U.S. drug benefit manager CVS Health said on Monday it would add Amgen Inc’s Repatha cholesterol treatment to its list of covered drugs for private plans over a competing treatment from Regeneron Pharmaceuticals and Sanofi SA.
CVS chooses Amgen’s new cholesterol drug over competitor
The two competing treatments, which can slash “bad” LDL cholesterol by more than 60 percent, were approved this summer by the U.S. Food and Drug Administration and belong to a new class of medicines called PCSK9 inhibitors.
But the cost of the drugs has drawn criticism at a time when the national focus has turned to increases in healthcare costs, and in particular, the out-of-pocket costs to consumers.
The FDA approved Repatha and Praluent, made by Regeneron and Sanofi, within weeks of each other last summer for patients with hereditary forms of high cholesterol and those with cardiovascular disease requiring additional cholesterol lowering.
Sales of the PCSK9 inhibitors have been held back by strict access policies at CVS and other pharmacy benefit managers who say their more than $14,000 annual price tag is too high. Other independent cost benefit agencies have backed that view.
Amgen shares rose 1.8 percent, or $2.81, to $162.72 on Monday, while Regeneron fell by 1.2 percent, or $6.76, to $572.82. Both trade on the Nasdaq.
Sanofi and Regeneron said patients and physicians should have a choice regarding their treatment. “We are in ongoing discussions with other insurers to provide access to Praluent for appropriate patients,” the companies said a statement provided by Sanofi spokeswoman Mary Kathryn Steel.
Praluent costs $14,600 for a year of treatment and Amgen set an annual price of $14,100 for its Repatha. The companies were expected to offer rebates and discounts that would bring down the cost to the mid-$12,000 range. In comparison, the annual cost of generic statins, which are used by millions of Americans who have high levels of low-density lipoprotein cholesterol, is in the hundreds of dollars.
Dr. Troyen Brennan, chief medical officer of CVS Health, declined to provide details of the discount or rebate that it and Amgen agreed upon, but described it as “substantial.”
“The key factor was the decision that the medications are therapeutically equivalent. Once we made that decision then we were like anybody else that’s in a bargaining situation where you have two competitors interested in maximizing revenues,” Brennan said.
The decision contrasts with that of Express Scripts Holdings Corp, the largest U.S. drug benefit manager, which signed deals to provide coverage for both drugs.
Brennan said that while CVS would add Repatha to its coverage list starting Dec. 1, the company would continue to limit its use.
The PCSK9 inhibitors are stronger than traditional cholesterol-lowering statin drugs, such as Pfizer Inc’s Lipitor. But it is not known whether their cholesterol-lowering power will translate into a reduced number of heart attacks.
CVS Makes Exclusive Deal to Cover Amgen’s Cholesterol Drug
CVS Health Corp.’s drug-benefits unit will cover Amgen Inc.’s new cholesterol-cutting injections while excluding a competing treatment from Sanofi and Regeneron Pharmaceuticals Inc., pushing for savings from medications that list for more than $14,000 a year.
The decision, which applies to workers whose employers use CVS Health for drug coverage, shows that benefit managers are continuing to be aggressive about setting exclusive deals with drugmakers to get better prices for expensive new therapies.
CVS said that its independent pharmacy and therapeutics committee had reviewed data for Amgen’s Repatha, as well as Praluent from Sanofi and Regeneron Pharmaceuticals, and concluded that the drugs were clinically equivalent.
“That puts us in a situation where we can bargain with the drug manufacturers” and get a significant discount in return for an exclusive deal, said Troyen Brennan, CVS’s chief medical officer, said in a phone interview. “You have to use every tool that you have to try to keep costs down today.”
While the discount CVS obtained from Amgen was “substantial,” Brennan said he would not reveal the amount or the length of the contract with Amgen. CVS will continue to require that prescriptions for Amgen’s drug be approved in advance, a practice known as prior authorization that can limit use of the medicine.
Amgen shares rose 1.8 percent to $162.74 at 9:59 a.m. in New York. Regeneron was up less than 1 percent to $582, and Sanofi fell less than 1 percent to 82.75 euros.
Hepatitis Competition
CVS’s decision is just the latest example of pharmacy benefit managers excluding some expensive drugs from coverage in a category in order to gain better prices for the competing drugs they do decide to cover.
Last December, Gilead Sciences Inc.’s hepatitis C treatment Harvoni was excluded from Express Scripts Holding Co.’s main list of 2015 covered drugs in favor of a competing treatment from AbbVie Inc. That move set off a price war over hepatitis C drugs, with several other insurers and payers, including CVS, deciding to cover only the Gilead medicine.
