Stat: In A Shift, Debate Over Drug Prices Overshadows Obamacare

Obamacare? That’s so last month. On Capitol Hill, drug prices are now the hot topic

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Obamacare? That’s so last month. On Capitol Hill, drug prices are now the hot topic.

Drug prices finally have lawmakers’ attention.

After years in which the debate over Obamacare has dominated all health policymaking discussion on Capitol Hill, U.S. lawmakers are increasingly turning their attention to the prices that everyday Americans pay for their prescription drugs.

Less than one year ago, when the Senate health committee spent four hours grilling Tom Price, President Trump’s nominee as secretary of health and human services, Democrats focused their most aggressive attention on his support for repealing Obamacare and for making major changes to the Medicare and Medicaid programs, as well as his investments in an Australian biotech company.

After years in which the debate over Obamacare has dominated all health policymaking discussion on Capitol Hill, U.S. lawmakers are increasingly turning their attention to the prices that everyday Americans pay for their prescription drugs.

Less than one year ago, when the Senate health committee spent four hours grilling Tom Price, President Trump’s nominee as secretary of health and human services, Democrats focused their most aggressive attention on his support for repealing Obamacare and for making major changes to the Medicare and Medicaid programs, as well as his investments in an Australian biotech company.

On Wednesday, the same panel heard from Alex Azar, who has been nominated as the next official to take over the helm of HHS. This time the grilling was bipartisan: All but four of the 18 lawmakers, on both sides of the aisle, used their opening remarks and questions to press Azar about different drug pricing and pharmaceutical issues.

Chairman Lamar Alexander of Tennessee and the panel’s top Democrat, Sen. Patty Murray of Washington, made drug prices the subject of their very first questions. Sen. Johnny Isakson (R-Ga.) pressed Azar to draft a list of proposals to “end the gaming of the system” by drug makers and other companies before next July. And Sen. Rand Paul (R-Ky.) suggested he could even oppose Azar’s confirmation unless he receives clearer answers on the safety risks of drug importation.

Most of the Obamacare questions, if they came at all, came as the hearing wound down. Other issues, like Medicare payment initiatives, got almost no attention. It was a stark contrast to the same panel’s focus even just in June, when Democrats derailed a hearing on drug pricing to focus on Republican efforts to repeal Obamacare.

Even Alexander noticed something different was taking place on Wednesday.

“For the last, oh, seems like forever, we have focused on health insurance,” he said in his closing remarks. “There’s so much other important [work] we should we working on when we talk about health, health care and the agencies that you work on. Drug pricing is one this committee has a great interest in.”

The debate over Obamacare is hardly over; a tax reform bill approved by the House and a similar version up for consideration in the Senate this week, for instance, would repeal the law’s individual mandate, a provision that has prompted outcry among Democrats.

It’s also true that congressional interest in drug prices isn’t entirely new. Lawmakers turned their attention to drug pricing in the wake of state-budget-busting drugs like the hepatitis C treatment Sovaldi, headline-grabbing increases like Martin Shkreli’s 5,500 percent price spike for the HIV medication Daraprim, and widespread public outcry. Trump made the issue a central tenet of his campaign for president, and lawmakers on both sides of the aisle have introduced legislation aimed at tackling aspects of the issue.

For the most part, however, lawmakers’ interest has yielded few concrete results. They have largely avoided any policymaking on the issue, even as they delivered major priorities for the industry, like a package of so-called user fees and the 21st Century Cures Act to spur medical innovation.

Azar, a former pharmaceutical executive at Eli Lilly, was sensitive to the shift in tone over drug prices on Wednesday, and gave far longer and more detailed answers to related questions than to queries about issues like access to contraception. He took an early stand on the topic himself, saying the issue would be his top priority for his time at the agency and declaring emphatically, in his opening remarks, that prices are “too high.”

For the most part, the policy solutions he offered are more in line with other conservative thinkers than with Trump, who broke with some Republicans to support more liberal policies like drug importation and Medicare price negotiations on the campaign trail. Azar pushed back on importation in his testimony and dodged questions about negotiation, highlighting instead efforts to increase generic competition and deter abuses of the patent system.

