Drug Benefits

Switching to Immediate-Release Drugs May Save Billions

March 20, 2020

The Medicare Part D and Medicaid programs could save a significant amount of money if more patients took immediate-release (IR) medications that require two doses per day instead of extended-release (ER) versions that are taken just once a day, according to a recent study. The cross-sectional study analyzed 20 extended-release drugs with 37 Medicare formulations and 36 Medicaid formulations. Between 2012 and 2017, Medicare Part D and Medicaid could have saved a combined $13.7 billion through a switch from ER to IR formulations.

by Jinghong Chen

The Medicare Part D and Medicaid programs could save a significant amount of money if more patients took immediate-release (IR) medications that require two doses per day instead of extended-release (ER) versions that are taken just once a day, according to a recent study. The cross-sectional study analyzed 20 extended-release drugs with 37 Medicare formulations and 36 Medicaid formulations. Between 2012 and 2017, Medicare Part D and Medicaid could have saved a combined $13.7 billion through a switch from ER to IR formulations. “It’s not a huge difference in terms of patient convenience, but the cost difference is remarkable,” study coauthor Ambarish Pandey, M.D., of the University of Texas Southwestern Medical Center, told Reuters.

SOURCES: “Economic Burden Associated With Extended-Release vs Immediate-Release Drug Formulations Among Medicare Part D and Medicaid Beneficiaries,” JAMA Network Open. 2020; 3(2): e200181. doi:10.1001/jamanetworkopen.2020.0181; Reuters, visit https://reut.rs/2Q42D4A.

COVID-19 Outbreak Could Impact Drug Supply Long-Term

March 18, 2020

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

By Peter Johnson

Industry experts say the COVID-19 outbreak is unlikely to limit U.S. drug supplies in the short or middle term. However, they tell AIS Health that increased demand for longer-duration stocks of medication from self-isolating patients could strain supplies going forward.

“We are told at this point that we’re not seeing any [drug] shortages in the marketplace today,” says Kelly McGrail-Pokuta, Prime Therapeutics’ vice president of pharmaceutical trade.

On Feb. 27, FDA Commissioner Stephen Hahn released a statement that said disruptions to the pharmaceutical supply chain have been minimal so far. The statement also said that the FDA was especially focused on 20 manufacturers that are particularly dependent on operations in China, and found that “none of these firms have reported any shortage to date.”

But on March 10, the FDA postponed all inspections of overseas drug manufacturing facilities “through April, effective immediately,” according to another statement released by Hahn.

During a pandemic, the CDC recommends anyone taking prescription medication to manage a chronic condition keep an expanded supply of their medicine on hand. As more people self-isolate, and consumers seek to spend less time in stores and other public places, demand for backup medication is likely to increase.

Mike Schneider, a principal at Avalere Health who previously worked for CVS Caremark, says PBMs and payers will have to rethink their typical posture toward chronic medication as enrollees stock up in anticipation of self-isolation.

“Hopefully, with everything going on related to coronavirus and people wanting to stock up, those quantity limits would be eased or eliminated for the most part for chronic meds,” says Schneider.

The Blue Cross Blue Shield Association’s “network of 36 independent and locally operated” affiliates have all decided to waive prescription refill limits on maintenance medications, according to America’s Health Insurance Plans. Other non-Blues insurers have also taken steps to allow members to refill prescriptions in advance.

Experts say it’s difficult to know whether the drug supply will be affected down the road. Schneider says consumer stockpiling and the FDA’s move to suspend foreign inspections could both make an impact on future supply.

Datapoint: Jardiance Gets Fast-Tracked Kidney Disease Review

March 17, 2020

The FDA last week granted a fast-tracked review to Eli Lilly and Boehringer Ingelheim’s Jardiance for the treatment of chronic kidney disease. Jardiance, an SGLT2 inhibitor, is currently approved for the treatment of type 2 diabetes, and holds preferred formulary status for 50% of all covered lives, growing to 90% with prior authorization and/or step therapy.

