broadly represent multiple classes of nonopioid drugs with efficacy for chronic pain: topical diclofenac, oral diclofenac, celecoxib, meloxicam, baclofen, duloxetine, and gabapentinoids (pregabalin and gabapentin).⁵ Combining these data, we computed the total count of chronic pain episodes associated with at least 1 prescription fill for these medications within a given calendar year and quarter. Finally, we computed the share of chronic pain episodes associated with each selected medication by dividing the count of episodes associated with at least 1 prescription fill by the total number of chronic pain episodes for each calendar year and quarter. We show prescribing trends for each medication based on these data.⁸ Furthermore, we examined whether increases in topical diclofenac usage were limited to FDA-approved indications by showing prescribing patterns among beneficiaries with a single chronic pain condition for which the drug is FDA approved (chronic joint pain, which is primarily osteoarthritis of the knee or hand) vs those with a condition for which it is not approved (chronic back pain or a composite of 11 other chronic pain conditions).^8,9

To examine pharmaceutical marketing, we extracted CMS Open Payments data, which record payments to prescribers above certain thresholds (per-payment and annual) since 2013.¹⁰ We identified all payments for diclofenac, nonopioid pain treatments, and common drugs not used in pain management (eAppendix TABLE [eAppendix available at ajmc.com]). We aggregated total payments by national provider identifier, drug name, state, year, and quarter for 2013-2020 data; we treated the District of Columbia as a state, but we excluded payments in US territories. Separately, we also explored changes in marketing payments for diclofenac and other drugs, including several that are unlikely to be affected by policy changes related to pain management.

We used PubMed to identify guidelines and systematic reviews related to topical diclofenac for chronic pain published from 2000 to 2020. We identified systematic reviews or clinical practice guidelines that noted topical NSAIDs or noted both diclofenac and pain. We excluded studies that focused exclusively on acute pain, oral mucositis, actinic keratosis, or oral usage, as well as narrative reviews. For systematic reviews, we included studies that analyzed randomized controlled trials. For guidelines, we identified studies sponsored by a medical specialty society and informed by a systematic review.

Analysis
We conducted a descriptive, retrospective serial cross-sectional study. First, for each calendar year and quarter, we calculated the proportion of chronic pain episodes with at least 1 qualifying prescription fill for topical diclofenac and 6 other nonopioid substitutes (oral diclofenac, celecoxib, meloxicam, baclofen, duloxetine, and gabapentinoids). We then visually compared national trends between drugs during 2011-2020. We also computed and compared the proportion of chronic pain episodes with a fill for topical diclofenac for FDA-approved (chronic joint pain in the extremities) and nonapproved indications (chronic back pain and a composite of all other chronic pain conditions). Finally, we plotted the proportions of chronic pain episodes associated with topical diclofenac and with oral diclofenac relative to key consensus studies in the literature as well as per capita marketing payments for diclofenac; we described trends, but we did not conduct formal statistical hypothesis testing. We conducted data processing and analysis in Python.

RESULTS

Topical diclofenac usage in chronic pain episodes increased more than usage of other nonopioid pain management medications (Figure 1). Topical diclofenac usage increased substantially between 2015 and 2019 in Medicare Part D beneficiaries with chronic pain: 0.4% of chronic pain episodes (40,550 prescriptions) in 2015 to 6.8% of chronic pain episodes (689,131 prescriptions) in 2019, representing an increase of 6.4 percentage points and a 1620% relative increase in share, and a 1600% relative increase in prescriptions. In comparison, the use of gabapentinoids increased by 3.8 percentage points, a relative increase of 60%. Use of other nonopioid alternatives (celecoxib, meloxicam, baclofen, and duloxetine) increased from 2015 to 2019, but by 1 percentage point or less (with relative increases < 100%). Furthermore, usage of both topical diclofenac and gabapentinoids increased sharply after publication of the 2016 CDC opioid prescribing guideline.⁴ Despite topical diclofenac’s limited usage in 2015, the use had exceeded that of other common NSAIDs targeting chronic pain (including oral diclofenac) by 2019, although its use remained lower than the overall usage of gabapentinoids.

Given the striking growth rate shown in Figure 1, we studied whether this trend was unique to particular states between 2015 and 2019 (eAppendix Figure). We found considerable cross-state variation in growth—ranging from +2.2 percentage points in Rhode Island to +11.1 percentage points in Alaska—but all 50 states (and the District of Columbia) experienced increases, indicating general agreement with the national trend.

We next compared the use of topical diclofenac (ie, the share of chronic pain episodes for which it was used) among patients with single chronic pain conditions. Although usage increased from 0.04% to 2.76% (2.72 percentage points or a relative increase of 7500%) for an FDA-approved indication (chronic joint pain in the extremities), usage also rose for nonapproved indications such as chronic back pain (+0.56 percentage points [0.02% to 0.58%], representing a relative increase of 3200%) and a composite of chronic pain conditions not related to chronic joint pain (+0.23 percentage points [0.02% to 0.25%] or a relative increase of 1400%). This pattern suggests increasingly widespread off-label usage for pain management across chronic conditions, even without regulatory approval for those indications.

