- In a letter to BioPharma Dive, Amgen has refuted the ‘flawed analysis’ that attacked the value of PCSK9 cholesterol drugs.
- The study, published in JAMA, claimed that PCSK9 inhibitors were not as cost effective as other treatment options; in this letter, Amgen counter-claims that the study has exaggerated the costs of PCSK9 inhibitors.
- Amgen states that the study “could have consequences for patients” by making it more difficult for patients to access PCSK9s.
The advent of the PCSK9 inhibitors has been an exciting one and has attracted a lot of interest and coverage, from the positive (news of their safety, efficacy and tolerability) to the not so positive (speculations that they will be “very expensive”).
While the prices of innovative drugs, especially biologics, are generally high, the drug developers of the PCSK9 inhibitors have built cost effectiveness arguments around them. These measure the price of the drug against the poor adherence to statins, which though they are low cost are high in side effects, and the expense to the healthcare system, said the companies.
The latest bit of excitement about the PCSK9 inhibitors has surrounded a piece in JAMA that claimed that the drugs were not cost-effective at their 2015 prices and would only reach the cost-effectiveness thresholds for US healthcare if the annual drug prices were reduced "from more than $14,000 to $4,536."
The letter from Amgen’s Raymond C. Jordan, SVP of corporate affairs, refutes the argument, stating that the authors exaggerate the costs of the PCSK9 inhibitors and their argument "threatens to make it more difficult for patients to access [the drugs]."
According to Jordan: "the authors use a model with assumptions that over-estimate the size and underestimate the risk of the treated population resulting in exaggerated costs and low estimated value."
He adds that the study also used list price rather than the price patients actually pay after rebates and discounts, resulting in estimates that "are around 400 times higher than the 2016 analyst consensus estimates for PCSK9 inhibitors."
The drugs, which have only been approved for a select patient population, have drawn the ire of payers for their high price tags and limited use. While both Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab) were highly anticipated prior to their launch last summer, they have failed to gain traction so far due to limited labels and pushback from payers.