EpiPens, blood-pressure meds have highest drug price hikes: CMS database

Medicare is spending more money on drugs than ever before, and it’s not because patients are taking more medications.

The Centers for Medicare & Medicaid Services (CMS) updated its drug pricing dashboards this week, and data suggest increased spending is due to higher drug prices, with many medications seeing double-digit price bumps in just a few short years.

According to the database, epinephrine, the drug in Epi-Pens, saw the largest price increase under Part D for drugs with more than 20,000 patients, with an average price jump of 189.6% each year between 2012 and 2016.

Epi-pen, itself, saw a 28.5% average annual price increase, ranking it among the top 20 drugs serving more than 200,000 beneficiaries. Additionally, average Part D spending on Epi-pen jumped from $106.53 in 2012, to $290.67 in 2016, a more than 272% increase.

Mylan CEO Heather Bresch faced criticism from lawmakers in 2016 for massive increases in the price of EpiPens. The company eventually agreed to pay a $465 million settlement for misclassifying the drug in the Medicaid Drug Rebate program.

For medications used by more than 50,000 beneficiaries, Captopril, which is used to treat high blood pressure, saw its price increase by 85% per year over that same five-year span.

Under Part B, the price of cyanocobalamin, an injectionable medication that treats vitamin B12 deficiencies, jumped by 61.4% per year on average from 2012 to 2016. The drug is popular and was used by 586,000 beneficiaries last year and saw the highest price increase compared with drugs with similar utilization.

Rixubis, used to control bleeding, saw a massive 2189.8% increase, the highest for any Part B drug, with the cost of the average dose jumping from $24.52 to $561.55. However, the drug is rather uncommon and treated only 22 people with hemophilia B in 2016.

Administrator Seema Verma

@SeemaCMS

As @SecAzar has pointed out, #Medicare incentives have  list prices for drugs, & this enhanced dashboard is an important step to bringing transparency & accountability to what has been a largely hidden process.https://go.cms.gov/2Ilu5Jg 

6:42 PM – May 15, 2018

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Medicaid was no exception to price bumps, either. Diabetes medication Lantus saw a nearly 19% increase during the same four-year period, with the agency shelling out about $785 million for the drug in 2016. Humira, used to treat arthritis and Crohn’s disease, and Enbrel, an arthritis drug, also saw increases of 17.5% and 17.6%, respectively. The Medicaid dashboard does not include the number of beneficiaries who were prescribed each drug.

According to the database, the agency spent $174 billion on drugs in 2016, almost a quarter of its budget and a 62.6% increase from $107 billion only four years prior.

The Trump administration recently rolled out a drug pricing blueprint that included several potential changes to Medicare such as value-based drug purchasing. The administration called out Medicare’s payment structure for enabling drug price growth.

“As Secretary Azar has repeatedly pointed out, for years Medicare incentives have actually encouraged higher list prices for drugs, and this updated and enhanced dashboard is an important step to bringing transparency and accountability to what has been a largely hidden process,” CMS Administrator Seema Verma said in a statement earlier this week.

https://bit.ly/2wQyLSh

States could face budgetary squeeze as Medicaid expansion funding drops off

States that have expanded Medicaid have seen strong gains in coverage and better access to care without having to sacrifice other social programs, new research has found.

But that may not last long.

An analysis by the Kaiser Family Foundation found the 33 states that expanded their Medicaid program to 133% of the poverty line saw a 7.4% decrease in the uninsured rate from 2013 to 2017 compared to a 2.7% drop to those that didn’t.

The states’ economies also did better due to the expanded coverage. Expansion states saw both a decrease in uncompensated care costs and state-funded health programs, like behavioral health and corrections, as well as an increase in gross domestic product and jobs.

