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December 01, 2007
Dear Health Care Provider,
We have heard from many health care providers regarding their concerns with Medicare coverage for enzymatic debriding agents employed in the treatment of wounds and burns. It seems that one of our competitors may have confused you regarding Medicare coverage for these agents. We have also heard from health care providers that competitors are telling them that Kovia and Ziox will not be manufactured after January 1st 2008.
Rest assured that there are no critical concerns on the horizon. Therefore, we have prepared the following Questions and Answers to address your concerns and present the entire situation to you.
Stratus Pharmaceuticals, Inc. manufacturers and markets several wound care products including the enzymatic wound debriding agents, KOVIAÒ Ointment (Papain-Urea Debriding Ointment) and ZIOXÒ Ointment (Papain-Urea-Chlorophyllin Copper Complex Sodium Ointment).
As wound care specialists, we are concerned that you have all the necessary medical and regulatory facts relating to the use of debriding agents and the proper selection of the best products for the different patient populations. As such Stratus and its medical and regulatory consultants stand ready to answer any questions you may have. Please call us at (305) 254-6793 or send an email to ahoyo@bellsouth.net if you have additional concerns or questions. We look forward to hearing from you.
Stratus Pharmaceuticals, Inc.
Alberto Hoyo President
Enzymatic Debriding Agents Questions & Answers
Q: I have heard from pharmaceutical representatives that enzymatic debriding agents containing papain and urea will have limited eligibility for reimbursement coverage under Medicare starting in 2008?
A: You may not have been provided with complete and concise information. KoviaÒ Ointment (Papain-Urea Debriding Ointment) and ZioxÒ Ointment (Papain-Urea-Chlorophyllin Copper Complex Sodium Ointment) will not be affected under Medicare Part A and Part B as described below. The changes proposed to Medicare Part D are also explained below.
Q: What will change with the Medicare Part D program regarding papain-urea ointments in 2008?
A: The Center for Medicare and Medicaid Services (CMS) released the annual Formulary Reference NDC File (FRF) for CY 2008 earlier this year. The FRF is a listing of proxy codes that Part D plan sponsors may utilize in the submission of Part D formularies to CMS. This updated list will only contain drug products with FDA approved New Drug Applications (NDAs) and certain DESI drug products specifically defined by CMS. Due to this change, roughly 1500 NDC codes were removed from the FRF list. Hundreds of prescription drugs with varying indications and dosage forms were removed from this reference list including papain-urea ointments. It should be noted that the FRF is only a reference list for Medicare Part D formularies and does not determine coverage under Medicare.
Q: What is Medicare Part D and how does it relate to the other parts of Medicare?
A: Medicare Part D provides prescription drug coverage for outpatients and differs from Medicare Part A which helps cover inpatients while they are in hospitals, skilled nursing facilities, hospice and home health care and from Medicare Part B which covers medical services and drugs in conjunction with physician services. The overwhelming majority (~80%) of wound care patients are covered by Medicare Part A and Part B and these are NOT affected by this decision.
Q: How does the updated CMS Formulary Reference NDC File (FRF) impact reimbursement through Medicare for KoviaÒ Ointment and ZioxÒ Ointment?
A: KoviaÒ and ZioxÒ are categorized as DESI drug products that may be eligible for continued limited reimbursement from Medicare Part D. Please keep in mind that the change in the FRF only addresses Medicare Part D formularies. Sponsors for the Medicare Part D program have the option of using or not using this reference list as a guide for their formulary.
Q: Is this situation with papain-urea products similar to FDA’s actions toward XenadermÒ and similar trypsin-containing ointments?
A: No. Combination trypsin-balsam peru-castor oil products (GranulexÒ, XenadermÒ, etc.) were deemed by FDA to lack substantial evidence of effectiveness for the labeled claims and subsequently moved to DESI-5/DESI-6 (see DESI 10110, February 12, 1972 (37 FR 3202), CMS Release No. 144 dated December 15, 2006 and CMS Release No. 145, dated March 7, 2007). Please note that KoviaÒ (papain/urea) and ZioxÒ (papain/urea/chlorophyllin) are NOT in this group of excluded products.
Q: Will the therapeutic options of the Dermatological Wound Care Agent Class be greatly reduced starting in 2008?
A: To date, CMS has not stated that it will reduce the therapeutic options for this drug class. In addition, CMS has not stated that papain-urea ointments should not be used in 2008. Also, CMS has not stated that papain-urea ointments will not be reimbursable in 2008. Patients under Medicare Part A and B treated with KoviaÒ and ZioxÒ will not be affected.
Q: Should I transition patients who depend on Medicare Part D for their prescription drugs and who are currently treated with papain-urea ointments to collagenase ointment ? What considerable burden will this place on healthcare professionals?
A: CMS and the FDA have NOT recommended any product substitutions relating to the 2008 FRF. The FRF is only a guide for sponsor in determining their formularies. Moreover, papain-urea ointments are not the same as collagenase ointments. Different wounds require different treatment considerations.
Please note the comparative study data published by O. M. Alvarez, et.al. and titled A Prospective, Randomized, Comparative Study of Collagenase and Papain-Urea for Pressure Ulcer Debridement (Wounds 2002 14(8); 293-301). This prospective, randomized, parallel group, open label, multicenter trial was supported by Healthpoint, Ltd. and compared the debriding capabilities of collagenase ointment with an ointment containing papain and urea in nursing home patients with pressure ulcers. The authors noted that “the papain-urea debriding ointment was significantly more effective (p < 0.0167) than the collagenase ointment in reducing the amount of necrotic tissue at each of the three prospectively determined weekly evaluations”. This data confirms that all patients cannot be treated with the same debriding agent. As previously discussed, CMS has not stated that it will reduce the therapeutic options for this drug class. In addition, CMS has not stated that papain-urea ointments should not be used in 2008. Also, CMS has not stated that papain-urea ointments will not be reimbursable in 2008. KoviaÒ and ZioxÒ remain cost-effective products in the enzymatic wound debriding marketplace.
KoviaÒ and ZioxÒ are trademarks of Stratus Pharmaceuticals, Inc. GranulexÒ is a trademark of Mylan Bertex Pharmaceuticals, Inc. XenadermÒ is a trademark of Healthpoint, Ltd.
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