Innoviant Rx InStep Programs for Cost Management

Our commitment to offering programs that deliver economic value is second to none. Providing you with options that promote appropriate use and achieve cost savings, creates new pathways that allow administrative control beyond that of a standard formulary.

Our Rx InStep (step-therapy) programs provide additional tools to manage pharmacy benefit costs. In presenting options for cost management, Innoviant offers programs that have minimal or no impact to the member as well as programs that have a visible impact to the member. Most step-therapy edit programs are going to have a noticeable impact on members. We work diligently with plan sponsors, physicians, pharmacies and members to ensure this impact is minimal and short-lived.

Overview of Intent

Within a therapeutic category, there may be a number of products that deliver similar clinical value (the desired safety and the desired effectiveness). In considering acquisition cost and/or rebate opportunities, the products could have different economic impact to the plan sponsor's cost.

• Proton Pump Inhibitors
• HMGs (statins)
• Cox-II agents (non-steroidal anti-inflammatory drugs)
• Leukotriene Modifier agents
• Incretins (GLP-1 Agonists)

These step-therapy programs employ "smart edits" that require patients to use a preferred product in that therapeutic category, and preferred status is awarded to products that deliver good clinical value as well as the best economic value for the plan sponsor.

Access to Innoviant Rx InStep programs is not limited by benefit design. Any Standard (open) or Select (three-tier) plan design benefit has the ability incorporate these programs.

As we discuss the Rx InStep programs, you will hear reference to the Pharmacy & Therapeutics (P&T) Committee. The P & T Committee governs the Innoviant Preferred Products List and step-therapy programs. The P & T Committee considers FDA recommendations, published clinical recommendations as well as manufacturer package labeling instructions. A medication's benefit and net cost are the primary factors for placing a medication on a step-therapy edit program.

Within each category, the preferred medications referenced are listed on the Innoviant Preferred Product List (PPL), also known as a formulary. The nonpreferred medications are not listed and are subject to the Rx InStep program edits.

Gastrointestinal Agents

In the class of Proton Pump Inhibitors (PPIs) the preferred brand medications are Nexium and Kapidex. The generic PPIs, lansoprazole, omeprazole and pantoprazole are also covered. If the Plan Sponsor chooses the PPI Rx Instep Program, Nexium and Kapidex are covered at a preferred brand co-pay. The generic PPIs, and the Over-The-Counter version of Prilosec (Prilosec OTC) are covered at the generic co-pay. Prilosec OTC coverage is dependent upon the Plan Sponsor's choice to cover Prilosec OTC through Innoviant's Rx OTC Program. Nonpreferred brand products, Aciphex, Prevacid, Prilosec, Protonix, and Zegerid are not covered unless step therapy requirements are met.

No single drug works for 100% of the people for any therapeutic category and the same is true for the PPIs. By offering a variety of choices with Nexium, Kapidex, the generic PPIs, and the OTC version of Prilosec, it is expected that greater than 90% of the patients will receive relief from their symptoms with one of these agents. The estimated savings per claim by switching members from a non-preferred PPI to a preferred PPI ranges from $35 to $100 per month depending on product chosen. Depending on the patient's diagnosis, these medications are generally taken for a long duration of time with periodic evaluation by the prescriber.

Cholesterol Lowering Agents - statins

Products in the category of HMG medications (a.k.a. statins) are taken for extended periods of time. The preferred brand medications in this category are Advicor, Crestor, Lipitor, and Vytorin. Lipitor has been a preferred product for several years and is the most widely used statin. Advicor, Crestor, and Vytorin are also preferred brands in the statin category, and along with Lipitor, are competitively priced. The cost per day for the preferred statin medications averages $1.00 less per day than the average of nonpreferred brands Lescol/XL, Altoprev, Livalo, Zocor, Pravachol, and Mevacor. The average cost per day of treatment with one of the generic statins (lovastatin, pravastatin and simvastatin) is $2.80 per day less than the nonpreferred brands. As nonpreferred brands, Lescol/XL, Altoprev, Livalo, Zocor, Pravachol, and Mevacor are not covered unless the step therapy requirement is met. The estimated savings per claim by switching a member from a nonpreferred statin to a generic or preferred brand statin ranges from $30.00 to $84 per month depending on the product chosen.

Cox-II Medications

Within the class of non-steroidal anti-inflammatory drugs (NSAIDs) are Cox-II medications. These agents are reserved for use as second-line therapy, or for high-risk patients, as recommended by the P&T Committee. All generic NSAIDS are preferred. All branded NSAIDs are nonpreferred. The Cox-II medication Celebrex is subject to step-therapy edits.

