In new guide to tapering opioids, fed health chiefs eye balanced prescribing

Federal health officials on Thursday released a guide for clinicians who are considering tapering patients’ opioid prescriptions, highlighting the benefits of safe reductions in dosages while warning against abrupt drops for people who have been on the drugs for long periods.
The recommendations come amid concerns that some chronic pain patients’ dosages have been unsafely pulled back and that providers have sometimes abandoned patients. Some experts and advocates have warned that overly aggressive reductions or forced cutbacks have led some patients who are dependent on the drugs to seek out illicit sources of opioids or consider suicide.
The anxiety around prescribing built in response to the opioid crisis, which drove more than 47,000 fatal overdoses in 2017 alone. The crisis was caused in part by some clinicians overprescribing the drugs, leading to cases of addiction in patients and a source of pills that were diverted. Prescribing levels have dropped since 2012, and some advocates have warned that the fear around opioids has left some patients unable to get them.

The new guide marks the government’s attempt to strike a balance between reducing the amount of opioids prescribed and ensuring patients aren’t left behind. It also reflects concerns that prescribing guidelines released by the government in 2016 were misapplied and contributed to inappropriate tapers.
On a call with reporters Wednesday, Dr. Brett Giroir, an assistant secretary at the Department of Health and Human Services, said it was possible to address the roots of the addiction crisis while helping people receive the medications they need.
“It is a false choice to say we can only limit opioid use disorder, or addiction, or have pain control,” he said.

Overall, the guide casts the decision to taper as an individualized one that prescribers and patients should reach together. Tapers may need to go slowly and their effects should be reviewed throughout the process. Patients need to have their concerns addressed, the guide stresses. It even suggests clinicians reiterate to patients that, “I’ll stick by you through this,” and to offer other forms of support.
Successful tapers to lower dosages can lead to improvements in sleep, mood, and overall daily function without leading to a resurgence of pain, according to the guide. But it also describes the risks of rapid tapering on the first of its six pages. It warns that doing so can induce withdrawal symptoms and recommends that abrupt dose reductions only happen when there are concerns about impending overdoses or other life-threatening issues. It also provides examples of when patients and prescribers should consider tapering, including when the drugs appear not to be working for pain control, or when the patient has side effects or starts taking certain other types of medications, including benzodiazepines.
On the call with reporters, Dr. Deborah Dowell of the Centers for Disease Control and Prevention said there are not specific targets that dose reductions should try to hit. Instead, patients and clinicians should find doses where the benefits of opioid use outweigh the risks.
“Tapering success does not mean getting down to zero or to any particular dose,” Dowell said.
While experts widely agree that overprescribing contributed to the opioid addiction crisis, there’s been an ongoing debate about how insistently to pursue tapers for chronic pain patients. Many who have been on opioids for years have grown dependent on the drugs, and it can be difficult for them to come off the medications. It can also be hard to distinguish whether tapering is leading to a return of pain or temporary symptoms of withdrawal.
While some experts have preached caution — in some cases advocating leaving patients at high doses if tapering could throw off their lives — others argue that leaving patients on these doses for long periods is bad medicine. Higher dosages of opioids are associated with overdose risk, and there is evidence that chronic opioid use can leave people more sensitive to pain and contribute to anxiety and depression.

Much of the debate has focused on a set of 2016 prescribing recommendations from the CDC. The guidelines were a measured set of proposals, including that clinicians treating chronic pain try other therapies before opioids and prescribe only the lowest effective dose and duration of the drugs. The CDC suggested that prescribers “work with patients to taper opioid to lower dosages or to taper and discontinue opioids” in cases where the harms of taking the drugs outweigh the benefits.
But after the guidelines came out, insurers, pharmacies, states, and law enforcement agencies started cracking down on high prescribing, often pointing to the guidelines as the source of their policies. Clinicians grew even more nervous about treating chronic pain patients, advocates said, and sometimes dismissed their patients.
Earlier this year, the authors of the CDC guidelines wrote in a follow-up paper that their recommendations had been misapplied. They said that some agencies and companies used the guidelines incorrectly to justify an “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drugs dosages.”
Dowell (who is one of the authors of the CDC guidelines), Giroir, and Dr. Wilson Compton of the National Institute on Drug Abuse also wrote a piece in JAMA Thursday describing the tapering guide. In it, they write that “clinicians have a responsibility to provide care for or arrange for management of patients’ pain and should not abandon patients.”
They add: “For patients who are unable or unwilling to taper and who continue receiving high-dose or otherwise high-risk opioid regimens … close monitoring and mitigation of overdose risk are recommended.”

