Preview: RADAR on Drug Benefits

FDA Approval of Alzheimer’s Drug Stirs Up Heated Debate

With Chart: Current Market Access to Alzheimer’s Disease Medications

June 10, 2021

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

Alzheimer’s, which affects more than 6 million Americans and tens of millions of people worldwide, is marked by progressive cognitive and functional decline that eventually results in death. It kills more people than breast and prostate cancers combined and, along with other forms of dementia, is expected to cost the U.S. $355 billion this year alone, according to the Alzheimer’s Association.

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

Alzheimer’s, which affects more than 6 million Americans and tens of millions of people worldwide, is marked by progressive cognitive and functional decline that eventually results in death. It kills more people than breast and prostate cancers combined and, along with other forms of dementia, is expected to cost the U.S. $355 billion this year alone, according to the Alzheimer’s Association.

Aduhelm stands out from the other drugs currently used to treat Alzheimer’s (see infographic, p. 6) because it aims to slow the progression of the disease rather than just address its symptoms, Douglas Scharre, M.D., tells AIS Health, a division of MMIT. Scharre is a neurologist and director of the division of Cognitive Neurology at Ohio State Wexner Medical Center, and he worked on clinical trials for the drug.

“Aducanumab is the first of a kind in that it is designed to get rid of this protein called amyloid from the brain,” Scharre says.

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Amazon Plans to Offer 6-Month, Discount Generic Rx Fills

June 10, 2021

Amazon.com, Inc. launched a long-anticipated expansion of its pharmacy business on June 8, saying it will allow Prime members to purchase up to six-month supplies of generic prescription drugs for $6. Experts say Amazon is well positioned to claim substantial market share in the growing prescription drug delivery market, which incumbent players have already begun to target.

Industry watchers have argued over the notion that the web retailer would make a disruptive move into the pharmacy space ever since Amazon acquired PillPack in 2018. Experts tell AIS Health that Amazon’s well-developed logistics and internet retail abilities mean it will be a formidable player.

Amazon.com, Inc. launched a long-anticipated expansion of its pharmacy business on June 8, saying it will allow Prime members to purchase up to six-month supplies of generic prescription drugs for $6. Experts say Amazon is well positioned to claim substantial market share in the growing prescription drug delivery market, which incumbent players have already begun to target.

Industry watchers have argued over the notion that the web retailer would make a disruptive move into the pharmacy space ever since Amazon acquired PillPack in 2018. Experts tell AIS Health that Amazon’s well-developed logistics and internet retail abilities mean it will be a formidable player.

“I love the model,” Ashraf Shehata, national sector leader for health care and life sciences at KMPG, tells AIS Health, a division of MMIT. Shehata expects that Amazon will offer “almost a branded generic, although it’s branded by the distributor, not the manufacturer. I wouldn’t be surprised if we’re going to see an Amazon Basics side of this — they already have a branded category for other commodities that would fit nicely into this.”

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Payers Create CAR-T Approval Systems as Adoption Increases

June 10, 2021

Spurred by CMS’s decision to cover chimeric antigen receptor T-cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up, experts say.

“Despite the costs of CAR-T, I know many plans were already looking at providing coverage prior to the CMS decision,” which was released in October 2019, says Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue. “CMS’s decision provided confirmation that they were on the right track,” he tells AIS Health, a division of MMIT.

Spurred by CMS’s decision to cover chimeric antigen receptor T-cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up, experts say.

“Despite the costs of CAR-T, I know many plans were already looking at providing coverage prior to the CMS decision,” which was released in October 2019, says Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue. “CMS’s decision provided confirmation that they were on the right track,” he tells AIS Health, a division of MMIT.

Following the CMS changes, many health plans subsequently updated their medical necessity guidelines around T-cell therapies, adds Ashraf Shehata, national sector lead for life sciences at KPMG.

Case History Will Drive Authorizations

“There’s probably some space between case-by-case approvals and what I would call process-based approvals,” Shehata tells AIS Health. “They still need quite a bit of documentation. They have to make sure that the person has no prior treatment with CAR-T, proper organ function, no active infection, no history of allergies around stem cell transplant. And then we’ve seen a lot more visibility on the approvals of the treatment facility itself. Those parts of the process have been much more consistent.”

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News Briefs

June 10, 2021

HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

The White House, HHS and the FDA on June 8 released a report containing several policy recommendations to address “vulnerabilities in U.S. pharmaceutical supply chains” that the COVID-19 pandemic revealed. For its part, HHS will make an initial commitment of about $60 million, sourced from the Defense Production Act appropriation in the American Rescue Plan, “to develop novel platform technologies to increase domestic manufacturing capacity for API [active pharmaceutical ingredients].” The report’s overall policy recommendations, meanwhile, are based on four main themes: boosting local production and fostering international cooperation; promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience; creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and leveraging data to improve supply chain resilience.

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GoodRx Acquisition Highlights Strong 1Q Despite Amazon Threat

May 27, 2021

Prescription drug shopping app GoodRx, Inc.’s 2021 is off to a good start, with strong growth in its first publicly traded quarter yielding enough liquidity for the startup to purchase one of its competitors, RxSaver, for $50 million in cash. Experts say the deal and the company’s strong results are proof that it is here to stay, regardless of how retail giants like CVS Health Corp. and Amazon.com Inc. try to shake up the prescription drug market.

GoodRx reported 20% revenue growth year over year for the first quarter of 2021 and 9% growth in prescription volume, although income was only $1.7 million due to the acquisition of RxSaver and expenses related to the firm’s initial public offering. It acquired health and wellness video production company HealthiNation in April.

Prescription drug shopping app GoodRx, Inc.’s 2021 is off to a good start, with strong growth in its first publicly traded quarter yielding enough liquidity for the startup to purchase one of its competitors, RxSaver, for $50 million in cash. Experts say the deal and the company’s strong results are proof that it is here to stay, regardless of how retail giants like CVS Health Corp. and Amazon.com Inc. try to shake up the prescription drug market.

GoodRx reported 20% revenue growth year over year for the first quarter of 2021 and 9% growth in prescription volume, although income was only $1.7 million due to the acquisition of RxSaver and expenses related to the firm’s initial public offering. It acquired health and wellness video production company HealthiNation in April.

GoodRx’s main business is a smartphone-based coupon program, which also includes price comparison tools. The company aggregates coupons by contracting with a number of PBMs, including Cigna Corp.’s Express Scripts, and offering patients the cheapest price for a drug among those partners’ negotiated network rates. If a patient uses a GoodRx coupon, the company collects a fee from a partner PBM.

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