Introduced in 1998, the medications known as Cox-II agents have demonstrated the ability to reduce the incidence of gastrointestinal bleeding in the general population by only 0.5% to 1.0% vs. traditional therapies such as ibuprofen and naproxen. In numerous studies, the Cox-II agents have not demonstrated superiority over traditional therapies at relieving pain or reducing dyspepsia (gastrointestinal discomfort). Any generic NSAID is significantly less expensive than any of the Cox-II medications. Based on clinical and economic data, the following criteria need to be met in order for a patient's prescription for a Cox-II medication to be approved:

• Patient is over age 60, or
• Patient is on another arthritis medication, or
• Patient is taking corticosteroids, or
• Patient is taking anti-coagulant medication(s), or
• Patient has already tried two generic NSAID medications, or
• Patient has taken Bextra or Celebrex in the past

The Rx InStep edits will automatically allow a prescription for Celebrex if any of the criteria are met (claim review edits will consider the last six months of medication history). If claim history is not available or is insufficient, a completed Prior Authorization request form will be required from the prescribing physician. Approved requests will be accompanied with a recommendation to use Celebrex, when appropriate. This decision is based on precautions and price.

Leukotriene Modifier Agents

The leukotriene receptor blockers, Accolate and Singulair are approved for the treatment of asthma. Singulair may also be used for the treatment of exercise-induced bronchoconstriction and for the relief of the symptoms of allergy. Both agents will be covered for members with a confirmed diagnosis of asthma, and Singulair will also be covered to prevent exercise-induced bronchospasm.

The standard for allergy treatment includes nasal corticosteroids and oral antihistamines. At this time, the Average Wholesale Price (AWP) for leukotriene modifiers is significantly greater than for nasal corticosteroids or antihistamines. Based on the efficacy of other available products to treat allergy, the Innoviant Pharmacy & Therapeutics Committee has elected to add step-therapy requirements for Singulair when used in the treatment of allergies. Rx InStep edits require prior therapies or guidelines be met for the medication to be processed. The following guidelines were recommended for Singulair allergy treatment:

1. History of one formulary intranasal steroid (fluticasone, Nasonex, Veramyst)
   
   OR
   
   
2. History of one formulary non-sedating antihistamine (fexofenadine, loratadine**, Alavert/D**, cetirizine**, **as part of the RxOTC program)
   
   OR
   
   
3. For patients less than or equal to 18 years of age.

If a patient meets one or more of the above criteria, the claim will process at the brand co-pay. If one of the above criteria are not met, the claim will deny.

The following allergy treatments are listed on the Preferred Products List: brompheniramine, chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, fexofenadine, hydroxyzine, loratadine**, Alavert/D**, and cetirizine** (**as part of the RxOTC Program). Preferred agents in the Allergy-Intranasal category include fluticasone, ipratropium, Astelin, Astepro, Nasonex, Patanase, and Veramyst.

Diabetes Agents – Incretins (GLP-1 Agonists)

Several types of medications are available for the treatment of type 2 diabetes mellitus. Innoviant includes all available generic oral antidiabetic agents, including glipizide, glimepiride, glyburide, and metformin at the tier 1 copay. Several branded oral medications, including Actos, Actoplusmet, Avandamet, Avandia, Avandaryl, and Duetact, have preferred status. Additionally, the insulin products, Novolin, Novolog, Humulin, Humalog, and Lantus are also preferred brands.

Within the last several years, a new type of self- injectable medication, GLP-1 agonists, have become available for the treatment of type 2 diabetes mellitus. GLP-1 agonists are long acting versions of naturally occurring hormones, known as incretins, which stimulate the release of insulin from pancreatic cells when glucose is present. Byetta, the first GLP-1 agonist to be marketed, has preferred status through the Innoviant pharmacy benefit, and is included in the Rx InStep program because it is usually prescribed after therapeutic failure with oral antidiabetic agents and insulin. As part of the Rx InStep program, Byetta is not covered unless a member has tried any combination of two generic or preferred brand agents listed above. Victoza, a GLP-1 agonist released in 2010, is a nonpreferred agent and will not be covered unless a member has tried Byetta first.

Regulations and Exceptions

For all Rx InStep edit programs, smart edits determine if the patient has tried and failed therapy on the preferred medication in the past. In those cases, the step smart edit will allow the patient to utilize their prescription benefit to purchase a nonpreferred medication automatically.

If the claim information is not available in the online claim system (i.e. new members to the plan) then the edit cannot verify that the patient has tried the preferred medication and the claim will not automatically process using the prescription benefit. In such cases a Prior Authorization (PA) review is in order. The PA can be initiated by contacting the Innoviant customer service center. The customer service center will provide the PA form to the prescriber's office. On the PA form the prescriber should indicate which (preferred) medication the patient has tried and failed in the past. Clinical review of the PA request will be performed and if the criteria for approval are met, the patient will be able to use their prescription benefit to obtain a nonpreferred medication.

While the PA process may seem cumbersome, it is required only once for each medication. These are medications that may be filled on a monthly basis for years to come. Long term savings to the plan for successfully switching members to preferred products will be substantial.

If you are interested in more information, or to discuss potential plan savings projected through implementation of one or more of the Rx Instep programs please contact us.