Data & Analytics

Trends That Matter for AML Therapy Class

October 10, 2019

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

“Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed,” said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.

Many of the newer drugs are oral formulations, which, “in general, are easier to administer,” points out Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “Rather than having to go into a hospital or clinic for treatment, a patient can simply take a medication orally for their condition.”

Payers utilize a variety of management tactics with AML therapies. “Payers often require prior authorization of these therapies due to safety, concern for off-label usage and cost,” says Tegenu. A variety of drugs are used off-label for certain patient populations, he notes.

The graphic below show the current market access to AML drugs across commercial, Health Exchange, Medicare and Medicaid formularies for all payers under the pharmacy benefit:

Radar On Market Access: CMS Projects Record-High Medicare Advantage Enrollment in 2020

October 8, 2019

2020 is shaping up to be another competitive year for the Medicare Advantage program, which will feature an additional 600 plan choices and a continued decline in the average monthly premium, AIS Health reported. With its annual release of the so-called landscape files for the MA and Part D programs, CMS on Sept. 24 said it expects MA enrollment to reach an all-time high of 24.4 million in 2020, up 10% from the current enrollment of 22.2 million.

2020 is shaping up to be another competitive year for the Medicare Advantage program, which will feature an additional 600 plan choices and a continued decline in the average monthly premium, AIS Health reported. With its annual release of the so-called landscape files for the MA and Part D programs, CMS on Sept. 24 said it expects MA enrollment to reach an all-time high of 24.4 million in 2020, up 10% from the current enrollment of 22.2 million.

For 2020, the average monthly MA plan premium will drop by 14% to an estimated $23, the lowest average monthly premium since 2007. As the Affordable Care Act health insurer fee (HIF) returns in 2020, CMS’s bullish enrollment outlook “indicates most plans are prioritizing stability of benefits and enrollment,” observed securities analyst Michael Newshel in a Sept. 24 research note from Evercore ISI.

According to data released alongside the 2020 MA and Part D landscape files, beneficiaries will have an average number of 39 plan choices per county, CMS estimated. Moreover, CMS said there are about 1,200 more MA plans operating in 2020 than in 2018.

According to estimates from Citi Research, there will also be a substantial rise in the number of plans with a $0 monthly premium, with Centene Corp. showing the greatest increase (56%) in $0 premium offerings.

Meanwhile, the Special Needs Plan (SNP) market will continue to expand. According to estimates from Chicago-based consulting firm Clear View Solutions, LLC, there are 171 net new SNP plan IDs, up from 60 net new plans in 2019. In addition, the number of stand-alone Prescription Drug Plan offerings will rise from 1,369 in 2019 to 1,433 next year.

Medicare beneficiaries may begin perusing their 2020 coverage options on Oct. 1. Open enrollment begins on Oct. 15 and ends on Dec. 7.

Radar On Market Access: Does New Medicare Plan Finder Make Part D Plans Tougher to Parse?

October 1, 2019

Some Medicare experts are expressing concern and frustration about changes to the Medicare Plan Finder that may make it more difficult for beneficiaries to find the best Part D plan for their unique circumstances, AIS Health reported.

Some Medicare experts are expressing concern and frustration about changes to the Medicare Plan Finder that may make it more difficult for beneficiaries to find the best Part D plan for their unique circumstances, AIS Health reported.

For example, the version of the new plan finder that CMS debuted does not include the ability to sort Part D plans based on a beneficiary’s total out-of-pocket drug costs (including plan premium) for the rest of the year, says Ann Kayrish, who is the National Council on Aging’s senior program manager for Medicare.

The good news, she says, is that CMS notified stakeholders that the total-cost calculator feature will be in place in time for the annual election period (AEP) that begins Oct. 15 — which CMS confirmed to AIS Health.

However, Kayrish says it’s still problematic that the total-cost calculator isn’t yet available to test before the hectic AEP begins. “We don’t want open enrollment to be like a beta test for the new plan finder,” she says.

