Category: Pharmacy, PBMs, and Pharma costs

Apr
23

Friday catch-up

Posted by Joe Paduda on Friday, April 23rd, 2021 | Comments

Good to be back in the habit of regular posting…lots going on deserving of your attention.

Drugs

From myMatrixx, a very useful post from Phil Walls, everyone’s favorite pharmacist. Phil highlights three drugs in the pipeline that may well find a place in work comp.

Nalmefene was developed as the naloxone for fentanyl. While naloxone has saved countless people on the verge of dying from opioid overdose, a single dose isn’t strong enough to save someone on fentanyl. Read Phil’s post for details.

Two other meds – Molnupiravir and Ofev may help patients battling COVID. The former is an anti-viral, easily administered and offering the potential to reduce the length of infection.  Ofev is more narrowly focused on combating a very serious lung disorder associated with COVID.

Opioids

As if Florida, Mississippi, and other states needed yet another reason to expand Medicaid...individuals with Opioid Use Disorder referred by criminal justice agencies were more likely to receive  medications for OUD in states that expanded Medicaid compared with those in states that did not.

Considering overdose deaths dramatically increased after the pandemic started, legislators in non-expansion states need to get off their collective butts and do the right thing. Stop with the bullshit arguments and do something that actually helps people.

And the Biden Administration should do the same – fast track authorization for medical providers to prescribe buprenorphine. We’ve been waiting over three months, Mr President…

Hospital profits

Hospital and facility owner HCA reported profits more than doubled in the first quarter of 2021 over 2020. The really scary part is

“Same facility revenue per equivalent admission increased 16.6 percent in the first quarter of 2021, compared to the first quarter of 2020, due to increases in acuity of patients treated and favorable payer mix.”

In English – employers and taxpayers’ facility costs shot up. Here’s looking at you, workers’ comp…

Workers comp

Despite the rampant profiteering off workers’ comp by HCA and others, workers’ comp remains a very profitable line of business. That’s mostly because rates are still too high, frequency continues to decline, and medical trend remains flat.

National Underwriter reported WC was the fourth most profitable P&C line in 2019, at with a “relative net worth” of 12.2%. I’m not entirely sure what “relative net worth” is…perhaps the best way to compare margins across not-for-profit, mutual, and stock companies?

Anyone?

Finally – be Skeptical!

Did 4% of Americans gargle with bleach last year?

You may have read the news reports on a “study” that found a bunch of us were gargling with bleach. Bunch of morons…typical (insert demographic group here),

But, the answer is likely no.  In fact, the “study” had fatal flaws, flaws which came to the surface when a well-designed study followed up.

Takeaway – beware of clickbait, ESPECIALLY when it supports your own opinions and biases. Here’s looking…in the mirror.

Lastly, a request.

Smile at someone you don’t know today. Things are getting better by the day, and you can spread the joy.

Mar
30

Chronic pain, opioids, and other drugs – the latest research

Posted by Joe Paduda on Tuesday, March 30th, 2021 | Comments

Dr Steve Feinberg pointed me to two studies conducted by the Agency for Healthcare Research and Quality on chronic pain, both systematic reviews [reviews of published studies of a specific topic]. One focused on opioid treatments for chronic pain, the other on non-opioid pharmacologic treatment.

The non-opioid research reviewed 190 studies, of which 185 were RCTs. Researchers concluded:

improvement in pain and function was small with specific anticonvulsants, moderate with specific antidepressants in diabetic peripheral neuropathy/post-herpetic neuralgia and fibromyalgia, and small with nonsteroidal anti-inflammatory drugs (NSAIDs) in osteoarthritis and inflammatory arthritis.

The takeaways include there are some benefits from some drugs, often dependent on the patient’s medical condition.

The opioid treatment for chronic pain study was based on a review of 162 studies; “115 randomized controlled trials (RCTs) [the gold standard of clinical research], 40 observational studies, and 7 studies of predictive accuracy.”

Note that for research purposes, chronic pain is described as pain that lasts more than 3 to 6 months.

There was more credible research available to assess short-term outcomes vs longer-term outcomes; there was no RCT comparing opioids to placebo for medium or longer-term periods.

Takeaways included (and these are direct quotes):

  • There were no differences between opioids and nonopioid medications in pain, function, or other short-term outcomes
  • Opioids were associated with small benefits versus placebo in short-term pain, function, and sleep quality.
  • There was a small dose-dependent effect on pain, and effects were attenuated [reduced] at longer (3 to 6 month) versus shorter (1 to 3 month) followup.

Most concerning, “there is evidence of increased risk of serious harms that appear to be dose dependent” [the higher the dose, the greater the risk].

This crossed my desk the day before a good friend’s brother died of an apparent opioid overdose, adding a painful exclamation mark to the study’s conclusion.

Extensive research in Australia focused on long-term opioid use in patients with chronic non-cancer pain found that:

Despite limited evidence of efficacy, there has been a considerable increase in the long-term prescribing of opioids for chronic non-cancer pain in several countries

Here’s the thing; the research we do have clearly demonstrates the risk of opioids is high, and the benefits are limited. However, there isn’t near enough research on the efficacy of long-term usage of opioids for chronic pain.

Anecdotal evidence indicates some patients can do well on opioids for extended periods.

That said, the evidence we do have suggests that overall, efficacy may be limited at best, and the risks are high. Fortunately more research on opioid efficacy and risks and chronic pain has already been funded.

What we cannot do is force patients off opioids; this is dangerous and unethical.

What does this mean for you?

Opioids have their place – but be very careful, especially when use is long-term. Life is precious. 

 

Mar
17

COVID quick update

Posted by Joe Paduda on Wednesday, March 17th, 2021 | Comments

Quick takes on stuff you need to know – and most of it is good news indeed.

Eli Lilly has what may be one of the more promising treatments, a cocktail of two unpronounceable drugs showed strong results in a recently-completed double-blind trial involving 769 patients.  The bamlanivimab-etesevimab duo cut the risk of hospitalization and death by 87% versus placebo.

Unlike the hydoxycholoroquine “research” touted by the former occupant of the White House, this is real science by reputable scientists which shows the drug has a positive impact.

Other research indicates the Pfizer vaccine works to stop the Brazilian variant; since I’m getting my first shot – and it’s the Pfizer version – Monday, that’s good news indeed. Pfizer also believes its vaccine will work against the South African variant as well.

These are all good news, as economists believe an economic recovery is highly dependent on stopping COVID.  One stated: “The vaccine is truly incredible…. It’s the best kind of stimulus we could want.” Excellent podcast for your morning walk or pm drive is here.

Terrific research out of CWCI last week; in their annual meeting, Alex Swedlow, Rena David and colleagues provided a lot of information on what’s happened with claim counts, costs, claim duration, and treatment timing. One very bright spot – February saw a huge drop in COVID workers’ comp claims. Rena also reported that “many workers with non-COVID claims got faster treatment than before the pandemic…” A big chunk was via telemedicine, which hit 25% of office visits in April and May, then dropped to about 18% in October. [thanks to WCC’s Mark Powell for his reporting]

I’m hoping to interview Alex and will provide more intel in a future post.

What does this mean for you?

Science, people. 

Mar
4

Drug prices are going up…or not.

Posted by Joe Paduda on Thursday, March 4th, 2021 | Comments

Optum’s work comp folks inform us that prices for some brand name drugs went up in January. The list includes medications that often appear on Medicare Set-aside cost projections – including some new-to-the-market meds that are pretty expensive.

As in $34.50 per pill expensive for Vivlodex, indicated for osteoarthritis and pain and almost 50 bucks per tablet for Vimovo, also for arthritis and pain.  As in a 5% increase for OxyContin, 10% jump for Nucynta, and 5% for a brand form of Opioid Use Disorder medication suboxone.

Two takeaways.

First, at least two of these meds should/must be replaced with generics.

VivlodexTM is a brand version of meloxicam, which is available in a generic form at a tiny fraction of the cost. drugs.com indicates pricing is about 13 cents per tablet…

meloxicam oral tablet 15 mg is around $13 for a supply of 100 tablets

Similarly, there are also generic substitutes for VimovoTM -which is simply a combination of naproxen (aka AleveTM) and omeprazole (aka PrilosecTM). The “substitute” would be to buy these two over-the-counter medications…

[Embarrassing disclosure time – I consulted for Vimovo’s manufacturer for a while till I figured out what the drug really was. Ouch. Lesson learned.]

Second, the price increases noted in Optum’s post do NOT reflect rebates. These can amount to 1/3 or more of a brand drug’s retail price, dollars that flow to the PBM and other entities on the supply chain.  As we’ve learned, all the news about drug price increases must be considered in the context of rebates.

courtesy Adam Fein PhD’s Drug Channels

The left most column reflects rebates etc paid to commercial insurers/PBMs etc

What does this mean for you?

Ask about rebates. There’s beaucoup bucks there.

 

Mar
2

The CDC’s Opioids for Chronic Pain Guidelines; Myths and facts

Posted by Joe Paduda on Tuesday, March 2nd, 2021 | Comments

After my posts last week it is clear there’s a lot of misinformation and misunderstanding about the CDC’s opioid and chronic pain guidelines. At MCM we take the old-school approach to these things; we focus on the facts.

So, here they are.

The CDC’s guidelines mandate strict limits on dosage and require tapering  for patients on long-term opioids.

False.  As Dr Beth Darnall of Stanford University noted recently;

some health care organizations and states have wrongly cited the 2016 CDC Guideline as a basis to substantiate prescribing “dose-based limits” or to mandate that physicians and prescribers taper patients taking long-term opioids to specific thresholds (eg, < 90 mg, or < 50 mg). Such dose-based opioid prescribing policies are neither supported by the CDC, nor do they account for the medical circumstances of the individual patient. [emphasis added]

Further;

The CDC [issued] a clarifying statement that derided the misapplication of the opioid guideline and discouraged the dose-based policies and practices that fall outside of its scope, as well as use of the guideline to substantiate tapering.

The Guidelines for Prescribing Opioids for Chronic Pain were developed in secret.

False.  The process fully complied with CDC and AHRQ requirements and standards, and the results were shared with the public and public comment sought prior to promulgation of the final guidelines in 2016.

The Guidelines aren’t working; look at all the opioid-related deaths.

False.

  1. The big increase in drug poisonings (technical term for overdosing) is driven by a rapid increase in the use of synthetic opioids, both prescription and non-prescription. The synthetic opioid death rate increased over 1000% from 2013 to 2019, with the biggest increase in the western US. Fentanyl and Tramadol are examples of synthetic opioids
  2.  There’s been a small but measurable decrease in the death rate (4.4 to 4.2) from prescription opioids that correlates with the guidelines’ publication date.  Of course, correlation is not causation, but clearly the guidelines have been impactful.

3.  Further, when you count the deaths due solely to prescription opioids, the drop in the prescription opioid death rate is even more remarkable. The bold line is prescription opioid-only; the guidelines were introduced in 2016.

The net is those who claim the guidelines are somehow “failing” are conflating law enforcement issues with public health issues, and are ignoring the very real post-guideline decline in deaths from prescription opioids.

The guidelines are killing people.

The guidelines are just that – guidelines.

The guidelines do NOT require or mandate dosage restrictions or tapering. Blaming the guidelines – and those who developed the guidelines – for physicians not following the guideline’s explicit recommendations is wrong, and does nothing to solve the problem of bad legislation and poor physician behavior.

Here’s what the CDC actually said:

Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. [emphasis added]

There are a lot of anecdotal reports of patients unable to get prescriptions renewed or otherwise forced off their opioid regimen, many with awful consequences. Yes, the guidelines did suggest/encourage/support these tools in certain circumstances, but – as you can read above – these are NOT requirements and require clinicians to evaluate and balance risk and harm.

What does this mean for you?

The real problem with Opioid Guidelines is states, insurers, and other entities – as well as prescribing physicians – failing to use the guidelines as intended.

reminder to commenters – valid email addresses are required, and disagreements are welcome as long as they are supported with credible citations.

 

Feb
22

The scammers fighting CDC’s opioid guidelines

Posted by Joe Paduda on Monday, February 22nd, 2021 | Comments

Several commenters purporting to be chronic pain patients responded to my post about the AMA’s bemoaning CDC’s opioid guidelines. 

Their stories were tragic; heartfelt; full of pain, suffering, and grief.  All decried the CDC’s guidelines as wildly misplaced, directly responsible for their terrible suffering, a governmental overreach, and a grossly misplaced intrusion of the government into the hallowed doctor-patient relationship.

Several attacked Dr Andrew Kolodny, making all kinds of ugly claims, attacking his ethics and denigrating his motivations. [Dr Kolodny is Executive Director of Physicians for Responsible Opioid Prescribing.]

And all but one came from email addresses that are bogus. I know that because I emailed each of them and asked them to confirm they sent a comment to MCM.  Here’s an example of one response.

I’ve known Dr Kolodny for over a decade. We met at the first few RxSummit conferences where colleagues introduced us. He was one of the first clinicians to raise the alarm about prescription opioids, and PROP has been instrumental in helping states, the CDC, and other governmental entities address the opioid crisis. I deeply respect Dr Kolodny – his relentless effort to stop the devastation caused by opioids has saved countless lives.

I do not know who is behind these attacks on the CDC and the attempts to libel and slander Dr Kolodny. I do not know if they are the product of the Opioid Industry, another example of their insidious effort to legitimize its criminal behavior and its lethal consequences. The Opioid Industry’s tentacles take the form of organizations that sound legitimate but are just mouthpieces for Big Opioids.

Big Opioid sponsors so-called patient advocacy groups, yet another example of Astroturfing (go to p 29, about halfway down, to see a description of the practice; or just search for Astroturf).

I also wrote on this several years ago.

The Astroturfers’ clever messaging convinces some chronic pain sufferers that the solution is more opioids, and anyone who disagrees is a self-serving, uncaring profiteer who is somehow profiting from their pain.

I hate Big Opioid and the people who propagate their lies. They are killing people, devastating families and destroying communities, all in the name of profits.

They are mass murderers – nothing less.

 

 

 

Feb
18

The prescription opioid crisis is far from over

Posted by Joe Paduda on Thursday, February 18th, 2021 | Comments

There’s still lots of money in the peddling of opioids, and lots of misinformation out there about opioid control efforts going too far.

Correlated? You tell me.

The American Medical Association sent a letter to the CDC claiming  “the nation no longer has a prescription opioid-driven epidemic...the AMA urges governors and state legislators to take action [to] remove …. arbitrary dose, quantity and refill restrictions on controlled substances.” [emphasis added]

In a letter sent to the AMA that was also published in the British Medical Journal, Physicians for Responsible Opioid Prescribing took the AMA to task, noting the AMA’s position is misguided at best:

 There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.

PROP’s letter goes on to state:

Suggested dose and duration restrictions are not “arbitrary”, they are based on considerable evidence of when harm far exceeds benefit.

I do not know why the AMA is mischaracterizing the CDC guidelines. I do know opioid manufacturers are very, very good at working the levers of power, expert at manipulating government officials, and extremely generous in their political contributions.

The AMA’s anti-opioid guideline stance is kind of bizarre, bizarre as in Through the Looking Glass. On the one hand, it is mischaracterizing and decrying CDC guidelines that have been instrumental in mitigating the opioid disaster.

On the other, the AMA is claiming credit for reducing opioid use, deaths from overdoses, and various other positive trends, stating “the [AMA Opioid] task force’s recommendations have led to significant progress…”

That’s rather bold, considering:

And, of course, those CDC guidelines have been widely adopted by states, and are widely credited with reducing the damage done by opioids.

At times the guidelines have been misapplied, doctors have arbitrarily applied them, and patients have been abruptly cut off. That is NOT the fault of the guidelines, that are just that – guidelines. Rather, it is the fault of those mis-applying them to patients.

What does this mean for you?

The opioid crisis is far from over.

Controlling inappropriate use of prescription opioids is as important today as it has ever been.

Dec
18

Opioid deaths up…Perdue family completely blameless

Posted by Joe Paduda on Friday, December 18th, 2020 | Comments

Two members of the Perdue family, the folks who made tens of billions of dollars addicting patients to dangerous drugs, testified before Congress yesterday.  Both averred there was nothing they could have done to avoid/prevent the damage their company did.

Yesterday the CDC reported 81,230 drug overdose deaths occurred in the United States in the 12-months ending in May 2020.

Quoting the CDC:

This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded.

The Perdue family’s complicity in this national disaster is obvious and damning to everyone but the billionaires who’ve parked more than $10 billion of their profits from drug dealing offshore, safe from recovery efforts by American law enforcement and Perdue’s victims.

This from Kathe Perdue:

“I have tried to figure out, was there anything that I could have done differently? Knowing what I knew then — not what I know now?” said Dr. Sackler, who served on the board from 1990 to 2018. “There’s nothing that I can find that I would have done differently based on what I believed and understood then.”

Perdue on the Board through 2018, many years after Perdue Pharma’s criminal sales practices had been prosecuted, fines paid, settlements authorized. She was on the Board in 2007 when it authorized a $600 million settlement to resolve just one set of charges.

Oh, that represented 1/50th of the family’s net worth.

Two conclusions are possible – and only two.

Either Ms Perdue really couldn’t think of anything she could have “done differently” to stop her company’s ongoing, continuous and highly effective efforts to addict people, or she’s a bald-faced liar.

In the first instance, she’s a psychopath.

In the second, she lied to Congress.

What does this mean for you?

When are you going to sue these bastards for what they’ve done to your customers, employees, members, and organization?

Thanks to Steve Feinberg MD for the heads up on the CDC data.

Oct
6

Opioids – Deaths up, Sacklers likely to escape justice

Posted by Joe Paduda on Tuesday, October 6th, 2020 | Comments

Three news items hit the desk, ranging from bad to awful.

More than 73,000 of us died of drug overdoses in the 12 months ending February, 2020. That’s four thousand more deaths than the previous year.

(note graph below is for a slightly different time period)

And it is getting worse.

