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ProVIDER education Outcomes-Based Drug List Selection Process Our unique process combines rigorous critical appraisal of literature with real-world data. The result is an outcomes-based drug list containing medications with proven benefit for patients. ProVIDER education Our drug list (also referred to as a formulary) is created by the Pharmacy and Therapeutics (P&T) Committee, which consists of two subcommittees: the Clinical Review Committee (CRC) and the Value Assessment Committee (VAC). The CRC consists of a large group of independently practicing clinicians representing diverse specialties who are not employed by this company or its subsidiaries. The VAC is made up of company-employed physicians, pharmacists, and analysts representing both clinical and business perspectives. Together, these groups combine clinical evaluation and value-based decision-making to determine the medications included on our drug list. Clinical evidence meeting quality criteria in more than 25 areas are considered for each review, which helps ensure that data of the highest quality are shaping each decision. Three well-defined steps guide this process: 1. Clinical review - the foundation of our drug list 2. Value assessment - considering the value each drug brings to our drug list 3. Tier placement - determining coverage levels within tiers Clinical review The internal drug information team gathers and critically appraises all available clinical data, including: • Published literature, e.g., practice guidelines, systematic reviews, meta analyses and clinical trials • Food and Drug Administration documents, e.g., medical reviews and safety updates • Manufacturer information, e.g., product labels, dossiers and presentations Each piece of clinical data is critically appraised for quality using a rigorous evidence-based process. Evidence meeting quality criteria in more than 25 areas, including appropriate study design and methodology, acceptable subject drop-out rates and handling of missing data, are considered for inclusion in each review. Emphasis is placed on reporting of clinically important improvements and evaluation of patient-oriented outcomes (e.g., cardiovascular event rate reduction) instead of disease-oriented or surrogate endpoints (e.g., blood pressure lowering) – which helps ensure that data of the highest quality are shaping each decision. The clinical evidence for each drug is compared with that of similar drugs based on effectiveness, efficacy, safety and clinical attributes – drug-related characteristics important to prescribers and patients. Recommendations from specialty physicians and advisory panels are often gathered and included, and each drug receives a clinical ranking from the CRC based on the presented evidence. Additionally, the clinical appropriateness of our programs and initiatives, designed to help promote nationally recognized, effective and proven utilization of pharmacy benefits, is also reviewed. Value assessment The following information is provided to the VAC to determine drug list placement of each drug under review: • Clinical rankings and comments for each drug determined by the CRC • Real-world health outcomes data (internal and external) • Total cost of care analyses, including pharmacy, medical and laboratory data (internal) • General financial modeling Internal analyses are carefully reviewed by a panel of external pharmacoeconomic specialists before being reported to the VAC. 2 | Outcomes-Based Drug List Selection Process The VAC considers clinical ranking first to dictate tier placement options for each drug, followed by careful consideration of health outcomes information, financial data and other potential impact factors to further shape final tier placement decisions. Tier placement The last step in drug list development is assigning a coverage level using tiers – groups of drugs that fall within description and pricing groups. • Tier 1, usually limited to generic drugs, has the most affordable coinsurance payment, or copay. • Tier 2 and Tier 3 are often comprised of brand name drugs or more expensive generics, and cost slightly more. • Tier 4, commonly reserved for specialty drugs, has the highest copay amounts. An outcomes-based drug list Our drug list development process is involved. Critical evaluation of clinical evidence is integral and foremost in the process, and establishes the foundation for each drug list decision. Our value assessment process is unique and includes not only cost data, but also real-world outcomes and total cost of care information from a database of 35 million people – one of the largest in the world. We are confident that our robust evaluation process allows us to reach our goal of developing an outcomes-based drug list that includes medications of the highest clinical value, ultimately improving the health of our members. How our clinical review and value assessment process shaped two important drug list decisions: • Bisphosphonates medication class review results indicated that the medications with the best clinical trial data also demonstrated lower fracture rates and lower total cost of care. These were the medications chosen for and included on our drug list. • Our analysis showed that members with COPD taking more expensive medications had fewer emergency room and hospital visits than those taking less expensive medications. The expensive medications also had the best clinical trial data. They were placed on the drug list because they are best for members and decrease overall cost, despite availability of less expensive treatment alternatives. Outcomes-Based Drug List Selection Process | 3 Still have questions? Visit the Providers page of bcbsga.com for more information about the drug list. Blue Cross and Blue Shield of Georgia, Inc., is an independent licensee of the Blue Cross and Blue Shield Association. The Blue Cross and Blue Shield names and symbols are registered marks of the Blue Cross and Blue Shield Association. Si necesita ayuda en español para entender este documento, puede solicitarla sin costo adicional, llamando al número de servicio al cliente que aparece al dorso de su tarjeta de identificación o en el folleto de inscripción. 14257GAPENBGA | 122010