Biopharmaceutical innovations have contributed to meaningful improvements in patient health by preventing, treating, and even curing diseases. These advancements in medicine bring tremendous value to both individuals and society broadly, but poorly designed health insurance can create barriers for patients trying to access the high-value therapies they need, regardless of whether the treatment is offered at a “fair” or heavily discounted price.
A recent study published in Health Affairs examined payer coverage policies for specialty drugs for 10 major clinical conditions and found that overall, health care plans are applying step therapy in nearly 40% of drug coverage policies. Furthermore, over 55% of step therapy protocols were more restrictive than the corresponding clinical guidelines. These findings highlight how current health benefit designs can create access and affordability challenges for patients, and underscore the need to reform existing utilization management and cost-sharing practices to achieve more affordable, patient-centered care.
Recently, growing interest in eliminating barriers through benefit design reform has led to multi-stakeholder policy discussions about when utilization management and cost sharing requirements are appropriate and fair, and conversely, when such cost containment measures place an undue administrative, clinical, and financial burden on patients. Several organizations have initiated efforts to explore principles of “fair access” to health care treatments and services. The American Medical Association recently released “Prior Authorization and Utilization Reform Principles,” the National Pharmaceutical Council convened a multi-stakeholder panel to assess the appropriateness of step therapy protocols and areas of consensus that could inform industry standards, and the Institute for Clinical and Economic Review (ICER) published a white paper on “fair” access for drug coverage that identified specific “Fair Access Criteria” for implementing appropriate cost-sharing and utilization management strategies.
Today ICER released a new report, Barriers to Fair Access Assessment Report, which builds on its white paper and examines how coverage policies from 15 health care payers perform against select Fair Access Criteria (7 of 20 included in the white paper) for 28 prescription drugs. Their report is a welcome addition to ongoing stakeholder efforts to identify and eliminate medication access barriers and provides a useful starting point for discussions about these barriers. However, as the report itself notes, there are key limitations to the analysis and it “remains therefore an exploratory analysis intended to chart a roadmap for future research.” It should not be used to draw conclusions about whether payers are providing meaningful patient access to needed medications.
In order to 'prove' I needed the medication, the insurance company told me I needed to fail on two biologic injectable medications -- despite the fact my doctor, the staff in his office, and I repeatedly told the insurer that I have tried -- and failed -- on those same medications in the past. We also told them that not only had I tried and failed these medications that they were trying to force me to take had actually made my condition worse in the past. It didn't matter to them.
Utilization management strategies are undermining fair access
Results from ICER’s analysis of payer coverage policies reveal that despite multi-stakeholder efforts to promote fair access to evidence-based treatments, notable barriers to access remain. For example, several payers placed treatments for hereditary angioedema and hemophilia A on a high formulary tier, forcing patients to incur higher out-of-pocket costs even when no alternative treatments exist. This violates one of ICER’s identified ethical goals for cost sharing fair access: “cost sharing should not be structured primarily to shift health care costs to patients when they have few or no lower cost options that are medically appropriate.” In addition, multiple payers required patients to meet clinical eligibility criteria beyond what is included in clinical guidelines for a range of conditions including hemophilia A, acute lymphoblastic leukemia, and B-cell lymphoma.
The report also highlighted concerning practices related to payers’ step therapy protocols. First, the authors found widespread implementation of step therapy policies for high-value medications. Most payers required at least one step for 18 of the 28 evaluated therapies. Second, the report found substantial variation in the number of steps payers require before patients can receive coverage for a treatment, with some payers requiring up to 10 steps for select treatments.
My mom spends hours on the phone fighting to get my treatments approved by the insurance company. Now that my current treatment is failing, my doctor is already talking about how we may have to fight the insurance company for it.
Opportunity for future analyses of fair access to be more comprehensive and patient-centered
As stated in the report, the authors’ assessment of barriers to fair access is not meant to produce a definitive evaluation of the issues related to fair access; rather they intend to provide a first step toward beginning a dialogue on the challenges and opportunities related to fair access to pharmaceuticals. ICER intends to release these assessment reports annually, which provides an opportunity to address methodological limitations and contextual issues to ensure that future assessments of fair access are more comprehensive and patient-centered.
ICER’s analysis could not address several Fair Access Criteria that promote the alignment of patient cost sharing with clinically appropriate care
Due to data limitations, only 7 of the 20 Fair Access Criteria could be evaluated for this analysis, so it includes only a subset of the medication access barriers patients face, undermining the reach and generalizability of this analysis. Several of the excluded criteria are critical patient protection measures that advocate for the alignment of cost sharing with clinically appropriate care to promote more meaningful and affordable access to treatments. ICER’s report did not assess three essential Fair Access Criteria:
- Patient cost sharing should be based on the net price to the plan sponsor, not the unnegotiated list price.
- All medications identified by the IRS as high-value therapies should receive pre-deductible coverage within high-deductible health plans.
- As part of economic step therapy, when patients try a lower cost option with a lower cost sharing level but do not achieve an adequate clinical response, cost sharing for further therapies also should be at the lower cost sharing level as long as those further therapies are priced fairly according to transparent criteria.
These criteria are critical for patient access and affordability and we hope that next year’s analysis expands to include an evaluation of these and the other cost sharing Fair Access Criteria. A comprehensive analysis of fair access must include assessments of how payers are reducing patient financial burden and removing barriers to access for evidence-based treatments.
Greater transparency of payer policies and implementation is needed
ICER’s “most salient conclusion from this assessment is that there should be greater transparency regarding how insurers frame and implement their coverage policies. Transparency certainly for affected patients and their clinicians, but also for the broader research community and the public.”
Limited data were available to evaluate many of ICER’s criteria. The analysis utilized a database that did not include any information on how prior authorization policies were implemented and administered, including the level of documentary burden or the ease of exemption, both of which are critical to fair access to prescription drugs. In addition, ICER was not able to access or evaluate any information about patient cost-sharing requirements, so its analysis was limited to using the plans’ tiering schemes rather than actual cost-sharing amounts to assess the relative magnitude of patient out-of-pocket requirements. This approach does not capture the wide variety of copayment and coinsurance requirements that plan sponsors may use within their tiering structures and does not speak to patient financial burden. More transparency from plan sponsors is critical for these efforts.
Though the report has limitations, it does raise an important issue, one that NPC and other patient organizations have been focused on for years: patients are still facing barriers created through health benefit design (see patient anecdotes on page 27 of the report). ICER’s report can help us start the cross-stakeholder conversation about how to get better data, how to learn from each other, and how to do better by patients.