Radar on Market Access

Radar on Market Access: Senate Will Likely Decide Fate of Drug Pricing, PBM Reforms

July 29, 2021

Congress is inching closer to passing the largest individual spending bill in U.S. history through budget reconciliation. D.C. insiders say some combination of Medicare Part D out-of-pocket spending caps, Medicare drug price negotiation, caps on launch prices and/or price growth, or PBM reform might make its way through both chambers, AIS Health reported. 

Congress is inching closer to passing the largest individual spending bill in U.S. history through budget reconciliation. D.C. insiders say some combination of Medicare Part D out-of-pocket spending caps, Medicare drug price negotiation, caps on launch prices and/or price growth, or PBM reform might make its way through both chambers, AIS Health reported.

Drug pricing measures: 

  • Consideration of drug pricing measures has moved to the Senate. Insiders expect H.R. 3has the votes to make it out of the lower chamber. However, few expect that the bill would make it through the Senate intact. H.R. 3, titled the Lower Drug Costs Now Act, caps Part D out-of-pocket costs, allows Medicare to negotiate drug prices and bans the price of drugs from increasing faster than the annual rate of inflation. Some — but not all — of those provisions could clear the Senate.

Patent reform: 

  • The Senate Judiciary Committee’s Subcommittee on Competition Policy, Antitrust and Consumer Rights held a hearing on July 13 on how patent reform could help lower drug prices. Experts and lobbyists from industry groups held forth on subjects including patent thickets and the biosimilar pipeline.

Medicare coverage expansion: 

  • According to Loren Adler, an associate director of the USC-Brookings Schaeffer Initiative for Health Policy, Democrats’ highest priority seems to be making expanded subsidies for marketplace enrollees permanent — but after that, expanding Medicare to include vision and dental is the most popular health care policy among the Democratic caucus.

James Gelfand, senior vice president for health policy at the ERISA Industry Committee, expects that a cap on out-of-pocket spending on Part D drugs will be included if plumping Medicare benefits does become a centerpiece of the Democrats’ health care agenda. But he thinks that’s a bad idea if it is not combined with negotiated prices in Part D or a cap on drug price hikes tied to inflation.

by Peter Johnson

 

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

 

Radar on Market Access: Executive Order Revives Standardized ACA Exchange Plans

July 22, 2021

In President Joe Biden’s new executive order aimed at promoting competition in the American economy, he directs HHS Secretary Xavier Becerra to “implement standardized options in the national Health Insurance Marketplace,” AIS Health reported.

Standardized plans on the federally run health insurance exchange, HealthCare.gov, are not a new concept: They were initially introduced during the Obama administration before being rolled back by the Trump administration. And several states that run their own exchanges currently have some form of standardized plans.

In President Joe Biden’s new executive order aimed at promoting competition in the American economy, he directs HHS Secretary Xavier Becerra to “implement standardized options in the national Health Insurance Marketplace,” AIS Health reported.

Standardized plans on the federally run health insurance exchange, HealthCare.gov, are not a new concept: They were initially introduced during the Obama administration before being rolled back by the Trump administration. And several states that run their own exchanges currently have some form of standardized plans.

What do industry experts say?

  • “Advocates of standardized plans will highlight goals of making plans simpler to use and putting key [health care services] before deductibles, things like that,” says Myra Simon, a principal at Avalere Health. “How standardized plans are implemented is going to affect to whether they contribute to those goals or not.”
  • In Simon’s view, the Biden administration would be wise to improve upon how standardized plans were displayed on HealthCare.gov in prior years. “I think some decision support optimization combined with standard plans would probably be more effective than just standard plans by themselves,” Simon suggests.
  • Joel Ario, a managing director at Manatt Health, notes that in addition to simplifying the shopping experience, standardized plans generally aim to feature lower cost-sharing levels than their non-standard counterparts. But that can result in such plans carrying higher premiums, he says, which makes it all the more important that such plans are paired with robust consumer-shopping tools that guide people to plans that offer the most value overall.

How will plans react to the reintroduction?

  • “It’s interesting to have it proposed as a way to increase competition, because I think what the issuers always said is that it was anti-competition,” points out Katherine Hempstead, senior adviser to the executive vice president at the Robert Wood Johnson Foundation. Insurers, she adds, said “that if you make them all sell the same thing, they can’t differentiate enough. I would expect that maybe they would say that again.”

On the other hand, “I feel kind of like standardizing plans has become more accepted, or it’s gotten a little more mainstream” since states like California have championed the concept, Hempstead says.

by Leslie Small

 

Radar on Market Access: UnitedHealth Touts Clinical Assets in 2Q Earnings Call

July 20, 2021

UnitedHealth Group — which in recent months has been tightening the screws on spending drivers like unnecessary emergency care and out-of-network utilization — is signaling that its greater goal for cost containment comprises much more than simply site-of-care management, AIS Health reported. Rather, the company’s emphasis on its care-delivery assets during its second-quarter earnings conference call may suggest that UnitedHealth is increasingly pursuing the strategy of “if you can’t beat them, own them.”

UnitedHealth Group — which in recent months has been tightening the screws on spending drivers like unnecessary emergency care and out-of-network utilization — is signaling that its greater goal for cost containment comprises much more than simply site-of-care management, AIS Health reported. Rather, the company’s emphasis on its care-delivery assets during its second-quarter earnings conference call may suggest that UnitedHealth is increasingly pursuing the strategy of “if you can’t beat them, own them.”

Pushing practices toward value-based care:

  • “I think you’re really starting to see OptumHealth…starting to demonstrate [its] capacity for growth because of the scale of the footprint that they now [have] established across the country,” UnitedHealth CEO Andrew Witty said of the company’s health services division during a July 15 call to discuss quarterly earnings.
  • OptumHealth expects to add about 10,000 clinicians this year, and “we’re well over halfway through that journey,” Witty said.
  • Beyond “simply having the practices and the clinicians,” UnitedHealth is placing an ever-increasing focus on shifting how care is delivered and reimbursed.
  • Wyatt Decker, M.D., who is the CEO of OptumHealth, noted that the UnitedHealth subsidiary is particularly focused on taking best practices from markets that have used capitated payment models for years — such as Texas and Southern California — and transferring them to markets that have historically been fee-for-service-centric, such as the Pacific Northwest and the Northeast.

UnitedHealth’s 2Q performance:

  • As health care utilization levels have begun to return to normal after ultra-high, peak-pandemic care deferral levels last year, UnitedHealth’s medical loss ratio (MLR) has ticked back up to 82.8% compared with 70.2% in the year-ago quarter. Still, UnitedHealth’s MLR beat the Wall Street consensus estimate of 83%, observed Citi analyst Ralph Giacobbe in a July 15 research note.
  • The firm continues to expect a $1.80 COVID-related negative impact on its earnings per share (EPS) for 2021 as a whole, with most of those effects predicted in the second half of the year.
  • During the second quarter, UnitedHealth recorded an adjusted EPS of $4.70, beating the consensus of $4.43.

by Leslie Small

 

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