PDE-5 Inhibitors Post-Prostectomy

[MedNecessReviewer]

Plans frequently exclude coverage of erectile dysfunction drugs. We've seen an increase in the number of exception requests related to the use of PDE-5 inhibitors for penile rehabilitation post prostectomy. Drugs like Viagra and Cialis are prescribed anywhere from 3-times per week to daily for rehabilitation and prevention of ED. Our review of the current literature found that the theory behind the rehabilitation is based on animal models and that that there is a lack of standard dosing regimens across the published clinical studies. This has led us to deny coverage for this particular indication due to investigational use.

How have others been reviewing and determining these coverage determinations?

[participant1]

We also found limited data but based on the expert consult we decided to allow daily use of PDE-5 inhibitors shortly after prostatectomy for up to 6 months.

[diana.papshev]

A review of publicly available policies showed that most plans do not specify coverage criteria in the cases of rehabilitation post prostatectomy. One managed care organization, the Regence Group, specifically stated that the use of PDE-5 inhibitors for preservation of penile function after radical prostatectomy is investigational (link to the Regence Group’s policy).

Of note, two related randomized placebo-controlled studies were published in July of 2008:
• Padma-Nathan et al. Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy. Int J Impot Res. ePub ahead of print, July 24, 2008. - 76 men (enrollment was prematurely stopped due to low response rates) were randomized to sildenafil 50 mg, sildenafil 100 mg, or placebo nightly for 36 weeks. Spontaneous erectile function occurred in 27% of the sildenafil group vs 4% of the placebo group (p < 0.02).
• Montorsi et al. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Eur Urol. ePub ahead of print, July 9, 2008. – 628 men were randomized to nightly vardenafil, on-demand vardenafil, or placebo for 9 months, followed by a 2-month washout period. After the washout period, differences in the percentages of patients with the International Index of Erectile Function erectile function domain score of >=22 were not statistically significant.

Does anyone know of any recent post prostrate cancer benefit studies done? Also, is the use of PDE-5 inhibitors in any certain guidelines?


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[Claygesic]

We currently still look at it as lifestyle enhancing but behavioral health concerns are beginning to bouble up. MD Anderson supports the utilization of these products along with vacuum products/injectibles and are committed to the rehab. Expert opinions generally drive coverage in oncology area if this is a sticking point for provider relations. We have not asked P&T for formal review or position at this time and allow current benefit to drive management

[chantell.reagan]

An updated literature search yielded several small studies looking at pharmacotherapy (primarily sildenafil) post-prostatectomy to preserve erectile function and eventual return of functional natural erections:

•A recent small study involved 40 men with normal pre-operative erectile function who were randomized to sildenafil or a control 2 weeks post radical prostatectomy (RP). Using the International Index of Erectile Function (IIEF) questionnaire, scores for the sildenafil group were statistically significant for the mean score (25 +/- 6 vs. 17 +/- 9, p < 0.05) and potency rate (87% vs. 56%) at 24 weeks after the surgery.
•In another prospective study with 77 patients, sildenafil or tidalafil (tiw) were evaluated in a postoperative penile rehabilitation protocol. More than 60% of patients discontinued therapy within 6 months.
•In a 2009 restrospective study of 92 patients, researchers attempted to predict success of using oral sildenafil or intracavernosal injection (if oral therapy failed) for penile rehabilitation during 18 months post-prostatectomy. They concluded that approximately 57% of patients using a pharmacological rehabilitation program had return of functional natural erections. The authors noted that "predictors of successful outcome included nerve-sparing surgery, early post-RP presentation, young age (<60), and absence of vascular comorbidities."

Additionally there is a handful of ongoing clinical trials assessing pharmacologic penile rehabilitation, including sildenafil and testosterone.

Sources:

Trials registered with NIH

Pace G et al. Penile rehabilitation therapy following radical prostatectomy. Disabil Rehabil. 2010 Feb 15. [Pubmed abstract]

Lee DJ et al. Penile rehabilitation protocol after robot-assisted radical prostatectomy: assessment of compliance with phosphodiesterase type 5 inhibitor therapy and effect on early potency. BJU Int. 2010 Feb;105(3):382-8. [Pubmed abstract]

Muller A et al. Penile rehabilitation following radical prostatectomy: predicting success. J Sex Med. 2009 Oct;6(10):2806-12. [Pubmed abstract]

[Nochmar]

We've only received a couple of requests for this indication. My conclusion was the same as the other writers; it is definitely still at the investigational stages, but it seems more likely to provide benefit for LUTS than erectile function. The requests that I have received have not been consistant with the doses used in the clinical trials. At this point, I don't believe there is enough information available to justify coverage. If coverage would be approved, I think we would place a time limit on it to help ensure we stay close to the limitations of our benefit certificate.

[diana.papshev]

Anonymous member request:

"I am wondering if you have any information on what plans are doing for patients requesting daily PDE-5 inhibitors for rehabilitation post prostatectomy?"

The survey will be conducted between May 10th and May 14th.

[diana.papshev]

Additional survey comments:

#1:

"There are no data from properly done RCTs that this use hastens or ensures the return to normal pharmacologically unassisted erectile function which is the really the reason for daily prolonged use of this treatment. Whatever plan quantity limits apply to use of these drugs to treat ED should also apply to this use."

#2:

"Use PA to identify selected population."

#3:

"We exclude these drugs for ANY reason"

[diana.papshev]

Additional survey comments (continued):

#4:

"If they were receiving Cialis daily how would you know?"

#5:

"Our group has reviewed many cases. Both our internal clinical team and independent reviewers have concluded that the use of daily pde-5 inhibitors post prostatectomy is investigational/experimental. There is no standard dosing or treatment duration in the literature. Additionally, most of the presumed benefits are based on animal studies and not humans."

#6:

"Depends on whether this type of drug is covered by the plan, and, if so, whether there are quantity restrictions. these are treated in the same manner as other requests for these drugs."

[diana.papshev]

Survey Results: