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New Cholesterol Drugs Estimated Costs $10 to $150 Billion A Year
  from Jules: while the federal govt, the White House & CMS ponder what to do they are holding HCV patients hostage.... lets see if there are very harsh restrictions to access for these new cholesterol drugs like drug users can't use it & only patients with frank heart disease can use it
"The big difference is that Sovaldi has a 90% cure rate for hepatitis C infections after only three months of therapy. PCSK9 inhibitors to lower cholesterol would be taken for life.
......the new drugs could set off healthcare cost shocks that make the turmoil caused by......hepatitis C .....look like a mild tremor. Estimates of the potential market range from $10 billion to $150 billion a year......The stakes for patients, the drug companies developing PCSK9 inhibitors, and the U.S. healthcare system are huge.......Prescribing the drugs to patients in all those groups could increase overall drug costs in the U.S. by more than 40%, according to Modern Healthcare calculations. Insurers and pharmacy benefit management firms are growing alarmed. Executives at Woonsocket, R.I.-based CVS Health did some back-of-the-envelope calculations on the potential cost for the new drugs in a Health Affairs blog post in February. Assuming a $10,000 price per patient per year, which they considered conservative, they estimated PCSK9 inhibitors will cost $16 billion a year just to treat patients with FH......New preliminary clinical trial data about two of the PCSK9 drugs are generating excitement among clinicians. In March, at the American College of Cardiology Scientific Session in San Diego, researchers reported that in a randomized controlled trial, 4,500 unstable angina patients receiving evolocumab after one year had rates of death, heart attack, stroke and hospitalization that were less than half the rates experienced by the placebo group. The study showed the drug lowered LDL an average of 61%.......Still, some experts raise questions about the efficacy and safety of the new drugs. Dr. Neil Stone, a lipid expert at Northwestern University and lead author of the 2013 American Heart Association/American College of Cardiology guidelines for treating cholesterol in people at high risk for cardiovascular diseases, called the new research "promising but not definitive."
..........The CVS executives estimated that if statin-intolerant patients who experience muscle pain from the drugs begin taking the new drugs en masse, it would add another $20 billion to the nation's annual tab. If the new drugs were prescribed off-label to everyone with a history of coronary heart disease, the tab would rise to $150 billion a year, they projected.
..............Pharmacy benefit managers and integrated providers already are mulling their options, recognizing it will difficult to limit use. Dr. Troyen Brennan, chief medical officer at CVS Health, and his colleagues, writing in Health Affairs, said pharmacy benefit managers will try to limit the number of patients taking the new drugs, based on clinical guidelines and expert opinion. Patients "will likely require laboratory tests to show evidence of muscle inflammation or liver damage before allowing treatment for those with statin intolerance," they said in the article. "But it is unclear how much these medical management efforts will limit utilization.".......http://www.modernhealthcare.com/article/20150411/MAGAZINE/304119937
FDA approves new cholesterol drug - at $14,600 a year - (07/29/15)
Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients - (07/29/15)
FDA Review Safety/Liver - Efficacy - New Cholesterol Drug Alirocumab - (07/29/15)
Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events - (07/29/15)
Lowering LDL Cholesterol Is Good, but How and in Whom? Editorial - (07/29/15) FDA Approves First PCSK9 Inhibitor - (07/29/15)
PCSK-9 inhibitors achieve next milestone, plus 4 more FDA actions, $150 Billion Annual Cost projected Dwarfing HCV - (06/22/15)
Insurers begin to review coverage of costly cholesterol drugs
By Bob Herman | August 28, 2015
Now that the Food and Drug Administration has given the OK to two pricey drugs that treat high cholesterol, health insurers and pharmacy benefit managers are evaluating if one drug should receive preferred coverage over the other.
In exchange for the preferred designation, drugmakers offer price discounts on their products. A flurry of these types of deals occurred this year with high-cost hepatitis C drugs.
This week, the FDA approved Repatha, an injectable drug made by Amgen that lowers a person's "bad" cholesterol level. It can be used only for patients who have certain inherited conditions or a history of serious heart ailments. Estimates put that patient base at around 5 million to 10 million people. These types of cholesterol drugs are called PCSK9 inhibitors.
Repatha's approval came about a month after Praluent, another cholesterol drug in the same class. Sanofi and Regeneron Pharmaceuticals make Praluent, which costs $14,600 a year for a normal course of treatment. Repatha is slightly cheaper at $14,100 a year.
Observers view the cholesterol drugs as potential budget-busters for public and private insurers. The hepatitis C drugs that made it to the market last year created an industrywide stir with their lofty price tags. Gilead Sciences' Harvoni costs $94,500 for a 12-week treatment. But in most instances, hepatitis C patients are cured after treatment. High cholesterol has to be managed continuously, and PCSK9 inhibitors hypothetically could be used indefinitely.
The cholesterol drugs have a lower initial price compared with the hepatitis C drugs, but the costs could balloon over time. Many believe that's drug companies trying to gouge the marketplace. "With several game-changing medications in the pipeline, we need to address the underlying issue of how these prices are set from the start before they hit the market," John Rother, president of the National Coalition on Health Care and leader of the Campaign for Sustainable Rx Pricing, said in a statement.
Several insurers and pharmacy management companies have indicated they will look at both cholesterol drugs soon to determine how they will fit on their formularies—and if discounts can be negotiated. The pharmacy and therapeutics committee at Express Scripts, one of the largest pharmacy benefit managers in the country, will review Praluent and Repatha in September.
"Any formulary announcements we may make—whether to cover one or both of these products—would come after this review," Express Scripts Chief Medical Officer Dr. Steve Miller said in a blog post.
Aetna covers Praluent, but strict criteria apply. Aetna mandates preauthorization of the drug. Specifically, doctors must diagnose patients with the specified diseases. In addition, two high-dose, lower-cost statins must be tried before Praluent, a process known as step therapy. Aetna is conducting a clinical review of both drugs now, a spokeswoman said.
An Anthem spokeswoman said Repatha has not yet gone through its review process but will in the coming weeks. "Until then, it will be placed on the highest tier available in each state," she said.
Harvard Pilgrim Health Care's pharmacy and therapeutics committee, composed of practicing physicians and pharmacists, will evaluate Praluent and Repatha in the near term. A spokeswoman said the Wellesley, Mass.-based insurer had no definitive timetable yet for the review. Harvard Pilgrim has said previously it is interested in negotiating discounts with all involved drugmakers.
"The drug companies and analysts are thinking blockbuster, and we're thinking, 'How do we pay for this?'" Harvard Pilgrim Chief Medical Officer Dr. Michael Sherman said in a February interview. "I can assure you we will be negotiating with both (groups of drug) companies."
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