Increases in Utilization Management of Oncology Medicines by US Payers

ABSTRACT

Objectives: To determine the aggressiveness of current payer oncology management techniques

Study Design: Zitter Health Insights’ (ZHI) Prior Authorization Tracking Tool is a subscription data service that monitors and analyzes details of managed care PA policies for a wide range of therapeutic categories. Policies are collected on an ongoing basis and analyzed by drug and payer.

Methods: The cancer subtypes highlighted in this article—chronic myelogenous leukemia, melanoma, and prostate cancer—were selected because they exemplify a variety of reasons for the initiation of utilization management (UM) policies, in addition to recent expansion of therapies available for treatment. ZHI analyzed hundreds of policies covering approximately 95% of all insured lives in the United States for these tumor types, between 2013 and 2014.

Results: Utilizing Zitter Health Insights’ Prior Authorization Tracking Tool, we found an initiation of a movement toward a more stringent payer UM of branded medications across a variety of cancer subtypes. Specifically, we showed that UM stringency correlates with increased numbers of therapies indicated for a given oncology subtype.

Conclusions: We anticipate that the observed shift found in oncology UM represents a larger trend, and will continue to propagate in payer organizations as more competitive treatments enter the oncology market. Further research is needed to determine the impact of these increased restrictions on patient access, outcomes, and long-term costs.

Am J Pharm Benefits. 2015;8(1):e9-e13

PRACTICAL IMPLICATIONS

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In recent years, payer organizations in the United States have begun changing their oncology utilization management (UM) practices. Utilizing Zitter Health Insights’ (ZHI) Prior Authorization Tracking Tool, we observed increasing use of payer UM of branded medications using a range of UM tools across a variety of cancer subtypes.¹

Specifically, we showed that heightened UM stringency correlated with increased numbers of therapies indicated for a given oncology subtype. We illustrated this trend using data for chronic myelogenous leukemia (CML), melanoma, and prostate cancer (PRC). We expect that the observed shift in oncology UM for these cancer subtypes represents a larger trend that will continue as payers seek to control rising treatment costs by deploying increasingly sophisticated UM tools and more competing treatments enter the oncology market. Further research is needed to determine the impact of these increased restrictions on patient access, outcomes, and long-term costs.

Historically, payers have been reluctant to apply UM criteria to oncology medicines due to the serious nature of the disease and general lack of treatment alternatives. However, as reflected in recent literature and oncologist surveys,² this has been changing over the past several years. Factors influencing this shift include federal health reform, increased pressure on health plans to control costs, and increased opportunity for more UM as a result of new product introductions, including more oral oncolytics and competing products with the same indication and/or mechanism of action (MOA).^3,4

As these market options increase, payers are developing UM policies to leverage competition among manufacturers. Although payers see these strategies as ways to save cost without disrupting patient outcomes, many physicians and patient advocacy organizations stress the need to maintain flexibility in prescription options to achieve optimal clinical outcomes, particularly as more molecular diagnostics and treatment combinations are adopted.

Thus, as payers develop UM strategies that implement limitations based on cancer type, concomitant use, and restrictions to specific lines of therapy, many recognize the importance of harmonizing their efforts with the interests of physicians and cancer patients.⁵ However, further research is needed on the extent to which UM strategies actually achieve this objective in practice.

Payer UM strategies include step-edits, prior authorizations (PA), and other tools to manage use or restrict access to certain oncology medicines. These tools may or may not be more limiting than the prescribing information in the FDA-approved package insert (PI), depending on payer utilization objectives—restrictions that are more limiting than the FDA-approved PI typically require the patient to meet additional diagnostic criteria and/or provide prescription claims data to confirm treatment history.

For example, step-edits may require trial and failure of a preferred treatment before authorizing subsequent drug therapies, and PA requires the doctor to contact the insurance company on behalf of the specific patient and make a reviewable case for the need for a specific medication—the latter case may require step-edits, lab results, and/or specialist prescriptions.

Although common in the nononcology space, patient cost-sharing has broader benefit design implications that make its application more difficult in oncology management. For example, cancer therapies administered in a provider’s office, and reimbursed under a medical benefit, have a fixed percentage of the cost to be shared (often 20%, up to a cap).⁶ Traditionally, for a given health plan, this applies to not only cancer therapies, but all provider-administered therapies, offering payers no ability to differentiate between medicines based on clinical or financial factors.

These facts notwithstanding, plans appear to be exposing patients to increased cost-sharing for oncology medicines. In contrast, UM tactics can be targeted to individual therapies, and therefore are the primary approach currently used by payers for oncology. This analysis does not examine additional emerging UM strategies in oncology.

ZHI’s Prior Authorization Tracking Tool is a subscription data service that monitors and analyzes details of managed care PA policies for a wide range of therapeutic categories.¹ ZHI analyzed hundreds of policies covering approximately 95% of all insured lives in the United States for the tumor types discussed above, between 2013 and 2014. This tool is able to trend and make direct comparisons across payers and drug management by abstracting each payer policy in a consistent format and grouping them into 5 phases (Figure 1) that describe distinct levels of stringency for the UM tools.

These phases range from phase 1, with payers requiring few to no PAs required, to phase 5, where management is more restrictive than the label and provide a basis for evaluating the evolution of UM restrictions. The cancer subtypes highlighted in this article—CML, melanoma, and prostate cancer—were selected because they exemplify a range of reasons for changes in UM policies, and have each had a recent expansion in the number of therapies available for treatment. Based on the diversity of these cancer subtypes, we anticipated that the trends found here would be likely to occur in other cancer types undergoing a surge in treatment options. Note that this analysis focused on changes in commercial payer UM, as this segment of insurance coverage is the most dynamic in response to market changes.

