I continue to be amazed at the crazy pricing of old drugs with new formulations, and Oracea at over $420./ month is a great example. Doxycycline first came to market 1967 and has been a commonly used antibiotic for my whole career in medicine, especially since it has been available as an inexpensive generic for years now. In recent years we have learned that the use of doxycycline for some conditions, especially periodontal disease, acne vulgaris and acne rosacea may be primarily effective for its anti-inflammatory effects rather than its antimicrobial effects. Doxycycline seems to have anti-inflammatory effects at doses below doses needed to have antimicrobial efficacy. Periostat, a 20 mg dose of doxycycline has been used as a twice daily dose for years by dentists and periodontists to reduce pocket cavity in periodontal disease, seeming to function as a collagenase inhibitor and give slightly improved results over routine aggressive dental care alone. Even better news is that generic doxycycline 20 mg is now available as an FDA approved generic alternative.
Oral antibiotic therapy, topical antibiotic therapy and combination of oral and topical antibiotic therapy has long been used in the treatment of rosacea. Rosacea is a very common and disconcerting facial skin condition. It is estimated to affect up to 16% of women and 6% of men in its milder form, and 1-3% or people in the more severe pustular type. Tetracycline antibiotics in particular have been popular in treatment of rosacea, and the inconvenience of use of tetracycline which needs to be taken on an empty stomach makes doxycycline more popular. The typical antimicrobial dose of doxycycline is 100 mg twice daily, but for rosacea lower doses seem as effective. Enter Oracea, a once daily 40 mg doxycycline dose, packaged as 30 mg of immediate release doxycycline combined with 10 mg that is released slowly to the intestinal tract to give longer low serum level concentrations of doxycycline. The manufacturers claim that this formulation keeps the serum levels of doxycycline below the concentrations needed for antibacterial effects during all or almost all of the day, and can thereby avoid the common doxycycline side effects of yeast infections as well as the induction of antimicrobial resistance. This sounds great, until you read find that the retail price of Oracea is $426.25 / 30 pills at Costco pharmacy vs. $60.51 / 100 pills of doxycyclie hyclate 20 mg, and $10.83 for 100 pills of doxycyline 50 mg. This means that in return for making 10 mg of the once daily dose of doxycycline sustained release Galderma labs marks up the price 11.7x the price of generic twice daily doxycycline, and 65x the price of taking 1/4 of a 50 mg doxycycline tablet. (not incidentally the cost of doxycycline 100 mg tabs is also $10.83/ 100 pills at Costco, the lowest price Costco gives on bottles of 100 pills of prescription). You might assume that it was tremendously expensive for the makers of Oracea to do vast studies of Oracea to prove its efficacy. Not likely as in the only placebo controlled studies I could find the total number of participants was 537 followed over 12 weeks. In these studies Oracea was in fact found to be more effective that placebo, with about a 50% reduction in the “active lesion” counts noted. Still in the first line of the study publication in the American Academy of Pediatrics the Background assumption was, “Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea.” I can find no study comparing 20 mg twice daily or 25 mg twice daily of generic doxycycline with Oracea.
I’ve seen the graphs shown by the Galderma reps showing a lower percentage of a 24 hour period where their product remains below the antimicrobial serum levels, while once daily doxycycline 50 mg rises into the antimicrobial range for part of the day. They jump to the conclusion that this will lead to more yeast infections and more antimicrobial resistance. I could not find any evidence proof of this being the case. Oracea claims an incidence of yeast infection of less than 1%, but has not compared the incidence of yeast infections with Oracea to generic doxycycline 20 mg twice daily. Dentists suggest that the incidence in their patients at this dose is quite low too. They also show not data to support their claim of lower antimicrobial resistance than alternative low dose doxycycline regimens.
Until Oracea has been shown in head-to-head studies to outperform low dose doxycycline immediate release once or twice daily, or has at least shows significantly lower incidence of doxycycline side effects than low dose immedicate release doxycycline I’ll just save my patients the expense of this ridiculously expensive reformulation of an old, well known and effective drug. Don’t fall for the Drug Discount Coupons theory that if it doesn’t cost the patient out-of-pocket dollars it is inexpensive. It’s still a real cost and one we can steer clear of at this point in time. It is estimated that oracea will bring in over $260 million in sales in 2011. That is a quarter of a billion dollars we can avoid in holding health care costs in line.