Speciality

MMIT Reality Check on Kidney Cancer (July 2021)

July 30, 2021

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

According to our recent payer coverage analysis for kidney cancer 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 kidney cancer treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In March 2021, the FDA approved Aveo Oncology’s Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received at least two prior systemic therapies.

by Matt Breese

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

 

Radar on Market Access: Rezurock Is Approved With More Transplant Agents in Pipeline

July 27, 2021

The FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic graft vs. host disease (GVHD) and for whom at least two prior systemic therapies have failed. But that isn’t the only therapy used to treat organ and tissue transplant patients that payers should be watching, AIS Health reported.

The FDA on July 16 approved Rezurock (belumosudil) for the treatment of patients 12 years and older who have chronic graft vs. host disease (GVHD) and for whom at least two prior systemic therapies have failed. But that isn’t the only therapy used to treat organ and tissue transplant patients that payers should be watching, AIS Health reported.

Background:

  • Rezurock targets patients whose cases are more difficult to treat, and it appears to be safe and well tolerated, according to Mesfin Tegenu, R.Ph., president and CEO of RxParadigm. Roughly 60% of chronic GVHD patients fail two or more lines of systemic therapy, meaning they could benefit from Rezurock — a first-in-class ROCK2 inhibitor and Kadmon Holdings, Inc.’s first FDA-approved drug.
  • With GVHD, “the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the host’s body. This is in contrast to organ transplant rejection where the recipient’s immune system attacks (rejects) the transplanted organ,” explains Arash Sadeghi, a clinical pharmacist at UnitedHealth Group’s OptumRx.

Other agents for transplant patients:

  • Maintenance treatments for prevention of organ transplant rejection (the opposite of  GHVD) include drugs like calcineurin inhibitors (such as tacrolimus and cyclosporine), mTOR inhibitors (including sirolimus and everolimus), antimetabolic agents (e.g., mycophenolate and azathioprine), and glucocorticoids like prednisone, Sadeghi says.
  • Mesfin Tegenu, R.Ph., president and CEO of RxParadigm, highlights polyclonal antibodies, which include thymoglobulin and atgam, and monoclonal antibodies (rituximab), as other available treatments.

How payers manage those therapies:

  • “These agents are generally on formulary; however, there may be variations in tiering,” Tegenu says. “Additionally, formulary positioning for monoclonal and polyclonal antibodies [is] more closely monitored with prior authorizations and placement in [the] specialty tier.”
  • OptumRx, however, does not have clinical utilization management in place for anti-organ-rejection drugs, according to Sadeghi. Generally, such therapies are generic and inexpensive, he says; a point on which Tegenu agrees.

More drugs in pipeline:

The drug pipeline for GVHD is beginning to get interesting. For acute GVHD, agents being studied include an anti-CD6 antibody that prevents T-cell activation and T-cell migration, called alpa-1 antitrypsin, and a double antibody conjugate that is an anti-CD3 and anti-CD7 agent, Tegenu says.

by Leslie Small

 

MMIT Reality Check on Bipolar Disorder (July 2021)

July 23, 2021

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

According to our recent payer coverage analysis for bipolar disorder 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 bipolar disorder treatments shows that under the pharmacy benefit, about 21% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In May 2021, the FDA approved Alkermes plc’s Lybalvi (olanzapine and samidorphan) for adults with schizophrenia and for adults with bipolar I disorder, for the acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate and as a maintenance monotherapy treatment.

by Matt Breese

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