He, like other Republicans and pharmaceutical executives, also shifted some blame from drugmakers and highlighted the role other industry players play in the pricing debate.

“Everybody in the system owns a piece of this,” he said, as Sen. Tammy Baldwin (D-Wis.) pushed him to admit that drug makers, too, had a role. “The system has to get fixed. That’s the problem. … What we need to do is work to fix the system so that [consumers] have insurance that covers that insulin, so they have low out-of-pockets. We’ve got to get the list prices down, also.”

If not for Azar’s tenure at Lilly, drug pricing might be considered an unusual focus for a hearing ostensibly aimed at vetting Azar as health secretary. Few of Azar’s day-to-day responsibilities — or even his authority — would center on drug pricing if he is confirmed. Most of the concerns senators raised would need to be addressed with congressional action, not regulatory changes at the Health and Human Services Department.

Sen. Maggie Hassan of New Hampshire, for example, pressed Azar to opine on the drug company Allergan’s efforts to avoid patent challenges by selling its intellectual property to a Native American tribe. Azar said he shared her concerns — but even he noted he wouldn’t have jurisdiction on the issue. Indeed, any of the major patent system changes he suggested Wednesday would fall to the Patent and Trademark Office Director or, more likely, to Congress.

Major changes to spur generic competitors to existing prescription drugs — the subject of questions from Sen. Susan Collins (R-Maine) — would likely require congressional action. Lawmakers, too, would have to make changes about who is held liable in cases like a Lilly lawsuit, focused on its marketing for the drug Zyprexa, that Sen. Elizabeth Warren (D-Mass.) made the centerpiece of her questions. The same goes for efforts to speed changes to over-the-counter drug marketing, as Sen. Lisa Murkowski (R-Alaska) raised.

In the handful of areas in which Azar could, if confirmed, actually affect pricing policy, his attitude was mixed.

Though he would legally have the authority to encourage the importation of drugs from other countries, he expressed great skepticism of that idea when pressed by Paul and other senators. That skepticism is in line with his earlier comments on the issue, though notably differs from Trump’s.

Interestingly, Azar suggested he would like to explore changes to the way Medicare pays for drugs administered by doctors — an area over which he would have jurisdiction alongside the administrator of the Centers for Medicare and Medicaid Services, Seema Verma. His remarks were notably vague, but offered insight into policies he may try to pursue if confirmed.

“How could we think about the ways to take the learnings from Part D and actually bring lower costs to the system, but also lower costs to the patient because they pay a share of whatever Medicare reimburses in part B?” he asked. “That’s a double win. Lower for the system and lower for the patient on their out-of-pocket costs. That’s the kind of thing I would have energy to see, where we could really save money and actually improve things for our patients.”

Many senators used their second round of questioning to press harder on Obamacare — and lawmakers on the Senate Finance Committee, which has jurisdiction over Medicare policy, will have another chance to question him on those and other issues when that panel takes up Azar’s nomination officially.

That hearing has not yet been scheduled. But Alexander used his remarks Wednesday to announce a few future hearings for his panel, including a Dec. 12 meeting — on drug prices.

Patients With Rare Diseases And Congress Square Off Over Orphan Drug Tax Credits

Patients With Rare Diseases And Congress Square Off Over Orphan Drug Tax Credits

As President Donald Trump talked tax reform on Capitol Hill Tuesday, Arkansas patient advocate Andrea Taylor was also meeting with lawmakers and asking them to save a corporate tax credit for rare-disease drug companies.

Taking the credit away, Taylor said, “eliminates the possibility for my child to have a bright and happy future.”

Taylor, whose 9-year-old son, Aiden, has a rare connective tissue disorder, spoke as part of a small rally thrown together this week by the National Organization for Rare Disorders (NORD) — the nation’s largest advocacy group for patients with rare diseases.