Preliminary data indicates the death count is up 13% so far this year.

The number of non-fatal overdoses in Vermont tripled this year, with almost 9 out of 10 involving fentanyl.

Meanwhile, the drug dealers directly responsible for much of the horror are about to escape with most of their billions in ill-gotten gains intact.

The drug dealers are the Sacklers, owners of Purdue Pharma. Purdue developed and marketed OxyContin; A recent study,  authored by the Wharton School, Notre Dame, and RAND reported “the introduction and marketing of OxyContin explain a substantial share of overdose deaths over the last two decades.”

This from a New Yorker article:

Behind the scenes, lawyers for Purdue and its owners have been quietly negotiating with Donald Trump’s Justice Department to resolve all the various federal investigations in an overarching settlement, which would likely involve a fine but no charges against individual executives. [emphasis added]

A lawsuit indicated over the last few years, the Sackler family has transferred billions of dollars offshore, effectively protecting those assets from the US justice system. This from the New Yorker:

In a deposition, one of the company’s own experts testified that the Sacklers had removed as much as thirteen billion dollars from Purdue.

The states have asserted in legal filings that the total cost of the opioid crisis exceeds two trillion dollars. Relative to that number, the three billion dollars that the Sacklers are guaranteeing in their offer is miniscule. It is also a small number relative to the fortune that the Sacklers appear likely to retain, which could be three or four times that amount. [emphasis added]

This country has jailed millions of poor people for decades for drug-related crimes; the Trump Administration appears poised to let the white-collar drug dealers most responsible for the opioid crisis walk away with billions of dollars they made addicting America.

What does this mean for you?

The Sacklers should rot in hell, but they will likely live on in unimaginable luxury. We should all be outraged.

 

Sep
25

Friday catch up

Posted by Joe Paduda on Friday, September 25th, 2020 | Comments

Pre-existing conditions, drug development, COVID-related GI problems, and marketing screwups…

First up, pre-existing conditions

Yesterday President Trump issued an executive order affirming “it is the official policy of the United States government to protect patients with pre-existing conditions.”

Well, yeah. It is today, because the ACA/Obamacare – which specifically protects patients with pre-existing conditions – is the law of the land, despite dozens of GOP efforts to overturn it. 

Couple other key issues.

  1. Without legislation signed into law, the Federal government – and the President – can’t enforce a “policy”.
  2. The executive order wasn’t released, so we don’t know what it actually says.
  3. The Trump Administration backs a lawsuit that would overturn the ACA and thereby eliminate pre-existing condition protections. 

What this means – don’t watch what someone says, watch what they do.

For more details on GOP and Democratic healthcare plans, click here.

Super-useful research on healthcare prices paid by private healthplans – kudos to RAND for updating their ongoing analysis. RAND compares prices paid by privately insurers – including work comp – to Medicare, allowing you to compare relative prices for individual facilities.

Thanks to Michael Costello for the link.

One takeaway – HCA hospitals are pretty expensive…(you can find prices for pretty much any hospital on RAND’s map)

Drug development

Pretty much all new drugs developed over the last decade relied on research you – the taxpayer – paid for.

That includes $6.5 billion of taxpayer dollars invested in remdesivir, one of the very few drugs found to be useful in treating COVID19.

COVID19

Alarming piece in JAMA yesterday reported patients with Acute Respiratory Distress Syndrome caused by COVID19 are at significantly higher risk for major gastrointestinal problems. Pretty solid science behind the research.

An earlier article highlighted the opioid epidemic during the COVID19 pandemic; there are definite limitations to the research due to small sample size and possible clinician bias. With those provisos, key takeaways include:

Good news – J&J will start Phase 3 trials of its vaccine. Unlike some other vaccines, it is a single shot and can be stored in a refrigerator for up to 3 months (others require two shots and must be stored at ultracold temps).

Marketing malfeasance

And lastly, an excellent article in the Harvard Business Review about marketing in current times.  A critical takeaway – do NOT just talk about social responsibility; DO it. Kudos to Starbucks; after mandating that workers could not wear anything with Black Lives Matter while working, the company realized it screwed up and reversed course.

For the umpteenth time, if you do screw up, apologize fully and without dissembling.  None of these “I’m sorry if anyone is offended” non-apology apologies; from the article:

With “cancel culture” as pervasive as it is, a one-time reaction is as good as letting an issue get ahead of you. Instead, treat apologies or mea culpas as the first steps of an ongoing dialogue designed to bring about thoughtful and meaningful progress.

Here’s hoping the White Sox turn things around in the upcoming series with the Cubs…and your team wins this weekend.

Be well.