Allison Inserro

A recent report from Avalere outlines patient access challenges to accessing chimeric antigen receptor (CAR) T-cell therapies due to geographic distance and a complete understanding of what their insurance benefits will cover.

Disparities in health care could worsen these access issues, the report said.

“The growing cell therapy market highlights an imminent need to address patient access barriers unique to these therapies, including the limited number of treatment sites, high drug and non-drug costs, complex logistics associated with travel, post-treatment monitoring, and long-term-care follow-up,” the report said.

Manufacturers seeking FDA approval for additional CAR T-cell therapies will need to examine these financial and logistical burdens and consider how to revamp patient support service offerings to address these challenges, the report said.

Five cellular therapies are approved; another 54 are in late-stage development worldwide.

To get a better understanding of the geographic challenges to access cell therapies, Avalere used the 100% sample of Medicare fee-for-service (FFS) claims between 2017 and 2019; the final population included in the analysis was less than 20% of the total Medicare FFS population.

In the Southern and Western parts of the country, patients had to travel significantly longer distances, compared with the densely populated Middle Atlantic and Northeast.

Given that some patients may need to travel across state lines to access treatment sites—CAR T is only given in approved cancer centers—patients may not have a clear understanding of their insurance benefits, including parameters for out-of-state or out-of-network treatment and any possible additional costs, including drug cost sharing.

Transportation and lodging costs could also be a burden for some patients, especially in parts of the country where median income is low.

The report recommended 5 ways that payers and manufacturers could increase access for these patients during their treatment:

Improving patient support program services to include the cost of the procedure, patient travel, non-drug expenses, long-term follow-up, and care coordination

Assistance with compliance challenges with regards to free or reduced-price drugs in the inpatient bundled payment system

Patient reported outcomes tracking longitudinal patient engagement

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Given that some patients may need to travel out of state to access CAR T sites of care, some may not have a clear understanding of their insurance benefits, including requirements for out-of-state or out-of-network treatment, as well as adequate assistance with the costs of medical-related travel.

Avalere Report Looks at Geographic Challenges to Accessing CAR T-Cell Therapies

 (AMCP) 2021 meeting, 2 researchers from Prime Therapeutics reviewed new specialty therapies that may reach the market this year, including biologics and cell and gene therapies.

Catherine Starner, PharmD, BCPS, senior principal health outcomes researcher, and Nicole Kjesbo, PharmD, BCPS, clinical program development director-pipeline, said the drugs in their forecast (except for the cell and gene therapies) have been submitted to the FDA and are expected to have a high impact based on per member per month (PMPM), given their internal claims data, which draw from commercial lines, Medicare, and Medicaid, depending on the proposed indication.

In cell and gene therapies, Prime starts observing the drugs before they are submitted to the FDA. For their presentation, they reviewed 3 candidates they thought had the highest likelihood of being submitted:

Eladocagene exuparvovec, for aromatic l-amino acid decarboxylase (AADC) deficiency

Micro-dystrophin, or SRP-9001, for Duchenne muscular dystrophy (DMD)

Etranacogene dezaparvovec, or AMT-061, for severe and moderately severe hemophilia 

. This drug, from PTC Therapeutics, provides a working copy of the 

 gene. AADC deficiency is extremely rare, affecting about 100 patients in the United States; one report said the 1-time infusion, surgically injected via MRI, will cost $4 million. Infants born with AADC deficiency fail to develop and have shortened life expectancy.

. This candidate is 1 of 60 in the DMD pipeline and 1 of 2 from Sarepta Therapeutics. The gene transfer therapy is given by a single intravenous infusion. DMD affects between 500 to 5000 males worldwide. Other companies in the space include Pfizer, Solid Biosciences, and Astellas.

. Severe and moderately severe hemophilia B affects 4000 males in the United States. There are 66 candidates for this indication in the pipeline; this one is from uniQure. Current treatment options are limited to factor IX products. Genentech has a similar therapy in development (fidanacogene elaparvovec).

