Category: Pharma

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

published date
August 12th, 2019 by
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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
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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.

 

 

Agenus plans digital security offering. PCG’s Jeff Ramson explains in this podcast

published date
February 25th, 2019 by

agenus logo

Biotech company Agenus is launching a “digital security offering” that will let people invest directly in a single biotech product, rather than the whole company. Jeff Ramson, founder and CEO of strategic communications firm PCG Advisory Group, became fascinated by the concept and reached out to me to discuss it, even though he is not involved in the offering. (And neither am I.)

In this podcast, we cover the following topics:

  1. Agenus is launching the first asset-backed digital security offering in healthcare. What does it mean?
  2. What is a Biotech Electronic Security Token (BEST)? What are the trends it leverages?
  3. How is it being used?
  4. Has something like this already been used in other industries?
  5. What are the advantages? How does it preserve shareholder equity?
  6. Any disadvantages?
  7. Why not a traditional stock offering?
  8. What is PCG Advisory Group and what is your role?

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

Ten pharma policy topics in just one article!

published date
April 17th, 2018 by

Kaiser Health News is a non-profit news service that does a great job of exploring healthcare policy topics. Still I was impressed that one article (How a drugmaker turned the abortion pill into a rare-disease profit machinemanaged to directly and indirectly raise at least 10 important policy topics.

Here’s my count:

  1. Abortion: A drug on the market to induce abortion appears to be highly effective against Cushing’s syndrome, a condition that can be fatal. Due to mifepristone’s association with abortion, there are tight restrictions on its use and it’s less likely to be prescribed off-label or developed for other conditions.
  2. Orphan drugs: Because Cushing’s only affects about 10,000 people in the US, treatments are eligible for orphan drug status, which provides seven-year market exclusivity for the manufacturer and therefore a chance to make an attractive profit. The orphan drug law can also be abused by jacking up prices on low-cost products.
  3. Drug price levels: The price for Korlym (as the Cushing version of the drug is known) is about $550, compared with $80 for the abortion drug. And the abortion drug is only needed once, whereas the Cushing drug might be needed up to 3x/day forever. The manufacturing cost is presumably close to zero.
  4. Drug price increases: Korlym came on the market at about $220 per pill, but the manufacturer has boosted the price substantially every year, with no end in site. Meanwhile the price of the abortion pill has stayed the same or dropped.
  5. Pharmacy benefit management: The article duly notes that the prices quoted are “before any discounts or rebates.”  Pharmacy benefit managers (PBMs) negotiate discounts and rebates. Depending on what’s happening behind the scenes, it’s possible that the big boosts in list price have not been matched by an equal run-up in actual price realization by the manufacturer, and it’s likely that there are significant differences from one PBM to the next. Meanwhile the PBMs may be benefiting from higher prices, which could boost their own revenues from rebates and other incentives and fees.
  6. Funding of drug development: Corcept Therapeutics, which developed Korlym, is developing a variety of other drugs, which may help more people with Cushing’s or treat aggressive forms of cancer –or may fail completely and help no one. One way the company rationalizes the high price of Korlym is as a source of funding for new drug development. But is there a reason Cushing patients and their insurers should be the source of such funding? Would the company charge less if it didn’t have other drugs in development?
  7. The role of generic drugs: Teva has filed a patent for a generic version of the drug, now that the exclusivity period is coming to an end. That could lower prices for those paying the bill and dent Corcept’s profits and stock price.
  8. How pharma tries to block generics from coming to market: Generic companies need to compare their product with the branded product to get it approved. But the branded company can sometimes interfere with that. Corcept’s CEO implies in the article that Teva may have obtained Korlym for testing through nefarious means. Corcept’s CEO says Teva won’t have an impact on Korlym soon because the issued will be tied up in court for years.
  9. Conflict of interest: The original idea for Corcept was to develop mifepristone  for major depression. But a co-founder left the company in 2007 after Congress investigated his conflict of interest.
  10. Patient advocacy: Corcept is a funder of a patient advocacy group for Cushing’s. These groups can be useful for patients and their families as advocates for treatment and reimbursement and for raising awareness and educating people. Of course the drug manufacturers have an interest in how it goes.

Every one of these topics merits extensive discussion –or at least a blog post of its own. Thanks to Kaiser Health News for bringing all these issues to the surface.


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

Reducing variance in medical device and drug utilization. Podcast with Lumere CEO Hani Elias

published date
March 26th, 2018 by
Lumere CEO, Hani Elias

To succeed in value based care, providers must reduce unwarranted variance in utilization and cost. Medical devices and drugs are good places to focus, since they represent big slices of the spending pie that are rarely optimized. In this podcast interview, Lumere CEO Hani Elias describes how his company deploys evidence based software and services to help health system clients take on variation.

Overview:

  • (0:12)What are some of the key challenges in healthcare?
  • (1:31) What do you mean by “unwarranted” variation?
  • (2:45) Are you able to tell which variation is appropriate and which is not?
  • (4:30) How does the decision making process differ between drugs and devices?
  • (6:42) Drug and device companies are large and are influential with physicians. How do you operate effectively in that environment?
  • (8:45) How do you differentiate from others who work on reducing cost and improving quality?
  • (10:30) What’s new, and what’s the same in this administration in Washington compared to the prior one?
  • (11:41) The company has a new name. Why?
  • (12:35) What does the future hold for Lumere?

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