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Sunday, June 7, 2020

Alnylam details successful lumasiran kidney/bladder study results

Following up on its initial announcement in December 2019, Alnylam Pharmaceuticals (NASDAQ:ALNY) releases detailed results from its successful Phase 3 clinical trial, ILLUMINATE-A, evaluating RNAi therapeutic candidate lumasiran in patients with primary hyperoxaluria type 1 (PH1), a rare inherited disorder characterized by kidney and bladder stones caused by excess levels of oxalate in the kidneys and urinary tract. The data were virtually presented at the European Renal Association-European Dialysis and Transplant Association International Congress.
The study met the primary endpoint demonstrating a statistically significant 53.5% average relative reduction in urinary oxalate versus placebo and a 65.4% mean absolute reduction from baseline. All secondary endpoints were also met.
On the safety front, the most common treatment-related adverse events were mild injection site reactions.
Lumasiran is designed to reduce oxalate in the body by reducing the levels of an enzyme called glycolate oxidase which depletes the substrate necessary for oxalate production.
Marketing applications are currently under review in the U.S. and Europe.
https://seekingalpha.com/news/3580970-alnylam-announces-detailed-results-from-successful-lumasiran-study-in-ph1

Biotech week ahead, June 8

The biotech space saw a flurry of activity last week, with coronavirus-related news, conference presentations and IPOs.
Negative clinical readouts led to some strong selling in stocks such as Iterum Therapeutics PLC ITRM 2.68% and Novus Therapeutics Inc NVUS 0.92%. On a positive note, Merck & Co., Inc. MRK 0.81% snagged another approval for its triple combo antibiotic.
Here are are the key catalysts for the unfolding week.

Conferences

  • Bio Digital: June 8-12
  • 41st Annual Goldman Sachs Global Healthcare Conference, held as a virtual event: June 9-11
  • The Endocrine Society’s ENDO Online 2020: June 8-22
  • 25th Edition of the European Hematology Association, or EHA, Annual Congress held in virtual format: June 11-21
  • American Academy of Dermatology, or AAD, Virtual Meeting Experience: June 12-14
  • The American Diabetes Association, or ADA, 80th Scientific Sessions – Virtual: June 12-16

PDUFA Dates

The FDA is set to rule on Viela Bio Inc’s VIE 3.15% BLA for inebilizumab in treating neuromyelitis optica spectrum disorder, a rare autoimmune disorder. (Thursday)