Three cell and gene therapies were among the drugs included in a specialty drugs pipeline forecast at the Academy of Managed Care Pharmacy 2021 meeting.

For 2021, Cell, Gene Therapies Make Prime's “Drugs to Watch” List

With President Joe Biden marking his 100th day in office at the end of the month, a health policy strategist sat down for a conversation—conducted over Zoom, of course—to discuss the new administration’s achievements and challenges at a session at the 

Academy of Managed Care Pharmacy 2021 meeting

Ceci Connolly, president and CEO of the Alliance of Community Health Plans, interviewed Chris Jennings, who worked for both Presidents Obama and Clinton as well as elsewhere in Washington, DC.

The two turned to the first major move by the administration, 

 (ARP), which is also the first major investment in the Affordable Care Act since the landmark law was passed in 2010.

Are these immediate quick fixes or is there potential for long-term impact, Connolly asked. Both, Jennings responded, noting the provisions regarding vaccine distribution and uptake, as well as the ones related to making health insurance policies purchased through the exchanges more affordable.

The bill made it through Congress through the reconciliation process, which means the measures are set to expire at the end of 2022—unless they are made permanent.

The measure covers premiums for those with incomes 100% to 150% of the poverty level and allows more individuals to qualify for subsidies, up to those with incomes over 400% of the federal poverty level. That affects the subsidy cliff, where currently income cutoffs (as low as $51,040 for a 60-year-old) mean that a monthly insurance premium doubles.

Jennings said Congress will be pressured to make these changes permanent.

“I don't see how you can have a 2-year policy where you provide that type of assistance, that people become used to those types of coverage policies, and then don't continue them on, so there'll be enormous pressure to make those permanent,” he said.

The ARP also includes incentives for states that have not yet expanded Medicaid to do so; even states that decide not to do that may face pressure regardless.

Reflecting on the crisis that has gripped the country and the world for nearly a year and a half, Jennings noted the faults and gaps that COVID-19 exposed, such as a lack of access to affordable care and health inequities, a health care system struggling to respond, and the new president's aggressive response.

“Because that's where the public is—the public doesn't want to go through this again,” he said. “There really is a theme of, it is our responsibility as a country to ensure that we are never so vulnerable as we were this time around for this type of crisis.”

In addition, despite the fact that the issues raised by the pandemic have been known to those inside the health care and health policy space for years, all sides of the health care system have not done a good job of addressing these challenges.

“We've failed on almost every single frame, whether we're talking about transportation or nutrition or housing or income or education,” he said, which made the health of the population vulnerable to the effects of COVID-19.

Asked what the role of industry is, Jennings said it starts with the health care industry becoming more sensitive to the individual needs of patients.

“It's well documented that we treat different patient populations differently within the health care system when we deliver health care. It's well documented that the health care system, in terms of how we cover people, almost explicitly says, ‘It's not my problem,’” when confronted with patients who come from poverty-stricken communities, he said.

Given that Biden did not endorse the idea of Medicare for All in the campaign, preferring instead to strengthen the ACA, Connolly asked, “What are the next steps that we are likely to see from a Biden White House and Congress in that that same vein of health reform, access, affordability, quality?”

Frame it as “cost, coverage, and complexity,” Jennings replied. “The public still is very frustrated with the complexity of our health care system, their out-of-pocket costs.”

Ultimately, he said, “the elephant in the room” has to be addressed—the cost of health care and the cost of prescription drugs. Containing cost would allow for investment in other health care areas, whether it is Medicaid, expanded ACA subsidies, or integrating value-based care with primary care, he said.

In another area of cost, Connolly asked Jennings for his opinion on a legislative priority of AMCP, 

the passage of a preapproval information exchange (PIE)

, which seeks to streamline 2 steps in the drug approval process into one. Under the idea, as a developer submits its product to the FDA for review, payers and health plans could begin a simultaneous evaluation of clinical trial and economic information in order to calculate demand and budgetary impacts.

