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 (statin)
• Cox-II agents (non-steroidal anti-inflammatory drugs)
• Leukotriene Modifier agents
• Enbrel

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 Innoviant 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 medication is Protonix. If the Plan Sponsor chooses the PPI Rx Instep Program, Protonix is covered at a preferred brand co-pay. The generic for Prilosec, omeprazole, as well as 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. Prevacid, Prilosec, Aciphex, and Nexium are not covered. No single drug works for 100% of the people for any therapeutic category and the same is true for the PPIs.

By offering two very solid choices with Protonix and the generic/OTC version of Prilosec, it is expected that greater than 90% of the patients will receive relief from their symptoms with one of these two agents. The estimated savings per claim by switching members from a non-preferred PPI to a preferred PPI is $35.00 per month. 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 medications in this category are Advicor, Crestor, Lipitor, and Vytorin. Lipitor has been our preferred product for five years and is the most widely used statin. Advicor, Crestor, and Vytorin are newly approved medications in the statin category and, along with Lipitor, are competitively priced. The cost per day for the preferred statin medications averages a dollar and one half less per day than Zocor. Zocor, Pravachol, Mevacor, and Lescol/XL are other brand statin medications in the cholesterol lowering class of medications. These medications are nonpreferred, and therefore not covered unless step therapy requirements are met. The step-therapy edits require patients to use Advicor, Crestor, Lipitor and Vytorin before using a nonpreferred statin medication. The estimated savings per claim by switching members from a nonpreferred statin to a preferred statin is $45.00 per month.

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 standard of care for asthma includes inhaled corticosteroid therapy. Inhaled corticosteroids work to reduce inflammation in the lungs. Luekotriene receptor blockers may offer benefit for treatment of asthma in selected patients. 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 asthma and allergy, the Innoviant Pharmacy & Therapeutics Committee has elected to add step-therapy requirements to Leukotriene Modifier Agents (Singulair and Accolate). Rx InStep edits require prior therapies or guidelines be met for the medication to be processed. The following guidelines were recommended for the leukotriene modifiers:

1. Documented diagnosis of asthma, or claim history for cromolyn, short-acting beta-agonists, long acting beta-agonists, inhaled corticosteroid or leukotriene modifier;
2. Age less than 19 years ;
3. Seasonal allergies, with history of treatment with antihistamine or nasal corticosteroid.

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 asthma treatments are listed on the preferred products listing: generic albuterol, generic cromolyn sodium, generic ipratropium nasal, generic metaproterenol sulfate, Advair, Asmanex, Atrovent inhaler, Azmacort, Combivent, Flovent, Foradil, Intal, ProAir HFA, Proventil HFA, Pulmicort, QVAR, Servent/LA, Spiriva, Tilade, and Ventolin HFA. The following allergy treatments are listed on the Preferred Products List: generic brompheniramine, generic chlorpheniramine, generic clemastine, generic cyproheptadine, generic diphenhydramine, generic fexofenadine, generic fluticasone nasal generic hydroxyzine, generic loratadine, Alavert/D, Astelin nasal, Atrovent nasal, Clarinex, Flonase, Nasonex, and Zyrtec.

Enbrel

Enbrel is approved by the FDA for the management of moderate to sever psoriasis, for patients where systemic or phototherapy is required. Medication history of methotrexate or oral psoralens is used to determine if the patient's diagnosis of psoriasis is of severity which necessitates systemic therapy. In the absence of history of such medications, clinical information will be obtained from the practitioner to approve treatment. Enbrel will be approved for other conditions including psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis, for which step-therapy rules do not apply.

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. The Prior Authorization Request Form is also available in the Members section of the Innoviant web site.

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.