Prior Approval Required for Oral Anticancer Drugs May Interfere with Treatment

At a glance:

  • The use of prior authorization by insurance companies to approve drugs and treatments has been increasing over the past decade.
  • A new analysis at Harvard Medical School shows that prior authorization can lead to delays in filling oral cancer prescriptions and a greater risk that patients may stop taking the drugs.
  • The findings raise concerns over access to care and adherence to oral anticancer medication.

Insurance companies’ use of prior authorizations for certain oral cancer drugs can lead to significant delays in patients getting the drug and make some more likely to stop taking the drug, according to a new study from Harvard Medical School researchers.

The research, conducted by co-authors Michael Anne Kyle and Nancy Keating of the Department of Health Care Policy at the Blavatnik Institute at HMS, will appear December 12 at Journal of Clinical Oncology.

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The study analyzed Medicare Part D claims data from 2010 to 2020 to examine the consequences of a new prior authorization policy on delayed prescription refills or discontinuations of oral anticancer drugs. Medicare covers 18 percent of the US population, primarily adults older than 65. The median age of people diagnosed with cancer is 66 years, giving Medicare a prominent role in cancer care coverage policy.

Prior authorization is used by insurance companies to verify a patients medical need for a particular treatment. The practice has increased over the past decade, drawing concerns from clinicians, patients, and regulators that it could create a barrier to access to treatment.

Harvard Medicine News spoke with Kyle about the implications of the research.

HMNews: What was the impetus for this study?

Kyle: Prior authorizations are a common utilization review measure used by insurance providers. They require that a proposed treatment be submitted to the insurance provider for review before the insurer agrees to pay for it. Clinicians, patients, and regulators have identified this as a common frustration and, at times, a barrier to access.

Financial factors such as high out-of-pocket costs for patients are well-known barriers to accessing prescription drugs, but there is little evidence about non-financial factors such as the administrative burden created by the need to obtain prior authorization before taking medication. So we want to study this aspect.

Patients may find prior authorization confusing, frustrating, and burdensome for a variety of reasons. For example, people vary in their language fluency, their ability and willingness to negotiate bureaucratic conflict, and the amount of time available during work hours to talk on the phone about the scope of insurance. People with complex health conditions also typically face more barriers to management.

Some people might shrug off these annoyances, but I worry that the same set of events might send a different message to someone who regularly experiences discrimination. It may be impossible to distinguish a system failure from structural discrimination or targeted discrimination, or some combination thereof.

HMNews: What were your main findings?

Kyle: The bottom line is that prior authorization requirements can delay access to drugs and even prevent people from continuing with a drug.

Specifically, we found that for patients enrolled in the federal Medicare Part D program who regularly filled an oral anticancer drug prescription, the introduction of the new prior authorization policy on that drug increased possibility of stopping the drug within 120 days. We also found an average delay of 10 days in refilling the first prescription after the policy change, compared to Medicare beneficiaries whose plans did not change the prior authorization policy on those drugs.

HMNews: What are the implications of these results?

Kyle: Our results highlight two major concerns: delayed access to medications and medication diversion due to prior authorization requirements. We found prior authorization mainly served to introduce delays in established drug regimens, which were ultimately continued by most patients. The clinical implications of discontinuations or delays in filling are likely to vary by drug. Our findings show that prior authorization wastes time and undermines access to care and oral anticancer drug adherence for patients who regularly use a particular drug.

However, it is important to remember that prior authorization is not all bad and it can play a role in discouraging the use of expensive drugs with uncertain benefit. Our study focused only on established, effective treatments, where prior authorization may have limited advantages and notable disadvantages.

There may be situations where prior authorization is required. Cancer drugs are increasingly approved with tentative evidence of efficacy and may remain on the market after failure of confirmatory trials. When drug approval processes do not clarify a drug’s therapeutic value, the task of figuring it out rests with medical plans and individual clinicians. The continued presence of unproven or unproven drugs on the market suggests that there is an important and necessary application of prior authorization to protect patients from expensive, low-cost care, care that is expensive but whose benefits remain unclear. .

HMNews: What are the takeaway messages for policy makers, physicians, and patients

Kyle: Prior authorization policy efforts broadly circle back to the larger dynamics around pricing and value in health care that we all know. One of the challenges in managing consumption is that it is disproportionately responsible for high prices. As FDA approval processes become more flexible, the job of assessing effectiveness is increasingly being shifted to clinicians and insurers to make what we call point-of-care coverage decisions. Many countries have a centralized health technology assessment process, but the US does not. Perhaps the growing frustration with usage management will make such methods more attractive.

Another important point here is that administrative burden is, at least in part, a feature rather than a bug of prior authorization, but process improvements such as standardized electronic forms are an important policy priority to alleviate burden on a stressed health care worker.

Disorganized, fragmented processes burden prescribers, particularly with clinician burnout dramatically increasing. There are several ongoing state and federal efforts to reform prior authorization processes, including in Massachusetts. Our findings offer important clarifications and evidence that can inform regulatory decisions.

Authorship, funding, disclosure

Supported by National Cancer Institute grants K99CA277367 (MAK) and T32CA092203 (MAK, NLK).

Authors’ disclosures of potential conflicts of interest are available at published paper.

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