Drugmakers slash prices to be eligible for China’s bulk-buy program

Global pharmaceutical majors and generic drugmakers chopped by 53% on average prices of some of their off-patent products in the latest bidding round under China’s national bulk-buy program, government officials said late on Friday.

Beijing has been pushing forward the program where drugmakers have to go through a bidding process and cut prices low enough to be considered over generic copies and be allowed to sell their products at public hospitals via large-volume government procurement.

Some global firms such as AstraZeneca (AZN.L) and Merck (MRK.N) have already cautioned about intensifying price pressures on their mature brands in the world’s second largest drug market, as China expands the usage of the program.

In the latest bidding on Friday that involved 33 drugs and 122 companies, Bayer (BAYGn.DE) slashed the price of its popular diabetes treatment Acarbose to 0.18 yuan ($0.0262) per pill, 78.5% lower than the price ceiling set by the government in December last year, elbowing some Chinese generic providers out of the tender, according to a Reuters calculation based on the preliminary results released by the authority overseeing the program.

“Products that won bids in this round of centralized procurement saw a huge price drop, which squeezes out unreasonable overpricing that has existed in drug distribution for a long time,” the authority said in a statement published alongside the preliminary result on Friday.

Sale prices of over 100 types of commonly used drugs are on average about 17 to 18 times of their manufacturing costs, the statement said.

Chinese copycats won bids for most of the 33 drugs, including generic versions for drugs ranging from Johnson & Johnson’s (JNJ.N) prostate cancer treatment Zytiga to Eli Lilly’s (LLY.N) erectile dysfunction treatment Cialis, the results showed.

In Friday’s bidding, for products with two bid winners, 60% of the government procurement volume can be shared among the winners, according to official document detailing the tender rules released in December. For products with four winners and more, as much as 80% of the volume can be shared among the companies.

In the first round of the nationwide implementation of the bulk-buy program in September, global drugmakers including Sanofi (SASY.PA) and Eli Lilly managed to cut some prices low enough to levels close to those offered by local generic makers.

https://www.reuters.com/article/us-china-drugs/drugmakers-slash-prices-to-be-eligible-for-chinas-bulk-buy-program-idUSKBN1ZH05M?il=0

With Introduction of Biosimilars, Biologics Prices Have Decreased

The net prices of biologic agents have decreased following the introduction of biosimilar or other alternatives, according to a study published in JAMA Network Open.

Researchers specifically assessed the originator biologics Neupogen® (filgrastim), Neulasta® (pegfilgrastim), Remicade® (infliximab), and insulin glargine; these were the only biologics that had had competition from biosimilars (filgrastim-sndz, filgrastim-aafi, pegfilgrastim-jmdb, infliximab-dyyb, and infliximab-abda) or other within-molecule substitutes (tbo-filgrastim and insulin glargine) during the study period.

They used pricing data from January 2007 to June 2018 from SSR Health, which provides quarterly estimates of list prices, net prices, Medicaid discounts, and discounts from other payers for branded products with U.S. sales reported by publicly traded companies.

Comparison of list and net prices before and after biosimilar introduction

List and net prices of filgrastim increased in parallel each year by a mean of 5.1% and 6.1%, respectively, until the introduction of a biosimilar in 2015. List prices then stagnated and net prices began to decrease by a mean of −7.7% annually.

List and net prices of pegfilgrastim also increased annually by a mean of 7.5% and 4.9%, respectively, until the introduction of a first biosimilar in 2018, after which list prices stagnated and net prices decreased by −7.4%.

List and net prices of infliximab both increased in parallel by a mean of 6.0% from 2007 to 2013, after which net prices started to decrease by a mean of −1.3% per year. After the introduction of a biosimilar in 2017, net prices decreased further to a mean of −13.6% per year.

From 2007 to 2014, list and net prices of insulin glargine increased annually by a mean of 14.7% and 8.8%, respectively. From 2015 to 2019, list price growth slowed to a mean of 5.8% annually. Net prices began to decline by a mean of −14.4% annually in 2015 and further decreased by −23.5% in 2017 following the entry of a substitute agent.

Overall, Medicaid discounts increased by 20.1 percentage points for filgrastim, 31.2 percentage points for pegfilgrastim, 33.8 percentage points for infliximab, and 35.2 percentage points for insulin glargine. For other payer types (non-Medicaid), discounts increased by 20.3 percentage points for filgrastim, 23.4 percentage points for pegfilgrastim, 50.6 percentage points for infliximab, and 76.1 percentage points for insulin glargine.

