Oral Chemotherapy & Split-Fill Program
Posted: Jan 18 2016

Oral Chemotherapy Overview

As the medication pipeline continues to move toward specialty medications, chemotherapy agents are a prominent category. In 2015, 14 of the 45 novel agents approved by the FDA were for the treatment of cancer.1

Traditionally, chemotherapy has been administered to patients intravenously (IV) in hospitals or clinics. This administration method, while generally effective, can be burdensome to patients who are required to make multiple trips to clinics and spend hours having medications infused. Oral chemotherapy agents are a relatively new and more convenient treatment option. They are administered in tablet or capsule form, dispensed from an outpatient pharmacy and in many cases, eliminate or reduce the need for frequent clinic visits while still offering effective treatment options. Several products are now available only in oral dosage forms; no equivalent alternative is available for administration in a clinic or hospital setting.

The cost of these agents is significant. The monthly cost for a single oral chemotherapy medication can easily exceed $10,000. Consequently, the need for programs that ensure clinically appropriate use and prevent medication waste is substantial.

Side Effects and Medication Adherence

From a patient perspective, oral chemotherapy medications are perceived to be safer and less toxic than their IV counterparts.2 This perception is not accurate. While a handful of oral agents may be associated with fewer side effects, most have a side effect profile that is as significant as traditional IV chemotherapy. Common side effects may include nausea and vomiting, fatigue, diarrhea, weight loss, hair loss, mouth ulcers, severe rashes, and alterations in red or white blood cell counts. These adverse reactions may be severe and/or life-threatening when not correctly identified and managed appropriately. For this reason, side effects are a key reason for patient non-adherence and early medication discontinuation. Considering the extremely high cost of these oral therapies, non-adherence and early medication discontinuation represent a significant financial burden to the healthcare system.

Split-Fill Programs3

The severe side effects often associated with oral chemotherapy are a major driver for early medication discontinuation. As with all prescription medications, oral chemotherapy that has been dispensed from an outpatient pharmacy cannot be returned to the pharmacy even if the patient can no longer take the medication, and is therefore discarded and wasted. The goal of a split-fill program is to reduce or eliminate such waste. Under a split-fill program, pharmacies may only dispense a partial supply (typically 15 days or less) of certain medications that are known to have high discontinuation rates. As a result, when a patient cannot tolerate a medication and is forced to discontinue therapy, less medication is wasted and total costs are reduced. During the year beginning in fourth quarter 2014, MedTrak plans experienced nearly $100,000 in cost avoidance as a result of the split-fill program. Fifteen patients had to discontinue therapy early due to medication side effects, and their plan sponsors were able to avoid the cost of their unused medication.

MedTrak’s Cost Management Strategies

  1. Oncology Split-Fill Program - In order to minimize medication waste and reduce Plan costs, MedTrak utilizes a split-fill program for select oral chemotherapy medications. As part of this program, MedTrak’s Clinical Care Center targeted 14 oral chemotherapy medications that associated with high discontinuation rates due to side effects. An additional five agents will be added to MedTrak’s split-fill list on February 1, 2016 – bringing the total number of agents targeted for split-fill to 19. These agents are listed in the table below. The program allows members to receive up to a 15 day supply of medication for the first 12 weeks of therapy. Copayments are adjusted proportionately for each prescription so that members are not penalized for the increased fill frequency. Members who are able to tolerate therapy after this introductory period will be permitted to fill a standard 30 day supply of medication moving forward.
    Note: MedTrak’s Oncology Split-Fill Program will only be applied to Plans who have opted to utilize MedTrak’s BIC Pharmacy Network.
  2. Prior Authorization – Nearly all oral chemotherapy agents are considered specialty medications and are subject to Prior Authorization (PA). PA criteria for these agents is developed by MedTrak’s Clinical Pharmacists. Key information evaluated as part of the PA process may include, but is not limited to: appropriate diagnosis, specific laboratory values, prior failed therapies, concurrent therapy, and genetic testing for specific mutations. The highly specific nature of MedTrak’s PA criteria for this category ensures clinically appropriate and cost-effective use of oral chemotherapy medications.

Oral Chemotherapy Agents Subject to MedTrak’s Split-Fill Program 3

Product NameCost Per Month (AWP*)Split-Fill Program Potential Savings Per Month (AWP*)
New Agents Subject to Split-Fill as of February 1, 2016
Product NameCost Per Month (AWP*)Split-Fill Program Potential Savings Per Month (AWP*)

*Doses, quantities, and subsequent total costs and/or potential savings will vary based on patient diagnosis and response to therapy. Based on pricing as of 1/5/2016.

  1. New Molecular Entity and New Therapeutic Biological Product Approvals for 2015. Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm. Accessed January, 5, 2016.
  2. Weingart S, Brown E, Bach P, et al. NCCN Task Force Report: Oral Chemotherapy. Journal of the National Comprehensive Cancer Network. 2008; 6 (3).
  3. DRUGDEX® System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com (cited: January 5, 2016).

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