Category: Pharma

Ten pharma policy topics in just one article!

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

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.

How formidable would Amazon be in pharmacy?

October 31st, 2017 by
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Oops

I’m a big fan and customer of Amazon, having placed thousands of orders since 1998. I understand why retailers (and other businesses) quake in their boots at the thought of Amazon disrupting them. As a healthcare insider, I also understand why healthcare companies are especially nervous. Deep down, we understand that US healthcare is tremendously wasteful and inefficient and that Amazon could make the industry look bad and eat its lunch.

Still, I’m not convinced that Amazon is going to take over the pharmacy business, the latest topic of discussion. The Wall Street Journal (Amazon’s push into pharmacy is full of promise and pitfalls) has a piece and we’re also told that CVS’s play for Aetna is a direct result of the Amazon threat.

My own recent experience with Amazon left a bitter taste in my mouth and provided a glimpse of just how hard pharmacy could be. I don’t usually take painkillers, but the past three weeks have been an exception. Since getting hit by a car while crossing the street, I have been a pretty good customer for OTC pain meds. On a recent Sunday I noticed I was running out of ibuprofen, and rather than asking family members to do one more errand, I used Amazon to place a same-day order.

I pressed the button around 9 am, and was promised that my order would be at my doorstep by 9 pm. By around noon the item was “out for delivery” but it hadn’t arrived by 8:30 pm and I was starting to get a little worried. Nine o’clock came and went, and Amazon switched my status to “delayed.” Finally I had to ask my wife to go out to the pharmacy, which luckily for us is close by and open late. I would have had a difficult night without my refill.

Eventually Amazon canceled the order and said my address was undeliverable –a weird claim for a home that receives Amazon shipments nearly every day.

Most of the skepticism about Amazon’s entry into pharmacy focuses on new complexities like third-party payment, which are admittedly pretty serious. But my own experience shows that Amazon’s current infrastructure isn’t robust enough for the basics, so I definitely won’t be among the first to sign up for AmazonRx.

Of course Amazon isn’t the only one with shipment woes, and this experience was an exception to my usual good ones. Still, it gives me pause.


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

Hospice: Another sad sector of the opioid crisis

August 30th, 2017 by
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Help yourself?

A person addicted to drugs might do anything to get their hands on the next dose. Whether that means ‘borrowing’ painkillers from a relative who had their wisdom teeth extracted, breaking into cars to grab small bills and coins, or stealing their mother’s jewelry –all things I’ve seen myself– there are no real limits. So I was saddened but not surprised to read Dying At Home In An Opioid Crisis: Hospices Grapple With Stolen Meds, which highlights the trouble dying patients face in keeping hold of their painkillers.

The Kaiser Health News examples are only anecdotal, but the combination of high quantities of opioids and homebound patients unable to fend for themselves is an ideal setting for diversion. The problem is two-fold: theft of drugs while the patient is alive, and diversion once the patient passes away. Since many patients die within days or weeks of beginning hospice, the second problem is a major one.

The examples offered in the article are heartbreaking:

  • In Mobile, Ala., a hospice nurse found a man at home in tears, holding his abdomen, complaining of pain at the top of a 10-point scale. The patient was dying of cancer, and his neighbors were stealing his opioid painkillers, day after day.

  • In Monroe, Mich., parents kept “losing” medications for a child dying at home of brain cancer, including a bottle of the painkiller methadone.

  • In Clinton, Mo., a woman at home on hospice began vomiting from anxiety from a tense family conflict: Her son had to physically fight off her daughter, who was stealing her medications. Her son implored the hospice to move his mom to a nursing home to escape the situation.

Some hospices are trying to do something about the problem, but it’s not easy. After all, their primary goal is to ease the pain of dying patients. It’s not really their job to keep track of and control everyone else. Some of the ideas being tried include:

  • Screening families for a history of drug addiction
  • Limiting the amount of meds delivered at any one time
  • Drafting agreements with families about consequences for drugs that disappear
  • Encouraging the destruction and disposal of drugs after the patient dies

None of these approaches is likely to succeed on its own. The country will have to address the broader opioid crisis in order to bring this part of it under control. However, there are a couple additional steps that could be taken now:

  • A few states let hospice employees destroy drugs once a patient dies. That should be expanded nationwide and made mandatory. There is no conflict here with the patient’s needs
  • Some patients, who would otherwise be eligible for home hospice, should be moved to facilities such as nursing homes, where controls can be tighter. (Much as I hate to argue against home care this needs to be part of the discussion)

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

Drug treatment for opioid addiction: Podcast interview with CleanSlate CEO Greg Marotta

March 20th, 2017 by

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The opioid epidemic gives addiction treatment providers an opportunity to demonstrate what they can do to stem the tide. CleanSlate operates treatment centers in multiple states, employing a medication assisted approach. In this podcast interview, CEO Greg Marotta describes what he’s seeing and how the company is responding.

We discussed:

  • (0:10) How serious is the opioid epidemic?
  • (1:09) What kind of approaches are traditionally to treat addiction? What works well and where are there shortcomings?
  • (2:22) Are people coming to treatment through primary care? Or the behavioral health system?
  • (4:06) How does medical/behavioral integration work? What does it really mean?
  • (6:56) CleanSlate is well know for medication based treatments. What kind of medications are available? Who is the approach best suited for?
  • (8:09) What is the typical course of treatment?
  • (9:49) As addiction has become more visible, it’s now front and center for others in health care. Do you collaborate with other organizations and if so, how has it gone?
  • (12:52) You operate in a variety of states, with different cultures. Do you see key differences between Massachusetts, and other states like Texas, Indiana and Wisconsin?
  • (14:53) Will we still be talking about an opioid epidemic in five years? What will it take to get out of it?

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