Category: Pharma

Russia rushes its COVID-19 vaccine. Why all is not what it seems

published date
August 10th, 2020 by
honor guard 67636 1280
Any volunteers?

Russia –yes the Russia that exerts special influence on our president– has done a poor job of keeping the COVID-19 virus in check. But now they claim to have a safe and effective vaccine that’s ready to go.

I’m quoted in the International Business Times (Questions Surround Russia’s Ability to Deliver a Safe, Effective Coronavirus Vaccine)

Some suggest that the vaccine may not be safe – or effective.

“It’s obvious that the Russians are rushing the vaccine to market without adequate testing,” David Eugene Williams, president at Health Business Group, told International Business Times in an email. “It’s possible that the vaccine will work, but there hasn’t been enough time to verify that it’s both safe and effective. The Russians haven’t released any data that would support their claims.”

“I don’t think people will travel to Russia to receive the vaccine because, 1) they won’t trust that it will work, 2) they could get COVID-19 on their travels to Russia, and 3) the Russians may allocate it to their own citizens,” he said.

It would be great if the Russian vaccine works. But we’ll have to wait and see –which is something the developers haven’t done.


By healthcare business consultant David E. Williams, president of Health Business Group.

Adaptive Clinical’s Tope Keyes on clinical trials in the COVID-19 era (podcast)

published date
June 25th, 2020 by
TK head shot 1
Temitope Keyes

Thanks to COVID-19, the era of decentralized trials is now upon us. In this podcast interview, Adaptive Clinical SystemsTemitope Keyes and I discuss how trials are changing and what clinical data infrastructure is needed to make them flow smoothly.

Questions include:

  • Changes are underway in clinical trials right now as a result of COVID-19
  • The imperative for “frictionless clinical data.”
  • Ensure optimal performance in the new environment
  • New data sources and endpoints that will be employed
  • Technological innovations that we can expect

Tope will be a panelist on a webinar I’m moderating on July 8: Moving Clinical Trials Forward with Digital Innovation in the COVID Era. We’ll be joined by Mark Mann of The Oxenham Group and Bob O’Hara of ResultWorks. Please register –the webinar is complimentary.


By healthcare business consultant David E. Williams, president of Health Business Group.

Abarca, Amgen push the envelope with outcomes-based plan for Enbrel

published date
December 18th, 2019 by
Javier
Abarca COO, Javier Gonazlez

Health plans should be more willing to pay for high-cost drugs if they actually produce the results patients expect: cures, symptom relief, etc. But pay-for-outcome deals are few and far between.

Abarca Health –a small pharmacy benefit manager (PBM)– recently announced an outcomes-based deal with Amgen for Enbrel. I interviewed Abarca’s chief operating officer, Javier Gonalzez about the announcement.

This is your second deal with Amgen. How did the first one go? What did you learn from it and how did that impact the Enbrel contract?

Abarca is in the process of implementing the outcomes-based agreement with Amgen for Repatha. Because of the innovative and complex nature of these agreements, implementation takes time both with the drug maker and the health plans.

All parties have learned a lot throughout this process, and we expect implementation to get faster with new agreements. We also know that each outcomes-based contract is different. What looks like success for a patient with high cholesterol–like those who take Repatha–might not be the same for someone who is taking Enbrel for rheumatoid arthritis.

The key to a successful outcomes-based contract is collaboration–so this process has allowed Abarca to build a solid working relationship with Amgen. Our organizations are very much aligned in our belief that these agreements have the potential to disrupt the entire healthcare reimbursement system.

The Enbrel arrangement is positioned as an outcomes based contract, but the outcome is just whether the patient stops using the drug. Why not something more advanced, like a clinical measure?

Although our agreement for Enbrel will initially measure discontinuation, we will also be collecting data that drills down further into why the patient stopped treatment–which could be related to side effects, adverse events, or failure to meet therapeutic outcomes.

Though we would like to see additional clinical measures become the determining factors for outcomes-based contracts, it’s important to remember that these agreements are still very much in their infancy. Manufacturers are proceeding very slowly and picking some basic pharmacy therapy outcome endpoints that are reliable and readily accessible—medication adherence and discontinuation, for example—as they build experience.

