Tag Archives: $ESRX

Gilead’s Sovaldi Is The $5.7B Canary In The Coal Mine For Specialty Medications

In case you haven’t been tracking specialty drug costs for the past decade, the recent news with Gilead’s Sovaldi ($GILD) is finally making this topic a front page issue for everyone to be aware of.  I think Dr. Brennan and Dr. Shrank’s viewpoint in JAMA this week did a good job of pointing that issue out.  They make several points:

  • Is this really an issue with Sovaldi or is this an issue with specialty drug prices?
  • Would this really be an issue if it weren’t for the large patient population?
  • Will this profit really continue or are they simply enjoying a small period of profitability before other products come to market?
  • Based on QALY (quality adjusted life years) is this really quick comparable cost to other therapies?

If you haven’t paid attention, here’s a few articles on Sovaldi which did $5.7B in sales in the first half of 2014 and which Gilead claims has CURED 9,000 Hep C patients.

But, don’t think of this as an isolated incident.  Vertex has Kalydeco which is a $300,000 drug for a subset of Cystic Fibrosis patients.  In general, I think this is where many people expected the large drug costs to be which is in orphan conditions or massively personalized drugs where there was a companion diagnostic or some other genetic marker to be used in prescribing the drug.

The rising costs of specialty medications has been a focus but has become the focus in the PBM and pharmacy world over the past few years.  This has led to groups like the Campaign for Sustainable Rx Pricing.  Here’s a few articles on the topic:

Of course, the one voice lost in all of this is that of the patient and the value of a cure to them.  Many people don’t know they have Hepatitis C (HCV), but it can progress and lead to a liver transplant or even ESRD (end state renal disease) which are expensive.  15,000 people die each year in the US due to Hep C (see top reasons for death in the US).  So, drugs like this can be literally and figuratively life savers.  These can change the course of their life by actually curing a lifetime condition.

This topic of specialty drug pricing isn’t going away.

At the end of the day, I’m still left with several questions:

  1. What is the average weighted cost of a patient with chronic Hep C?  Discounted to today’s dollars?  Hard dollars and soft dollars?  How does that compare to the cost of a cure?
  2. What’s the expected window of opportunity for Gilead?  If they have to pay for the full cost of this drug in one year, that explains a lot.  If they’re going to have a corner on the market for 10-years, that’s a different perspective.  (Hard to know prospectively)
  3. For any condition, what’s the value of a cure?  How is that value determined?  (This is generally a new question for the industry.)

And, a few questions that won’t get answered soon, but that this issue highlights are:

  1. What is a reasonable ROI for pharma to keep investing in R&D?
  2. What can be done using technology to lower the costs of bringing a drug to market?
  3. For a life-saving treatment, are we ready to put a value on life and how will we do that?
  4. What percentage of R&D costs (and therefore relative costs per pill) should the US pay versus other countries?
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The Era Of The Two-Tier PBM Strategy

After Aetna, Cigna, and Wellpoint all moved into different PBM relationships with CVS Caremark, CatamaranRx, and Express Scripts, it certainly marked the end of much of the debate on whether a captive PBM (i.e., owned and integrated with the managed care company) could compete with the standalone PBMs.  There are really only a few big integrated models left including Humana, OptumRx (as part of UHG) and Kaiser with Prime Therapeutics having a mixed model of ownership by a group of Blues plans but run as a standalone entity.  Regardless of where the latest Humana rumors take them, it made me think about what the market has become with these new relationships.

  1. Scale matters.  All of these relationships and discussions show that there are clear efficiencies in the marketplace.
    1. Drug procurement (i.e., negotiating with the manufacturers (brand and generic) and the wholesalers)
    2. Pharmacy networks (i.e., getting the lowest price for reimbursement with the retail pharmacies)
    3. Rebating (i.e., negotiating with the brand and specialty drug manufacturers for rebates)
  2. Outcomes matter.  If scale was all that mattered, there be no room for others in the marketplace.  But, we continue to see people look at this market and try to make money.  That means that “outcomes” matter in different ways:
    1. Clinical outcomes (i.e., does the PBM have clinical programs or intervention strategies that improve adherence and/or can demonstrate an ability to lower re-admissions or impact other healthcare costs?)
    2. Financial outcomes (i.e., does the PBM have innovative programs around utilization management (step therapy, prior authorization, quantity level limit) or other programs like academic detailing that impact costs?)
    3. Consumer experience (i.e., does the PBM’s mail order process or customer service process or member engagement (digital, call center, etc) drive a better experience which improves overall satisfaction and overall engagement…which drives outcomes?)
    4. Physician experience (i.e., does the PBM engage the physician community especially in specialty areas like oncology to work collaboratively to drive different outcomes?)
    5. Data (i.e., does the PBM use data in scientifically valid but creative ways to create new actionable insights into the population and the behavior to find new ways of saving money and improving outcomes?)

While I’ve been beating the drug of the risks of commoditization to the market for years, I’m going to make a nuanced shift in my discussions to say that there is still a risk of commoditization and driving down to the lowest cost, but we may be quickly approaching that point.  What I’m realizing is that there can be a two tier strategy where you commoditize certain areas of the business and let the other areas be differentiated.  And, that this can be a survival tactic where you either outsource the core transactional processes to one of these low cost providers or figure out how to be one of them while creating strategic differentiation in other areas.  

Maybe you can eat your cake and have it too!

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Care Is Coming To Your PBM

The creation of the “softer, gentler” PBM is one of my predictions driven by the rise in specialty pharmacy. While generic fill rates and mail order penetration still matter to earnings, the focus across the industry is on specialty. 

  • What can we expect in terms of pipeline?
  • How and when will genetic tests be required? (i.e., companion diagnostics)
  • How can we treat the patient not just fill the drug?

This will bring back a focus on how pharma and the PBMs work together which has had a bumpy past. Initially the two were very close. Then, with the rise of generics and more trend programs like prior authorization and step therapy, the PBMs and pharma butted heads frequently.

Of course, the situation for pharma has changed also. They are trying to figure out how to go “beyond the pill” and create new consumer relationship and make money. (Here’s a good article about pharma and digital from the other day.)

In case you missed them, here’s a few other things that are relevant:

And, I think this screenshot from the Barclays Global Healthcare Conference Presentation given by Express Scripts shows that they are focused on this care and delivery intersection by continuing to show the success from the Therapeutic Resource Centers.

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So, what do you think?  Will the PBMs become more care management focused?  Will they integrate with the other care providers?  Will this be the beginning of their focus on working with ACOs and PCMHs?  Will this change their approach?  Will we see PBMs differentiating around key, chronic diseases like the specialty pharmacies have done?  Will this create an opportunity for integrated PBMs (i.e., Humana, Cigna, Aetna) to differentiate?  

Express Scripts 2013 Drug Trend Report

I always enjoy reviewing the PBM Drug Trend Reports.  Even though these past two years I’ve been focused more on the care management side of healthcare, I continue to see these two paths colliding in interesting ways in the near future. 

Here’s my big takeaways from the report some of which you can get in their Executive Summary

(I’d also encourage you to look at Adam Fein’s review…where he unfortunately beat me to the punch again.)

  • Overall trend was 5.4% which they did a nice job of breaking out according to different lines of business.
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  • They also showed the breakout of trend comparing specialty drug trend versus traditional oral solid medications. 

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  • Specialty trend was up 14.1% based on a 2.5% increase in utilization and an 11.6% increase in unit cost.
  • A key point is that specialty now makes up 27.7% of the total drug spend for a payer (and that doesn’t even count the ~50% of specialty drugs billed under the medical benefit).
  • Diabetes was the standout category within traditional drug classes with increased utilization and price increases.  [Which isn’t surprising to those of us working on the clinical side that see huge innovation and investment in the diabetes area – Omada Health, Telcare, and Welldoc (for example).]
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  • While they make a key point with data that member cost share is going down and actual out-of-pocket costs are only going up marginally, I think it ignores the reality that consumers are feeling the pain of out-of-pocket spending more especially with all the High Deductible plans out there.
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  • They do reinforce their previous messaging around waste and also introduce their Health Decision ScienceTM approach.  (I personally would have liked to see more on this.  How is the blending of Consumerology and the Therapeutic Resource Centers impacting utilization, adherence, waste, clinical outcomes, patient satisfaction, or other key metrics?)
  • As always, you can dig into their forecasts by drug class.  I choose cancer as one area to look at.  (While this is focused on the basics, I would have loved more about what’s going on around cancer.  How are genetic tests impacting use?  What about survivorship?  How do Centers of Excellence affect outcomes, drug selection, pricing, and adherence?)
  • On top of being able to drill down on Medicare and Medicaid, you can also look at a Worker’s Compensation specific version of the drug trends.  This is interesting since that business is different than the traditional PBM market and is an area that Express Scripts has gone aggressively after in recent years. 
  • One thing I couldn’t find in the document (which is hard to read in the current format) is the average number of Rxs PMPM or PMPY which is just a good stat that I personally track. 
  • One note I will offer on methodology is the definition of specialty drugs.  This could lead to some differences between PBMs as we try to compare their trend numbers.  Here’s the definition Express Scripts offers:

“Specialty medications include injectable and noninjectable drugs that are typically used to treat chronic, complex conditions and may have one or more of the following qualities: frequent dosing adjustments or intensive clinical monitoring; intensive patient training and compliance assistance; limited distribution; and specialized handling or administration. – See more at: http://lab.express-scripts.com/drug-trend-report/appendix/methodology#sthash.dhJhFIZs.dpuf” 

 

Pharmacy Satisfaction – Retail Beats Mail

With the new JD Powers survey, the gap between retail pharmacy satisfaction and mail order has widened. The average mail order satisfaction score was 797 for mail versus 837 (out of 1,000) for retail.

I think one key comment from Scott Hawkins, director of the healthcare practice at JD powers was:

“One of the key things we’ve seen in the data is that if someone is feels compelled to use a mail-order [pharmacy] their satisfaction score is going to be lower than someone who chooses to use it on their own.” (From Nov 2013 Employee Benefits News article by Andrea Davis)

If I was still at a PBM, I’d push to see the results broken out both ways so I could compare apples to apples the then say the drag was from clients choosing mandatory mail.

The rankings for mail order were:

Kaiser – 868
Humana – 845
Walgreens Mail – 812
OptumRx – 798
Prime Therapeutics – 794
Express Scripts – 783
Aetna – 778
Cigna – 771
Caremark – 760

The two I find the most interesting are Prime Therapeutics and OptumRx as both of them have moved their mail order services in house in the past few years and seem to be doing well with it. Aetna has outsourced their solution to Caremark and Cigna just recently outsourced their mail order to Catamaran which wasn’t on the list (but may be in the survey).

Express Scripts Excludes 48 Drugs On 2014 Formulary

Is anyone really surprised here?  We saw CVS Caremark make some changes a few years ago that caught everyone’s attention.  (You can see a good list of 2013 and 2014 removals and options here for CVS Caremark.)  This year, it’s Express Scripts (ESRX) who’s caught the attention of the press.

Why do this?  I think Dr. Steve Miller did a great job of explaining it in a recent interview.  The most interesting thing to come out of this was the possible link to copay cards.

Pharmalot: Where to from here?

Miller: We obviously have a long-term strategy. This has sent a loud message to the marketplace that we have got to preserve the benefit for patients and plan sponsors and do things to rein in costs. As there are more products in the marketplace that are interchangeable, we’ll do more to seek the best value for our members. This is just the beginning of a multi-step process over the next several years.

Will there be more to come?  Of course.  The PBMs have to make a significant show of lowering the number of formulary drugs especially in the oral solid (traditional Rx) space to make the point to the pharmaceutical manufacturers that they control market access.  This is critical for them to create more opportunities in the specialty Rx space around rebates.  (Here’s the 2014 Express Scripts exclusion list)

Additionally, this is a low risk strategy for several reasons:

  • The disruption is minimal.  While 780,000 people sounds like a lot, it’s still just 2.6% of the population covered by these formularies.  The savings the employer will generate per disrupted member will pay for the extra customer service needed.  (Harsh reality to some people…I know)
  • As I’ve discussed before, the margins are in specialty pharmacy and mail order generics not in branded drugs which represent less than 20% of all drugs.  Therefore, this is a good place to make a stand.
    • From an old JP Morgan analysis from 2011, Lisa Gill estimated the PBM profits to be (all in 30-day equivalents):
      • $1.69 retail brand drug
      • $2.03 mail brand drug
      • $3.00 retail generic drug
      • $13.00 mail generic drug
  • This is based on a clinical review by an independent P&T committee.  Therefore, this is aligned with the health reform focus on outcomes and value.

New/Old Accusations About PBMs And Their Margins

PBMs (or Pharmacy Benefit Managers) are big business.  Just look at a few of the names and their place on the Fortune 500 list:

Not surprisingly, none of those are non-profits.  There is real money being made here.  It’s all part of the mark-up game in healthcare.  The question of course is does the money being made justify the profits.  For example, I’m happy to pay my banker lots of money as long as he’s earning me more than he’s making (and significantly more).

This is a complicated question.  (see past posts on What’s Next, Why People Don’t Save With Mail, and Growing Mail Order)  I’ve also presented on this topic several times in the past pointing out that the model needs to change, and re-iterating the fact that PBMs made a mistake by putting all their profits in the generic space.  I’ve always said that disintermediation would happen by focusing on generics at mail which is where all the money was at Express Script (8 years ago).  [People remind me that some of this has changed and is different across PBMs.]

The new Fortune article by Katherine Eban called “Painful Prescription” certains shows a dark story.  It focuses exactly on one of these scenarios which is the gap between acquisition cost and client cost.  The article talks about paying $26.91 for a drug but selling it to the client at $92.53.  I’m always reminded of the fact that at one time we used to buy fluoxetine (generic Prozac) for about $0.015 per pill.  On the flipside, we had brand drugs that we bought for more than we got reimbursed and lost money.  It was strange model.

So, here’s my questions:

  1. Do you want transparency?  If so, there are lots of “transparent PBMs” and many larger PBMs will do transparent deals.  You can also follow the Caterpillar model.  (Don’t forget that pharmacy represents less than 20% of your total healthcare spend so you can find yourself down the rabbit hole here trying to shave 2% of spend on 20% or 0.4% of your costs with a lot of effort.)
  2. Are you focused on anamolies like this one or average profits per Rx?
  3. Do you have the right plan design in place?
  4. Do you have a MAC (maximum allowable cost) list both at retail and mail order for generics?
  5. Are you getting the rebates and any admin fees from pharma for your claims passed through to you at the PBM?
  6. If you pay the PBM on a per Rx basis (i.e., no spread allowed), what are they doing to keep your drug costs down year over year (i.e., they have no more incentive to push down on suppliers)?
  7. Are you benchmarking your pricing?  Look at reports from places like PBMI.  For many smaller clients, I often wonder if the savings they find you is worth the costs.

I’m sure there’s more since I’ve been out of the industry for a few years, but while I don’t intend to be the defender of the industry, I do like to bring some balance to the conversation.

Walgreens and Express Scripts Collaborate To Compete With CVS Caremark

The recent press from Walgreens and Express Scripts is interesting on several fronts:

  1. We worked for years even when I was there to try to figure out a win-win around 90-day with Walgreens.  It wasn’t easy.
  2. Walgreens and Express Scripts have a “colorful” past regarding working together.
  3. This is definitely in the best interest of the patient which we don’t always see everyday in healthcare.
  4. This is a definite recognition of the success of the Maintenance Choice program by CVS Caremark.

Here’s some language from the Walgreens’ press release.

Under the new option, plan sponsors that choose to include Walgreens as part of the Smart90 program for their pharmacy benefit will provide their members who have chronic conditions such as high cholesterol, high blood pressure and diabetes, the choice to receive 90-day supplies of maintenance medications through home delivery from Express Scripts or directly at a Walgreens retail pharmacy for the same copayment. Pending adoption by benefit plan sponsors, plan members could access Smart90 Walgreens as early as January 2014.

“Working together with Express Scripts, Smart90 Walgreens will offer more pharmacy locations and better member access coverage than any single retail chain 90-day maintenance medication solution in the nation,” said Kermit Crawford, President of Walgreens Pharmacy, Health and Wellness. “Through Smart90 Walgreens, our more than 8,000 Walgreens retail pharmacies will provide plan sponsors with cost savings and will offer their members safe, easy and convenient access to important in-person pharmacist consultations and a wide-range of health and wellness services that can further improve medication adherence and lower overall healthcare costs.”

“Members will be able to continue to receive the safety, convenience, cost savings and care offered from Express Scripts home delivery pharmacies,” said Glen Stettin, M.D., senior vice president of research and new solutions at Express Scripts. “Our data are clear: 90-day prescriptions delivered to a member’s home improve medication adherence and health outcomes, lower the cost of care and add convenience when compared to 30-day prescriptions. Over the past few years, our Smart90 program has driven more 90-day prescriptions for participating clients, and we’re pleased to now offer this additional option.”

Why The Cigna PBM Deal With Catamaran Is Relevant?

Not a big shock to anyone, but Cigna announced yesterday that they were signing a 10-year deal with Catamaran (formerly SXC) to outsource the operations of their pharmacy (PBM) business.  (see WSJ article or the story on Adam Fein’s blog)

This PBM industry has been full of change over the past 5 years as I’ve discussed many times.  So, the question is why is this deal relevant or just another yawner.

Let me give a few reasons:

  1. This is the 3rd big managed care company (Aetna, Wellpoint, Cigna) to decide to create this type of long term relationship with one of the big PBMs.  They each picked a different one.  (Aetna/CVS, Wellpoint/Express, Cigna/Catamaran)  United brought their business in-house from Medco, and Humana has continued to expand their pharmacy business.  
  2. Eric Elliott (former head of Cigna’s PBM and now head of Prime Therapeutics PBM) and Dan Haron (current head of Cigna’s PBM) are both very smart executives who I believe saw lots of value in the integrated PBM story.

So, if I read between the lines here, I come to a few quick thoughts:

  1. Are they all structuring long term deals that get them through this reform period and minimize risk, but give them the chance to bring this back in house after this settles down?  
  2. Could this symbolize a further repositioning and commoditizing of the PBM industry that all of these companies want to retain marketing, engagement, strategy, and formulary but outsource call center, operations, contracting, network management, and other tasks?  Would this further accelerate a “race to the bottom” on price that I’ve talked about before?
  3. Does this have implications to specialty pharmacy?  Will that become split into two different businesses – operations versus clinical care?  (more on that later)
  4. I don’t know the bidding here, but scale used to matter a lot.  If CVS and Express Scripts didn’t aggressively bid for this contract, that might imply a point of diminishing returns in terms of scale.  (which I clearly believe exists)
  5. Under what circumstances does the integrated model work (i.e., what does Humana, United, and Kaiser see differently) or will all the payers look to outsource certain tasks to the big PBMs?

The interesting times in the industry continue.  It’s a head scratcher of what comes next!

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A Frustrating Pharmacy Experience Highlights Service Challenges #Fail

We all talk about the challenge of consumer engagement in healthcare.  If we can’t get consumers to engage, we’ll never get them to change behavior or be preventative.

But, as the recent Times article highlights, sometimes engagement still leads to failure which can be very frustrating.  As I think about my recent experience within the pharmacy system, I’m reminded of a comment that I re-tweeted yesterday.

In this case, I have connections which I suppose I could escalate this to, but it seems wrong that the only way to resolve my customer service issue is to call in personal favors from Express Scripts and CVS.

 

 

But, maybe that’s what I’ll have to do.  At this point, the only way I seem to be able to get my medication is to pay cash which seems like a total system failure.  (Thankfully, I can use the GoodRx app to figure out which pharmacies have the lowest cash price for me.)

So, here’s the scenario…

  • On 12/31/12, I requested a refill for my 90-day retail script that was getting filled at my local CVS store.  
  • I got busy and couldn’t go to pick it up until 1/2/13.
  • Obviously, my plan design changed on 1/1/13, and I was no longer eligible for 90-day retail scripts at CVS.
  • I asked the pharmacist to run it as a 30-day script.  They tried numerous times, but for whatever reason, they couldn’t get the 30-day script to go through.
  • I asked them to transfer the script to my local Schnucks (grocery store) pharmacy.
  • I filled the January 30-day script and a February 30-day script.
  • When I came back for my March refill, they were getting a RTS (refill-too-soon) reject from the PBM – Express Scripts.
  • The local pharmacist and I both jumped on our phones and talked to the pharmacy help desk and customer service at Express Scripts and got the same answer…”You should have another 59 days supply based on the 90-day Rx you picked up at CVS on 12/31/12.”
  • I tried explaining to the customer service rep that I never picked it up.  They said that I’d have to solve that with CVS since they show it in the Express Scripts system…which by the way had me very upset that it became my issue to resolve a problem between the pharmacy and the PBM.  The rep went on to explain to me that they don’t talk to retail pharmacies to resolve issues like this.  (This became one of very few times when I was shouting and upset on a customer service call.)
  • My local pharmacist called the CVS store that said they show the original claim, but it shows that they didn’t fill it.  They agreed to try to reverse it again.
  • One complicating factor here which I think is making this worse is that the 2012 plan was with Medco which has since been bought by Express Scripts.  As a new client to Express Scripts, I would assume Medco sent them an open refill file probably on 12/31/12 or 1/1/13.  A reversal after that day might never come over to Express Scripts.
  • So, I posted the above tweet out of frustration over a week ago.  Express Scripts’ social media team quickly followed-up and assigned someone to work the case…BUT, it’s still not fixed.
  • I talked to Express Scripts yesterday, and it was still something they were trying to resolve with CVS.
  • I talked with CVS who confirms that they never filled the script and show it never paid by Express Scripts.  They blame it on an issue with their software vendor that somehow the reversal was caught in the system.  They said it could get resolved in the next 48 hours.

Who knows when this will resolve itself, but everyone seems to be able to blame someone else here.  Never mind that the patient (me) can’t get their medication.  As someone who tries to look at this from the average consumer’s perspective, this is a nightmare and total customer experience failure.  I understand the system.  I understand plan design.  I know the pharmacists.  I know the teams at Express Scripts and CVS.  Even with all that, I’m stuck having to go outside the system, pay cash for my prescription, and hope that my paper claim will get processed and hit my deductible in my plan design.

fail-stamp

 


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