Opioid Exceptionalism – why these drugs are different than all others

Greetings – David Deitz here. Joe has kindly offered to let me provide a guest post on the latest report on the opioid epidemic from the National Academy of Sciences, Engineering and Medicine (NASEM). The report is available here. It’s also 389 pages long in its current pre-publication form, and because I think there are some really worthwhile parts relevant to many of you who follow MCM, I’m going to give you my summary of the highlights.

The quick take – opioids are fundamentally different from other drugs due to the harm they can cause – and the FDA should consider this when addressing opioids. (JP observation)

Why is this report important and why should you care? Well, for one, the opioid epidemic is a true, deadly epidemic, that has left few areas of America untouched. As NASEM puts it (emphasis mine):

Current national trends indicate that each year more people die of overdoses—the majority of which involve opioid drugs—than died in the entirety of the Vietnam War, the Korean War, or any armed conflict since the end of World War II.

That’s about 90 a day. Every day. I don’t think that’s “opioid hysteria”. And WC has a lot of reasons to care, since analgesic drugs, most of them opioids, are the principal drugs prescribed for occupational injuries.

It’s worth noting that last week also saw the release of the interim report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis. This report urged declaration of a national emergency – more on that below.

As many of you recognize, this is an incredibly difficult public policy issue, in which the legitimate needs of millions of patients with acute and chronic pain must be balanced with the harms opioids create. The earlier IOM report on pain in 2011 really punted on this one, but the NASEM gets right to it in the introduction:

  • How exactly does a regulator….balance, for any particular regulatory action limiting access to opioids, the otherwise avoidable suffering that patients with pain would experience against the harms, not only to those individuals and their families but also to society, that would be prevented by the restriction? (pg 1-16)

The answers from NASEM are brilliant, well-reasoned and based on large servings of evidence – not only on opioid harms, but also on efficacy for chronic pain, likelihood of use and abuse in different contexts, alternative treatments, epidemiology of addiction and value and availability of various opioid addiction treatments, to name only a few. One of the most valuable concepts going forward is the doctrine of “opioid exceptionalism” a term coined by co-author Dr. Aaron Kesselheim in the NASEM webinar (you can get the slides here).

Put simply, opioid exceptionalism means that the FDA, as well as other public agencies, should go beyond the risk/benefit paradigm they currently use for new drug approvals that is based on individual patients and consider the implications of an individual opioid to patient’s families and society.

In other words, public health considerations need to come in because the societal implications are so large for this category of drugs. Drug manufacturers and some pain management professionals (and probably, libertarians) aren’t going to like this, but I think NASEM makes a compelling case that business as usual isn’t going to reverse the trends. They don’t really mention the workplace much as part of the public health discussion – there’s an opportunity for ACOEM to push up to the table.

I won’t review all of NASEM’s public policy recommendations, but some have implications for WC, including:

  • Improved reporting and data collection. This has to include WC if it’s going to be complete.
  • A call for insurers to reimburse for comprehensive pain management, including interdisciplinary approaches. Many in WC do, but it has to get better.
  • Better patient and public education about opioids. Again, a role for WC here beginning at the first emergency department or occupational medicine clinic visit.
  • Expanded treatment for opioid use disorder. There are cost implications for employers here, but it’s the right thing to do.

Meanwhile, the President’s Commission mostly agrees, and provides some of the same recommendations. Unfortunately, there are some thorny political problems with that emergency declaration (which I agree with) – it’s difficult to reconcile recommendations to “rapidly increase treatment capacity” and expand benefits for substance abuse treatment with cuts to Medicaid.

The NASEM is the meatier of the two, is better thought through and overall is one of the most comprehensive public policy documents I’ve read in a while. Take a few minutes to look at the slides, they are a good summary of the recommendations. Where do they touch your organization?

Let’s not just hope that the NASEM report makes a difference, but do what we can to ensure it.

David Deitz, MD, PhD is principal of David Deitz & Associates, a healthcare consulting firm based in Massachusetts.

 

California’s work comp formulary

California’s work comp pharmacy formulary process is moving ahead, but I have grave concerns in two areas – timing and cost.  (these are my personal concerns and are not intended to represent the views of CompPharma, LLC.)

First, timing.

The rules writing process is ongoing, while the formulary is slated to be implemented January 1, 2018. 

The rules aren’t even finalized yet, and it’s August.

That’s less than five months away.  Five months for PBMs, payers, prescribers, patients and pharmacies to make massive changes to processes, internal formularies, IT systems, contracts, call scripts, and a thousand other things.

Next, cost.

I’ve talked with regulators, PBMs, payers, employers, about this issue, and tried to re-engage w regulators, without a whole lot of any success.

Regulators have told me that the drastic cut to the fee schedule won’t be a problem because:

a) Payers can pay for clinical and program management costs separately
Well, no.
Unbundling pharmacy management services is a non-starter.
 Most payers don’t have the ability to do pharmacy management inhouse, so they rely on their PBMs. Regardless the payers would have to figure out what should cost how much, and how to charge their employer customers for clinical and program management services. Payers don’t have any way to do this without massive IT changes plus re-doing their internal cost-allocation processes, and/or re-negotiating contracts and policy terms.

b) Payers can just pay above the fee schedule
Again, highly unlikely.
Most payers can and/or will NOT pay above fee schedule. Many TPAs and insurers are precluded from doing so in their contracts with employers, and most would have to re-program IT, reporting, and bill review systems. Plus, many employers just flat-out refuse to pay above fee schedule.

Now there’s a new formulary in the offing, one that will demand even more from PBMs. There remains much uncertainty around implementation details while the implementation date draws ever closer. Setting aside the very real problems inherent in unbundling clinical and program management services, there’s no way PBMs, payers, and pharmacies could plan for and implement all the things they’d need to do to implement an unbundled or above-fee-schedule pricing methodology by January 1.

The bigger issue is this – California employers’ drug costs have declined for several years, opioid and compound usage is down significantly, and the drastic cuts to the fee schedule plus increased costs to implement and manage the formulary are going to:

  • make it harder for all parties to implement the formulary; and
  • make pharmacy management a huge money-loser. 

I don’t understand the logic here.

PBMs have been instrumental in cutting opioid usage in California every year for the last five years, investing huge sums in work that dramatically increases patient safety, reduces employers’ costs, but actually reduces PBM revenues and profits. 

Now, regulators want to further cut PBM revenues while adding a LOT more work to pharmacy management…

That’s not to say the formulary in and of itself isn’t a potential positive.

From Alex Swedlow…

This formulary is an important step forward.  The legislative intent was to increase quality of care and lower the high cost of drugs and the huge frictional costs associated with managing those drugs.

The formulary and regs that link prescriptions to the standard of care (MTUS) will raise quality of care.  The exempt, special fill and perioperative drug lists will reduce some of the dispute resolution costs.  UR is supposed to be for low frequency, high cost treatment like inpatient services, less so for high frequency low cost care such as pharmacy.  That said, those who seek to exploit the new rules and regulations have the incentive and creativity to do so. 

Solution:

  1. Delay the implementation of the formulary and related changes for at least six months after the rules and regs are finalized.
  2. Significantly increase the drug fee schedule.

What does this mean for you?

Adding a lot of complexity to the drug approval and delivery process while continuing to slash reimbursement will lead to unintended and potentially adverse consequences.

 

Note – I’m president of CompPharma, a trade group for work comp PBMs, but fee schedule changes and the like have no financial impact on CompPharma or me personally.

 

Workers’ comp update

now that repeal and replace is dead, we can figure out what we missed while contemplating healthcare armageddon.

Workers’ comp

WCRI’s been publishing a flurry of great reports on injured worker outcomes, physician dispensing, opioids, and hospital costs. Sign up for a free webinar on outcomes here.

Coventry’s out with the second part of their work comp Drug Trends Report – download it here. This part deals with the differences between managed and unmanaged pharmacy.  Good video intro by Nikki Wilson too...

HealtheSystems is rumored to be looking to split the company in two, selling off the PBM and keeping the Ancillary Benefit Network business. With myMatrixx setting yet another high point for valuation recently, we’ll have to see if PBM prices remain stratospheric or drop a little closer to earth.

Given the myMatrixx – Express Scripts transaction had a ton of strategic benefit for the acquirer, a similar valuation for Healthe might be a tad optimistic. In addition, a very sizable chunk of the PBM business comes from one payer – the Travelers – a “customer concentration” issue that will give some pause.

BTW, I’m hearing optimism from many work comp pharma buyers about the “new” myMatrixx-ESI combination.  Guarded, but optimistic.

Medicare

Are you seeing an uptick in Commercial Repayment Center (CRC) demands coming from the Coordination of Benefits & Recovery Program? (COB&R)? A couple clients have mentioned this to me..the concern seems to be CMS is revisiting MSAs and looking for additional funds (I am likely not phrasing this correctly…Rafael, please clarify/correct!)

Physicians work for others…

About 2/3rds of younger physicians are employed.   Overall, less than half of practicing physicians have an ownership stake in their practice.

Finally, here’s a really interesting snapshot of price variation in a wide variety of healthcare markets

It’s not just opioids.

Yes, opioids are the biggest problem in workers’ compensation.  Not just work comp medical, but in the entire work comp industry.

Opioids kill patients, prolong and intensify disability, ruin families, run up huge costs, and lead to myriad other problems. But opioids are far from the only problematic drug class in our tiny little world

No, we have gabapentin, Soma, and anxiolytics. But today we’re going to focus on anti-psychotics – yet another mis-used medication that is causing harm to work comp patients.  

Reportedly some prescribers are writing scripts for these drugs as an alternative to opioids or other pain medications; they aren’t required to check PDMP databases or otherwise deal with opioid-related issues when prescribing anti-psychotics. This lower “hassle-factor” may drive increased use of these medications as opioid-related prescribing legislation becomes more common in more states.

As with opioids, a big issue is the side effects…in this case, tardive dyskinesia.

  From wikipedia:

TD is a disorder that results in involuntary, repetitive body movements.vThis may include grimacing, sticking out the tongue, or smacking of the lips. Additionally there may be rapid jerking movements or slow writhing movements.[1] In about 20% of people decreased functioning results.

Tardive dyskinesia occurs in some people as a result of long-term use of neuroleptic medications (antipsychotics, metoclopramide).[1][2] These medications are usually used for mental illness…older neuroleptics [drugs]…are associated with high risk for tardive dyskinesia. (emphasis added)

The photos above are the least disturbing I could quickly locate; suffice it to say that TD is pretty horrible.  One of TD’s causes is long-term usage of antipsychotics – which, believe it or not, are becoming more prevalent in workers compensation.  A close friend who runs the pharmacy program for a top ten insurer told me prescriptions for these drugs are becoming increasingly common – and he’s now seeing scripts for drugs to treat their chief side effect – TD.

The good news is there’s now treatment for TD.  The bad news is the cost – between $125 and $150 a DAY for Ingrezza – that’s $60,000 annually. Forever.

What does this mean for you?

unintended consequences can be horrific. 

Work comp’s drug problem

Is getting a lot better, a lot faster than the rest of the world’s.

thanks to you.

I’m in the midst of conducting the 14th Annual Survey of Prescription Drug Management in Workers’ Comp, a project I began way back when no one had heard of physician dispensing, and before opioids became a national disaster. (prior surveys can be downloaded at no cost here)

Physician dispensing in comp is slowly being solved – today WCRI released a comprehensive look at the issue which is well worth your time. (members get it for free, non-members pay a modest cost)

And we’ve made good progress on the opioid front, something few other payers can assert.  Overall, I’d hazard a guess that opioid spend – as a percentage of total drug spend – declined somewhat last year; we’ll know for sure in a couple of weeks.

The latest, albeit anecdotal takeaways from a dozen surveys I’ve done so far, indicates:

  • opioid spend continues to drop with some payers reporting double-digit percentage decreases
  • much of this comes from curtailing initial and secondary scripts
  • there’s a lot still to be done to address chronic users
  • payers are using a whole array of techniques, clinical resources, and tools to address opioid overuse, with many relying on PBMs for analytics, pharmacists, and physicians for peer-to-peer discussions
  • some payers expressed concern over the various overdose-prevention medications

Do NOT take this to mean we’ve won, that we’ve solved the opioid disaster, that we can take the rest of the summer off.

Far from it.

We’ve done the easy stuff, now comes the really knotty, tough problem of helping individual patients who’ve been prescribed way too many pills for far too long get their lives and health back.

What does this mean for you?

Thanks to all of you, who, through your work in the trenches, in policy, with individual patients and physicians and pharmacies, have made things better.  You have saved countless lives and countless families.

 

 

Tuesday catch-up

I’m going to announce something new tomorrow on the personal front; stay tuned for details…

Until then, here’s what I missed while doing a lot of non-work-related stuff over the last couple of weeks.

Medrisk has launched telerehab, a new service designed to deliver therapy and related services direct to patients at their worksite or home.  I’m a big fan; used appropriately telerehab can help patients heal faster and ensure their home exercises are performed correctly and consistently. (MedRisk is a consulting client).

Medical leadership at Broadspire is changing hands. Dr Marcos Iglesias is taking over from the estimable Dr Jake Lazarovic; Dr Jake has been at Broadspire for as long as I can remember.  He’s always been a pleasure to speak with; humble, highly observant, innovative and focused on always doing the right thing.  Dr Jake has long been one of the good people in our industry.

Dr Iglesias is a friend as well; Marcos has deep experience in occupational medicine as both a provider and insurance company clinical leader.

The first segment of Coventry’s annual drug trend report is out; key takeaways are:

  • opioid utilization dropped 8.5% from 2015 – 2016
  • Average Morphine Equivalents per script decreased 5.6%
  • Total drug costs were down 5.8%

This is yet more evidence that PBMs and payers are doing really good work in cutting employers’ costs and patient risks.  Note to regulators – this is happening across the country; please don’t do things that will hamper PBMs’ efforts to ensure patients get the right drugs.

An excellent review of where the dollars flow in pharma from HealthAffairs; note this is for ALL pharma, not just workers comp or health insurance. (chart from HealthAffairs)

WCRI’s released a series of reports on worker outcomes, following on the heels of an assessment of workers’ comp income benefit adequacy.  WCRI has been focusing on outcomes and worker satisfaction for some time now; kudos to John Ruser and predecessor Rick Victor for this important work.

Finally, a really interesting piece from Harvard Business Review on how some very large employers are dumping health insurers and buying healthcare direct.  I will predict this is going to happen more frequently, and is a big risk for the big four healthplans.  

Opioids are the largest killer of people under 50

62,000 moms, dads, kids, friends, uncles, aunts died from drug overdoses last year.

Thank you, opioid manufacturers.

Let’s be very clear – this would not be happening if the “legitimate” pill pushers hadn’t co-opted, bribed, lied, and sleazed, funded fake patient advocacy groups, paid hundreds of millions to lobbyists, all in the name of profit.

This is going to get a lot worse – and there is NO indication it’s going to get better.

Drug overdose deaths are skyrocketing in Maryland, Pennsylvania, Maine, and Florida. Researchers estimate Ohio’s death rate jumped by 25% last year.

The drugs users are taking are so powerful that Narcan – the “get out of jail free” injectable antidote – is becoming increasingly impotent. “E.M.S. crews are hitting them with 12, 13, 14 hits of Narcan with no effect,” said Mr. Burke, likening a shot of Narcan to “a squirt gun in a house fire.” (NYTimes)

More than two million of us are addicted, and over a quarter of us used prescription painkillers last year. That’s more than used tobacco.

States are suing opioid manufacturers in an attempt to recoup some of the billions of dollars this disaster is costing taxpayers, as well they should. But those efforts are happening at the same time the FDA is approving new “abuse deterrent” opioids.  FDA Commissioner Scott Gottlieb is focusing on opioids, which is a very good thing. And truth be told, today’s FDA has pretty limited ability to address the problem, in large part because drug manufacturers are going to make damn sure the FDA’s powers stay limited.

Over the last decade, opioid manufacturers spent close to a billion dollars on campaign contributions and lobbying against state laws limiting opioid prescribing. That’s eight times more than the NRA and the gun lobby.

Sounds like a lot of money, right?

Nope – according to Business Insider, in 2015 alone, Purdue, the manufacturer of Oxycontin, made $2.4 billion from opioid sales.

You may recall Oxycontin was marketed as “abuse deterrent”; Purdue told Business Insider last year “We support policies that align with the FDA and The White House’s view that opioids with abuse-deterrent properties are a public health priority.”

They are certainly a profit priority.

What does this mean for you?

You know someone who’s died, a family destroyed, lives ruined by opioids. There are more coming.

 

 

 

 

Sheral Kellar is right about formularies.

Formularies that always allow opioids make no sense. That should be obvious to anyone, and it is to Ms Kellar.

(I’m basing this on an article in today’s WorkCompCentral, which stated:

“A pharmacy formulary is a tool that can be used to address the opioid issue. But it is not the only tool. In fact, Dr. Marcus Dillender, a Ph.D. from W.E. Upjohn Institute for Employment Research, suggests that careful management by insurers and administrators can achieve the same result,”

Sheral Kellar, Esq. is the Director of Louisiana’s Office of Workers’ Compensation Administration; deeply experienced, thoughtful and competent. I met Ms Kellar at CompPharma’s annual meeting last fall when she and several other state regulators spoke about formularies and managing drug usage.

Ms Kellar’s state has the second highest rate of opioid usage among workers comp patients, so she is keenly aware of the issue. She also knows a formulary is NOT a panacea, rather just one tool in the armamentarium.

  • Prescription drug monitoring programs that require and facilitate pharmacist and physician participation,
  • Strong and well-designed utilization review programs,
  • Flexibility for PBMs and payers to customize medication therapy to ensure patients get ready access to appropriate drugs and reduce risks from inappropriate medications,
  • Carefully-planned implementation,
  • Drug testing, opioid agreements, and addiction/dependency treatment

are all key to the solution.

I hesitate to pick on one issue as THE problem – however any formulary that always allows hydrocodone is not what Louisiana’s workers need. According to WCRI

  • A higher proportion of injured workers prescribed pain medications in Louisiana (85 percent) received opioids.
  • Among study states, LA had the second highest rate of patients taking two or more opioids
  • LA had the highest morphine equivalents per claim. – 3540 MEDs, more than double the average.

When you have docs using opioids as first-line pain meds – which clearly is the case in Louisiana, and they prescribe more than twice as much as the average state (which is already too high), and they prescribe more than one opioid most of the time, a formulary that automatically allows docs to prescribe hydrocodone – the most commonly used opioid in LA – is not part of the solution.

What does this mean for you?

Yes, solutions require a multi-pronged approach, but those “prongs” should “first do no harm.”

 

 

Compounds in workers’ comp

CompPharma’s second research paper on compounds in workers’ comp was published last week. Authored by pharmacists and government affairs professionals from member PBMs, this paper builds on the ground-breaking research published in our first paper. (I’m president and co-founder of CompPharma)

The first research paper provided a solid foundation to provide stakeholders with a deep understanding of the history, practice, limitations, and issues associated with compounds.

This paper takes a deep dive into patient safety, efficacy, and cost.

It also includes a review of many legal issues surrounding compounds in workers comp and details regulatory and legal cases involving allegedly inappropriate activity by compounders and prescribers.

