Specialty Drugs

Since the FDA’s approval of the first biosimilar in 2015, the agency has approved almost 40 more agents. However, their adoption in the U.S. market has been slow. A recent study, published in the journal BioDrugs, found that biosimilars were covered more restrictively than their reference biologics in 19.4% of coverage decisions made by select commercial health plans.

The study examined 1,181 coverage decisions made by 17 commercial health plans as of August 2021 from the Tufts Medical Center Specialty Drug Evidence and Coverage database, which included 19 commercially available biosimilars for seven biologic reference products used in treating 28 conditions.

Since the FDA’s approval of the first biosimilar in 2015, the agency has approved almost 40 more agents. However, their adoption in the U.S. market has been slow. A recent study, published in the journal BioDrugs, found that biosimilars were covered more restrictively than their reference biologics in 19.4% of coverage decisions made by select commercial health plans.

The study examined 1,181 coverage decisions made by 17 commercial health plans as of August 2021 from the Tufts Medical Center Specialty Drug Evidence and Coverage database, which included 19 commercially available biosimilars for seven biologic reference products used in treating 28 conditions.

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.”

AbbVie states that it is “bring[ing] this action to stop Payer Matrix’s harmful conduct and protect its program so it can continue to serve its intended purpose — providing free drugs to uninsured and underinsured patients who otherwise could not afford their AbbVie medicine.”

The FDA recently expanded the patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the therapy becomes the first and only once-weekly growth hormone treatment for both children and adults.

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 [patient assistance program] through the enrollment of insured patients into a charitable program not intended for them.” Payer Matrix tells AIS Health, a division of MMIT, that it “vehemently dispute[s] the allegations.”

Prior to the filing and shortly before AbbVie updated its PAP language earlier this year, AIS Health conducted an interview with Michael Jordan, Payer Matrix’s chief business officer (CBO), to learn more about the company’s practices.

With premiums steadily rising and turbulence shaking up the market-share leaderboard, the stop-loss insurance segment has become integral to many health plans’ portfolios in recent years. Experts believe the level of competition will only grow as more employers transition to self-funded plans.

Net premiums earned (NPE) for stop-loss insurance, an additional layer of coverage that protects employers against extremely high-dollar claims, reached $26 billion in 2021, according to a new report from credit rating firm A.M. Best. That’s up from $24 billion in NPE in 2020 — and more than double the $11.6 billion in total NPE seven years earlier in 2014.

People receiving injectable fertility drugs through a specialty pharmacy order review program expressed high satisfaction with the offering, found a recent study by AllianceRx Walgreens Pharmacy and Walgreen Co. Researchers also observed that the services helped reduce waste due to incorrect storage and prevented late or missed doses, producing savings of almost $50,000.

In 2012, AllianceRx Walgreens started the Fertility Order Review (FOR) program to assist people who are self-administering injectable fertility medications, helping ease the anxiety that these patients often deal with. On the day a person’s first order arrives, a fertility nurse calls them to go over the order’s contents, including each item’s purpose and proper storage; direct them to online patient guides available in English and Spanish on administration, medication and fertility education; alert them to expiration dates; educate them about setting up refill reminders; and answer any patient questions.

Drug shortages have grabbed headlines in recent months, with patients struggling to fill prescription medications that treat conditions including asthma and attention-deficit/hyperactivity disorder (ADHD), and providers struggling to stock and administer specialty drugs, especially in oncology. Experts tell AIS Health, a division of MMIT, that PBMs don’t have an abundance of options to ameliorate the shortages and may be unlikely to try the limited workarounds that they do have.

New research prepared for the American Society of Health-System Pharmacists (ASHP) by researchers from the University of Utah found that 301 drug shortages were in effect by the end of the first quarter of the year — a five-year high.

April 11: The FDA expanded the patient population of Takeda’s HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) to include the treatment of primary immunodeficiency in people between the ages of 2 to 16 years. The agency first approved the drug on Sept. 12, 2014. Subcutaneous dosing can be administered at home or in an infusion center every three or four weeks after a ramping-up period. The volume administered is based on weight and trough level. Drugs.com lists the price of 160 u/mL for 105 milliliters as more than $2,464.

April 14: The FDA expanded the label of Novartis Pharmaceutical Corp. unit Sandoz Inc.’s Hyrimoz (adalimumab-adaz) for the treatment of moderate-to-severe hidradenitis suppurativa in adults. The agency initially approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Oct. 30, 2018. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. Drugs.com lists the price of two 40 mg/0.4 mL kits and two 40 mg/0.8 mL kits of Humira, each with two devices, as more than $7,299. Sandoz has said it will launch Hyrimoz on July 1 per the settlement of patent litigation with AbbVie.

Issues around so-called alternate funding companies that carve out specialty drugs have existed for several years now, but only recently has a manufacturer taken legal action against such a company. 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 [patient assistance program] through the enrollment of insured patients into a charitable program not intended for them.”

AbbVie states that it is “bring[ing] this action to stop Payer Matrix’s harmful conduct and protect its program so it can continue to serve its intended purpose — providing free drugs to uninsured and underinsured patients who otherwise could not afford their AbbVie medicine.”