Radar on Market Access

Radar On Market Access: Payers Try New Strategies to Control Diabetes Drug Costs

February 20, 2020

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

With the cost of diabetes drugs still growing, PBMs and payers are looking for more innovative strategies to hold down costs, AIS Health reported. For some, that might include a strategy similar to the one recently unveiled by CVS Health Corp.’s Caremark unit. The plan, called RxZERO, offers a slimmer formulary for the diabetes drug class, but with no out-of-pocket costs for members.

Mike Schneider, a principal in the commercialization and market access practice at Avalere Health, says the plan is innovative. “You’ve seen Express Scripts do something where they’re offering specific insulins at very low out-of-pocket costs, but this is the first time I’ve seen a PBM come up with a way to eliminate out-of-pocket costs completely,” he tells AIS Health.

With the elimination of copays and other cost-sharing payments for diabetes drugs, CVS is betting members will better adhere to drug regimens and potentially avoid unnecessary hospitalizations and other services.

But these types of plans might not work for all member populations. Marc Guieb, a pharmacy consultant at Milliman, Inc., says member satisfaction can play a part in whether a plan sponsor goes this route, or sticks to a more traditional strategy that places higher-cost drugs in a step therapy plan.

The market for diabetes drugs is tight, with a few big manufacturers that all have similar prices. But there’s one new player, Civica Rx, that’s aiming to change that. In January, 18 plans in the Blue Cross Blue Shield Association joined with Civica Rx to produce up to 10 generic drugs at low cost by 2021.

Included in the partnership is Blue Shield of California, where Alison Lum is the vice president of pharmacy services. “The way that we’ve managed [drugs] in the past probably won’t get us to be sustainably affordable in the future,” Lum says. “We have to think about new ways of doing things.”

Radar On Market Access: Some Experts Question Legality of Closed Medicaid Formularies

February 18, 2020

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

As part of long-awaited guidance that CMS issued to states on Jan. 30 outlining how they can test-drive a fixed federal Medicaid budget and more program flexibilities, the Trump administration invited states to try out something else that hasn’t been done before: implement a closed drug formulary for a portion of their Medicaid population, AIS Health reported.

“For the first time, participating states will have more negotiating power to manage drug costs by adopting a formulary similar to those provided in the commercial market, with special protections for individuals with HIV and behavioral health conditions,” CMS said in its press release unveiling the Healthy Adult Opportunity demonstration, which states can apply for via a Section 1115 Medicaid waiver.

Currently, states’ Medicaid programs must cover all FDA-approved drugs, as mandated by federal law. But CMS is suggesting that states can waive that requirement for the population they choose to cover under their demonstration — likely people who are covered by Medicaid expansion — and still participate in the Medicaid Drug Rebate Program.

But some industry experts tell AIS Health they’re not sure whether that will be legally permissible.

“I have my doubts as to whether this will bear legal scrutiny because it goes against the entire Medicaid Drug Rebate Program, which is rebates in exchange for open formularies,” says Jeff Myers, the former CEO of Medicaid Health Plans of America and founder of health care consulting firm OptDis.

Indeed, “the legal side is obviously the giant question with the whole Healthy Adult Opportunity program,” Jason Karcher, an actuary with Milliman, Inc., tells AIS Health. “We just don’t know how the courts will ultimately see this, although I think it would be fair to be skeptical that we’ll actually get to see a waiver under this [guidance] make it in the near future.”

Radar On Market Access: ACA Exchange Draft Regulation Drops

February 13, 2020

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

On Jan. 31, CMS released the 2021 Notice of Benefit and Payment Parameters (NBPP), which is the annual omnibus regulation that outlines the rules of the game for Affordable Care Act (ACA) exchange plans. But that was only after a trade group for safety-net health plans sent a strongly worded letter warning the Trump administration that the clock is ticking for issuers to finalize their 2021 premiums and benefit designs.

