June 27

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IN THIS ISSUE / JUNE 27, 2018


FDA does not approve topical psoriasis treatment

The U.S. Food and Drug Administration (FDA) has not approved plaque psoriasis lotion, halobetasol propionate and tazarotene (Doubrii). The FDA sent a Complete Response Letter (CRL) requesting that Valeant address questions related to pharmacokinetic data.The FDA did not “specify any deficiencies related to the clinical efficacy or safety” of the treatment. The agency’s letter “only noted questions regarding pharmacokinetic data,” said Joseph Papa, Valeant’s chairman and CEO.

In other psoriasis-related news, the FDA has approved a label update for secukinumab (Cosentyx) indicating the drug inhibits progression of joint structural damage in psoriatic arthritis.

While topical treatments may be a boon for patients with mild-to-moderate psoriasis, some patients may struggle with treatment adherence. Read more in Dermatology World.

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Medicare to limit reimbursement for aminolevulinic acid HCI, 10%

The AAD has learned of an impending nationwide Medicare limit on reimbursement for aminolevulinic acid HCl, 10% (Ameluz). Starting on July 1, 2018, all Medicare contractors may limit payment for this product to 30 mg (three 10 mg units), billed with code J7345. The product comes in a 2 gm, or 2000 mg tube, which would be 200 units. This is a consequence of a Medically Unlikely Edit (MUE) set at three that will activate on July 1.  

The Academy has appealed this limit and expects a resolution in the next several weeks. However, the reimbursement limit may not be rectified until Oct. 1, 2018. In the interim, please review all affected claim explanation of benefits (EOBs) for under-reimbursement for J7345 and appeal payment rejections to the appropriate Medicare Administrative Contractor (MAC) using the Medicare Redetermination Form 20027. For more information, contact Faith McNicholas at fmcnicholas@aad.org.


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Senators urge FDA to examine drug shortages

A group of 31 senators wrote a letter to FDA Commissioner Scott Gottlieb requesting recommendations on how to address nationwide drug shortages, reports The Hill. The letter, led by Sens. Chris Murphy (D-Conn.) and Bill Cassidy (R-La.), asked the agency to convene its Drug Shortages Task Force to determine the causes for drug shortages and policy recommendations to fix the issue no later than the end of 2019. The letter specifically calls attention to routinely used medications, such as local anesthetics and sterile IV fluids, citing that the shortages “limit patient access to the most appropriate care.” The letter stated, “These are essential products used every day, and for many of them are no suitable alternatives that are readily available.”

Dermatologists and their patients continue to be adversely impacted by drug shortages. The American Academy of Dermatology Association is engaged with stakeholders, including manufacturers, suppliers, the FDA, and Congress to facilitate access for patient care. Learn more about the Academy’s advocacy efforts on drug shortages, and stay tuned for the September issue of Dermatology World for an in-depth look at the causes and impact of these shortages.

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Sen. Schumer works to pull ‘sunscreen pills’ from market

Last month, the FDA issued a warning against four companies illegally marketing pills offering protection from the sun — lacking any data to back up its claims. Sen. Chuck Schumer (D-N.Y.) is arguing that the FDA’s warning is not enough and is urging the government to pull these ‘sunscreen pills’ from the market, as they falsely claim to protect users from sunburn. The pills are marketed under the brands Sunsafe Rx, Solaricare, Sunergetic, and Advanced Skin Brightening Formula.

Supplements aside, there are several sunscreen ingredients that are not approved for use in the United States. Read more about these ingredients and where things stand in the approval pipeline in Dermatology World.

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NEW: Urticaria guidelines

The American Academy of Dermatology (AAD) was one of 42 organizations from 25 countries that developed updated guidelines for urticaria. Check out the EAACI/GA²LEN/EDF/WAO Guideline for the Definition, Classification, Diagnosis and Management of Urticaria on the AAD website. Read more about these guidelines in this month’s issue of Dermatology World.

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