Clinical Readouts

ENDO Online Presentations
Opko Health Inc. OPK 3.52%: results from the global Phase 3 pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (Monday)
Neurocrine Biosciences, Inc. NBIX 3.54%: Results of the Phase 2 proof-of-concept study of crinecerfont in adult patients with congenital adrenal hyperplasia (Monday)
EHA Presentations
bluebird bio Inc BLUE 6.1%: data from its gene therapy programs for sickle cell disease, transfusion-dependent β-thalassemia and its cell therapy program for relapsed and refractory multiple myeloma
Merus NV MRUS 7.74%: interim data from the Phase 1 MCLA-117 acute myeloid leukemia trial and an analysis of an extensive, proprietary panel of CD3 bispecific antibodies
Blueprint Medicines Corp BPMC 2.39%: results from Phase 2 PIONEER study of avapritinib in patients with indolent systemic mastocytosis and updated Phase 1 data for avapritinib in patients with advanced systemic mastocytosis, regardless of prior midostaurin therapy
Autolus Therapeutics Ltd – ADR AUTL 0.69%: updated data using AUTO1 in relapsed/refractory B-Acute lymphoblastic leukemia, and Phase 1 data for AUTO3 with Merck’s Keytruda in patients with relapsed/refractory diffuse large B cell lymphoma
Vertex Pharmaceuticals Incorporated VRTX 2.61% and Crispr Therapeutics AG CRSP 2.21%: 12 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-111 trial in transfusion-dependent beta thalassemia and six months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-121 trial in severe sickle cell disease
Takeda Pharmaceutical Co Ltd TAK 0.95%: interim analysis from the Phase 2 OPTIC study of ponatinib in chronic-phase chronic myeloid leukemia patients who are resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Imara Inc IMRA 9.82%: interim data from the ongoing Phase 2a study of IMR-687 in patients with sickle cell disease
Principia Biopharma Inc PRNB 3.31%: updates on efficacy and safety, including durability of effect, from the ongoing open-label Phase 1/2 clinical trial in patients with immune thrombocytopenia
Constellation Pharmaceuticals Inc CNST 0.35%: updated preliminary data from the MANIFEST clinical trial of CPI-0610 in myelofibrosis
Protagonist Therapeutics Inc PTGX 1.05%: data from its Phase 2 trial of PTG-300 for the treatment of beta-thalassemia
Agios Pharmaceuticals Inc AGIO 2.2%: updated clinical proof-of-concept data from the Phase 2 study of mitapivat in in adults with non-transfusion-dependent thalassemia
AAD Presentations
Principia Biopharma: full data set presentation from the Phase 2 Part B pemphigus trial with its investigational drug rilzabrutinib (Friday)
ADA Presentations
Oramed Pharmaceuticals, Inc. ORMP 1.17%: poster presentations of oral insulin ORMD-0801’s effects on glucose parameters in uncontrolled Type 2 diabetes, oral insulin-induced reduction in liver fat content in Type 2 diabetic patients with non-alcoholic steatohepatitis and evening oral insulin glycemic effects in uncontrolled Type 2 diabetes patients (Friday)
vTv Therapeutics Inc. VTVT 1.05%: full clinical study results from the positive Phase 2 Simplici-T1 Study of TTP399 as an oral adjunctive therapy in type 1 diabetes (Saturday)

Earnings

Enzo Biochem, Inc. ENZ 3.41% (Monday, after the close)
Advaxis, Inc. ADXS 2.44% (Thursday, before the market opens)

IPO

Dallas, Texas-based clinical-stage biotech Lantern Pharma, which uses AI, machine language and genomic data to develop drugs and identify patients who can benefit from targeted oncology therapies, has filed to offer 1.563 million shares of its common stock at an estimated price range of $15-$17. The shares of the company have been approved for listing on the Nasdaq under the ticker symbol “LTRN.”

IPO Quiet Period Expiry

ADC Therapeutics SA ADCT 0.72%
https://www.benzinga.com/general/biotech/20/06/16193531/the-week-ahead-in-biotech-viela-fda-decision-hematology-conference-take-center-stage

