Medicare Advantage insurers and their distribution partners are bracing for a busy Annual Election Period, thanks in part to multiple Part D benefit changes resulting from the Inflation Reduction Act. Adding to their concerns about likely market disruption and enrollee confusion is a new drug manufacturer letter that raises operational and financial questions about the interplay between Patient Assistance Programs (PAPs) and the Medicare Payment Prescription Plan (M3P).

In a letter dated Aug. 19, Pfizer Inc. informed Part D beneficiaries using its Pfizer Oncology Together program that they must enroll in the M3P before they can be reconsidered for the PAP. According to the company’s website, Pfizer Oncology Together provides financial assistance with out-of-pocket (OOP) deductible, co-pay, or coinsurance costs for eligible patients who have been prescribed certain Pfizer Oncology oral and injectable medicines.

While plenty of telehealth and online drug dispensing companies have rolled out direct-to-consumer (DTC) offerings, two pharma manufacturers have unveiled their own digital platforms this year in a bid to streamline and simplify consumers’ experience with the U.S. health care system. Other drugmakers are likely to launch similar offerings, say industry experts, as they offer benefits to various stakeholders. Still, certain challenges exist for those stakeholders, and manufacturers will need to ensure that they take certain steps — both pre- and post-launch — to set themselves up for success while remaining compliant with various regulations.

On Aug. 27, Pfizer Inc. launched PfizerForAll, a “user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S.” It is aimed at Americans with migraine, COVID-19 or flu and offers adult vaccinations for conditions such as COVID-19, flu, respiratory syncytial virus (RSV) and pneumococcal pneumonia.

PBMs and health plans are increasingly relying on pharmacists to manage their members’ medication costs and improve adherence, particularly among marginalized groups who have often been overlooked, according to speakers at the third annual Pharmacoequity Conference, held May 3 at the University of Pittsburgh. The panelists also said pharmacists adopting a so-called “cost-plus” model can help bring more transparency to drug pricing, make medications more affordable, and help people become healthier and save payers money.

The term “pharmacoequity” was popularized in 2021 by Utibe Essien, M.D., an internal medicine physician and former professor at the University of Pittsburgh who is now at the University of California, Los Angeles. Essien has defined pharmacoequity as “equity in access to pharmacotherapies or ensuring that all patients, regardless of race and ethnicity, socioeconomic status, or availability of resources, have access to the highest quality of pharmacotherapy required to manage their health conditions.”

Although a newly finalized health insurance regulation clocks in at 748 pages, it is missing something patient advocates have been eagerly hoping to see: language stating CMS will enforce a court ruling regarding the use of copay accumulator programs. Due to that omission, a patient advocacy group says it is once again exploring its legal options to curtail the practice in which payers prevent drug manufacturer coupons from applying toward patients’ out-of-pocket cost obligations.

Patients and advocacy groups for years have filed official comments on the annual Notice of Benefit and Payment Parameters (NBPP), urging federal officials to curtail the use of copay accumulator programs, according to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “And every year, they’ve completely ignored those comments,” he tells AIS Health, a division of MMIT.

Eli Lilly & Co. will sell its glucagon-like peptide-1 (GLP-1) weight loss drugs directly to consumers through a telehealth service called LillyDirect, the drugmaker revealed on Jan. 4. Pharmacy benefit experts say that the move is sure to improve market access for Lilly’s weight loss drugs, but they also say that the impact of the new service on PBMs is likely to be minimal.

LillyDirect will contract with “independent healthcare providers,” per a press release, to prescribe the GLP-1 tirzepatide, known by the brand names Mounjaro () and Zepbound. Weight loss-focused telehealth provider Form Health Inc. will be one of those partners, NBC News reported. LillyDirect will also provide “tailored support” from unnamed providers. The service will also feature free “direct home delivery…through third-party pharmacy dispensing services.”

On Sept. 29, a U.S. District Court ruled in favor of patient advocates who challenged a regulation that allowed most individual and group market health plans to use copay accumulator programs. So far, it isn’t clear how CMS will respond to the ruling, likely leaving health plans and PBMs waiting eagerly for guidance from the agency. But one thing is certain: Health insurers aren’t happy about the decision.

Insurers created copay accumulator programs in response to the drug manufacturer practice of offering copay assistance programs — including coupons and copay cards — to defray high out-of-pocket costs patients might face for branded drugs. When copay accumulator programs are applied, health plan enrollees are not allowed to count any direct-to-consumer discounts toward their deductibles or out-of-pocket maximums.

After the introduction of newly FDA-approved, competing products in their therapeutic classes, the net price growth rate of select medications declined, according to an analysis published in the August issue of Health Affairs. The findings suggest that both “me too” therapies and PBM rebate negotiation might have an important role to play in reducing costs, researchers say.

The study found there was an estimated $10.4 billion reduction in net commercial spending for the existing therapies in the first three years after the introduction of the new medications. The authors noted that represented an 18.5% decline in projected spending on the existing therapies compared with if the new medications had never hit the market.

UnitedHealth Group has promoted Patrick Conway, M.D., to CEO of Optum Rx, the company’s PBM. Conway revealed the new role in a LinkedIn post. He was previously the CEO of Care Solutions at Optum, UnitedHealth’s health care services division. Heather Cianfrocco, Optum Rx’s CEO, is now the president of Optum. Before coming to UnitedHealth, Conway served as CEO of Blue Cross Blue Shield of North Carolina and as director of the Center for Medicare and Medicaid Innovation.

Mark Cuban Cost Plus Drug Co. has formed a partnership with Scripta Insights, a health care software company that works with health plans and self-insured employers to lower pharmacy benefit costs. Scripta plans on integrating the Mark Cuban company’s discounted pricing into its Med Mapper product. Alex Oshmyansky, CEO of Mark Cuban Cost Plus, said the companies “share a common goal of providing consumers the lowest possible price for their prescription medications.” The Mark Cuban company primarily sells generic medications at a discount, but earlier this year it began offering brand-name drugs from Janssen, a division of Johnson & Johnson Co., and IBSA Institut Biochimique SA, a pharmaceutical company based in Switzerland.

CVS Health Co.’s Caremark PBM struck a deal with GoodRx, Inc. that will allow eligible Caremark members to automatically access to GoodRx's prescription pricing at the pharmacy counter, which may lower their out-of-pocket costs for generic medications, per a July 12 press release. Using GoodRx coupons won’t affect members’ deductible and out-of-pocket threshold calculations, CVS added, noting that “plan members only need to utilize their existing benefit card at their preferred in-network pharmacy” to access the new discounts. “Through this program, patients don't have to choose between using their pharmacy benefit or using GoodRx to save on their prescriptions — now they can do both right at the counter so they have confidence they are always paying the lowest available price, said Scott Wagner, interim CEO of GoodRx. “This collaboration can make a meaningful difference for the tens of millions of Americans that CVS Caremark serves." The pact isn’t GoodRx’s first deal with a “big three” PBM — GoodRx also has a similar discount arrangement with The Cigna Group’s Express Scripts.

People with higher copays are significantly less likely to adhere to their commonly prescribed cardiovascular medications than those with low copays, according to a study published this month in JAMA Network Open. Utibe R. Essien, M.D., the study’s lead author, tells AIS Health the variations in adherence based on copays are “striking” and could have broader implications if some of the drugs are approved for obesity as expected and become even more widely used.

Utibe adds that people who do not take these drugs could have serious medical complications, leading to more of a health burden for them and financial burden for payers due to the high costs associated with hospitalizations, emergency room visits and other expenses.