- See Important Safety Information Below
- Full U.S. Prescribing Information including BOXED WARNING & Medication Guide
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REGRANEX® (becaplermin) Gel, 0.01%
Coverage Information



DISCLAMER: Product formulary positioning can change without notice and will vary by benefit design. The information provided herein does not constitute a guarantee that reimbursement will be received. Healthpoint is providing this information on an “AS IS” basis, and without warranty or guarantee, expressed or implied, as to completeness, reliability or otherwise. It is intended as general information only and provided as a courtesy and not as an authoritative basis for purchasing or clinical decisions.

REGRANEX® Gel is a biologic, self-administered drug; therefore it should be covered under a patient’s drug insurance benefit similar to other prescription drugs. There are many different payers and types of drug benefits within different market segments. Some examples are: Medicare Part D, commercial drug plans, fee-for-service state Medicaid, managed Medicaid plans within each state, and government payers like the Veterans Administration.

Medicare Part D
For the 2012 benefit year, REGRANEX® Gel is on formulary for approximately 94% of the seniors under the Part D program. Please note that approximately 75% of the patients whose plan covers Regranex Gel will have some type of formulary restriction that requires a combination of prior authorization and/or quantity limits. (Approximately 19% of seniors have unrestricted access to REGRANEX Gel.)

Tier placement for REGRANEX Gel for the Medicare Part D plans varies amongst preferred brand, non-preferred brand, or specialty tiers. Co-pay for seniors vary from a fixed co-pay range of approximately $38 to $90 per prescription to a co-insurance contribution ranging from 25% to 35% of the cost of the drug.

Commercial Drug Benefits
Healthpoint's research indicates that many of the national drug plans and pharmacy benefit managers list REGRANEX® Gel on their formulary with a mix of preferred or non-preferred positioning. You can expect to see a prior authorization requirement and/or monthly quantity limits on many of the formularies. Most of the copays appear to be a fixed dollar amount ranging from $25 to $90 per prescription.

Medicaid Fee for Service Benefit Coverage
The majority of state Medicaid agencies reimburse REGRANEX® Gel with a prior authorization requirement. In general, the conditions for approval of the prior authorization request mirror the clinical indications for REGRANEX Gel.

As more states enroll Medicaid beneficiaries into managed Medicaid plans, it is likely that coverage will vary between the plans operating in the same state.

 

References
U.S. Food and Drug Administration. Consumer Health Information (CHI). A guide to drug safety terms at FDA.
http:// www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107976.pdf. Last updated April 11, 2008. Last accessed July 11, 2011.

 

Indication and Important Safety Information including Boxed Warning

 

 

 

Indication

  • REGRANEX® (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.
  • Limitations of use:
    • The efficacy of REGRANEX® Gel has not been established for the treatment of pressure ulcers and 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 (State I or II, IAET staging classification) or ischemic diabetic ulcers.
    • The effects of REGRANEX® Gel on exposed joints, tendons, ligaments, and bone have not been established in humans.
    • REGRANEX® Gel is a non-sterile, low bioburden preserved product. Therefore it should not be used in wounds that close by primary intention.

 

Important Safety Information 

 

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY
An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX® Gel in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy. [See Warnings and Precautions (5.1)].

 

  • Contraindications—REGRANEX® Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.
  • Warnings and Precautions—
    • Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. REGRANEX® Gel shoul be used with caution in patients with a known malignancy.
    • If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered.
  • Commonly observed adverse reactions—
    • In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX® Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone.
    • Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX® Gel.
  • Use—
    • REGRANEX® Gel is for topical use; not for oral, ophthalmic or intravaginal use.
    • REGRANEX® Gel should not be used by patients sensitive to any of its components.
    • The use of REGRANEX® Gel with other topical drugs has not been studied.
    • The amount of REGRANEX® Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending upon the rate of change in ulcer area.
    • If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX® Gel should be reassessed.
  • Pediatric Patients—Safety and effectiveness of REGRANEX® Gel in pediatric patients below the age of 16 years have not been established.
  • Pregnancy & Nursing Mothers—REGRANEX® Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REGRANEX® Gel is administered to nursing women.

Please see Full Prescribing Information, including Boxed Warning and Medication Guide.

 

To report suspected adverse reactions, contact Healthpoint Biotherapeutics at 1-800-441-8227 or FDA at www.fda.gov/medwatch or at 1-800-FDA-1088.

 

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