Prior Auth Protocol

FDA Approved Indications:

Treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply

Health Net Approved Indications and Usage Guidelines:

Diabetic neuropathic ulcer must be on lower extremity with adequate blood supply

AND

Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues

AND

Agreement by the prescriber to provide required wound follow-up care, including debridement if needed

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
Ulcers secondary to vascular occlusion, due to sickle cell disease for example.
Uncorrected cause of recurrent ulceration such as failure to obtain correctly fitting shoe.
Patients with known neoplasm(s) at site(s) of application.

General Information:

The efficacy of Regranex has not been established for the treatment of venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers.
Regranex gel contains a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. Malignancies distant from the site of application have occurred in Regranex users in both a clinical study and in post-marketing use, and an increased rate of death from systemic malignancies was seen in patients who have received 3 or more tubes of Regranex gel

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Regranex	Regranex Gel should be applied topically once daily to the ulcer until complete healing has occurred. To calculate the length of Regranex to apply: Inches (0.65 g per inch): ulcer length X ulcer width X 0.6 Centimeters (0.25 g per centimeter): ulcer length X ulcer width divided by 4	Two week supply based on ulcer(s) size provided by the prescriber. Each two week supply is re-authorized based on required copies of prescriber's office notes for the previous two weeks. Documentation of efficacy of treatment based on reduction in ulcer size is required for continued authorization. The amount of gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. Maximum of 20 weeks.

Product Availability:

Topical Gel 0.01%, 15 gm multi-use tubes

References:

Regranex [Prescribing Information] Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc.; September 2012.
Frykberg, RG et.al. Diabetic Foot Disorders: A Clinical Practice Guideline. J Foot Ankle Surg 2006 Sep-Oct;45(5):S2-66.
APhA Drug Treatment Protocols; Management of Foot Ulcers in Patients with Diabetes. Journal of the American Pharmaceutical Association July/August 2000 Vol 40, No.4.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 26, 2015.