PracticalDermatology

’Tis the season for saying, “Thank you,” and this issue’s theme of forgotten dermatology lends itself nicely to expressing gratitude and remembering why we chose this specialty in the first place.

With all of the financial pressures, regulations, and road blocks, many of us are becoming burnt out and bitter, but we do have much to be thankful for. Here’s a list of some things for which we might be grateful.

Innovative, Life-saving Skin Cancer Medications

We’re thankful that our melanoma and metastatic squamous cell carcinoma (SCC) patients can now survive—and even thrive—with new treatments. Cemiplimab (Libtayo, Regeneron), a PD-1 checkpoint inhibitor, was FDA approved in September. For years, there was little, if anything, doctors could do for metastatic melanoma and SCC patients, but the landscape has totally changed, and there are even therapies that essentially cure metastatic melanoma, including immunotherapy agents, such as PD-1 and CTLA-4-blockers, and targeted therapies including BRAF and MEK inhibitors.

Moreover, the FDA granted accelerated approval to Bavencio (avelumab, EMD Serono/Pfizer) for metastatic Merkel cell carcinoma (MCC). This is the first FDA-approved treatment for metastatic MCC, and a big win for dermatologists and their patients.

Focus on Eczema and Rosacea Comorbidities

It is now widely accepted that psoriasis goes more than skin deep and that the inflammatory process is linked to a host of systemic illnesses, including metabolic syndrome, diabetes, and heart disease, among others. Now, we are seeing the same paradigm form around eczema and rosacea, as a growing body of evidence points to similar co-morbidities. The FDA approval of Dupixent (dupilumab, Sanofi/Regeneron) for eczema underscores how dramatically this disease affects quality of life.

Encouraging News for In-office Compounding

The FDA no longer includes physician offices in its list of settings referred to as “compounding facilities” where drugs are produced. This is a good thing for our patients and us, because it allows us to continue to safely prepare and administer medications. We may still have to deal with USP guidelines, but it helps to have support from the FDA.

The Passage of MACRA

The Medicare Access and CHIP Reauthorization Act (MACRA) created the Quality Payment Program (QPP), which offers two pathways for reimbursement: Merit-based Incentive System (MIPS) and Advanced Alternative Payment Models (APM). Its overarching aim is to move away from volume-based care and toward value-based care. And while it has been something of a mixed bag for us, MACRA’s passage did prevent the Centers for Medicare and Medicaid Services from pulling the global periods from our codes. This was huge, and we shouldn’t forget it.

Produced by and used here courtesy of The National Organization for Rare Disorders (NORD): rarediseases.org.

Orphan Disease Momentum

The FDA has approved more than 700 orphan therapies, nearly half of which have been cleared in the past eight years, according to the National Organization for Rare Disorders, Inc. In 2017, we saw 80 treatments approved by FDA for rare indications, the highest number ever.

Many of these rare, orphan diseases affect the skin. For example, the FDA has granted rare pediatric disease designation for Castle Creek Pharmaceuticals’ diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa (EB).

New Acne treatment, finally

With FDA’s approval of Almirall’s latest drug, Seysara (sarecycline) became the first new acne chemical entity approved in 40 years. Hopefully it will breathe new life into this category and usher in even more new treatments to address acne.

What are you most grateful for? Let us know. Email editor@bmctoday.com, Tweet @Practical_Derm, or comment on our Facebook or LinkedIn pages and we may include your thoughts in an upcoming edition.