The AAM’s Chip Davis tackles the issue of abandonment within US healthcare and proposes three measures to boost competition, thereby lowering drug prices and reducing abandonment rates.
Generic and biosimilar prescription drugs manufactured by member companies of the Association for Accessible Medicines (AAM) play an integral role in the health of Americans. This achievement would be even more gratifying if all the people who need medicine were taking it. That’s what access is all about.
Two other ‘a’ words to keep in mind:
- Adherence happens when patients take their drugs as prescribed. According to the American Pharmacists Association, “The terms ‘medication adherence’ and ‘medication compliance’ are often used interchangeably in healthcare. ‘Medication adherence’ is typically preferred because the term ‘medication compliance’ suggests a passive following of provider directions and implies that the patient was not involved in developing the treatment plan.”
- Abandonment happens when the patient brings or calls in his or her prescription to the pharmacy but does not collect the medicine. A New York Times article states that abandonment “explains why so many patients don’t get better, suffer surprising relapses or even die when they are given drug prescriptions that should keep their disorders under control.”
According to the Centers for Disease and Control and Prevention, 85 percent of US adults had contact with a healthcare professional in the past year. That relatively encouraging data point, however, already means that millions of adults are not seeing the doctor and will not get the treatment or drugs they need to stay healthy and productive. Focusing on those who do visit the doctor, one can easily grasp the importance of reducing friction in the process of obtaining and taking medication.
After seeing the doctor, getting the right prescription to the right patient is an important next step. According to IQVIA, more than four billion prescriptions were filled in the United States in 2018, 90 percent of which were generic, even though generics account for less than one-quarter of prescription drug costs. (Discover this and other recent findings in my August column for PharmaBoardroom.)
The Annals for Internal Medicine estimates the rate of noncompliance to be about 20-30 percent—quite high when you realize it’s an entirely preventable syndrome—and quantifies the damage in the United States:
- approximately 125,000 deaths
- at least 10 percent of hospitalizations
- USD 100 billion-USD 289 billion in annual costs
The main reason for abandonment should come as no surprise. It’s the cost. There is ample data to back up this claim: A 2018 IQVIA study determined, “Ultimately, patients with higher out-of-pocket costs are more likely to abandon their new prescriptions at the pharmacy. For instance, 69 percent of commercial patients did not start therapy when faced with out-of-pocket costs exceeding USD 250. In contrast, only 11 percent of patients whose final out-of-pocket costs were less than USD 30 did not start therapy.” Furthermore, in 2017, patients (commercial and Medicare Part D) who were prescribed more expensive brand-name drugs were 2-3 times more likely to abandon their prescriptions than they were for generics.
IQVIA reports that the average copay for generic prescriptions is USD 5.63, with 95 percent of them filled at USD 20 or less. Effective, FDA-approved, low-cost generic drugs contribute to increased adherence, and competition is a vital ingredient for increasing compliance rates.
Here are four promising avenues for boosting competition in the pharmaceutical market, thereby lowering prices and reducing abandonment rates:
Taking measures to stop patent gamesmanship
The US patent system is designed to balance innovation in medical sciences with public health concerns, but for many years the former has maintained a decided advantage. Health and Human Services Secretary Alex Azar put it this way on CNBC: “There’s a deal in our Hatch-Waxman statute. There’s a deal in the biosimilar legislation. It says you get the exclusive right to practice this molecule and this patent, up to this date, and at that point ‘katy, bar the door’ – full generic competition, full biosimilar competition. Stop the gamesmanship … stop the evergreening.” A recent white paper from the AAM team explores how brand-name manufacturers use so-called patent thickets to delay competition and discourage manufacturers from pursuing and launching biosimilars to their products. As I described in a previous column, patent settlements are a useful tool for expanding patients’ access to more affordable generic or biosimilar medicine, decrease costs for patients and the larger healthcare system, and prevent anti-competitive forces from continuing to pervert the US patent system.
The manner in which a healthcare plan composes its list of brand-name and generic drugs available to patients can have dramatic consequences for how competition plays out. According to this Health Affairs blog, “Higher out-of-pocket costs under current Medicare Part D policies are associated with markedly higher rates of abandonment of new specialty drug prescriptions; reductions and delays in treatment initiation following a new diagnosis or disease progression; delays between refills or treatment interruptions; and earlier discontinuation of treatment.” Drug formulary design in Medicare and Medicaid should be reformed to ensure federal programs encourage the use of lower-cost therapeutically equivalent generics and biosimilars.
Eliminating rebate traps
Kaiser Health News has exposed the way “drug companies routinely make hidden pacts with middlemen that effectively block patients from getting cheaper generic medicines.” Rebate-influenced barriers represent perverse incentives to smother competition and, ultimately, blunt the ability of generics to bring prices down. Executive and legislative solutions to the problem are sorely needed.
Confronting REMS abuse
The brand-name companies put up yet another barrier to competition when they refuse to provide generic manufacturers with the product samples needed to conduct tests. The delay tactic involves misapplying FDA-mandated Risk Evaluation and Mitigation Strategies (REMS), which are designed to ensure that the benefits of a drug outweigh its safety risks. Bipartisan legislation in the House and Senate – The CREATES Act (S. 340/H.R. 965) and the FAST Generics Act (H.R. 985) – prohibits companies from using restricted access programs to avoid generic competition. I look forward to seeing this legislation advance.
The World Health Organization has found that better medication adherence could have a “far greater impact on the health of the population than any improvement in specific medical treatments.” We can—and must—do better.