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Hepatitis C Treatment Guidelines Add Section on Cost-Effectiveness

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HCVguidelines.org, a regularly updated website providing U.S. guidelines for testing, managing, and treating people with hepatitis C, has revised several sections and added a new section looking at the cost-effectiveness of treatment using new interferon-free direct-acting antiviral regimens.

First launched in January 2014, HCVguidelines.org was developed by the American Association of the Study for Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with International Antiviral Society-USA (IAS-USA).

"This new section discusses the U.S. payer system, explains the concepts of cost, price, cost-effectiveness, value, and affordability, and reviews current evidence of the cost-effectiveness of strategies to improve access to treatment," according to a recent AASLD announcement. "It is important to note that this section is informational only and does not utilize cost-effectiveness analysis to guide recommendations at this time."

Traditionally, U.S. Food and Drug Administration drug approvals and treatment guidelines from U.S. medical organizations have not considered cost, aiming to recommend the best possible treatment regardless of expense. However, the high price of many new therapies is leading a growing number of medical professionals to take cost into account when discussing treatment options with their patients.

Guidelines Excerpt

The following new section of the HCV Guidance has been released, Overview of Cost, Reimbursement, and Cost-Effectiveness Considerations for Hepatitis C Treatment Regimens.

OVERVIEW OF COST, REIMBURSEMENT, AND COST-EFFECTIVENESS CONSIDERATIONS FOR HEPATITIS C TREATMENT REGIMENS

The Hepatitis C Guidance describes how to diagnose, link to care, and treat most groups of patients with HCV. (AASLD/IDSA/IAS-USA, 2015) However, a common challenge is reduced access to treatment caused by restrictions on drug reimbursement. This section summarizes the U.S. payer system, explains the concepts of cost, price, cost-effectiveness, value, and affordability, and reviews current evidence of the cost-effectiveness of strategies to improve access to treatment. Although these may sound similar and are often confused, the following discussion will seek to clarify these terms with regard to HCV therapy. To be clear, this section is informational. As explained below, actual costs are rarely known. Accordingly, the HCV Guidance does not utilize cost-effectiveness analysis to guide recommendations at this time.

Conclusions

Although the wholesale acquisition costs of HCV drugs often result in ICERs [incremental cost-effectiveness ratios] that make treatment appear unaffordable, the reality is that insurers, PBMs [pharmacy benefit managers], and government agencies negotiate pricing and few actually pay the much-publicized WAC [wholesale acquisition cost] (retail). However, the negotiated pricing and cost structure for pharmaceutical products in the U.S. are not transparent, and it is therefore difficult to estimate the true cost and cost-effectiveness of HCV drugs.

Whatever the actual current cost of HCV DAAs, competition and negotiated pricing have not improved access to care for many persons with HCV infection and continue to limit the public health impact of these new therapies. Insurers, government, and pharmaceutical companies should work together to bring medication prices to the point where all of those in need of treatment are able to afford and readily access it.

9/2/15

Source

AASLD, IDSA, and IAS-USA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. www.HCVguidelines.org. Updated August 20, 2015.