Spotlight on Market Access

Alternate funding companies that carve out specialty drugs and then get funding for patients via manufacturers’ patient assistance programs (PAPs) have existed for several years, and pharma manufacturers have long complained about them. And although a few have begun restricting who can access their PAPs, that was the extent of the response — until now. On May 5, AbbVie Inc. filed a lawsuit (1:23-cv-02836) against Payer Matrix, LLC in the U.S. District Court for the Northern District of Illinois Eastern Division over its “fraudulent and deceptive scheme to enrich itself by exploiting AbbVie’s PAP through the enrollment of insured patients into a charitable program not intended for them.”

The pharmaceutical and health products industry poured over a record amount — more than $373.7 million — into lobbying and outspent all other industries in 2022, according to data compiled by OpenSecrets.

During the 2021-2022 election cycle, the pharma/health products industry bucked its historical trend of favoring Republicans and distributed around 60% of donated campaign funds to Democratic lawmakers. Among the 20 lawmakers who received the most contributions from the industry during the election cycle, 14 are Democrats. Sen. Raphael Warnock (D-Ga.) topped the list, receiving over $764,000.

Mark Cuban Cost Plus Drug Co., the wholesale, direct-to-consumer drug manufacturer and pharmacy launched by the eponymous entrepreneur, will sell brand-name diabetes drugs from Janssen, a division of Johnson & Johnson. Cuban also says that the company will soon sell hypothyroidism treatment Tirosint (levothyroxine). The drugs are the first brand-name products to be sold by the company, which has previously focused exclusively on generics; Cuban says that the company plans to sell whatever brand-name drugs that it can, depending on drugmakers’ interest.

Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl) are now available from the startup, according to an April 3 tweet. Invokana will cost $243.90 for a 30-day supply, while Invokamet and Invokamet XR will each cost $244.20 for a 60-day supply. During a March 23 panel on prescription drug pricing and policy convened by Vanderbilt University, Cuban said that he doesn’t expect to stop at offering just a few brand-name drugs.

As the use of patient-paid prescriptions continues to grow, it is posing a challenge to the pharmacy benefit market, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

The issue of patient-paid prescriptions — which include both cash-pay claims and discount-card claims — is “potentially something that’s going to actually be genuinely disruptive, actually something that could change the structure of both the PBM industry and how plan sponsors” think about benefit design, Fein asserted. Both approaches, he explained, remove the third-party payer, allowing patients to make a transaction directly with a pharmacy.

In 2028, the federal government will likely negotiate the prices of 38 drugs covered under Medicare Part D and two under Medicare Part B, according to an analysis published this month in the Journal of Managed Care & Specialty Pharmacy. Inmaculada Hernandez, Pharm.D., Ph.D., one of the study’s authors, tells AIS Health the evaluation “is going to be very helpful for health plans and PBMs to know which drugs are going to be negotiated” as they evaluate the impact of the Inflation Reduction Act (IRA).

The IRA, which passed last year, includes a provision that requires the government to negotiate for the first time with pharmaceutical manufacturers the prices of some high-cost medications that are not subject to generic or biosimilar competition. It will begin with 10 Part D drugs in 2026, an additional 15 Part D drugs for 2027, another 15 Part D and Part B drugs in 2028 and an additional 20 Part D and Part B medications each year starting in 2029. Part D covers retail prescription drugs, while Part B covers provider-administered medications.