Prior Auth Protocol

FDA Approved Indications:

Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
Delaying time to disease progression in patients with severe, malignant osteopetrosis

Health Net Approved Indications and Usage Guidelines:

Diagnosis of chronic granulomatous disease.

AND

A hematologist or infectious disease specialist must request initial authorization for chronic granulomatous disease.

OR

Diagnosis of osteopetrosis.

AND

An endocrinologist must request initial authorization for osteopetrosis.

Coverage is Not Authorized For:

Pulmonary Fibrosis
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:

The manufacturer`s pivotal study for Actimmune showed the drug offered no benefit versus placebo for primary study endpoints for Idiopathic Pulmonary Fibrosis. Analysis of secondary endpoints demonstrated a trend toward increased overall survival in patients treated with Actimmune with baseline forced vital capacity (FVC) > 70% of predicted. An analysis reported that patients with FVC > 55% also benefited. However, the subgroup with FVC > 60% of predicted did not. Therefore, use of baseline FVC to predict benefit is at best speculative at this time.
A second post-hoc analysis also indicated no benefit in mortality if a dose of > 100 mcg/m² was administered. Additional clarification of appropriate dosing needs to occur. Detailed data on cause of death was not provided. It is currently impossible to speculate that Actimmune was the cause of reduced overall mortality. The absolute number of deaths differed by eight in the study.
Idiopathic pulmonary fibrosis has a Class III recommendation in Micromedex, indicating that the use of Actimmune for this indication is "not useful, and should be avoided".

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
azathioprine (Imuran^R)	various	Up to 3 mg/kg/day
calcitriol (Rocaltrol^R)	various	Up to 32 mcg/day
cyclophosphamide	various	Up to 2 mg/kg/day
prednisone	various	Up to 2 mg/kg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Actimmune	BSA (body surface area) > 0.5 m²: 50 mcg/m² SC TIW BSA ≤ 0.5 m²: 1.5 mcg/kg/dose SC TIW	Length of benefit For AHCS requests: One Year

Product Availability:

Single-Use vial for injection: 100 mcg (2 million IU)/0.5 ml

References:

1. Actimmune [Prescribing information] Roswell, GA: Vidara Therapeutics Inc; June 2013.

2. Raghu G, Brown KK, Bradford WZ et al. A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis. N Engl J Med 2004;350:125:133.

5. Actimmune. In: Drugpoints^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 15, 2015.

6. Gross TJ, Hunninghake GW. Idiopathic pulmonary fibrosis. N Engl J Med 2001;345(7):517-25.

7. Hunninghake GW, Zimmerman MB, Schwartz DA, et al. Utility of a lung biopsy for the diagnosis of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2001;164(2):193-196.

8. Ziesche R, Hofbauer E. Wittmann K, et al. A preliminary study of long-term treatment with interferon gamma-1b and low dose prednisolone in patients with idiopathic pulmonary fibrosis. N Engl J Med 1999;341(17):1264-69.

9. King TE, et al. Ad hoc committee of the Assembly on Clinical Problems, American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. Am J Respi Crit Care Med 2000;161:665-673.

10. Key LL, Rodriguiz RM, Willi SM, et al. Long-term treatment of Osteopetrosis with recombinant human interferon gamma. N Eng J Med 1995;332(24):1594-1599.

11. International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med 1991;324(8):509-516.

12. Walter N, Collard HR, King T. Current perspectives on the treatment of idiopathic pulmonary fibrosis. Proceedings of the Am Thorac Soc. 2006;3(4):330-8.

13. FDA Drug Info Web site. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search-Drug-Name. Accessed June 15, 2015.

14. Actimmune. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed .June 15, 2015.

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

16. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 15,2015.