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.

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%.

When pharma companies launch a successful product, the process leading up to that point contains many key decisions from various teams across a manufacturer, including commercial. And with science leading to more and more innovations and many drugs coming to market via an accelerated process, it’s critical now more than ever to understand when to bring in the commercial team and how it can help with the development of a drug and its ultimate success in the market.

During a recent webinar, which was part of the Fierce Leaders in Sciences Forum sponsored by Fierce Pharma, moderator Lisa Johnson Pratt, a board member for Assembly Biosciences, kicked off the discussion by asking what the biggest challenges are for companies that are trying to bring a strong commercial point of view and input into the product development process.

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

As prices for specialty pharmacy products continue to soar, payers are looking for new ways to gain more control over the distribution of expensive, often-provider-administered drugs. Last week, Kaiser Permanente and Highmark Blue Cross Blue Shield both struck deals aimed at managing specialty pharmacy spend — and one expert says that more deals like them are coming, especially from Kaiser’s new business partner, Cigna Corp. subsidiary Evernorth.

Kaiser Permanente (KP), the multistate integrated payer-provider based in California, doesn’t enter agreements with service providers outside its self-contained system very often. That said, Kaiser Permanente spokesperson Stephen Shivinsky tells AIS Health that “Kaiser Permanente and Accredo” — the specialty pharmacy division of Evernorth — “have had an existing relationship, which will expand further under part of this new agreement.”