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MMIT Reality Check on Psoriatic Arthritis (July 2021)

July 16, 2021

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for psoriatic arthritis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 70% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In September 2020, the FDA expanded the use of the Janssen Pharmaceutical Companies of Johnson & Johnson’s Simponi Aria (golimumab) for people at least 2 years of age for the treatment of active polyarticular juvenile idiopathic arthritis and expanded the active psoriatic arthritis indication to the same patient population.

by Matt Breese

Trends That Matter for Aduhelm’s Approval to Medicare

July 15, 2021

Marking the first FDA approval of an Alzheimer’s disease treatment in nearly 20 years, the federal agency on June 7 gave accelerated approval to Biogen Inc. and Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa), AIS Health reported.

Marking the first FDA approval of an Alzheimer’s disease treatment in nearly 20 years, the federal agency on June 7 gave accelerated approval to Biogen Inc. and Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa), AIS Health reported.

Controversial approval:

  • Aduhelm’s two Phase III trials showed contradictory results regarding efficacy. Moreover, patients reported temporary swelling in areas of the brain that caused symptoms such as headache, confusion and nausea, and an adverse reaction. The Institute for Clinical and Economic Review in a draft evidence report concluded that the evidence was “insufficient” to determine the net health benefit of Aduhelm.

Medical benefit coverage:

  • Aduhelm is infused once every four weeks and therefore likely to be covered under the medical benefit. Biogen has said it expects about 80% of potential Aduhelm patients to be covered through Medicare Part B, which would easily double the $37 billion Medicare already spends on Part B drugs annually if Biogen’s estimates are correct that roughly 1 to 2 million Americans would qualify for treatment.

Implications for Medicare:

  • “New generations of drugs are increasingly tied to diagnostic monitoring. In this case, patients may be required to undergo Magnetic Resonance Imaging (MRI) to determine disease progression,” observes Jay Jackson, a principal at Avalere Health. And MRI is a currently covered diagnostic for Alzheimer’s patients, he notes. “While most Medicare beneficiaries have some form of secondary insurance…out-of-pocket expenses for both for those patients without such secondary coverage could create barriers to access.”
  • For MCOs, the drug and related imaging presents a “major incremental cost” to Medicare and could trigger the “significant cost” threshold in Medicare, suggested analysts from Evercore ISI in a June 7 research note.
  • Since MA plan bids were due on June 7, it’s too late for Aduhelm’s approval to be factored into their 2022 capitation rates and it’s unclear at this time what CMS will do for the 2023 capitation rates, suggests Brad Piper, a principal and consulting actuary with Milliman.

by Lauren Flynn Kelly

 

Radar on Market Access: Zeposia May Have Challenges Within Ulcerative Colitis Class

July 15, 2021

On May 27, the FDA gave an additional indication to Bristol Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. However, according to payers responding to a survey by Zitter Insights, the treatment may have some challenges breaking into the space, AIS Health reported.

On May 27, the FDA gave an additional indication to Bristol Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. However, according to payers responding to a survey by Zitter Insights, the treatment may have some challenges breaking into the space, AIS Health reported.

How much will Zeposia cost?

  • Treatment is initiated with a 0.23 mg dose once daily on days one through four, then 0.46 mg once daily on days five through seven and then 0.92 mg once daily afterwards. The price of a starter kit consisting of the initial 37-day supply is $9,110, and a 30-day supply is $7,387 for an annual wholesale acquisition cost of just under $90,000.

How will payers manage Zeposia?

  • For the Managed Care Biologics & Injectables Index: Q3 2020, between Aug. 25, 2020, and Sept. 28, 2020, Zitter Insights polled 50 commercial payers with 127.5 million covered lives. Payers with 67% of covered lives said they are unlikely to prefer Zeposia over other therapies approved for ulcerative colitis or to incentivize physicians to prescribe it. Almost one-quarter said they are likely to exclude it from formulary.

How will gastroenterologists prescribe Zeposia?

  • During the same time frame, Zitter Insights polled 50 gastroenterologists about their anticipated prescribing of Zeposia. Almost two-thirds said that they are likely to prescribe the agent for people with ulcerative colitis who had not responded to a previous treatment, and more than half said they are unlikely to prescribe the new drug as a first-line therapy for ulcerative colitis.
  • Almost half said they would prescribe it over certain agents in the class, with those respondents citing AbbVie Inc.’s Humira (adalimumab) and Simponi (golimumab) from Janssen Biotech, Inc., a Johnson & Johnson company, as the drugs they were likely to prescribe instead of Zeposia.

by Angela Maas

 

Radar on Market Access: Walmart’s Discount Insulin Could Attract Insured Customers

July 13, 2021

Walmart Inc. recently made one of its biggest moves yet in the health care space by partnering with Novo Nordisk to launch private-label insulin at a steeply discounted cash price, AIS Health reported.