Congress Shouldn’t Sneak Insurance Handout into Next COVID Relief Package

While Congress debates a fourth relief package addressing the fallout from the COVID-19 pandemic, health care providers are risking their lives on the front lines to provide care for the sick. But instead of focusing on priorities like ensuring widespread availability of personal protective equipment for health care personnel, or on how best to provide relief for ordinary Americans denied the opportunity to work, some in Congress see this emergency as an opportunity to pass a so-called solution to surprise medical bills that would devastate an already strained health care system.
For health care providers, fallout from the pandemic is not limited to hotspots like New York City. Elective surgeries across most of the nation have been postponed indefinitely and physicians are seeing few patients in their offices to reduce the spread of disease. As a result, back line providers, such as dentists, pediatricians, and surgeons, are experiencing tremendous financial strain. Without the typical level of business, providers are having to cut costs by furloughing workers even as they attempt to prepare for a possible influx of coronavirus cases.
Against this backdrop you would think it insane that Congress would consider a dramatic change to the health care system that hospitals and doctors have consistently warned would be ruinous. Yet that is precisely what is happening as Sen. Lamar Alexander (R-TN), Rep. Greg Walden (R-OR), and Rep. Frank Pallone (D-NJ), with the backing of insurers, once again push their proposal to impose government rate-setting as the answer to surprise medical bills. Unfortunately, it is a case of the cure being at least as bad if not worse than the disease.
Doctors are not the only ones raising the alarm. A letter from the Coalition Against Rate-Setting, signed by 27 taxpayer and consumer protection groups, argues that “it is deeply disturbing that special interest groups are still seeking to promote legislation which will short change our frontline medical workers and lead to reduced accessibility to health care through the nationwide consolidation of health care facilities.”
Having the government set the appropriate rate for out-of-network services would introduce all the usual negative consequences that come with price controls, such as shortages, quality reduction, and rationing. Basing that rate on a median in-network rate would also create a perverse incentive for insurers to narrow networks to get the most favorable price.
This is not mere theorizing. California has tried the rate-setting approach and the results are dismal. A survey by the California Medical Association reports that physicians in the state overwhelming found that California’s surprise billing law accelerated consolidation of independent practices, reduced access to emergency care, and led to a narrowing of insurance contracts.
In contrast, an approach tested in New York has produced promising results. The state reports that over 4 years it has seen a reduction in out-of-network billing of 34 percent, for a savings of $400 million for consumers. To get this result they enacted an arbitration system known as Independent Dispute Resolution that relies on neutral health care experts to adjudicate conflicting claims between insurers and providers, incentivizing robust networks and compromise. Best of all, patients are left out of it.
A bipartisan bill (H.R. 3502) with 110 cosponsors, more than any other surprise billing legislation, would adopt the New York model. While this approach is not likely to prove perfect, it denies either insurers or providers a negotiating advantage and seems the best that can be achieved without a wholesale reimagining of our health care system.
The middle of a once-in-a-century health crisis is not the time to make far-reaching changes to the nation’s health care system. But if Congress insists on addressing surprise billing now instead of waiting until the crisis has passed, they should unquestionably choose the solution with a track record of success, and the most support within Congress, over the proven failure. A Congress grateful for the continued sacrifices of doctors and nurses won’t sell them out to the special interests of insurers.
Andrew F. Quinlan is co-founder and president of the Center for Freedom and Prosperity.
https://www.realclearhealth.com/articles/2020/05/22/congress_shouldnt_sneak_insurance_handout_into_next_covid_relief_package

