At CarelonRx, we strive to promote the use of drugs and therapies with the best overall clinical evidence to improve outcomes for our members and lower total cost of care.
How do we do that? It’s all about careful attention to details and the comprehensive evidence-based process we use. From the extensive surveillance of drugs in the development pipeline, to the promotion of high-value, effective therapies, we use a clinical-first approach with a member-first mindset.
Pipeline monitoring for better insights
CarelonRx clinicians gather information on drugs prior to Food and Drug Administration (FDA) approval, which allows for a systematic evaluation throughout the life cycle of the drug. We don’t wait until final FDA approval to understand the potential clinical value and cost of care impact of a new drug.
Why this matters:
- Gathering intelligence early leads to better insights on how pivotal trials are being designed and how closely the study population mirrors our membership.
- This early assessment informs our clinical strategy development process by helping us better predict how a new drug may impact treatment and adoption patterns across our membership.
- During this pipeline evaluation stage, we estimate total cost of care impacts (pharmacy and medical) on the healthcare system for future planning and clinical strategy.
What happens next:
Once clinical trial results are released, our clinicians conduct a “deep dive” analysis to understand the quality of the clinical evidence and how study outcomes compare to other drugs in the class and to standard of care.
Reviewing evidence to determine comparability
A team of clinical pharmacists with specialized training in evidence-based medicine use widely accepted critical evaluation methods to determine the relative comparability of drugs. They conduct extensive literature and evidence searches identifying the scope of the evidence review [population, interventions being compared and key clinical outcomes (PICO)], critically evaluating, and grading the quality and strength of the body of evidence.
What we consider:
Randomized Clinical Trials (RCTs) are considered the gold standard in providing high-quality evidence. Both direct and indirect comparisons of similar trials are used, when high quality systematic reviews and meta-analyses are unavailable, to evaluate comparability of products.
Why it’s important: These trials – when conducted following rigorous study design methods like blinding and randomization – help accurately determine the true benefits and harms of a drug.
Systematic reviews and meta-analyses require meticulous evaluation of included trials' quality and methods to determine precision in results. These types of analyses may not be available for newer drugs or may be limited by study design biases and flaws, or timeliness of information.
Why it’s important: These reviews can provide comparative effectiveness of drugs, particularly if they cover important questions such as the comparability of therapies within a drug class and their impact on clinically significant health outcomes.
FDA Medical and Statistical reviews often reveal flaws and limitations in studies that are otherwise not reported in published trial results.
Why it’s important: This kind of review provides important context and deeper insight into how a new drug might perform in real-world populations.
Evidence-based Treatment Guidelines are assessed for their trustworthiness, relevance, and utility in decision making. This includes a critical evaluation of potential bias, conflicts of interest, and the quality of the evidential basis supporting the recommendations.
Why it’s important: Guidelines can provide insight for understanding current clinical practice patterns and broad use of drugs in disease treatment.
Broad literature searches help identify reports of rare and serious side effects of new drugs to allow comparison to drugs with long-term clinical experience.
Why it’s important: RCTs, systematic reviews, and meta-analyses provide insight on comparative efficacy and safety, but only in a controlled setting, while FDA Medical Reviews can help identify details of rare safety signals observed during clinical development. Post-marketing studies are leveraged to help identify rare safety events in broad populations closer to how drugs are used in the real-world setting.What happens next:
Once the evidence is compiled, the process of deciding on formulary additions or updates – the Pharmacy & Therapeutics (P&T) evidence review process – begins.
Making formulary recommendations and updates
The CarelonRx P&T process uses a clinical-first approach to drug list development, with the goal of promoting drugs that improve members' health while keeping health care affordable.
Our unique P&T charter includes:
FDA Medical and Statistical reviews often reveal flaws and limitations in studies that are otherwise not reported in published trial results.
An independent P&T committee of physicians and pharmacists with limited conflicts of interest, broad representation both geographically and across medical specialties, and who practice in leading academic medical centers and community medical practices review the evidence. Committee members are trained in evidence-based medicine.
Dedicated subcommittees for the specialized areas of hematology & oncology, behavioral health, and drug utilization & policy review.
A focus on promoting high value therapies with cost-effectiveness based on evidence of efficacy, safety, clinical attributes, and cost of care.
A systematic value assessment process for reviewing P&T recommendations through the lens of tiering decisions, utilization patterns, member and provider impact, and more.
A process that stays current with evidence to weigh overall benefits against potential harms of drugs, and to support best decision-making through ongoing assessment of new information.
Formularies are carefully updated with product additions and clinical utilization management criteria, once approved through the P&T Process, and all drugs are reviewed at least annually.
Through our formulary development methodology, CarelonRx allows clinical evidence and outcomes data to help make formulary decisions that support our P&T goal: to positively impact health outcomes, lower total cost of care and improve the member and provider experience.
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