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Molly Beinfeld, senior research lead, evidence synthesis at the Institute for Clinical and Economic Review, talks about the organization’s research assessing payer coverage policies of prescription drugs.
The Institute for Clinical and Economic Review (ICER) has released the protocol for its second annual review of insurance company policies to assess fair access to prescription drugs. ICER will evaluate whether 15 large U.S. commercial payers, the two largest state health exchange plans, and the Department of Veterans Affairs have formularies and procedures that provide appropriate access to the prescription drugs reviewed by ICER in 2020. These drugs include those that treat patients with cystic fibrosis, hemophilia A, migraine, sickle cell disease, and ulcerative colitis.
The analysis is expected to be completed in November 2022.
“The extent to which insurance coverage for drugs provides fair access to patients is not something that has been looked at systematically. It’s definitely an understudied area,” Molly Beinfeld, senior research lead, evidence synthesis at ICER, said in an interview with Formulary Watch.
She said the goal of ICER’s first assessment, which was released in December 2021, was to show the organization’s methods. “There were a lot of limitations, so the second annual report will build on that initial body of work.”
In this first Fair Access Report, ICER analysts found that most of the payer pharmacy and medical policies available for review were structured to support fair access to medications. In 67 (96%), ICER rated the payer’s policies as consistent for all fair access criteria.
But ICER reviewers were unable to assess the full set of information for all drugs for all insurers. The database used, MMIT’s market access analytics solution, did not include all policies or coverage because those policies were not available from the payers. Tiering information or prior authorization and step policies could not be determined for all insurers.
“The biggest issue we found was the lack of transparency,” Beinfeld said. “We’re trying to do this in a systematic way, and we're trying to get equal amount of information for each payer. That just wasn’t possible. We call on insurers to make both their prior authorization criteria and cost-sharing information available to consumers prior to enrollment. This way, they can make informed decisions.”
The 2021 assessment reviewed drugs that ICER had considered cost-effective. The next review will include both therapies that are cost-effective, as well as those that ICER says are not priced fairly. “We believe there is a relationship between cost and access. So, the higher the cost, the more access issues. Some of the areas that we’re looking at moving forward, like cystic fibrosis and sickle cell disease, are drugs that were priced very high. We want to see what kind of barriers have been put in front of patients.”
What is fair access to medications?
ICER outlined a set of criteria for establishing for how it would assess fair access in a white paper in September 2020. The company has developed four key areas for reviewing fair access: cost-sharing, eligibility criteria, step therapy, and prescriber restrictions. These areas aim to balance the need for cost control with appropriate cost-sharing and utilization management strategies.
“In this world of very high-priced drugs, it is appropriate to limit access to patients who will benefit most from that drug for whom there isn’t a harm,” Beinfeld said. “But this should not be limited to the point where it narrows the population of eligible patients, relative to the common standards, such as the FDA label, or clinical guidelines, for example.”
On the clinical side, any limitations on access should be based on evidence, Beinfeld said. ICER looks at both the drug label and clinical guidelines. For example, in eczema, drug labels can be broad. “We will look at the coverage policy to see how it defines moderate to severe, for example, and we’ll look to see if the coverage policy is using a definition that’s stricter than a clinical guideline might say.”
If an insurer limits coverage to patients who are more severe than a clinical guideline, ICER would issue a fail on clinical eligibility. “Oftentimes, we did find examples where payers would limit the eligible population to something that isn’t a part of the label.”
Several payers changed their policies after ICER spoke with them. These include 10 coverage policies from six companies. (See table below.) In some cases, these changes were minor clarifications of clinical eligibility criteria, but other policy changes included more substantial broadening of coverage or important shifts in tiering placement that would lead to lower out-of-pocket cost sharing.
One insurer, for example, was limiting access to Dupixent (dupilumab), developed by Sanofi and Regeneron, to patients who had moderate-to-severe atopic dermatitis for more than three years. “The three-year requirement was arbitrary,” Beinfeld said. “That’s the kind of narrowing of the population who could get access in a non-evidenced-based way.”
Beinfeld also said ICER also looks at prior authorization closely in its analysis. “We look at whether a patient is eligible for therapy from a clinical perspective. Does the patient meet the definition of severity of the disease? We also look at what the step therapy requirements are or what are the other treatments that patients are going to have start with. ICER’s stated position is that patients should have at least one alternative among a class of drugs in the lowest relevant tier of the formulary.”
In the next assessment, Beinfeld said, ICER has added another dimension for review: documentation burden, including how difficult is it to get prior authorization, how transparent are the prior authorization requirements, and how easy is it for patients to access information before enrolling about the cost sharing and clinical eligibility requirements.
Removed its prior authorization criteria for sacubitril/valsartan, effective August 1, 2021
Blue Cross Blue Shield of Minnesota
Blue Cross Blue Shield of Massachusetts
Will be moving elagolix from its specialty tier to Tier 2 (Preferred Brand), effective January 1, 2022.
Removed criteria that differentiates between symptomatic infantile onset and later onset SMA, effective July 1, 2021
Source: ICER. December 2021; Assessment of Barriers to Fair Access