The Virus’s Uneven Path

In this miserable Covid-19 spring, it’s tempting for remote workers to vent our frustrations with being hemmed in, forced to stare at screens while unable to do much else other than walk around the block or go to Costco. Yet the pain felt by the teleworking middle class is dwarfed by that of working-class Americans.
Outside of nursing homes, the coronavirus has hit poor communities hardest, a problem tied to living and working in close proximity with the public. Unlike the affluent of Gotham, some 30 percent or more of whom, in certain neighborhoods, were able to leave town and work remotely, few people in poor communities have fallback options. They remain where they are, riding public transit and enduring crowded conditions. The far poorer Bronx has suffered nearly twice as many deaths from Covid-19 as more prosperous, but even denser Manhattan.
Public-transit use appears to be a significant factor in infection, not only in New York but also in car-dominated cities like Detroit, Houston, and Los Angeles, where the poor constitute a disproportionate share of riders. Living conditions for poorer populations represent another factor, according to a recent study by the Furman Institute at New York University. In working-class communities, many residents share homes or apartments with extended family. It’s difficult, if not impossible, to socially distance or quarantine when you live in a confined space containing multiple adults. This is particularly true in Los Angeles County, home to five of the ten most crowded zip codes—including the most crowded—in the U.S. Living in multigenerational homes may be one reason why the poor in areas like South Central Los Angeles or East L.A., according to an L.A. County survey, have suffered virus death rates twice those of better-off precincts.
Much the same pattern can be seen in Houston, where poor, often immigrant families in areas like the First or Third Wards have experienced far higher rates of infection and fatalities. An analysis by the Houston Chronicle revealed that seven of the ten zip codes with the highest rates of infection were majority black and low-income communities. Some had double or triple the average per-capita rate in the county.
Over time, the biggest impact of the pandemic, will likely be economic. Income and capital could dry up, undermining cash-strapped entrepreneurs and chipping away at the nonprofit safety belt that helps poor communities endure harsh times. The wage gains made during the first two years of the Trump administration among low-income workers could well evaporate. Almost 40 percent of Americans making less than $40,000 a year have lost their jobs during the pandemic. It’s not clear yet how many of those positions will be regained as the economy reopens.
To a large extent, the public sector and those parts of the economy that operate by keystroke—knowledge workers in fields like media, finance, software, and accounting— have faced inconvenience but not the threat of obliteration. Salaried workers have been laid off at roughly half the rate of hourly workers. The unemployment rate of those with less than a high school diploma jumped from 6.8 percent to 21.2 percent; for college graduates, it rose from 2.5 percent to 8.4 percent. The biggest drops in hiring have been concentrated in recreation and travel, mostly “personal contact” jobs that employ many poor workers. Employment in this sector has dropped 70 percent, while remaining stable in such fields as computer networking, as well as throughout the entire public sector.
Hiring has taken place at Amazon warehouses, food-delivery systems, and other “essential” businesses, but many workers in the inner cities were employed in restaurants, hair salons, and across the vast hospitality sector as hotel chambermaids, ticket sellers, shuttle-bus drivers, and car-rental agents. These enterprises have been devastated. In Southern California, the largest job losses have been in food preparation and personal care, both major sources of employment for minorities and immigrants. “There’s a general paranoia and people here are struggling,” observed Rudy Espinoza, executive director of the Leadership for Urban Renewal Network in East L.A. “Here, this is not about convenience—it’s about putting food on the table or paying the rent.”
Manufacturing job losses could intensify in states where lockdowns extend over the summer. The potential relocation of Tesla’s Milpitas plant due to the lockdown in Alameda County would not hit code-writing Stanford graduates but largely working-class people from the far reaches of the Bay Area and the adjacent Central Valley.
Even in business-friendly Houston—far less affected by the virus—things could be tough. In its most recent update, the Texas Workforce Commission reported 286,000 unemployment benefit claims across the Houston region, the highest number in the state. Food-service and retail workers lost 33,000 jobs, and people working largely blue-collar jobs in oil and gas were also hit hard.
In minority and working-class neighborhoods, small businesses are often the only local employers. They’re also, in many cases, the bulwark of local society, supporting churches, charities, and community events. In many Latino and Asian areas, entrepreneurship provides a way for those with limited education and language skills to boost themselves into the middle class. During the pandemic, many such firms have taken on debt that they may have trouble repaying. According to the JP Morgan Institute, 50 percent of small businesses have 15 days or less of cash on hand. If the shutdown lasts much longer, as many as three quarters of independent restaurants won’t survive.
Many of these small companies, notes John Hobson, executive director of Cielo, a nonprofit in Orange County, lack the financial records or bank relationships needed to access stimulus funds. Irinia Soto Welty, executive director of OC Mecca, another nonprofit assisting businesses in poor areas, says that business owners may be limited by their immigration status and often have limited English skills. Many small restaurateurs also lack the expertise and technical resources to shift their business model from dine-in to pick-up or delivery, as well-capitalized chain restaurants have done.
In places like Leimert Park, a predominantly African-American, middle-class enclave, many local businesses—including popular coffee shops, boutiques, and barber shops—remain closed, and may never reopen. Mass unemployment, notes attorney Diane Robertson, also harms local landlords, who, with tenants unable to pay, lack the resources to absorb months of losses. “These small landlords have been forgotten,” Robertson suggests. “There’s a growing sense of frustration.”
A discouraging mood is sweeping these communities, which struggle in the best of times. “There is a lot of resentment out there now,” Espinoza says. “People are struggling more than ever and many of them blame the government for letting them down.” Large cutbacks in social services from the now fiscally stressed state will likely not ease tensions.
The summer could see mounting disorder, particularly with the influx, in many cities, of criminal elements, a result of pandemic-induced releases from jails and prisons, including in New York. Evidence already exists that some of the released are exercising their new freedom by committing crime, often victimizing the poorer communities that they came from. At a time when cities like Los Angeles and even-crime ridden Baltimore and Chicago adopt “tough” policies about enforcing Covid-19 lockdowns and arresting violators, a cohort of criminals has been put back out on the streets.
The pandemic could accelerate the exodus of middle-class residents and employers out of disorderly areas. Extended lockdowns, in tandem with high housing and energy prices, will hurt the communities that need the most help in reopening and reviving their economies. The pandemic has revealed, and widened, the enormous divide between the poor and working class, on the one hand, and the upper-middle class, on the other. The virus has already made an impact on American public health—but if its economic consequences are not addressed, it could also infect the urban social order.
https://www.city-journal.org/working-class-economic-stress

