Summary:
A6049 – S5110 would prohibit fail first policies and unauthorized therapeutic substitution by insurers.

Background & Problem:
The bill has a prior legislative history originating in 2010 with A10411, which was referred to the Insurance Committee.

Fail first practices and therapeutic switching have been shown to yield adverse patient reactions, disruption in long-term treatment, and overall higher care costs, especially in instances where prescribing physicians and patients were not informed of the insurers actions beforehand.

Fail first practices, or step therapy, require a patient to exhaust the least expensive drug options before insurers will cover more expensive treatment options.

Therapeutic interchange is the practice of switching drugs by the insurer or at the pharmacy that are chemically distinct but therapeutically similar in terms of their efficacy, safety, and tolerability profiles.

According to an October, 2010 study conducted by the Global Healthy Living Foundation, 70 percent of patients had prescription drugs switched at the pharmacy.  Further, 38 percent of patients were forced to fail first on another medication in the last 12 months, and for 87 percent of those patients, the fail first drugs were not effective.

A 2009 study published in the American Journal of Managed Care examining the impact of therapeutic switching in long-term care found that in about 75% of the case histories collected there was a negative clinical impact.

According to 2008 Harris Interactive survey, 78% of patients support a requirement that physicians be consulted before any substitution takes place, and 85% want to be notified if their prescriptions are changed.

In 2006, the American Psychiatric Institute for Research and Education investigated the clinical impact of psychopharmacologic prescription drug utilization management policies, such as fail-first protocols, in 10 state Medicaid programs and found:
– All the medication access problems studied were strongly associated with increased adverse events, including emergency room visits, hospitalizations, incarceration or homelessness.

– 72% of patients with medication access problems had an adverse event compared to 49% of patients without access problems.

The New England Journal of Medicine published a study that compared the clinical and economic outcomes in 2003 of Medicare beneficiaries whose annual drug benefits were capped and beneficiaries whose drug benefits were unlimited. The study concluded, “the savings in drug cost from the cap were offset by increases in the costs of hospitalization and emergency department care.”

Solution:
Beginning 120 days after it becomes law, the bill will authorize prescribing physicians to override fail first protocols in situations when the fail first treatment is expected to be ineffective in treating the patient's medical condition or is likely to cause an adverse reaction.

Insurers will be required to provide access to medications with no generic equivalent and for which the prescribing physician feels there is no appropriate therapeutic alternative.

The bill will require a “switch communication” informing the insured of the originally proscribed medication in any recommended substitution, ensuring greater transparency.

The bill establishes penalties for any unauthorized therapeutic substitution or false/non-compliant switch communication up to $25,000. Thus, the bill would provide consumers with safeguards, transparency, and medical oversight necessary to ensure their health and safety.

Support:
To date, 41 organizations listed below have endorsed the fail first initiative. Some have submitted a letter of support, and others have sent members to participate in the GHLF Advocacy Day May 10, 2011. To view a full list of supporters, please click here.