Dr. Reddy’s Laboratories Ltd. launched six strengths of lenalidomide, and two of them — 2.5 mg and 20 mg — are eligible for first-to-market 180-day exclusivity, the company said Sept. 7. The FDA approved those two strengths and gave tentative approval to the others on Oct. 14, 2021. Teva Pharmaceuticals Ltd. launched the first generics of the other four strengths of the generic of Bristol Myers Squibb’s Revlimid — 5 mg, 10 mg, 15 mg and 25 mg — on March 7. Lenalidomide is approved for six indications for the treatment of adults with (1) multiple myeloma in combination with dexamethasone; (2) MM as maintenance treatment following autologous hematopoietic stem cell transplantation; (3) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities; (4) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib; (5) previously treated follicular lymphoma in combination with a rituximab product; and (6) previously treated marginal zone lymphoma in combination with a rituximab product. On Sept. 17, 2020, Dr. Reddy’s said that it had settled patent litigation with Bristol Myers subsidiary Celgene Corp. that would allow it to sell volume-limited amounts of the generic as of a confidential date after March 2022. As of Jan. 31, 2026, Dr. Reddy’s can sell lenalidomide without limitation.
With companies trying to keep their prescription drug spending down, some have turned to alternate funding companies. While their approaches may seem appealing initially, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say industry sources, who encourage companies to take a closer look at what their savings actually are.
During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Paydhealth, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.
Walgreens’ Purchase of Remaining Shields Stake Signals Threat to Independent Specialty Pharmacy Landscape
After increasing its share in Shields Health Solutions last year, Walgreens Boots Alliance, Inc. has entered into an agreement to purchase the remaining stake of the health system-owned specialty pharmacy integrator. The move, says one industry expert, may represent one more step in putting independent specialty pharmacies out of business.
After making incremental investments in Shields, Walgreens said on Sept. 20 that it would purchase the remaining 30% stake for approximately $1.37 billion. Shields — which partners with health systems to help them create and grow a hospital-owned specialty pharmacy program — has served more than 1 million people and has almost 80 health system partners that represent nearly 1,000 hospitals across the U.S. Shields will operate as a separate business and brand within Walgreens.
The manufacturers of many drugs granted accelerated approval by the FDA do not complete timely confirmatory trials of the drugs’ efficacy, according to a recent study published in the journal Health Affairs — meaning that the pricing for many accelerated approval drugs has nothing to do with their clinical efficacy. The study’s author tells AIS Health, a division of MMIT, that “the market doesn’t work very well” for drugs that have received accelerated approval, and “what it leads us to is overpaying at the beginning and underpaying, potentially, later.”
After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. The accelerated approval designation is given to new, unproven drugs that could potentially meet a dire need for a new or more effective therapy to treat a terminal disease. The intention behind the confirmatory trial system is to make sure that the drug actually does what its developer says it will.
Pharmaceutical companies often profit from their donations to non-profit patient assistance charities that are intended to help people afford high-cost medications, according to a study published in this month’s edition of the journal Health Affairs.
HHS’s Office of Inspector General (OIG) has provided guidance on the charities and cracked down in recent years on several charities and drug manufacturers. However, the authors noted that “the current regulations or enforcement permit donations that violate the spirit of Medicare’s Anti-Kickback Statute,” which prohibits pharma companies from covering Medicare Advantage enrollees’ out-of-pocket drug spending for the drugs they manufacture.
As FDA approval of biosimilars continues and agents are expanding into new indications, more payers are using these drugs and seeing cost savings through that utilization, according to Zitter Insights.
When the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) on Sept. 1, it was the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency had approved. It also was the 38th biosimilar approved since the first one, Novartis Pharmaceutical Corp. division Sandoz’s Zarxio (filgrastim-sndz), was approved March 6, 2015, referencing Amgen’s Neupogen (filgrastim).
Aug. 10: The FDA converted the accelerated approval for Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) to full approval for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. The agency granted that accelerated approval on May 6, 2020. Dosing of the tablet is 400 mg twice daily. GoodRx lists the price of 112 200 mg tablets as more than $19,667.
Aug. 11: The FDA gave accelerated approval to AstraZeneca and Daiichi Sankyo, Inc.’s Enhertu (fam-trastuzumab deruxtecan-nxki) for adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations as detected by an FDA-approved test (see below briefs) and who have received a prior systemic therapy. This is the first drug that the agency has approved for HER2-mutant NSCLC. The FDA first approved the antibody drug conjugate on Dec. 20, 2019. The drug received priority review and breakthrough therapy designation. Dosing for the newest use is 5.4 mg/kg via intravenous infusion once every three weeks.
Multiple companies that provide alternate funding options for patients have been launching over the last several years. But one maximizer company has found itself the target of a legal battle with manufacturer Johnson & Johnson over its strategy to reclassify drugs and maximize the copay assistance it gets from pharma manufacturers.
Copay maximizers have companies classify some drugs as “non-essential health benefits” (NEHBs) as outlined in the Affordable Care Act (ACA). They then secure patient assistance for these drugs through manufacturers’ or charitable foundations’ patient assistance programs, taking the full annual amount of assistance per drug and spreading out that money over the course of the year (see story). The programs are seen as follow-on offerings to copay accumulators, which take the maximum assistance up front and deplete the contribution before the end of the year.
Multiple companies are offering copay maximizer — also known as variable copay — programs. And while they may be attractive to firms that implement them, a closer look might reveal them to be not as appealing as they seem at first blush, say industry experts. The programs also are being challenged in legal settings, including a lawsuit by manufacturer Johnson & Johnson against SaveOnSP (see story).
Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. But copay maximizer programs will distribute 100% of available manufacturer copay offset funds over 12 months, as opposed to copay accumulators, which apply the maximum manufacturer assistance up front and deplete that contribution before the end of the year. Payments in both approaches do not count toward members’ deductibles and out-of-pocket maximums.
News Briefs: Cancer Replaced Musculoskeletal Conditions as Biggest Driver of Large Companies’ Health Care Costs
Cancer replaced musculoskeletal conditions as the biggest driver of large companies’ health care costs, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey. The survey found that “13% of employers said they have seen more late-stage cancers and another 44% anticipate seeing such an increase in the future, likely due to pandemic-related delays in care.” Between May 31, 2022, and July 13, 2022, the organization polled 135 large employers in various sectors that cover more than 18 million people in the U.S. The survey also found that 99% of respondents said that they are concerned about prescription drug trend. Last year, prescription drugs were responsible for a median of 21% of the companies’ health care costs, and specialty drugs accounted for more than half of pharmacy spend.