USPSTF: Lifestyle Counseling Advised for Overweight, Obese Adults With Other Cardiovascular Risk Factors
Authors: Joan Stephenson
Journal: JAMA (2014)

High Costs, Limited Data A recent review of the comparative evidenceandcost-effectivenessofnewerHCV therapies raised important questions about the value of these drugs to patients and the health system. PatientswithHCVhave long faceddifficult treatmentoptions.Until a fewyearsago, pegylated interferon with ribavirin was the best treatmentoptionavailable,accordingto the review (Ollendorf DA et al. JAMA Intern Med. 2014;174[7]:1170-1171). This treatment cured about half of those with genotype 1 HCV,but it requiredayearof therapyandoften caused serious adverse effects that led many patients to drop out of treatment. Improvedoptionscamealongin2011 intheform of thedirect-actingantiviralsboceprevir and telaprevir used in combination with pegylated interferonandribavirin,buttheseregimens required numerous pills and posed an even greater burden of adverse effects. Theapprovalofsofosbuvirandsimeprevir last yearofferedpatientshopeof shorter, simpler treatment regimens and a cure rate greater than80%(KohliAetal. JAMA. 2014; 312[6]:631-640). However, limited comparative effectivenessdata are available for these 2 new drugs. Sofosbuvir was approved through the US Food and Drug Administration’s “breakthrough” drug pathway, which allowed the drugmaker to drop comparator groups from some of its trials, explained Daniel A. Ollendorf, MPH, of the Institute forClinical andEconomicReview in Boston.Simeprevir alsohasa lowercure rate of 58% for patients with genotype 1 HCV who have certain genetic variations. Countering the good news of faster and easier treatment is its steep price. In California alone, Ollendorf and colleagues estimated that the costs ofHCVcare could jump from$12billion to $34billion in the first year. Over the longer term, reductions in costs for liver complicationswould offset someof the expense,butthenewregimenswouldstilladd $6 billion to treatment costs in the first year theyareavailable.Onlyofferingthenewtherapies to those with advanced liver disease, however, could save $1 billion over 20 years. One of the challenges of trying to treat only thoseat greatest risk is that it canbedifficult to predict who will develop complications, explainedOllendorf. Clearing the virus in all patients would be optimal, he said, and wouldalsoreducetheriskoffurthertransmission.However,thehighcostsofthedrugmake suchwidespread treatment unaffordable. “Unless theprices of the newdrugs decrease, public and private insurers face an untenable spike in short-termcosts andwill be forced todevelop stringent patient eligibility criteria as the onlyway tomanage the tension between access and affordability,” Ollendorf and colleagues concluded. Ollendorf explained that it is not unusual forcertaincancermedicationsor treatments for rare diseases to carry price tags similar to sofosbuvir’s. But HCV affects a much larger population of patients,making its costs a bigger shock to the system. While the professional groups’ guidelinesidesteppedthe issueofcosts,oneof the panel members acknowledged during the press conference that thenewdrug’s cost is “the elephant in the room” that underscores the need to prioritize its use. “We understand the system is struggling because the medication is expensive, andweneedtogivesomeprioritization,”said Michael Saag, MD, of the University of Alabama at Birmingham and a cochair of the panel, representing IAS-USA.