Medicare Price Negotiations for Three Rheumatoid Arthritis Drugs

Under the Inflation Reduction Act of 2022, the Centers for Medicare & Medicaid Services (CMS) gained authority to negotiate lower prices for selected drugs used by Medicare beneficiaries.[1]

Of the 40 drugs so far subject to Medicare price negotiations, four are for rheumatoid arthritis or related conditions, including psoriatic arthritis.[2],[3],[4] Etanercept (ENBREL), a tumor necrosis factor (TNF) inhibitor approved for rheumatoid arthritis and other conditions, was one of the first drugs selected. As of Jan. 1, 2026, the negotiated price (paid by those without insurance) for a 30-day supply was $2,355, about a two-thirds reduction from the previous price of about $7,100.[5] Public Citizen’s Health Research Group has designated etanercept as Limited Use because it increases the risk of serious infections and malignancies and because safer, less expensive alternative drugs are available.[6]

Prices for three additional rheumatoid arthritis drugs — abatacept (ORENCIA), certolizumab pegol (CIMZIA) and tofacitinib (XELJANZ) — are subjects of the current CMS price negotiations slated to take effect in January 2028. At present, the U.S. price for these three drugs ranges from approximately $3,000 to $6,300 for a 30-day supply.[7],[8],[9] We have designated abatacept as Limited Use because there are safer, less expensive, first-line treatments available.[10] We have designated certolizumab pegol as Do Not Use because it carries serious risks, such as complete hair loss, kidney failure and cardiovascular disease, and there is no evidence that it is more effective than alternative drugs.[11] We have designated tofacitinib as Do Not Use because of the risks of serious infections and malignancies, and because safer alternative drugs are available.[12]

Background

Rheumatoid arthritis is an autoimmune disease that leads to progressive and painful damage to the joints; it can also damage the lungs and heart and lead to premature death.[13] The disease affects about 4% of adults 20 years or older in the United States.[14] Rheumatoid arthritis usually develops between 30 and 60 years of age, and often leads to progressive disability.[15] Psoriatic arthritis is an autoimmune disease characterized by scaly, flaky patches of skin, as well as joint stiffness and pain.[16] This disease is less common, affecting about 0.4% of U.S. adults 20 years or older.

Public Citizen’s Comments to CMS

Below is a summary of information we submitted to CMS to support price negotiations regarding abatacept, certolizumab pegol and tofacitinib.[17]

Initial disease-modifying treatments for rheumatoid arthritis include methotrexate (JYLAMVO, RASUVO, TREXALL, XATMEP and generics) and hydroxychloroquine (PLAQUENIL, SOVUNA and generics).[18] If those drugs are ineffective, then second-line drugs may be used, including TNF inhibitors such as adalimumab (HUMIRA and biosimilars; certolizumab pegol is also included in this class); interleukin inhibitors such as tocilizumab (ACTEMRA and biosimilars); and other biologics like rituximab (RITUXAN) and abatacept. Janus kinase (JAK) inhibitors (for example, tofacitinib) are indicated only if TNF inhibitors are intolerable or fail to yield an adequate response.[19]

Three different mechanisms

Abatacept inhibits the activation of specific T-cells, white blood cells that attack invading pathogens and tumor cells, as well as “helper” T-cells that otherwise assist in the immune response.[20],[21] Certolizumab pegol acts by neutralizing a TNF-alpha cytokine, a small protein involved in inflammation.[22],[23] Tofacitinib is a JAK inhibitor, meaning it dampens biochemical signals triggered by cytokines and growth factors that influence blood and immune cell function.[24]

Administration

For rheumatoid arthritis and most other indicated conditions, after the first month of treatment with high-dose intravenous infusions every other week, abatacept can be given subcutaneously weekly. Certolizumab pegol is similarly administered, but by subcutaneous injection only. Tofacitinib is taken orally once or twice per day.

