appealing insurance authorization decision for post-RRP penile therapy

I recently asked the clinician who has been prescribing Viagra for
treatment post-RRP ED to assist me by submitting a request for
authorization to increase my allotted 18 Viagra tablets ever 90 days.
Today I received a reply from "a board certified Empire Blue Cross/
Blue Shield medical director" named Anne Kaeser, MD, whom a Google
search indicates is a board-certified anesthesiologist in
Connecticut:

"Coverage for Viagra in excess of 18 tablets per 90 days is not a
benefit of the Plan. In addition, the quantity limit override request
for the continued use of Viagra for the diagnosis of Prostatectomy
resulting in Erectile Dysfunction (ED) is not supported by the FDA or
substantiative clinical peer reviewed literature. Therefore, the use
is considered reinvestigational or experimental."

Has anyone here had any success in obtaining quantity limit override
request authorization from Empire BC/BS for Viagra following RRP?

Can anyone point me to a recently published review of peer-reviewed
clinical literature on this subject that might aid in the preparation
of an appeal?

Any other suggestions, or would I be better off ordering online from
India? (I'm only half serious.)

Thanks.

Tom

On Jul 12, 8:59 pm, mountainguy1958 <mountainguy1...@gmail.com> wrote:
***
> Can anyone point me to a recently published review of peer-reviewed
> clinical literature on this subject that might aid in the preparation
> of an appeal?
***

Here are a couple of items in response to my own question. Any more
along this line, or related suggestions, would be appreciated.


=================

Efficacy of Sildenafil Citrate in Men with Erectile Dysfunction
Following Radical Prostatectomy: A Systematic Review of Clinical Data

Authors: Montorsi, Francesco; McCullough, Andrew1

Source: The Journal of Sexual Medicine, Volume 2, Number 5, September
2005 , pp. 658-667(10)

Publisher: Blackwell Publishing

Abstract:

Introduction.

Radical prostatectomy is a frequently used treatment option for
prostate cancer; however, prostatectomy is often associated with
significant morbidity, including erectile dysfunction (ED). Aim.

To analyze the efficacy of sildenafil citrate in treating ED after
radical prostatectomy. Materials and Methods.

MEDLINE and CANCERLIT (1998 to January 2004) were searched for English
language articles using the key words prostatectomy, sildenafil, and
phosphodiesterase inhibitors. Eleven studies fulfilled the inclusion
criteria: primary, discrete data sets of postprostatectomy patients
with ED treated with sildenafil monotherapy. Results.

Sample sizes ranged from 13 to 198 (mean age, 61 ± 3 years). Treatment
durations were 4 weeks (or more than four doses) to 1 year, and
sildenafil dosing was in the recommended range (25-100 mg). Seven
studies reported a response rate (range, 14% 53%) for an end point
consistent with the primary analysis outcome (erection sufficient for
vaginal intercourse); the combined estimate of probability of response
was 35% (95% confidence interval [CI], 24% 48%). There was strong
evidence for a lower response rate after non-nerve-sparing (range, 0%
15%) versus nerve-sparing surgery (range, 35% 75%; combined odds
ratio [OR] = 12.1; 95% CI, 5.5-26.6) but not after unilateral (range,
10% 80%) versus bilateral nerve-sparing surgery (range, 46% 72%;
combined OR = 2.21; 95% CI, 0.75-6.54). Conclusions.

The results of these studies demonstrate that with sildenafil, more
than one third of patients with postprostatectomy ED achieved erection
sufficient for intercourse. The odds of responding improved 12-fold
with preservation of at least one neurovascular bundle. Early
treatment failure does not necessarily imply lack of efficacy in the
future, and patients should be encouraged to continue trying
sildenafil, titrating up to 100 mg as needed. Montorsi F, and
McCullough A. Efficacy of sildenafil citrate in men with erectile
dysfunction following radical prostatectomy: a systematic review of
clinical data. J Sex Med 2005;2:658-667.


http://www.ingentaconnect.com/conten...e?format=print

=====================

Nightly Sildenafil Aids Erectile Function After Radical Prostatectomy

Emma Hitt, PhD

April 30, 2003 (Chicago) - Nightly dosing of sildenafil appears to
increase the return of spontaneous nocturnal erections after nerve-
sparing retropubic radical prostatectomy (NSRRP), according to new
study findings presented here at the annual meeting of the American
Urological Association.

Harin Padma-Nathan, MD, from The Male Clinic in Beverly Hills,
California, and colleagues conducted a double-blind study of 76 men
with normal preoperative erectile function, defined as a combined
score of 8 or greater for questions 3 and 4 from the International
Index of Erectile Function (IIEF) and normal nocturnal penile
tumescence (NPT) testing (>/= 10 continuous minutes of 55% or more
base rigidity).

Patients underwent bilateral NSRRP and received postoperative nightly
sildenafil, 50 mg (n = 23) or 100 mg (n = 28), or placebo (n = 25) for
a period of 36 weeks beginning four weeks after surgery.

The researchers assessed erectile function eight weeks after
discontinuation of drug treatment by asking the question, "Over the
past 4 weeks, have your erections been good enough for satisfactory
sexual activity?" as well as by IIEF and NPT assessments. They defined
responders as those having a combined score of 8 or greater for IIEF
questions 3 and 4 and a positive response to the erection question.

Forty-eight weeks after bilateral NSRRP, 14 (27%) of 51 patients
receiving sildenafil had a return of spontaneous erectile function
compared with 1 (4%) of 25 patients in the placebo group (P = .0156).
Postoperative NPT assessments corroborated these results.

No serious treatment-related adverse events were reported, although
two patients left the trial due to treatment-related adverse events.
According to Dr. Padma-Nathan, one had fatigue and the other had
headaches; these patients were both in the 50-mg per night sildenafil
groups.

"Nightly administration of sildenafil for 9 months post-NSRRP
increased the return of spontaneous erections 7-fold compared with
placebo and was well tolerated," the researchers write. The regimen
should be considered as an adjunct treatment to NSRRP, they conclude.

The researchers note that sildenafil may improve oxygenation at the
time of nocturnal erections and/or neuronal regeneration.

"We hypothesized that if we started nightly sildenafil for nine months
early on following surgery, we could influence the preservation of
tissue that is damaged during nerve-sparing prostatectomy and causes
ED, and maybe even improve the rate of repair of the nerve," Dr. Padma-
Nathan said.

But he added that the treatment in this study was not designed to
produce erections for intercourse, just erections during sleep. "They
might not have been very good erections and sildenafil doesn't work
very well until about nine to 18 months after surgery," he pointed
out.

"But clearly the results point to consideration of this therapy in
patients undergoing nerve-sparing prostatectomy," he said.

According to William D. Borkon, MD, director of the Sexual Health
Center at the Park-Nicollet Clinic, in Minneapolis, Minnesota, two or
three centers have been trying this approach in the last year or so,
with the idea that if you treat these people early, they do better.

"Some institutions have suggested using a vacuum device regularly to
keep elasticity of tissue," he said. Another approach is to give an
injection. "This works magnificently on most radical prostatectomy
patients, whether they have had nerve-sparing surgery or not. But
sildenafil only seems to work in patients that have had nerve-sparing
prostatectomy," he said.

The study was sponsored by Pfizer.

AUA 98th Annual Meeting: Abstract 1402. Presented April 29, 2003.