Prior Auth Protocol

FDA Approved Indications:

For the treatment of hypertension.
- Azor, Tekamlo, Tekturna, and Tekturna HCT are indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals
- Amturnide and Tribenzor are not indicated for initial therapy.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of hypertension

AND

Failure or clinically significant adverse effects to one formulary, Angiotensin II Receptor Blocker (ARB) or ARB combinations (e.g., Benicar (olmesartan)/Benicar HCT (olmesartan/hctz), irbesartan, losartan, candesartan, telmisartan, valsartan)

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:

Use of Tekturna in combination with maximal doses of angiotensin-converting enzyme (ACE) inhibitors has not been adequately studied.
Tekturna may be administered with other antihypertensive agents. Most exposure to date is with diuretics, an angiotensin receptor blocker (valsartan), or a calcium channel blocker (amlodipine) and the drugs together have a greater effect at their maximum recommended doses than either drug alone. Tekturna should not be used in combination with ARBs or ACE inhibitors in diabetics.
The rates of cough for Tekturna were about one-third to one-half the rates observed in the ACE inhibitor arms in active-controlled trials.
All products in this group have the boxed warning that the medications should be discontinued as soon as pregnancy is detected. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus.
Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Benicar^R(olmesartan)	20 - 40 mg PO QD	40 mg/day
valsartan (Diovan^R)	80 - 320 mg PO QD	320 mg/day
losartan(Cozaar^R)	25 mg - 100 mg PO QD	100 mg/day
losartan/HCTZ (Hyzaar^R)	50 mg/12.5 mg - 100 mg/25 mg PO QD	100 mg/25 mg/day
irbesartan (Avapro^R)	150 - 300 mg PO QD	300 mg/day
irbesartan/HCTZ (Avalide^R )	150/12.5 - 300/25 mg PO QD	300/25 mg/day
telmisartan/amlodipine (Twynsta^R)	40/5 - 80/10 mg PO QD	80/10 mg/day
amlodipine /valsartan (Exforge)	5/160 - 10/320 mg PO QD	10/320 mg/day
Benicar^R HCT (olmesartan/HCTZ)	20/12.5 - 40/25 mg PO QD	40/25 mg/day
valsartan/HCTZ (Diovan^RHCT)	160/12.5 - 320/25 mg PO QD	320/25 mg/day
amlodipine/valsartan/HCTZ (Exforge HCT)	5/160/12.5 - 10/320/25 mg PO QD	10/320/25 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Tekturna	150 to 300 mg PO QD	Length of Benefit
Tekturna HCT	150 - 300 mg aliskiren/12.5-25 mg hydrochlorothiazide PO QD	Length of Benefit
Azor	5-10 mg amlodipine/20-40 mg olmesartan PO QD	Length of Benefit
Tribenzor	20-40 mg olmesartan/5-10 mg amlodipine/12.5-25 mg hydrochlorothiazide PO QD	Length of Benefit
Tekamlo	150-300 mg aliskiren/5-10 mg amlodipine PO QD	Length of Benefit
Amturnide	150-300 mg aliskiren/5-10 mg amlodipine/12.5-25 mg hydrochlorothiazide PO QD	Length of Benefit

Product Availability:

Amturnide (aliskiren/amlodipine/hydrochlorothiazide): 150 mg/5 mg/12.5 mg, 300 mg/5 mg/12.5 mg, 300 mg/5 mg/25 mg, 300 mg/10 mg/12.5 mg, 300 mg/10 mg/25 mg tablet
Azor (amlodipine/olmesartan): 5 mg/20 mg; 5 mg/40 mg; 10 mg/20 mg; 10 mg/40 mg tablet
Tekamlo (aliskiren/amlodipine): 150 mg/5 mg; 150 mg/10 mg; 300 mg/5 mg; 300 mg/10 mg tablet
Tekturna: 150 mg, 300 mg tablet
Tekturna HCT (aliskiren/hydrochlorothiazide): 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg tablet
Tribenzor (olmesartan/amlodipine/hydrochlorothiazide): 20 mg/5 mg/12.5 mg; 40 mg/5 mg/12.5 mg; 40 mg/5 mg/25 mg; 40 mg/10 mg/12.5 mg; 40 mg/10 mg/25 mg tablet

References:

1. Tekturna [Prescribing Information]. East Hanover, NJ: Novartis; March 2015.

2. Azor [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo; September 2014.

3. Tekturna HCT [Prescribing Information]. East Hanover, NJ: Novartis; March 2015.

4. Tribenzor [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo; September 2015.

5. Tekamlo [Prescribing Information]. East Hanover, NJ: Novartis; March 2015.

6. Amturnide [Prescribing Information]. East Hanover, NJ: Novartis; March 2015.

7. 2014 Evidence-based guideline for the management of high blood pressure in adults. Report from the panel mambers appointed to the eighth joint national committee (JNC8). JAMA. 2014;311(5):507-520.

8. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically.Accessed: June 15, 2015.