Yes, overall spending on prescription drugs has slowed recently, but expect Democrats to pummel Alex Azar over sky-high prices of specialty and cutting-edge medications as he testifies before a Senate panel this morning.
The former Eli Lilly executive is inching closer to confirmation as secretary of the Department of Health and Human Services — a position vacant since Tom Price’s resignation four months ago — with a hearing at the Senate Finance Committee starting at 10 a.m. (You can watch it streaming here.) The panel will give Azar’s Democratic critics a forum to contend that his role in helping to approve rising pharmaceutical prices while at Lilly means he's ill-suited to carry out President Trump’s stated goal of making medicines more affordable, my colleagues Juliet Eilperin and Amy Goldstein report.
If Azar is confirmed -- and it's likely he will be -- he would be HHS's first secretary with a background in the pharmaceutical industry. On that note, we thought it would be timely to look at 10 of the new drugs expected to rack up the most money as they hit the market this year (although none of them are Lilly products.) The following list is from the London-based firm EvaluatePharma, and the drugs are ranked according to projected U.S. sales in 2022.
1. Bictegravir; Gilead Sciences: $3.2 billion
This new, highly anticipated HIV drug is expected to get final FDA approval in February. Gilead — which has rolled out several top HIV drugs over the past several years — has predicted Bictegravir will become the market’s top medication, even referring to the drug as its “Mount Everest.”
2. Ozempic; Novo Nordisk: $1.8 billion
Longer-acting than Novo’s hugely popular diabetes drug Victoza, Ozempic is injected once a week by patients with Type 2 diabetes. Studies have shown it more effective at lowering blood sugar levels and promoting weight loss than competitors such as Eli Lilly’s Trulicity.
3. Epacadostat; Incyte: $1.6 billion
This drug could be the year’s most-anticipated cancer immunotherapy. Designed as a first-line treatment for metastatic melanoma, it’s used in combination with Merck’s Keytruda. Studies have shown that 56 percent of melanoma patients treated with the combination responded to the therapy for a median 45 weeks, and their cancer didn’t progress for a median 12.4 months. The FDA probably won’t approve the drug until late in the year, given the hurdles still facing Incyte.
4. Ozanimod; Celgene: $979 million
Designed for multiple sclerosis patients, this drug curtails the inflammatory process by blocking two receptors located at the surface of certain immune cells. Celgene is hoping Ozanimod will become its next blockbuster drug over the next few years, assuming the FDA approves it this year. Trials have shown the oral medication to be more effective reducing relapse rates and MRI brain lesions compared with Avonex, the current therapy of choice.
5. Rova-T; AbbVie: $971 million
The latest cancer drug to join AbbVie’s all-star lineup, Rova-T could be the first targeted drug approved for highly lethal small-cell lung cancer, which kills 60,000 people a year. Clinical trials have found that it led to tumor shrinkage in 18 percent of patients and some clinical benefit in 41 percent of patients.
6. Lanadelumab; Shire; $914 million
Treats Hereditary Angiodema (known as HAE) a rare and potentially life-threatening genetic condition which involves swelling in various parts of the body. Shire, which already sells some HAE medications, has conducted studies finding that Lanadelumab eliminated attacks in 38 percent of patients.
7. Elagolix; AbbVie; $877 million
Industry-watchers expect this new endometriosis drug to make waves in 2018. The FDA granted it priority review in October and an approval decision is expected in the early part of the year's second quarter. AbbVie is also evaluating Elagolix in a late-stage study for treatment of uterine fibroids.
8. JCAR017; Juno Therapeutics; $828 million
A new therapy for non-Hodgkin lymphoma in an already crowded market. If JCAR-017 is approved this year, it will compete with similar drugs sold by Gilead Sciences' Yescarta and Novartis' Kymriah.
