Shanna Miranti, MPAS, PA-C, shares updates on the status of roflumilast foam 0.3% and Cabtreo available in US pharmacies.
“It's always very exciting to get the FDA approval for new products. But until we actually get our hands on these products, we don't always know what the future is going to be for the newly FDA-approved topicals," said Shanna Miranti, MPAS, PA-C, while discussing how to properly access roflumilast foam 0.3% (Zoryve; Arcutis Biotherapeutics) and Cabtreo (Ortho Dermatologics) for patients. Miranti, a board-certified physician assistant at Riverchase Dermatology in Naples, Florida, and the Dermatology Times Q3 Editor in Chief has been eagerly awaiting access to these 2 new topicals along with her colleagues.
Roflumilast foam was approved for the treatment of seborrheic dermatitis by the FDA in December 2023 as the first drug approved for seborrheic dermatitis in more than 2 decades. Roflumilast foam officially became available to clinicians and their patients on January 22, 2024, one month after its approval.
Cabtreo (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) was approved for the treatment of moderate to severe acne vulgaris in October 2023 as the first FDA-approved fixed-dose triple-combination gel for acne. According to Miranti, clinical trial data has proven that Cabtreo is the second most effective product for acne behind isotretinoin. Cabtreo officially became available in pharmacies in mid-February 2024.
In her discussion, Miranti stresses that gaining access to new medications can be difficult, but through proper documentation and patience, dermatology clinicians can get these 2 new topical agents for their patients who need them the most.
“Remember to lean on the resources that the pharmaceutical industry can provide for us. Most companies have Patient Access Managers (PAMs), or Field Reimbursement Managers (FRMs) that can help with any/all access questions and problems if you want to get a particular medicine for your patient,” concluded Miranti.
Hi, my name is Shanna Miranti. I'm a dermatology PA with Riverchase Dermatology in Naples, Florida. Today I wanted to talk to you about a couple of new products that are brand new to the dermatology space, brand new to the market. It's always very exciting to get the FDA approval for new products. But until we actually get our hands on these products, we don't always know what the future is going to be for the newly FDA-approved topicals. It's very exciting to announce that we now have 2 brand new therapies to give to our patients in this early 2024 timeframe. These were products that were originally FDA-approved in the fall of 2023. But it's just taken some time for them to come to the pharmacy space. The first is Zoryve foam, which is roflumilast 0.3%. This is the first FDA-approved product that is in a foam vehicle for seborrheic dermatitis in ages 9 years of age and older. It's very exciting to get our hands on this product. It was not in our electronic medical record system until just last week, but it actually has been now in pharmacies since late January, so we are free to prescribe that.
I want to talk to you a little bit about how to gain access to these products. Because it's not like it used to be in the good old days, we can't just write a prescription and have that patient walk out the door and cross our fingers and hope that the insurance is going to be gracious enough to approve it on the first pass. It's very important to make sure that we do the steps necessary so that we can get the best products for our patients. If we deem that that is the best product for our patients. Access pearls for this product are you want to make sure you're using the correct FDA-approved indication in your notes. If you have to fill out prior authorizations and send in office visit notes, this product is not going to be approved for psoriasis, it's not going to be approved for atopic dermatitis, it's not going to be approved for other psoriasiform dermatosis or eczematous dermatitis. Right now it only has FDA approval for seborrheic dermatitis 9 years of age and older. A little bit of a variation there from the Zoryve cream that is indicated for psoriasis 6 years of age and older. Make sure your age indications and also FDA-approved disease state indications are correct and that we're using the correct product for the correct patient. Also access pearls, we're going to get some denials based upon kind of tried and failed medications in the past.
