AJPB staff

The Institute for Clinical and Economic Review (ICER) found that Novartis’ experimental gene therapy for spinal muscular atrophy (SMA) would be worth up to $900,000, 

 reported. According to the article, the ICER made the determination using a cost-effectiveness threshold that values each “quality-adjusted life year” (QALY) gained at $100,000 to $150,000. Novartis said the price will be determined in negotiations with health plans, but it believes the therapy would be cost effective at $4 million to $5 million as a 1-time treatment, the article reported.

 suggests that prenatal exposure to nicotine from smoking may be linked to the development of attention-deficit/hyperactivity disorder (ADHD) in offspring. According to the study, the researchers used a national database in Finland to analyze the measurements of nicotine levels in blood samples of 950,000 pregnant women and tracked children who developed ADHD. The data showed  that mothers of children with an ADHD diagnosis had a mean blood cotinine level more than double that of mothers of the control children.

Preliminary data suggest that increasing mortality from synthetic opioids was more prevalent in the eastern United States, according to a study from 

. According to the study, the researchers utilized data from the CDC’s National Center for Health Statistics and the US census to identify 351,630 opioid-related deaths from 1999 to 2016. The findings showed that New Hampshire and West Virginia had the biggest drops in life expectancy due to opioid deaths, and Montana and Oregon were the only states to see a decline in opioid deaths from 1999 to 2016.

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Top news of the day from across the health care landscape.

Trending News Today: Study Links Prenatal Nicotine Exposure to ADHD in Offspring

Merck’s cancer therapy pembrolizumab (Keytruda) failed to meet the main goals of slowing disease progression and extending the life of patients with hepatocellular carcinoma (HCC) in a late-stage study, 

 reported. According to the article, the Keynote-240 study was testing pembrolizumab in patients with advanced HCC who were previously treated with systemic therapy. Although patients treated with the drug did see some improvement in overall survival and disease progression compared with those in the placebo group, the results were not statistically significant, the article reported.

 found that the FDA and opioid manufacturers failed to adequately monitor the restricted use of fentanyl, 

 reported. According to the article, the study, based on a review of 4877 pages of FDA reports and other documents, looked at transmucosal immediate-release fentanyls. The researchers found that over a 4-year period, 51% of patients in the analysis who were prescribed these fentanyls were “opioid-nontolerant,” the article reported.

Maryland state legislation may soon allow minors to consent to pre-exposure prophylaxis (PrEP) treatment, 

 reported. According to the article, the bill states that providers may still choose to inform the parents of a minor who has been provided the treatment, but minors would be able to consent to the preventative treatment. Seventeen other states currently allow minors to give consent for treatment with PrEP, the article reported. 

Top news of the day across the health care landscape.
 

Trending News Today: FDA, Manufacturers Failed to Monitor Restricted Fentanyl Prescribing

On Tuesday, Johnson & Johnson won endorsement from an independent advisory committee convened by the FDA for its depression treatment esketamine, 

 reported. According to the article, the panel voted 14 to 2 to recommend the drug for approval. Esketamine, which is delivered in a nasal spray, is a novel type of rapid-acting treatment that is related to the anesthetic ketamine, the article reported. If approved, it would be the first major depression treatment approved in decades.

A new study found that approximately 45% of Americans under the age of 65 who have heart disease experience financial hardships from medical costs, 

 reported. According to the article, the researchers studied data from 2013 to 2017 on 6160 adults under 65 with atherosclerotic cardiovascular disease. Additionally, the study showed that almost 1 in 5 of them can’t afford to pay their medical bills at all, the article reported.  

Advances in breast cancer treatment and greater usage of preventive screening measures have averted as many as 614,500 breast cancer deaths since 1989, 

reported. According to the article, the study researchers observed that breast cancer mortality rates began to decrease 1.8% per year from 1990 to 1995, 3.4% from 1995 to 1998, and 1.8% from 1998 to 2015. Cumulatively, breast cancer mortality rates among women between the ages of 40 and 84 dropped by 41.6% from 1989 to 2015, the article reported.