Elizabeth Gavino, founder of insurance consulting firm Lewin & Gavino and an independent broker and a general agent for Medicare plans located in the New York City area, also has qualms with the way the new plan finder is designed.

The old plan finder allowed brokers to quickly scan multiple Part D plans and see whether all of the person’s medications are on their formularies. Now, that information is only available by clicking on a “plan details” button for each individual Part D plan, she explains.

“I could do a review for a client in 10 minutes” with the old system, Gavino says. “The way it is now, this is going to be a nightmare.”

Trends That Matter for High-Touch Care Management for Chronic Conditions

September 26, 2019

Though PBMs are most known for the influence they have on prescription drug costs, some firms are increasingly focused on offering high-touch condition management services that give them a more active role in patient care, AIS Health reported.

Though PBMs are most known for the influence they have on prescription drug costs, some firms are increasingly focused on offering high-touch condition management services that give them a more active role in patient care, AIS Health reported.

For specialty PBM AscellaHealth, LLC, that means harnessing a variety of resources to help better manage treatment for hemophilia, a notoriously expensive disease state.

Not only does the PBM leverage its specialty pharmacy network to obtain the best prices for hemophilia clotting factor, but it also uses technology to monitor medication dispensing in real time and provides clinical interventions when necessary, explains Mike Baldzicki, AscellaHealth’s executive vice president of growth and strategy.

Meanwhile, CVS Health Corp. is expanding its Transform Diabetes Care program, which helps members of its PBM, Caremark, control their diabetes by providing technology-enabled, personalized support and coaching focused on improving medication adherence and controlling blood-sugar levels. As part of the expansion, the program will also focus on the prevention and early identification of diabetes as well as hypertension, which is twice as common in diabetes patients as the regular population.

Radar On Market Access: Industry Groups Praise OIG Report on Medicare Part D Rebates

September 26, 2019

Industry trade groups that would like rebates preserved in the Medicare Part D purchasing system were thrilled to see a Sept. 13 report from the HHS Office of Inspector General that they viewed as dispelling the oft-purported “myth” that rebates are responsible for high drug prices, AIS Health reported.

Industry trade groups that would like rebates preserved in the Medicare Part D purchasing system were thrilled to see a Sept. 13 report from the HHS Office of Inspector General that they viewed as dispelling the oft-purported “myth” that rebates are responsible for high drug prices, AIS Health reported.

The report examining the more than 1,510 brand-name drugs with Part D reimbursement and rebates between 2011 and 2015 found that rebates did not always go up when unit reimbursement grew.

The report also observed that total rebates for brand-name drugs reviewed in Part D rose from $9 billion in 2011 to $17 billion in 2015, but the majority (60%) of that rebate growth was driven by only 10% of drugs. Furthermore, OIG said that while rebates substantially reduced overall Part D spending growth, “they did not prevent increased overall Part D spending…as Medicare still spent $2 billion more for brand-name drugs with rebates in 2015 than in 2011.”

America’s Health Insurance Plans issued a statement from President and CEO Matt Eyles: “This new HHS-OIG report…clearly demonstrates our effectiveness as a negotiator — and the rebates we secure for seniors in Part D lead to lower costs.”

The Pharmaceutical Care Management Association also praised the report for putting to rest “the false narrative about PBM-negotiated rebates” and confirming that rebates lead to lower prescription drug costs in Part D.

But one industry expert says he doesn’t think this will alter any possible government action on drug pricing and Part D.

“The OIG’s analysis is unfortunately a historical document — in that it only reports on changes in drug prices through 2015,” observes Avalere Health Founder Dan Mendelson. And while rebates are “an important market mechanism” for negotiating drug prices, rebates “alone won’t solve the consumer crisis of drug affordability,” he says.

Trends That Matter for RM/AT Products

September 12, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.

The Alliance for Regenerative Medicine published the report, titled Quarterly Global Regenerative Medicine Sector Report: Q2 2019, on Aug. 1. It shows there are 1,069 clinical trials using specific RM/AT technologies, which include gene therapy, gene-modified cell therapy, cell therapy and tissue engineering. Ninety-four of those products are in Phase III trials.