Kaiser Family Foundation

@KaiserFamFound

Multiple studies suggest that #MedicaidExpansion can result in state savings by offsetting state costs in other areas, including behavioral health services, crime and the criminal justice system, and the Supplemental Security Income program. https://www.kff.org/medicaid/issue-brief/implications-of-the-aca-medicaid-expansion-a-look-at-the-data-and-evidence/ … #Medicaid

6:22 PM – May 17, 2018

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Another recent study by Joelle Abramowitz, an economist with the University of Michigan Institute for Social Research, found that expansion has reduced out-of-pocket medical costs.

Opponents of expansion argue that state spending on the program will lead to cuts in other public sectors, like education and infrastructure, but KFF’s research has shown that is not the case, at least not yet.

“National research found that there were no significant increases in spending from state funds as a result of Medicaid expansion and no significant reductions in state spending on education, transportation, or other state programs as a result of expansion,” the analysis said.

Future cuts

Kaiser’s results only look at results from 2014 to 2016, however, when costs of expansion were completely covered by the federal government. But that level of support is slowly shifting. Federal funding for the program fell to 95% in 2017, 94% in 2018 and will fall to 93% next year. It’s final drop is to 90% in 2020 and beyond.

The resulting increase in state spending for the program might lead to additional budget cuts, possibly in the Medicaid program itself.

“States’ cost for expansion increase each starting last year; its possible that over time, states’ spending on Medicaid might see some changes,” Megan Olsen, senior manager at Avalere Health, told FierceHealthcare.

Additionally, a report published this week by the Urban Institute found that if the remaining 19 states expanded their programs, state budgets would increase by $2.6 billion and the federal budget by $34.4 billion. The budget increases would, however, be cushioned by an $8 billion decrease in demand for uncompensated care.

Some expansion states have already attempted to offset Medicaid spending.

Kentucky, Arkansas and Indiana have been approved to initiate work requirements, which are intended to lower participation in the program and offset costs. Such requirements could become more popular if proven to control state costs.

And other social programs, like education and transportation, could be on the hook for additional cuts, going against the trend reported by KFF.

“As states take on more of the cost, it will force states to make decisions,” Olsen added.

https://bit.ly/2rThWAk

FDA: Immune Treatment Monotherapy in Bladder Cancer May Worsen Survival

Pembrolizumab (Keytruda) or atezolizumab (Tecentriq) monotherapy for certain patients with advanced or metastatic urothelial carcinoma were each associated with decreased survival compared with chemotherapy, the FDA said in an alert issuedFriday.

The data safety and monitoring committees of two trials reported the decreased survival in patients with low expression levels of programmed death ligand 1 (PD-L1) who were treated with either of these agents as monotherapy.

Both trials — KEYNOTE-361 (Merck) and IMVIGOR-130 (Genentech) — have stopped enrolling such patients.

“Healthcare professionals should be aware that the populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy, and therefore differ from those enrolled in the trials that led to the accelerated approvals of both Keytruda and Tecentriq,” the FDA stated.

KEYNOTE-361 is studying pembrolizumab with or without chemotherapy (cisplatin plus gemcitabine or carboplatin plus gemcitabine).

IMVIGOR-130 is studying atezolizumab with or without chemotherapy (cisplatin plus gemcitabine or carboplatin plus gemcitabine) in untreated patients.

The combination and chemotherapy-alone arms will remain open in both trials. Each trial also has a monotherapy arm for each respective immunotherapy, which will remain open only to patients with high levels of PD-L1 expression.

Both drugs are currently approved, irrespective of PD-L1 status, for the treatment of locally advanced or metastatic urothelial carcinoma in patients ineligible for cisplatin-containing chemotherapy. Urothelial carcinoma accounts for about 90% of all bladder cancer in the U.S.

In 2016, atezolizumab became the first PD-L1 inhibitor to gain approval in bladder cancer, indicated for patients with locally advanced or metastatic urothelial carcinoma who had progressed during or after platinum-based chemotherapy, or within 12 months of receiving either neoadjuvant or adjuvant platinum-based chemotherapy.

In 2017, the FDA approved pembrolizumab for this same patient population.

