Unbiased Analysis of Today's Healthcare Issues

Providers move into digital health

Written By: Jason Shafrin - Aug• 04•16

Marketplace reports:

On a recent visit to the hospital, Riley, who is five years old, swallowed a tiny white pill with an embedded sensor – roughly the size of a grain of sand. When it reached her stomach, it sent a signal to a patch she’s wearing on her skin and alerted her parents and doctors that she’d taken her medication.

Making sure Riley has taken her pills is especially important because she had a kidney transplant earlier this year.

Why would hospitals use this technology? Not only to improve patient health but to cement their relationship with patients.

Children’s hospitals are searching for the best way to monitor patients and keep them out of the ER. Digital health startups are looking for patients to test their products. Julie Hall-Barrow, Senior Director of Healthcare Innovation at Dallas Children’s Medical Center, says keeping kids healthy means finding partners outside of the hospital, in the home, in the school, and with faith-based organizations…

“These companies gave them convenience and an app, what we as an industry missed was they also wanted to extend the relationship with their network of caregivers,” Perialas said.

Combining the latest technologies with established medical providers seems to be a recipe for success for both the patient and provider perspective.


Impact of Brexit on Pharma

Written By: Jason Shafrin - Aug• 04•16

There is a lot of talk that Brexit will be a disaster.  While I believe that much of this disaster talk is overblown, there are clear business implications.  Pharmafile provides an example of how Brexit would affect a small pharmaceutical company conducting clinical trials in the UK.

In the latter case, UK-based pharmaceutical companies with no other offices or manufacturing plants in the EU/EEA may do well to consider relocating to an EU/EEA country in order to continue benefitting from the advantages that come with being established in the EU/EEA. The implications of not relocating are significant for companies that rely on clinical trials conducted in the UK to support an EU marketing authorisation application, as Pharma business conducted in the UK will be considered conducted in a third country. This means that, among other things, in order to rely on clinical trials, the applicant will have to demonstrate that they were conducted in compliance with at least EU equivalent standards.

There is still much regulatory uncertainty in health care and other industries, but we do know that Brexit will be causing some changes.

Incentives for investing in “off label” trials

Written By: Jason Shafrin - Aug• 01•16

Aaron Carroll of the Incidental Economist draws on a column from his colleague Austin Frakt in The Upshot to explain why there is not more research into off-label uses of patented or generic drugs.


Off Label Drug Use

Written By: Jason Shafrin - Jul• 31•16

Approximately one in five prescriptions for drugs in the US are for off label use.  In some cases, this may be inapprorpiate as there is typically limited clinical evidence supporting off label use.  In other cases, off label use is approrpiate.  Clinical trials rarely enroll children or pregnant women and thus medictions are often not indicaated for these populations; however, children and pregnant women get sick too, so it is entirely appropriate to have off-label prescribing for these populations, although doing so does carry additional risks.

Can drug companies promoto their drugs for off-label use?  Promote: no.  Communicate: sometimes.  Health Affairs has a nice policy brief that clarifies the off-label prescribing issue:

Under FDA rules, any promotional materials distributed by a company should be truthful, balanced, nonmisleading, and supported by substantial evidence. In addition, it has been illegal for drug manufacturers to directly promote or advertise a drug for any indication that the FDA has not approved. However, companies are not categorically prohibited from disseminating information about off-label uses, and the FDA’s approach to regulating and enforcing the distinction between communication and promotion has evolved over the past several decades in response to both legislative changes and legal challenges.

Manufacturers can communicate about off-label uses of their drugs in a number of ways. Companies are permitted to respond to unsolicited requests from health care professionals about unapproved uses and might also support independent continuing medical education activities at which off-label uses are discussed. Since the passage of the Food and Drug Administration Modernization Act (FDAMA) of 1997, companies are also permitted to distribute peer-reviewed journals and reference books that discuss off-label uses, although this practice is subject to certain limitations. In 2014 the FDA expanded this authority to include non-peer-reviewed clinical practice guidelines.

Under Section 114 of the FDAMA, companies were also given the power to share health care economic information about approved uses of their drugs with formulary committees, managed care organizations, and other entities that make reimbursement and coverage decisions. However, it is unclear how often drug companies have used this pathway, which some attribute to a lack of clarity on how the FDA interprets that section of the law, as well as to the availability of alternative channels for health economic communication (principally, the Academy of Managed Care Pharmacy’s Format for Formulary Submissions, which provides comprehensive drug information to managed care organizations).