With a new guide to tapering opioids, federal health officials seek a balanced approach to prescribing

Puma Bio down 6% after Sanders callout on Nerlynx price hike

Puma Biotechnology (PBYI -5.5%) is down, albeit on below-average volume, in apparent response to disparaging comments on Twitter from Presidential hopeful Sen. Bernie Sanders (I-VT) about its 20% price hike on breast cancer med Nerlynx (neratinib).
https://seekingalpha.com/news/3505061-puma-bio-6-percent-sanders-callout-nerlynx-price-hike

Humana up 3% on expanded partnership with Accolade

Humana (HUM +2.8%) will expand its collaboration with personalized health and benefits solutions platform developer Accolade aimed at customizing the Humana with Accolade solution for a broader based of potential customers. Their plan, supported by a $20M investment from Humana, involves a significantly larger geographic footprint commencing next year and beyond (Humana with Accolade is currently available in the Milwaukee, WI and Cincinnati, OH areas).

The companies launched their partnership in March.

https://seekingalpha.com/news/3505063-humana-3-percent-expanded-partnership-accolade

Proposed Drug Price Reform Would Short-Change Rare Disease Patients

A prominent healthcare watchdog has found the solution to high drug prices – or so it claims.
For years, the nonprofit Institute for Clinical and Economic Review (ICER) has analyzed and rated the cost-effectiveness of new drugs. ICER wants insurers and government programs like Medicare and Medicaid to use these ratings to determine which medicines are worth covering. If health plans only cover drugs that provide a good “value” to patients and taxpayers, ICER believes drug expenditures would plummet.

This approach probably would cut short-term spending – but it would also endanger patients, especially those with rare diseases that afflict fewer than 200,000 people. Millions of Americans could lose access to life-enhancing drugs. And research into rare disease treatments would grind to a halt.
For each drug it evaluates, ICER offers a suggested price range based on how many additional months or years of good health the treatment provides to patients. In the United States, ICER recommends that drugs not cost more than $175,000 for each “quality adjusted life year” – 12 months of good health – they deliver.
Rare disease drugs hardly ever meet ICER’s standards. Four out of the five rare disease therapies that ICER assessed between December 2014 and August 2018 were deemed low value.
Consider revolutionary treatments for spinal muscular atrophy or SMA, the leading genetic cause of death for infants. The FDA approved the first therapy for SMA in 2016. Before that, many patients would die before age two. The drug enabled previously immobile children to stand, walk, and breathe more freely. Parents credit the drug with saving their children and enabling them to hit developmental milestones that were previously unreachable.
But ICER recently determined the therapy fell short of “traditional cost-effectiveness” thresholds. To fit within those thresholds, its price would have to drop up to 90 percent.
So are these treatments overpriced? Not at all. ICER assumes innovators would be willing to take a 70 to 90 percent price cut and still find it financially viable to manufacture and distribute a medicine.
This is wildly unrealistic.
On average, it costs $2.6 billion to bring a new drug to market. If public and private health plans used ICER’s cost assessments to deny coverage to certain medicines, drug researchers would have little incentive to develop new therapies.
This is especially true when it comes to drugs for rare diseases, which often affect just a few thousand people. Many companies won’t even roll the dice on rare disease drug research. Consequently, 93 percent of rare diseases lack an FDA-approved treatment.
When companies successfully create rare disease drugs, they must set prices high enough to recover their development costs from a small patient population. As a result, these treatments cost much more per dose than traditional drugs, whose costs can be spread over millions of customers.
ICER doesn’t sufficiently account for this fundamental difference between mass-market and rare disease drugs. Nor does it consider the smaller-than-average size of rare disease clinical trials when declaring them “inconclusive” in determining a drug’s benefits for patients. And it also evaluates drugs before reliable information is available – it is currently reviewing a treatment for Duchenne muscular dystrophy that is still under FDA review.
Despite its limitations, ICER’s approach appeals to policymakers and insurers who want to cut drug spending. They could point to an ICER analysis as an “objective” reason to not cover certain drugs.
This is already happening in the United Kingdom, where officials in the national health system only cover drugs deemed cost-effective. The National Institute for Health and Care Excellence — which uses a framework somewhat similar to ICER’s – routinely recommends denying patients access to potentially life-saving drugs for conditions ranging from cancer to cystic fibrosis.
If the United States adopted a similar approach, 30 million rare disease patients could face similar barriers to treatment almost immediately.
The long-term effects would be even worse. If insurers and government programs stop paying for rare disease treatments, the financial incentive to develop these drugs would evaporate. Research into thousands of rare diseases would dry up, along with patients’ hope for a long, healthy life.
Lowering drug spending is a worthy goal. But not at the expense of stifling research and condemning millions of patients.
Kenneth E. Thorpe is a professor of health policy at Emory University and chairman of the Partnership to Fight Chronic Disease. 
https://www.realclearhealth.com/articles/2019/10/10/proposed_drug_price_reform_would_short-change_rare_disease_patients_110953.html