Ex-NYT reporter Berenson: Unreported truths about COVID-19 and lockdowns

Editor’s note: This is adapted from an excerpt of Alex Berenson’s booklet “Unreported Truths about COVID-19 and Lockdowns” posted on his website alexberenson.com. Amazon initially refused to sell the booklet but then reversed its decision. 
Maybe the most important questions of all about the COVID-19 pandemic are: How lethal is the virus SARS-COV-2? Whom does it kill? Are the death counts accurate – and, if not, are they overstated or understated?
Estimates for the lethality of the coronavirus have varied widely since January. Early Chinese data suggested the virus might have an “infection fatality rate” as high as 1.4 to 2 percent.
A death rate in that range could mean the coronavirus might kill more than 6 million Americans, although even under the worst-case scenarios some people would not be exposed, and others might have natural immunity that would prevent them from being infected at all.

As we have learned more about the virus, estimates of its lethality have fallen. Calculating fatality rates is complex, because despite all of our testing for COVID-19, we still don’t know how many people have been infected.

Some people who are infected may have no or mild symptoms. Even those with more severe symptoms may resist going to the hospital, then recover on their own. We have a clear view of the top of the iceberg – the serious infections that require hospitalization – but at least in the early stages of the epidemic we have to guess at the mild, hidden infections.
But to calculate the true fatality rate, we need to know the true infection rate. If 10,000 people die out of 100,000 infections, that means the virus kills 10 percent of all the people it infects – making it very, very dangerous. But if 10,000 people die from 10 million infections, the death rate is actually 0.1 percent – similar to the flu.
Unfortunately, figuring out the real infection rate is very difficult. Probably the best way is through antibody tests, which measure how many people have already been infected and recovered – even if they never were hospitalized or even had symptoms.
Studies in which many people in a city, state, or even country are tested at random to see if they are currently infected can also help. Believe it or not, so can tests of municipal sewage.
For now, the crucial point is this: randomized antibody tests from all over the world have repeatedly shown many more people have been infected with coronavirus than is revealed by tests for active infection. Many people who are infected with SARS-COV-2 don’t even know it.
So the hidden part of the iceberg is huge. And in turn, scientists have repeatedly reduced their estimates for how dangerous the coronavirus might be.
The most important estimate came on May 20, when the Centers for Disease Control and Prevention reported its best estimate was that the virus would kill 0.26 percent of people it infected, or about 1 in 400 people. (The virus would kill 0.4 percent of those who developed symptoms. But about one out of three people would have no symptoms at all, the CDC said.)
Similarly, a German study in April reported a fatality rate of 0.37 percent. A large study in April in Los Angeles predicted a death rate in the range of 0.15 to 0.3 percent.
Some estimates have been even lower. Others have been somewhat higher – especially in regions that experienced periods of severe stress on their health care systems.
In New York City, for example, the death rates appear somewhat higher, possibly above 0.5 percent – though New York may be an outlier, both because it has counted deaths aggressively (more on this later) and because its hospitals seem to have used ventilators particularly aggressively.
Thus the CDC’s estimate for deaths is probably the best place to begin. Using that figure along with several other papers and studies suggests the coronavirus has an infection fatality rate in the range of 0.15 percent to 0.4 percent.
In other words, SARS-COV-2 likely kills between 1 in 250 and 1 in 650 of the people whom it infects. Again, though, not everyone who is exposed will become infected. Some people do not contract the virus, perhaps because their T-cells – which help the immune system destroy invading viruses and bacteria – have already been primed by exposure to other coronaviruses.
Several other coronaviruses exist; the most common versions usually cause minor colds in the people they infect.
An early May paper in the journal Cell suggests that as many as 60 percent of people may have some preexisting immune response, though not all will necessarily be immune.
The experience of outbreaks on large ships such as aircraft carriers and cruise liners also shows that some people do not become infected. The best estimates are that the virus probably can infect somewhere between 50 to 70 percent of people.