Companies may not always follow these rules.  When they do not, they are liable for significant fines.

In 2012, for example, GlaxoSmithKline (GSK) was fined $3 billion by the federal government, in part for off-label promotion of several of its drugs

Why don’t pharmaceutical firms just do the clinical trials necessary to demonstrate that the drugs are safe and effective for other indication?  The answer is the cost.  The trials can cost millions of dollars and take many years to complete.

Regardless of the current off-label statutes, the law and regulations will almost certainly evolve over time.


Friday Links

Written By: Jason Shafrin - Jul• 28•16

Can physicians affect medication adherence?

Written By: Jason Shafrin - Jul• 27•16

According to a recent study by Koulayev, Simeonova, and Skipper (2016) using data from Denmark, the answer is ‘yes’.

Non-compliance with medication therapy remains an unsolved and expensive problem for healthcare systems around the world, yet we know little about the factors that affect a patient’s decision to follow treatment recommendations. In particular, there is little evidence on the extent to which doctors can influence patient adherence behavior. This study uses a unique panel dataset comprising all prescription drug users, physicians, and all prescription drug sales in Denmark over 7 years to analyze the contributions of doctor-specific, patient-specific, and drug-specific factors to the adherence decision. We find that physicians exert substantial influence on patient compliance. Further, the quality of the match between a doctor and a patient accounts for a substantial portion of the variation in adherence outcomes. This suggests that the sorting of patients across doctors is an important mechanism that affects patient adherence beyond the effects of individual patient-specific and physician-specific factors.

It would be interesting to see if the results would be the same if applied to U.S. patients and physicians.


Physician Access in California Obamacare Plans

Written By: Jason Shafrin - Jul• 27•16

Health plans in the health insurance marketplaces have been competing to keep prices low, while still offering all the services mandated under the Affordable Care Act. One way to do this is to restrict provider networks to lower cost providers.   For patients, restricting provider networks may be a good deal if (i) the quality of care in these restricted networks is good and (ii) they are able to readily access providers when they need them.

To answer the latter question, a paper by Haeder, Weimer, and Mukamel (2016) used a “secret shopper” survey to see how long it would take to make an appointment for primary care services. They compared wait times among health plans both inside and outside of the health insurance exchanges in California. They found that:

…obtaining access to primary care providers was generally equally challenging both inside and outside insurance Marketplaces. In less than 30 percent of cases were consumers able to schedule an appointment with an initially selected physician provider. Information about provider networks was often inaccurate.

Specifically, comparing providers both inside and outside of the Covered California exchanges, the share of providers not accepting new patients (10.2% in market places vs. 10.2% outside the marketplace), unable to reach the provider (18.0% vs. 19.0%), insurance not accepted (4.4% vs. 1.4%) and unable to get an appointment with the original provider (72.7% vs. 70.7%).

Nothing NICE about ICER?

Written By: Jason Shafrin - Jul• 24•16

On it’s website, the Instititute for Clinical and Economic Review (ICER) claims that it is “…a trusted non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system. ”

A recent article in Huffington Post however, disagrees.  They make two key points.

First, although ICER claims to be independent, the ICER framework is clearly implemented from a payer (i.e., health insurer) point of view.  ICER’s own website says:

ICER led an initiative to develop a conceptual framework which insurers can apply to guide their assessment of the value of medical services, including drugs, medical devices, and procedures.

HuffPo also notes that the majority of the board of directors are from insurance companies.

Second, because ICER takes a payer perspective, it does not take into account all the factors that patients value.  For instance:

And “benefits” to a patient may include non-economic items such as living long enough to see lifecycle events — marriages, births, graduations and weddings, those moments that make life worth living in the first place. sadly, these unquantifiable experiences have no place in the value calculations done by those that rely on spreadsheets, apps or an abacus to apportion care.

To address this shortcoming, ICER did add two patient advocacy experts to their Governance Board. It remains to be seen, however, how their perspectives will be incorporated into ICER’s modeling decisions.

HWR is up

Written By: Jason Shafrin - Jul• 22•16

Steve Anderson has posted Health Wonk Review, the Yuuuuuuuge Edition at medicareresources.org blog.

Check it out!

Friday Links

Written By: Jason Shafrin - Jul• 21•16