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Women's health: choosing a treatment for menorrhagia?

Heavy menstrual bleeding, called menorrhagia, is reported to afflict greater than 10 million American women annually. (1) Reducing hospital costs and improving patient outcomes is a high-stakes challenge for all medical device manufacturers, so it is important to understand how physicians view the technology and the surgical procedures they recommend to patients. This article will examine physician perspective based on data collected comparing the choice among recommending hysterectomy, endometrial resection and ablation, and oral medical therapy for menorrhagia.

In a cost-benefit study conducted in Hong Kong, China, three treatments for women were assessed to better understand treatment and quality of life associated with women's health. (2) The conventional treatment for menorrhagia is hysterectomy, a highly invasive but very effective treatment. A minimally invasive alternative is endometrial resection for the purposes of ablating the uterine lining. It has been compared to the outcomes for hysterectomy and oral medications in multiple randomized studies performed as far back as 1991 and it has been determined that the data on endometrial resection and ablation correlates with lower morbidity. (3) Oral medical treatment is considered safer, but has been proven to be less effective than surgical intervention. (4)

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Using the quality-adjusted life-year (QALY) to estimate benefit, the Hong Kong study assigned total QALYs as 4.575 with oral medications, 4.624 with endometrial resection and ablation and 4.725 with hysterectomy. (6) A QALY is a health improvement measurement tool used to guide healthcare resource allocation decisions. It is a standardized methodology to assess cost-effectiveness of healthcare interventions and is considered to be a valuation of health benefit. The National Institute for Health and Care Excellence defines the QALY as a "measure of a person's length of life weighted by a valuation of their health-related quality of life."

It was surprising that the hysterectomy QALY was higher, considering that hysterectomy is a highly invasive surgery. This is because the QALY for each intervention primarily was calculated by the duration of the recovery period, post-surgery, for the surgical arms of the study, and the duration of menorrhagia and resolved menorrhagia. (7) Hysterectomy resolves menorrhagia completely and when used as a QALY measure, helps increase the QALY score.

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The total cost per patient is $5,508 with oral medication, $6,185 with endometrial resection and ablation, and $6,878 with hysterectomy.

Data Prevails

It is critical for medical device and diagnostics manufacturers to understand the journal articles and literature that guide the process of healthcare provider and physician decision-making, to understand the recommendations they are making to patients. U.S. hospitals also will be interested in this data, because an estimated 600,000 hysterectomies are performed annually in the United States. (10) An additional 307,000 endometrial ablations also are performed every year in the United States. (11) High procedure rates such as these are sure to come under scrutiny by hospital committees as they seek to reduce cost substantially.

Do you know the clinical data and outcomes associated with the competitive procedures for your device?

Editor's note: Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria.

References

(1.) www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html

(2.) You J H, Sahota D S, MoYuen P. A cost-utility analysis of hysterectomy, endometrial resection and ablation and medical therapy for menorrhagia. Human Reproduction. 2006;21(7):1878-1883

(3.) Gannon MJ, Holt EM, Fairbank J, Fitzgerald M, Milne MA, Crystal AM and Greenhalf JO (1991) A randomized trial comparing endometrial resection and abdominal hysterectomy for the treatment of menorrhagia. Br Med J 303, 1362-1364

(4.) Cooper KG, Parkin DE, Garratt AM and Grant AM (1999) Twoyear follow up of women randomized to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes. Br J Obstet Gynaecol 106, 258-265

(5.) Fergusson RJ, Lethaby A, Shepperd S, Farquhar C, Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding The Cochrane Collaboration

(6.) Op. cit. 3

(7.) Op. cit. 3

(8.) Op. cit. 3

(9.) Op. cit. 3

(10.) www.cdc.gov/reproductivehealth/data_stats/

(11.) Ablation Devices: Technologies and Global Markets, BCC Research, January 2014

Maria Shepherd * Data Decision Group

Maria Shepherd has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. Following a career including roles as vice president of marketing for Oridion Medical (acquired by Covidien), director of marketing for Philips Medical and senior management roles at Boston Scientific Corp., she founded Data Decision Group. Shepherd recently was appointed to the board of the ALIGO Healthcare Investment Committee. She can be reached at (617) 548-9892, mshepherd@ddecisiongroup.com, www.ddecisiongroup.com, or followed on Twitter @ MedTechResearch.
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Title Annotation:Datawatch
Author:Shepherd, Maria
Publication:Medical Product Outsourcing
Date:May 1, 2015
Words:799
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