Spotlight on Market Access

Multiple companies have been launching over the last several years that provide alternate funding options for patients. But one maximizer company has found itself the target of a legal battle with manufacturer Johnson & Johnson over its strategy to reclassify drugs and maximize the copay assistance it gets from pharma manufacturers.

Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. But copay maximizer programs will distribute 100% of available manufacturer copay offset funds over 12 months, as opposed to copay accumulators, which apply the maximum manufacturer assistance up front and deplete that contribution before the end of the year. Payments in both approaches do not count toward members’ deductibles and out-of-pocket maximums.

A new formulation of a narcolepsy drug may get uptake among providers, according to Zitter Insights research. But payers indicate that they are likely to require patients to fail at least one generic drug before getting access to the new agent and other branded medications.

On July 19, Avadel Pharmaceuticals plc said that the FDA had granted tentative approval to its Lumryz (sodium oxybate) for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. The drug — which is also known as FT218 — is a once-at-bedtime extended-release version of Jazz Pharmaceuticals plc’s Xyrem, which requires one dose at bedtime and then another dose between two-and-a-half to four hours later.

As soon as Friday, Congress is expected to pass Medicare prescription drug price reforms as part of the Inflation Reduction Act (IRA). [Editorial update: The House passed the legislation on Aug. 12, and President Joe Biden signed it into law on Aug. 16.] The reforms are less ambitious than previous versions of drug pricing legislation considered by the current Congress, but various experts and health care stakeholders are mounting vehement arguments about the reforms’ ultimate impact on prices.

Under the bill, HHS would be able to negotiate the price of a gradually increasing number of drugs starting in 2026, when 10 drugs will be eligible for negotiation. The bill would also limit out-of-pocket drug costs for Medicare Advantage and Part D beneficiaries to $2,000 per year, and repeal the so-called rebate rule in Medicare Part D. In addition, the proposal would bar Medicare Part B and Part D drug prices from growing faster than inflation. In a summary of the late version of the reconciliation bill, Senate Democrats estimated that the drug pricing reform program would save $288 billion over 10 years.

More than 1.4 million Medicare beneficiaries could see their medication costs plunge if the Senate passes a budget reconciliation bill that contains drug pricing reforms, Kaiser Family Foundation estimated.

The bill — put forward by Senate Majority Leader Chuck Schumer (D-N.Y.) and Sen. Joe Manchin III (D-W.Va.) — will allow Medicare to negotiate some prescription drug prices starting in 2026 and require drug companies to pay rebates if drug prices rise faster than inflation starting in 2023. Between 2019 and 2020, half of drugs covered by Medicare Part D and 48% of drugs covered by Medicare Part B saw price increases greater than the rate of inflation (1.0%), according to a previous Kaiser Family Foundation analysis.

Multiple trends are occurring within the specialty pharmacy industry that could have a huge impact on the space, maintained longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. Those include greater competition among specialty products, a slowing of payer spending on specialty drugs and more vertical integration among both payers and providers. “We’re at kind of an inflection point in the specialty market,” he contended during the July 29 webinar, titled Specialty Drugs Update: Trends, Controversies, and Outlook.

Among PBMs reporting their commercial plan sponsor clients’ spend, the average share of prescriptions by specialty drugs, both generic and brand, was 2% in 2021. The share of pharmacy revenues for specialty drugs was 38%, and the share of commercial payers’ net spending was 51%. “For the last few years, drug spending has been growing in the low-to-mid single digits, and that’s really the blend of traditional drugs” that have gone down in price due to generics, as well as the gross-to-net bubble — the growing difference between a drug’s gross sales at list price vs. its sales at net price, which includes rebates and other concessions. “Specialty drug spending has also been slowing down. It spiked quite a bit with the introduction of hepatitis C treatments and has been hovering in the 10% to 15% a year range,…but more recently, i.e., last year, it actually dropped.” He pointed out that CVS and Express Scripts reported that their specialty drug spending growth was only 5% to 6%.

Canton, Mass.-based Point32Health was established Jan. 1, 2021, following the successful merger of Harvard Pilgrim Health Care and Tufts Health Plan, two major players in the New England health insurance markets. Its name, unveiled in June 2021, alludes to the 32 points on a compass and represents a shift toward person-centered, technology-focused care delivery, according to an article in the Boston Globe. With more than 1.7 million members, Point32Health is one of the largest insurers in New England, serving members across the spectrum of insurance products. The org’s top state market is Massachusetts, where it is the second-largest insurer overall, serving the state’s managed Medicaid program and offering products through its Affordable Care Act exchanges. Notably, Point32Health is the largest Medicare Advantage insurer in Massachusetts, beating out UnitedHealthcare and Blue Cross Blue Shield of Massachusetts.

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.