Hepatitis C drugs have been big targets for pharmacy benefit managers (PBMs) and the media for the “astronomical” price tags carried by these treatments. Gilead’s Sovaldi costs roughly $84,000 for a 12-week treatment and Harvoni (a combination therapy) is around $94,500.1 Now a new class of cholesterol-lowering drugs—PCSK9 inhibitors—is poised to intensify the price war between manufacturers and PBMs.
Promising Results, Priority Review
PCSK9 inhibitors are currently in phase III trials with three manufacturers; Amgen, Regeneron, and Pfizer. Trial results are extremely promising for some patients: alirocumab, a monoclonal antibody under development by Regeneron and Sanofi, lowered LDL cholesterol by 62% in patients using statins.2 For patients with severe cardiovascular risk and intractable LDL-C levels, this could be a miracle drug.
According to Reuters, alirocumab (to be marketed as Praluent ) may be the first to hit the market with a priority review slated for completion July 24th, 2015. Repatha (evolocumab) from Amgen is expected to hit the market in late August of this year.3
The Real Battle: Price vs. Value
Beyond the clinical promise, the anticipated prices of these new therapies are commanding attention among PBMs. Praluent is planning on releasing a low dose bi-weekly injection at 75mg and 150mg. According to Geoffery Porges, an analyst from Sanford Bernstein, the anticipated cost of the drug is around $5,000 for a low dose and $10,000 for higher doses. The PCSK9 inhibitors are anticipated to be a lifetime—or at least long term—treatment.4 Chronic use means that PCSK9 inhibitors have the potential to be a $3 billion a year category. For the manufacturers, this is great news. Payers are less enthusiastic.
According to Fierce Biotech, “Express Scripts and other payers have made it clear that they intend to press hard for low prices, pitting drug manufacturers against each other whenever possible.”4 Competition among PCSK9s, coupled with the many lower-cost lipid-lowering agents already on the market, may work in payers’ and patients’ favor while putting pressure on manufacturers’ margins.
The manufacturers are keeping their silence on pricing issues. Analysts can always make educated decisions about where they believe the price will be, but the public will not know until the end of June when Praluent hits the market.
PCSK9 inhibitors are the future of cholesterol lowering agents. For patients who are considered to have high LDL with levels of 160 mg/dl and greater, this new class of drug could potentially be a life saver. But it will be interesting to see how payers restrict this product on their formularies. If payers decide to restrict users of PCSK9 inhibitors to patients with LDL-C levels greater than 190 mg/dl, this could severely impact sales of the product. There are no pharmacoeconomic studies nor cost-effectiveness studies published on PCSK9s as of yet. A concrete price will be needed to determine cost-effectiveness. Manufacturers hope that this scenario plays out the way the hepatitis C story has, where the high price tag up front is thought to mitigate a lifetime of direct and indirect medical costs related to uncontrolled disease. Calcium will be watching closely as this story unfolds.
- Robert Langreth. Hepatitis Drug Prices Fall So Low, No Exclusives Needed. Bloomberg Business. January 2015
- Robinson JG, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99.
- Ransdell Pierson, Reuters. CVS urges cost controls for new cholesterol, specialty drug. February 2015
- John Carroll. The Gilead effect: PCSK9 rivals Amgen, Sanofi/Regeneron prep for a price war. Fierce Biotech. May 2015