February 27
IN THIS ISSUE / February 27, 2019
- FDA approves new neurotoxin for frown lines
- Breaking down the FDA’s new sunscreen proposal
- Update on Anthem instituting new modifier 25 payment policy
- A new way to help diagnose allergic versus irritant contact dermatitis
- Dermatologists concerned over use of equine medicine to treat rosacea
- AAD and NPF release new guideline for treatment of psoriasis with biologics
- Skin biopsy rate: An assessment of provider utilization
FDA approves new neurotoxin for frown lines
The U.S. Food and Drug Administration (FDA) has approved prabotulinumtoxinA-xvfs (Jeuveau™), an intramuscular injection for the temporary improvement in the appearance of moderate to severe glabellar lines in adults. It is injected into five different sites of the muscles of the frown lines, and should not be given more frequently than every three months.
FDA approval was supported by clinical data from two U.S. Phase III clinical trials, both of which demonstrated efficacy compared with placebo after 30 days. In the first trial, 67% of patients had temporary improvement of wrinkles between the eyebrows compared to 1% of patients in the placebo group. In the second trial, 71% of patients had temporary improvement of wrinkles between the eyebrows compared to 1% of patients in the placebo group.
In addition to toxins, more dermal fillers targeting specific anatomic areas are expected to make their way to the United States in the near future. Read more in Dermatology World.
Related Links:
- The elixir of youth – Dermatology World (March 2016)
- Experts discuss current and new treatments for hyperhidrosis – Dermatology World (August 2016)
- Body contouring carves out its niche – Dermatology World (June 2016)
- AAD store: Patient Safety in Dermatology
- For your patients: Cosmetic treatments
Breaking down the FDA’s new sunscreen proposal
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that outlines the final monograph for nonprescription, over-the-counter (OTC) sunscreen products. The goal of the sunscreen monograph is to update nonprescription, OTC sunscreens — that are marketed in the United States without FDA-approved applications — to ensure that consumers have access to sun protection options that are considered safe and effective.
What does this mean for the future of sunscreen products? The FDA’s proposal includes provisions that address sunscreen active ingredient safety, dosage forms, SPF, broad-spectrum requirements, and labeling:
Sunscreen ingredient safety (generally recognized as safe and effective, or GRASE):
- Proposes to ban the ingredients trolamine salicylate and PABA from non-prescription sunscreen products as they are not considered GRASE.
- Is requesting sunscreen manufacturers to provide additional safety and effectiveness data on 12 other sunscreen ingredients including: oxybenzone, octinoxate, avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octisalate, octocrylene, padimate O, and sulisobenzone;
- Proposes that products that combine sunscreens with insect repellents are not GRASE.
Dosage forms:
- Proposes that dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks;
- Proposes that powders are eligible for inclusion in the monograph, but requires additional data;
- Proposes that wipes, towelettes, body washes, shampoos, and other dosage forms be categorized as new drugs.
SPF and broad-spectrum requirements:
- Proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+;
- Proposes to require sunscreens with an SPF value of 15 or higher to provide broad spectrum protection. Additionally, as SPF increases for broad-spectrum products, the extent of protection against UVA radiation should also increase.
Labeling requirements:
- Proposes requiring the front of the sunscreen package to list the active ingredients;
- For sunscreens that have not been shown to help prevent skin cancer, proposes new labeling that includes a note to consumers to that effect on the front of the package;
- Proposes to revise the formats for SPF, broad spectrum, and water resistance statements.
Read more about these specific provisions in the proposed rule. The AADA will continue to review the proposed rule and will be issuing official comments to the FDA. Stay tuned to DWW for additional updates.
Related Links:
- Profiling sunscreen ingredients not approved for use in the U.S. – Dermatology World (May 2016)
- Say Yes to Sun Protection infographic
- What are the environmental effects of oxybenzone and other sunscreen ingredients? – Dermatology World (October 2018)
- How to Select a Sunscreen infographic
- Stats and facts: Vitamin D
Update on Anthem instituting new modifier 25 payment policy
On Feb. 26, 2019, the AADA and Anthem met to discuss its announcement that on March 1, 2019, it would begin denying reimbursement when evaluation and management (E/M) services are billed with a modifier 25 on the day of a related procedure when there is a recent service or procedure for the same or similar diagnosis on record.
