Spotlight on Market Access

The health insurer trade group AHIP recently unveiled a new advertising campaign that accuses the pharmaceutical industry of deflecting blame for its “price-gouging” practices and undermining the “evidence-based, market-driven tools” that health insurers use to keep drug costs in check. But the campaign doesn’t appear to mention PBMs, even though they’re the ones conducting drug-price negotiations with manufacturers on behalf of health plans and employers.

Health care industry observers say that omission is unsurprising since PBMs are currently facing a growing wave of scrutiny — scrutiny that insurers likely want to minimize even if they don’t want to lobby for that explicitly. Pharmaceutical Research and Manufacturers of America (PhRMA), meanwhile, pounced on the opportunity to call out what it sees as the unspoken, PBM-supporting message in AHIP’s new campaign.

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.

Sessions during the cell and gene therapy (CGT) track at the Reuters Pharma USA conference, held March 28 and 29 in Philadelphia, echoed much of the same advice for pharma companies commercializing one of these products. Starting the process early and collaborating with and forming partnerships with a variety of stakeholders are critical steps to success, multiple speakers emphasized.

Companies looking to bring a cell and gene therapy (CGT) to market should start preparing early on issues such as manufacturing and logistical matters, market access and patient access, advised Warner Biddle, senior vice president and global head of commercial for Kite Pharma, a Gilead Sciences, Inc. company. Kite has two chimeric antigen receptor T-cell therapies on the U.S. market: Yescarta (axicabtagene ciloleucel) — the second CAR-T to secure FDA approval — and Tecartus (brexucabtagene autoleucel).

The FDA recently approved a new first-in-class agent for follicular lymphoma, an important development for people with the condition, according to one oncologist. Payers and oncologists both agreed that the drug’s approval should help ease the disease burden somewhat for people suffering from the condition, according to a Zitter Insights survey.

On Dec. 22, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. The drug is a first-in-class CD20xCD3 T-cell engaging bispecific antibody. Dosing for the agent — which can be done in an outpatient setting — is 1 mg via intravenous infusion on day one of cycle one, 2 mg on day eight of cycle one and 60 mg on day 15 of cycle one, each over a minimum of four hours. On day one of cycle two, dosing is 60 mg, and then in cycle three and following cycles, dosing is 30 mg on day one; administration can be reduced to two hours if cycle one infusions were tolerated. Dosing for eight cycles is recommended. If people have a partial response or stable disease after eight cycles, an additional nine cycles may be administered. The drug’s price for eight cycles is about $180,000.

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.

As the largest health insurance companies become increasingly diversified, Anthem, Inc., the second-largest insurer in the U.S., rebranded as Elevance Health in June 2022. In addition to its legacy insurance business, Elevance offers technology-enabled health care solutions, pharmacy benefits management, data analytics, behavioral health and population health management via Carelon, its health care services unit. Its various payer subsidiaries include Anthem Blue Cross Blue Shield, Amerigroup, WellPoint, Empire Blue Cross Blue Shield and MMM Healthcare. Elevance was founded in Indiana in 1946 as a mutual insurance company, eventually growing to become the largest Blue Cross and Blue Shield affiliate in the U.S. Gail Boudreaux has served as Elevance's CEO since 2017.

While drugs are increasingly hitting the market that address unmet needs and even offer cures for some rare diseases, private insurers are highly concerned about such therapies’ eye-popping price tags, a recent survey indicated. But one prominent payer executive who spoke during AHIP’s Medicare, Medicaid, Duals & Commercial Markets Forum suggested that insurers are better off working collaboratively with drugmakers to ensure prices are tied to value — rather than engaging in an inter-industry war of words.

“More and more we’re seeing drugs come through with limited evidence through accelerated approval processes, which generally is a marker for an unmet need, which is a good thing. But the evidence can be thin,” said Michael Sherman, M.D., executive vice president and chief medical officer of Point32Health. During a March 14 panel at the AHIP forum, Sherman pointed to the example of Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births but failed to prove clinical effectiveness in trials conducted after it received accelerated approval. With the FDA poised to make a final decision on the drug’s status, Clovis Pharma Group recently announced it would voluntarily pull Makena off the market.

Most new drugs covered under Medicare Part D are subject to prior authorization (PA) requirements, largely due to their high launch prices. A recent study published in JAMA Health Forum observed that these policies are frequently inconsistent across payers and may prove too burdensome for patients and providers.

Researchers identified drugs approved between 2013 and 2017 and reviewed the 2020 formularies of the eight largest Part D payers, which cover about 90% of all Part D beneficiaries. They compared PA policies to each drug’s FDA-approved indications and noted if payers mirrored the approved labeling or were more restrictive than the drug’s label. Researchers observed substantial variation in the frequency and type of PA across payers, and they found that about 40% of the new drugs had PA criteria that went beyond the drug’s labeling.

Pharma manufacturers may be breathing a sigh of relief as PBMs appear now to be the main focus of lawmakers’ actions on prescription drug pricing. January saw the reintroduction of two pieces of bipartisan Senate legislation, while February brought a Senate hearing focused on PBMs’ transparency and accountability. And in March, Rep. James Comer (R-Ky.), chairman of the House Committee on Oversight and Reform, revealed that he is launching an investigation into those practices. The move continues to keep pressure on the entities over some of their practices and lack of transparency amid concerns around drug prices.

Comer’s move comes more than a year after that committee held a forum titled Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets. Held Nov. 17, 2021, that event featured a variety of stakeholders within the health care system who spoke about an array of issues, including PBM consolidation, “anticompetitive tactics,” rebates, the need for transparency and PBMs’ role in drug costs. That December, the committee published a report conducted by its staffers on these practices and other issues titled A View from Congress: The Role of Pharmacy Benefit Managers in Pharmaceutical Markets.