Prior Auth Protocol

FDA Approved Indications:

Indicated to improve glycemic control in adults with diabetes mellitus

Health Net Approved Indications and Usage Guidelines:

Diagnosis of type 1 diabetes mellitus

OR

Diagnosis of type 2 diabetes mellitus

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:

Tresiba is contraindicated during episodes of hypoglycemia
Long-term safety and efficacy of Tresiba in patients who are pregnant or nursing has not been established
Tresiba is dosed once daily, at any time of the day with a half-life of 25 hours and an extended duration of action of 42 hours.
Tresiba has been shown to be non-inferior to insulin glargine and insulin detemir for type 1 and type 2 diabetes mellitus.
The mean reduction in HbA1c met the pre-specified non-inferiority margin of 0.4%, with an estimated treatment difference of -0.01% (95% CI -0.14 to 0.11) in type 1 patients, and an estimated treatment difference of 0.09% (95% CI -0.04 to 0.22) in type 2 patients.
The rate of nocturnal hypoglycemic episodes was significantly lower in the maintenance phase for type 2 patients using Tresiba with a difference of 0.64 nocturnal confirmed hypoglycemic episodes per patient-year of exposure (95% CI 0.42 to 0.98).

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Insulin glargine (Lantus^R Solostar^R)	Diabetes mellitus, type 1 Approximately one-third to one-half of the total daily insulin dose SC QD, with a rapid- or short-acting insulin. Diabetes mellitus, type 2 0.2 units/kg SC QD	Diabetes mellitus, type 1 Individualize dosage Diabetes mellitus, type 2 10 units/day
Insulin detemir (Levemir^R Flexpen^R)	Diabetes mellitus, type 1 Approximately one-third of the total daily insulin SC QD, with a rapid-or short-acting insulin. Diabetes mellitus, type 2 10 units/day (or 0.1-0.2 units/kg) SC QD in the evening	Diabetes mellitus, type 1 Individualize dosage Diabetes mellitus, type 2 10 units/day
Insulin glargine (Toujeo^R Solostar^R)	Diabetes mellitus, type 1 Approximately one-third to one-half of the total daily insulin dose SC QD, with a rapid- or short-acting insulin. Diabetes mellitus, type 2 0.2 units/kg SC QD	Diabetes mellitus, type 1 Individualize dosage Diabetes mellitus, type 2 10 units/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Tresiba	Diabetes mellitus, type 1 One-third to one-half of the total daily insulin dose SC QD with the remainder given as a short-acting insulin divided between each daily meal. Diabetes mellitus, type 2 10 units SC QD initially.	Length of benefit

Product Availability:

Insulin human 3ml Flextouch disposable prefilled pen; 100 units/ml (U-100), 200 units/ml (U-200)

References:

1. Tresiba [Prescribing Information]. Bagsvaerd, Denmark: Novo Nordisk A/S; September 2015.

2. Cefalu WT, et al. Standards of Medical Care in Diabetes 2015. Diabetes Care, volume 38, supplement 1, January 2015.

3. Inzucchi SE, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes care (online). care.diabetesjournals.org. April 2012.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending