State laws trying to force drug price transparency come up short

Transparency in drug pricing sounds like a great idea, but a new study from the University of Southern California (USC) found almost none of the laws passed in an attempt to force transparency will do much good.
In fact, fewer than 5% of the drug pricing laws passed by states in the past few years would result in new information about drug pricing, according to the study by Neeraj Sood and Martha Ryan at USC’s Shaeffer Center for Health Policy & Economics, published in JAMA.
The problem is, the laws don’t go far enough in shedding light on the current opaque drug supply chain, Sood said. That is, while some of the laws require list price or some transaction pricing data, none require true transaction information at the drug level and none require it from every participant in the drug chain. The study identified pharma manufacturers, insurers, pharmacy benefit managers (PBMs), wholesalers and pharmacies as the five participants.

“These laws are really not truly making the system more transparent. They’re really not helping us tell whose story is right—are the pharma companies right or are the wholesalers right or are the PBMs right? Look, it’s good that there’s some activity going on, but we haven’t solved the problem even with all these laws,” he said.
Sood and Ryan reviewed 166 drug pricing laws passed between 2015 and 2018 and found that 35 bills in 22 states included transparency mandates. Only seven of the laws were deemed informative, such as Maine’s law requiring drugmakers to report net prices and Oregon and Nevada laws forcing pharma to report profits.

Of the less-effective laws, one key problem was compelling list-price disclosures. As Sood pointed out, not only is that information already readily available, list price is pretty disconnected from the real price patients pay, and it doesn’t reveal who’s making the profits and where.
That’s an opinion shared by drugmakers, who in recent years have pointed the finger at PBMs and accused them of pocketing the discounts drug companies offer on their products. With the drug-pricing debate sparking ire from the public, many drugmakers have made a point to demonstrate that their net prices are actually falling.
Federal regulations that cover all states would be one way to address the disparate transparency, Sood said. However, those kinds of efforts to date have languished in committee on Capitol Hill or been rebuffed by lawmakers. Even the drug list price regulation for TV ads mandated by the Department of Health and Human Services (HHS) earlier this year has been shut down, blocked by a lawsuit and federal court ruling that the HHS did not have the authority to issue it. HHS is currently appealing that ruling.
https://www.fiercepharma.com/pharma/state-laws-trying-to-force-drug-price-transparency-come-up-short-study-says

J&J bridging its $2B patent cliff gap, with help from Stelara, Darzalex

Johnson & Johnson is dealing with a multibillion-dollar hit this year as generics and biosimilars eat away at sales. That’s the bad news. The good? Its newer meds continue to deliver enough oomph to push up its top line.

The company’s immunology unit grew 10% in the third quarter, trailed by 9% growth for oncology and 8% for neuroscience. Altogether, J&J’s pharma group turned in 6.4% operational growth to $10.9 billion for the quarter, easily outpacing its other business units.

The performances come as J&J deals with copycat versions of prostate cancer med Zytiga and rheumatoid arthritis blockbuster Remicade, along with other recent patent losses. Previously, the company said generics and biosimilars would erode sales by $3 billion to $3.5 billion in 2019. But now, J&J expects the hit to be $2 billion, pharma chairman Jennifer Taubert said on a Tuesday conference call. The copies will keep digging into sales next year, she said.

On the flip side, 10 J&J drugs posted double-digit sales growth in the third quarter. Executives highlighted operational sales jumps of 31% for Stelara, 57% for Darzalex, 33% for Imbruvica, 70% for Tremfya and 95% for Erleada.

And there’s more ahead for Darzalex, Taubert said. The drug is already competing in second-line and later uses in multiple myeloma, but J&J now has an opportunity to move into frontline use. The med won approval for previously untreated patients ineligible for stem-cell transplant in June and in transplant-eligible patients in September.

J&J recently filed a subcutaneous version of Darzalex, which would take the dosing procedure from a multiple-hour infusion to a five-minute injection process. She said the more convenient formula would be an “important catalyst for growth,” especially in the outpatient setting.

On Xarelto, J&J execs said they were “pleased” to see the med hold its own during the third quarter after previous declines. The company has been working to get past sales hits from the Medicare donut hole and payer rebates, execs said. Plus, the drug on Monday scored its eighth approval, this time to help prevent blood clots in acutely ill patients without a high risk of bleeding, both during and after hospitalization.

With the third-quarter performance, J&J raised its 2019 sales guidance to $83.7 billion to $84.2 billion, up from a previous range of $82.4 billion to $83.2 billion. The new forecast translates to top-line growth of 2.5% to 3%. J&J’s shares were up 2% Tuesday morning after the company released earnings.

Also on Tuesday’s call, J&J CFO Joe Wolk addressed recent legal setbacks the company has faced. J&J expects an “egregious” $8 billion Risperdal verdict, leveled last week, to be reduced in appeals, Wolk said.

As for its load of opioid litigation, Wolk said J&J couldn’t reach a “reasonable” settlement in Oklahoma, and it will now appeal the $572 million verdict. In Ohio, by contrast, J&J was able to strike a deal Wolk called reasonable and the company was “particularly pleased” the money was set to benefit opioid addiction victims.

And on the thousands of talc lawsuits J&J’s facing, the CFO said it’s “probably the poster child for how big a business plaintiffs attorneys” have made suing life sciences companies such as J&J.

Overall, 50% of product liability cases are over life sciences products at a time when “products have never been safer,” he said. Wolk insists the science supports J&J and that plaintiffs attorneys are spending hundreds of millions of dollars on TV advertising to create a $36 billion litigation industry.

https://www.fiercepharma.com/pharma/despite-2b-patent-cliff-johnson-johnson-s-pharma-group-powers-ahead

Pfizer scrambles to fill void as Teva stops making chemo drug often given children

Pfizer is playing a new role in the dramas that often surround drug shortages. While manufacturing issues at its Hospira unit have sometimes been responsible for hospital drug shortages, Pfizer is now trying to fill a serious shortfall after Teva Pharmaceutical discontinued production of a chemo drug used to cure children of serious cancers.

It is ramping up production of vincristine—often used with other drugs to treat leukemia, brain tumors and lymphomas—after Teva in July notified the FDA that it had made the “business decision” to discontinue production. Its move has left pediatric oncologists scrambling to find supplies.

“Due to a competitor’s outage, we are expediting additional shipments of this critical product over the next few weeks to support three to four times our typical production output. Pfizer is committed to providing this important medicine to patients,” Pfizer said today in an email.

The New York Times reports that vincristine is so widely used that the shortage is affecting clinical trials as well as treatments.

“Vincristine is our water. It’s our bread and butter. I can’t think of a disease in childhood cancer that doesn’t use vincristine,” Yoram Unguru, M.D., a pediatric oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore, tells the NYT.

Teva did not respond to the newspaper about its decision to discontinue vincristine, a drug that has been on and off the FDA shortage list for years. With margins on generics having gotten very thin in recent years, many drugmakers have given up production of products where they are not dominant in the marketplace. There are currently 202 drug discontinuations listed on the FDA Drug Shortages website.

Teva also has been closing many plants as part of its attempt to cut $3 billion in annual costs in an effort to return to financial stability after the company found itself in dire economic straits several years ago. Often with a plant closure, it can been easier to give up certain drugs than move production to another facility.
Playing the hero in a drug shortage is a turnabout for Pfizer, which has been under pressure to upgrade several plants after manufacturing issues left certain drugs in very short supply. Problems at a Hospira plant in Kansas led to shortages at hospitals of some injected pain meds. Issues at another Pfizer facility that makes injectors resulted in shortages of Mylan’s popular EpiPen for treating anaphylactic shock.
https://www.fiercepharma.com/manufacturing/pfizer-scrambles-to-fill-void-after-teva-stops-making-chemo-drug-often-children

Johnson & Johnson $110M talc verdict overturned

An appeals court in Missouri has overturned a $110M verdict against Johnson & Johnson (NYSE:JNJ) over whether its talc caused ovarian cancer.

That reverses a 2017 decision in favor of a Virginia woman who says she developed the cancer after decades of using the talc for feminine hygiene.

The appeals court cited a state supreme court ruling limiting out-of-state plaintiffs’ ability to sue in the state.

The company still faces several other lawsuits in St. Louis, including the one that brought a record $4.69B talc verdict against it.

https://seekingalpha.com/news/3505990-johnson-and-johnson-sees-110m-talc-verdict-overturned

Fewer emergency surgeries, more deaths in British hospitals vs U.S.

When patients in England or the U.S. have abdominal emergencies like appendicitis or a ruptured aneurysm, half as many in England get surgery and many more die, a new study suggests.
Deaths in the hospital were significantly higher in England for all seven types of abdominal emergencies analyzed in the study, suggesting that some of these deaths might be attributable to not having received surgery to correct the problem, researchers write in Annals of Surgery.
Differences between England’s publicly-funded National Health Service and the private medical centers of the U.S. may influence the availability of resources and services, “including life-saving treatment in an emergency setting,” Sheraz R. Markar of Imperial College London and St. George’s University of London and colleagues write.
Past research has found higher mortality rates for several cancers and for hospitalized patients with certain conditions in England compared with the U.S., but these studies have not “clearly identified the differences in clinical practices that are responsible,” the authors note.
They did not respond to requests for comment.
Markar’s team reviewed data from 2006 to 2012 on patients admitted with ruptured abdominal aortic aneurysm, aortic dissection, appendicitis, perforated esophagus, peptic ulcer perforation, small intestine or large intestine perforation, or an incarcerated or strangulated abdominal or groin hernias.
There were 136,047 admissions in England and 1.8 million in the U.S.
“Noncorrective care” – meaning no surgical correction – was more common than surgery for all conditions in England, as were deaths in hospital.
Patients in England, for example, were 4.25 times as likely as those in the U.S. to receive noncorrective care for ruptured aortic aneurysm and 8.53 times as likely with appendicitis.
For a perforated esophagus, 42% of patients in England received noncorrective care compared with 31% in the U.S. The overall hospital mortality rate for this condition was 11% in England versus 6% in the U.S. Patterns were similar for the other conditions.
When researchers looked only at patients who did not receive surgery, death rates were higher in England for four conditions: aortic dissection, peptic ulcer perforation, small bowel or large bowel perforation and incarcerated or strangulated hernias.

Some of the differences between the countries might be explained by factors the study could not measure, the authors acknowledge.
“This type of study contains many potential sources of bias that can mislead the reader into believing results are better in the U.S. than the UK,” said Dr. Derek Alderson, emeritus professor of surgery at the University of Birmingham and president of the Royal College of Surgeons of England.
“The study only looked at ‘in-hospital’ mortality – a term that might mean death within 30 days of surgery or any time during that admission,” Alderson, who was not involved the study, told Reuters Health by email.
“Attitudes to ongoing care and further interventions may well be different in an insurance-led system versus one that is free at the point of access, especially patients who have undergone an intervention,” he added.
The researchers say limited resources in England’s socialized healthcare system could explain a more “frugal approach to utilization of interventional treatment,” but they note they did not look at the role of doctors’ choices about care.
There appears to be a difference in thresholds for surgical intervention in England and the U.S., and factors around this are “extremely complex and cannot be identified by a study of this nature,” the authors write.
Alderson agrees.
“In neither country do we know the numbers of patients who were not admitted to hospitals who died from these conditions,” he told Reuters Health.

“It would be unwise to interpret the data as implying some form of rationing of surgery by surgeons in the UK.”
Societal attitudes, investment in healthcare and resource limitations must all play some part in decisions to intervene, he said.
SOURCE: bit.ly/2prrXHf Annals of Surgery, online October 9, 2019.
https://www.reuters.com/article/us-health-surgery/fewer-emergency-surgeries-more-deaths-in-british-hospitals-vs-u-s-idUSKBN1WU2H5

Michigan judge blocks flavored vape ban

A Michigan judge on Tuesday blocked the state’s ban on flavored e-cigarettes about two weeks after it took effect, a victory for retailers who are challenging the ban in court.
Michigan Governor Gretchen Whitmer had ordered the ban in September, declaring that teenagers’ use of e-cigarettes, known as vaping, was a public health emergency.
Judge Cynthia Diane Stephens of the Michigan Court of Common Claims said that vaping was a public health concern, but agreed with the retailers that there was likely no basis for the governor to use her emergency powers.
The ruling is a preliminary injunction, meaning it will remain in effect while the retailers and the state continue to litigate the dispute.

Whitmer’s office had no immediate comment.
Michigan is one of several states, including New York and Rhode Island, that have moved to restrict sales of flavored e-cigarettes on the grounds that they pose a health risk to teenagers.
https://www.reuters.com/article/us-health-vaping-michigan/michigan-judge-blocks-flavored-vape-ban-idUSKBN1WU2PB

NeuroMetrix Announces Updates to Quell 2.0 Commercial Strategy

NeuroMetrix, Inc., (Nasdaq:NURO), a health technology company that develops and commercializes products for the chronic pain and diabetes markets, today announced important updates to its Quell^® 2.0 commercial strategy.  This novel wearable device for the symptomatic relief of chronic pain is central to the Company’s vision of helping people reclaim their lives from chronic pain through neuroscience and technology.

The Company is shifting to an exclusively direct-to-consumer model delivered via the QuellRelief.com website, that will allow it to offer the innovative Quell 2.0 system at accessible price points.  This streamlined distribution model will allow more people with chronic pain to benefit from the advanced Quell pain relief technology.  The new approach will also open the door for more people to take advantage of electrode savings through a subscription service.
This new business model is an outcome of extensive consumer research and in-market validation that started earlier this year.  The Company expects to see improved economics through reduced customer acquisition costs, distribution channel savings, and higher retention rates, resulting in increased customer lifetime value.
“Our vision is a world where people can live their best life despite chronic pain,” said Shai N. Gozani M.D., Ph.D., President, and Chief Executive Officer, NeuroMetrix.  “To achieve this goal, we believe that everyone living with chronic pain should have the opportunity to experience Quell and determine if it is beneficial to their particular form of chronic pain.  Therefore, we have worked over the past several quarters to refine our business model and distribution system to position us to deliver Quell 2.0 at widely attainable price points.”
About Quell
Quell is an advanced, wearable technology for the symptomatic relief and management of chronic pain. It can be worn during the day while active and at night while sleeping. Quell is drug-free.  Quell users can personalize and manage therapy discreetly via the Quell app.  Quell also offers health tracking metrics relevant to chronic pain sufferers, including pain, sleep, activity, and gait. Quell users can synchronize their data with the Quell Health Cloud™, which provides customized feedback and powers one of the world’s largest chronic pain databases.  Visit QuellRelief.com for more information.
https://www.biospace.com/article/releases/neurometrix-announces-updates-to-quell-2-0-commercial-strategy/