Prior Auth Protocol

FDA Approved Indications:

For the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS)

Health Net Approved Indications and Usage Guidelines:

Diagnosis of vasomotor symptoms associated with menopause (e.g., hot flashes, night sweats)

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Because of the well-established safety profile of paroxetine at higher doses, FDA agreed that the development of Brisdelle could rely on FDA`s findings of safety for Paxil^R (paroxetine hydrochloride) and referencing the nonclinical and clinical pharmacology data previously submitted in the New Drug Application (NDA) for Pexeva^R (higher dose paroxetine mesylate formulation approved for psychiatric indications). The Pexeva NDA included studies directly comparing Paxil and Pexeva that demonstrated no difference in toxicity, mutagenicity, or PK parameters of the two salt forms.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
estradiol (Estrace^R) oral tablet	1 to 2 mg PO QD of estradiol; administration should be cyclic (e.g., 3 weeks on and 1 week off)	2 mg per day
Alora^R, Esclim^R, Estraderm^R, Minivelle^R, Vivelle^R, Vivelle-Dot^R, Climara^R, Climara^R Pro (estradiol) transdermal patch	Alora, Esclim, Estraderm, Minivelle, Vivelle, Vivelle-Dot: one patch topically twice weekly Climara, Climara Pro: one patch topically once weekly	Alora, Esclim, Estraderm, Minivelle, Vivelle, Vivelle-Dot: one patch twice weekly Climara, Climara Pro: one patch once weekly
Premarin^R (conjugated estrogens) oral tablet	0.3 mg PO QD	0.3 mg per day
PremPro^R, PremPhase^R (conjugated estrogen/medroxyprogesterone) oral tablet	PremPro: one tablet PO QD PremPhase: one tablet containing conjugated estrogens 0.625 mg PO on days 1-14 followed by 1 tablet containing conjugated estrogens 0.625 mg/medroxyprogesterone 5 mg PO on days 15-28	0.625 mg/5 mg per day
Menest^R (esterified estrogen) oral tablet	1.25 mg PO QD	1.25 mg per day
estropipate (Ogen^R) oral tablet	0.75 mg PO QD	6 mg per day
esterified estrogen/methyltestosterone (Estratest^R, Estratest^R H.S.)	0.625 mg/1.25 mg - 1.25 mg/2.5 mg PO QD cyclically (e.g., 3 weeks on, 1 week off)	1.25 mg/2.5 mg per day
norethindrone/ethinyl estradiol (FemHRT^R) oral tablet	5 mcg/1 mg PO QD	5 mcg/1 mg per day
estradiol/norethindrone (Activella^R) oral tablet	0.5 mg/0.1 mg - 1 mg/0.5 mg PO QD	1 mg/0.5 mg per day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Brisdelle (paroxetine)	7.5 mg PO QHS	Length of Benefit

Product Availability:

Capsule: 7.5 mg

References:

Brisdelle [Prescribing Information]. Miami, FL: Noven Therapeutics, LLC; July 2013.