NORD advocate Andrea Taylor holds a picture of her sons, Aiden, 9, and Aaron, 11. Aiden has the rare connective-tissue disorder arterial tortuosity syndrome, which causes symptoms such as aneurysms and congestive heart failure. The syndrome has no treatment. Taylor says Congress is sending a message “that my child’s life does not matter” if the orphan drug tax credit is eliminated or reduced. (Sarah Jane Tribble/KHN)

Earlier this month, House Republicans proposed eliminating the orphan drug tax credits, which Congress passed as part of a basket of financial incentives for drugmakers in the 1983 Orphan Drug Act. The law, intended to spur development of medicines for rare diseases, also gives seven years of market exclusivity for drugs that treat a specific condition that affects fewer than 200,000 people.

The Senate Finance Committee, led by Sen. Orrin Hatch (R-Utah), put the tax credit back into the tax legislation. After some negotiations, the committee settled on reducing the credit to 27.5 percent of the costs of preapproved clinical research, compared with the current 50 percent. The committee also restored a provision that would have eliminated any credits for drugmakers who repurpose a mass-market drug as an orphan.

“As with any major reform, tough choices have to be made,” a Hatch spokesperson wrote in an emailed statement, adding that the senator will continue to work “to make the appropriate policy decisions” to deliver a comprehensive tax overhaul.

Hatch, a member of a rare-disease congressional caucus, received $102,600 in campaign contributions from pharmaceutical and related trade group political action committees in the first half of 2017, making him the top recipient of pharmaceutical cash in the Senate.

If the Senate provision remains untouched, reducing the tax credit would save the federal government nearly $30 billion over a decade, according to a markup of the bill released late last week.

Orphan drug development has become big business in recent years and advocates as well as critics of the industry say tax credits have been an important motivation for companies. Orphan drugs accounted for 7.9 percent of total U.S. drug sales last year, according to a report released by QuintilesIMS and NORD.

Because patient populations for rare-disease drugs are relatively small, companies often charge premium prices for the medicines. EvaluatePharma, a company that analyzes the drug industry, estimates that among the top 100 drugs in the U.S. the average annual cost per patient for an orphan drug last year was $140,443. Giant pharmaceutical companies such as Celgene, Roche, Novartis, AbbVie and Johnson & Johnson have led worldwide sales in the orphan market, according to EvaluatePharma’s 2017 Orphan Drug Report.

Jonathan Gardner, the U.S. news editor for EvaluatePharma, said the orphan drug tax credit is “probably the most important incentive for developing an orphan drug.” Cutting the credit will force even the large companies to question development of drugs for rare diseases, Gardner said.

Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, has been critical of the Orphan Drug Act’s incentives and of companies taking advantage of the law’s financial incentives for profit. But he warned against rushing to eliminate the tax credit.

“We need to think about ways we can improve the Orphan Drug Act and stop people from gaming the system and exploiting it,” Kesselheim said. But there “are a lot of rare diseases that don’t have treatments. So, we need to be careful in making changes.”

The battle over the tax credit is the latest controversy for the Food and Drug Administration’s orphan drug program. FDA Commissioner Scott Gottlieb announced a “modernization” plan for the agency this summer, closing a pediatric testing loophole and eliminating a backlog of corporate applications for orphan drug status. And, this week, the agency confirmed that Dr. Gayatri Rao, director for the Office of Orphan Products Development, is leaving.

Meanwhile, the Government Accountability Office confirmed this month that it recently launched an investigation of the orphan drug program. The GAO’s review was sparked by a letter from top Republican Sens. Hatch, Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.), asking the agency to investigate whether drugmakers “might be taking advantage” of the drug approval process.

When the 1983 Orphan Drug Act was passed, the law described an orphan drug as one that affects so few people that drugmakers might lose money after covering the cost of developing a drug. Congress added the 200,000-patient limit in 1984.

Today, many orphan medicines treat more than one condition and often come with astronomical prices. Many of the medicines aren’t entirely new, either. A Kaiser Health News investigation, which was also aired and published by NPR, found that more than 70 of the roughly 450 individual drugs given orphan status were first approved for mass-market use, including cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, which for years was the best-selling medicine in the world.

More than 80 other orphans won FDA approval for more than one rare disease and, in some cases, multiple rare diseases, the KHN investigation showed.

The pharmaceutical industry has had a muted response to the tax bill, which includes a corporate tax cut. The powerful industry lobbying group PhRMA said it is pleased Congress is looking at overhauling the tax code but “encourages policymakers to maintain incentives” for rare diseases. BIO, the Biotechnology Innovation Organization that represents biomedical companies, said it was “gratified” the Senate committee chose to partially retain the credit but would prefer to keep the existing incentive.

