PHARMACY

Study: Drug cost estimates trend higher than actual sales

BY DSN STAFF
BEVERLY HILLS — Cost estimates put out before the launch of new drugs can often overestimate their impact on healthcare spending, according to a new study from research consultancy the Partnership for Health Analytics Research. 
 
One of the most recent and notable examples PHAR’s analysis points to is a cost estimate put out by the Institute for Clinical and Economic Review, which predicted that the new class of injectable cholesterol drugs, PCSK9 inhibitors, would cost the healthcare system $7.2 billion. According to initial quarters of sales reports, PHAR said, the drugs have actually costs around $83 million, 1.2% of the estimate. The drugs were predicted in The New England Journal of Medicine to raise patients’s premiums by $124 per person, but PHAR cites an Avalere Health study putting the increase in premiums at $3.29 per member per month. 
 
“Overestimating drug costs by so much cannot lead to good decision making.” PHAR president Dr. Michael Broder said. “In fact, it is likely that patients feel the negative effects of such predictions in the form of early access restrictions and higher copayments.”
 
The whole study looked at predictions for 14 drugs launched since 2012 in various indications. On average, predictions were 11 times higher than the sales reported once the drugs hit the market. Another example the study highlights is Viekira Pak, whose sales were 28% of the predicted $2.9 billion in its first year. 
 
“Drug usage predictions are used to inform pharmacy policy.  Our goal in pointing out these discrepancies is to help improve predictions and decisionmaking,” Broder said. “Ideally, payers and policymakers would be able to use them as planning tools. In their current form, I'm afraid these predictions are so far off that they may just be scaring people into making bad decisions about limiting access to new drugs.”
 
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FDA approves Lupin’s generic Klor-Con

BY David Salazar
MUMBAI — The Food and Drug Administration has approved Lupin subsidiary Gavis Pharmaceuticals’ generic of Klor-Con  (potassium chloride) extended-release tablets, the company announced Wednesday. The drug is indicated to treat patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and patients with hypokalemic familial periodic paralysis. It’s also indicated to prevent hypokalemia in patients at risk if they developed it — for example, patients with significant cardiac arrhythmias. 
 
Lupin’s generic will be available in 600- and 800-mg dosage strengths. U.S. sales for the product were $101.3 million for the 12 months ended June 2016, according to IMS Health. 
 
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Endo names new president, U.S. branded pharmaceuticals

BY David Salazar
DUBLIN — Endo International this week announced the appointment of Joseph Ciaffoni as president, U.S. branded pharmaceuticals, effective Aug. 15. Ciaffoni was most recently SVP global specialty medicines group for Biogen, where he led development and execution of global strategy for the company’s marketed and pipeline products. 
 
"We are excited to announce the addition of Joe to the Endo executive team. His industry experience is extensive and includes building commercial businesses, leading multi-function organizations and achieving stellar results across primary care, specialty and rare disease markets,” Endo president and CEO Rajiv De Silva said. “His proven track record of success across nearly 20 product launches and the commercialization of more than 70 products will be instrumental as we continue to focus on strategically growing our U.S. Branded business.”
 
Ciaffoni began at Biogen in 2012, and held various titles there, including SVP U.S. commercial. He has also previously served as EVP and  CFO of Shionogi and president of Shionogi Pharmaceuticals, as well as VP sales for Schering-Plough (now Merck). 
 
“I am thrilled to be joining Endo at a time of such significant opportunity for the business,” Ciaffoni said. “I look forward to leading Endo's U.S. branded pharmaceutical business, driving the development and execution of Endo's branded strategy and accelerating key growth drivers while, ultimately, helping improve patients' lives.”
 
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