November 24, 2004
David P. Sheridan, MD, M.S.
Medical Affairs Part B
P.O. Box 100190
Columbia, SC 29202-3190
Re: Palmetto GBA draft LCD #DL18612, Abarelix (Plenaxis) for Prostate Cancer
Dear Dr. Sheridan:
On behalf of the American Urological Association (AUA), I am pleased to comment on the draft local coverage determination (LCD) for the use of Abarelix to treat prostate cancer. As you know, Abarelix was approved by the Food & Drug Administration (FDA) in November 2003 and is marketed under a risk management program that restricts the use of the drug to patients with advanced prostate cancer who have no alternative therapy.
Clinical comparability of Plenaxis and LH-RH drugs
The utilization guidelines of Palmetto's draft LCD state:
If Abarelix is reasonable and necessary for the prevention of testosterone flair, Medicare will allow reimbursement for the drug according to existing pricing procedures for the doses at day 0 and day 15. Beyond these doses castrate levels of testosterone have been achieved and there is no additional clinical benefit of the drug. Therefore, after day 15, reimbursement will be made at the rate of the lowest GnRH analogue of comparable duration.
Also, according to Palmetto LMRP #L6135, Luteinizing Hormone-Releasing Hormone Analogs For Treatment Of Advanced Carcinoma, "if two services are clinically comparable, then Medicare does not cover the additional expense of the more costly one, because this additional expense is not attributable to an item or service that is medically reasonable and necessary."
However, Plenaxis is not clinically comparable to the LH-RH agonists, which precludes grouping it with the drugs that are included in the least costly alternative policy. For example, goserelin acetate (J9202) and leuprolide acetate (J9217) are synthetic LH-RH agonists, whereas Plenaxis is a GnRH antagonist. The mechanism of action of these two types of drugs is different, as Plenaxis reduces testosterone much more rapidly and without testosterone surge that results in clinical flare in many prostate cancer patients who are being treated with LH-RH agonists.
The symptoms associated with testosterone surge can be particularly dangerous for patients with advanced symptomatic prostate cancer, which is part of the reason a physician would choose to treat them with Plenaxis in the first place. Also, Plenaxis is indicated for the treatment of the symptoms of men with advanced prostate cancer for whom LH-RH therapy is contraindicated. Therefore, it is not appropriate to assume that LH-RH agonists and Plenaxis are equivalent after the second dose of Plenaxis.
Draft utilization guidelines 15-day limit
Because the FDA has already established limited guidelines for prescribing Plenaxis, Palmetto's draft utilization guidelines are inappropriately restrictive and do not fall within any FDA approved usage of the medication. The utilization guidelines should be revised with this in mind. Currently, there is no clinical data to support Palmetto's proposed utilization guidelines. Therefore, a physician prescribing Plenaxis within the guidelines of the FDA and the Plenaxis User Safety (PLUS) Program should determine the appropriate therapy and the appropriate timing of therapy for their prostate cancer patients based on the patient's clinical status.
Forcing physicians to switch to an LH-RH agonist after two doses of Plenaxis will undermine the reasons for prescribing Plenaxis, the FDA safety precautions that are already in place and the labeling indications. This may limit the number of physicians who are willing to prescribe Plenaxis, which would be detrimental for patients with advanced symptomatic prostate cancer who have limited treatment alternatives.
Currently, the Centers for Medicare & Medicaid Services (CMS) is developing a national coverage determination for Plenaxis and there are also additional clinical trials being conducted. We urge you to postpone or at least revise your draft LCD until further clinical studies are done to support the utilization guidelines you have proposed or until CMS develops its national coverage determination.
Premature enforcement of an LCD
Also, for patients who were previously treated with leuprolide, you have reduced physician reimbursement for Plenaxis to the least costly GnRH analogue for a comparable duration of treatment based on the rationale that Medicare does not consider this reasonable and necessary. Yet, there is no evidence to suggest that patients have to be naïve of prior hormonal therapy when they receive their first dose of Plenaxis. Also, it is inappropriate to enforce a draft LCD before its effective date. Therefore, we request that this payment differential be reinstated for urologists in South Carolina for whom you have reduced payment without notifying them of this policy in advance.
Thank you for considering our comments. If you have any questions or need additional information, please contact AUA Reimbursement Systems Manager John Ridge, at 410-689-3780.
Brendan M. Fox, MD