9. Sublocade; Indivior; $767 million
The FDA recently approved this new drug to fight opioid addiction. It has attracted the attention of the addiction treatment community, basically working as an injectable form of the established drug buprenorphine, which helps patients follow a long-term treatment plan to ease away from their opioid addictions.
10. Epidiolex; GW Pharmaceuticals; $749 million
This cannabis-derived product has been shown in trials to help epileptics by reducing frequency and severity of seizures. It's likely to be approved this year, although under the Trump administration there could be additional bureaucratic barriers to its distribution.
Here's one ad against Azar being run by the pro-ACA group Protect Our Care:
From Politico's Rachana Pradhan:
Alex Azar's record as a drug company executive is likely to dominate his Finance Committee confirmation hearing tomorrow. Here's something big to know, via @SarahKarlin https://t.co/i7TQCLqGrJ pic.twitter.com/if5D0UX3Gh— Rachana D. Pradhan (@rachanadixit) January 8, 2018
Rep. Lloyd Doggett (D-Tex.):
Azar is just another Trump broken promise. Instead of stopping the "murder" Trump said Big Pharma was committing, he put another of their hitmen in charge. I have urged the Senate Finance Cmte to hold Azar accountable for skyrocketing costs at Eli Lilly. https://t.co/fO167jBita— Lloyd Doggett (@RepLloydDoggett) January 8, 2018
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AHH: Today, the Colorado Supreme Court hears oral arguments in an embryo-custody dispute, a case which could prompt a landmark ruling on balancing one person's constitutional right to procreate with another's countervailing constitutional right to not procreate.
"The question parallels similar arguments used in other reproductive health cases, namely the Supreme Court’s landmark 1973 abortion decision in Roe v. Wade. If women have the right to not be forced to be a gestational parent, do men — or women — have the right not to be forced to be a genetic parent?" my colleague Ariana Eunjung Cha reports.
This particular case involves a divorcing couple who can't agree on what to do with six frozen embryos. While the husband doesn't want to have any more children, the wife wants them preserved for potential future attempts to get pregnant. Although several other cases have made their way to states’ high courts, legal experts say the issues here present front-and-center constitutional questions in a way past cases haven't.
"The dispute is one of a number of embryo-custody battles that have landed in the courts over the past quarter-century, resolved by different judges in different states with no consistent pattern," Ariana writes. "Rulings sometimes have awarded the frozen contents to the parent who wanted to use them, while other times determining that they could be discarded."
OOF: For those who want states to expand Medicaid, here's another argument: It lowers the rate of hospital closures, particularly in rural areas. A study published yesterday by Health Affairs details a crucial consequence of the divide between liberal-leaning states that accepted the Affordable Care Act's Medicaid expansion and conservative-leaning states that rejected it. Hospitals in expansion states benefited from a wave of newly insured patients, while hospitals in non-expansion states continued seeing larger populations of patients unable to pay for their care.
“Various forces are driving hospitals to shut down, including industry consolidation and a long-term shift toward outpatient care,” Stat News reports. “But this data indicates that Medicaid coverage is a ballast against those forces for many facilities, especially those that serve high levels of uninsured patients who cannot pay their bills.”
Hospitals in Medicaid expansion states were 84 percent less likely to shut their doors than hospitals in non-expansion states, University of Colorado researchers found. The trend was particularly apparent among rural hospitals, which are prone to closure. And the rate of hospital closures saw the most improvement in areas with the worst uninsured rates.
“It underscores how important the expansion has been for rural communities,” Andrea Callow, associate director of Medicaid initiatives at Families USA, told Stat. “Rural hospitals rely on Medicaid and Medicare as primary payers.”
OUCH: Guess what -- dieting isn't the most effective way for the severely obese to lose weight. Weight loss surgery is. Vox’s Julia Belluz writes people are ignoring what may be the most effective treatment for severe obesity. Recent studies have shown people with obesity who had surgery were able to lose a dramatic amount of weight and in some cases reverse or prevent any related health concerns, such as diabetes or high cholesterol, yet only 1 percent received such surgeries out of 20 million people in the U.S. who are eligible.