Trending News Today: Nearly Half of Americans With Heart Disease Struggle to Pay Medical Costs

Catalyst Pharmaceuticals announced that it anticipates its rare disease drug Firdapse to cost more than $300,000 per year, including rebates to insurers and other discounts, 

reported. According to the article, Firdapse, which is used to treat a rare neuromuscular disorder called Lambert-Eaton Myasthenic Syndrome, was previously available to patients for free from Jacobus Pharmaceuticals through the FDA’s “compassionate use” program. Catalyst won FDA approval in November to sell the drug at a list price of $375,000 per year, the article reported.

FDA Commissioner Scott Gottlieb, MD, said the FDA is planning to launch policy changes aimed to strengthen regulations for the dietary supplement industry, 

 reported. According to the article, Dr Gottlieb said the changes could lead to the most important regulatory modernization since the enactment of the 1994 Dietary Supplement Health and Education Act. Additionally, the FDA recently sent 12 warning letters and 5 advisory letters to companies selling dozens of products that contain unapproved drugs or making illegal claims for treating Alzheimer disease or other serious conditions, the article reported.

A recent study found that physicians are twice as likely to prescribe opioids to residents of predominantly white neighborhoods than residents of neighborhoods with a high proportion of minorities, 

 reported. According to the article, the study examined prescribing practices across all of California’s ZIP codes between 2011 and 2015. Overall, the researchers found that in each of the 5 years studied, approximately 24% of Californians left a physician’s office at least once with a prescription for an opioid narcotic, the article reported.

Trending News Today: FDA Warns Supplement Makers, Plans for Tougher Regulations

Sanofi SA and Regeneron Pharmaceuticals announced they are going to reduce the US list price for their cholesterol drug Praluent by 60%, 

 reported. According to the article, the new list price for Praluent will be $5850 per year, which matches the price of Amgen’s competing PCSK9 inhibitor Repatha. The companies said they expect the lower-priced Praluent to be available for pharmacies in March, the article reported.

A recent report found that the uninsured rate remains unchanged from before President Donald Trump took office but more people are underinsured, 

 reported. According to the article, the Biennial Health Insurance Survey examined the extent and quality of coverage for working-age adults. The results showed that among those with insurance for a full year, 29% were uninsured in 2018, up from 23% in 2014, the article reported.

FDA Commissioner Scott Gottlieb, MD, is questioning whether electronic cigarette maker Juul and its partner Altria are committed to combatting underage vaping, 

 reported. According to the article, Dr Gottlieb called for a joint meeting to discuss what he calls “inconsistent” statements from the companies. Juul previously shut down its social media accounts and pulled several of its fruit and candy flavors from retail stores, however, Dr Gottlieb said he doubts youth vaping will decline this year, the article reported.

Trending News Today: Report Shows Underinsured Rate on the Rise

HIV advocates suggest that prevention campaigns should focus on reaching more black women with pre-exposure prophylaxis (PrEP), 

reported. According to the article, Leisha McKinley-Beach, a national HIV/AIDS consultant, said that the “unequal roll-out of PrEP to women” should be resolved in the Trump administration’s new plan to eradicate HIV. Black women make up 62% of all new HIV diagnoses among women, but knowledge about PrEP among women, particularly for black and Latina women, is low, the article reported.

Johnson & Johnson announced it would start disclosing list prices of its prescription drugs in television ads, 

 reported. According to the article, the company will begin with its medication Xarelto and will provide the pill’s list price plus typical out-of-pocket costs in the commercial. Johnson & Johnson will be the first drug manufacturer to include its list prices in its TV ads, the article reported.

The FDA is cracking down on Walgreens after finding that 22% of the 6350 stores it has inspected sold tobacco products to minors, 

 reported. According to the article, the agency is putting the pharmacy chain on notice and FDA Commissioner Scott Gottlieb, MD, has requested a meeting with Walgreens’ corporate management to warn them about additional enforcement avenues. A Walgreens spokesman said in a statement that the company is taking steps to address the problem, the article reported.