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Biologics and Prior Authorization

Physicians trying to prescribe a biologic for a patient often run into a prior authorization perfect storm: A patient excited about a new medication option, a payer less than enthusiastic about the cost of the medication, and clinical staffers frustrated with the prior authorization system.

Indeed, in a June article in Practical Dermatology, Dr. Michael Sherling describes a 45-year-old man who suffers from psoriasis so severe he rarely goes out in warm weather. Various topical therapies have proven ineffective, so his dermatologist prescribes a new biologic. He arrives at the pharmacy to pick up the medication and is told his insurance will not cover it because his physician’s office has done something wrong.

Of course, the disappointed patient knows nothing about the work the dermatologist and his staff have done to try to fulfill the prior authorization required by his insurer, nor the mountain of paperwork sitting on their desks associated with the dozens of prior authorizations they’re still dealing with that week.

Biologics, sometimes referred to as biopharmaceuticals or biological drugs, are often produced using recombinant DNA technology, combining complex molecules manufactured using living microorganisms, plants, or animal cells. Needless to say, they are not on many insurer’s prescription plan and are more expensive than your widely prescribed generic medications.

Allergists tell a similar story about biologic therapies. “These precision medicines can change the lives of our patients who suffer from urticaria, severe asthma, and atopic dermatitis, but try to get the insurance companies to understand that,” writes Dr. Bradley Chipps, president of the American College of Allergy, Asthma, and Immunology (ACAAI).

Chipps describes the labyrinthine process for getting asthma biologics covered initially. Obtaining reauthorization or a change in biologics requires a blood eosinophil count, which is sometimes decreased because of a biologic that lowered it. “Try getting the insurance company to understand why that happened,” he writes. “For urticaria patients, some plans have mandatory six-month limits, and then the patient has to come off to see what happens. Their disease worsens, and then we need another prior authorization to get them back on. Who is that benefitting?”

Insurers’ concerns about the cost of specialty drugs is understandable. According to Dr. Sammuel Anderegg, a health information technology and pharmacy consultant, only two to three percent of all patients are on specialty medications, but more than 40% of all spending on medications in the US is on specialty medications.

Still, the process is highly burdensome to physicians and their staff and can be baffling to patients. After being told prior authorization is necessary and waiting for that initial stage to occur, the patient sometimes faces a pre authorization denial and must wait days or weeks for the appeals process to play out. “A lot of times, the patients get lost in this process,” says Dr. Anderegg.

There are efforts underway by lawmakers, healthcare coalitions, and nonprofits to ease the burden of prior authorization. Some are focused on streamlining the process, as with the ACAAI’s Prior Authorization Toolkit.

Others, such as Sherling, are advocating for electronic prior authorization (ePA). “Imagine if the dermatologist treating [the psoriasis patient described above] had ePA integrated into their EHR system that prospectively initiated the patient’s prior approval. Even if the authorization was declined (as it so often is), the dermatologists staff would have been made aware of this through the EHR system that day and could immediately file an appeal, which may then be approved,” he writes.
Sources:

  1. “Digital Innovation to the Rescue: The Future of Electronic Prior Authorization in Dermatology,” Dr. Michael Sherling, Practical Dermatology, June 2018, http://practicaldermatology.com/2018/06/digital-innovation-to-the-rescue-the-future-of-electronic-prior-authorization-in-dermatology/
  2. “Reducing the Burden of Prior Authorizations,” Dr. Bradley Chipps, College Insider, January 15, 2018, https://college.acaai.org/publications/college-insider/reducing-burden-prior-authorizations
  3. “Why Prior Authorizations for Specialty Drugs Take So Long,” Menachem Wecker, CreakyJoints.org, 2016, https://creakyjoints.org/acr-2016/prior-authorizations-specialty-drugs-take-long/
  4. “2017 AMA Prior Authorization Physician Survey,” https://www.ama-assn.org/sites/default/files/media-browser/public/arc/prior-auth-2017.pdf

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