Spotlight on Market Access

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

Among people who filled at least one insulin prescription, 14.1% reached catastrophic health spending — out-of-pocket medical spending greater than 40% of a household’s remaining income after subsistence needs are met — and almost two-thirds of them were Medicare beneficiaries, according to a recent Health Affairs study.

The study was based on data from the Medical Expenditure Panel Survey in 2017 and 2018. Among the respondents who filled at least one insulin prescription, 41.1% were covered by Medicare and 35.7% by private insurance. Median annual out-of-pocket spending on insulin was $97.72, while people with Medicare coverage and private insurance paid much more than Medicaid enrollees.

Democrats are once again seeking to pass drug pricing reform with a new proposal published earlier this month. While the bill is similar to previous ones, most notably with having Medicare conduct drug price negotiations, it also offers some changes from past efforts, including not basing those drug prices on an international reference model. Still, many pharma stakeholders expressed disappointment over aspects of the bill, and while its odds of passing have slightly improved more recently, industry experts are somewhat divided on the bill’s chance of approval.

The newest proposal was released on July 6 after negotiations with Sen. Joe Manchin (D-W.Va.), who squelched earlier administration attempts at drug pricing reform.

A recent FDA approval of a label expansion put the three marketed therapies for spinal muscular atrophy (SMA) on equal footing for the youngest patients. A recent survey found that many payers are covering sequential use of the costly agents, including a gene therapy.

The FDA initially approved Evrysdi (risdiplam) from Roche Group member Genentech USA, Inc. on Aug. 7, 2020, for the treatment of SMA in people at least 2 months old. On May 30, 2022, the agency expanded the drug’s label to include the treatment of babies less than 2 months old. The medication is an oral solution administered by mouth or feeding tube and can be administered by a patient or caregiver at home after a recommended consultation with a health care professional prior to the first dose.

As Congress again proposes drug pricing efforts, many of its members, as well as a couple of government agencies, have pharma manufacturers in their crosshairs for a somewhat related reason: their patent processes. The FDA and the U.S. Patent and Trademark Office (USPTO) recently said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

The move follows President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

In 2022, the majority of plan sponsors used a drug benefit consultant while designing their drug benefit programs, according to Pharmaceutical Strategies Group’s 2022 “Trends in Drug Benefit Design Report,” sponsored by Rx Savings Solutions. The report, which is based on surveys of 153 individuals representing employers, union/Taft-Hartley plans and health plans that covered an estimated 35.1 million lives, also revealed an increasing focus on member satisfaction.

When pharma companies launch a successful product, the process leading up to that point contains many key decisions from various teams across a manufacturer, including commercial. And with science leading to more and more innovations and many drugs coming to market via an accelerated process, it’s critical now more than ever to understand when to bring in the commercial team and how it can help with the development of a drug and its ultimate success in the market.

During a recent webinar, which was part of the Fierce Leaders in Sciences Forum sponsored by Fierce Pharma, moderator Lisa Johnson Pratt, a board member for Assembly Biosciences, kicked off the discussion by asking what the biggest challenges are for companies that are trying to bring a strong commercial point of view and input into the product development process.

Priority Health is the insurance unit of BHSH Health, a health system of 22 hospitals based in Grand Rapids, Michigan. BHSH Health is the temporary name for the combined entity formed by the merger of Spectrum Health (the original owner of Priority Health) and Beaumont Health, which was finalized in February 2022. It is the second-largest health insurer in Michigan, serving members across the spectrum of insurance products, including Michigan’s managed Medicaid program and the Affordable Care Act exchanges. Cigna Corp.’s Express Scripts serves as Priority Health’s primary pharmacy benefits manager, while Accredo Health Group, Inc. (a unit of Express Scripts) manages specialty pharmacy.

With COVID-19 infections surging once again, the Biden administration has stepped up efforts to increase the supply of Paxlovid, the Pfizer Inc. antiviral that garnered emergency use authorization as a therapeutic treatment for the coronavirus. However, increased availability for Paxlovid might end in coming months — Congress has stalled on providing the increased COVID-19 response funding that the administration requested, and experts say health plans are likely to treat the drug like any other if the federal government isn’t picking up the tab for treatments.

The Biden administration has pushed in recent weeks to increase the availability of Paxlovid, free of charge, to COVID-19 patients. On May 26, the White House released a statement touting the rollout of more than 2,500 “test-to-treat” sites where free testing and Paxlovid courses are available, along with 40,000 locations where antivirals are available for patients. The administration also noted that it had “increased the number of people benefiting from oral antivirals in the last seven weeks, from about 27,000 prescriptions filled each week to more than 182,000 last week.”

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.