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PCSK-9 inhibitors achieve next milestone, plus 4 more FDA actions, $150 Billion Annual Cost projected Dwarfing HCV
  ....."these drugs will add nearly $50 per month to the premium costs for every insured person in the United States......cost range of $7,000 to $12,000.....15 million Americans could eventually be considered candidates for this new class of drugs once approved.......only the beginning.....HCV medicines generally offer a cure in about 12 weeks.....PCSK9 inhibitors will be prescribed as a maintenance medication for the duration of patients' lives, which could span decades......The price tag of curing all of the 1.5 million people currently known to be infected with Hepatitis C in the United States could be as high as $150 billion......PCSK9 inhibitors.....treat everyone with a history of coronary artery disease (up to 15 million people) with PCSK9 inhibitors.......hypercholesterolemia and severe hypercholesteremia alone would represent a $16 billion market, dwarfing initial Sovaldi costs......Statin intolerant patients would add an additional $20 billion set of costs. And those with a history of coronary disease could add as much as $150 billion annually."
June 17, 2015
[BLOG] Pipeline advancement responsible for upturn in global pharma R&D
FDA' s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.
The panel said that evolocumab should be approved in a rare disease called homozygous familial hypercholesterolemia (HoFH), a genetic disorder that causes very high cholesterol levels and can lead to heart attacks in childhood, according to an article in Forbes. The panel also said the drug could be used in other indications such as the more common heterozygous familial hypercholesterolemia (heFH), but stopped short of recommending it for the general elevated cholesterol population.
The drug manufacturers are hoping for approval for more general use in patients with elevated cholesterol who cannot tolerate statins or who cannot achieve their LDL-C targets on statin therapy alone, according to PMLive. Evolocumab has already been recommended for approval in Europe for hoFH as well as the larger target population.
In briefing documents released late last week, FDA staff generally approved of alirocumab's safety and efficacy.
"The benefit-risk profile of alirocumab is favorable," according to the briefing documents prepared by FDA staff. "Alirocumab provides clinically meaningful mean reductions of LDL-C in patients not achieving adequate reductions with their existing statin, or in patients unable or unwilling to take status to achieve their LDL goals." In clinical studies, alirocumab provided up to 63% mean reductions on top of statin therapy in patients with high cardiovascular risk who were not well-controlled, despite their current therapies.
In a randomized, double-blind study of patients with a history of statin intolerance, alirocumab demonstrated greater efficacy than ezetimibe and a lower rate of muscle-related adverse events than with either statin or ezetimibe treatment. "These data indicate that alirocumab is a valuable treatment for patients who are unable or unwilling to take a statin and support the proposed indication in this patient population," the document said.
Based upon currently available clinical data, Anna Goldbeck, a principal in the National Pharmacy Practice at Buck Consultants at Xerox expects utilization management controls for PCSK-9 Inhibitors to include prior authorization with step therapy as a component.
According to Goldbeck, the criteria utilized will likely include:
· A small segment of the population diagnosed with familial hypercholesterolemia
· Patients with high cholesterol not controlled by other cholesterol-lowering therapies, titrated to appropriate dosing levels
· Patients with high cholesterol that cannot tolerate or have contraindications to other cholesterol-lowering therapies (eg, statins)
"Also, we would expect continued use of the PCSK9s to be limited to those meeting specific reauthorization criteria, which would focus on demonstrated effectiveness [cholesterol levels]," Goldbeck said.
Move over Sovaldi: Could PCSK9 inhibitors be a bigger cost challenge?
The introduction of high-cost, high-use PCSK9 inhibitors (proprotein convertase subtilisin/kexin 9) enzyme inhibitors to treat high cholesterol may take the industry a step closer to a future where "healthcare costs break the bank," according to industry insiders.
Estimates of annual pricing for PCSK9 inhibitors are in the cost range of $7,000 to $12,000. Even if PCSK9 inhibitors are indicated for a very narrow patient population, cost estimates show that this new class of drugs will eclipse initial costs of Sovaldi seen at its launch. In addition, PCSK9 inhibitors are biologics, so there will not be a simple pathway to less-costly generics for at least 10 years.
Several pharmaceutical manufacturers are currently developing PCSK9 inhibitors, which are projected to gain FDA approval by mid-2015.
"The cost of these drugs will add nearly $50 per month to the premium costs for every insured person in the United States," said Don Hall, a former health plan CEO of Delta Sigma LLC, in Littleton, Colo. "If this was the last of the high-cost, high-use pharmaceuticals, the system could adjust and move forward. Unfortunately it's only the beginning as new drugs for a range of neuromuscular diseases and cancer are poised to hit the market in the next few years. We are quickly getting to the point where healthcare costs crush our economy."
Currently, patients with high cholesterol levels are often prescribed a statin, a once-a-day oral medicine. Statins are effective and affordable for the majority of people with high cholesterol.
CVS Health weighed in on the next chapter in the debate about the impact of expensive drugs on the healthcare system in a commentary in a Health Affairs blog.
"With the launch of Sovaldi to treat hepatitis C in 2013, we saw a first glimpse of the impact of high-priced specialty drugs that serve patient populations in the millions, but that was just the tip of the iceberg," Troyen A. Brennan, MD, chief medical officer, CVS Health, said in a press release. "Like the hepatitis C treatments, PCSK9 inhibitors represent a significant advance in treating intractable diseases convenient and highly effective with few side effects but they also pose a much more complex financial dilemma since, unlike the hepatitis C treatments which offer a cure in as little as 12 weeks, PCSK9 inhibitors will be prescribed as ongoing maintenance therapy for the duration of patients' lives."
While the annual cost of treatment with a PCSK9 inhibitor will likely be a lot lower than a course of treatment with one of the HCV medicines, costs will be compounded over the long-term, according to CVS. HCV medicines generally offer a cure in about 12 weeks, but PCSK9 inhibitors will be prescribed as a maintenance medication for the duration of patients' lives, which could span decades.
Injected once or twice a month, evidence from clinical trials suggests PCSK9 inhibitors are well-tolerated and highly effective in reducing low-density lipoprotein (LDL) or bad cholesterol. Many believe these medicines will first be indicated for familial hypercholesterolemia, a genetic form of high cholesterol affecting approximately 620,000 Americans. Yet, there is a growing interest in additional patient subgroups where PCSK9 inhibitors may be appropriate, including for patients who are intolerant to statins, those who have more severe cases where statins are not effective, and those with a history of coronary artery disease. As a result, as many as 15 million Americans could eventually be considered candidates for this new class of drugs once approved.
Once approved, formulary managers will consider several factors when making decisions about formulary placement, including the efficacy of the drug(s), their indication and the size of the eligible patient population, according to CVS.
Experts agree that careful managed care oversight and compliance with clinical guidelines will be vital to ensuring quality of care for patients while helping control healthcare costs when PCSK9 inhibitors are approved.

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