Spotlight on Market Access

Having a successful product launch and securing payer coverage come well before FDA approval of a drug. But some drugmakers face an uphill battle after launch because they fail to engage with both payers and patients in a timely fashion, as well as provide them with truly useful information.

To engage payers effectively, pharma companies should individualize their value propositions with a focus on what’s important to each one rather than a one-size-fits-all tactic, says Dominic Galante, M.D., chief medical officer at Precision AQ. He also recommends that manufacturers think beyond traditional pricing models and “adopt flexible pricing strategies and innovative reimbursement models that align with payer budgets and value-based care initiatives.”

The FDA recently approved a new combination treatment for a very small population of cancer patients that has dismal survival rates. In response to a Zitter Insights survey, most oncologists said they believe the new treatment will have at least some impact on their prescribing.

On Jan. 16, the FDA gave another approval to Amgen Inc.’s Lumakras (sotorasib) in combination with the company’s Vectibix (panitumumab) for the treatment of adults with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

In defiance of some industry watchers’ expectations, there was no mass exodus from stand-alone Prescription Drug Plans (PDPs) to Medicare Advantage Prescription Drug (MA-PD) plans between 2024 and 2025, one prominent Part D actuary has observed. 

“Total enrollment was effectively flat from December [20]24 to February 2025; that’s a little bit at odds with what some might have expected,” explains Brooks Conway, principal with Oliver Wyman.  

As for why enrollment trends this year defied expectations, Avalere Health Principal Robin Duddy-Tenbrunsel points out that “there’s been quite a bit going on” in the Part D world. 

Extending inflation-based prescription drug rebates to all commercial health plans, rather than just applying them to the Medicare program, could potentially save as much as $8.1 billion annually, a recent Health Affairs study finds.

The Inflation Reduction Act (IRA) requires pharmaceutical manufacturers to pay rebates to Medicare if they raise prices faster than the rate of inflation for certain drugs. To gauge the effects of extending the program beyond Medicare, researchers analyzed 130 million claims — comprising 16,107 drugs — for 11 million enrollees in commercial plans in 2021. They found that if the IRA rebate program was applied to the entire commercially insured population, savings would be largely driven by a small number of drugs with high total spending.

When the Medicare Drug Price Negotiation Program became law a few years ago, supporters cheered that CMS would finally be able to negotiate prices on drugs for Medicare beneficiaries. But manufacturers criticized it, calling it government overreach that would threaten drug development. To link into that, researchers at the IQVIA Institute for Human Data Science analyzed initial drug approvals and expansions that followed and found that due to some aspects of the program, clinical development after a drug’s initial approval may indeed be impacted, according to a new report, titled Proliferation of Innovation Over Time: Frequency, Timing and Clinical Value of Expansions Post-Initial Approval.

Genentech USA, Inc., a member of the Roche Group, provided funding for the report.