The group that rallied Tuesday — wearing bright-orange shirts that read “Save the Orphan Drug Tax Credit” — planned to meet with a couple of dozen lawmakers, including Grassley, who is a member of the Senate Finance Committee.

NORD, like many patient advocacy groups, receives funding from pharmaceutical companies, but the organization’s leaders say the industry does not have members on the board and does not dictate how general donations are spent.

On Tuesday, NORD leaders said they are open to discussions about the tax credit and whether the overall law is working as intended.

“We’re here to have that conversation, we’re ready to have that conversation,” said Paul Melmeyer, director of federal policy for NORD. “Sadly, that’s not the conversation we are having today.”

Abbey Meyers, a founder of NORD and the leading advocate behind passing the initial 1983 law, said she fears the high cost of the drugs will make it impossible to sustain the orphan drug program. Now retired, Meyers said she has followed the law’s success over the years and believes the tax credit should not be changed.

“There are other things that have happened since the law was passed where there wasn’t any logic to what they did,” Meyers said, adding “because somebody went to a senator and they put into the law.”

 

Stabilization Bill Couldn’t Fix the Damage of Repealing Obamacare’s Mandate

https://www.bloomberg.com/news/articles/2017-11-29/obamacare-stabilization-bill-can-t-fix-harms-of-mandate-repeal

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  • CBO has estimated 4 million would lose coverage in 2019
  • Stabilization bill would have no impact on predictions: CBO

Passing a bipartisan Obamacare stabilization bill wouldn’t do much to cushion the blow from repealing the health law’s requirement that all individuals buy health insurance, the Congressional Budget Office said.

 The CBO has estimated that scrapping the mandate would result in 4 million people losing health coverage in 2019 and premiums in the individual market to increase by 10 percent. On Wednesday, the nonpartisan Congressional agency said a stabilization proposal backed by some Republican Senators would have no impact on its calculations.
The CBO’s conclusion could have an impact on the fate of the Senate tax overhaul bill that is expected to get a vote this week. Senate Republicans included the repeal of the Affordable Care Act’s individual mandate in their tax proposal. And several Senators concerned about their states’ health insurance markets, including Susan Collins of Maine and Lisa Murkowski of Alaska, had pushed forward the stabilization bill as a way to mitigate the blow.
President Donald Trump endorsed the proposal, known as the Bipartisan Health Care Stabilization Act, on Tuesday.

“The effects on premiums and the number of people with health insurance coverage would be similar to those referenced above,” the CBO said Wednesday.

The CBO projection comes with caveats. It compares the effect of the stabilization bill to a baseline in which Obamacare’s cost-sharing reduction subsidies are paid. The Trump administration has halted the payments, which lower deductibles and out-of-pocket costs for low-income people, and the funds are the subject of a legal dispute.

“I find it baffling,” Collins said Wednesday. She and Murkowski voted against earlier Republican efforts to repeal the ACA, blocking them.

The CBO report also doesn’t evaluate the effect of giving insurers additional funding, an approach that’s also under discussion. Collins introduced a bill with Senator Bill Nelson of Florida to give states seed money for high-risk pools “which would ensure that people with pre-existing conditions are protected and also to lower premiums,” she said on Tuesday. Alexander specified that Collins’s bill would provide $3 billion to $5 billion to states to set up the high-risk pools. Collins said on Tuesday that Trump also supporters her proposal.

Are You Your Organization’s Editor-in-Chief?

https://www.masterclass.com/classes/ron-howard-teaches-directing?utm_source=Paid&utm_medium=Facebook&utm_term=Aq-Prospecting&utm_content=Video&utm_campaign=RH

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About 15% of Americans with HIV don’t know they’re infected, CDC report says

http://www.latimes.com/science/sciencenow/la-sci-sn-hiv-infection-knowing-20171128-story.html

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Half of the Americans recently diagnosed with HIV had been living with the virus for at least three years without realizing it, missing out on opportunities for early treatment and in some cases spreading it to others, according to a new report by the Centers for Disease Control and Prevention.

