Coverage Further Validates Laparoscopic Radiofrequency Ablation for Women with Uterine Fibroids

Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that Anthem Blue Cross Blue Shield, the second largest health plan in the United States, has updated its medical policy to cover Radiofrequency Ablation (LAP-RFA), which includes the Acessa® procedure (CPT Code 58674), for women suffering from uterine fibroids. The updated policy creates access to uterine-preserving care for Anthem’s approximately 40 million members in all 50 states, providing a safe and effective alternative for millions of women who otherwise might have to resort to unwanted hysterectomies.

Anthem’s updated medical policy says the use of laparoscopic or transcervical radiofrequency ablation as a treatment for symptomatic uterine fibroids (e.g. excessive uterine bleeding or pelvic discomfort caused by uterine fibroids) is considered medically necessary when uterine preservation is desired, fibroids are less than 10 cm in any diameter and uterine size does not exceed 16 weeks gestation.¹

“Women’s health issues remain chronically underserved and this has never been more apparent than with the millions of women living with uterine fibroids,” said Essex Mitchell, Division President GYN Surgical Solutions, Hologic. “Anthem’s decision will create significantly greater access to options that align with the strong preferences many women and their physicians have for safe and effective treatment that enables both symptom relief and uterine preservation.”

An estimated 11 million women in the United States are currently diagnosed with uterine fibroids, with an additional 3.7 million undiagnosed women self-identified as having symptoms suggestive of uterine fibroids.² Up to 80% of women are diagnosed with uterine fibroids by the age of 50.³ Women with symptomatic uterine fibroids often fear losing their uterus because of hysterectomy but are either not offered or able to afford non-reimbursed alternative treatment options. This leaves too many women heavily burdened by their fibroid symptoms, leading to a reduced quality of life.⁴ Black women are disproportionately affected by fibroids, making access to fibroid treatment a key focus in the effort to address racial disparities in healthcare.

“I have personally treated dozens of women who wanted this treatment but had to choose another option because it was not covered by their insurance,” said Dr. Soyini Hawkins, a minimally invasive gynecologist who founded and leads the Fibroid and Pelvic Center of Georgia. “Anthem’s decision is fantastic and will not only improve the health outcomes for women but also enable their preferences to be honored.”

The Acessa procedure is a minimally invasive, outpatient treatment designed to treat women with symptomatic uterine fibroids and is clinically proven with long-term data as a safe alternative to hysterectomy and myomectomy.^5,6 Women experience minimal discomfort after the procedure and typically return to work in four to five days.⁵ For more information about the benefits and risks of the Acessa procedure, visit www.gynsurgicalsolutions.com

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Acessa product. There can be no assurance this product will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the product can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that this product will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions, or circumstances on which any such statements are based.

Hologic, Acessa, and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Sources

1. SURG.00077. Anthem Blue Cross Blue Shield: Health Insurance, Medicare & More. (2021, August 19). https://www.anthem.com/dam/medpolicies/abcbs/active/policies/mp_pw_a053391.html.
2. Marsh EE, Al-Hendy A, Kappus D, Galitsky A, Stewart EA, Kerolous M. Burden, Prevalence, and Treatment of Uterine Fibroids: A Survey of U.S. Women. J Womens Health. 2018;27(11):1359-1367.
3. Coyne KS, Harrington A, Currie BM, Chen J, Gillard P, Spies JB. Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). J Patient-Rep Outcomes. 2019;3(1):57.
4. Giuliani E, As‐Sanie S, Marsh EE. Epidemiology and management of uterine fibroids. Int J Gynecol Obstet. 2020;149(1):3-9.
5. SG Chudnoff, et al. Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas. Obstetrics and Gynecology, 2013;121(5):1075–82.
6. Yelena Havryliuk, MD, Robert Setton, MD, John Carlow, EdD, MPH, Barry D. Shaktman, MD, Management of symptomatic fibroids: review and meta-analysis of the literature (2006 -2016), Journal of the Society of Laparoendoscopic Surgeons, Vol. 21 (3) Jul-Sept 2017

Notes and Disclaimers

IMPORTANT SAFETY INFORMATION The Acessa ProVu system is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa ProVu system is contraindicated for patients who are not candidates for laparoscopic surgery and/or patients with a uterus adherent to pelvic tissue or viscera. The Acessa ProVu system’s guidance system is not intended for diagnostic use. Please read all instructions for use of the Acessa ProVu system prior to its use. Safe and effective electrosurgery is dependent not only on equipment design but also on factors under control of the operator. Rare but serious risks include, but are not limited to, infection, injury to adjacent structures, blood loss and complications related to laparoscopy and/or general anesthesia. Insufficient data exists on which to evaluate the safety and effectiveness of the Acessa ProVu system in women who plan future pregnancy, therefore the Acessa ProVu system is not recommended for women who are planning future pregnancy.

SOURCE Hologic, Inc.

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Anthem, Nation’s Second Largest Health Plan, Now Covers Hologic’s Acessa Procedure as a Treatment for Uterine Fibroids