There’s a disconnect in the way researchers view the causes and treatments for severe obesity compared with how the American public views it. While researchers observe genetic and hormonal characteristics that could make people more prone to weight gain, the public views obesity as something that can be fixed by a stronger will, a trip to the gym and a diet. Julia cites a 2016 survey that found 60 percent of participants said dieting and exercise were more effective for long-term weight loss than surgery. And various polling data reveals Americans believe bariatric surgery for weight loss is dangerous and ineffective.
"Bariatric surgery’s benefits appear to vastly outweigh its harms on average, and it is shaping up to be a genuine help for people struggling through one of the most urgent health crises of our time. It’s time we started paying attention," Julia writes.
--The White House is struggling to contain the national discussion about President Trump’s mental acuity and fitness for the job, concerns which have overshadowed the administration’s agenda for the past week, The Post's Philip Rucker and Ashley Parker report. Over the weekend, Trump himself waded into the debate by claiming he's "like, really smart" and "a very stable genius" in reaction to Michael Wolff’s "Fire and Fury" inside account of the presidency.
"In doing so, the president underscored his administration’s response strategy — by being forceful and combative — while also undermining it by gleefully entering a debate his aides have tried to avoid," Philip and Ashley write. "Trump privately resents the now-regular chatter on cable television news shows about his mental health."
Yet doubts about Trump’s state of mind have been whispered around Washington since before he was elected and have occasionally broken into the open. "So far, Trump’s advisers have adopted a posture of umbrage and indignation. Rather than dignifying questions about whether their 71-year-old boss is fit to be president, they attack the inquisitors for having the gall to ask," my colleagues write.
In a statement yesterday, White House press secretary Sarah Huckabee Sanders slammed what she called “ridiculous reports from detractors” and described an “outpouring of support from a totally indignant staff.”
“The White House perspective is outrage and disgust that people who do not know this President or understand the true depth of his intellectual capabilities would be so filled with hate they would resort to something so far outside the realm of reality or decency,” she said.
Trump's physical exam, scheduled for Friday at Walter Reed National Military Medical Center, will not include a psychiatric component. That's per deputy White House press secretary Hogan Gidley, who barely engaged the question when posed by reporters, simply replying “No.”
--Mitt Romney, who's currently eyeing a run for retiring Sen. Orrin Hatch's Utah seat, was treated for prostate cancer last summer, Phil reports. An aide to the 2012 presidential nominee told Phil that Romney was “diagnosed with a slow-growing prostate cancer” last year which was “removed surgically and found not to have spread beyond the prostate.” A second person close to the former Massachusetts governor said Romney’s prognosis is “very good” and that he was “treated successfully."
Back during the 2012 presidential campaign, Romney had released a letter from his longtime personal physician, Randall Gaz at Massachusetts General Hospital, who described him as a “healthy appearing, energetic, strong, physically fit male,” adding that he had a mild enlargement of the prostate and had a family history of prostate cancer.
Meghan McCain, daughter of Arizona Sen. John McCain, who was diagnosed with brain cancer last summer, tweeted Monday that she was “happy to hear [Romney] is doing well” and expressed “prayers to him and his family. “
--Lawmakers provided a $3 billion emergency stopgap bill to fund the Children's Health Insurance Program through the end of March. But states are reporting they could run out of money in just a few weeks and now the Centers for Medicare and Medicaid Services says it can only guarantee full funding for all states through the end of January, Talking Points Memo's Alice Ollstein reports.
CMS is "unable to say with certainty" whether the stopgap CHIP bill will allow every state to continue its program through March 31, as certain factors including hurricane damage have drained funding faster than projected, CMS spokesman Johnathan Monroe told TPM.
“We appreciate that Congress included funding for CHIP in the continuing resolution that runs through January 19, 2018," Monroe said. "The funding included in the CR should carry all the states through January 19th based upon best estimates of state expenditures to date.”
