Barriers to Equitable Access—Health Care Economist

Last month, ICER released their 2023 “Assessment of Barriers to Equitable Access” . The report reached the following conclusions for the 18 drugs evaluated.

ICER defines “fair access” based on the following criteria:

Cost Allocation

1. Cost allocation based on net price. Patient cost-sharing should be based on the plan sponsor's net price, not the unnegotiated sticker price.
2. High-value treatments at no cost. All drugs deemed high-value therapies by the IRS should receive predeductible coverage in high-deductible health plans.
3. Each category offers a low-cost option. Unless all drugs are priced above an established fair value threshold, at least one drug in each category should be covered at the lowest relevant cost-sharing level.
4. High costs can be spread if cost-effective drugs are not available. If a class of drugs is priced such that no single drug represents fair value as determined through a value assessment, then it is reasonable for the payer to place all drugs at a higher cost-sharing level.
5. Prescription dispensing is acceptable if all drugs are priced at fair value. If pricing for all drugs in a class represents fair value, it would still be reasonable for payers to use preferential formulary dispensing and tiered cost-sharing to help reduce overall costs.
6. Limited cost sharing if phased implementation is required. As part of an economic ladder of care, when patients try lower-cost options at lower cost-sharing levels but do not achieve an adequate clinical response, cost-sharing for further treatments should also be at lower cost-sharing levels, as long as these further treatments are cost-effective Fair pricing based on transparent standards.

Although ICER lists six criteria, only three of them (#3, #4, and #5) are formally evaluated in its report.

clinical qualifications

• Payers should offer alternatives to prior authorization agreements, such as programs that provide clinicians with feedback on prescribing patterns or waive prior authorization requirements for clinicians if they demonstrate high fidelity to evidence-based prescribing (“gold cards”).
• Payers should document at least annually that clinical eligibility criteria are based on high-quality, current evidence and the opinions of clinicians with the same or similar clinical expertise.
• Clinical eligibility criteria should be developed with clear mechanisms requiring payer staff to document that they: (i) take into account limitations of the evidence due to underrepresentation of minority groups; (ii) provide insights into the biology, culture, or society of diverse communities (iii) Confirm that the clinical eligibility criteria do not go beyond the reasonable use of clinical trial inclusion/exclusion criteria to interpret or narrow the scope of FDA labeling language so that patients with Patients with underlying disabilities unrelated to the disease being treated are disadvantaged
• For all drugs: Clinical eligibility criteria that supplement FDA labeling language may be used to: (i) set diagnostic criteria; and/or • define clinical terms that are uncertain in FDA labeling (e.g., “moderate to “severe”); and/or (ii) triage patients based on clinical acuity when the payer clearly demonstrates that triage is reasonable and necessary
• For drugs with a deemed reasonable price increase or increase: Beyond the three purposes above, clinical eligibility criteria should not deviate from FDA labeling language and thereby reduce coverage.
• For drugs whose prices or price increases are deemed justified: Documentation that patients meet clinical eligibility criteria should represent a lighter administrative burden, including acceptance of clinician certification in lieu of more formal medical record documentation, unless documentation is critical to ensuring patient safety.
• For drugs whose price or price increase is deemed unreasonable: If implemented with reasonable flexibility and supported by a robust appeals process, clinical eligibility criteria may reduce coverage by applying specific eligibility criteria from pivotal trials that Trials are used to generate evidence for FDA approval. Implement standards.

Step therapy and conversion

• To justify economic step therapy policies beyond the scope of FDA labeling, payers should clearly confirm or provide evidence documenting all of the following: • Use of step therapy reduces overall health care spending, not just drug spending
• Step 1 treatment is clinically appropriate for all or nearly all patients and does not pose any greater risk of significant side effects or harm.
• Patients will have a reasonable opportunity to achieve their clinical goals with first-step treatment.
• Failure of the first-step drug and the resulting delay in the second-step drug will not cause long-term harm to the patient.
• Patients do not need to retry first-line medications with which they have previously experienced adverse side effects or had inadequate response at reasonable doses and durations.
• To justify a required switch policy, payers should explicitly confirm or provide evidence documenting all of the following: (i) Use of the required drug will reduce overall health care spending. (ii) The desired switch therapy is based on the same mechanism of action or has comparable risks and side effects as the index therapy. (iii) The required conversion therapy has the same route of administration or the difference in route of administration does not have a significant negative impact on the patient due to clinical or socioeconomic factors. (iv) Patients do not need to switch to drugs previously used at reasonable doses and durations with inadequate response and/or significant side effects, including earlier use by different payers

Supplier qualifications

• Coverage limitations on professional prescribers are reasonable for one or more of the following reasons: II) Accurate diagnosis and prescription require professional training, and there is a risk that lay clinicians will prescribe drugs for patients who are likely to suffer harm or are unlikely to benefit. risk. (ii) Because treatments can have serious side effects, determining the risks and benefits of treatment for individual patients requires professional training. (iii) Dosing, side effect monitoring, and overall care coordination require specialized training to ensure safe and effective use of medications.
• When this condition is often treated in primary care settings, requiring non-specialist clinicians to demonstrate that they are caring for patients in consultation with relevant specialists is a reasonable option, but there are elements of dosing, side effect monitoring, and/or overall coordination that are problematic for many patients. Nursing will benefit from expert input

fair access standards

• Cost-sharing policies should be clearly presented to consumers before choosing a health plan so that all individuals understand what cost-sharing they will face for treatments they are currently taking or considering.
• Any significant changes to the formulary or cost-sharing structure should not occur mid-cycle unless the plan sponsor uses this as a qualifying event to allow plan participants to switch plans.
• At the point of care, clinicians and patients should be able to quickly determine the cost-sharing requirements for any treatment and the cost-sharing of other alternatives.
• Individuals considering enrolling in a health plan should be provided with clear information about whether they meet the clinical criteria for treatments currently being accepted by their insurance company. These policies should also clarify the rationale behind them and be easy to understand.
• Clinicians and patients should be able to quickly determine the clinical criteria for any treatment and review the clinical rationale supporting those criteria. The clinical information referenced should be readily available to prescribing/ordering providers and the public.
• Individuals considering enrolling in a health plan should be provided with clear information about whether treatments they are currently taking or intending to take will be affected by non-medical step treatment or switching policies.
• Clinicians, pharmacists and patients should be able to quickly identify the requirements associated with step treatment and switching policies and easily view the full rationale from the insurance company.
• Individuals considering enrolling in a health plan should be able to easily find information related to coverage criteria, including prescriber eligibility for medications they or a family member are currently taking.
• Clinicians and patients should be able to quickly determine whether the prescription of any treatment is restricted.Insurers should provide ready assistance, as needed, to primary care clinicians seeking access to relevant specialists for consultation

You can read the full report here.