It’s no secret that specialty drugs make up the fastest growing, and now largest, portion of the pharma market by revenue. Yet, this class of drugs still represents a small fraction of the total drugs prescribed annually.
In 2020, specialty drugs accounted for roughly $190 billion of total pharmacy spend, and by 2030, that number is expected to rise by over 60%, to $310 billion worth of spend.
However, Karina Castagna, senior vice president of access solutions at the health technology company OptimizeRx, says what isn’t widely acknowledged in the industry is the impact access hurdles to these medications have on prescriber choices.
A recent survey conducted by OptimizeRx of specialty physicians found that, on average, doctors would prescribe a different therapy for 33% of their patients if medication access was not a factor. The physicians surveyed also admitted to changing treatment plans for roughly one out of every four patients due to access challenges.
"There's this denial [in pharma] that … access programs are completely separate from [a] doctor's choice. And that's just not true. It's not the reality,” Castagna says.
While the high cost of these medications and coverage issues add to access challenges, Castagna says that plenty of other issues hindering a physician's ability to prescribe medication also must be addressed. Among these other factors are administrative barriers, prior authorization requirements and drug availability limitations.
“Part of access is how much red tape there is,” she says. “The patient has to be allowed to be on this therapy and they have to prove it to the payer. So, the first step is [whether] the patient [is] covered, and next step is what are the requirements and can [the doctor] prove them?”
Castagna is acutely aware of these challenges from her years working in market and patient access roles for a large pharma manufacturer.
“One of the prior authorizations on my brand required a doctor to answer over 40 questions in order to prescribe the medication,” Castagna says of one of the drugs she worked on, noting that even a minor error would lead to a rejection. “Due to the doctor’s lack of visibility into the prescribing requirements, about 90% of patients who should have gotten it were rejected at launch.”
The drug Repatha illustrates the market challenges associated with these access hurdles.
When it first launched in 2015, Repatha was priced at roughly $14,000 a year and was hailed by doctors as a major milestone in treating high cholesterol. But because of the steep cost, many payers added prior authorization and cost sharing requirements that led nearly half of patients to be denied coverage.
Even when Amgen lowered the price by 60% because of pushback from payers — as well as competition from Sanofi and Regeneron’s rival drug Praluent — the added requirements didn't go away and patients were still being rejected.
Lack of solutions
Decreasing administrative requirements and expanding coverage are vital to ensuring that physicians can prescribe their first-choice medication and that patients can gain access to life-saving treatments in areas of unmet need, Castagna says.
Physicians surveyed in OptimizeRx’s March 2022 study said their offices spend nearly four hours a day helping patients gain access to medications, costing their businesses an average of $5,800 per month.
With that precious time and money being diverted from care, Castagna says it’s no wonder that sometimes “doctors are switching patients to an alternative that may not be the best for the patient.”
The difficulty is finding easily implementable solutions to these challenges.
A 2020 report published by the American Heart Association (AHA) argues that administrative barriers to access are “perpetuated by a fractured and opaque drug pricing and a purchasing system that involves multiple intermediaries and limits consumer market forces.”
In the report, the nonprofit proposed that payers adopt a more transparent and streamlined process that would “render their decisions to clinicians and patients in a modernized and automated system integrated with electronic health records.” According to AHA, an updated process would ease access-related burdens on doctors.
AHA also urged payers to base formulary exclusions and coverage requirements on publicly cited clinical criteria that acknowledges the “differences in covered populations, economics, and interpretations of the evidence.”
Prompting payers and manufacturers to implement changes on a large scale is an important next step to help decrease access burdens. First, however, Castagna says the pharma industry needs to widely accept that access is a factor prescribers consider so that drug manufacturers can mobilize to help create new solutions.
“We've just reached this pivotal point where access has become such a big hurdle,” Castagna says. “It is a factor and I think it's got to be acknowledged and we have to figure out how to do something more about it to fi