Results of the EMD Serono Specialty Digest™, 9th Edition

San Diego—With major provisions from the Patient Protection and Affordable Care Act becoming effective next year, the healthcare industry is facing a challenge keeping medication costs in check due to, in part, the proliferation of expensive specialty drugs. To deal with the issue, health plans are taking numerous steps such as implementing utilization management techniques and increasing the emphasis on cost effectiveness and comparative effectiveness research.

At the AMCP meeting, panelists discussed results of the EMD Serono Specialty Digest^™, 9th Edition, which included responses from 102 health plans in the United States covering >106 million lives representing commercial insurance, Medicare Advantage plans, and managed Medicaid. They spoke during a Managed Care Essentials session at the AMCP meeting titled Specialty Pharmacy Trends: Managed Care Strategies to Improve Outcomes. Detailed results are online at specialtydigest.emdserono.com.

Rxperts, Inc., a healthcare consulting company, gathered the responses in December 2012 via an online survey. The firm also developed the survey questions and content of the report, but a 6-person editorial advisory board reviewed and approved the digest prior to publication. Michael Fine, MD, medical director at Health Net in Huntington Beach, California and a member of the advisory board, presented selected data from the survey during the session.

Debbie Stern, RPh, president of Rxperts, Inc., said there is no set definition for specialty drugs, however, she said, they usually refer to products that are high cost, have difficult medication delivery, and/or are associated with complex treatment maintenance. The AMCP’s Format for Formulary Submissions, updated in January 2013, defines specialty pharmaceuticals as having a difficult or unusual process of delivery or requiring patient management. Dr. Stern noted AMCP does not include high cost as a prerequisite for defining a specialty drug.

Of the 70 commercial plans sharing their data, 51% had specialty tiers for drugs covered under the pharmacy benefit. In addition, 55% of commercial plans and 60% of Medicare Advantage plans had cost sharing for their medical benefit, with 70% offering coinsurance and 30% offering copayment programs.

The use of prior authorization was common for the medical benefit. For infused oncology products, 61% of prior authorizations were done prospectively, 15% were done electronically using a web portal, 9% were done using a retrospective, postpayment review, and 15% were done through other methods. For infused nononcology products, 76% of prior authorizations were done prospectively, 11% were done electronically using a web portal, 4% were done using a retrospective, postpayment review, and 8% were done through other methods.

Dr. Stern said oncology products were the most common specialty drugs and that this trend will continue. In 2012, 15 novel cancer drugs received FDA approval, and there are currently 900 oncology drugs in clinical development. The largest categories in the pipeline include drugs for lung cancer, lymphoma, breast cancer, prostate cancer, skin cancer, and colorectal cancer. According to the survey results, plans are managing oncology by promoting the use of palliative care and end-of-life programs, adopting guidelines set by major cancer organizations, and relying on oncologists to follow their own treatment pathways.

Dr. Fine mentioned that as the population ages, brain diseases such as Alzheimer’s disease will become a major focus in the next few years. He cited the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which, announced by President Barack Obama in April, is part of a new presidential focus aimed at revolutionizing our understanding of the human brain. There are also concerns about the rising costs associated with brain diseases, with a recent study finding dementia costs in the United States are $215 billion per year, according to Dr. Fine.