Specialty pharmacy pipelines, healthy behaviors, and regulation took the stage at the Academy of Managed Care Pharmacy (AMCP)’s 2016 Nexus conference, which was held October 3-6 in National Harbor, Maryland.
Specialty pharmacy pipelines, healthy behaviors, and regulation took the stage at the Academy of Managed Care Pharmacy (AMCP)’s 2016 Nexus conference, which was held October 3-6 in National Harbor, Maryland.
Here are the top 5 takeaways from the meeting.
1. NASH should be on your radar
If you haven’t heard that nonalcoholic steatohepatitis (NASH) has a growing pipeline and is set to have a huge budget impact, then where have you been, joked Nicole Trask, PharmD, during her session on preparing for the 2018 drug spend. NASH impacts the liver—fat in the liver along with liver inflammation and liver damage—and the increased number of patients with NASH is associated with the rise in the obesity rate in the US. While NASH affects the liver, the leading cause of death in these patients is actually cardiovascular events.
Aimee Tharaldson, PharmD, covered NASH in her session on specialty pharmaceuticals in development, which kicked off AMCP’s meeting.
2. Orphan drug development remains huge
There has been more focus on orphan drugs than on cancer medications. Tharaldson explained in her session that cancer drugs (non-orphan status) account for 22% of the specialty drug pipeline, while orphan drugs account for 40%.
Orphan drugs are helping to drive the growth in specialty drug development. In the past 6 years, the FDA has approved more specialty medications than traditional ones.
3. Regulations need to change
In 1997, Congress passed the FDA Modernization Act (FDAMA), which included a section on the promotion of healthcare economic information. Since then, there have been no updates to this legislation to reflect the changing worlds of healthcare and information sharing. Part of the issue is the undefined terminology used, said Daniel C. Malone, RPh, PhD, FAMCP.
Legislative language is also an issue for biosimilars. The legislation states that biosimilars have to be “highly similar,” but there is some confusion over what that means, said Kevin M. Nelson, JD. In addition, while interchangeability is part of the legislation, at this time the FDA hasn’t explained how a drug maker would show interchangeability.
4. Precision medicine can be integrated into primary care
Genetics, environment, and lifestyle can all work together to make patients respond differently to the same drugs. Precision medicine, and specifically pharmacogenomics, can help overcome the uncertainty of how some patients will respond, speakers said.
Screening patients allows pharmacists to review information about what drugs patients are prescribed that may or may not have a genetic variant that could affect their therapy. And if the patient was not stable on their medication, this pharmacogenomics information can allow pharmacists and providers to find something that would be a better fit.
5. Financial incentives aren’t the only way to get people to be healthier
In other industries, behavioral economic tricks have often worked a lot better than they do in healthcare. But simplifying people’s choices can help nudge them into making healthier decisions, according to 2 speakers from Humana.
While there has been a lot of focus on financial incentives to get people to be healthier, this actually isn’t all that successful. Part of the problem is that once money is introduced to get people to change their behavior, they revert once the money is taken away. Michael Relish, MA, explained that making things easier has a big effect. This could mean synchronizing refills so patients don’t have to keep track of multiple bills and multiple refill dates, or making it easy to choose an auto-refill option.
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