Radar on Specialty Pharmacy

✦Walgreen Co. and Kroger Co. can continue to pursue a lawsuit (No. 19-1730) over Remicade (infliximab) against Janssen Biotech Inc. and its parent company, Johnson & Johnson, according to a decision by the U.S. Court of Appeals. The lawsuit claims that Janssen “used its size and bargaining power in the broader pharmaceutical market to enter into exclusive contracts and anticompetitive bundling agreements with health insurers that suppressed generic competition to Remicade, which in turn allowed Janssen to sell Remicade at supracompetitive prices.” The decision overturns a ruling by the U.S. District Court for the Eastern District of Pennsylvania (D.C. No. 2-18-cv-02357), which ruled in Janssen’s favor in March 2019. View the decision at https://bit.ly/2Tx21pa.

✦The U.S. Preventive Services Task Force (USPSTF) gave a B grade to screening for hepatitis C infection in people between the ages of 18 and 79. The Affordable Care Act mandates that private insurers cover preventive services with a USPSTF grade of A or B. View the recommendation at https://bit.ly/38kjMxx.

✦ Feb. 10: The FDA granted final approval to Eagle Pharmaceuticals, Inc.’s Pemfexy (pemetrexed) for the treatment of people with locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. The drug, to which the FDA granted tentative approval in 2017, is a branded alternative to Eli Lilly and Company’s Alimta (pemetrexed). The two drugmakers reached a settlement in patent litigation on Dec. 13, 2019, that will allow Pemfexy to launch with a three-week supply on Feb. 1, 2022, then an uncapped entry on April 1, 2022. Dosing for the intravenous injection depends on the indication. For more information, visit https://bit.ly/2vkZBSi.

✦ Feb. 18: The FDA approved a new dosage form for Procysbi (cysteamine bitartrate) for the treatment of people at least one year old with nephropathic cystinosis. The Horizon Pharma plc drug is now available in delayed-release oral granules, as well as capsules. The granules, also known as microbeads, will be available in packets of 75 mg and 300 mg strengths in the first half of 2020. The agency initially approved the capsule in 1994. Dosing is weight-based. Website Drugs.com lists the price of 250 75 mg delayed-release capsules as $26,454. Visit www.procysbi.com.

As the practice of white bagging grows, Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, tells AIS Health that the approach has many potential issues that should be addressed in payer contracts with specialty pharmacies and providers:

✦ “If a drug is administered to the patient as prescribed and as supplied under white bagging by the specialty pharmacy, how is the payer informed — via a billing that shows administration of the drug’s J-code and administered number of HCPCS [i.e., Healthcare Common Procedural Coding System] units, but with an indicator that this is for information purposes, not for reimbursement to the practice? If so, does the payer match up the specialty pharmacy billing with the provider billing to validate that the drug was administered as prescribed?”

As health plans seek to have more control over their spending on provider-administered specialty drugs, many physicians are pushing back, as seen most recently with BlueCross BlueShield of Tennessee’s (BCBST) new program (see story, p. 1). But at least one survey of commercial payers shows that mandating the use of a specialty pharmacy to acquire these therapies is replacing the longstanding approach, a trend that respondents anticipate will continue even though industry experts vary on the benefits and challenges of such an approach.

Providers traditionally have acquired therapies they administer through a practice known as buy and bill, by which they will purchase a drug from a wholesaler or distributor, keep it in their office and administer it to patients as needed, submitting a claim to the payer afterwards. Through this approach, providers can make a profit by marking up the drug.

As the Affordable Care Act approaches the 10-year anniversary of its being signed into law, one aspect of the ACA is poised to finally take effect this month. When the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted as part of the ACA, Congress left much of the details up to the FDA to determine. In addition to creating the 351(k) biosimilar approval pathway, Congress via the BPCIA intended to bring all biologics together under the same law, which it planned to do through the “deemed to be a license” provision.

While most biologics are licensed under the Public Health Service (PHS) Act and approved through a biologics license application (BLA), some protein products have gained FDA approval under the Federal Food, Drug, and Cosmetic (FD&C) Act through a new drug application (NDA). The BPCIA did two things to impact this: First, it modified the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide).” Second, it said that biologics approved under the FD&C Act on or before March 23, 2020 — 10 years after the BPCIA was enacted — would transition over to the PHS Act. Thus, an approved marketing application for one of these drugs under section 505 of the FD&C Act would be deemed to be a license for the product under section 351 of the PHS Act.