Specialty Rx, evidence-based approach top 2016 trends
Look for highly targeted, biologically engineered drug therapies and a more integrated, teamwork-driven and evidence-based approach to medication therapy to dominate the pharmacy landscape in 2016.
(To view the full Category Review, click here.)
The rise of specialty drugs has had a profound impact on the pharmaceutical marketplace in recent years, and that impact will continue as drug manufacturers shift more of their research and development efforts to breakthrough biotech medicines and gene-based molecular research. And with the Food and Drug Administration having finally established an approval pathway for biosimilars, that surge will continue.
“New medicines ... will be weighted to specialty and biologics,” noted Murray Aitken, director of the IMS Institute, in a November report on global pharmaceutical trends. “Patients will have greater access to breakthrough therapies and clusters of innovation around hepatitis C, autoimmune diseases, heart disease, orphan diseases and others by 2020.”
One such breakthrough in 2015 was Gilead Sciences’ Harvoni, a bioengineered treatment shown to cure, in most cases, hepatitis C. Harvoni captured the top sales spot among all U.S. pharmaceuticals in 2015, with nearly $9.5 billion in sales for the 12 months ended June 2015, according to IMS Health.
A huge focus for drug research and development in future years, Aitken added, will be breakthroughs in oncology. “Cancer treatments represent the largest category of the 225 new medicines expected to be introduced within the next five years,” he reported. Orphan drugs also will get more attention from pharmaceutical manufacturers, with the expected addition of “more than 470 drugs ... available to treat orphan diseases for the 7,000 rare diseases with no or limited treatments available.”
New openings for generics
Also surging with renewed growth momentum is generics. Patent expirations will hit many more branded medicines, building generic drugs’ total share of the U.S. market to more than 9-of-every-10 prescriptions dispensed by 2020, according to IMS.
“Generics will continue to dominate prescription drug usage in the United States, rising from 88% to 91% to 92% of all prescriptions dispensed by 2020,” noted Aitken.
“Products facing loss of exclusivity in the next four years are valued at $78.4 billion [in annual sales],” predicted Doug Long, VP industry relations for IMS Health. The list includes AstraZeneca’s blockbuster Nexium for acid reflux and ulcers — which faced me-too competition for the first time in early 2015 — as well as Otsuka’s Abilify for bipolar disorder, ranked third among top-selling U.S. medicines in mid-2015 with $7.2 billion in annual sales, according to IMS. Other big-selling medicines facing patent-loss challenges include Teva MS treatment Copaxone and Forest Labs’ treatment for Alzheimer’s and dementia, Namenda.
Aligning pharmacies and health systems
On the retail front, pharmacy retailers are in a rush to ally themselves with hospitals, local and regional health systems, physician groups and health plans as they campaign at the federal and state level for full provider status and full membership in today’s new model of collaborative, team-based health care. Generally, pharmacy leaders are basing their efforts to elevate pharmacy’s position and partner with other providers on core competencies that most chains and independents are already fully equipped for and capable of providing, including medication therapy management, immunizations and medication adherence programs for patients.
“We’re moving to a value-based healthcare system where providers, hospitals and other organizations are going to be paid based on their ability to both generate positive outcomes and control costs,” said Anne Burns, VP professional affairs for the American Pharmacists Association. “New care delivery models, such as patient-centered medical homes, are expanding across the country. Pharmacists are increasingly being incorporated into these models as members of inter professional healthcare teams that collaborate and better coordinate the care of their patients.”
Both national and regional drug chains — not to mention independent pharmacy retailers and their wholesale service partners — pushed hard in 2015 to expand their ability to boost medication adherence rates among millions of patients through pharmacist-administered and data-enabled adherence programs, often in collaboration with regional health systems, individual hospitals and health plans. With evidence mounting that those efforts pay significant dividends in improved patient outcomes, reduced hospital readmission rates and lower overall health costs, those efforts continue to gain momentum.