What’s more, of the 39,720 Americans newly diagnosed with HIV in 2015, one-quarter had been infected for seven years or more without knowing they were ill.

Among all 1.2 million Americans living with HIV in 2015, the CDC estimates that about 15% were unaware of their HIV-positive status. Those people are thought to be responsible for 40% of new transmissions of HIV, according to the study published Tuesday in the CDC’s Morbidity and Mortality Weekly Report.

The human immunodeficiency virus, or HIV, is responsible for causing AIDS. Infection used to be considered a death sentence, until antiretroviral medications capable of suppressing the virus came into broad use in the late 1990s.

For each of the new cases diagnosed in 2015, researchers estimated a rough time of infection on the basis of a patient’s level of disease progression. Based on patients’ initial count of infection-fighting CD4 cells, they gleaned how long the HIV virus likely had replicated unchecked. A normal range for CD4 cells lies between 500 and 1,500; a CD4 count below 200 brings a diagnosis of AIDS.

Although the median time between infection and diagnosis for all Americans was three years, there was considerable variability among patients of different racial and ethnic groups.

For instance, half of African Americans had been infected for 3.3 years when they were diagnosed, while the median time for whites was 2.2 years. This gap was seen despite the fact that African Americans were more likely than whites to have been tested for HIV in the previous year.

For Latinos, the median time to diagnosis was also 3.3 years; for Asian Americans, it was 4.2 years.

The authors of the CDC report surmised that the longer diagnosis delay among nonwhite racial and ethnic groups might reflect an observed trend: For whites, men who have sex with men are the predominant sources of HIV spread, but for other groups, sexual contact between men and women is responsible for a higher proportion of infections.

Age, too, was a key factor, with older patients more likely than younger ones to go years without knowing they were HIV-positive. Half of newly-diagnosed patients 55 and over were HIV-positive for 4.5 years or more without knowing it. Among those 34 and younger, the median delay between infection and diagnosis was about 2.5 years.

Fully half of people with undiagnosed HIV infection in 2015 were living in the South, the CDC said. States with the highest rates of undiagnosed HIV infection — between 16% and 19% — included Nevada, Arizona, Texas, Michigan, Iowa, Indiana, North Dakota and Wisconsin. New Jersey, Pennsylvania, Vermont and South Dakota and Idaho had the lowest rates, between 5% and 10%.

Overall, the three-year gap between infection and diagnosis actually represents progress. In 2011 — the last time the CDC took such measures — half of Americans newly diagnosed with HIV had been infected for 3.6 years or more.

That suggests that public health campaigns started by the CDC, including the “Testing Makes Us Stronger” push rolled out in 11 cities, have made inroads. Two CDC campaigns, launched in 2007 and 2011, set out to encourage testing and early HIV care on the part of African Americans and Latinos, and particularly among men who have sex with men.

Such public health efforts have increased rates of testing among many groups at high risk. Among men who have sex with men, 71% told surveyors they had been tested in the last year, as did 58% of people who inject drugs. Only 41% of heterosexual Americans at increased risk of HIV infection said they had been tested in the last 12 months.

Taking HIV medicine as prescribed allows people with the virus to live a virtually normal lifespan, generally without health complications. Managing one’s HIV infection with medication also significantly reduces the likelihood of transmitting the virus to sexual partners.

“The benefits are clear,” said Dr. Jonathan Mermin, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “Prompt diagnosis is prevention. It is the first step to protecting people living with HIV and their partners.”

The CDC recommends testing all people between the age of 13 and 64 for HIV at least once in their lifetime, and people at higher risk for HIV — including IV drug users and sexual partners of infected persons — at least annually. Healthcare providers may find it beneficial to test some sexually active gay and bisexual men as frequently as every three to six months.

Dr. Brenda Fitzgerald, the CDC’s director, called the new statistics “more encouraging signs that the tide continues to turn on our nation’s HIV epidemic.”

HIV is being diagnosed more quickly, Fitzgerald said. The number of people who have the virus under control is up, and annual infections are down, she added.

“While we celebrate our progress, we pledge to work together to end this epidemic forever,” she said.