Lawmakers took to Twitter yesterday with reminders it's been 100 days since long-term CHIP funding expired:
Sen. Jeanne Shaheen (D-N.H.):
Sen. Bob Casey (D-Pa.):
#CHIP legislation has now been held up for 100 days.— Senator Bob Casey (@SenBobCasey) January 8, 2018
Republicans are holding the healthcare of 9 million kids hostage over the “cost” of the CHIP reauthorization - $800 million.— Senator Bob Casey (@SenBobCasey) January 8, 2018
Meanwhile, Republicans rammed $9.5 trillion in tax changes through Congress in 49 days.— Senator Bob Casey (@SenBobCasey) January 8, 2018
Former CMS administrator Andy Slavitt:
Today marks 100 days since the Children’s Health Insurance Program funding expired. #CHIP— Andy Slavitt (@ASlavitt) January 8, 2018
Send the message that 9 million low income kids and their families matter.
The American Academy of Pediatrics:
Today is day 100 since Congress failed to pass long-term funding for CHIP. The short-term CHIP funding that was passed before the holiday recess does not provide the stability 9 million children need. AAP will be joining child advocates Wednesday to tell Congress to #SaveCHIP. pic.twitter.com/tzAE2r4zCG— Amer Acad Pediatrics (@AmerAcadPeds) January 8, 2018
--Your Health 202 author is still shivering here in Washington, but we're recalling last year at this time when we were enjoying some warmer (albeit rainy) weather at J.P. Morgan's annual health-care conference in San Francisco. We'll be keeping an eye long-distance this week, as the conference typically prompts big industry news from the major drugmakers.
Already, Celgene has announced it's spending at least $1.1 billion -- and maybe as much as $6 billion on top of that -- to buy Impact Biomedicines, a private biotechnology company with an experimental medicine for the bone marrow disorder myelofibrosis. If the FDA approves fedratinib, it would be a competitor to Incyte's blood-disease drug Jakafi.
"That's business as usual for the summit, which draws thousands of investors, executives and analysts to San Francisco each January," CNBC's Meg Tirrell reports. "More than 450 companies are scheduled to present at the conference, setting the stage for the year ahead ... On everyone's minds this week: Will the U.S. tax overhaul spur acquisitions? And will the president once again attack the industry for its pricing practices?"
Meg has more developments to watch at J.P. Morgan here.
--A few more good reads from The Post and beyond:
- The Senate Finance Committee holds a nomination hearing for Alex Azar to serve as the secretary of Health and Human Services.
- The Senate Health, Education, Labor and Pensions Committee holds a hearing on the opioid crisis.
- The Cato Institute holds a book discussion on "The Elephant in the Brain: Hidden Motives in Everyday Life.”
- The House Veterans’ Affairs Subcommittee on Economic Opportunity holds a hearing on "Home Loan Churning Practices and How Veteran Homebuyers are Being Affected” on Wednesday.
- The National Academy of Sciences holds a workshop on "The Promise of Genome Editing Tools to Advance Environmental Health Research” on Wednesday and Thursday.
- MedPAC holds a public meeting on Thursday and Friday.
- The Bipartisan Policy Center holds a discussion on “Reinventing Rural Health Care: A Case Study of Seven Upper Midwest States” on Jan. 17.
- The House Veterans’ Affairs Subcommittees on Health and on Economic Opportunity hold a joint hearing on addressing veteran homelessness on Jan. 18.
- Kaiser Health News holds an event on what’s in store for health care in 2018 on Jan. 18.
Dozens of same-sex couples exchanged wedding vows at midnight as a new law took effect in Australia:
President Trump attended the NCAA Football National Championship game in Atlanta between the University of Georgia and the University of Alabama:
Decades before President Trump ran for office, he joked that Oprah would be his “first choice” for vice president:
Late-night comedians had a lot to say about the possibility of Oprah running for president: