July 11

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IN THIS ISSUE / JULY 11, 2018


Amazon upends drug market with purchase of online pharmacy

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Amazon recently announced it will purchase online pharmacy PillPack for about $1 billion. PillPack claims to simplify treatment plans for patients with chronic conditions by sorting medication by dose and delivering the drugs to patients’ doorsteps. 

According to a research firm, about 90% of all prescriptions are filled at a pharmacy counter. Although Amazon may have a new opportunity, said Stephen Buck, a pharmaceutical supply-chain expert who co-founded the drug-pricing website GoodRx, “A growing number of Americans are without health insurance or have such high deductibles that they may be better off bargain shopping on their own.”  

According to a 2017 Consumer Reports survey, in 2016-2017 four million Americans walked away from the pharmacy empty-handed because the cost of their medications was too much to bear. Read more about soaring drug prices and what is being done to bring costs down in Dermatology World. Need help getting your patients the medication they need? Check out prior authorization assistance tools, including a templated letter generator, in the AADA's Practice Management Center.

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JAAD paper reviews research on chemical sunscreen and the environment

A new study published in the Journal of the American Academy of Dermatology examines the current research regarding the potential environmental impact of chemical sunscreen ingredients. This paper comes on the heels of Hawaiian legislation banning the sale and distribution of sunscreens containing the ingredients oxybenzone and octinoxate, citing research that suggests they may contribute to coral bleaching. While the scientific evidence highlighted in the article raises environmental concerns related to sunscreen, the authors maintain that more research is necessary and emphasize the importance of protection from UV exposure. To view a press release issued by the Academy, visit the AAD website.

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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Clarification: FDA response to topical psoriasis treatment application

In the June 27 issue, DWW reported that the U.S. Food and Drug Administration (FDA) “denied approval for plaque psoriasis lotion, halobetasol propionate and tazarotene (Doubrii).” To clarify, the FDA sent a Complete Response Letter (CRL) requesting that Valeant address questions related to pharmacokinetic data. The FDA did not indicate that there were any deficiencies related to the clinical efficacy or safety of the treatment.


CMS posts 2017 Open Payments data

The Centers for Medicare and Medicaid Services (CMS) released 2017 Open Payments data disclosed by more than 1,500 manufacturers and group purchasing organizations (GPOs). CMS reported $8.40 billion in payments and ownership and investment interests to physicians and teaching hospitals in 2017.

Open Payments ― also known as the Sunshine Act ― is a national disclosure program designed to promote transparency and accountability in the health care system. Payments are reported in three categories: General payments, research payments, and ownership or investment interests. View the published Open Payments data at https://openpaymentsdata.cms.gov/

Learn more about how Sunshine Act data is reported and how a physician can dispute inaccurate information in this month’s Dermatology World.

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Novel targets, treatments needed for metastatic melanoma

Recent data published in the European Journal of Cancer show that about 70% of patients with metastatic melanoma survive for one year when treated with novel therapies — about half of whom achieve long-term benefit. “The other half of patients with advanced melanoma will experience disease progression.”

With FDA approval of new biologics, metastatic melanoma is transforming from a virtual death sentence to a treatable disease. Read about how biologics have made headway against metastatic melanoma in Dermatology World.

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FDA commissioner gives statement about compounded drugs 

FDA Commissioner Scott Gottlieb, MD, addressed the agency’s efforts to find balance between drug access and safety in his statement about compounded drugs for patients who cannot use an FDA-approved drug

Gottlieb referenced the numerous health care fraud enforcement actions regarding reimbursement for medically unnecessary compounded drugs, including compounded pain and scar creams. “Clinicians and patients may not be aware of potential safety risks, or the potential lack of effectiveness, associated with certain ingredients and combinations of ingredients in their compounded topical pain creams.” 

The FDA also indicated that it is ensuring that outsourcing facilities are compounding drugs from bulk substances for which there is a clinical need. Earlier this year, the FDA issued draft guidance regarding the “bulk drug substances for which there is a clinical need” as well as other factors for evaluating whether to include a bulk drug substance on the list.

Gottlieb affirmed the FDA’s commitment to ensuring that compounding remains a practice of tailoring medications for individual patients whose needs cannot be met by FDA-approved drugs. Read more about compounding guidelines that pit safety concerns against patient access in Dermatology World.

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Trump administration threatens drug manufacturers 

In its meetings with more than a dozen pharmaceutical companies, the Department of Health and Human Services (HHS) warned that if manufacturers do not reduce prescription drug prices, the agency will impose more stringent regulations on the industry, reports the Washington Examiner

HHS Secretary Alex Azar blamed pharmacy benefit managers (PBMs), who act as middlemen between insurers and manufacturers, for the difficulties. “We had had many major drug companies with major products who want to make substantial and material price decreases. The pharmacy benefit managers and the wholesalers are all dependent on getting a percent of list price.”

While the Trump administration is working to make the American Patients First proposal a reality, the question remains as to whether it will curb increasing drug prices. The plan does not allow Medicare to negotiate drug prices, address the annual increases in drug prices, or permit drug importation for personal use. Read more about how the Trump administration is addressing drug prices and other health care issues in Dermatology World.

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