In its Jan. 27 letter, the Association for Community Affiliated Plans (ACAP) complained to CMS that the proposed 2021 NBPP “appears to be stalled at the Office of Management and Budget.” (The OMB completed its review of the regulation on Jan. 29.) Insurers need to submit qualified health plan (QHP) applications starting in early May, ACAP pointed out. “Building in a minimum 30-day comment period in addition to 30 days for the Department to review, revise, and release the final [rule] would allow just one month for issuers to operationalize and implement necessary updates,” the group wrote. “This timeframe will not allow issuers sufficient time to prepare products and operations for Benefit Year 2021.”

Fritz Busch, an actuary with Milliman Inc., tells AIS Health that the final NBPP has come out in April during the past two years, but before that arrived much earlier. The delay of the NBPP “presents operational challenges for a lot of plans, because so many plans are right in the middle of doing their pricing and other planning for the year,” he adds.

As for the content of the draft NBPP, the most attention-grabbing proposed changes to the rules surrounding subsidy eligibility. CMS said it’s seeking public comment on “new automatic re-enrollment processes for enrollees whose share of the premium after applying premium subsidies is $0, in order to reduce the risk of incorrect expenditures on subsidies that cannot be recovered through reconciliation.” In addition, “periodic data matching standards would be amended to help ensure premium subsidies are not inappropriately paid to enrollees who are determined to be deceased, or dually eligible for Medicare.”

Radar On Market Access: New Oncology Biosimilar Launches Could Prompt Preferencing

February 11, 2020

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

2019 saw the launch of the first oncology biosimilars when Amgen and Allergan plc launched Kanjinti (trastuzumab-anns), a Herceptin (trastuzumab) biosimilar, and Mvasi (bevacizumab-awwb), an Avastin (bevacizumab) biosimilar, on July 18. Both reference drugs are from Genentech USA, Inc., a Roche Group unit. Then, on Nov. 7, Teva Pharmaceuticals USA, Inc. and Celltrion launched Truxima (rituximab-abbs), with reference drug Rituxan (rituximab) from Genentech and Biogen.

The Dec. 2 launch of Mylan N.V. and Biocon Ltd.’s Ogivri (trastuzumab-dkst) brought a second biosimilar of Herceptin onto the U.S. market, with a third — Pfizer’s Trazimera (trastuzumab-qyyp) — expected Feb. 15. Also expected to launch in the first part of this year are Ontruzant (trastuzumab-dttb) from Samsung Bioepis Co., Ltd. and Herzuma (trastuzumab-pkrb) from Celltrion and Teva.

A second Avastin biosimilar came onto the U.S. market Dec. 31 when Pfizer launched Zirabev (bevacizumab-bvzr). Rituxan also had additional biosimilar competition on Jan. 23 when Pfizer’s Ruxience (rituximab-pvvr) launched.

Kanjinti is priced 15% less than Herceptin, and its average sales price (ASP) is 13% below the reference drug. Ogivri’s price is “at a competitive discount,” according to Mylan and Biocon. Mvasi is priced 15% less than Avastin, and its ASP is 12% less than that of the reference drug. Zirabev is priced 23% less than Avastin, and Ruxience is 24% less than Rituxan.

“As more health plans set biosimilars on a preferred status, adoption and utilization should increase,” says Martin Burruano, R.Ph., vice president, pharmacy services at Independent Health. “As more become available, there will be opportunity to plan formulary selection to drive costs down. Projections are modest at 12%-15% cost savings initially but will potentially reach 70% cost savings in five years.”

Radar On Market Access: Sanofi Backs Away From U.S. PCSK9 Market, While Novartis Bets Big With Inclisiran

February 6, 2020

Sanofi S.A. is cutting its losses on its PCSK9 inhibitor, exiting the U.S. market for the drug completely after various tactics, including slashing prices and promoting value-based contracts to payers, failed to spark sales for the high cholesterol treatment. But at the same time, Novartis International AG is betting big on the PCSK9 market by acquiring the manufacturer of an investigational PCSK9 that has strong Phase 3 results, AIS Health reported.

