< Back

July, 2014

The Impact on Patients and Specialty Pharmacies of Evolving Payer Interventions to Manage Hepatitis C Agents

Speciality Pharma Journal, 6/2014

Management of Hepatitis C Treatments is a Top Priority
The approval of considerably improved therapies for hepatitis C has radically changed the treatment paradigm for patients while significantly increasing drug expenditures for payers. The need to mitigate rising costs while providing quality patient care is driving payers to intensify management efforts in a market that has traditionally faced limited access barriers and payer interventions. This article reports on recent research from Health Strategies Group that evaluated current and future payer dynamics that directly impact the market and patient access to hepatitis C agents.

Since the approval of the first-generation protease inhibitors (PIs), payer focus on hepatitis C management has spiked, moving this from among the lowest-priority categories to one of the most important (see Figure 1). Plans more closely scrutinize utilization trends, product differentiators, and contract offers when making access decisions in high-priority categories. Increased treatment options that sufficiently address clinical unmet needs also drive perceptions of a commoditized market and allow plans to leverage favorable access to gain contracting concessions from biopharmaceutical companies.

Plans are investing resources to ensure appropriate use and increase the likelihood of achieving a sustained viral response. On average, commercial plans are significantly more likely to use three or more interventions to manage use and access for hepatitis C agents than for other specialty categories. Notably, the percentage of plans using this level of intervention rose nearly 20 percentage points, from 57% to 75%, in the last year. If this trend continues, we can expect virtually all plans to be using multiple management tactics and interventions for hepatitis C products in the near future. 

Despite limited resources, many managed Medicaid plans have also steadily increased management of hepatitis C agents over the past few years. Specifically, the number of Medicaid plans utilizing five or more interventions to manage hepatitis C agents has nearly doubled every year since 2012.

Plan Interventions Mitigate Inappropriate Use and Influence Treatment Selection
High drug costs, potential for inappropriate or unsafe use, and defined protocols for achieving optimal success compel plans to rely heavily on prior authorization requirements to judiciously manage drug utilization (see Figure 4). PA criteria align closely with FDA-approved product labels and industry clinical guidelines. In addition, most plans limit initial authorization of current agents to 12 or fewer weeks to align prescribing with complex label specifications relating to patient type and clinical response.

Stricter oversight allows plans to mitigate costs due to early discontinuation of ineffective or intolerable therapies. Seeking to document and ensure accuracy of patient response, most plans evaluate actual medical records prior to approving continued use of hepatitis C agents. Plans’ investment of critical resources to conduct medical records evaluations emphasizes their high level of interest in mitigating costs through utilization management.

Plans also employ interventions to influence product selection, such as patient cost sharing differentials. Few plans use step therapy, a traditional utilization management tactic, to mandate use of a specific protease inhibitor, recognizing the necessity of providing treatment choice due to variations in side effects and individual patient characteristics (e.g., risk profile for resistance, duration of treatment length tolerance). However, many plans implement step edits for pegylated interferons due to long standing perceptions of interchangeability, setting a precedent for future management in this category.

Increasing Use of Payer Interventions Will Create Challenges for Broad Patient Access to Therapies
FDA approval of additional oral agents and CDC efforts to identify patients will expand utilization and increase plan expenditures. Growing cost pressures will influence plans to modify current approaches to managing hepatitis C agents by 2016.

Following the entrance of multiple interferon-free regimens, most plans will consider advantaging one or more through lower cost sharing and step edits, essentially restricting patient access to select regimens. In similar high-cost specialty drug categories with multiple poorly differentiated agents within classes (e.g., multiple sclerosis, rheumatoid arthritis), plans often mandate trials of a preferred brand. Plans perceive that a highly effective interferon-free regimen with a short treatment duration will adequately address critical unmet needs.

Coverage policies for off-label use of first-generation PIs have been relatively lenient due to the lack of treatment alternatives for patients failing the standard of care. However, potential doubling of price and strong demand for experimental regimens are likely to prompt policies that deny off-label use of future regimens in patient types where efficacious and tolerable treatment options already exist. In addition, most plans will implement treatment pathways that drive utilization to specific products according to genotype, including subgenotype, and prior treatment response. Plan management efforts seek to optimize outcomes and minimize therapy waste.

Payers Will Seek Increased Collaboration with Specialty Pharmacies
Health plans view specialty pharmacies (SPs) as partners to help improve patient outcomes while lowering overall costs. To most effectively increase SP use across patients, health plans mandate their use. Over the past five years, health plans that mandate SP use has increased in general; more specifically, nearly three-quarters of plans now mandate SP use to access hepatitis C products. This greatly increases specialty pharmacists’ access to patients and role with health plans in managing product use and ensuring patient adherence and compliance

Payers Will Seek Increased Collaboration with Specialty Pharmacies
Health plans view specialty pharmacies (SPs) as partners to help improve patient outcomes while lowering overall costs. To most effectively increase SP use across patients, health plans mandate their use. Over the past five years, health plans that mandate SP use has increased in general; more specifically, nearly three-quarters of plans now mandate SP use to access hepatitis C products. This greatly increases specialty pharmacists’ access to patients and role with health plans in managing product use and ensuring patient adherence and compliance

Authors:

Fiona Frascella, Senior Consultant, Health Strategies Group

Tucker Hurtado, Senior Consultant, Health Strategies Group

 

Disclaimer

 

Please complete the form to have this document sent to your email.

 

Please complete the form to have this document sent to your email.