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Letter to Doctors and ADAP directors about changes in weight loss/quality of life medication access

Posted Dec 18 2008 7:28pm
May 8, 2007



Dear ADAP Director:


As you may be aware, your HIV patients will soon face an abrupt change in available treatment options for HIV-related weight loss and AIDS wasting syndrome. In March 2007, Watson Laboratories, the sole manufacturer of the inexpensive HIV anti-wasting agent nandrolone decanoate (also known as Deca-Durabolin), halted production of this agent. Instead, Watson will promote their generic version of Oxandrin (oxandrolone). As patient advocates, we are alarmed that patients now will have to switch to an agent that is over five times the cost, with a greater risk of hepatotoxicity.

Watson had a previous licensing agreement with Savient Pharmaceuticals, the maker of Oxandrin brand oxandrolone. In December 2006, Watson received the go-ahead from Savient to begin marketing oxandrolone as an AB generic.

After acquiring rights to sell generic oxandrolone, in March 2007 Watson stopped production of nandrolone. This left oxandrolone as the only other anabolic steroid treatment on the market that has been studied in trials for AIDS wasting.

BTG Pharmaceuticals, later bought out by Savient Pharmaceuticals, set up a patient assistance program (PAP) for Oxandrin when it was launched in the mid 90’s. But in April, Savient announced the end of the old patient assistance plan. Patients who are most in need and have the fewest resources are plain out of luck.

The projected cost of the generic Oxandrin will be virtually the same as the ‘brand name’ version, with less than a 15% price difference at the time of this letter. A key HIV pharmacy in Los Angeles will be charging $1350.00 for a typical month's worth (20 mg /day) of branded Oxandrin from Savient, versus $1100.00 for the AB generic from Watson. (This compares with a cost of about $200 per month for 200 mg a week of nandrolone.)

Out of the fifty states, only nine AIDS Drug Assistance Program (ADAP) formularies (Alaska, Arizona, California, Delaware, Florida, Maryland, New Hampshire, and New Jersey) cover Oxandrin and nandrolone, six (Connecticut, DC, Kansas, Michigan, Mississipi, and Oklahoma) cover Oxandrin only, and four (Georgia, Indiana, Nevada, and New York) cover nandrolone only; patients in the remaining states either pay for it out-of-pocket, or obtained it through the now-defunct patient assistance program. Private insurers often do not cover Oxandrin without time-consuming prior authorizations, which will leave your HIV wasting patients without medication for weeks if not months. These burdensome prior authorizations must be repeated every three months.

One stop-gap solution for your patients is to avail themselves of nandrolone composed at compounding pharmacies, whose prices are usually even less than Watson's version of nandrolone. However, these pharmacies do not process insurance claims or are equipped to supply ADAPs, Medicaids and Medicare Part D vendors. (A list of compounding pharmacies is attached to this letter.)

Still, use of compounding pharmacies is a stop-gap solution. Your patients and third party payment systems need a more permanent solution. It is imperative that Watson hear from credible health care providers such as yourself that their actions have adversely affected your patients' treatment options, and that Watson should resume nandrolone manufacturing. It would also be important to let Savient hear about how their decision of stopping Oxandrin’s PAP would negatively affect your patients. Watson's fax number is 951-493-5842 and corporate office is 951-493-5300. Savient’s telephone is 732-418-9300 and fax 732-418-0570

We have enclosed copies of two articles on this subject, a list of compounding pharmacies that supply nandrolone, oxandrolone and testosterone gels, and our non-profit resource post cards. For more information on this matter and future updates, please visit http://savehivwastingmeds.blogspot.com/ or our main portal www.powerusa.org. If you wish to help us with this patient advocacy issue, there are sample letters in that blog that could be sent to Watson and Savient from your office.

Fortunately, the incidence of involuntary weight loss has decreased in the post-HAART era but there still is a small number of patients that may need help after an opportunistic infection or other illness. According to a study at Tufts University, 29% of people with undetectable viremia still experience involuntary weight loss and have low body mass index. According to over 9 studies performed in men and women with HIV, physician-monitored use of anabolic agents has been shown to help those patients regain body mass and stamina.

Please do not hesitate to let us know if you need any more information and if you can help us to inform the patient community about their treatment options for involuntary weight loss.


Sincerely,



Nelson Vergel
Director


Applied Pharmacy Services 3207 International Drive
Mobile, AL 36606 877-729-1015 877-729-1019 www.appliedpharmacyrx.com info@appliedpharmacyrx.com $9.50 per ml in a 10 ml multi dose vial or $9.75 per ml for a 4 ml multi dose vial or $10.00 per ml in a 1 ml vial


The Compounding Shop 4000 Park St. N St Petersburg Florida 33709 866-792-6731 727-347-2056 www.gotocompoundingshop.com info@gotocompoundingshop.com $12.00 per ml in 10 ml multi dose vial


Collage Pharmacy 3505 Austin Bluffs Parkway, Suite 101
Colorado Springs, CO 80918
800-888-9358 (800) 556-5893 or (719) 262-0035 http://collegepharmacy.com info@collegepharmacy.com only available as a 10 ml multi dose vial for $94.75 this is for 200 mg/ml, this compounder also offers100 mg/ml


Kronos Compounding Pharmacy Now sold to AnazaoHealth 3675 S. Rainbow Blvd.
Suite #103
Las Vegas, NV 89103-1059 800-723-7455 800-238-8239 www.anazaohealth.com info@anziohealth.com $26.50 per ml for a 10 ML vial


Medaus Pharmacy 2637 Valleydale Road
Birmingham, Alabama 35244 800-526-9184
800-526-9184
http://www.medaus.com\ info@medaus.com $44.00 per ml in one ml vials or or 18.60 per ml in 10 ml multi dose vials


B&B Pharmacy 10244 Rosecrans Ave BellFlower, CA 90706 562-866-8363 http://www.bbpharmacy.com/index.html info@BBPharmacy.com Unavailable at this time,
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