Business Leaders Should Crunch the Numbers On Medicare for All

Big business appears to be getting behind Medicare for All.
That’s one way to read a new report from the National Business Group on Health. The organization recently asked 147 large employers that provide coverage to over 15.6 million workers and their dependents for their opinions of Medicare for All.

Some employers expressed concern about the quality of care under Medicare for All, or how much it would cost. Others embraced it or had little idea what it would entail.
This lack of awareness about the details of Medicare for All is problematic. Even its proponents acknowledge that it would raise taxes or introduce new taxes, particularly on businesses. Evidence from other countries with similar systems, meanwhile, shows that Medicare for All would deliver poor care to patients.
Not every employer realizes what the transition to Medicare for All would entail. Four in five respondents to the National Business Group on Health’s survey correctly said the government would have to raise taxes to get the program off the ground. But around one in five did not know whether taxes would go up or down.
That’s alarming. Medicare for All could cost as much as $40 trillion in its first decade, according to one of its own architects, Senator Bernie Sanders. He’d raise a big chunk of that money by taxing employers.
Chief among the levies he has in mind is a 7.5 percent payroll tax. He expects this will extract $3.9 trillion from employers over 10 years. Sanders has also proposed a tax hike on capital gains for those earning above $250,000 annually and a 4 percent tax on every American household.
Even that wouldn’t be enough to finance the plan. So employers are likely to face even higher taxes down the line.
Employers are equally unclear about how Medicare for All would affect their workers. Less than half the respondents in the National Business Group on Health survey believed their employees’ health costs would go up under Medicare for All. Some said Medicare for All would drive down their workers’ health costs.
But that’s not the case. More than 70 percent of working, privately insured households would pay more for health care under a fully-funded single-payer plan than they currently do, according to an analysis from Emory University professor Ken Thorpe. Another study found that Medicare for All would cause the average American’s post-tax income to shrink by more than 10 percent.
Employers seem equally misinformed about how Medicare for All would transform the U.S. healthcare system. Only 56 percent of those polled by the National Business Group on Health said the plan would decrease the quality of patient care; a mere 40 percent said it would reduce healthcare access.
By making care free to patients at the point of access, Medicare for All could induce effectively unlimited demand for care. That surge in demand would encounter comparatively limited supply. The country is already projected to be short 122,000 physicians by 2032. Long waits would be the result.
For proof, look to Canada, whose healthcare system is the model for Medicare for All. Last year, Canadian patients waited a median of 19.8 weeks to receive treatment from a specialist after receiving a referral from a general practitioner, according to the Fraser Institute. For some specialties, the wait is even worse. Patients waited a median of 39 weeks for orthopedic surgery.
Medicare for All may seem tempting to businesses struggling to absorb the steadily rising cost of health benefits. But it would deliver a major hit to their bottom lines — and consign their workers to long waits for substandard care.
https://www.realclearmarkets.com/articles/2019/10/09/business_leaders_should_crunch_the_numbers_on_medicare_for_all_103939.html

Hexo gives prelim Q4 revenue, pulls 2020 guidance

HEXO Corp (“HEXO” or the “Company”) (TSX: HEXO; NYSE: HEXO) is providing preliminary revenue for its fiscal fourth quarter and year ended July 31, 2019 and is also withdrawing its previously issued financial outlook for fiscal 2020.

