By Jason Snyder
At WordWrite Communications, we’ve shared many healthcare stories. We’ve worked with health systems, medical device and pharmaceutical companies and patient advocacy groups, to name a few.
Regardless of whose healthcare story we are telling, one thing remains constant: the patient is always at the center. The focus of health care is inherently, or at least should be, on the patient. Yet that premise seems to be largely missing in recent reporting on a significant new aspect of the new health reform bill.
Health insurers and pharmacy benefit managers are fighting manufacturers of biotechnology drugs over the law’s provision granting the drug makers “exclusivity,” the right to protect the details of their ground-breaking drugs, for 12 years.
The Wall Street Journal reported that, although the new healthcare law says brand-name manufacturers of biotechnology drugs, or biologics, are entitled to this exclusivity, insurers and drug distributors are questioning whether generic manufacturers should have to wait that entire period before beginning to seek approval for their own versions of biologics.
Biologics are expensive specialty drugs for patients who suffer from multiple sclerosis, HIV, cancer, rheumatoid arthritis and other debilitating diseases. Those who want faster approval of generic versions of these drugs contend this will lower costs for those who pay for the drugs, including insurers and employers. Brand-name drug makers reason that exclusivity was intended as an incentive for them to innovate and create new drugs, given the huge research-related costs for biologics. The U.S. Food and Drug Administration is reviewing comments from both sides.
Based on my healthcare experience and multiple conversations I’ve had with doctors about this topic, the patients’ story is really the crux of the matter. Yes, a huge amount of money is at play here. But patients need these drugs, and they need better access to them now.
Specialty drugs are made for the sickest patients, and these drugs are placed in what is known as Tier 4 of an insurance company’s tiered drug formulary. In Tiers 1 through 3, co-pays generally fall within a fixed range, with those ranges increasing as the tier increases. Within Tier 4, however, there usually is no defined co-pay. Instead, a percent of the cost of the drug is charged. If that percentage is 60, for example, and one month’s worth of the drug costs $1,000, the patient needs to come up with $600 a month. A pretty hefty amount, indeed.
Regardless of what the FDA decides on the issue, insured patients who need biologics are looking for help today. There are plenty of stories of patients in need of specialty drugs who must choose between food and medicine or live with debilitating diseases because they can’t afford their medicine. The focus of medicine should be on the patient. Telling the story of patients who are denied a specialty drug because of cost barriers is critical as the FDA weighs arguments.
Regardless of who wins this battle, 12 years is a long time for patients to wait for access to a specialty drug. They ultimately lose, and many of them may not be alive in 12 years.
Should insurers be able to increase co-pays for different classes of drugs? Should the federal government get involved, and pass legislation that would cap co-pays? What is the solution to help patients who, after all, should be front and center in this debate?
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Jason Snyder is a vice president for WordWrite Communications