“FDA recommends providers select patients for the treatment of locally advanced or metastatic urothelial cancer using the criteria described in Section 14 of each label,” the agency said. “These criteria supported the approvals for Keytruda and Tecentriq for initial monotherapy in cisplatin-ineligible patients.”

The FDA noted that patients taking either of these immunotherapies for other cancer types should continue to take their medication as directed by their healthcare professional, but requested that any adverse events be reported to the agency’s MedWatch Adverse Event Reporting program.

https://bit.ly/2rSWmMv

Trump picks acting chief Wilkie to head VA

President Trump used a White House summit on prison reform Friday to announce he will nominate Acting Veterans Affairs Secretary Robert Wilkie to be the agency’s permanent secretary, in an announcement that shocked not only the audience, but Wilkie himself.

“I’ll be informing him in a little while, he doesn’t know this yet, that we’re going to be putting his name up for nomination to be secretary of the Veterans Administration,” the president said, to applause. “Fantastic. I’m sorry that I ruined the surprise.”

Mr. Trump had previously tapped White House doctor Ronny Jackson to run the VA, but unsubstantiated allegations about Jackson’s conduct tanked that nomination, and Jackson withdrew. Mr. Trump ousted his former VA secretary, David Shulkin, on Twitter earlier this year. Wilkie has been the acting director since then.

Wilkie served both Robert Gates and Donald Rumsfeld as an assistant secretary of defense between 2005 an 2008, and served as special assistant to the president for national security affairs under Condoleezza Rice, according to the VA.

https://cbsn.ws/2karF1V

Merck, Bristol Myers Shares Move On Alleged FDA Alert On Keytruda

The U.S. Food and Drug Administration issued an alert on issues discovered in ongoing studies of Merck & Co., Inc. MRK 0.12%’s Keytruda Roche’s Tecentriq, according to a headline from Bloomberg. Regulators reportedly found that some patients had decreased survival.

Why It’s Important

Keytruda, which is already approved for the treatment of cancers such as melanoma, non-small cell lung cancer and Hodgkin lymphoma, is a considered a major opportunity for Merck. Updates on the drug are enough to move the stock and sway bearish experts.

A threat to Keytruda is notable for Merck, but it also carries implications for Bristol-Myers Squibb Co BMY 0.06%, whose Opdivo competes for market share. BMO Capital Markets recently noted the drugs are “more similar than different.”

Merck shares initially fell 3 percent on the news, while Bristol Myers rose marginally.

What’s Next

The FDA has not yet published a report on the matter, but clarity on the alleged “issues” could help or hurt the rival drugmakers.

https://bit.ly/2LcQ8jj

Jennifer Lawrence-led Theranos Movie Biopic Snags ‘Shape of Water’ Writer

As the end looms near for the embattled Theranos and founder Elizabeth Holmes, there has been new movement with the addition of a noted screenwriter for the planned film about the rise and fall of the beleaguered medtech company.

Vanessa Taylor, who was the screenwriter for the Oscar-winning “Shape of Water” as well as two seasons of “Game of Thrones,” will be writing the script for the Theranos story, “Bad Blood.” Deadline Hollywood reported she will be working with director Adam McKay, best known for his “The Big Short” script, which won the Oscar for the best-adapted screenplay in 2016. McKay had been set to write the script for “Bad Blood,” which is based off the book written by The Wall Street Journal’s Pulitzer Prize-winning investigative journalist John Carreyrou, but has become too busy due to other project commitments, The Silicon Valley Business Journal reported. Carrreyrou’s book will be available this month.

While the film’s writer has changed, the project still includes Hollywood star Jennifer Lawrence in the role of Theranos founder Holmes, who at one time was the youngest female billionaire in the United States. Her net value is significantly lower now given the dire straits of her company. In Hollywood, the Theranos story has been a hot commodity. The SVBJ reported that nine production companies had been bidding on the project, with Legendary Entertainment finally winning out.

