Comparative Effectiveness and Academic Detailing to Evaluate Prescription Drugs

5/21/2019

Comparative Effectiveness and Academic Detailing

As drug costs continue to rise, policymakers look for ways to get the most value for the state’s dollar. Value-based purchasing and comparing the effectiveness of treatments has gained increased attention. Over the past 15 years, several multi-state, collaborative pharmaceutical policy initiatives have focused on comparing effectiveness and cost-effectiveness, rather than direct government or commercial purchases. This report highlights several of these efforts.

Comparative effectiveness reviews take a systematic look at existing research on the effectiveness of medicines compared to other treatments, and on the harms of different health care interventions. They intregate relevant evidence to inform real-world health care decisions by patients, providers and policymakers. According to the Harvard T.H. Chan School of Public Health, “Comparative effectiveness research (CER) is research that identifies what clinical and public health interventions work best for improving health.”

Each of the six CER and value-based purchasing initiatives highlighted below:

  • Are structured as non-profit entities, some using state funds.
  • Seek to obtain and provide objective and balanced facts, that include brand and generic drug products.
  • Publish medical-oriented research reports.
  • Do not engage in final decisions on use or price.
  • Do not engage in purchasing any prescription drugs.

Drug Effectiveness Review Project (DERP): State-Funded Effort to Evaluate Drugs

State Medicaid agencies and other organizations formed a collaborative group in 2003 to commission high-quality comparative effectiveness reviews to inform evidence-based decisions about which drugs would be available to Medicaid recipients. More than a dozen states joined together to fund the Drug Effectiveness Review Project (DERP), an initiative run by the Oregon Evidence-Based Practice Center Project.  The project uses academic reviewers who examine multiple drug studies to help state policymakers purchase the least expensive, yet most effective, medicines. 

The Oregon-based researchers have reviewed more than 30 classes of medicines, including migraine pain relievers and cholesterol-lowering drugs.  Many of the DERP Final Reports are available online to the public. Reports issued after 2013 are proprietary and not available online.

As of February 2019, DERP includes 14 states: Arkansas, Colorado, Idaho, Minnesota, Missouri, Montana, New York, North Carolina, Oregon, Tennessee, Texas, Virginia, Washington and Wisconsin.  States can gain access to the findings by paying $75,000 a year for three years to fund the research.

The Institute for Clinical and Economic Review (ICER)

Another major player influencing the direction of value-based pharmaceutical purchasing is ICER, the Institute for Clinical and Economic Review.  ICER is a non-profit organization founded in 2006 that describes itself as an “independent, non-partisan research organization that objectively evaluates the clinical and economic value of prescription drugs, medical tests, and other health care and health care delivery innovations.” One of its main research goals is to use clinical data on the effectiveness of drugs to shape prescription drug policy and increase the efficiency of the health care industry. 

ICER publishes reports on how well new drugs work by examining patients’ health outcomes using quality of life metrics and comparing those to the price of the drug. ICER started calculating specific drug costs in 2014 when they published a report on the ground-breaking Hepatitis C cure. The report argued the drug was not worth the 2014 purchase price of over $80,000. ICER evaluates and rates each new drug’s cost-effectiveness compared to a certain benchmark. They assess the budget impacts of new drugs and make recommendations about what prices would be cost-effective.

ICER is funded through a combination of grants, contracts and unrestricted gifts. ICER explains that “funding is not accepted from manufacturers or private insurers to perform reviews of specific pharmacologic technologies.”

Many insurance companies now cite ICER’s reports when deciding whether to cover new drugs coming on the market. This is mainly because no other organization does similar work of the same scope in the U.S., besides insurers and drug industry companies themselves.

ICER provides a service to insurers in the U.S. that was not previously available. However, there has been some pushback from pharmaceutical manufacturers and patient advocates who question ICER’s methods, bias, and agenda.  One argument against ICER is that their reports will reduce access to new and potentially life-saving drugs by recommending that new drugs not be covered. Critics also argue that ICER is helping the insurance industry by trying to drive down prices of pharmaceuticals. Opponents also question ICER’s funding sources.

Some advocacy organizations also say that ICER’s process does not fully incorporate patient preferences and ignores the societal benefits of drugs, like increased work productivity, in their analyses. Groups such as pharmaceutical industry associations say that ICER’s methodology is flawed because the reports are not subject to peer review and focus on short-term cost impacts instead of long-term benefits to patients and society. Although there are numerous views about ICER and their recommendations, these arguments demonstrate the high degree of tension in the U.S. market about new pharmaceuticals, how they should be priced, and how they should be evaluated.

The Medicaid Evidence-based Decisions Project (MED)

The Medicaid Evidence-based Decisions Project (MED) created a collaboration among state Medicaid programs for the purpose of making scientific evidence available to states to aid their benefit design and coverage decisions. Although it focuses on non-pharmaceutical medical equipment, services and treatments, the project includes access to the following decision-making tools:

  • High-quality systematic reviews of existing evidence.
  • Technology assessments of existing and emerging health technologies.
  • A web-based clearinghouse.
  • Support in designing rapid evaluations of products where no evidence exists.
  • The support of highly qualified research staff to assist members in applying the evidence to their own need.

State agencies currently participating in the MED project are: Alabama, Alaska, Arkansas, Colorado, Delaware, Louisiana, Michigan, Minnesota, Missouri, Nebraska, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wisconsin.

The MED Project also provides rapid response to those agencies allowing participants to request brief reviews of the evidence on state issues.

Pharmaceutical Detailing by Drug Manufacturers

For decades the practice of marketing prescription drugs to doctors, known as “detailing,” has been a widespread, often commercially competitive, practice that provides medical information to physicians, practitioners and authorized prescribers.

