Patients Infrequently Screened Before Immunosuppressive Specialty Drug Therapy, Study Finds

In recent years, drugmakers have launched complex drugs — known as specialty drugs — that often require special handling, administration or monitoring.[1] These drugs are used to treat chronic, complex or rare conditions (including cancer) and inflammatory immune diseases affecting the joints (such as rheumatoid arthritis), skin (such as psoriasis) and gut (such as ulcerative colitis).

With annual costs that can reach $100,000 per drug, specialty drugs are a major concern for consumers and health insurers.[2] For example, brand-name specialty drugs accounted for about 30% of the overall spending on prescription drugs under Medicare Part D and Medicaid in 2015, despite the fact that they accounted for only about 1% of all prescriptions dispensed in each program that year.[3]

Injectable forms of specialty drugs include new disease-modifying antirheumatic drugs (DMARDs) — known as “biologics” — such as adalimumab (AMJEVITA, CYLTEZO, HUMIRA, HYRIMOZ). Oral forms include non-biologic DMARDs, such as tofacitinib (XELJANZ, XELJANZ XR).

These drugs tend to work faster than traditional drugs. However, specialty drugs also tend to be more potent suppressors of the immune system than traditional drugs, increasing the risk of serious infections. This prompted the Food and Drug Administration (FDA) to require safety warnings on the labeling of these drugs that recommend specific screening procedures before the initiation of these therapies to reduce the risk of life-threatening infections. Due to these risks, Public Citizen’s Health Research Group generally classifies immunosuppressive specialty drugs as Limited Use or in some cases, such as tofactinib, Do Not Use.[4],[5],[6]

A recent federally funded study showed that, despite these FDA warnings, only about one-quarter of new users of several specialty drugs were properly screened for inactive tuberculosis, hepatitis B virus and hepatitis C virus prior to therapy. The study was conducted by U.S. researchers and was published online in the Joint Commission Journal on Quality and Patient Safety on Jan. 24.

The new study[7]

Using data from electronic health records in a large university health system serving almost 3.5 million patients, the researchers identified over 2,000 new users of immunosuppressive specialty drugs from July 2013 to October 2017. The mean age for these patients was 44 years, and 53% were women. Most of these patients had taken one of the following drugs: adalimumab, etanercept (ENBREL, ERELZI, ETICOVO), infliximab (INFLECTRA, IXIFI, REMICADE, RENFLEXIS), rituximab (RITUXAN, TRUXIMA), tofacitinib and ustekinumab (STELARA).

The researchers looked for documentation in the electronic record system and medical charts of these patients to determine whether they were screened for silent tuberculosis, hepatitis B virus and hepatitis C virus, as applicable, either 12 months before or two months after the initiation of these medications.

They found that only 62% of the patients taking specialty drugs that require screening for tuberculosis had documentation that they received this screening during the specified screening window. Likewise, only 52% and 42% of those requiring screening for hepatitis B virus and hepatitis C virus, respectively, had documentation that they received this screening.

In terms of documentation for receipt of all required screening across all drugs, just 26% of all patients had documentation proving that such screening was done during the screening window. When the researchers expanded their screening timeframe from any time before drug initiation to two months after initiation of specialty drugs, they still found that only 36% of the patients had documentation of screening for these infections as applicable.

The researchers also found safety gaps in adherence to other laboratory screening, which is required for some specialty drugs. For example, only 45% of tofacitinib users had documentation of pretreatment blood cholesterol levels, although such testing is required before treatment because the drug can increase cholesterol levels.

What You Can Do

Whenever possible, consider immunosuppressive specialty drugs only after traditional therapies, such as methotrexate (OTREXUP, RASUVO, TREXALL, XATMEP) for rheumatoid arthritis, have failed because of the increased risk of infection and cancers associated with specialty drugs. Avoid taking tofacitinib because of its increased risks, especially the risks of blood clots in the lungs and death in rheumatoid arthritis patients.[8],[9] If you decide to take an immunosuppressive specialty drug, ask your doctor whether he or she should test you for tuberculosis, hepatitis B virus or hepatitis C virus before or during therapy. Do not stop any medication before talking to your doctor.
 

References

[1] Congressional Budget Office. Prices for and spending on specialty drugs in Medicare part D and Medicaid. March 2019. URL. Accessed May 6, 2019.

[2] The Pew Charitable Trusts. A fact sheet: Specialty drugs and health care costs. December 2016. http://www.pewtrusts.org/~/media/assets/2016/12/specialty_drugs_and_health_care_costs.pdf. Accessed May 6, 2019.

[3] Congressional Budget Office. Prices for and spending on specialty drugs in Medicare part D and Medicaid. March 2019. https://www.cbo.gov/system/files?file=2019-03/54964-Specialty_Drugs.pdf. Accessed May 6, 2019.

[4] Drug profile: adalimumab (AMJEVITA, CYLTEZO, HUMIRA); anakinra (KINERET); etanercept (ENBREL, ERELZI); infliximab (INFLECTRA, IXIFI, REMICADE, RENFLEXIS). February 2019. /monographs/view/137. Accessed May 6, 2019.

[5] Tofacitinib (XELJANZ): The wrong choice for rheumatoid arthritis. Worst Pills, Best Pills News. October 2017. /newsletters/view/1155. Accessed May 6, 2019.

[6] New biologic drugs for rheumatoid arthritis: Which are safe? Worst Pills, Best Pills News. March 2016. /newsletters/view/1024. Accessed May 6, 2019.

[7] Patterson S, Schmajuk G, Evans M, et al. Gaps in ambulatory patient safety for immunosuppressive specialty medications [published online January 24, 2019]. Jt Comm J Qual Patient Saf. doi:10.1016/j.jcjq.2018.12.003.

[8] Tofacitinib (XELJANZ): The wrong choice for rheumatoid arthritis. Worst Pills, Best Pills News. October 2017. /newsletters/view/1155. Accessed May 6, 2019.

[9] WorstPills.org. E-Alert: FDA warns of life-threatening blood clots with use of high-dose tofacitinib (XELJANZ, XELJANZ XR). March 2019. https://www.worstpills.org/member/ealert.cfm?ea_id=126. Accessed May 6, 2019.