Winning an exclusive deal with a benefits manager is a mixed blessing for drugmakers, who ensure a market for their drugs but may sacrifice a lot in discounts. AbbVie’s hepatitis C treatment generated $469 million in sales last quarter, while Gilead’s drugs, which require patients to take fewer daily pills, brought in $4.8 billion.
Bad Cholesterol
PCSK9 inhibitors are designed to help people with high levels of bad cholesterol who can’t get their condition under control with statins such as Pfizer Inc.’s Lipitor. Payers of insurance benefits have worried they could become one of the costliest drug classes ever, with the potential for $100 billion in annual sales if widely used. For now, their scope is more limited to people who have genetic conditions or particularly stubborn cholesterol levels.
Brennan said CVS was thinking about how to control costs of the PCSK9 drugs over the long term.
While usage now is modest, large clinical trials examining whether the therapies can lower rates of heart attacks and other cardiovascular events could have results next fall, he said, leading to wider use.
“It is going to be a long game here,” Brennan said. “So far we have been very pleased with what we have seen in terms of ability to control the utilization.”
CVS said its decision is effective on Dec. 1. Overall, CVS manages drug coverage for 70 million Americans, but the company doesn’t break out how many are on the company’s commercial coverage lists, spokeswoman Christine Cramer said in an e-mail.
Amgen said it was “delighted” with the choice. “We will continue to engage constructively with other payers to enable patients to have access to Repatha,” Anthony Hooper, Amgen’s head of commercial operations, said in a statement Monday.
“Sanofi and Regeneron are disappointed about the decision CVS made in limiting access to Praluent,” the two companies said in a joint statement. “Patients and physicians should have a choice regarding their treatment and access to the right therapy to meet individual patient needs.” Sanofi and Regeneron are in ongoing discussions with other insurers over Praluent coverage, according to the statement.
‘Small Percentage’
In October, Express Scripts, the largest manager of prescription drug benefits for employers and insurers in the U.S., said it would cover both Praluent and Repatha. It was the first major coverage decision for the drugs on a national basis in the U.S.
Sanofi and Regeneron’s drug Praluent won approval from U.S. regulators on July 24, while Amgen’s PCSK9 drug Repatha was approved on Aug. 27. Since then, doctors, patients and investors have been speculating on how insurers would cover the drugs and what restrictions would be imposed on their use.
In its statement, CVS said that for most patients with high cholesterol, statin drugs will remain the standard of care. The PCSK9 drugs are necessary for “a small percentage of patients” who can’t achieve their treatment goals with other therapies, it said.
CVS chooses Amgen’s new cholesterol drug over competitor
The two competing treatments, which can slash “bad” LDL cholesterol by more than 60 percent, were approved this summer by the U.S. Food and Drug Administration and belong to a new class of medicines called PCSK9 inhibitors.
But the cost of the drugs has drawn criticism at a time when the national focus has turned to increases in healthcare costs, and in particular, the out-of-pocket costs to consumers.
The FDA approved Repatha and Praluent, made by Regeneron and Sanofi, within weeks of each other last summer for patients with hereditary forms of high cholesterol and those with cardiovascular disease requiring additional cholesterol lowering.
Sales of the PCSK9 inhibitors have been held back by strict access policies at CVS and other pharmacy benefit managers who say their more than $14,000 annual price tag is too high. Other independent cost benefit agencies have backed that view.
Amgen shares rose 1.8 percent, or $2.81, to $162.72 on Monday, while Regeneron fell by 1.2 percent, or $6.76, to $572.82. Both trade on the Nasdaq.
Sanofi and Regeneron said patients and physicians should have a choice regarding their treatment. “We are in ongoing discussions with other insurers to provide access to Praluent for appropriate patients,” the companies said a statement provided by Sanofi spokeswoman Mary Kathryn Steel.
Praluent costs $14,600 for a year of treatment and Amgen set an annual price of $14,100 for its Repatha. The companies were expected to offer rebates and discounts that would bring down the cost to the mid-$12,000 range. In comparison, the annual cost of generic statins, which are used by millions of Americans who have high levels of low-density lipoprotein cholesterol, is in the hundreds of dollars.
Dr. Troyen Brennan, chief medical officer of CVS Health, declined to provide details of the discount or rebate that it and Amgen agreed upon, but described it as “substantial.”
“The key factor was the decision that the medications are therapeutically equivalent. Once we made that decision then we were like anybody else that’s in a bargaining situation where you have two competitors interested in maximizing revenues,” Brennan said.
The decision contrasts with that of Express Scripts Holdings Corp, the largest U.S. drug benefit manager, which signed deals to provide coverage for both drugs.
Brennan said that while CVS would add Repatha to its coverage list starting Dec. 1, the company would continue to limit its use.
