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Programs Raise Awareness of Risks Associated with Testosterone Replacement Therapy

Online First - Online First, Genitourinary Cancers
Chase Doyle

Two pilot programs aimed at reducing the utilization of in­appropriate testosterone replacement therapy, particularly in the treatment of men with age-related hypogonadism, have shown success in raising awareness of evidence and safety concerns.

Presented at the 2015 annual meeting of the Academy of Managed Care Pharmacy, the study sought to determine the influence of educational efforts on provider practice patterns and internal practice guidelines, as well as patient interest in evidence-based assessments of their medications, as gauged by website views, survey responses, and e-mail sign-ups. The initial goal of researchers was to coordinate with a regional health system to improve the quality of care and reduce prescription costs; however, based on early findings, a broader outreach program was initiated to develop patient-centered tools.

“Although challenging, partnerships between health systems and health plans may lead to improved quality of care and lowered costs,” reported Kevin L. Chang, PharmD, Clinical Pharmacist Consultant at OmedaRx, Portland, OR. “Based on website visits, it appears that [health plan] members are interested in evidence-based assessments for the therapies they are currently taking.”

Utilization of testosterone replacement therapy has increased significantly over the past several years, Dr Chang noted. From 2010 to 2013, the number of patients in the United States who received a prescription for a testosterone drug rose from 1.3 million annually to 2.3 million annually. Much of this increase, however, has come in men with age-related hypogonadism, a population in whom therapy offers an unclear benefit and poses a potential risk of heart attack or stroke.

“Critical appraisals of the evidence by OmedaRx have concluded that [testosterone replacement therapy] does not provide a clinically meaningful benefit in men with age-related hypogonadism, and there may be a potential cardiovascular risk,” reported Dr Chang.

In a March 2015 Drug Safety Communication, the US Food and Drug Administration (FDA) emphasized this assessment, cautioning against the use of testosterone replacement therapy for age-related hypogonadism, and stating that labeling changes will be required to inform patients and providers of possible increased risk of heart attack and stroke.

Pilot Programs

Before the FDA announcement, the 2 pilot programs were developed with the goal of increasing awareness related to evidence and safety concerns of using testosterone replacement therapy for age-related hypogonadism. The first program, a health system initiative, included commercially insured members with membership attributed to a single health system located in the Pacific Northwest, Dr Chang reported. Members were identified via OmedaRx pharmacy claims.

“Targeted chart reviews were performed to analyze prescribing trends and adherence to institution-specific clinical guidelines,” Dr Chang explained. “Recommendations on specific patient cases were made based on national practice guidelines.”

These potential recommendations included confirming a diagnosis, performing follow-up laboratory monitoring, and following up on symptom improvement. An educational in-service was also provided to clinical staff to report findings and describe the current state of the evidence, including a critical appraisal of the evidence that had been previously performed by OmedaRx.

The second program, the informational initiative, used Regence Pharmacy claims to identify male, commercially insured members who initiated therapy with any testosterone drug between September 1, 2014, and December 31, 2014. Researchers designed a 1-page informational mailing and website to highlight a lack of evidence for the use of testosterone replacement therapy in men with age-related hypogonadism and provide information on the potential safety concerns to these members.

Health System Initiative

The majority of the charts reviewed was consistent with internal guidelines, according to Dr Chang. Because of recent implementation of a new electronic medical record system, however, historical data on initiation of therapy were not available for all members. Of the 21 charts reviewed in December 2014, recommendations were generated for 7 patients. At the time the study results were presented, health system staff had not yet implemented these recommendations.

“Two patients were noted to have discussed the safety and efficacy with the prescribing physician based on news related to [testosterone replacement therapy] they had read,” noted Dr Chang. “Based on these findings, it was hypothesized that a broader, patient-focused, educational initiative would bring value to members currently on therapy.”

Informational Initiative

Of the 311 members who met inclusion criteria to receive the informational mailing, 27% had initiated therapy with a brand drug and 72% had initiated therapy with a generic drug (1% had utilized a compounded product). As of March 4, 2015, Dr Chang reported that the informational website had received 58 visits.

“Of the references listed,” Dr Chang noted, “the FDA summary Minutes from the Advisory Committee meeting on [testosterone replacement therapy] was visited the most. However, clicks for all references were relatively low.”

Future Research Opportunities

The impact of either intervention on pharmacy costs had not yet been fully captured, Dr Chang indicated. In addition, the informational initiative did not have a control group, so it is unknown how much of a change in pharmacy costs would be attributable to the intervention.

“We will continue to monitor the impact of the health plan–health system partnership and compare results to other health systems that did not receive any outreach,” Dr Chang concluded. “We will also look to explore different ways of presenting evidence-based assessments to broader groups of patients and providers.”

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Last modified: November 9, 2015