But, as payers and PBMs build frameworks that can connect disparate patient health data points, and report outcomes through robust analytical platforms, we believe that they will be in a better position to take these agreements to the next level. To help move the industry to this point, Abarca is developing a specialty quality pay-for-performance program to establish clinical, operational, and compliance efficiencies for health plans that will create a game changing experience for patients, pharmacies, and physicians while delivering competitive pricing. We plan to announce this initiative early next year.

What interventions, if any, are utilized to encourage patients to stay on Enbrel? Do you work with any vendors to help?

Our clinical teams work closely with our clients to track adherence across all therapy classes on an ongoing basis. We also have our award-winning Medication Therapy Management (MTM) initiative and programs in place, which look at adherence for high risk patients.

Additionally, we are in the process of ramping up our offerings around the management of specialty patients. Our multi-pronged approach will feature advanced technology, and the eventual development of a quality pay-for-performance program that relies heavily on adherence as a factor to determine success. 

I’ve never heard of Abarca. How big are you? Who are your customers?

Abarca was built on the belief that with a smarter technology and a straightforward approach to business, it can provide a better experience and greater value for payers and consumers–and we’ve been delivering on that mission for more than a decade.

As a full-service PBM, Abarca’s clients include self-insured employers, Medicare and commercial plans, and large insurers across the US. We manage more than $2 billion in drug costs for 2.8 million members in commercial, self-insured, Medicare, and Medicaid plans. We also provide Darwin, our advanced technology platform that our team built in-house, to health plans and PBMs.

There have been a lot of companies claiming that they were going to disrupt or revolutionize the PBM industry. Often they use terms like “transparency” to try to differentiate themselves. But they haven’t been very successful. Why would Abarca succeed where others haven’t?

The largest players in the PBM space have found–and maintained–success by adhering to the status quo. Unfortunately, too often those practices favor the company, and not the clients and members they serve. And while some organizations may use the word transparency, we are building relationships with our clients to deliver transparency starting from day one.

For Abarca, transparency means is holding ourselves to a higher standard. It means to be able to look our clients in the eye and tell them “this is exactly what each of your drugs costs and why.” We don’t believe that transparency should be touted as a differentiator, it should be the industry standard.

Our company was founded to throw out the PBM playbook and find a better way in healthcare–and we have structured every aspect of our business in pursuit of that mission.

We have built industry-leading technology from scratch that makes PBM processes integrated, user-friendly, and modern–and has attracted the attention of some of the nation’s leading PBMs. Within a two year period, we will have doubled the size of our team to accommodate our ongoing growth. And, while many PBMs are in the process of debating outcomes based contracts, we’re executing them with some of the nation’s leading pharmaceutical manufacturers.

What other kinds of outcomes based contracts do you have in the pipeline? What kinds of drugs are good candidates?

Abarca will be focusing on high-cost, high-risk specialty medications for our future outcomes-based contracts. Specifically, we’re looking at treatments for multiple sclerosis, rheumatoid arthritis, hypercholesteremia, and breast cancer, among other disease states.

Do pharma companies want to do more of these deals? Why?

The adoption of innovative drug contracts has been slow and steady over the last few years. In fact, a recent report by PhRMA found that the list of publicly announced value-based contracts grew from 39% to 43% during 2018. But, there are several important trends that are emerging that could change healthcare significantly, including pay-for-performance, calls for transparency, and, potentially, moves away from existing rebate models.

Based on these factors, I believe that pharmaceutical companies are increasingly warming to these types of agreements. There is also the added bonus that outcomes-based agreements give drug makers critical, real-world insight into the performance of their products.

In general, pharmacy can be a very slow moving industry. But, those who are willing to innovate on their own accord–rather than industry mandate–will be in a better position for long-term success.

How about payers? What is their motivation?

Payers are really looking forward to the widespread adoption of these agreements, for a few reasons. First, it puts more accountability on manufacturers for the performance of their products. Additionally, it will help to facilitate better fact-based formulary decisions.

Today, there are a number of factors that contribute to whether or not a drug appears on a formulary but, in many cases, the process can be quite opaque. That’s not how important decisions that impact member health should be made. As outcomes-based agreements become commonplace, we will have the data necessary to manage formularies with more transparency, and objectivity. Specifically, the total impact of cost will be easier to manage and decisions can be made based on clinical outcomes, rather than pharmacy-based data points. 

Do you expect these outcomes based plans to be emulated by other PBMs? Does Abarca provide technology to other PBMs that will help?

We would hope that these types of agreements become the standard in our market. However, we recognize that not every PBM has the technology necessary to support them.

