Issue link: https://www.epageflip.net/i/669487
ByMatthewPerrone The Associated Press WASHINGTON When a powerful pair of choles- terol-lowering drugs first hit the market last sum- mer, initial excitement in the medical community quickly turned to panic. The new drugs prom- ised to reduce artery-clog- ging cholesterol by nearly twice as much as older ones. But they came at an eye-popping price: more than $14,000 per year, com- pared with roughly $150 for the standard drugs. Some experts predicted a doomsday scenario in which the two injectable drugs, Repatha and Pralu- ent, would add a staggering $100 billion to the U.S. drug bill as doctors signed up millions of patients with el- evated cholesterol. But then something unexpected hap- pened: not much. Caught between skepti- cal doctors and cost-con- scious insurers, the drugs have barely sold. Sanofi re- ported a meager $10 mil- lion from Praluent in the last quarter, which it co- markets with Regeneron Pharmaceuticals. Amgen Inc. declined to break out Repatha sales. Spending on pricey spe- cialty drugs has doubled over the last five years to $150 billion, contributing 70 percent of the growth in U.S. medication spending since 2010, according to IMS Health. But the star- tlingly slow launch of Pral- uent and Repatha suggests insurers may have found their own formula for fight- ing back: proof-of-effec- tiveness requirements and rigorous paperwork that limits how many patients ultimately receive high-cost drugs. Experts see an esca- lating feud between drug- makers and insurers with little relief in sight. "The companies think that their drug is going to save a lot of lives and pay- ers tend to be skeptical of those claims — somewhere in the middle is the truth" says Professor Darius Lak- dawalla of the University of Southern California. Generally speaking, in- surers only cover the costs of the new drugs for pa- tients with extremely-high cholesterol caused by ge- netic disorders, or those with a history of heart problems and elevated cho- lesterol. The insurance pa- perwork can run several pages and often requires a detailed history of past treatments. Caught in the middle of the coverage fight are pa- tients who say they desper- ately need more options to control bad cholesterol, or LDL. Christian Jacobs, 24, takes eight medications to manage his cholesterol and related complications, in- cluding blood thinners for the seven artery-opening stents he's received since 2011. He has a rare form of inheritable cholesterol that occurs in roughly one in a million people. So he was shocked when his in- surance provider, United- Health, rejected his doc- tors' prescription for Re- patha. "I was floored," he said. "How in the world can we be rejected for a medica- tion that I meet every sin- gle standard for?" Jacobs said United- Health recommended he continue his current drug regimen to see if it lowers his cholesterol. He is ap- pealing the decision. UnitedHealth, which de- clined to comment on Ja- cobs' situation due to pa- tient privacy laws, said in a statement it uses "clinical guidelines and scientific ev- idence" when making cov- erage decisions. "These new therapies offer additional LDL cho- lesterol lowering and out- comes studies are still pending," said the firm. Recent medical history is littered with once-promis- ing drugs that lowered test results like cholesterol, yet failed to actually help pa- tients. Considering the high prices and limited data, many doctors favor a "go slow" approach. "If you're going to spend that kind of money on a medication then you need to know that it's really do- ing something," said Dr. Hal Chadow of Brookdale Uni- versity Hospital. Chadow has successfully prescribed the drugs to several high- risk patients, but he wants to see more research before using them more broadly. Some of the nation's top cardiologists predict the drugs will eventually re- duce heart attack rates far below levels currently seen with statin pills, the stan- dard-of-care for high cho- lesterol since the 1990s. But studies confirming those benefits are still months away, a key reason insur- ers demand extensive docu- mentation before reimburs- ing the drugs. "I really think it's a dis- service to the public health to put people in charge of this who are essentially bean counters," said Dr. Steven Nissen of the Cleve- land Clinic. The medical center has assigned an ex- pert to coach doctors on completing the insurance paperwork. Industry figures sug- gest a high bar: 90 percent of claims for Repatha and Praluent were initially re- jected in the last quarter of 2015, according Symphony Health, a firm that analyzes insurance data. The companies doing the rejecting say they are merely following prescrib- ing instructions on the medicines, which are ap- proved by the Food and Drug Administration. Dr. Steve Miller of Express Scripts, the largest phar- macy benefit manager, says the company is approving more claims as doctors get better at picking "the right patients and making sure they have adequate sup- porting data." Wall Street continues to bet that the drugs, known as PCSK9 inhibitors, will become blockbusters — eventually. While many have slashed short-term estimates, most analysts predict that Repatha and Praluent will generate com- bined annual sales of over $5 billion by 2020, accord- ing to polling by Evaluate Pharma. Drugs that gener- ate $1 billion or more annu- ally are considered block- busters. Breakthroughcholesteroldrugs fizzle amid price pushback HEALTH ROBERTDAWSON—AMGENINCFILE The market for cholesterol drugs is in chaos, affecting Repatha (shown) and Praluent, among others. By Michael Kunzelman and Kevin Mcgill The Associated Press NEW ORLEANS Five for- mer police officers pleaded guilty Wednesday to a re- duced number of charges in the deadly shootings on the Danziger Bridge in the days following Hurricane Katrina and were sentenced to far less prison time than they originally faced. The officers were con- victed by a jury in 2011 but U.S. District Judge Kurt Engelhardt set aside the verdict two years later be- cause of misconduct by fed- eral prosecutors — includ- ing anonymous online com- ments about the case. Four of the former offi- cers have been locked up for nearly six years while the fifth has been out on bond. Their original convictions called for them to serve anywhere from 65 years to six years in prison. The plea deal calls for them to serve a range of 12 to three years. On Sept. 4, 2005, days af- ter the levees failed and wa- ter swamped the city, po- lice gunned down 17-year- old James Brissette and 40-year-old Ronald Mad- ison, who were both un- armed, and wounded four others on the Danziger Bridge. To cover it up, the of- ficers planted a gun, fabri- cated witnesses and falsified reports, prosecutors have said. Police said at the time the officers were respond- ing to a report of other offi- cers down when they came under fire. However, after hearing from five dozen wit- nesses and examining 400 pieces of evidence during a monthlong trial, a federal jury convicted the officers for opening fire and trying to cover up wrongdoing. Former officer Robert Faulcon was sentenced to 65 years in prison; ex-Sgts. Kenneth Bowen and Rob- ert Gisevius each received 40 years; Anthony Villa- vaso got 38 years; and Ar- thur Kaufman, now out on bond, received a six-year sentence. Underthenewpleaagree- ment, they will get credit for time served and most of them could be released from prison anywhere from the next one to six years. A scandal involving Jus- tice Department employ- ees unraveled the convic- tions and sentences. In Sep- tember 2013, the judge said the case had been tainted by "grotesque prosecuto- rial misconduct," including leaks to media and posting of anonymous comments by at least three government attorneys on a New Orleans newspaper's website. REDUCED CHARGES 5 ex -c op s pl ea d gu il ty i n de ad ly shootings a er Hurricane Katrina | NEWS | REDBLUFFDAILYNEWS.COM THURSDAY, APRIL 21, 2016 4 B