Unbiased Analysis of Today's Healthcare Issues

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.

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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

Can long acting injectables save money?

Written By: Jason Shafrin - Jul• 20•16

Patients with serious mental illnesses such as schizophrenia often struggle with medication adherence, due to lack of insight into their disease, medication side effects, forgetfulness, and a variety of other factors.  One solution to this problem is to use long-acting injectables or LAIs.  Whereas most antipsychotics are oral medications, LAIs are typically injectables that you need to get only about once per month.

Can using LAIs improve outcomes and decrease cost?  According to a study by MacEwan et al., (2016), the answer is yes.

LAIs were associated with significantly lower probability of rehospitalization compared with oral antipsychotics at 60 days for schizophrenia-only patients (adjusted odds ratio [AOR]=.60, 95% confidence interval [CI]=.41–.90) and for all patients (AOR=.70, CI=.52–.95). The absolute difference in probability of rehospitalization for all patients was significantly lower by 5.0% at 60 days in the LAI group compared with the oral antipsychotics group.

Patients that receive LAIs likely have more severe form of the disease on average than patients using oral antipsychotics so the authors–which include some of my colleagues at PHE–used  multivariate logistic regression and propensity score matching (PSM) methods.

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Quotation of the Day

Written By: Jason Shafrin - Jul• 19•16

“We are drowning in information, while starving for wisdom. The world henceforth will be run by synthesizers, people able to put together the right information at the right time, think critically about it, and make important choices wisely.”

US Healthcare Spending Projections

Written By: Jason Shafrin - Jul• 18•16

In 2016 we will hit a milestone: national health spending per capita is projected to exceed $10,000 for the first time.  This estimate is from an article by Keehan et al. (2016).  In this paper, CMS’ Office of the Actuary (OACT) estimates costs not only this year but over the coming 10 years.  According to their projects, health care costs will continue to rise.

Health spending growth in the United States for 2015–25 is projected to average 5.8 percent—1.3 percentage points faster than growth in the gross domestic product—and to represent 20.1 percent of the total economy by 2025…In addition, the share of total health expenditures paid for by federal, state, and local governments is projected to increase to 47 percent by 2025.

Although the U.S. is seen as a market-based system, the government will pay for about half of all health care spending by 2025. In the near term, OACT estimates the following growth rates between 2017-2019:

  • Overall: 5.7%
  • Medicare: 6.7%
  • Medicaid: 5.6%
  • Private health insurance: 5.6%

Medicare will grow the fastest due to the baby boom.  OACT blames “the continued use of high-cost specialty drugs and faster growth in drug prices” for the relatively fast increase in private health insurance cost.