With Introduction of Biosimilars, Biologics Prices Have Decreased

Just 2% of Patients Who Need It Get Anti-Opioid Drug Naloxone

Naloxone can prevent opioid overdose deaths, but only a tiny percentage of Americans at risk are prescribed the lifesaving drug.

That’s the key finding from an analysis of nationwide data on adults with private health insurance.

The researchers found that while naloxone (Evzio, Narcan) prescriptions in this group rose between January 2014 and mid-2017, only 1.6% of those taking high doses of prescription opioid painkillers had filled a naloxone prescription by the last six months of the study period.

And the percentage of filled naloxone prescriptions was no higher among adults who had survived an overdose or had been diagnosed with opioid addiction (“opioid use disorder”), the study found.

Naloxone can help reverse an overdose of many types of opioids, including prescription pain medicines (such as oxycodone) and illegal drugs such as heroin.

The study — done by a team from the University of Michigan and VA Ann Arbor Healthcare System — was recently published in the Journal of General Internal Medicine.

U.S. Centers for Disease Control and Prevention guidelines recommend prescribing naloxone to any patient who takes high doses of opioid pain medicines or who has other major overdose risk factors, including a history of opioid use disorder or opioid overdose.

Naloxone is also recommended for patients who take opioids and the sedative benzodiazepine at the same time, because the two drugs can interact.

“The vast majority of naloxone prescribing is to patients who have received opioid prescriptions, but there are other groups at high risk for overdose but not receiving prescription opioids, including people using only street drugs, that warrant further attention,” said research team leader Dr. Lewei (Allison) Lin, an addiction psychiatrist at the University of Michigan Addiction Center.

“Over the course of the entire study period, we also found that although both high-dosage opioid prescriptions and having an opioid use disorder were associated with receiving naloxone, the same wasn’t true for those with a history of overdose or those with other substance use disorders,” she said in a university news release.

Lin said more work is needed to guide naloxone prescribing to patients at highest risk for overdose.

More information

The U.S. National Institute on Drug Abuse has more about naloxone.

SOURCE: University of Michigan, news release, Jan. 8, 2020

https://consumer.healthday.com/general-health-information-16/prescription-drug-news-551/just-2-37-of-patients-who-need-it-get-anti-opioid-drug-naloxone-753886.html

Surgical weight loss beats diet and exercise for reversing diabetes

People who have weight-loss surgery are more likely to achieve remission of diabetes than those who try to shed excess pounds by dieting and exercising, a recent study suggests.

Researchers randomly assigned 61 participants with type 2 diabetes to one of three weight-loss interventions: an operation known as Roux-en-Y gastric bypass; a type of surgery known as laparoscopic adjustable gastric banding; or an intensive weight-loss program focused on cutting calories and increasing exercise

After five years, six people who got the Roux-en-Y procedures, or 30%, achieved partial or complete diabetes remission, compared with four people, or 19%, of the participants who had gastric banding, the study found. None of the people in the diet-and-exercise group achieved remission.

“Any degree of weight loss, even that achieved by non-surgical means (typically about 5% of starting weight as shown in this study), can be helpful in controlling health issues such as diabetes, lipids, and hypertension,” said Dr. Anita Courcoulas of the University of Pittsburgh Medical Center, the study’s lead author.

“Nevertheless, the head-to-head comparison of lifestyle treatment versus surgical procedures, as in this study, shows (the) superiority of the surgical treatments for diabetes-control endpoints and weight loss,” Courcoulas said by email.

Laparoscopic adjustable gastric banding, also known as lap-band surgery, is a less-invasive procedure that involves placing an adjustable inflatable belt around the upper portion of the stomach. The band can be made of silicone and tightened by adding saline, and the effects are reversible. It effectively reduces the amount of food the stomach can hold, and people are advised to eat portions about the size of a shot glass post-surgery.

Roux-en-Y gastric bypass is a more invasive procedure in which a surgeon staples off the upper portion of the stomach and reroutes food to bypass the rest of the stomach and the small intestine. The working part of the stomach is reduced to the size of an egg, and this cannot be reversed.

Everyone in the study had type 2 diabetes, which is associated with aging and excess weight. Patients were 47 years old, on average, obese and living with dangerously elevated blood sugar levels.

Five years after the procedures, people who had the Roux-en-Y bypass surgery lost an average of 25% of their body weight, compared with about 13% with the lap-band and 5% in the group assigned to intensive lifestyle management.