Although it is not known when production on the film will begin, the true story of Theranos will likely have played out. The company that was once worth an estimated $9 billion may not survive through the July 4 holiday. The company is nearly out of money and has been unable to field any of its vaunted medical testing devices, including the latest portable lab idea.

Holmes founded Theranos when she was 19 years old. She founded the company with a vision of creating a blood-testing technology that could yield multiple diagnostic results from a single drop of blood. Through her Svengali-like ability to dangle promising technology she could never deliver, Holmes was successful in making Theranos a darling of Silicon Valley. Besides her entrepreneurial vision that made her and her company a darling of Silicon Valley investors, Holmes is known for wearing an all-black ensemble of slacks and a turtleneck, much like the now deceased Apple visionary Steve Jobs, in order to have people focus on her and what she was saying about her product rather than what she was wearing.

In 2015 though, the proverbial wheels came off the company after the Wall Street Journal’s Carreyrou began investigating the secretive company and its technological claims. Scandals followed involving inaccurate blood test data that patients used to manage their healthcare and then, of course, Holmes recently paid a $500,000 fine for fraud. Theranos is now on the verge of shutting down. Reports in April refer to an email Holmes sent to investors suggesting that the company could shut down and liquidated by June or July if she is unable to secure any additional funding. In early April, about nine days before Holmes sent the note to her investors, Theranos laid off an additional 100 employees as it sought to prevent bankruptcy. At that time the Holmes made an appeal to investors for additional financial support in order to hold off the possibility of shutting down.

https://bit.ly/2IwTYC3

Retailers File Lawsuit Against Allergan over Restasis Patents

Allergan has gone to great lengths to defend the patents for its blockbuster dry-eye drug Restasis and it looks like the company will have to head back to court again. This time the company is being challenged by retail pharmacies for anti-trust violations regarding the blocking of generic competition.

Major pharmacy retailers like Walgreens, Kroger, Albertsons and HEB Grocery have filed a lawsuit against Allergan claiming the Ireland-based company is trying to stop generic drugmakers from selling their version of the dry-eye medication, Reuters reported. Among the complaints filed against Allergan are the methods it has used to fight losing its patents for Restasis, which includes last year’s attempt to transfer the rights to a Native American tribe that has sovereign status. Allergan attempted to sell the patents to the Saint Regis Mohawk Tribe in New York. The company made the move last year as part of an attempt to take advantage of the Mohawk tribe’s sovereign immunity would shield the drug from the Inter Partes Review challenges to its patents on Restasis.

The lawsuit is taking place against a backdrop of a new cry for lower prescription drug prices. Last week President Donald Trump initiated a new call to bring down the retail price of medications.

In the lawsuit, Walgreen Co et al v Allergan Inc, the companies allege that Allergan engaged in an “unlawful scheme” to protect its sales of Restasis. FiercePharma noted that the plaintiffs also allege Allergan made “material misrepresentations” to obtain additional patents to cover the drug as its original intellectual property rights were about to expire.

The lawsuit further states that Allergan “improperly listed” its additional patents in the U.S. Food and Drug Administration’s Orange Book, the official listing of patents and exclusivity, before then suing generic drugmakers for infringement of those patents, FiercePharma added.

“Allergan filed the lawsuits simply to trigger the automatic thirty-month stay of FDA approval and delay the entry of its generic competitors,” the complaint alleges, as reported by FiercePharma.

If Allergan had drug the patents through the courts those retailers allege that a generic to Restasis could have been on the market in the United States four years ago. The retailers said that Allergan should be forced to pay damages “for its anticompetitive conduct,” Reuters said.

Last week Teva Pharmaceuticals launched its generic to Restasis, Teva-Cyclosporine, in Canada,

Allergan’s patents for Restasis cover various elements of the drug through 2024. Restasis brought in more than $1.4 billion for Allergan in 2017, which accounted for nearly 10 percent of the company’s total revenue.

https://bit.ly/2KCKVQO