The retail giant’s ReliOn NovoLog Insulin will offer insulin vials for $72.88 and FlexPens for $85.88, representing a 58% to 75% savings compared with the cash price of branded analog insulin products.

Walmart Inc. recently made one of its biggest moves yet in the health care space by partnering with Novo Nordisk to launch private-label insulin at a steeply discounted cash price, AIS Health reported.

The retail giant’s ReliOn NovoLog Insulin will offer insulin vials for $72.88 and FlexPens for $85.88, representing a 58% to 75% savings compared with the cash price of branded analog insulin products.

Some patient advocates aren’t impressed:

  • “The announcement of Walmart selling Novolog insulin is not a solution to the insulin price crisis. It is not a replacement for real action, and adds another talking point for pharmaceutical companies’ supposed interest in patients’ needs,” the group T1International said in a statement. “The only solution is legislative action to truly hold the industry accountable and lower the list price.”

Industry expert sees promise:

  • Michael Abrams, a principal and co-founder at health care consulting firm Numerof & Associates, thinks Walmart’s new offering will make a difference for people with diabetes — although he adds that “expectations do have to be realistic.”
  • Walmart’s private-label insulin, Abrams says, is “a very high visibility example of [a] non-traditional provider that is forcing a correction in the market. And I do think that, by example, we may see others [do so] if there are similar opportunities like this one where there’s a big audience and a big gap between the current price and what [a product] could be sold for.”

Offering may appeal to the high-deductible set:

  • Walmart’s new private-label insulin is chiefly marketed toward individuals who opt to pay cash for insulin rather than use insurance. And insured patients who have met their health plan’s annual deductible would likely get the lowest price by asking their prescriber for brand-name NovoLog “and then going to any in-network pharmacy to fill that prescription,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.
  • But uninsured patients — or insured ones who haven’t met their annual deductible — “would likely achieve a lowest out-of-pocket cost by asking the prescriber to prescribe ReliOn NovoLog, and then going to Walmart or Sam’s Club to fill the prescription,” Rubinstein says.

by Leslie Small

 

MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2021)

July 9, 2021

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for acute lymphoblastic leukemia treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In July 2021, the FDA approved Jazz Pharmaceuticals plc’s Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma in pediatric and adult patients 1 month and older who are allergic to E. coli-derived asparaginase products.

by Matt Breese

Perspectives on Amazon’s Expanded Pharmacy Business

July 8, 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, AIS Health reported.

“I love the model,” says Ashraf Shehata, national sector leader for health care and life sciences at KMPG. 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.”

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, AIS Health reported.

“I love the model,” says Ashraf Shehata, national sector leader for health care and life sciences at KMPG. 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.”

Shehata says the idea of a white-label generic drug line isn’t novel, but Amazon’s unmatched online retail operation gives it meaningful differentiation.

What separates Amazon is “consumer convenience,” he says. Customers are going to be swayed, he predicts, “not only by the branded generics and the pricing, but people like the familiar consumer front end.”

Text on Amazon’s landing page for the expanded service indicates that, while the company will seek to enter pharmacy networks with insurance carriers, the firm will try to bypass them when possible and capture rebate revenue for itself. While the site says that “we work with most insurance plans,” it also says customers can “save by paying with Amazon Prime.” According to a June 8 note by Citi analyst Ralph Giacobbe, Amazon’s Prime prescription drug operation is administered by Inside Rx, a subsidiary of Cigna Corp.’s Evernorth PBM.

Brian Anderson, a principal at Milliman Inc., says that Amazon will be in the pole position as consumers begin to think of online retail as the default space for filling prescriptions, particularly for maintenance medications. He also expects that Amazon pharmacy could increase utilization.

Shehata says that Amazon’s logistics give the company a notable advantage over legacy players. He also predicts that Amazon can “have a much more predictable inventory of these categories of drugs,” since it will have a more centralized pharmacy operation than legacy pharmacies. What’s more, Amazon “knows a lot about the individual [members.]”

by Peter Johnson

 

Radar on Market Access: Insurers Assess Impact of COVID on Seniors’ Mental Health

July 8, 2021

A recent Health Affairs study, “Decline In New Starts Of Psychotropic Medications During The COVID-19 Pandemic,” shows that new starts of antidepressants and anti-anxiety drugs among seniors during the five months between March and August 2020 were well below expected and historical levels, AIS Health reported.

A recent Health Affairs study, “Decline In New Starts Of Psychotropic Medications During The COVID-19 Pandemic,” shows that new starts of antidepressants and anti-anxiety drugs among seniors during the five months between March and August 2020 were well below expected and historical levels, AIS Health reported.