Based on preliminary financial information and subject to year-end closing adjustments, HEXO expects net revenue for the fourth quarter to be approximately $14.5 million to $16.5 million and net revenue for the year to be approximately $46.5 million to $48.5 million.

“Fourth quarter revenue is below our expectation and guidance, primarily due to lower than expected product sell through,” commented Sebastien St-Louis, CEO and co-founder of HEXO Corp. “While we are disappointed with these results, we are making significant changes to our sales and operations strategy to drive future results. Over the past quarter, we began re-configuring our operations to focus on high-selling strains and initiated a new sales strategy that we believe will meaningfully improve performance.  We plan to discuss these in more detail on our upcoming earnings call.”

Slower than expected store rollouts, a delay in government approval for cannabis derivative products and early signs of pricing pressure are being felt nationally. The delay in retail store openings in our major markets has meant that the access to a majority of the target customers has been limited.  Additionally, regulatory uncertainty across the pan-Canadian system and jurisdictional decisions to limit the availability and types of cannabis derivative products have contributed to an increased level of unpredictability. As a result, HEXO is withdrawing its previously issued financial outlook for fiscal year 2020.

“Withdrawing our outlook for fiscal year 2020 has been a difficult decision,” added St-Louis. “However, given the uncertainties in the marketplace, we have determined that it is the appropriate course of action. We are also placing a greater focus on profitability. We are evaluating our plans and operations to see where we can be even more efficient. We are at our best when we are highly focused on our strategic priorities, always with a view to drive long-term value for shareholders. Growing low-cost, quality cannabis and developing innovative products is our priority and we are renewing our commitment to do so.”

The Company plans to release its complete financial results for the year ended July 31, 2019 on Thursday, October 24, 2019, before markets open, as well as host a webcast for investors and analysts at 8:30 a.m. EDT that same day.

Webcast Details
Date: October 24, 2019
Time: 8:30 a.m. EDT
Webcast: https://event.on24.com/wcc/r/2112048/C13DC676CE53A5FD2CEB4095D0FF4A3A
Replay information: A replay of the call will be accessible by telephone until 11:59 a.m. EDT on November 7, 2019.
Toll Free Dial-In Number: 1-888-390-0541.
Replay Password: 531469#

https://finance.yahoo.com/news/hexo-corp-provides-preliminary-fourth-103000615.html

European biotech firm BioNtech jumps 10% in U.S. market debut

Shares of BioNTech SE jumped on their market debut on Thursday, after the German biotech firm downsized its initial public offering (IPO) and priced its stock below an earlier expected range.

The shares, whose launch was the latest test of fragile sentiment this year for primary stock market offerings, opened up 10% at $16.50 and rose as high as $16.69 in early trading on Nasdaq, giving the company a market valuation of $3.78 billion (3.08 billion pounds).
The company had originally aimed to sell 13.2 million American Depository Share (ADS) at between $18 and $20 apiece, but on Wednesday cut the deal size to 10 million ADS at $15 to $16 per share.
The final pricing of its public flotation at $15 per ADS helped BioNtech raise about $150 million less than a month after the dramatic collapse of another major IPO for WeWork owner The We Company.
The Mainz, Germany-based company specializes in messenger RNA (mRNA) molecules that prompt human cells to produce therapeutic proteins, triggering an immune response against cancer or infectious diseases.
Its closest rivals are Massachusetts-based Moderna and Belgium’s eTheRNA, which are currently locked in the race to develop mRNA therapies.
BioNtech said it expects to use proceeds from the public share sale for general corporate purposes and to acquire or invest in complementary technologies and products.
J.P. Morgan, BofA Securities and UBS were the lead underwriters of the IPO.

https://www.marketscreener.com/news/European-biotech-firm-BioNtech-jumps-10-in-U-S-market-debut–29362460/