Figure 2 shows the national trend in diclofenac usage from 2011 to 2020 for all types of chronic pain (ie, both off- and on-label usage), as well as the trend in marketing payments to prescribers for diclofenac between 2013 and 2020. Based on our PubMed search, we identified 1 clinical practice guideline and 5 systematic reviews published between 2009 and 2020; all indicated that topical NSAIDs (including diclofenac) are effective and safe in treating chronic pain.^6,11-15 The first guideline identified in PubMed that supported the use of topical diclofenac was published in 2009 (before our analysis sample), and the first systematic review specific to diclofenac was published in 2012.^6,11

CMS Open Payments data show a substantial increase in payments in 2015, peaking at $138,000 nationally in the third quarter (Q3) of 2015, then declining to less than $6000 total during 2017-2020. Diclofenac sales continued to increase after the initial marketing efforts, which were modest compared with those of the top 20 drugs in the US by 2015 sales,¹⁶ which had average quarterly marketing payments of $2.6 million. For example, rivaroxaban (Xarelto; the 16th top-selling drug in 2015) had total payments of $6.8 million in Q3 2015. Payments related to other nonopioid pain medications also showed substantial variation (not shown) but remained above zero in 2019: meloxicam ($24,000), baclofen ($228,000), celecoxib ($19,000), and duloxetine ($16,000).

Figure 2 combines data series on usage and marketing with key literature events: Despite the substantial preexisting literature and expert consensus, and limited marketing (especially after 2015), the share of chronic pain episodes for which topical diclofenac was used grew by 1620% from 2015 to 2019 and by 2900% between 2011 and Q1 2020.

DISCUSSION

We found a substantial increase in prescriptions for topical diclofenac from 2011 to 2020, including a sharp increase from 2015 to 2019 among Medicare Part D beneficiaries with chronic pain, an increase that has not been previously reported in the literature. This increase in usage did not directly follow new published evidence suggesting substantially improved effectiveness or changes in recommendations in new clinical practice guidelines related to topical NSAIDs. Furthermore, spending on diclofenac marketing was modest between 2013 and 2015 but nearly fell to zero by 2017, in contrast to other medications with high sales volumes and several other nonopioid pain medications. In addition, topical diclofenac usage has increased for both FDA-approved treatment indications (chronic joint pain) and other types of chronic pain for which the medication had not gained FDA approval.⁹ Given the ongoing opioid crisis and the urgent need for effective, safer analgesics, this pattern suggests that diclofenac may have been used as an alternative to opioids, in accordance with the 2016 CDC opioid prescribing guideline.⁴ This study was descriptive and could not identify a causal link between diclofenac usage and prescribers’ aims for decreasing opioid prescriptions. Further research should examine whether efforts to reduce inappropriate opioid prescribing, such as guideline revisions or PDMPs, led to increased usage of diclofenac.

Limitations

This study had several limitations. First, this was an observational study that cannot show causal relationships between diclofenac usage and other factors. Second, we defined medication use as fills occurring within 1 year of a chronic pain diagnosis code in Medicare claims. Although chronic pain conditions may have variable durations and their associated symptom severity may increase or decrease over time, we elected to use 1-year time windows when matching medication fills with chronic pain conditions. This practice follows prior literature⁸; however, using episodes with fixed thresholds may be associated with unavoidable inaccuracies when using administrative claims data. To mitigate such inaccuracies, we observed trends over time while using consistent definitions. Third, we studied only Medicare claims data rather than all-payer claims. However, the Medicare population has relatively high rates of pain incidence and opioid use,^17,18 with 78% of all Medicare enrollees experiencing chronic pain compared with 20% of all US adults.¹⁹ Fourth, we did not study usage of OTC medications such as ibuprofen or acetaminophen because Medicare Part D pharmacy claims data do not capture fills for these medications.

CONCLUSIONS

The 1620% increase in topical diclofenac usage among Medicare beneficiaries is potentially a therapeutic substitution resulting from national efforts to curb opioid prescribing rather than a product of pharmaceutical promotion or new evidence. As prescribing shifts away from opioids, health systems and payers should anticipate corresponding growth in nonopioid analgesic volume and ensure formulary designs support cost-effective access to these safer alternatives.

Acknowledgments

The authors thank Ms. Julie Lai (RAND Corporation, Santa Monica, CA) for research programming assistance.

Author Affiliations: RAND Corporation (KDS, EDP), Santa Monica, CA; University of Pennsylvania Perelman School of Medicine (DP), Philadelphia, PA.

Source of Funding: National Institute on Drug Abuse.

Author Disclosures: Drs Shetty, Peet, and Powell report grant receipt from the National Institute on Drug Abuse.

Authorship Information: Concept and design (KDS, EDP, DP); acquisition of data (KDS, EDP); analysis and interpretation of data (KDS, EDP, DP); drafting of the manuscript (KDS); critical revision of the manuscript for important intellectual content (KDS, EDP); statistical analysis (KDS); provision of patients or study materials (KDS); and obtaining funding (EDP, DP).

Address Correspondence to: Kanaka D. Shetty, MD, MS, RAND Corporation, 1776 Main St, Santa Monica, CA 90401. Email: kanakashetty@gmail.com.

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