IDOI’s Formulary Review in 2018

1. IDOI’s Formulary Review in 2018 Plan year 2019 UPDATED ON 4/11/2018

2. Outline • Background, overview and goals of this review • Changes to this review from what was previously proposed in November 2017 • Overview of the review • FAQ

3. Background Since 2015, the IDOI has collaborated with the Butler University College of Pharmacy and Health Sciences to develop and implement a state specific clinical appropriateness review for ACA compliant major medical plans. These tools were developed by clinical pharmacy specialists and will be used in addition to all formulary review tools and standards developed by CMS.

4. Proposed Changes that will Not go into Effect • Sexual Dysfunction (as a secondary indication) • In response to carrier feedback, sexual dysfunction will not be part of Indiana’s State Specific Clinical Appropriateness Review • Changes in the restrictions that will be allowed • After reviewing carrier feedback, we have decided not to create specific standards specifying which RxCUI’s may not have prior authorization (PA) or step therapy (ST). Instead, we will continue to use an outlier analysis to insure that ST and PA are being used appropriately. This same outlier analysis has been used for the past two years and will look at the % of covered drugs for each disease state that require PA or ST.

5. Goals of this State Specific Review • Increase IDOI’s understanding of carrier formularies • Increase comparability of formularies • Review for discriminatory formulary design • Promote competitiveness in formulary design • Ensure adequate formulary coverage • Allow for the review of disease states pertinent in Indiana

6. Disease States for Plan Year 2019

7. Subgroups • The RxCUIs used to treat each disease state are placed into subgroups of drugs that can be used for substantially similar treatments. • RxCUIs with the same main ingredient may be placed in different subgroups due to differences in their intended use, dose strength, and/or delivery method. • The goal of these subgroups is to insure that consumers (almost) always have at least one covered RxCUI option that adequately address their specific need.

8. Covering Subgroups • A Subgroup is considered “covered” if at least one RxCUI in that subgroup is covered. • Example: The ADHD subgroup ADDA4 contains 14 RxCUIs. This subgroup will be considered covered if at least one of the 14 RxCUIs are covered by the formulary.

9. Covering Subgroups (cont.) • Ideally, a formulary would cover every subgroup. However, since there are a number of specialized subgroups that only contain 1 RxCUI, then requiring every subgroup to be covered would be a requirement to cover specific RxCUIs, which is not a goal of the IDOI. To avoid this and to provide carriers more flexibility in designing their formularies, the IDOI will only require that 70% of the subgroups be covered for each disease state. • Example: ADHD has 23 subgroups and 179 RxCUIs. At least 70% of the 23 subgroups will need to be covered and since 0.7 x 23 = 16.1 then at least 17 subgroups (round up) will need to be represented by a covered RxCUI. This is a minimally restrictive requirement since it can be satisfied by covering 17 of the 179 ADHD RxCUIs.

10. FAQs • 1. The review contains products that only differ in dosage form and are still in separate Subgroups, please explain. • The subgroups for each disease state were carefully considered and created to balance flexibility for the carrier and coverage for all types of patients. Different dosage forms may be separated into different subgroups to ensure medication access for different patient demographics (pediatric or pregnant patients), potential drug interactions (higher or lower dose due to frequent concomitant use), minimization of adverse effects especially in disease states with public health concerns for the state of Indiana (infectious diseases), etc.  Occasionally, patient adherence (combination products or unique dosage forms) may have been used to create separate subgroups but our intent was to only do this in cases where clinical evidence clearly supports use.  We would be happy to reconsider specific circumstances if the carrier provides the medical literature that supports the interchangeability of a product.

11. FAQs • 2. Why does the state feel the need to add additional requirements to those already completed in the CMS review? Please address specifically the addition of other disease states such as sexual dysfunction. • This additional level of review provides checks not specified in the CMS tools. This includes additional disease states and a more comprehensive clinical review. Additional disease states have been selected that are of specific interest in the state of Indiana either by prevalence or other area of interest. The sexual dysfunction tool will not be utilized for 2019 plan review.

12. FAQs • 3. If the carrier meets a subgroup by covering a product under the medical benefit rather than the pharmacy benefit, will that satisfy subgroup requirements? • Yes. However, this information will need to be communicated to the IDOI. Two options for how to communicate this are: • A) Create a Medical Service Tier in the Formulary template and include all medical benefit drugs that are intended to cover subgroups in this tier. This would only need to be done for the medical benefit RxCUIs the carrier wants counted in this review. • B) Carriers can provide a list of RxCUIs that are covered under the medical benefit and indicate to which plans, products, or formularies these medical benefits apply.

13. Questions? We appreciate the constructive comments and questions we’ve received and we continue to refine this tool based on carrier feedback. Please continue to submit any questions or suggestions to us by email at: compliance@idoi.in.gov.