Amneal launches generic Concerta
Amneal Pharmaceuticals has introduced its generic Concerta (methylphenidate hydrochloride extended-release) tablets. The drug is indicated to treat attention deficit/hyperactivity disorder as part of a total treatment program.
“We are extremely pleased to add our methylphenidate to the list of therapeutically equivalent generics for Concerta,” Jim Luce, executive vice president of sales and marketing at Brdigewater, N.J.-based Amneal, said. “The entrance of another AB-rated option adds to the choices provided to patients, prescribers and payers beyond non-substitutable BX-rated products and the brand.”
Amneal’s generic Concerta has begun shipping and is available in 18-, 27-, 36- and 54-mg dosage strengths, all of which are available in 90-count bottles, with 30-count bottles also available.
The product had a U.S. market size of $1.5 billion for the 12 months ended December 2017, according to IQVIA data.
Is billing chilling biosimilar adoption?
The biosimilars wave is here. The lower-cost versions of such pricy biologic drugs as Humira and Remicade are set to bring serious savings in the coming years, as long as they can clear hurdles that trade groups and manufacturers have identified.
The National Association of Chain Drug Stores recently noted that branded biologic drugs could cost the U.S. healthcare system $120 billion by 2024, based on projections from Express Scripts. But a 2017 Rand report found $54 billion in potential savings from biosimilars in the next 10 years.
With the selling point of biosimilars being their lower price than an origin drug — they are roughly 10% to 15% less expensive than a biologic — a big part of biosimilar adoption is getting them reimbursed properly. The Association for Accessible Medicines and the National Association of Chain Drug Stores are lobbying Congress and the White House for a change in the Centers for Medicare and Medicaid Services’ policy on reimbursement for biosimilar medicines. Such a change, AAM reported, also could yield significant savings to U.S. taxpayers.
“CMS currently groups all biosimilars of a reference biologic under a single billing code and payment rate,” the group noted recently. “A variety of stakeholders have raised concerns that this policy undermines patient access to affordable biosimilar medicines and stifles the creation of a robust biosimilars market.”
Sheila Frame, vice president and head of North American biopharmaceuticals at Sandoz, maker of the first FDA-approved biosimilar Zarxio (filgrastim-sndz) recently highlighted the need for proper reimbursement for biosimilars.
“Unique reimbursement codes are necessary to foster a competitive marketplace and support direct and indirect cost savings that will make our health system more sustainable,” she said.
Savings take center stage for generics makers
The money saved by using generic drugs — and their impact on patient accessibility — is limited only by how much the health system can utilize them. That’s according to the latest numbers from IQVIA and the Association for Affordable Medicines.
In 2016, the most recent year for which figures are yet available, generics accounted for 89% of all U.S. prescriptions dispensed, but only 26% of the nation’s pharmaceutical bill, according to research giant IQVIA and AAM report. The organizations note that generics have saved the health system roughly $1.67 trillion in the last decade.
What’s more, the federal health system could wring billions more in savings out of generics if Medicare and Medicaid adopted payment policies that fully encouraged their use. AAM and the National Association of Chain Drug Stores note that a 1% increase in use of generics can save as much as $558 million. The savings would be $6.56 billion annually if Medicare and Medicaid were able to match Hawaii’s 82.7% generic utilization rate.
Beyond healthcare systems savings, generics offer an important value proposition to patients, 21% of whom have skipped filling a prescription for themselves or a family member in the last year due to cost, according to the Kaiser Family Foundation. AAM research has found that the abandonment rate for branded drugs is 266% higher than it is for generics — 90% of which have a sub-$20 copay, compared with 39% of branded drugs that do.
Because of the impact generics can have on patient health, generic manufacturers and service providers have made cost savings and improved adherence rates for healthier patients central to their mission and drug development efforts.
At FamilyWize, which negotiates discounts on prescription medications through the use of its free card and mobile app, chief pharmacy officer Ken Majkowski and president and CEO Joseph Sanginiti said they are using new partnerships and initiatives to focus on transparency and improving prescription affordability.
As a result, “prescriptions that patients may not have been able to afford are now more affordable,” Majkowski and Sanginiti said. “First-fill and subsequent fills are now more likely to occur. The end result: adherence.”
With high costs focused largely on specialty products, Jim Luce, executive vice president of sales and marketing at Bridgewater, N.J.-based Amneal Pharmaceuticals, said the company has “enhanced our focus on providing more and more complex, specialty, high-value pharmaceuticals products to the U.S. market. To date, we’ve had much success with these products and will continue on that pathway.”
Luce said the goal is to offer generic options for treatments that previously were not available or had limited availability. The company has plans to launch more than 100 products in 2018, many of which Luce noted were the first generic available or part of a small group of available generics.
“Our industry-benchmark R&D team is able to successfully file high-barrier-to-entry formulations and dosage forms,” Luce said. “This enables Amneal to bring an ever-increasing portfolio of life-changing medicine to the public at more affordable price points.”
Maple Grove, Minn.-based Upsher-Smith — which in 2017 was acquired by Japan’s Sawai Pharmaceutical — also is focused on building up its generic product portfolio and boosting lower-cost treatment options.
“We are committed to meeting the needs of our pharmacy partners by significantly increasing our pipeline of products to include new dosage forms, as well as more traditional and specialty products,” president and CEO Rusty Field said. “As always, we will continue to support programs and initiatives that enhance the important role played by pharmacists in advancing patient care and improving health outcomes.”