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Trends That Matter

Trends That Matter for Zeposia

July 29, 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

 

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

 

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

 

Trends That Matter for PBM Customer Satisfaction

June 17, 2021

While client-filed lawsuits against PBMs and regulatory scrutiny of their business models continue to make headlines, a newly released survey finds that plan sponsors’ overall satisfaction with their PBMs is relatively high. But Pharmaceutical Strategies Group’s 2020 Pharmacy Benefit Manager Customer Satisfaction Report also reveals that customer satisfaction of PBMs varies depending on the firms’ size and the type of client being served, AIS Health reported.

“The size of the PBM does make a difference, often in the services that are provided because of scale. It also makes a difference in the types of customers who choose a PBM — so many customers are looking to middle-market, midsized PBMs for more flexibility, where others look to the larger PBMs for perhaps deeper discounts,” Sharon Phares, Ph.D., senior vice president of research and data innovation at PSG, said during a May 25 webinar.

While client-filed lawsuits against PBMs and regulatory scrutiny of their business models continue to make headlines, a newly released survey finds that plan sponsors’ overall satisfaction with their PBMs is relatively high. But Pharmaceutical Strategies Group’s 2020 Pharmacy Benefit Manager Customer Satisfaction Report also reveals that customer satisfaction of PBMs varies depending on the firms’ size and the type of client being served, AIS Health reported.

“The size of the PBM does make a difference, often in the services that are provided because of scale. It also makes a difference in the types of customers who choose a PBM — so many customers are looking to middle-market, midsized PBMs for more flexibility, where others look to the larger PBMs for perhaps deeper discounts,” Sharon Phares, Ph.D., senior vice president of research and data innovation at PSG, said during a May 25 webinar.

In its survey of 269 plan sponsors who provide pharmacy benefits to their employees/members, PSG found that overall satisfaction with PBMs averaged 8.0 on a 1-10 scale in 2020. PBMs with more than 20 million members had a 7.9 average satisfaction rating, while PBMs with 20 million or fewer members scored an 8.6.

Satisfaction levels also varied based on plan sponsor type, with employers averaging an 8.1 out of 10 and labor unions averaging 8.6, while the category comprising health plans, insurance companies and third-party administrators averaged a lower 7.7.

In addition, 84% of respondents indicated that their PBMs were aligned with their goals — with the percentage slightly higher (94%) among clients of small- to midsized PBMs than among clients of large PBMs (82%). Like alignment of goals, another measure — financial transparency — is critical for fostering trust between PBMs and their customers, Tracy Spencer, senior vice president and practice leader for employer groups, labor and health systems at PSG, pointed out during the webinar.

While the percentage of respondents to PSG’s survey who said their financial relationship with their PBM was somewhat or completely transparent was high — 90% — respondents’ overall satisfaction rating with their PBMs’ transparency was only 7.3 out of 10.

by Leslie Small

 

Trends That Matter for Atopic Dermatitis Medications

June 3, 2021

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Meanwhile, the FDA requested additional data on LEO Pharma A/S’s biologic tralokinumab, intended for adults with moderate to severe AD, but only on a device component, not on efficacy or safety, the company said in April. Tralokinumab would offer a novel mechanism of action for AD, noted the latest quarterly Drug Pipeline Insights Report from UnitedHealth Group’s OptumRx, although it also pointed out that “efficacy appears more modest than competing existing treatment options like Dupixent.”

Finally, a topical JAK inhibitor, Incyte’s ruxolitinib, was accepted for FDA priority review in February, with a target FDA action date in late June.

“The new oral and injectable therapies may bring new formulary options compared to Dupixent,” says Mesfin Tegenu, CEO and chairman at RxParadigm. “Depending upon how these new products are priced, market forces may play a role to bring down the annual cost for Dupixent. However, for any responsible prescriber there’s an abundance of generic topical corticosteroids available for treatment.”

At Prime Therapeutics, Dupixent is preferred on the PBM’s standard formulary as a specialty medication, says April Kunze, Pharm.D., senior director of clinical program development. It is subject to utilization management, Kunze says, adding, “there has been more awareness to this category, and biologics such as Dupixent have been approved with good efficacy results.”

Meanwhile, Eucrisa (crisaborole), a steroid-free topical treatment from Anacor Pharmaceuticals, Inc., is preferred on Prime’s standard A-Series NetResults formulary with no utilization management in place, Kunze adds.

The newer agents are unlikely to shake up treatment of most patients, according to Tegenu. “Treatment starts with the more conventional options, as there is much more data available and cost is significantly lower,” he says.

by Jane Anderson

 

Trends that Matter for Medicare Prescription Drug Spending

May 20, 2021

An April 19 analysis by the Kaiser Family Foundation (KFF) found that a small number of drugs accounted for the majority of drug spending in Medicare, and that negotiating drug prices could lower overall spending in the program, AIS Health reported.

According to the report, the 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition accounted for 60% of net total Part D spending, while the top 50 drugs covered under Medicare Part B accounted for 80% of total Part B drug spending.

An April 19 analysis by the Kaiser Family Foundation (KFF) found that a small number of drugs accounted for the majority of drug spending in Medicare, and that negotiating drug prices could lower overall spending in the program, AIS Health reported.

According to the report, the 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition accounted for 60% of net total Part D spending, while the top 50 drugs covered under Medicare Part B accounted for 80% of total Part B drug spending.

While the report concludes that negotiating drug prices could save the public money, there is a potential tradeoff to negotiating all drug prices, report coauthor Juliette Cubanksi, Ph.D., tells AIS Health. Cubanski is deputy director of KFF’s Program on Medicare Policy.

KFF cannot estimate “what the administrative burden would be for HHS in the process of negotiation,” Cubanksi explains, observing that Part D covers about 3,000 drugs, including many generics.

“Negotiating the price of 3,000 prescription drug products is going to be a massive undertaking that for the majority of those products is not likely to get you much savings,” she adds.

“You’re likely getting the most bang for the buck if you focus on drugs that account for a relatively large share of program spending and that don’t have a generic or biosimilar equivalent,” Cubanski says. “If you’ve only got one manufacturer and the price is pretty high, that makes an easier target than inexpensive products with multiple, competing manufacturers.”

However, there are additional considerations to price negotiation. Cubanski says that it’s “entirely possible” that lower prices in Medicare could result in manufacturers ratcheting up prices in the commercial market to offset losses. Cubanski also observes that pharma companies have argued they would not be able to fund as much research and development if their Medicare profits were eroded, though she is not sure that is the case.

by Peter Johnson