In addition, 56% of the people who had Roux-en-Y procedures had stopped taking medications to manage diabetes by the end of the study, compared with 45% of the people who had laparoscopic adjustable gastric banding and none of the participants in the lifestyle group.

One limitation of the study is that researchers only tested one approach to diet and exercise for weight loss, and other approaches might have achieved different results, the study team notes in the Journal of Clinical Endocrinology & Metabolism. The study was also small, and done at a single medical center, so results might differ with more people or in other locations.

Still, the findings add to evidence suggesting that surgical weight loss may be the best approach to achieving diabetes remission, said Dr. Michel Gagner of Herbert Wertheim School of Medicine at Florida International University in Miami.

“It decreases the overall caloric intake more efficiently and sustainably than just diets,” Gagner, who wasn’t involved in the study, said by email.

Patients with poorly controlled diabetes should consider surgery when they’re obese and unable to lower their blood sugar enough with medications, said Dr. Ricardo Cohen, director of the Center for the Treatment of Obesity and Diabetes at Hospital Oswaldo Cruz in Sao Paulo, Brazil.

“The best option for medically uncontrolled type 2 and (obesity) is the Roux-en-Y gastric bypass,” Cohen, who wasn’t involved in the study, said by email.

SOURCE: bit.ly/3ageNjt Journal of Clinical Endocrinology & Metabolism, online January 9, 2020.

https://www.reuters.com/article/us-health-diabetes-obesity/surgical-weight-loss-beats-diet-and-exercise-for-reversing-diabetes-idUSKBN1ZF2VW

Risks associated with cannabis exposure during pregnancy

A new study from researchers at Western University and Queen’s University definitively shows that regular exposure to THC, the main psychoactive ingredient in cannabis, during pregnancy has significant impact on placental and fetal development. With more than a year since the legalization of recreational cannabis in Canada, the effects of its use during pregnancy are only now beginning to be understood.

The study, published today in Scientific Reports, uses a rat model and human placental cells to show that maternal exposure to THC during pregnancy has a measurable impact on both the development of the organs of the fetus and the gene expression that is essential to placental function.

The researchers demonstrated in a rat model that regular exposure to a low-dose of THC that mimics daily use of cannabis during pregnancy led to a reduction in birth weight of 8 per cent and decreased brain and liver growth by more than 20 per cent.

“This data supports clinical studies that suggest cannabis use during pregnancy it is associated with low birth weight babies. Clinical data is complicated because it is confounded by other factors such as socioeconomic status,” said Dan Hardy, Ph.D., Associate Professor at Western’s Schulich School of Medicine & Dentistry and co-author on the paper. “This is the first study to definitively support the fact that THC alone has a direct impact on placental and fetal growth.”

The research team was also able to characterize how THC prevents oxygen and nutrients from crossing the placenta into the developing fetus. By studying human placental cells, the researchers found that exposure to THC caused a decrease in a glucose transporter called GLUT-1. This indicates that the THC is preventing the placental transfer of glucose, a key nutrient, from the mother to the fetus. They also found a reduction in placental vasculature in the rat model suggesting reduced blood flow from the mother to the fetus.

The researchers say both of those factors are likely contributing to the growth restriction that they observed in the offspring.

The researchers point out that there are currently no clear guidelines from Health Canada on the use of cannabis in pregnancy and some studies have shown that up to one in five women are using cannabis during pregnancy to prevent morning sickness, for anxiety or for social reasons.

“Marjiuana has been legalized in Canada and in many states in the US, however, its use during pregnancy has not been well studied up until this point. This study is important to support clinicians in communicating the very real risks associated with cannabis use during pregnancy,” said David Natale, Ph.D., Associate Professor at Queen’s and co-author on the paper.

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More information: Bryony V. Natale et al, Δ9-tetrahydrocannabinol exposure during rat pregnancy leads to symmetrical fetal growth restriction and labyrinth-specific vascular defects in the placenta, Scientific Reports (2020). DOI: 10.1038/s41598-019-57318-6

https://medicalxpress.com/news/2020-01-real-cannabis-exposure-pregnancy.html

No Change to Medicare Doc Payments Needed for 2021, MedPAC Says

No change is needed for the current update planned for Medicare physician payments in calendar year 2021, members of the Medicare Payment Advisory Commission (MedPAC) agreed Thursday. But commissioners also emphasized the need for collecting more data on the costs of running a physician practice.