Sanofi S.A. is cutting its losses on its PCSK9 inhibitor, exiting the U.S. market for the drug completely after various tactics, including slashing prices and promoting value-based contracts to payers, failed to spark sales for the high cholesterol treatment. But at the same time, Novartis International AG is betting big on the PCSK9 market by acquiring the manufacturer of an investigational PCSK9 that has strong Phase 3 results, AIS Health reported.

Sanofi, which had partnered with Regeneron Pharmaceuticals on Praluent (alirocumab), will turn the U.S. marketing of Praluent over to Regeneron beginning in the first quarter of 2020, and availability of the drug is not expected to be affected.

The company’s decision points to the difficulty inherent in pitting an expensive new product against long-standing successful drugs, in this case statins and other cardiovascular therapies, one observer says. Both Praluent and competitor Repatha (evolocumab) from Amgen have failed to catch on in a big way.

“These products do have a place in therapy but to expect them to be blockbusters isn’t realistic, since the class is satisfied with a lot of cheaper generic alternatives,” Mesfin Tegenu, R.Ph., president of PerformRx, tells AIS Health.

However, Novartis is bucking the PCSK9 trend, betting that a third PCSK9 therapy could become a blockbuster. Novartis announced plans on Nov. 24 to purchase the Medicines Company for $9.7 billion, citing “potentially transformational” potential for the company’s investigational product inclisiran.

The Medicines Company has wrapped up Phase 3 studies and has reported positive results. Inclisiran’s biologic mechanism enables twice-yearly subcutaneous dosing, which the manufacturer says could improve adherence and patient outcomes.

Inclisiran “could become one of the largest products by sales in [the] Novartis portfolio,” the company said. The firm also previewed “flexible market access strategies and value-based pricing,” which it said “can enable broad access.”

According to Novartis CEO Vas Narasimhan, “inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia. With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help health care systems address the leading global cause of death.”

Radar on Market Access: Nebraska Proposes A Two-Tiered Medicaid Expansion

February 4, 2020

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which last month submitted its own Section 1115 waiver application, is trying a different tactic, AIS Health reported.

With Medicaid demonstration programs that include work requirements struck down in three states, it’s become increasingly clear that such waivers may not survive legal scrutiny. So Nebraska, which last month submitted its own Section 1115 waiver application, is trying a different tactic, AIS Health reported.

In its application to CMS, the state proposes to modify voter-approved Medicaid expansion by creating two tiers of coverage: Basic, which includes “comprehensive medical, behavioral health and prescription drug coverage” as required by federal law, and Prime, which is the Basic package plus vision, dental and over-the-counter medication coverage.

“Unlike other states, everyone who meets underlying eligibility criteria will receive at least the robust Basic benefits package,” the application notes.
One of the questions surrounding Nebraska’s unique waiver request is whether it could better withstand legal scrutiny than the Arkansas, Kentucky and New Hampshire work requirements waivers, which have been blocked by federal judges, according to Patricia Boozang, a senior managing director at Manatt Health.

Rather than threatening to end Medicaid coverage for people who don’t comply with the state’s requirements, Nebraska would simply give them a less-generous benefits package, Boozang tells AIS Health.

“The courts really have to opine on that,” she adds regarding whether Nebraska’s approach is more legally permissible.

However, even if the waiver survives a court challenge, that “doesn’t mean it’s good policy,” says Jerry Vitti, founder and CEO of Healthcare Financial, Inc.

Nebraska is asking people who are very vulnerable, who often have language or literacy barriers, and who may even be transient, to comply with “a pretty burdensome requirement for that demographic,” he says. “It’s counterintuitive to me that you’re going to cut benefits for those least able to comply.”

Both Vitti and Boozang agreed that if approved, Nebraska’s waiver program could add some administrative burden for the state and, depending on how it organizes the program, its Medicaid MCOs.