Effectiveness[25],[26],[27]

Several blinded, randomized clinical studies support the effectiveness of abatacept, certolizumab pegol or tofacitinib as treatments for moderate to severe rheumatoid arthritis. One abatacept trial is illustrative of such effects. The trial compared treatment with either methotrexate plus the drug (n=424) or methotrexate plus placebo (n=214). After 52 weeks, the trial found that 48% of the abatacept participants and 18% of the placebo participants experienced at least a 50% improvement on the American College of Rheumatology criteria for disease severity.[28] In a smaller, 12-week trial without methotrexate, those percentages were 16% and 6%, respectively.

Safety[29],[30],[31]

Certolizumab pegol and tofacitinib both have boxed warnings, the strongest safety warning the FDA can require. Use of these drugs increases the risk for serious infections and malignancies. For example, in patients with rheumatoid arthritis, upper respiratory infection occurred in approximately 6% of those using certolizumab pegol and 2% of those using placebo; new cancers (excluding skin cancer) occurred in 1.1% of those using tofacitinib and 0.77% of those using TNF inhibitors; and new serious infections occurred in 3.0% of tofacitinib users and 2.5% of TNF inhibitor users. Tofacitinib’s boxed warning additionally cautions that the drug increases the risk of major cardiovascular events, including blood clots.

Although abatacept does not carry a boxed warning, the prescribing information prominently cautions about the risk of serious infection, especially when the drug is used with a TNF inhibitor. Headaches, nasopharyngitis (inflammation of the nose and throat, often caused by a virus) and hypertension (high blood pressure) are more common with abatacept compared with placebo (7%-18% versus 4%-13%, respectively).

What You Can Do

If you have unexplained or otherwise worrisome joint pain or related symptoms, seek medical attention for diagnosis and treatment recommendations. Especially if you are a Medicare beneficiary, drug price negotiations may reduce the price of three drugs for rheumatoid arthritis and related conditions by January 2028. Public Citizen’s Health Research group, however, has classified two of these drugs, certolizumab pegol and tofacitinib, as Do Not Use for rheumatoid arthritis, and the third drug, abatacept, as Limited Use.
 

References

[1] Cubanski J, Neuman T. Key facts about Medicare drug price negotiation. Kaiser Family Foundation. March 11, 2026. https://www.kff.org/medicare/key-facts-about-medicare-drug-price-negotiation/. Accessed May 1, 2026.

[2] Centers for Medicare & Medicaid Services. Medicare Drug price negotiation program: Selected drugs for initial price applicability year 2026. August 2023. https://www.cms.gov/files/document/fact-sheet-medicare-selected-drug-negotiation-list-ipay-2026.pdf. Accessed May 1, 2026.

[3] Centers for Medicare & Medicaid Services. Medicare drug price negotiation program: Selected drugs for initial price applicability year 2027. January 2025. https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2027.pdf. Accessed May 1, 2026.

[4] Cubanski J, Neuman T. Key facts about Medicare drug price negotiation. Kaiser Family Foundation. March 11, 2026. https://www.kff.org/medicare/key-facts-about-medicare-drug-price-negotiation/. Accessed May 1, 2026.

[5] Centers for Medicare & Medicaid Services. Medicare drug price negotiation program: Negotiated prices for initial price applicability year 2026. https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf. Accessed May 1, 2026.

[6] New biologic drugs for rheumatoid arthritis: Which are safe? Worst Pills, Best Pills News. March 2016. https://www.worstpills.org/newsletters/view/1024. Accessed May 12, 2026.

[7] GoodRx. Xeljanz (tofacitinib). 2026. https://www.goodrx.com/xeljanz. Accessed May 1, 2026.

[8] GoodRx. Orencia (abatacept). 2026. https://www.goodrx.com/orencia. Accessed May 1, 2026.

