Trends That Matter

Trends That Matter for Parkinson’s Disease Medications

October 24, 2019

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

That may change in the long term as new gene therapies that currently are in development are approved and come online. But none of those potential new treatments are close to market right now, says Mesfin Tegenu, R.Ph., president of PerformRx.

“Many commonly used therapies for Parkinson’s disease — carbidopa-levodopa, MAO-Bs, dopamine agonists — have available generics, which on most plans would be considered formulary options, or one generic product within each class would be selected as formulary,” Tegenu tells AIS Health.

The FDA in August approved Kyowa Kirin, Inc.’s Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing motor fluctuations. In February, the FDA approved Osmotica Pharmaceutical US LLC’s Osmolex ER (amantadine) for the treatment of Parkinson’s disease. And in late December, the FDA approved Accorda Therapeutics’ Inbrija (levodopa inhalation powder) for intermittent treatment of off episodes in people with Parkinson’s disease taking carbidopa/levodopa.

Still, plans are stocking their formularies with less expensive generic medications. The graphics below show the current market access to Parkinson’s disease drugs for all payers under the pharmacy benefit and their utilization management restrictions.

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:

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.

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.

Trends That Matter for Hepatitis C Drugs

August 29, 2019

Beginning last month, Louisiana has been able to treat hundreds of patients who were waiting to receive a pricey cure for hepatitis C thanks to after hammering out an innovative payment model with a drug manufacturer, AIS Health reported.

Beginning last month, Louisiana has been able to treat hundreds of patients who were waiting to receive a pricey cure for hepatitis C thanks to after hammering out an innovative payment model with a drug manufacturer, AIS Health reported.

But the road to get there was long and difficult, according to Rebekah Gee, M.D., secretary of the Louisiana Dept. of Health, who, during a July 22 event hosted by the Brookings Institution, detailed the challenges she faced in trying to get a costly curative therapy to more people while facing down a $2 billion budget deficit. “We were told ‘No’ at least 50 times from a variety of people, whether it was the industry, or policymakers or individuals at the CDC…because it had never been done before,” she said.

Here’s how the “modified subscription model” works: The state pays a fixed amount to Asegua Therapeutics LLC, a subsidiary of Gilead Sciences, Inc., for the authorized generic of Epclusa (sofosbuvir/velpatasvir tablets), up to a set spending cap, and in return gets unlimited access to the therapy for Medicaid beneficiaries.

For states that want to successfully replicate what Louisiana has done, not only do they need a solid partnership with CMS, but they must understand that price is not the only barrier to expanding treatment, said Neeraj Sood, a professor at the University of Southern California, who helped develop the model.

The graphic below show the current market access to hepatitis C drugs across the Medicaid formularies.

Trends That Matter for Medicare Part D Costs

August 15, 2019

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

The study found that, assuming a 61% discount between brand-name and generic drugs, Part D beneficiaries with prescriptions costing between $22,000 and $80,000 per year would have lower out-of-pocket spending if they use brand-name drugs over a generic, AIS Health reported.

The graphics below show the annual out-of-pocket savings associated with generic drugs and the median-point-of-sale price differences of brand-name drugs and their generic counterparts.