Marketplace Trends: Specialty Spending, Generics and Biosimilars, Medication Adherence, and More

Total spending on medicine in the United States was $435 billion in 2017, with a growth of only 1.4%. Specialty growth is outpacing traditional growth (9.4% vs 4.0%, respectively, in 2017) and now comprises 43.3% of the total non-discounted spend. During a packed session at AMCP Annual Meeting 2018, Douglas Long, BS, MBA, vice president of industry relations at IQVIA, discussed trends in the pharmaceutical marketplace.

First, he gave IQVIA’s definition of specialty, joking, “Everyone wants to be specialty, but here are our six definitions…” This includes agents that are not self-administered; require special handling or unique and narrow distribution; require patient monitoring, counseling, or Risk Evaluation and Mitigation Strategy program; cost in excess of $6,000 per year; are specialist-initiated; and require reimbursement assistance.

Specialty pharmaceuticals are continuing to show value growth in the current calendar year, while traditional value growth is declining (+$16.8 billion vs –$10.7 billion, respectively). Autoimmune disease and oncology are driving the value growth in specialty pharmaceuticals, while diabetes, respiratory agents, and anticoagulants lead traditional absolute value growth.

Oncology therapeutics are leading the late-phase research and development pipeline with 748 agents. In 2017, the majority of new launches were for orphan disease indications: 42 products launched in 2017 versus 19 in 2016, which Mr. Long attributed to a lot of novel therapies getting approval ahead of schedule in late 2015. He projected that Alzheimer’s disease and dementia are on the horizon for innovative products, saying, “If you thought hepatitis was a tsunami in the marketplace, just wait until these drugs hit.”

Mr. Long then discussed generics, saying that 2017 was a great year for generic approvals, but just 10% of these agents were in a unique therapeutic area, while the other 90% were in crowded markets. But he also noted that 206 generic products that received final approval in 2017 had not launched by Q4. “People are refusing to launch, which shows what the dynamics are [in] the marketplace,” said Mr. Long.

Mr. Long then discussed the upcoming opportunity for generic and biosimilar agents, as many key patents will be losing protection. So far, nine biosimilars have received approvals, but just three have launched, and the uptake of these agents is still low. “Infliximab‑qbtxis is the most disappointing to me,” he said of the biosimilar agent for the reference drug Remicade, which is approved for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The uptake of this particular biosimilar has been less than 3%, with many payers choosing to remain with rebates for the reference agent. “This is short-sighted,” Mr. Long commented.

He then briefly talked about the opioid crisis, noting that the use of medically assisted treatment is increasing, while regulatory restrictions have resulted in less dispensing of narcotics. He mentioned, “There is not as much dialogue on fentanyl as there should be.” On the prescription side, fentanyl is responsible for one-third of opioid-related deaths. He described surgery as a “gateway” to opioid use and noted that women 40 to 59 years of age are prescribed opioids more often. Those with mental health disorders are also a vulnerable population that received more than 50% of opioid prescriptions.

“Adherence is the holy grail,” said Mr. Long, moving into a discussion on the topic. He said one benefit of the Affordable Care Act is the focus on Star Ratings, which has helped with adherence. “There’s something in adherence for everyone—the patient, hospital, pharmacy,” he said. “If people are adherent, all [stakeholders] will save money.” Medication synchronization programs are designed by pharmacies to simplify the refill process by enabling patients to pick up all medications in a single visit, which is critical to improving adherence, particularly for chronic diseases.

He concluded with six key issues facing market access teams:

• Tighter, more consolidated payer management
• Higher patient out-of-pocket payments as payers transfer a higher percentage to patients (the average commercial copay increase between 2016 and 2017 was 14%)
• Amplified public pressure and demand for price transparency
• More stringent medical benefit management
• Increase in value-based models
• Evolving provider landscape with growth in the number of integrated delivery networks and accountable care organizations

Presentation H1: AMCP Headline Session: 2017-2018 Pharmaceutical Marketplace Trends. AMCP Annual Meeting 2018.