Success Factors for Getting High-Cost Drugs Approved
“We’re coming in prepared rather than going in blind,” says Erin Collins, URMC’s manager of high-cost drugs.
Many new drugs are coming on line for neurologic conditions that, until now, have had no therapies to slow disease progression. The drugs are expensive, and, in most cases, health plans require a lot of information to obtain prior authorization.
Erin Collins, manager of high-cost drugs for the University of Rochester Medical Center (URMC) neurology department, is responsible for making sure that patients get access to appropriate drugs and mitigating the department’s financial risk associated with buying and administering them.
See related tool: Job Description: Manager, High-Cost Drugs
“These drugs can cost hundreds of thousands of dollars, so the hospital really wants to make sure that we are getting the correct authorization,” she says.
A big part of her job is working with patients and family members so they understand their role in a drug approval. “Many of these patients have never had the option of having treatments before so there’s a lot to learn,” she says. “I explain to patients and hold their hands through the insurance and the pre-procedure information.”
By focusing on a specific set of drugs, she is developing expertise that increases the likelihood of getting prior authorization and, over time, increases the efficiency with which that authorization is obtained.
“At first, we were experiencing a lot of denials,” she says. “But now we’re coming in prepared, rather than going in blind.”
Many requests—perhaps 50 percent—are still denied on first request. That prompts appeals, if necessary, all the way to the top level, which requires that a neurologist review the request.
“Once we get to that level, not all of our requests get approved, but a big percentage do,” Collins says.
Collins focuses on a handful of therapies, all of which have been approved by the Food & Drug Administration (FDA) within the past few years. The most expensive is Spinraza (nusinersen), the first disease-modifying treatment for spinal muscular atrophy; it costs $750,000 the first year and $375,000 in subsequent years.
Other drugs she is responsible for include two therapies for Duchenne muscular dystrophy, one of which costs $300,000 a year and the other $90,000; a drug to treat Lou Gehrig’s disease that costs $146,000 a year; and a drug for primary progressive multiple sclerosis that costs $65,000 a year.
The new drugs present several challenges for provider organizations that buy and administer them:
Coverage policies. When a new drug first gets approval, health plans typically do not have coverage policies in place, so it is unclear what information they need to provide preauthorization.
Coordination. When policies are published, they do not always conform with the FDA approval.
Compliance. Coverage policies have many requirements. For example, one health plan’s policy for Spinraza has specific criteria for the prescriber; how the diagnosis was made; results of genetic testing or notes documenting symptoms before 6 months of age; and documentation of specific test results. Subsequent approval, which must be obtained every six months, requires documentation of a positive response to therapy as measured by specific tests.
Missing criteria. Physicians sometimes prescribe drugs for patients who do not meet one of the criteria. For example, a patient might not be ambulatory—one of the criteria—but could still likely benefit in other ways from the therapy.
Recognizing that Information is Power
Collins’ top advice: Learn health plan criteria for authorizing specific drugs, meet every criterion, anticipate questions or concerns, and provide even more information.
“The biggest mistake is not having enough information,” she says. “We send a lot of paper in—sometimes close to 100 pages by the time I complete a case.”
Collins also shares these lessons learned:
Comply with the coverage policy. If a health plan has published a coverage policy, find out what information is required and do not submit an authorization request until that information is available.
That means communicating closely with physicians about how to make the best cases for authorizations. “There is a learning curve for all of us,” Collins says. “The documentation needs to be stronger than it used to be because we didn’t have treatments to offer.”
When she is notified that a physician plans to prescribe a high-cost drug, Collins meets with the physician before the patient’s appointment to go over the details of the health plan’s coverage policy. “We have a pow-wow ahead of time, so I can say ‘We need to make sure that to do this evaluation and order this test we have to review the health plan requirements,’” she says.
Be proactive . Instead of waiting for initial requests to be determined “not medically necessary,” Collins helps physicians prepare medical necessity letters as part of initial requests. The letters include the following details:
- Providers’ education, experience, and expertise with the medical diagnoses at issue
- Reasons for requesting the drugs and how they will affect patient care
- Results of evaluations
- Results of tests
- Office notes
- Supporting documentation
“If I can find any research studies or information about ongoing clinical trials, I’ll send that along,” she says. “And a lot of the drug companies have patient access managers, so I reach out to them to see if there are any published posters or reports or other supportive data that might help with the request.”
Partner with patients . Collins works with patients and family members to make sure they understand prior authorization processes, their out-of-pocket costs after insurance, and what they must do to increase likelihood of getting approved. This includes getting the tests and evaluations their physician orders and also gathering information that family members might forget to share.
“If we are going for a re-authorization, I ask ‘What are you noticing in their daily routine that maybe we don’t notice at clinic visits where we only see them every three or six months?” she says. “Can (the patient) now lift a cup? Or feed himself? These normal, daily functions aren’t always captured in those office visits, but we need to make sure we include that information in our letters.”
Make it personal . Collins shares patient details that underscore why costly drugs are appropriate. “We’re not just asking for this drug for ID number 890,” she says. “This is our patient, and he has this going on in his life, and we want to help him remain stable, if not improve, if we can. And anything to slow progression of the disease is something.”
This is where she tries to head off quick denials based on patient status. For example, if a health plan’s policy for a certain drug requires that the patient be able to walk, she makes the case that the coverage policy might be too limiting. “So maybe the patient is nonambulatory but he’s in college and can still use his hands for his computer,” Collins says. “Yes, maybe that doesn’t fit exactly into the policy, but think of all the ways the patient can benefit from being stable. It requires thinking a little bit outside the box if we have to.”
Address discrepancies between coverage policy and FDA approval . Health plan policies do not always conform to the dosing information in the FDA approval. For example, a plan might authorize 12 treatments a year even though the FDA label calls for a dose every four weeks, which is 13 treatments a year.
Collins sends the prescribing instructions as part of the initial request. “I outline to the insurance company that ‘Your policy states this, but the FDA approval was based on this, so that is why we are prescribing it this way,’” she says.
Focusing on the Challenge
URMC’s neurology department is using a proactive, patient-centered approach to tackle the challenge of high-drug costs. By creating a managerial position to focus on this area on a patient-by-patient basis, the medical center is reducing denials and improving patient experience.
Lola Butcher is a freelance writer and editor based in Missouri.
Interviewed for this article:
Erin Collins is high-cost drug manager, neurology department, University of Rochester Medical Center, Rochester, N.Y.