The obstacles to reimbursement of therapies for rosacea prevent many patients with this condition from receiving the most effective treatments, according to 2 dermatologists who spoke with American Health & Drug Benefits.
“I want to put many of my patients on 1% MetroGel right from the beginning, because practically all rosacea has a redness component,” said Jennifer Allen, MD, of Allen Dermatology and Skin Cancer in Macon, GA. She explained that this metronidazole agent addresses redness, can often keep the condition in check, and can help avoid the need for an oral antibiotic. Unfortunately, reimbursement issues usually prevent this, she said.
The .75% concentration of metronidazole gel, which is approved by the US Food and Drug Administration (FDA) for the treatment of rosacea, has been available for years in generic form, and therefore is usually readily covered by commercial health insurers and by Medicare, “but it does not help with redness,” Dr Allen noted.
By contrast, 1% MetroGel contains niacinamide, which may have some effect on redness and helps with papules and pustules as well. To be reimbursed for 1% MetroGel, however, patients must first try and fail therapy with .75% metronidazole or pay out of pocket. “In some cases, the 1% MetroGel will still not be approved [by payers],” Dr Allen said. “This is very frustrating for dermatologists and for patients.”
Joshua Zeichner, MD, Assistant Professor of Dermatology and Director of Cosmetic and Clinical Research at Mt Sinai Medical Center in New York, agreed. “Reimbursement depends on the drug plan. Especially with older patients, where Medicare is the primary payer, even with supplemental coverage reimbursement can be a problem. Often, we have to resort to generic medications, because the branded agents are too expensive for them,” he said.
Drug Formulation Matters in Dermatology
Dr Zeichner emphasized that, in dermatology especially, generic drugs are not equivalent to the brand-name medications and therefore do not achieve the same results. He pointed out differences not only in the concentration of the active ingredient, but also in the hydrating vehicle base and the treatment schedule.
“For the topical medications metronidazole and azelaic acid, the brand-name products have enhanced penetration due to the makeup of the vehicle, and this provides better efficacy with less irritation. Formulation matters in dermatology,” Dr Zeichner maintained.
Beyond the product’s ingredients, he noted, “Generic metronidazole is a .75% gel that needs to be applied twice daily. The 1% MetroGel is applied only once a day. Studies have shown that the simpler the regimen, the more adherent the patient. With the 1% MetroGel there are fewer opportunities for a missed application,” Dr Zeichner pointed out.
Dr Allen indicated that obtaining FDA approval for the brand-name azelaic acid drugs, Finacea and Azelex, has also been a problem. She added that intense pulsed light can be quite effective for the redness, but again, there is no third-party reimbursement for this. “Laser costs about $330 per treatment, and many patients require this about 4 times a year to control redness,” Dr Allen noted.
The same principle applies to oral therapies, the dermatologists pointed out. “The sustained-release 40-mg doxycycline pill, Oracea, is sub-antimicrobial, which is not the same product as the 50-mg generic doxycycline. The pharmacokinetic data are very different,” Dr Zeichner pointed out.
“Oracea is the only approved oral therapy for rosacea, and it should not be substituted. The highest concentration of this drug is still below the minimal inhibitory concentration. It truly is sub-antimicrobial, and that is not true of the 50-mg doxycycline,” he emphasized. “This is one case where the generic drug may be less expensive, but it truly is not the same drug as the brand-name drug. With the generic, which is antibacterial, you also run the risk of developing bacterial resistance with long-term use, and these drugs are designed for long-term use, as rosacea is a chronic condition,” Dr Zeichner added. “You can quickly improve symptoms, but if you stop treating it, the disease will continue marching along and you will get flares.”
Dr Allen noted that she too is frustrated by the lack of reimbursement for Oracea. “Medicare only pays for generic medications for the first-line treatment of dermatologic conditions, and these are not always the best treatments,” she reiterated. “For example, I like to prescribe low-dose 40-mg doxycycline, but Medicare won’t pay for this because there is no generic version.”
Other Limitations to Treating Effectively
Dr Zeichner and Dr Allen advocate the use of manufacturer rebates and discounts. “Since branded medications for rosacea can be expensive for the patient, we often take advantage of manufacturer’s coupons, which can defray some of the cost to the patient,” Dr Allen said.
But this form of assistance only goes so far, they agreed. “They may be capped at $50 or $150, or used only for the initial prescription, not refills. And for the most part, these cards don’t work for Medicare,” Dr Zeichner noted. He added that some third-party payers approve only topical medications in smaller-sized tubes if 2 sizes are available.
Dr Zeichner and Dr Allen said that the financial expense of treating rosacea is part of the burden felt by individuals who suffer from this chronic medical condition. “The cost of treating rosacea often must be borne by the patient due to problems with reimbursement,” Dr Allen emphasized. “This is really a challenge for patients and physicians who want better drugs but they are not available,” Dr Zeichner added.
Addressing the question of payer coverage for dermatologic conditions such as rosacea, Matthew Mitchell, PharmD, MBA, Manager, Pharmacy Services, SelectHealth, said that “unlike psoriasis, which is on the payer’s radar, treatment options for acne and rosacea may not carry as much priority” for payers at present. However, he said, this is gradually changing. Dr Mitchell noted that with the growing availability of new and promising therapies for rosacea and other dermatologic conditions, the need to provide appropriate coverage for patients suffering from these conditions has “contributed to the need for payers to reevaluate the benefit of these therapies compared with generic tetracycline options.”