Although the postoperative pain market is sizeable in terms of both dollars and the potential patient pool, treatment is very fragmented, with many drugs and formulations available within each drug class. Furthermore, physicians’ comfort with currently available therapies, many of which are generically available and well entrenched in treatment protocols, creates challenges for novel pain therapies hoping to gain traction in the postoperative pain space. Nevertheless, in recent years, there have been several important treatment advances and regulatory approvals, including the launch of Cumberland Pharmaceuticals’ Caldolor (injectable ibuprofen; the second parenteral NSAID to reach the U.S. market), Mallinckrodt Pharmaceuticals’ (formerly Cadence Pharmaceuticals’) Ofirmev (injectable acetaminophen; the first parenteral acetaminophen formulation to reach the U.S. market), and Pacira’s long-acting depot injection of bupivacaine (Exparel). The launch of these therapies—as well as the recent and potential forthcoming entry of several more—many of which are alternative formulations of current mainstays and bring with them the promise of incremental, yet meaningful, improvements on time-tested therapies, has and will continue to create an increasingly complex treatment landscape.
The changing treatment environment for postoperative pain will present to physicians and hospital P&T formulary committee members the challenge of considering each new therapy’s unique balance of benefits, drawbacks, risks, and rewards when making treatment and formulary decisions. Because emerging therapies will be entering a crowded and mature analgesic market, they will need to demonstrate clear safety and/or efficacy advantages compared with (or when added to) current therapies if they are to gain approval, attain price premiums, secure formulary coverage, and garner any material share of this pain market. Furthermore, the ever-tightening reimbursement environment in the United States, coupled with the burgeoning number of available postoperative pain treatment options, many of which are generically available and well-established, will result in increased market access challenges for novel therapies. Although physicians may acknowledge the advantages of emerging pain therapies, treatment decisions will ultimately be driven by hospital formulary access; therefore, securing formulary coverage will be critical to ensuring uptake for postoperative pain in the hospital setting.
In this report, we surveyed 102 physicians (surgeons and anesthesiologists) and 31 hospital pharmacy directors (PDs) to assess the dynamics that affect prescribing practices and formulary coverage of treatments for moderate to severe acute postoperative pain in the United States. We explore the factors that shape current and future treatment patterns as well as reimbursement trends in the postoperative pain space. Additionally, this report offers physicians’ and hospital PDs’ insights and perceptions of mainstay and select branded pain therapies as well as select emerging therapies that are forecast to launch in the United States over the next few years.