“I support the recommendation [to collect additional data], but I hope we’ll take the work up next year,” said commission member Karen DeSalvo, MD, MPH, chief health officer at Google.

“We really need to get a better handle on physician expenses from 2020 and beyond, including for health IT” and the costs of running a practice team. For physicians looking to change the way they’re paid by Medicare, “it’s expensive to hire consultants to help you move to alternative payment models,” she added.

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy, had a similar thought. “The information we have on physician practice expenditures compared to what we could know is a big gulf,” because the last Centers for Medicare & Medicaid Services (CMS) survey was based on data from 2007 and 2008, he said. “I think we should take it on ourselves to encourage CMS, because the appearance that we can’t afford a survey more than once every 10 or 15 years seems not to be a good way to manage policy.”

Under current Medicare policy, no payment increase is planned for 2021, but clinicians who participate in the Merit-based Incentive Payment System (MIPS) program will receive updates of +/- 7%, and some may be eligible for an “exceptional” performance bonus, said Rachel Burton, MPP, a senior analyst at MedPAC. Doctors who participate in advanced alternative payment models (AAPMs) are eligible for a 5% incentive payment depending on their performance.

One reason no payment changes were recommended is that beneficiaries’ access to care remains good. Most beneficiaries had no problems obtaining an appointment with a physician when they needed one, or finding a new physician who takes Medicare, said Burton. And the number of clinicians billing Medicare fee-for-service grew at a faster rate than the number of beneficiaries from 2013 to 2018, she added.

A total of 99.6% of providers’ fee-for-service claims were paid “on assignment,” meaning that the providers accepted the approved Medicare rate as full payment; that rate includes a 20% patient copay in addition to the 80% that Medicare itself pays. In addition, about 1 million providers — the vast majority of those who treat Medicare patients — received additional payments through the MIPS program or from the AAPM bonus program, Burton said. Following the recommendation to stick with current law for 2021 shouldn’t affect beneficiaries’ access to care or doctors’ willingness to furnish care, according to MedPAC staff.

Larry Casalino, MD, PhD, professor of healthcare policy and research at Weill Cornell Medical College in New York City, said that if nearly everyone is getting payment bonuses, “it must mean the bonuses are quite small.” Burton agreed, noting that the bonus amount went only as high as 1.7%.

MedPAC chairman Francis Crosson, MD, of Palo Alto, California, said the high bonus rate was not really a big surprise. “Just to be clear, it was the projection of this commission based on staff work that what is currently playing out was going to play out,” he said. “That’s one of the reasons we suggested that the MIPS program needs to be replaced with something else.” Their suggestion has not been taken up by CMS, so for now, the commission voted 16-0, with one commissioner absent, in favor of the recommendation to keep to the current update.

The commissioners also discussed Medicare payments for kidney disease treatment; currently Medicare uses a bundled payment system for care of patients with end-stage renal disease (ESRD). The commission voted to recommend that payments under the system for treating ESRD in 2021 be updated consistent with current law.

However, the commissioners were very concerned that Medicare take into consideration any new drugs that might come along for ESRD patients; Medicare should quickly update its payment bundle to accommodate new drugs, especially if they save costs overall, and not wait until the scheduled time for an update.

“Say there’s another tPA [tissue plasminogen activator] that comes along,” said commissioner Kathy Buto, a health policy consultant in Arlington, Virginia. “You’d want another manufacturer to feel that’s going to be recognized sooner” than whenever the next bundle update is scheduled, she said.

https://www.medpagetoday.com/publichealthpolicy/medicare/84440

CDC narrows recommendations on vaping

The U.S. Centers for Disease Control and Prevention has removed language from its website recommending that people abstain from vaping during its investigation into vaping-related lung illnesses.

Its updated warning recommends that people stop vaping THC, the psychoactive ingredient in cannabis, and consider avoiding vaping altogether if concerned about the risk to lungs. Evidence continues to build implicating a thickening agent, vitamin E acetate, that is added to illicit THC products as the culprit in the illnesses which have hospitalized 2,668 people and killed 60.

The CDC also recommends that former smokers who use e-cigarettes should not go back to tobacco and should contact their healthcare providers if they need help quitting the habit.

Selected tickers: JUUL, MO, BTI, PM, VGR, OTCPK:GLLA, OTCPK:VAPE, OTCQX:IMBBY

https://seekingalpha.com/news/3532833-cdc-narrows-recommendations-on-vaping