For example, on one French aircraft carrier, 60 percent of sailors were infected (none died and only two out of 1,074 infected sailors required intensive care).
Thus – in a worst-case scenario – if we took no steps to mitigate its spread or protect vulnerable people, a completely unchecked coronavirus might kill between 0.075 and 0.28 percent of the United States population – between 1 in 360 and 1 in 1,300 Americans.
This is higher than the seasonal flu in most years. Influenza is usually said to have a fatality rate among symptomatic cases of 1 in 1,000 and an overall fatality rate of around 1 in 2,000.

However, influenza mutates rapidly, and its dangerousness varies year by year. The coronavirus appears far less dangerous than the Spanish flu a century ago, which was commonly said to have killed 1 in 50 of the people it infected.
The current coronavirus pandemic appears more comparable in terms of overall mortality to the influenza epidemics of 1957 and 1968, or the British flu epidemics of the late 1990s. Of course, the United States and United Kingdom did not only not shut down for any of those epidemics, they received little attention outside the health care system.
https://www.foxnews.com/opinion/unreported-truths-covid-19-lockdowns-alex-berenson

Congress Has no Clue About What’s Driving up Drug Prices

A coalition of think tanks and health care organizations – dubbed Lower Drug Prices Now – just launched a campaign to promote price controls on coronavirus treatments in development. Several Democratic House leaders want such language included in future stimulus packages.
Treatment affordability is certainly a laudable goal. But price controls aren’t the right solution.
Currently there are over 70 clinical trials for new medicines for COVID-19, from vaccines to acute therapies for ICU patients. Companies are investing huge resources in hopes of succeeding and getting an adequate return on investment. They know that some won’t succeed or will take a long time to prove effective, like Gilead’s remdesivir.
Price control provisions will attack drug manufacturers and stifle innovation at a time when these new treatments are needed most. And they fail to address the primary reason why Americans feel so much pain at the pharmacy counter – middlemen in the drug supply chain.
The coronavirus pandemic comes at a time when patients are paying more than ever for their prescriptions. In 2018, Americans spent $440 billion at the pharmacy counter. That’s up more than 60 percent from the $269 billion paid in 2013.
Most Americans blame drug makers for this increase in spending. Eight in 10 Americans say drug companies’ profits are a major reason prescription costs are rising.
This sentiment is misguided. A new objective study from the Berkeley Research Group proves as much. According to the report, the slice of drug spending collected by drug manufacturers actually dropped by 12.5 percent between 2013 and 2018. Meanwhile, total annual drug industry revenues rose slightly below 3 percent, which is roughly on pace with inflation.
In other words, patients are paying more out-of-pocket, but drug industry revenues aren’t rising.
So, where is all that money going?
According to the report, other entities – like health insurers and pharmacy benefit managers – absorb roughly $50 for every $100 of U.S. spending on drugs. And this share is up from just 33 percent in 2013. They’ve benefitted off the backs of the manufacturers without providing any of the cures.
Health insurers hire PBMs to do the nitty-gritty work of forming insurer drug formularies, or the list of drugs insurers will cover. PBMs work with drug manufacturers to secure massive rebates and discounts, often knocking 30 percent off a drug’s initial list price.
