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As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.
Pharmacy benefit manager Prime Therapeutics released research outlining how proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, meant to lower low density lipoprotein (LDL), could cost the US health system up to $23.3 billion per year. Two PCSK9 inhibitors in particular-Regeneron and Sanofi’s Praluent (alirocumab), and Amgen’s Repatha (evolocumab)-are of interest because an FDA advisory committee will meet to discuss them in June 2015. FDA will review PCSK9 inhibitor Praulent first, on June 9, 2015, and Repatha will be reviewed one day later, on June 10, 2015. The FDA advisory committees will review each drug’s nonclinical background, efficacy and safety, clinical efficacy, and clinical pharmacology profiles.
In the research released by Prime, the addition of these drugs to the marketplace could increase per member per month (PMPM) costs by $0.93 to $6.71 in commercially insured coverage costs, and up to $15.66 PMPM in Medicare coverage costs. The drugs, if approved, would primarily be used to treat familial hypercholesterolemia, but could also be approved to lower cholesterol in for a larger population of patients who are statin intolerant. Estimates of the potential drug prices are between $7000 and $12,000 per year. In a model to estimate the number of members who may use these products, Prime used an estimated cost of $10,000 per year and reviewed pharmacy and medical claims of commercially insured and Medicare Part D members in 2014 and 2015.
Prime developed three scenarios for approval of PCSK9s and “forecasted potential use and associated costs among Prime’s commercial population at one year after launch.” The first scenario includes an increase of $0.93 PMPM if approved to treat patients with familial hypercholesterolemia with an intolerance or resistance to traditional statins. If approved for this indication, an estimated 112 per 100,000 commercially insured patients could receive the drugs at this cost. The second scenario includes approval for the treatment of familial hypercholesterolemia with an intolerance or resistance to traditional statins and approval for secondary prevention in patients with cardiovascular disease “who are at high risk and are statin intolerant or resistant.” This scenario would affect an estimated 395 per 100,000 commercially insured members who could receive the drugs, costing them $3.29 PMPM. The third scenario would be if the drug became available to all statin intolerant or resistant people, regardless of risks involved. This would affect approximately 806 per 100,000 commercially insured members who could receive the drug at $6.71 PMPM. Costs for Medicare Part D members with a high risk of cardiovascular disease were estimated to be much higher, ranging from 1500 per 100,000 members treated at $12.56 PMPM to 1880 per 100,000 members treated at $15.66 PMPM, due to the need for this patient group to use medicines to control cholesterol.
“If not managed appropriately, the costs of PCSK9s could have a dramatic impact on overall drug spending starting later this summer. In a couple years PCSK9s could cost America the equivalent of $73 per person per year,” said Pete Clagett, senior vice-president of integrated care and specialty at Prime, in a press release.
Source: Prime Therapeutics