Tag Archives: SP

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?

Getting To Zero Trend In Specialty Pharmacy – CVS Caremark – AHIP

When I was at AHIP last week in Seattle, I had a chance to see Alan Lotvin from CVS Caremark present on specialty pharmacy.  It was one of the best presentations that I’ve seen in a while.  

It was good because I actually heard things that I’d never heard discussed around specialty pharmacy before.  And, as he pointed out, specialty will represent 50% of the pharmacy spend and about $235B in total spend by 2018.  This is where everyone is focused and the opportunity for differentiation exists. 

  1. He talked about how to get to zero trend in specialty.
  2. He talked about the consumer experience in specialty.
  3. He talked about care coordination and its value in specialty.
  4. He talked about the need for a beyond the pill approach by the specialty pharmacy.

So, what does all this mean?  Let me share some highlights:

  • Specialty pricing is starting higher based on government pricing constraints.  You can’t raise price.  It’s easier to start high, discount, and/or come down over time.
  • Pharma is beginning to price based on Quality Adjusted Life Year (QALY).
  • 3.6% of patients drive 25% of costs (not a surprise)…but 43% of their total costs are not from the specialty condition but from their co-morbidities.  (Why treating the patient not the condition is critical.)
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  • Site of care (which is the hot buzz today) can save you 17% or more.
  • Developing an exclusion formulary is important to counteract copay cards and help reduce costs.

o   This article says that CVS Caremark is working on a formulary with 200 brand drugs excluded.

  • They are moving from 12-month contracting with pharma to 2-3 month contracts to really keep on top of market conditions. 
  • Coordinated care can drive lower costs in terms of readmissions and other total medical costs. 
  • You can use generics to replace biologics.  For example, he showed switching out an HIV biologic costing almost $3,000 / month with 3 generics costing $101 per month.  (I’ve never heard anyone else talk about this.)
  • He also reinforced the fact that today’s specialty benefits are not coordinated across medical and pharmacy.  For example, he used the RA example where there are 9 drugs with 4 of them commonly used under the medical benefit and 5 under the pharmacy benefit. 

But, the most important thing was their strategy to get clients to ZERO TREND for specialty pharmacy.  (It reminded me of the program I developed at Express Scripts where we actually guaranteed a 3-year zero trend…if you followed our very aggressive recommendations.)  He outlined the following:

  • 1.5% savings from their formulary
  • 0.5% savings from an exclusive specialty network
  • 1.9% savings from an aggressive generic policy
  • 1.0% savings from innovative pricing
  • 3.6% savings from optimizing site of care
  • 2.5% savings from medical claims editing and repricing
  • 6.0% savings from enhanced prior authorization

He also went on to talk about the consumer experience.  I think a lot of specialty pharmacies are thinking about the same things, but there were several things he shared that were new to me.  It was exciting. 

As I’ve said before, as specialty pharmacies really start to think about the patient and focus on the experience over time, we will start to see more coordination with pharma about going beyond the pill and driving lower total costs.  

Prime Therapeutics Drug Trend Report 2014 Report

The Prime Therapeutics Drug Trend Report was released yesterday.  Interestingly, they start out the report by making the point that what really should matter is net ingredient cost not trend.  I’ve made the point before that trend isn’t a great number to focus on for many reasons.  And, if you’re comparing trend numbers (which we all do), then you need to understand different methodologies.  I think Adam Fein does a good job of summarizing that in his post.  (BTW – This is a tough discussion to have especially when you’re getting spreadsheeted by consultants as part of an RFP.)

As comparisons, you can see my reviews of the other drug trend reports here:

Their report was short and to the point.  Here’s some of the key data points:

  • 25M members
  • 80.6% generic fill rate
  • 12.7 Rxs PMPY
  • Overall drug trend = 3.3%
  • Specialty drug trend = 19.5%
  • Net ingredient cost trend = 2.2%

Prime Trend Drivers DTR 2013

 

  • The net ingredient cost per Rx = $58.99 (this is net of rebates and takes into account acquisition costs and network discounts)
    • They state that this beats the competition by $6.00 per Rx

Prime Net Ing Cost DTR 2013

 

Of course, anything anyone really cares about these days is specialty.  Specialty represents only 0.4% of the scripts they fill but 20.5% of the spend for a commercial account.  (They point out that this is much less as a percentage of scripts than other PBMs which have closer to 1% of their scripts classified as specialty…which could influence trend numbers.)  The chart below shows how some of the things we all did around traditional drugs apply to specialty drugs.

Prime Trad vs Specialty Rx DTR 2013

 

And, they make a few predictions going forward:

Prime Forecast DTR 2013

 

7 Steps To Manage Specialty Drugs – From Prime Therapeutics

Prime Therapeutics is a PBM owned by the Blues.  Several years ago, they insourced their specialty pharmacy operations from Walgreens.  This has been part of their transformation which was a result of new leadership under Eric Elliott who used to run Cigna’s PBM.  

As a PBM that’s owned by the Blues, I’ve talked about them before as an interesting cross of a standalone PBM (ala Express Scripts) and an integrated PBM (ala Humana Rightsource).  

As everyone in the industry knows, the shift in pharmacy has moved from innovator drugs in the traditional space to innovation in the specialty or biopharmaceutical space.  This includes both branded products and biosimilars.  This is critical path for employers, payers, and PBMs.  

A traditional strategy of promoting generic drugs and mail order or preferred pharmacies just doesn’t cut it anymore.  Although specialty drugs are still only used by about 1% of the population, they are the fastest growing area in healthcare.  According to Prime Therapeutics Drug Trend Report, their clients saw a 19% increase in specialty spending last year.  And, specialty drugs now account for over 30% of all the drug spend.  

If you look at the drug pipeline, this is going to continue to explode.  I just met with a series of specialty pharmacies to discuss their offerings and strategies.  There are several drugs coming that claim to “cure” some of these specialty conditions are at least meaningfully impact the patient outcomes in ways that weren’t even envisioned years ago.  And, I think we all know that’s not going to come cheap!

So, tomorrow (10/10/13), Prime is releasing a new report – “Specialty: Today & Tomorrow” which highlights Prime’s specialty drug trend over the past year and recommends strategies that high-performing plans use to manage the steady rise in these costs.  [My comments in brackets.]

1.        Bridge the benefit divide: use combined pharmacy and medical benefit data to see the full scope of specialty spending and seek solutions.  [Critical.  IMO – No one is doing this well yet, but this is something that everyone’s trying to figure out.]

2.        Focus on the biggest issues: use combined data to target the most urgent issues and focus on the areas that can provide the greatest return on investment.  [I’d expand this to be an integrated set of data – medical, pharmacy, lab, patient reported, EMR, etc.  This has to then be integrated with tools for depression screening and others to make sure the patient is supported.]

3.        Narrow the specialty network: use cost-effective distribution channels and limit the number of distributors to secure lower prices. [Fairly obvious.  I think many people are doing this.  I would expand on this to include looking at site of distribution for savings.]

4.        Embrace a management mindset: make sure the right specialty drugs are used properly by those who will benefit the most. [Agree.  I’ve talked about this before.  Some of these drugs still have huge adherence issues which limits their effectiveness leading to massive cost issues.  This is why some people are using only 14-day fills.]

5.        Promote preferred drug use: build plans that encourage desired behaviors. [I think we’re finally at a point where we’ll see specialty formularies, more rebating, and with bio-similars there may be more utilization management programs.]

6.        Protect members from high costs: limit members’ out-of-pocket costs and use available tools to reduce the burden on highly vulnerable members. [Critical.  The specialty pharmacy has to help the member limit their financial exposure.]

7.        Pick the right partner: select a trusted advisor with comprehensive capabilities and deep connections to help anticipate and address specialty drug challenges.  [Agree.  An aligned philosophy and strategy to work with these critical patients is fundamental.  This small group of patients drives most healthcare costs.] 

A copy of the specialty report is now available on Prime’s website and short videos about each of the seven steps can be found on Prime’s You Tube channel. This new report is the first specialty-focused report published by Prime. It follows Prime’s 2013 Drug Trend Insights infographic released in May. Visit the Industry Insights of Prime’s website for more drug trend information.