Hepatitis C

Gilead Sciences' Harvoni represents the first once-a-day, complete treatment pill approved by the FDA to treat the hepatitis C virus (HCV). And for some patients, the drug will be less expensive than Gilead's other HCV treatment, Sovaldi.

While still being on the receiving end for the high cost of sofosbuvir, Gilead's combination pill for Hepatitis C (sofosbuvir + ledipasvir) was today approved by the FDA.

The approval follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).

The mid-stage trial was conducted in a small group of patients, but further studies will roll-out soon.

Bottom line: Sovaldi will not save the system money. It will cost money-a lot of money-to reduce premature mortality due to chronic hepatitis C infection.

Management of hepatitis C screening results can be optimized to ensure that patients receive high-quality care, reducing morbidity and costs related to the virus.

A new report suggests that the cost of hepatitis C (HCV) drugs -including Gilead Sciences Inc.'s $1,000-a-day treatment Sovaldi-will increase federal spending for Medicare Part D as much as $3 to $6 billion in 2015.

However, a point to note is that this was a small cohort study without a comparator arm.

The American Journal of Managed Care will host a two-day event September 25-26, 2014, to take on some of healthcare's biggest challenges: Treatments that cure hepatitis C are making news but upending balance sheets. A recent recommendation seeks preventive therapy to stop new cases of HIV. Hospitals and public health officials are grappling with how to prevent the spread of MERS. Only AJMC will bring payers, clinicians, policy leaders, and pharmaceutical representatives together to share ideas.

Specialty pharmaceuticals are currently the object of payer focus as one of the major drivers of increased pharmacy spending in 2014 and beyond.

Medicaid managed-care plans are demanding relief from state officials to meet mounting outlays for Gilead Sciences' wonder drug, while insurer WellPoint called Sovaldi its biggest watch item.

AJMC Panel Reviews Treatment, Cost Impacts of Emerging Shift to All-Oral Regimens With High Cure Rates

Doctors should consider expensive new hepatitis C drugs for patients with advanced liver disease, including those awaiting transplants, but ask most others to wait for drugs in development, the Department of Veterans Affairs said Wednesday.

Groundbreaking hepatitis C therapies represent a new era in treatment. But their cost is unprecedented, meaning health plans and PBMs are facing difficult formulary decisions.

While newer drugs used to treat hepatitis C virus may be more effective, they may not always be the best value option for patients. This is because the costs of emerging treatments can range from $60,000 to $80,000 per treatment course, and that cost undermines the ultimate goals of lowering healthcare costs in the US.

AJMC Panel Touts Shift from 'Chronic' to 'Cured' as FDA Gives Breakthrough Status to BMS All-Oral Combo Regimen

In the concluding segment, Dr Fendrick asks the panel to provide closing remarks about the future of treating hepatitis C (HCV). Dr Afdal says he believes this is a moment in time where a revolution is taking place.

Dr Fendrick says that while indication and utilization of major innovations should be widespread, there are still questions of who will pay for them. As mentioned, plan sponsors (employers) are only 1 option.

Dr Fendrick urges the panel to discuss which tools involving benefit design are being put into place to make sure that only those patients who would benefit most from new drugs are receiving them.

The panelists continue to debate whether hepatitis C virus (HCV) treatment should be administered by primary care physicians (PCPs) or hepatologists.

While some patients and physicians are not aware of the costs of care, others are concerned about whether they can afford treatment options at all. Dr Miller describes some of the major steps to the incremental benefits and incremental costs incurred by new agents.

Despite the relatively inexpensive 1-time tests to screen for hepatitis C virus (HCV), Dr Fendrick and the panel explore the concerns that plan sponsors may have regarding the costs of new specialty drugs made to treat HCV.