New starts are lower than expected: 

  • Relative to forecasted levels, researchers observed an 18.6% decline in antidepressant new starts for the initial stay-at-home period of mid-March to mid-May, followed by a 1.4% decline from May 15 to Aug. 8, and an overall drop of 8.9%. Changes in new starts of anxiolytics among seniors fell 15.2% below the forecast in the initial period, 1.8% in the three-month period and 7.7% over the five months. Meanwhile, antipsychotic prescriptions in the initial period were 4.3% below expected levels but increased by 3.4% from May 15 to Aug. 8.

Insurers’ Experience:

  • SCAN Health Plan observed about a 10-fold increase in mental health-related telehealth visits during the “peak months” of the pandemic and in the volume of mental health inquiries, according to Chief Medical Officer Romilla Batra, M.D.
  • The insurer shifted to “an all-hands on deck approach” to ensure members had the appropriate support, such as establishing a dedicated resources hotline for members calling in with concerns about mental health and conducting outreach calls to more than 100,000 members to check on their medical and social needs.
  • The insurer expanded existing partnerships with virtual behavioral health providers to increase access to telehealth and telepsychiatry, made changes to its prior authorization policies to allow for more direct access to mental health care, and launched a partnership with PsychHUB.

by Lauren Flynn Kelly

 

Radar on Market Access: Cigna Doubles Down on Incentives to Spur Biosimilar Adoption

July 6, 2021

Cigna Corp. revealed in a recent press release that starting in July, it “will offer all eligible customers the option to receive a one-time $500 debit card for health care services and products if they decide to switch to a biosimilar or another preferred medication.” The insurer also gave preferred status on its formularies to two approved biosimilars for Janssen’s immunosuppressive drug Remicade (infliximab), Avsola and Inflectra, AIS Health reported.

Cigna Corp. revealed in a recent press release that starting in July, it “will offer all eligible customers the option to receive a one-time $500 debit card for health care services and products if they decide to switch to a biosimilar or another preferred medication.” The insurer also gave preferred status on its formularies to two approved biosimilars for Janssen’s immunosuppressive drug Remicade (infliximab), Avsola and Inflectra, AIS Health reported.

Background:

  • The new “Shared Savings Program” comes months after the American Journal of Managed Care obtained a letter sent to providers by the insurer, stating that patients could receive a $500 debit card if they switch from Novartis’ Cosentyx (secukinumab) to Eli Lilly & Co.’s Taltz (ixekizumab) or an older biologic before Aug. 31 and then refill the prescription before Dec. 31.
  • At the time, Taltz was already preferred over Cosentyx on most of Cigna’s 2021 formularies, “so the $500 card program may have been a signal that Cigna didn’t feel that their traditional utilization management tools were as effective at migrating existing patients to a preferred drug when it comes to these chronic drugs,” says Omar Hafez, managing director at Avalere Health.

Expert’s view:

  • According to Hafez, patient preferences as well as “continuity of care/non-medical switching/step therapy laws” are all barriers to moving patients from their existing biologics, “but the $500 card could help convince some patients to switch on their own, partially neutralizing these barriers.”
  • “The fact that Cigna is rolling this out to the infliximabs could be a sign that Cigna was pleased with the results of [the Taltz/Cosentyx] program and is trying to replicate it in a physician administered drug setting,” Hafez says.

by Leslie Small

 

MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2021)

July 2, 2021

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 45% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors.

by Matt Breese

Trends That Matter for New MS Drug Ponvory’s Management

July 1, 2021

Although there are more than 20 FDA-approved disease-modifying therapies for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label, AIS Health reported.

On March 19, the FDA approved Ponvory to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

Although there are more than 20 FDA-approved disease-modifying therapies for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label, AIS Health reported.

On March 19, the FDA approved Ponvory to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

The sphingosine 1-phosphate (S1P) receptor modulator joins other oral agents within that class: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and Bristol Myers Squibb’s Zeposia (ozanimod).

For the Managed Care Biologics & Injectables Index: Q1 2021, between Feb. 25, 2021, and April 2, 2021, Zitter Insights polled 40 commercial payers with 128.6 million covered lives. Payers covering 82% of lives responded that they anticipate they will manage Ponvory to label following pharmacy and therapeutics committee review, which 70% of respondents expected to occur within three to four months of the drug’s launch. Payers with 11% of lives said they are likely to manage the agent more restrictively than its label.

Zitter Insights also polled 50 neurologists during the same time frame. Almost two-thirds said they expect to prescribe Ponvory over certain MS therapies. More than half anticipated prescribing Ponvory interchangeably with all other MS agents, and only 30% said they are likely to transition current patients to the new drug.

Payers with 12% of lives expect that Ponvory and another pipeline agent, TG Therapeutics’ ublituximab, will face barriers to entry because of their lack of differentiation from other drugs in the class and the difficulty in overcoming existing contracts for other treatments.

by Angela Maas