Patients almost never see those discounts at the pharmacy counter, though. That’s because PBMs keep a portion for themselves and funnel any remaining savings to insurers. While insurers use those savings to lower premiums – typically by a few dollars a month – that does little to cut out-of-pocket spending for patients. Between 2017 and 2018, average out-of-pocket costs increased by 12 percent.
To make matters worse, PBMs don’t disclose the rebates they’ve secured. This allows insurers and PBMs to charge patients based on a drug’s list price, not the negotiated discount they received. So, patients pay more than their fair share for vital prescriptions.
Sadly, this rebate system isn’t the end of the supply chain subterfuge. The Berkeley study also found that hospitals have been profiting off the 340B program, which was intended to help poor patients afford drugs. In essence, 340B requires pharmaceutical firms to provide special rebates to hospitals serving low-income populations.
Those discounts often aren’t making their way to patients either. The 340B program has become a cash cow for middlemen: hospitals purchase cheap drugs in bulk, charge patients the full price, and take home the difference. In fact, the Berkeley study found that provider margins for the 340B program have jumped ninefold between 2013 and 2018.
Congress has identified a real problem but the wrong villain. And policies stemming from that misperception – such as price controls – could have disastrous repercussions for patients.
The U.S. biopharmaceutical industry poured $97 billion into research and development in 2017 – double the federal government’s annual investment.
The results of these investments have been miraculous. Cancer deaths have fallen by a third since the 1990s – a drop largely attributable to the creation of new medicines. And powerful new drug cocktails have turned HIV/AIDS from a death sentence to a manageable condition.
To deliver coronavirus treatments equitably, congress needs to focus on the true cause of patients’ pain: PBMs, insurers and other middlemen siphoning away rebates intended for patients. There’s no good reason one major PBM should have made $113 billion last year, a 12 percent increase. That’s crazy.
Sandip Shah is founder and president of Market Access Solutions, which develops strategies to optimize patient access to life-changing therapies.
https://www.realclearhealth.com/articles/2020/06/04/congress_has_no_clue_about_whats_driving_up_drug_prices_111053.html

Coronavirus Withdrawals From An IRA Or 401(k): Who Can, And Should

Part of the CARES Act allowed individuals to tap IRAs or 401(k) retirement plans if they were impacted by the coronavirus and needed cash. The law permits withdrawals up to $100,000 (or the account balance, if lesser), without penalty. The funds can be paid back, though it’s optional. For struggling business owners and workers, tapping retirement accounts may seem like a good option. But the provisions may not be available to everyone and those who can use retirement funds may be wondering whether they should.

The rules for tapping your IRA or 401(k) in 2020

Here’s a summary of the rules regarding distributions from retirement accounts if you’ve been affected by Covid-19:
  • Withdrawals are limited to the lesser of $100,000 or aggregated account balances across all IRA and 401(k)s.
  • You (the account owner), your spouse or dependent must have been diagnosed with Coronavirus or impacted financially because of the pandemic. This includes parents who couldn’t work because daycares weren’t open.
  • The CARES Act stipulates that while the coronavirus related distribution (CRD) is taxable as ordinary income, you can pay the tax over three years.
  • You have the option to pay back the money within three years and can file amended tax returns to recoup the tax already paid.
  • CRDs are exempt from the 10% penalty that typically applies to early withdrawals.
  • You can use the money for any purpose.
  • As of now, coronavirus related distributions are only in effect for 2020.
The IRS CRD FAQ page has further details.