The PCSK9 inhibitors are stronger than traditional cholesterol-lowering statin drugs, such as Pfizer Inc’s Lipitor. But it is not known whether their cholesterol-lowering power will translate into a reduced number of heart attacks.
CVS Makes Exclusive Deal to Cover Amgen’s Cholesterol Drug
CVS Health Corp.’s drug-benefits unit will cover Amgen Inc.’s new cholesterol-cutting injections while excluding a competing treatment from Sanofi and Regeneron Pharmaceuticals Inc., pushing for savings from medications that list for more than $14,000 a year.
The decision, which applies to workers whose employers use CVS Health for drug coverage, shows that benefit managers are continuing to be aggressive about setting exclusive deals with drugmakers to get better prices for expensive new therapies.
CVS said that its independent pharmacy and therapeutics committee had reviewed data for Amgen’s Repatha, as well as Praluent from Sanofi and Regeneron Pharmaceuticals, and concluded that the drugs were clinically equivalent.
“That puts us in a situation where we can bargain with the drug manufacturers” and get a significant discount in return for an exclusive deal, said Troyen Brennan, CVS’s chief medical officer, said in a phone interview. “You have to use every tool that you have to try to keep costs down today.”
While the discount CVS obtained from Amgen was “substantial,” Brennan said he would not reveal the amount or the length of the contract with Amgen. CVS will continue to require that prescriptions for Amgen’s drug be approved in advance, a practice known as prior authorization that can limit use of the medicine.
Amgen shares rose 1.8 percent to $162.74 at 9:59 a.m. in New York. Regeneron was up less than 1 percent to $582, and Sanofi fell less than 1 percent to 82.75 euros.
Hepatitis Competition
CVS’s decision is just the latest example of pharmacy benefit managers excluding some expensive drugs from coverage in a category in order to gain better prices for the competing drugs they do decide to cover.
Last December, Gilead Sciences Inc.’s hepatitis C treatment Harvoni was excluded from Express Scripts Holding Co.’s main list of 2015 covered drugs in favor of a competing treatment from AbbVie Inc. That move set off a price war over hepatitis C drugs, with several other insurers and payers, including CVS, deciding to cover only the Gilead medicine.
Winning an exclusive deal with a benefits manager is a mixed blessing for drugmakers, who ensure a market for their drugs but may sacrifice a lot in discounts. AbbVie’s hepatitis C treatment generated $469 million in sales last quarter, while Gilead’s drugs, which require patients to take fewer daily pills, brought in $4.8 billion.
Bad Cholesterol
PCSK9 inhibitors are designed to help people with high levels of bad cholesterol who can’t get their condition under control with statins such as Pfizer Inc.’s Lipitor. Payers of insurance benefits have worried they could become one of the costliest drug classes ever, with the potential for $100 billion in annual sales if widely used. For now, their scope is more limited to people who have genetic conditions or particularly stubborn cholesterol levels.
Brennan said CVS was thinking about how to control costs of the PCSK9 drugs over the long term.
While usage now is modest, large clinical trials examining whether the therapies can lower rates of heart attacks and other cardiovascular events could have results next fall, he said, leading to wider use.
“It is going to be a long game here,” Brennan said. “So far we have been very pleased with what we have seen in terms of ability to control the utilization.”
CVS said its decision is effective on Dec. 1. Overall, CVS manages drug coverage for 70 million Americans, but the company doesn’t break out how many are on the company’s commercial coverage lists, spokeswoman Christine Cramer said in an e-mail.
Amgen said it was “delighted” with the choice. “We will continue to engage constructively with other payers to enable patients to have access to Repatha,” Anthony Hooper, Amgen’s head of commercial operations, said in a statement Monday.
“Sanofi and Regeneron are disappointed about the decision CVS made in limiting access to Praluent,” the two companies said in a joint statement. “Patients and physicians should have a choice regarding their treatment and access to the right therapy to meet individual patient needs.” Sanofi and Regeneron are in ongoing discussions with other insurers over Praluent coverage, according to the statement.
‘Small Percentage’
In October, Express Scripts, the largest manager of prescription drug benefits for employers and insurers in the U.S., said it would cover both Praluent and Repatha. It was the first major coverage decision for the drugs on a national basis in the U.S.
Sanofi and Regeneron’s drug Praluent won approval from U.S. regulators on July 24, while Amgen’s PCSK9 drug Repatha was approved on Aug. 27. Since then, doctors, patients and investors have been speculating on how insurers would cover the drugs and what restrictions would be imposed on their use.
In its statement, CVS said that for most patients with high cholesterol, statin drugs will remain the standard of care. The PCSK9 drugs are necessary for “a small percentage of patients” who can’t achieve their treatment goals with other therapies, it said.
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