[9] UCB USA. “How much should I expect to pay for CIMZIA (certolizumab pegol)?” 2026. https://www.ucb-usa.com/Responsibility/Affordability/Cimzia-Pricing-Info. Accessed May 6, 2026.

[10] New biologic drugs for rheumatoid arthritis: Which are safe? Worst Pills, Best Pills News. March 2016. https://www.worstpills.org/newsletters/view/1024. Accessed May 12, 2026.

[11] Review of tumor necrosis factor blocker adalimumab (HUMIRA). Worst Pills, Best Pills News. August 2024. https://www.worstpills.org/newsletters/view/1611. Accessed May 12, 2026.

[12] Tofacitinib (XELJANZ): The wrong choice for rheumatoid arthritis. Worst Pills, Best Pills News. October 2017. https://www.worstpills.org/newsletters/view/1155. Accessed May 12, 2026.

[13] Cleveland Clinic. Rheumatoid arthritis. November 6, 2024. https://my.clevelandclinic.org/health/diseases/4924-rheumatoid-arthritis. Accessed May 1, 2026.

[14] Foster AL, Boring MA, Lites TD, et al. Distribution of arthritis subtypes among adults with arthritis in the United States, 2017-March 2020. Prev Chronic Dis. 2025;22(June 19):E28.

[15] Cleveland Clinic. Rheumatoid arthritis. November 6, 2024. https://my.clevelandclinic.org/health/diseases/4924-rheumatoid-arthritis. Accessed May 1, 2026.

[16] Cleveland Clinic. Psoriatic arthritis vs. rheumatoid arthritis. December 13, 2021. https://health.clevelandclinic.org/psoriatic-arthritis-vs-rheumatoid-arthritis. Accessed May 1, 2026.

[17] Public Citizen. Comments to CMS regarding selected drugs for price negotiations (round 3). March 1, 2026. https://www.citizen.org/wp-content/uploads/2777.pdf. Accessed May 1, 2026.

[18] Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2021;63(1637):177-184.

[19] Pfizer. Label: tofacitinib (Xeljanz). March 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208246s027lbl.pdf. Accessed May 1, 2026.

[20] Bristol-Myers Squibb. Label: abatacept (ORENCIA). May 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s255lbl.pdf. Accessed May 1, 2026.

[21] Cleveland Clinic. T cells. January 17, 2023. https://my.clevelandclinic.org/health/body/24630-t-cells.  Accessed May 1, 2026.

[22] UCB. Label: certolizumab pegol (CIMZIA). September 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125160s315lbl.pdf. Accessed May 1, 2026.

[23] Review of the tumor necrosis factor blocker adalimumab (HUMIRA). Worst Pills, Best Pills News. August 2024. https://www.worstpills.org/newsletters/view/1611. Accessed May 1, 2026.

[24] Pfizer. Label: tofacitinib (XELJANZ). March 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208246s027lbl.pdf. Accessed May 1, 2026.

[25] UCB. Label: certolizumab pegol (CIMZIA). September 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125160s315lbl.pdf. Accessed May 1, 2026.

[26] Bristol-Myers Squibb. Label: abatacept (ORENCIA). May 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s255lbl.pdf. Accessed May 1, 2026.

[27] Pfizer. Label: tofacitinib (Xeljanz). March, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208246s027lbl.pdf. Accessed May April 28, 2026.

[28] Quanticate’s Statistical Consultancy Team. ACR response criteria in rheumatoid arthritis clinical trials. September 25, 2024. https://www.quanticate.com/blog/acr-response-criteria. Accessed May 1, 2026.

[29] UCB. Label: certolizumab pegol (CIMZIA). September 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125160s315lbl.pdf. Accessed May 1, 2026.

[30] Bristol-Myers Squibb. Label: abatacept (ORENCIA). May 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s255lbl.pdf. Accessed May 1, 2026.

[31] Pfizer. Label: tofacitinib (Xeljanz). March, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208246s027lbl.pdf. Accessed May April 281, 2026.