Drug Pricing

Part of a long-running lawsuit filed by Elevance Health, Inc. against The Cigna Group, over what Elevance considers inappropriate contract practices by Cigna's Express Scripts PBM, entered mediation mandated by the Second Circuit Court of Appeals, according to court documents and Elevance’s latest 10-K filing with the Securities and Exchange Commission (SEC). Elevance was seeking to recover $14.8 billion in damages and is now appealing a district court judge’s dismissal of its remaining claim.

David Kaufman, an attorney at Laurus Law Group LLC, says that the mediation mandated by the Second Circuit is unlikely to do much to satisfy Elevance.

A study published this month in JAMA Health Forum indicates people with diabetes can see short-term health benefits from enrolling in plans offering preventive drug lists (PDLs) that sharply reduce or eliminate cost-sharing for certain medications. However, the study’s lead author and a pharmacy benefits consultant tell AIS Health, a division of MMIT, that more work needs to be done to evaluate whether such programs are cost-effective for employer-sponsored plans.

Still, they were encouraged with the results, which found that people who switched to plans with PDLs had an 8.4% reduction in acute, preventable diabetes complication days compared with the non-PDL group. In addition, there was a 10.4% reduction in preventable diabetes complication days among members from lower-income areas who switched to PDLs.

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

The Federal Trade Commission (FTC) and HHS issued a request for information (RFI) on Feb. 14 regarding the role of health care group purchasing organizations (GPOs) and drug wholesalers in widespread generic drug shortages. The agencies are seeking public input about market concentration and contracting practices in those two industries and their involvement in the generic drug market. The agencies noted in a press release that they want information about “how both entities may influence the pricing and availability of pharmaceutical drugs.” Last year, the FTC announced an investigation into rebate-aggregating GPOs tied to major PBMs.

A federal judge on Feb. 12 dismissed a lawsuit brought by the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) challenging the Medicare drug price negotiation program. PhRMA sought to overturn the section of the Inflation Reduction Act creating the program, which allows the federal government to negotiate the price of select high-cost medications. Individual drugmakers such as Merck & Co., Bristol Myers Squibb Co., Johnson & Johnson and AstraZeneca PLC all have similar suits underway. CMS on Feb. 1 sent initial price offers to the manufacturers of the first 10 medications that were selected for the Medicare drug price negotiation program, which goes into effect in 2026.

The FDA approved the highest number of novel therapies in years in 2023, and multiple potential blockbusters are slated for decisions in 2024. In addition, the Inflation Reduction Act looms large over the pharma industry as HHS negotiates the prices of the initial 10 Medicare Part D agents and lawsuits over the legality of the IRA play out. And while life sciences dealmaking was down a bit in 2023, the new year already looks to be more promising. AIS Health, a division of MMIT, spoke with some industry experts about their outlook for 2024.

AIS Health: What are some pharma issues to keep an eye on in 2024, and why?

In late 2023, the FDA approved a new treatment regimen for urothelial cancer that represents a “paradigm change,” according to one industry expert. The cost of the therapy, however, could pose a barrier to its uptake.

On Dec. 15, 2023, the FDA approved Pfizer Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) in combination with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with locally advanced or metastatic urothelial cancer (la/mUC). The agency gave accelerated approval to this combination for people with la/mUC who are not eligible for cisplatin-containing chemotherapy on April 3, 2023. The newest approval converts that accelerated approval to full and expands the labeled indication to include the treatment of people eligible for cisplatin chemotherapy. The application had priority review and breakthrough therapy designation.

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

Seniors who experienced fluctuations in eligibility for Medicare Part D’s low-income subsidy (LIS) spent more money on prescription drugs and filled fewer prescriptions overall, according to new research published in JAMA Health Forum. While researchers said questions remain about whether these temporary losses can impact medication adherence and health outcomes — particularly among non-white seniors — policymakers should consider streamlining LIS eligibility systems to reduce administrative barriers.

In 2023, 13.4 million Part D beneficiaries received full or partial LIS benefits. The program provides assistance with paying premiums and deductibles, and it reduces any post-deductible cost sharing for beneficiaries. The majority of LIS beneficiaries are “deemed,” meaning they are automatically enrolled in the program based on dual eligibility with Medicaid and/or enrollment in a Medicare Savings Program (MSP). (This also includes non-duals who receive Supplemental Security Income.) But 17% of LIS beneficiaries are “nondeemed,” meaning they are not enrolled in Medicaid or an MSP and must apply for LIS themselves. All LIS beneficiaries undergo annual redeterminations, but the process for deemed beneficiaries is automatic, leaving the nondeemed population to face potential administrative challenges and unnecessary coverage loss.

The pharmaceutical and health products industry, which has consistently outspent all other industries on federal campaign contributions and lobbying, spent nearly $378.6 million in 2023 to further policy goals, according to data compiled by OpenSecrets.

With the 2024 presidential election around the corner, the pharma/health products industry nearly evenly distributed their donated campaign funds to Democratic and Republican lawmakers during the 2023-2024 election cycle. Among the 20 lawmakers who received the most contributions from the industry, nine are Democrats. President Joe Biden, who is running for re-election this year, topped the list, receiving over $232,000.

Payers face challenges incorporating drug spending into value-based payment models, making it difficult to reduce overall health care costs, according to panelists who participated in a session at the virtual Value-Based Payment Summit on Jan. 31. The speakers were encouraged with the increased attention being paid to expensive medications and difficulties in ensuring people take their prescriptions. However, they stressed that more needs to be done to educate providers and ensure pharmacy spending is in check.

Frank W. McStay, II, assistant research director at the Duke University Margolis Institute for Health Policy and the session’s moderator, noted the federal government and states have recently proposed and implemented policies to reduce drug costs and increase access to medications. For instance, the Biden administration on Jan. 30 announced that it planned to increase access to sickle cell treatments via the Cell and Gene Therapy (CGT) Access Model that CMS introduced last year.