Not all workers with 401(k) or 403(b) plans will qualify for coronavirus related distribution

Employer-sponsored retirement plans are optional benefits that companies can offer their workforce. Obviously, if you don’t have a 401(k), you can’t tap it if you need cash. But even if you do, you might not be able to take a coronavirus related distribution.
The CARES Act gave employers the option allow coronavirus related distributions and/or expand the terms of plan loan provisions to permit workers to take loans up to $100,000 from their 401(k). Until September 22, 2020, 401(k) plans can choose to increase maximum loan size from $50,000 up to the lesser of $100,000 (minus outstanding plan loans of the individual), or the individual’s vested account balance.

Employers decide whether to participate

Before Covid-19, employers could choose to adopt provisions to allow 401(k) loans within certain parameters. The key word here is choose.
Just as companies did not have to offer 401(k) loans pre-Covid-19, they aren’t required to include plan provisions to allow CRDs or expand loan limits. Modifying plan documents costs money, and in a time where employers have been suspending 401(k) matches or even terminating plans, they might not be inclined or able to do so.
Unfortunately, plan rules are one of the downsides to over-saving in a 401(k). If your asset mix is very heavily weighted towards retirement plans, consider broadening your investments to taxable brokerage accounts after you get back on your feet.

Ask your employer about the plan rules

If you’re still working for the company, ask your HR department about the plan rules for CRDs or 401(k) loans. If the plan sponsor doesn’t offer Covid-19 withdrawals, you may be able to take a loan instead.
Before taking a loan, make sure you understand the terms. 401(k) loans are essentially a loan to yourself that must be repaid to your account with interest. But if you leave your job, the full loan can be due immediately. Talk to your plan sponsor to learn more about the pros and cons.

Options for old 401(k) plans

If you have an old 401(k) plan, it could be an opportunity to do a 401(k) rollover to an IRA. The process is quite simple and may have other benefits too.

Should you take money from your 401(k) or IRA if you’ve been impacted by Coronavirus?

Tapping your retirement accounts shouldn’t be considered lightly. But depending on your situation, you may not have many other options. If your emergency fund has been depleted or you don’t have a non-retirement investment account, your IRA or 401(k) could your only liquid asset.

Think long and hard before using home equity

While using home equity could be an option, you may end up adding even more financial risk to your situation and could potentially lose your home if you fall behind. It also takes time and costs money to get a home equity loan or line of credit. If you’re already behind on your mortgage, tapping home equity likely won’t be an option.

What about credit cards?

Making minimum payments on credit cards typically works for a very short period of time. Interest rates are usually over 20% and the debt can compound quickly. Speak with your credit card company to see if there’s any leniency. Unless you just need to bridge a short gap between now and guaranteed future income, you might be better off using money from a retirement account. At least it won’t harm your credit.

Stop saving towards other goals

It may seem obvious, but diligent investors are reluctant to stop saving towards other goals, even when faced with financial uncertainty. Before using money from your retirement accounts, consider temporarily freezing contributions to 529 college savings plans and other non-essential goals. If you have federal student loans, take advantage of deferred payments while they’re still available. Stop over-paying your mortgage.
If you’re in a financial emergency, try to do what you can to only put money towards expenses that must continue to be paid. Conserving now will make it easier to recover and resume good financial habits later.

If you take money from your retirement accounts

If you need to take money from your retirement accounts, make sure you only take what you need. Cut back on any non-essential expenses until you get back on your feet. Keep details records and work with a CPA to help ensure you file your taxes properly.
Tapping retirement funds is generally less risky if you’re confident you can pay it back. Otherwise, it could be a risk to your retirement. That said, if you need money for essentials today and have no other options, it sort of is what it is. Once you’ve recovered, you can work to cut back in other ways to catch up.
https://www.forbes.com/sites/kristinmckenna/2020/06/05/coronavirus-withdrawals-from-an-ira-or-401k-who-can-and-should-tap-retirement-accounts/#586a2a715b08