Commentary

What does Liletta cost 
to non-340B providers?

Letters from readers


 

References

SEPTEMBER 2015

“YOUR TEENAGE PATIENT AND CONTRACEPTION: THINK 
‘LONG-ACTING’ FIRST”
DAVID R. KATTAN, MD, MPH, AND 
RONALD T. BURKMAN, MD (SEPTEMBER 2015)

What does Liletta cost 
to non-340B providers?
Drs. Kattan and Burkman state in their article: “For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs.”

Could you provide a cost range and the source for the non-340B cost?
Sharon J. Hawthorne, MBA

St. Louis, Missouri

Drs. Kattan and Burkman respond:
Thank you for your question and for allowing us to clarify. The manufacturer of Liletta, Actavis, offers a Patient Savings Program for private insurance patients to limit their out-of-pocket cost to $75. This program will end on December 31, 2015. Information is available at http://www.lilettacard.com.

For non-340B providers, the cost per IUD is higher, although this should be reimbursed by the patient’s insurance program. After volume discounts, the price per device is as low as $537. Without volume discounts, the price per device is $600. For more information, visit: https://www.lilettahcp.com/content/pdf/LILETTA-Quick-Reference-Guide.pdf.

Medicines360, the nonprofit partner of Actavis, states the following on its Web site (http://medicines360.org/our-mission): “Through our pharmaceutical partnerships, commercial product sales help support an affordable price to public sector clinics. This allows low income women or those without insurance the opportunity to access more healthcare choices.”

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?”
CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach.

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary.

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps.

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