Most insurance companies and PBMs are going to want to see that patients have tried at least one topical corticosteroid in the past 12 months, and sometimes even a TCI [Topical calcineurin inhibitor.] Even though TCIs are not indicated for seborrheic dermatitis, don't be surprised if you see that on your prior authorization paperwork. So, make sure that you fill out any and all tried and failed. And if we put these into our notes in very kind of bold letters, maybe in a diagnosis comment right up at the top along with that FDA-approved indication and the correct ICD-10 code, it's going to help move that prior authorization process a lot faster for us. Once your electronic medical record system has these loaded, hopefully they'll start prompting us to do electronic prior authorizations, which can then attach the notes. Wouldn't it be wonderful if all of these computers can finally talk to each other and we can have these very easy conversations right now it becomes very, very difficult when we try to approve new products. And we ended up drowning in prior authorization paperwork, which is the last thing we want to do at the end of a very busy day. But if you fill out the steps correctly, if we're using the correct product for the correct indication, then we certainly have a lot better success getting branded products into the hands of our patients. Zoryve foam, just one more little pearl, also has been proven safe and effective for sensitive areas. If you are using it on eyelids behind the ears on the face, because it is nonsteroidal that's important information to include in your prior authorization as well.
The second brand new product that is new in 2024 we actually can get our hands on is Cabtreo. This is a topical product for acne vulgaris by Ortho Dermatologics- Bausch Health. Cab "C A B" stands for clindamycin, adapalene, and benzoyl peroxide; it is the very first triple combination therapy for acne that we have ever had. Now clindamycin, adapalene, and benzoyl peroxide, these are products we have had in our armament for a very long time. A lot of you may be wondering, who cares? You know, they're all together for the very first time is this a big deal? It actually is a very big deal. The data behind this product was phenomenal. It actually has been proven to be the second most effective product for acne behind isotretinoin. It was studied for moderate to severe acne vulgaris, so for really challenging acne cases, and it was one product once a day. So, a single QD dose really helps drive compliance. This is indicated for moderate to severe acne down to age 12 years of age. And it is a specific formulation of clindamycin, adapalene, and benzoyl peroxide that is not able to be combined or compounded. It's finally available in pharmacies.
This is a product that was FDA-approved back in October, and we've been waiting to get our hands on these products. Certainly, those of us who love to treat acne have been very, very excited and very, very excited for this launch. It was finally launched in January, and there were some delays getting it into the pharmacy, but I'm happy to announce it's finally out and pharmacies did receive this product as of the second week of February. If you're going to be prescribing these products for your patients remember to go through specialty pharmacies, the big box pharmacies are typically not going to have these on their shelves as of yet, so you may want to find the best specialty pharmacy that can get access to these products. Both McKesson and Cardinal now have these products available in their warehouses and can ship to specialty pharmacies. Remember, these are going to be your access pearls for getting Cabtreo covered for your patients. It should be moderate to severe acne vulgaris: make sure we are using the proper ICD-10 codes.
A lot of times insurances are going to want our patients to try and fail their formulary alternatives within the past year. So, we can't go back five or six years and see what they tried and failed a decade ago, they may actually make us try and fail some of the individual components of this combination therapy. Now there is more data in the works, and we are going to be seeing more data coming out about safety and efficacy with the individual components of this medication or even two out of the three components of this medication. But that data is not quite available just yet for us to use in our defense of prescribing this medication. It is though at a reasonable price point, it typically is going to be about $75 if it's not covered, instead of paying three individual co-pays for three different products, you can tell your patients are going to pay one copay, it'll be $75 or less, in most situations, and the product will last them about two to three months. This product being again, monotherapy, once a day, can hit three out of the four pillars of acne pathogenesis. When you are trying to decide upon your acne treatment options, make sure you are hitting as many of those four pillars as possible, we want to make sure we are really trying to give our patients the best options and we know that acne is very complex and not every patient can just walk out of the door with one prescription until now. So, this is very, very exciting that we are able to give a patient one product that can really help them stay compliant with their acne regimen.
Please, please remember to be compassionate for your patients, please give your patients some of these wonderful new options that we do have available on the market if you deem that they are going to be appropriate for your commercial patients. And make sure that we are taking the proper steps to make our lives easier for access and help work through that prior authorization process. Whether it be going through cover my meds or whether it be going through specialty pharmacies, maybe even reach out to the pharmaceutical companies. These can be a little bit painful at first and we have to kind of go through the growing pains of learning how to prescribe new products. Once you get it down. I think we will all hopefully be able to get better access to these products which will make our patients happy and hopefully drive success. This is Shanna Miranti and I hope you are all doing well, and I wish you all a wonderful week. Take care.
[Transcript lightly edited for space and clarity]