During this meeting Anthem clarified that this policy will primarily impact claims when the initial encounter and both the E/M and procedure of the follow-up encounter are for the same or related diagnosis. Read more about the Academy’s attempts to rein in this policy, and other payer policies in Dermatology World.
Related Links:
- To 25 or not? Part one – Dermatology World (June 2013)
- To 25 or not? Part two – Dermatology World (July 2013)
- NEW: AADA Coding Resource Center
A new way to help diagnose allergic versus irritant contact dermatitis
According to a new study published in Allergology International, thermography is an effective and reliable way to distinguish between allergic contact dermatitis and irritant contact dermatitis. Researchers sought to evaluate a new method for the noncontact infrared reading of patch tests.
Positive reactions were assessed by an independent patch test reader and classified as an allergic or an irritant reaction. Concurrently, a forward-looking (FLIR) camera attachment for an iPhone was used to acquire infrared thermal images of the patch tests. The results of the study showed that allergic patch test reactions were exemplified by increases in temperature of 0.72°C±0.67°C compared with the surrounding skin. In contrast, irritant reactions were associated with a temperature rise of only 0.17°C±0.31°C. The results suggest that infrared imaging has the potential to become a useful tool for the assessment of patch tests.
While patch testing has been the gold standard for diagnosing allergic contact dermatitis for a century, the key is combining the patient’s history and clinical examination with the results to determine the relevance of positive patch testing. Read more about how to become a rash whisperer in Dermatology World.
Related Links:
- The case for comprehensive patch testing – Dermatology World (September 2018)
- Managing contact dermatitis in patients with metal implants and prosthetics – Dermatology World (October 2017)
- AAD product: Digital patient pamphlets
Dermatologists concerned over use of equine medicine to treat rosacea
The frustrations of living with rosacea are driving some people to experiment with a veterinary medication originally designed to treat parasites in horses, commonly called “horse paste,” Business Insider reported. Horse paste contains ivermectin, the same active ingredient used in an FDA-approved topical gel commonly prescribed to treat rosacea. The compound is believed to inhibit tiny mites of the Demodex genus, which naturally live on human skin. The equine medicine can be purchased for as little as $4 without a prescription.
Dermatologists are concerned because the medicine has not been tested on humans and it’s taken in different formulation and concentration than what is prescribed by dermatologists. “Ivermectin is an excellent treatment for the Demodex mite which can colonize the skin of rosacea patients and lead to flares,” said Margo Weishar, MD, a clinical dermatologist in eastern Pennsylvania. However, “Although the active ingredient is the same as in the veterinary preparation, the [rest of the medicine’s ingredients] have not been studied in humans and may be irritating, cause allergy, or worse when applied to human skin.”
Learn more about how rosacea experts have reexamined the disease’s classification system and about new treatments on the horizon in Dermatology World.
Related Links:
- The many uses of microneedling – Dermatology World (September 2018)
- Connections found between rosacea and dementia, glioma, and Parkinson’s – Dermatology World (August 2016)
- Unlocking the mysteries of rosacea – Dermatology World (August 2013)
- Academy learning module: Acne and rosacea
- Academy product: Rosacea pamphlets
AAD and NPF release new guideline for treatment of psoriasis with biologics
The American Academy of Dermatology and National Psoriasis Foundation (NPF) have released a new guideline for the management and treatment of psoriasis with biologics. The joint guideline, published in JAAD, emphasizes treatment recommendations and the role of the dermatologist in monitoring and educating patients about the benefits and risks of biologic treatments. Read the psoriasis guideline highlights or view more Academy clinical guidelines in the Academy’s Practice Management Center.
Learn more about new and upcoming joint guidelines, as well as the challenges and benefits of the joint guideline development process in this month’s Dermatology World.
Skin biopsy rates: An assessment of provider utilization
According to a study accepted for publication in Dermatologic Surgery, physicians have a lower average biopsy rate than non-physician clinicians. Researchers utilized data from the Medicare Provider Utilization and Payment Data Public Use Files to determine the number of claimed biopsy services for each unique National Provider Identifier (NPI). Additionally, the study found that the average rate of biopsy per provider (physician and non-physician providers) was 0.31 services per visit, which is approximately one biopsy every three visits. Of 18,000 providers, there were 38 outliers — defined as providers who averaged three or more biopsies per visit. According to the study authors, the results do not indicate widespread overutilization of skin biopsy services.
Related Links:
