Dova $DOVA didn’t have to pay much when it bagged the rights to Doptelet (avatrombopag) from Eisai — laying out only $5 million for the castoff. And now that the FDA has come through with a marketing approval for a set of chronic liver disease patients suffering from low blood platelet counts, it’s not passing on any of the savings.
Dova reported today that it’s slapped a wholesale list price of $9,000 for the 40 mg daily dose and $13,500 for the 60 mg daily dose, which raised the eyebrows of Leerink’s Geoffrey Porges — who’s been tracking the launch.
In many cases, says Porges, the cost of the pre-treatment regimen the drug is good for will outstrip the cost of the procedure patients require. He noted:
This is above our and consensus expectations and will test the market’s appetite for premium pricing for specialty therapeutics. Over the next few months, this price will also stretch Dova’s capacity for co-pay assistance and temporary free goods as payers prepare and implement their coverage policies for this medicine. Even in this indication, it is hard to predict how payers will react to a pre-treatment regimen whose cost is significantly higher, in many cases, than the procedure itself (e.g., dental extraction, uncomplicated endoscopy, etc.).
There are about 70,0000 chronic liver disease patients who suffer from thrombocytopenia. Standard operating procedure here is to assure patients that the company will work to limit any out-of-pocket expenses, and Dova is walking the line.
“We remain committed to ensuring access to Doptelet through Dova 1Source, our physician and patient reimbursement support center,” said CEO Alex Sapir.
Ironwood has successfully fended off activist investor Alex Denner from joining its board, the company announced Thursday following a shareholder meeting. But Denner isn’t done giving out tips.
Denner’s company Sarissa Capital took a stake in Ironwood late last year, and soon after announced plans to snag a seat at the table. Ironwood $IRWD campaigned for shareholders to reject Denner earlier this month, although it first seemed open to the idea. Denner is probably best known as Carl Icahn’s protégé, with a history of spurring acquisitions of the companies in which he invests. He served as chairman of Ariad before Takeda acquired the cancer company for $5.2 billion last year. He was also a board member at Bioverativ before it was sold to Sanofi for $11.6 billion earlier this year. And he recently took control of The Medicines Co $MDCO amid considerable buzz.
But after three meetings with Denner to better understand his intentions for the company, Ironwood’s executives decided they weren’t thrilled with the prospect of him on their board. In a statement, the company said Sarissa hadn’t made a strong enough case to appoint Denner, considering the boards existing diversity.
Shareholders apparently agree, as they voted Thursday to appoint three independent directors who were up for re-election rather than bring in Denner.
“We look forward to continuing to engage with our shareholders as we seek to deliver on our 2018 goals and to execute on our intent to separate Ironwood into two focused and durable businesses each with substantial opportunity for long-term growth and value creation,” Ironwood said.
Under pressure from Denner to boost shareholder value, Ironwood said earlier this month it would soon split into two companies: spinning out a pipeline of early- and mid-stage drugs into a separate, publicly traded biotech company while keeping its marketed products and related development projects in house at a scaled down, and more profitable, mother company.
Denner thinks that’s a good idea and had more advice to offer. Just after Ironwood announced its board vote results, Denner released a statement of his own. He wants three things from Ironwood:
The two post-spinout companies should be completely separate entities without cross-ownership. Each company should have modern, shareholder-friendly governance without classified boards, supervoting stock, etc. Capital allocation should be optimal. For example, adding significant debt to one company to capitalize the other or an IPO of 20% of one of the companies in order to capitalize the other would destroy significant shareholder value.
Emily Fischer is likely one of the few people whose summer plans were buoyed by a recent forecast that much of the western United States faces another worse-than-normal wildfire season. Unusually warm weather and drought, together with plenty of dry grass and brush, are expected to create prime conditions for blazes this summer, federal officials announced on 10 May.
The forecast has local officials bracing for the worst. But it represents an opportunity for Fischer, an atmospheric scientist at Colorado State University in Fort Collins who is preparing to spend the summer flying through plumes of wildfire smoke aboard a C-130 cargo plane jammed full of scientific equipment. The flights are the highlight of an unprecedented effort, costing more than $30 million, that involves aircraft, satellites, instrumented vans, and even researchers traveling on foot. Over the next 2 years, two coordinated campaigns—one funded by the National Science Foundation (NSF), and the other by NASA and the National Oceanic and Atmospheric Administration (NOAA)—aim to better understand the chemistry and physics of wildfire smoke, as well as how it affects climate, air pollution, and human health.
“This is definitely the largest fire experiment that has ever happened,” says atmospheric chemist Carsten Warneke of NOAA’s Earth System Research Laboratory in Boulder, Colorado, one of the lead scientists. Wildfire smoke, he adds, is “one of the largest problems facing air quality and climate issues going forward.”
The problem is growing as the size and intensity of wildfires rise in the western United States, marinating communities in smoke. Wildfires account for more than two-thirds of the particulate matter in the West on days that exceed federal clean air standards, according to a 2016 study in the journal Climatic Change. And global warming is likely to stoke even more fire in coming years, by making wildlands more combustible. By midcentury, more than 80 million people living across much of the West can expect a 57% increase in the number of “smoke waves”—events that shroud a community for 2 days or more—according to the 2016 study. The consequences for public health could be sobering; smoke includes an array of noxious compounds and tiny particles that can complicate breathing and promote disease. Other parts of the Americas as well as Europe, Africa, Asia, and Australia are likely to experience the same climate-driven surge in wildfires, according to U.S. Forest Service researchers.
Despite the potential threat, wildfire smoke has received little sustained scientific attention. The two new campaigns aim to change that. This year, the NSF-funded team that includes Fischer aims to fly its instrumented C-130 through 15 to 20 wildfire plumes. And next year, researchers with NASA and NOAA will have access to a bigger aircraft—a DC-8 jet—that will scour smoky skies across the United States.
One goal is to inventory the chemicals released by wildfires, including nitrogen oxides and carbon monoxide, and a vast array of volatile organic compounds. Current models for predicting the chemical makeup of smoke, which rely largely on satellite observations, have a huge margin for error, Warneke says. In part, that’s because of uncertainty about how much vegetation wildfires consume. New studies that combine data from satellites, aircraft, and ground-based researchers scrutinizing burn sites should help fine-tune those estimates.
If wildfires are burning in the Pacific Northwest, what does that mean for Colorado … ?
Researchers will also use the C-130 to chase plumes during their first 24 hours aloft, to see how the chemistry of smoke changes as it wafts through the atmosphere. In particular, they hope to get a more precise picture of what happens to the nitrogen released by burned vegetation, including how much is converted into nitrogen oxides that can contribute to ground-level ozone, a regulated pollutant that can worsen breathing problems. Such data, Fischer says, could help answer questions like: “If wildfires are burning in the Pacific Northwest, what does that mean for Colorado air quality?”
Researchers also plan to track the evolution of aerosols—minute particles that can either scatter or absorb sunlight, and play a major role in shaping climate. And they want to observe plumes as they collide with clouds, to better understand how the two affect each other. Smoke particles can alter cloud formation by acting as nuclei for ice particles, potentially influencing the weather, and cloud moisture can alter smoke chemistry. The results could help improve weather forecasts.
At night, falling temperatures can cause smoke plumes to sink into valleys, worsening air quality there. NOAA and NASA researchers will track the plumes with aircraft, vans, and a drone. That initiative will also involve DC-8 flights beyond the West, into the Midwest and Southeast, tracking smoke from fires intentionally set to clear farm fields and prescribed burns in forests. The goal of collecting such a wide array of data, Warneke says, is “to do the whole picture at one time and understand how the whole thing plays together.”
Beyond these projects, public health researchers are taking a growing interest in what happens when smoke blankets communities, sometimes for weeks at a time. Past studies have found that short-term smoke exposure can increase problems for people with asthma and other lung ailments, but “there’s really not much information at all” about the effects of long-term, chronic exposure, says Curtis Noonan, an environmental epidemiologist at the University of Montana in Missoula.
Noonan was at the center of some of the worst smoke of the 2017 wildfire season, when Montana was hit by fires that burned 400,000 hectares. The biggest blow fell on Seeley Lake, a town of 1600 located 50 kilometers northeast of Missoula. The nearby Rice Ridge fire filled the town with smoke for much of August and early September 2017, driving levels of fine particulate matter to nearly 20 times the acceptable limit set by the Environmental Protection Agency.
Noonan is now working with colleagues to gather health information from residents of Seeley Lake and several other Montana towns. They aim to track how respiratory performance, mental states, and genetic markers related to inflammation change when smoke descends. Noonan is also seeking funding to sift through health records of wildland firefighters to understand how sustained smoke exposure has affected them.
Farther north, Sarah Henderson, an environmental epidemiologist and veteran smoke researcher at the British Columbia Centre for Disease Control in Vancouver, Canada, hopes to track the fate of children born during high-smoke events. One big question, she says, is: “If you’re born into really smoky conditions with your extremely sensitive, newborn lungs, what does that mean for you?”
As scientists prepare to tackle such questions, health officials in Missoula are preparing for a possible repeat of last year’s smoke waves. The health department is stockpiling indoor air filters for day care centers, schools, and other gathering spots.
Fischer, for one, hopes they aren’t needed. Although she requires fire for her studies, she says, “I’m just wishing for an average wildfire year with wildfires in wilderness areas that don’t cause any property damage.”
The Food and Drug Administration announced Wednesday an “innovation challenge” aimed at encouraging the development of medical devices such as digital health applications and diagnostic tests aimed at detecting, treating and preventing opioid addiction.
The agency is accepting proposals between June and September from developers with products at any stage of development, or with an existing product attempting to show an improved risk profile compared to opioids for pain management.
FDA’s device center will choose which applicants are accepted into the program in November. Those selected will have “enhanced interactions with FDA review divisions” during the development of their products, and FDA will grant the Breakthrough Device designation to products that meet the statutory criteria without requiring a separate application.
FDA expects that the products that go through the program will ultimately submit “one or more formal applications” for approval through its various device approval pathways.
“The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” FDA device chief Jeff Shuren said in a statement.
The agency plugged the opportunity to work closely with the agency as an incentive for developers to create products that address the opioid crisis. Examples of desirable products include diagnostics that can identify those at high risk of addiction, treatments for pain that could replace opioids, treatments that could help alleviate opioid withdrawal symptoms and technologies that prevent illicit diversion of prescription opioids.
The innovation challenge builds upon HHS’ efforts to address the opioid crisis by encouraging the development of novel pain treatments, an element of its Five-point Strategy to Combat the Opioid Crisis.
The Centers for Disease Control and Prevention said in March that drug overdoses killed 63,632 Americans in 2016, with 66% of those deaths attributable to a prescription or illicit opioid. The surgeon general has said more Americans should carry around naloxone, which can reverse the effects of an opioid overdose.
As the opioid epidemic continues to take its devastating toll across the country, providers and payers have developed policies aimed at curbing misuse of the drugs. Prescribers are being asked to consider alternative pain management treatments and to check prescription drug monitoring programs. Some organizations are using data analyses to pinpoint patients who may be at high risk of opioid addiction in an attempt to stop a disorder before it starts.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” FDA Commissioner Scott Gottlieb said in a statement.
Also, both chambers of Congress are in the process of moving sizable packages of opioid bills aimed at further tackling the crisis. Cowen Washington Research Group predicts a package is likely to pass Congress before the August recess.
New York City has a new method of warning people about the dangers of cocaine use: They’re telling them how to use it safely.
The move was prompted after the drug fentanyl was found to be laced in the cocaine supply.
nycHealthy
@nycHealthy
ICYMI: We’re warning patrons of bars/nightclubs on the Lower East Side about the dangers of cocaine laced with fentanyl: http://on.nyc.gov/2Lo0M6P#HealingNYC
Fentanyl is an opioid that’s 30-50 times more potent than heroin, according to the Health Department.
“People who may use cocaine occasionally may be at risk of an opioid overdose,” the Health Department said in a press release.
So Health Department officials have been visiting bars and clubs on the Lower East Side to spread the word. They’ve been passing out free coasters warning about fentanyl laced cocaine. The coasters include some safety tips: Those tips include using cocaine with others, so that in the event of an overdose there’s someone who could help. They also urge users to carry naloxone or narcan, which can reverse an overdose.
Users can call 311 to find out where to get naloxone. For treatment, users can call 888-NYC-WELL.
CBS2’s Andrea Grymes asked Mayor Bill de Blasio if he thought this would encourage cocaine use.
He said that people are using cocaine, so the city is doing whatever it can to get the message out.
“The city is not encouraging drug usage, we are encouraging safety,” officials said in a statement. ” We can’t connect New Yorkers to treatment if they are dead.”
A national nonprofit organization representing oncologists filed a lawsuit on Wednesday against the Trump administration calling for an end to "illegal" cuts that impact cancer drug reimbursement.
The Community Oncology Alliance filed the suit (PDF) in the U.S. District Court for the District of Columbia, saying the Centers for Medicare & Medicaid Services should stop applying a 2% sequester cut to Medicare Part D drug reimbursement. The application of that cut to Part B reimbursement is "illegal and unconstitutional," the COA said in a statement.
"What's interesting about Part B drug reimbursement, as opposed to any other Medicare reimbursement, is that Medicare Part B reimbursement to physicians is defined in law. That rate is defined in law as average sales price plus 6%," said Ted Okon, executive director of COA, in an interview with FierceHealthcare. He was referring to the Medicare Modernization Act of 2003. "It's an overreach of the executive branch in terms of basically bypassing the Congress," Okon said. The U.S. Department of Health and Human Services and the White House Office of Management and Budget are both named in the lawsuit. Neither had yet returned a request for comment on Thursday morning by press time.
The automatic across-the-board sequestration cuts have been applied to the Part B program since 2013 under the Obama administration. COA said it has raised concerns about their negative impact on the nation's cancer care system since with members of Congress and representatives at both HHS and OMB under both the Obama and Trump administrations.
The cuts hurt patients in the form of less access to cancer care as treatment is pushed into higher cost hospital settings, Okon said. Since sequestration cuts began being applied in 2013, about 135 independent community cancer clinics have closed and about 190 clinics have been acquired by hospitals.
"It has literally been a slow drip of torture" on the bottom line of independent practices which administer these drugs and have to cover the costs associated with procuring, preparing and disposing of cancer drugs for patients, he said. "It's pushed practices toward the hospitals. The hospitals, with half of them having 340B discounts, are ready to basically take the practice. Then when the patient goes into the hospital, the billing is done by the hospital system and patients pay more," Okon said. This also drives up overall costs to Medicare. COA research estimates consolidation cost Medicare (PDF) an extra $2 billion in 2014.
Most recently, he said the group received a letter from CMS which defended the application of the sequester cut to Medicare, Okon said. "This was a last resort. We were getting nowhere and exhausted every possibility," he said about the lawsuit.
COA said it also submitted a letter (PDF) to HHS Secretary Alex Azar explaining the legal action, as well as explaining concerns about how recent proposals to change Medicare Part B under the president's blueprint on drug prices would hurt cancer patients. For example, research released by Avalere Health last week finds that Medicare out-of-pocket costs vary significantly and in 2016, the average cost to patients for Part D covered cancer therapies was $3,200, compared to $2,400 under Part B, a 33% difference. The main driver between the cost difference is common use of supplemental coverage under Part B, which is limited under Part D.
https://bit.ly/2xtTFqL
The Food and Drug Administration has officially unveiled new guidance that aims to increase competition in drug markets.
The agency released a pair of draft guidance documents that could allow generic drugmakers to apply to create their own Risk Evaluation and Mitigation Strategy (REMS) program if they’re struggling to acquire samples from branded companies to use in drug development.
FDA Commissioner Scott Gottlieb, M.D., previewed the plans earlier this month. The first guidance document (PDF) provides details on what a REMS program should look like, while the second (PDF) outlines when the FDA will consider the waivers.
Generic drug companies argue their brand-name peers can use REMS to hinder competition and make it harder for them to bring generics to market. Brand-name drugmakers have said there are a number of scenarios beyond gaming that could delay REMS agreements and said they can’t sell samples to generic companies because those competitors have not agreed to REMS limits.
Gottlieb said in a statement that the goal of the new guidance is to maintain the safety protocols REMS provide while also making it easier for generics to enter the market.
“The REMS shouldn’t become a tool that drug companies use to delay or block competition from generic products or hinder their entry to the market,” Gottlieb said.
Having a more clearly defined set of parameters for REMS should enable companies to operate better within them, according to the FDA. An efficient REMS program will promote, not hinder, drug market competition.
However, the FDA said it will consider waivers at any time, according to the document, though it does seek to encourage companies to effectively band together under the shared REMS system first.
New policies we’ve issued today are another step we’re taking to help generic drug makers get their products developed efficiently while maintaining safety controls of a REMS program: https://go.usa.gov/xQwYX
We believe a more efficient process for developing shared system REMS and clarity on when we’ll issue waivers to generic firms to develop their own REMS will help end some gaming tactics that can delay generic entry https://go.usa.gov/xQwYX
“Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful [intellectual property] has lapsed on a brand-name drug,” Gottlieb said. “Our market-based system for rewarding innovation is dependent on this kind of legal competition.”
The FDA rolled out its first initiative under the Trump administration’s “American Patients First” blueprint to reduce drug pricing in mid-May, when it launched a website that would detail which brand-name drugs generic drug companies had the hardest time accessing.
Gottlieb said at the time the website would ensure “branded companies are on notice” for behavior that could hold generic drugmakers back.
The FDA is also planning to reveal policies that overhaul its drug approval process in early June, Gottlieb said.
Department of Health and Human Services Secretary Alex Azar praised the FDA’s actions in a statement, saying the agency will “continue taking action to promote competition.”
“The FDA’s announcement today will help generic drug manufacturers bring low-cost competition to market faster and discourage brand-name companies’ misuse of laws meant to protect public health,” Azar said. “Greater competition in drug markets is one of the key pieces of our plan to bring down drug prices.”