Along with being a full-service PBM, Abarca provides the technology, analytics, and reporting capabilities for health plans and PBMs to support innovative drug contracting–and other clinical initiatives. It may seem a little counterintuitive to provide what some see as our “secret sauce” to the competition, but we believe that health plans, pharmacists, physicians, and, most importantly, patients deserve a better experience–no matter who their PBM is.

——

By healthcare business consultant David E. Williams, president of Health Business Group.

 

 

Life Image CTO Janak Joshi discusses real world evidence (RWE) –podcast

published date
August 12th, 2019 by
footprint 3490875 1280
Real world evidence?

Real World Evidence (RWE) is becoming more important in US healthcare, but the fragmented system and lack of interoperability makes it hard to collect and analyze. In this podcast, Life Image CTO Janak Joshi discusses  the state of the field and how it’s evolving.

Overview:

  • (0:12) How would you describe the evolution of medical data?
  • (2:36) Real world evidence and real world data are becoming more prominent in healthcare –and for good reason. What are some of the challenges in assembling RWD and RWE? How can they be overcome?
  • (6:36) Is it really true that unstructured notes are becoming quantifiable and useful?
  • (9:46) There are major efforts by the US government and private sector to improve interoperability and end data blocking. You have groups like CommonWell and Carequality –now working together. What’s the current state of play and how are things changing?
  • (13:56) You talk about data brokers like Datavant and HealthVerity. How much of their success is because the US system is so broken? Do you see them having the same success elsewhere?
  • (17:31) Promoters of AI and Machine Learning –including Life Image—tout the opportunity to revolution healthcare with these new techniques. Is it for real or overhyped? And how does interoperability tie in?
  • (22:20) What are you most excited about over the next few years?

By healthcare business consultant David E. Williams, president of Health Business Group.

Should ICER be NICER? The case for analyzing the value of drugs

published date
June 20th, 2019 by
tree 1959267 1280
It’s a tree of ICE, for those who hold fast to it

The headline in today’s Boston GlobePrice watchdog’s influence on drug makers expands; As nonprofit assesses treatments, some fear it inhibits key options— could have been written by a drug industry lobbyist. [And maybe it was, since the online headline instead uses the squeaky phrase ‘mouse that roared.’]

The article itself is more balanced. Of course it quotes the parents of a couple of kids who take expensive meds, objecting to anyone putting a price tag on their lives. But it also quotes health economics experts pointing out that the price can’t be infinity.

The Institute for Clinical and Economic Review (ICER) follows a data-based approach to assessing the value of drugs, utilizing Quality Adjusted Life Years (QALY) and other well developed metrics. It provides guidance on what a drug could be worth, both on an absolute basis and relative to other treatment options. It doesn’t set prices or prevent a drug from being made available by a public or private health plan. At most, it helps contain the prices of drugs that enter the market and points out cases of outright rip-offs.

Elsewhere in the world (pretty much everywhere) there are real forces limiting drug prices and impacting access. In the UK for example, the National Institute for Health and Clinical Excellence (NICE) decides which drugs and treatments will be provided to patients in the National Health Service. Sometimes drugs are rejected or their use is heavily restricted. On the flip side, patients don’t pay for the drugs that are approved.

In the US the drug pricing forces are heavily weighted in favor of higher prices. We shouldn’t fret about an entity like ICER.

Many drug companies have decided to play ball with ICER by providing data to help justify the value of their products. Some, like Vertex and Serepta have pulled back, saying ICER is biased against drugs for rare diseases. I don’t read ICER’s analyses that way.

The quality of ICER’s research is high, but of course the reports are limited by the data and analytical techniques that are available to the organization. The correct response is to build up the availability of real world evidence (RWE), especially from clinical registries that demonstrate how a drug actually improves (or doesn’t improve) the lives of patients. Patient-generated data and information from claims and electronic medical records can be helpful as well.

With better data we can have answers we are more confident in, and we can accumulate evidence on how drugs perform after they are launched, which can offer a refined understanding of their value.

Thanks to the 21st Century Cures Act, enacted in 2016, there is an increased demand for the generation of RWE. The industry is ramping up its spending on RWE for drug approval, safety monitoring, and reimbursement. New analytical techniques and enhanced data availability from wearable devices and other electronic sources are ushering in a heyday for RWE.


By healthcare business consultant David E. Williams, president of Health Business Group.