Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer

Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of bladder cancer staging

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Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, there were an estimated 699,450 people living with bladder cancer in the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020).
NCCN Guidelines for Bladder Cancer (version 6.2020) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high risk and are similarly treated with adjuvant intravesical therapy with BCG being a Category 1 recommendation. (NCCN, 2020).

Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization, bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and AUA Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS).

A higher score is the preferred result and indicates better quality

Reference Type: CITATION

Reference Text: 'Chamie, K., Saigal, C.S., Lai, J., Hanley, J.M., Setodji, C.M., Konety, B.R., Litwin, M.S., & Urologic Diseases in America Project (2011). Compliance with Guidelines for Patients with Bladder Cancer: Variation in the Delivery of Care. Cancer.2011 Dec 1: 117(23): 5392--5401.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206145/'

Reference Type: CITATION

Reference Text: 'Chang, S.S., Boorjian, S.A., Chou, R., Clark, P.E., Daneshmand, S., Konety, B.R., Pruthi, R., Quale, D.Z., Ritch, C.R., Seigne, J.D., Skinner, E.C., Smith, N.M., & Mckiernan, J. M., (2016, April) American Urological Association. Non-Muscle Invasive Bladder Cancer.
https://www.auanet.org/education/guidelines/non-muscle-invasive-bladder-cancer.cfm'

Reference Type: CITATION

Reference Text: 'Hall, M.C., Chang, S.S., Dalbagni, G., Pruthi, R.S., Schellhammer, P.F., Seigne, J.D., Skinner, E.C., & Wolf .S., (2016). American Urological Association. Guideline for the Management of Non-muscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): Update 2016.
https://www.auajournals.org/doi/10.1016/j.juro.2007.09.003'

Reference Type: CITATION

Reference Text: 'Kassouf, W., Black, P., (2016) Treatment of primary non-muscle invasive urothelial bladder cancer.  Literature review current through Dec. 2016.
https://www.uptodate.com/contents/treatment-of-primary-non-muscle-invasive-urothelial-bladder-cancer?source=search_result&search=Treatment%20of%20primary%20non-muscle%20invasive%20urothelial%20bladder%20cancer&selectedTitle=1~150 T of primary'

Reference Type: CITATION

Reference Text: 'NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). (2021). Bladder Cancer.  Version 6.2021-December 6. 2021.
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf'

Reference Type: CITATION

Reference Text: 'NIH National Cancer Institute Surveillance, Epidemiology, and End Results Program. SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda,MD, https://seer.cancer.gov/statfacts/html/urinb.html'

Reference Type: CITATION

Reference Text: 'Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University. (2016). PCORI Topic Brief. Comparative Effectiveness of Treatments for Non-Muscle-Invasive Bladder Cancer
http://www.pcori.org/sites/default/files/PCORI-Assessment-Options-Advisory-Panel-Fall-2016-Topic-Brief-Non-Muscle-Invasive-Bladder-Cancer.pdf'

Intravesical - Within the urinary bladder
Bacillus Calmette-Guerin (BCG) - A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970's.
Tumor location: urinary bladder
Histology: urothelial carcinoma
Primary Tumor (T) stage:
Ta - Noninvasive and high grade
Tis - Carcinoma in situ: "flat tumor"
T1- tumor invades subepithelial connective tissue (high grade or low grade)

Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines.
The BCG dose can be full or partial and can be from any lot or manufacturer.

This eCQM is a patient-based measure.

Telehealth encounters are not eligible for this measure because the measure requires a clinical action that cannot be conducted via telehealth.

This version of the eCQM uses QDM version 5.6.  Please refer to the eCQI resource center (https://ecqi.healthit.gov/qdm) for more information on the QDM.

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All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer and a qualified encounter in the measurement period

Equals Initial Population

Immunosuppressed patients, includes HIV and immunocompromised state.
Immunosuppressive drug therapy.
Active Tuberculosis.
Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease.
Patients who undergo cystectomy, chemotherapy or radiation within 6 months of Bladder Cancer Staging.

Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series
BCG is initiated within 6 months of the bladder cancer staging and during the measurement period

Not Applicable

Unavailability of BCG

For every patient evaluated by this measure also identify payer, race, ethnicity and sex

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