Spotlight on Market Access

As prices for health care services, especially drugs, continue to be under the microscope of public scrutiny, life sciences companies are under pressure now more than ever to make sure that they can demonstrate the value of their products. But this may be easier said than done, as a patient’s perception of value may be quite different than, for example, that of a payer. But these conversations are starting to happen and need to continue to evolve and include all industry stakeholders to truly incorporate value into the equation, say life sciences experts.

According to Daniel C. Lane, Pharm.D., Ph.D., director of US Access Marketing-Customer & Portfolio Value Generation for Bristol Myers Squibb, “Value is something that’s very individualized…If you think about value on a conceptual level, it’s a benefit being received over some type of value-assessment measure…At the elemental level, that’s what we as a life science industry are really trying to understand — how do we communicate that?”

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

On March 16, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.

New research published in JAMA Health Forum found that rebate revenue for PBMs grew between 2015 and 2019 — but that growing rebate revenue was not passed on to patients.

The research letter’s authors measured both prerebate and postrebate drug costs taken from medical loss ratio (MLR) filings made by plans to CMS. The research sample includes commercial insurance filings from small group, individual and large group health plans across “approximately 2,200 unique health plans” covering 70 million lives.

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from best price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers — and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

Founded in 1933 as Durham, North Carolina’s Hospital Care Association, Blue Cross and Blue Shield of North Carolina (Blue Cross NC) is now the largest insurer in the state, serving nearly 3 million lives. It offers commercial health products, including plans sold on the Affordable Care Act exchanges in North Carolina, as well as Medicare Advantage (MA) and Medicaid plans. Blue Cross NC is the ninth-largest Blues affiliate in the U.S.

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.”

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

Pharma manufacturers depend on contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — to ensure favorable formulary positioning with PBMs’ health plan and employer clients. But as those contracts have grown more complex and less transparent, drugmakers may be at risk of losing significant amounts of money, according to industry experts. In a two-part series, AIS Health, a division of MMIT, explores the details within the contracts and how those complexities may result in losses of billions of dollars across the pharma industry.

Revenue leakage — unintended revenue loss because of process inefficiencies — can be a huge financial drain on pharma manufacturers. It also may potentially result in compliance risks with the Anti-Kickback Statute and its discount safe harbor protections, “so it always has to be clearly defined as to what the rebate or any monies between pharma and the PBM being exchanged; there has to be a reason,” explains Stephanie Seadler, vice president of Trade Relations at EmsanaRx.

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

Large numbers of Medicare beneficiaries who are ineligible for low-income subsidies and have been prescribed high-price prescription drugs for conditions such as cancer don’t initiate their treatment, likely because they can’t afford it, according to new research published in Health Affairs. One of the study’s authors tells AIS Health that severe illness is a possible outcome of noninitiation in the studied clinical areas and adds that proposals under consideration in Congress to cap out-of-pocket spending for Medicare beneficiaries would make a big difference to the affected patients.

According to the paper, “among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia.”