This feature is part of a series focused on drug adherence. To view other posts in the series, check out the spotlight page.
If you don’t take your medication, it’s not going to work. Unfortunately for the pharmaceutical industry, this is often one of the hardest lessons for a company to learn — even if clinical trials prove your drug effective, real-world outcomes may differ greatly if patients don’t take their medication the way they are supposed to, if at all.
The problem of adherence is driven by a number of factors, including how often a drug needs to be taken (daily medications are often missed), how easy a drug is to administer (no one likes to inject things), and even the cost of medication (patients will take pricey meds less often to make them last longer).
By some estimates, non-adherence is rampant. According to one, as many as 50% of patients don’t take their medications as prescribed, and approximations range as high as $300 billion for the cost burden this has on the healthcare system.
While drug adherence is a problem that hasn’t been solved yet, here is a look at five trends that are changing the space:
Newer long-acting formulations
Adherence is a problem that drug developers in the schizophrenia space have been battling for years. Schizophrenia is a tricky and devastating disease that usually emerges in a patient’s late-teens or early-20s. The disease results in patients having delusions, hallucinations and often losing touch with reality.
For years, antipsychotics were considered very effective, but they were required to be taken every day. For patients with schizophrenia, taking a daily medication can be a major burden that results in horrible life consequences if they miss doses. In fact, real-world data shows that about 75% of these patients stop taking their meds within two years.
Drug developers including Johnson & Johnson, Alkermes and Eli Lilly have developed long-acting injectable versions of well-known antipsychotics to help battle the problem of adherence. Lilly’s Zyprexa Relprevv is the long-acting version of its oral Zyprexa (olanzapine) and Alkermes’ Aristada (aripiprazole lauroxil) is a long-acting version of Otsuka’s Abilify (aripiprazole). These new formulations are given once a month, or even once every three months, providing schizophrenic patients long-term defense against their disease symptoms.
The rise of technology such as smart phones is changing how patients take their medications. There are more than 20,000 medical or health apps available, and at least 200 of them deal with medication adherence.
These apps can hold your pill schedule and provide alarms to patients when they need to take pills. They also can give patients reminders when they need to refill prescriptions. While these apps can be a great tool, they are reliant on patient input, which can be faulty.
But smart phone apps aren’t the only tech that can help patients. There are now smart pill bottles that can detect when medication is removed – either through sensors in the cap or through the weight of the pill bottle. Of course, this is all based on the assumption that after a pill is removed from the bottle, the patient takes it.
Other technology goes one step further, with companies including Proteus Digital Health making ingestible sensors that can tell when a patient has swallowed a pill. The Proteus system consists of a sensor the size of a grain of sand that is in the medication. The sensor dissolves once its hits the gastrointestinal tract. Patients wear a patch that detects when the sensor dissolves and then logs that the patient took the drug in a mobile app.
As evidenced by the Proteus system, some combination of technologies is likely going to be the best solution.
Increased use of real-world evidence
One of President Obama’s last acts as president was to sign into law the 21st Century Cures Act, which not only directed funding to research at the National Institutes of Health, but included a provision that requires the Food and Drug Administration to develop a framework for using real-world evidence to better inform decisions about the approval of a drug for other indications, as well as to satisfy post-marketing requirements.
Real-world evidence often shows that, unfortunately, drugs aren’t as effective as they were in clinical trials — because patients aren’t taking them.
While it’s still early days for the 21st Century Cures Act, further use of real-world evidence and trials that look at how effective drugs are in the actual population could drive the industry to focus more on finding new ways for making patients adherent.
Clinical trial protocols
Drugmakers used to rely on patient logs and pill counts to check adherence during clinical trials. While those methods are still used, pharma has gotten a bit more sophisticated with its methods of making sure patients take their drugs like they’re supposed to.
Companies now have programs in place that include video tutorials, mobile app reminders and electronic informed consent documents. Most of these programs center around increased interaction between patients and clinicians — greater attention increases the likelihood that patients will be compliant.
And it’s no wonder that pharma companies are willing to put these programs in place. Non-adherence can lead to huge problems, including high drop out rates in trials and skewed results that don’t reflect the true efficacy of the drug.
New payment models
The high cost of drugs has everyone thinking about how they can get the most bang for their buck — and not just patients, but payers and insurers as well.
Companies have begun inking outcome-based deals with insurers that link the success of their drugs to how much the company charges. In some, biopharmas can charge a higher net price to payers if the drug works as it is supposed to, while insurers will pay less for drugs that don't.
Adherence becomes a big part of this solution. For drugs to work successfully, patients have to take them as prescribed. For many of these contracts, there are built-in periods where patients have to be compliant with taking their meds. For example, Amgen has a deal with Harvard Pilgrim where it will refund the cost of its cholesterol-lowering drug Repatha (evolocumab) if a patient has a heart attack or stroke, but only on the condition that those patients have been compliant with taking the drug for at least six months.