The U.S. National Institutes of Health (NIH) describes the practice and research on the issue in a 2017 post on their website:

“Drug companies often promote products during events or sales visits to doctors. This type of marketing is known as detailing because doctors learn details about drug benefits and side effects. Doctors may also receive gifts such as meals and free samples. Some academic medical centers have begun to restrict detailing. But little is known about the impact of detailing on prescribing practices.”

 A team led by Dr. Ian Larkin at the University of California, Los Angeles, and Dr. George Loewenstein at Carnegie Mellon University examined whether policies to limit detailing affect prescription patterns. “There has long been concern that drug marketing to physicians might influence their prescribing,” says co-author Dr. Michael Schoenbaum of the National Institute of Mental Health (NIMH), which also helped fund the research. “Many medical schools have adopted policies to limit such marketing, and this study is one of the first to document what effect these policies actually have.”

The researchers examined prescriptions in 19 academic medical centers that restricted detailing from January 2006 to June 2012. The study encompassed more than 2,000 doctors affiliated with the centers. For comparison, the team examined prescriptions by nearly 25,000 doctors not at the medical centers.

Results published in a 2017 issue of the Journal of the American Medical Association concluded that the changes in mean market share, which is the number of drugs prescribed, were statistically significant for six of the eight drug classes. Changes varied across academic medical centers, likely because their policies varied widely. According to the research, centers with the most stringent policies, such as salesperson registration and training requirements, had the greatest declines in detailed drug prescriptions.

The Agency for Healthcare Research and Quality - National Resource Center for Academic Detailing (NaRCAD)

As opposed to pharmaceutical detailing, academic detailing is the noncommercial education of health care professionals, typically conducted by physicians, pharmacists and nurses, about the evidence-based efficacy, safety and cost of therapies. 

A recent federal initiative supported by a $300 million grant through the Agency for Healthcare Research and Quality (AHRQ) conducts comparative effectiveness research designed to compare therapies for various conditions to determine which treatments work best. 

The National Resource Center for Academic Detailing (NaRCAD) program was founded in 2010 and is funded in part by AHRQ. NaRCAD operates within Boston’s Brigham & Women's Division of Pharmacoepidemiology & Pharmacoeconomics. The resource center supports clinical outreach education programs across the United States, Canada and beyond.

According to NaRCAD, the core focus of academic detailing is an innovative, one-on-one outreach education technique that helps clinicians provide their patients with evidence-based care. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers change clinician behavior, which ultimately improves patient health. A successful academic detailing visit is a highly interactive dialogue, and continuously assesses a clinician’s individual needs to promote better prescribing, screening and patient education.

State laws based on "counter-detailing" or pharmaceutical detailing have been enacted in Maine, Mississippi, Vermont and Massachusetts.

Value-Based Insurance Design: The V-BID Project

Designed by University of Michigan faculty, Value-Based Insurance Design (V-BID) is built on the principle of lowering or removing financial barriers to essential, high-value clinical services. V-BID plans are designed to align patients’ out-of-pocket costs, such as copayments, with the value of services. These products are designed with the tenets of “clinical nuance” in mind. The tenets of clinical nuance are that 1) medical services differ in the amount of health produced, and 2) the clinical benefit derived from a specific service depends on the consumer using it, as well as when, where, and by whom the service is provided.

For over a decade, researchers at the V-BID Center have worked across payer, consumer, provider and benefit designer boundaries to implement and evaluate innovative health benefit designs that balance cost and quality.  The goal is to encourage the use of high-value services and discourage the use of low-value services that do not significantly improve health in relation to costs.

Multiple state and local governments have introduced V-BID into their public employee benefit package to promote high-value care and encourage employees to take an active role in their own health care decisions. For example, Minnesota began a program in 2018 that is based on V-BID principles and targeted toward state employees with diabetes.

As Medicaid enrollment expands, some states have embraced this as a prime opportunity to take advantage of these new flexibilities to design value-based plans that engage beneficiaries and improve health outcomes.

If implemented successfully, a clinically nuanced cost-sharing model can enhance the use of high-value clinical services and reduce use of unnecessary and costly services, while fostering consumer engagement and personal accountability.  Using V-BID principles to set enrollee cost-sharing levels, Medicaid programs can improve quality of care, remove waste, and mitigate the legitimate concern that non-nuanced cost-sharing may lead individuals to forgo clinically important care.

For example, New Mexico, with the approval of a 1115 waiver from the Centers for Medicare and Medicaid Services (CMS), implemented the Centennial Care Program to prompt individuals to accept greater accountability for their health care decisions. Enrollees must make a co-pay for certain services like doctor’s visits and prescription drugs.

In 2017, CMS tested the VBID model for Medicare Advantage plans in seven states: Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania, and Tennessee. CMS allowed testing of VBID interventions for diabetes, congestive heart failure, chronic obstructive pulmonary disease (COPD), past stroke, hypertension, coronary artery disease, mood disorders, and combinations of these categories. The following year, CMS updated the model to include Alabama, Michigan, and Texas and also allowed for VBID interventions for dementia and rheumatoid arthritis.

For 2019, CMS extended this model to an additional 15 states: California, Colorado, Florida, Georgia, Hawaii, Maine, Minnesota, Montana, New Jersey, New Mexico, North Carolina, North Dakota, South Dakota, Virginia and West Virginia. With the approval of their applications, this proposal allowed participating states to propose a methodology that either identifies enrollees with different chronic conditions than those previously established by CMS or revises the existing approved CMS chronic condition category to focus on a broader or smaller subset of the existing chronic condition. Federal action in 2018 required that the model be revised to include all 50 states and territories by 2020. 

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