A few key quotes:

CompPharma supports the use of compounding when prescribed by a licensed practitioner with knowledge of evidence-based medicine supporting the use of a compound for a single patient with special needs that prevent the use of a drug approved by the Food and Drug Administration (FDA). [emphasis added]

the use of topical compounded products is not recommended as first-line treatment for workers’ compensation patients [emphasis added]

CompPharma’s 2014 compound research paper stated, “Pharmacies have received FDA warnings regarding topical lidocaine in concentrations greater than 5% and other topical anesthetics.” Some compounding pharmacists responding to the 2014 paper characterized this statement as a misrepresentation. The authors stand by the statement…

…a chief criticism is that by acting as intermediaries, PBMs profit from the use of compounds and other over-priced medications. In reality, the clinical management programs employed by these companies actually decrease PBMs’ top-line revenue [emphasis added]

The first paper upset a few compounding advocates. Their complaints mostly arose because we didn’t address compounding outside of work comp. Frankly, the paper’s focus was, and the latest paper’s focus still is, purposely limited to workers’ comp. Others are welcome to address non-work comp issues, that’s not what we do.

You can download the paper here – there’s no charge and no registration required.

CompPharma is proud to have been the leading force educating the work comp world about compound drugs; thanks to member PBMs for supporting our work, and a special thank you to

  • Phil Walls, RPh, myMatrixx
  • Deborah Conlon, RPh,  BS Pharm, PharmD, OptumRx
  • Brigette Nelson, MS, PharmD, BCNP, Express Scripts
  • Kevin Tribout, OptumRx
  • Nikki Wilson, PharmD/MBA, Coventry

and Contributing Editor Robert E. Bonner, MD, MPH, Principal, Bonner Consulting Group, LLC.

What does this mean for you?

Compounds can be useful and appropriate for patients with unique and unusual needs. This report provides objective, thoroughly-researched information essential to understanding this issue.

Express Scripts buys myMatrixx – a smart move for both

This isn’t surprising; workers’ comp is a very mature industry which demands consolidation.  As the market shrinks, winners will be those with size, scale, and buying power.

myMatrixx has a very strong brand, excellent customer implementation and service, strong clinical capabilities and a solid portal. What it doesn’t have is buying power, and the biggest payers shied away from myMatrixx as it is one of the smaller PBMs with a dearth of hundred-million-dollar accounts.

Express Scripts’ work comp division has scale, a core group of really good professionals, and a few marquee customers.  What it doesn’t have is a strong brand image and the resources demanded by payers increasingly relying on their PBMs for all-things-pharmacy; opioid management, data reporting, patient enrollment and monitoring, physician profiling, high-risk-claim flagging.

Artemis Emslie will assume overall leadership.  I’ve known Artemis for 25 years; she has a very good reputation in the industry and knows work comp pharmacy deeply. As she takes over what is now a very large work comp PBM, I’d encourage her and her new bosses to consider a couple things.

Keep the myMatrixx brand.  Brand is all powerful, and the market message that will be heard is things are changing, ESI is investing in and providing resources for work comp. That is critical.

Keep doing the smart marketing mM has done for years – rides from airports to conferences, the Phil Walls webinars, the overwhelming focus on pleasing customers.

Get out to all customers today, and listen listen listen.  Don’t inundate them with corporate speak and blather, rather ask questions, dig deep, and document everything. This is a great opportunity to hear directly from customers – a very valuable opportunity.

Staff at both companies are excited about the merger; I’ve spoken with several who are pretty pumped.  This itself is unusual and speaks to their inherent grasp of each company’s challenges.

While terms weren’t disclosed (they likely will be at some point as ESI is a public company) my sources indicate the price was in the $300 – $350 million range, a hefty valuation indeed.

What does this mean for you?

The whole is rarely greater than the sum of the parts.  In this case, it will be – if the new entity has adequate resources and sticks with what made mM successful. A stronger PBM with more capabilities is good news for all payers.