RESULTS

The UM criteria for CML treatment have shown recent coinciding with the introduction of multiple medications with the same mechanism of action (MOA). The primary MOA of all 5 FDA-approved CML targeted therapies is inhibition of tyrosine kinase,⁷ an enzyme intimately involved in the activation of cellular growth. Due to this similarity, payers are increasing the use of step-edits, and restrictions more limiting than the PI, within the CML space to encourage the use of their preferred therapy.⁷

This increase in management is observed on both the individual therapy level and the class overall. As shown in Figure 1 (a), since Q1 2013, there has been a 29-percentage point increase in the percent of CML-covered lives with payers reporting phase 5 management, thus driving management to more restrictive than PI. Figure 2 (a) shows the change in management of a TK-inhibitor therapy between Q1 2013 and Q3 2014. In Q1 2013, 12% of covered lives were subject to restrictions beyond the CML TKI’s indicated label, and by Q3 2014, these restrictions had jumped to 26% of covered lives. Overall, the CML indicated therapies have undergone a steep increase in payer management.

Growth in UM for melanoma therapies exemplifies both payer-initiated requirements to satisfy clinical criteria for drug coverage and manage multiple treatment options. Genetic testing can show if treatments designed to work on cancer with specific genetic mutations, such as BRAF gene mutations, may be effective. If a genetic mutation is found in the BRAF gene, patients are more likely to be treated successfully by BRAF or MEK inhibitors. By utilizing genetic screening, payers can restrict access to BRAF/MEK-based medications to patients most likely to benefit from these treatments.⁸

Additionally, for BRAF mutation—negative melanoma, multiple immunotherapy options have also driven increased management. Figure 2 (b) shows an example of a specific immunotherapy agent that has experienced an 8-percentage point increase in the share of covered lives facing restrictions that are more stringent than the prescribing information in the label from Q1 2013 to Q3 2014. The increase from 44% of covered lives to 62% between Q1 2013 and Q3 2014 (Figure 1 [b]) indicates that payers are increasingly requiring PAs on all melanoma drugs and leveraging differential tier placement to distinguish the medicines from one another.

Available treatment options for prostate cancer (PRC) also have grown in recent years and now include immunotherapy, chemotherapeutic agents, radioactive treatments, and several antiandrogen hormone therapies. To clinically and/or financially drive use to the preferred drugs, payers are implementing step-edits, particularly for the hormone-based therapies.⁹

Between Q1 2013 and Q3 2014, payers introduced step-edit management for conventional chemotherapeutic drugs and/or through other hormone therapies, affecting 34% of covered lives (Figure 2 [c]). PRC medications, overall, have seen an increase in payers driving preferred therapies, with more than one-third of covered lives now more restrictive than the product insert in Q3 2014 (Figure 1 [c]). The increase in PRC UM exemplifies the extent to which payers can rapidly adopt new UM tools as treatment options expand and evolve.¹⁰

DISCUSSION

The significant shift toward more, and more stringent, UM for these 3 cancer types illustrates payers’ growing ability to apply UM in oncology generally, and in categories with multiple treatment options in particular. This, however, may come at the expense of broad patient and physician access to individual therapies. In all of the cases analyzed here, more restrictive management has meant limits on coverage for the use of drugs that go beyond each product’s label, and increased step-edits and PA requirements. To the extent these policies reflect standard of care and variability in patient needs and preferences, such restrictions may have no impact on patient outcomes while reducing overall costs.

To the extent that restrictions obscure differences in patient treatment response or individual treatment goals, these policies may negatively impact clinical and/or other outcomes (eg, quality of life, productivity). If patient outcomes are negative, payers may realize an increase in patient cost and administrative costs associated with enforcing UM criteria. Currently, there is little evidence to shed light on this issue; based on the data provided in this commentary, we expect to see increased UM activity by payers for branded oncology drugs. Additional research needs to be done to elucidate whether, and how, increasing payer UM affects patient outcomes and total cost.

CONCLUSIONS

Payer management of oncology medicines has increased steadily over time across various oncology subtypes. This has been driven by a range of factors, including regulatory changes and increased pressure to contain cost, combined with new opportunities to deploy more sophisticated UM strategies in areas where multiple treatment options are available.

These strategies have included more restrictive utilization management, including step-edits, prior authorizations, tier differentiation, restrictions that go beyond product labels, and designation of preferred medicines. Notably, drugs for CML, melanoma, and prostate cancer have seen meaningful shifts to policies more restrictive than their labels for select oncology medications over a relatively short period of time.¹ Further research is needed to determine the impact of these increased restrictions on costs, provider choice, and patient outcomes.

Author Affiliations: Zitter Health Insights, Livingston, NJ (MH) and San Francisco, CA (MZ); Branding Science (NK), San Francisco, CA; IMS Consulting Group (AR), New York, NY.

Funding Source: Funded by PhRMA.

Author Disclosures: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (NK, AR, MH, MZ); acquisition of data (NK, AR, MH); analysis and interpretation of data (NK, AR); drafting of the manuscript (NK, AR, MZ); critical revision of the manuscript for important intellectual content (NK, AR, MZ); statistical analysis (AR); obtaining funding (MZ); administrative, technical, or logistic support (NK, MH, MZ); and supervision (MH, MZ)

Send correspondence to: Melinda Haren, RN, 290 West Mt. Pleasant Ave, Ste 2210, Livingston, NJ 07039. E-mail: mharen@zitter.com.

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