“I would say it makes a lot of sense,” said Jennings. For a payer, if a drug comes out that was not expected, at a high cost, it becomes very difficult to manage and increases premiums. However, he noted, “It is one tool. It is not 

Paying for specialty drugs, which represent a growing share of drug spending for a relatively small slice of the population, is going to become a much larger challenge, Jennings said.

“I don't think we as a country are prepared for some of the pricing that is about to come around the corner here on some of these products,” he said. While increasing access to biosimilars and ending patent abuse would help, he also said policy makers need to be prepared to deal with pricing that at some point becomes abusive.

With President Joe Biden marking his 100th day in office at the end of the month, a health policy strategist sat down for a conversation to discuss the new administration’s achievements and challenges.

What’s Next in Health Policy After the First 100 Days of the Biden Presidency?

 (HDHPs) has increased in recent years, as employers shift costs to workers. While these plans are thought to reduce unnecessary health care resource utilization (HCRU), concerns have been raised as to whether 

 truly understand these plans, especially those with lower incomes, as well as whether the plans deter people from seeking preventive care, filling prescriptions, and more.

A poster presentation at the Academy of Managed Care Pharmacy 2021 meeting examined the impact of HDHPs on access to care and HCRU in the United States and the interaction of race, ethnicity, and income.

Researchers performed a 10-year targeted review using Medline/EMBASE, trade publications, and the internet. Besides examining data describing the impact of HDHPs on health outcomes related to access to care, such as deferring care due to cost, or affect on medication adherence and physician visits, the researchers also wanted to see if sociodemographic status is a factor. 

Data were grouped by outcomes such as medication adherence and care access and stratified by race, ethnicity, and income level.

Thirteen articles, 1 abstract, and 10 reports were reviewed, and in line with other concerns, the review found not only that HDHPs reduced some health care use as well as access to care, but also was linked to increased high-intensity and high-cost treatment, such as emergency department visits and hospitalizations.

Some of the studies focused on all therapeutic areas, while others focused on chronic conditions such as 

Overall, individuals in HDHPs were more likely to report delaying necessary medical care, have cost barriers, have claims rejected by insurance, have challenges finding a provider, or were unable to get an appointment. This effect was greater for patients with lower incomes.

Patients with diabetes and HDHPs had the fewest number of specialist visits, compared with patients with a low deductible or no deductible. Another study found the plans were linked with the discontinuation of branded medications, while a diabetes study found that low-income patients had a higher level of more intensive health care usage.

Three studies examined the impact of race/ethnicity on access to care and HCRUs and found that non-White cancer survivors had poorer adherence. Non-White survivors used less medication, delayed filling prescriptions, and were more frequently unable to afford specialists compared with White survivors. 

The authors noted that the review was not systematic, and some references may have been missed. In addition, the interaction between race/ethnicity and income/socioeconomic status on the association between HDHP use and access to care or health care was not discussed.

The authors wrote that while it is possible that decreased HCRU may stem from other factors besides the design of HDHPs, their work suggests that additional research is needed to evaluate the impact of race, ethnicity, and income while considering other sociodemographic factors on the association between HDHP and health outcomes related to access to care.

Szabo SM, Kuti E, Friesen E, Pimple P, Corepal R, Donato B. Disparities in use of healthcare among those with high deductible health plans: a targeted review. Presented at: The Academy of Managed Care 2021; April 12-16, 2021. Poster E2.

A poster at the Academy of Managed Care Pharmacy 2021 meeting examined the impact of high-deductible health plans (HDHPs) on access to health care and resource use in the United States and the interaction of race, ethnicity, and income.

Allison Inserro

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Avalere Report Looks at Geographic Challenges to Accessing CAR T-Cell Therapies

For 2021, Cell, Gene Therapies Make Prime's “Drugs to Watch” List

What’s Next in Health Policy After the First 100 Days of the Biden Presidency?

Low-Income, Non-White Patients Delay Care Using HDHPs, Study Says