The FDA last week granted a fast-tracked review to Eli Lilly and Boehringer Ingelheim’s Jardiance for the treatment of chronic kidney disease. Jardiance, an SGLT2 inhibitor, is currently approved for the treatment of type 2 diabetes, and holds preferred formulary status for 50% of all covered lives, growing to 90% with prior authorization and/or step therapy.

SOURCE: MMIT Analytics, as of 3/16/20

Insurers, Pharma Spar Over Copay Accumulator Provision

March 16, 2020

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

By Leslie Small

Health insurers are praising a provision in a recently proposed regulation that gives commercial plans greater leeway to run so-called copay accumulator programs, which prevent drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits. But the pharmaceutical industry slammed the proposal as “misguided” and liable to prevent patients from getting vital medications.

“I do think these programs are here to stay, and I do think they will continue to grow in terms of the absolute numbers as we head into ’22 and beyond,” says Jayson Slotnik, a partner at Health Policy Strategies, LLC. From insurers’ point of view, copay accumulator programs help combat the perverse incentives that drug manufacturer coupons create: steering patients to pricey brand-name drugs by obscuring their true cost.

In its 2021 proposed Notice of Benefit and Payment Parameters, CMS clarifies that all non-grandfathered individual and group market health plans “have the flexibility to determine whether to include or exclude coupon amounts from the annual limitation on cost sharing, regardless of whether a generic equivalent is available.”

To America’s Health Insurance Plans, it’s important to allow the use of copay accumulator programs even for drugs that don’t have a generic version in order to spur competition between branded drugs that can treat the same condition. “Drug manufacturers recognize this and spend billions of dollars to dilute the impact of competition by providing coupons for brand drugs that do not have a generic equivalent,” the trade group wrote in its comment letter about the proposed rule.

But the Pharmaceutical Research and Manufacturers of America (PhRMA) sees it very differently.

“It would compromise patients’ ability to adhere to prescribed medicines at a moment when insurance coverage for medicines continues to erode; it would put patient health and financial security in danger; it would run directly counter to the Administration’s stated policy of lowering patient out-of-pocket costs for prescription drugs; and it could undermine the appeal and availability of high-deductible health plans,” PhRMA wrote.

Datapoint: Ofev Is First-in-Class for Group of Progressive Lung Diseases

March 12, 2020

The FDA this week approved Boehringer Ingelheim’s Ofev for the treatment of a group of progressive lung diseases with chronic fibrosing. Ofev is now the first FDA-approved therapy in this class. For the treatment of idiopathic pulmonary fibrosis, Ofev currently holds preferred status for 4% of covered lives, growing to 33% with prior authorization and/or step therapy.

The FDA this week approved Boehringer Ingelheim’s Ofev for the treatment of a group of progressive lung diseases with chronic fibrosing. Ofev is now the first FDA-approved therapy in this class. For the treatment of idiopathic pulmonary fibrosis, Ofev currently holds preferred status for 4% of covered lives, growing to 33% with prior authorization and/or step therapy.

SOURCE: MMIT Analytics, as of 3/11/20

Datapoint: FDA Approves Sanofi’s First Oncology Drug Since 2010

March 5, 2020

The FDA this week approved Sanofi’s Sarclisa for the treatment of relapsed refractory multiple myeloma in patients who have already tried at least two other therapies. This marks Sanofi’s first approval for a wholly owned oncology drug since 2010. Among the most advantaged therapies in the multiple myeloma class are Celgene’s Revlimid, which holds preferred status for 11% of covered lives (growing to 56% with prior authorization and/or step therapy), and Thalomid, another Celgene drug, which holds preferred status for 14% of covered lives (growing to 47% with PA/ST).

The FDA this week approved Sanofi’s Sarclisa for the treatment of relapsed refractory multiple myeloma in patients who have already tried at least two other therapies. This marks Sanofi’s first approval for a wholly owned oncology drug since 2010. Among the most advantaged therapies in the multiple myeloma class are Celgene’s Revlimid, which holds preferred status for 11% of covered lives (growing to 56% with prior authorization and/or step therapy), and Thalomid, another Celgene drug, which holds preferred status for 14% of covered lives (growing to 47% with PA/ST).

SOURCE: MMIT Analytics, as of 3/4/20